Mauna Kea Technologies Sa Class O · EURONEXT:ALMKT
Mauna Kea Technologies Sa Class O — Investor Presentation (November 2022)
39 slides from Mauna Kea Technologies Sa Class O's investor presentation, November 2022
Slide 1: Corporate Presentation – November 2022
Corporate Presentation – November 2022
Slide 2: Disclaimer
Disclaimer • This document has been prepared by Mauna Kea Technologies (the "Company") and is provided for information purposes only. • The information and opinions contained in this document speak only as of the date of this document and may be updated, supplemented, revised, verified or amended, a
Slide 3: See Cells. Change Lives.
See Cells. Change Lives. By creating the first platform to image the human body at the cellular level, we’ve changed the way physicians see and treat their patients. Mission With Cellvizio®, our advanced cellular imaging platform, we provide partners and providers with cutting edge technologies to t
Slide 4: Who we are
Creator of Cellvizio®, a proprietary imaging platform that produces real-time, in vivo images used to identify and target abnormal cells An intellectual property complex including 250+ issued patents, 20 FDA Who we are 510(k) clearances and CE mark, Category I CPT® codes in the US Tens of thousands
Slide 5: Our Seasoned Team has Decades of Combined Industry Experience
Our Seasoned Team has Decades of Combined Industry Experience Sacha Loiseau, Ph.D. Chairman and CEO Founder Yves Gosset François Lacombe, Ph.D. Acting Chief Financial Officer Chief Scientific Officer Bruno Villaret Frédéric Banégas, Ph.D., MBA Vice President, International Sales Chief Technology Off
Slide 6: Cellvizio: a Proprietary In Vivo Cellular Imaging Platform
Cellvizio : a Proprietary In Vivo Cellular Imaging Platform ® The only real-time probe-based in vivo functional and dynamic cellular imaging platform The Cellvizio System Portfolio of Miniprobes Confocal Miniprobes™ Capital equipment Consumables © 2022 Mauna Kea Technologies 6
Slide 7: Cellvizio Provides Real-Time In Situ Functional Cellular Imaging
Cellvizio Provides Real-Time In Situ Functional Cellular Imaging From H&E histology… one image - static view …to Cellvizio® Hundreds of live microscopic images per minute: a unique dynamic functional view of biological tissues BRAIN COLON ESOPHAGUS “Patients are better served if biopsies can be bett
Slide 8: Investment Thesis
Investment Thesis 2021 In 2021, building on a decade of invaluable experience and investments, the Company made a strategic decision to pivot from direct marketing to strategic partnerships with leading medtech/pharma firms. Announced plans to develop a partnership-focused commercial strategy and cl
Slide 9: Our Business Strategy
Our Business Strategy We target commercial-scale biopharma / CURRENT TARGET medtech companies selling oncology-focused MARKETS solutions where Cellvizio’s advanced imaging technology can differentiate clinical effectiveness and patient outcomes More capital efficient business model Robust and stable
Slide 10: We Are Addressing Large Market Opportunities
We Are Addressing Large Market Opportunities SIZE OF MARKET High Urology (Endourology / Surgery) GI / IBD / IBS $2.2B + / yr $1B/yr $400M+ $1B $300M + M Capital Sales Capital Sales GI / Barrett’s Esophagus $0.5B/yr and Stomach cancer $0.5B/yr +$100M /yr $400M + $200M + Low Capital Sales $300M + Capi
Slide 11: We Have a Replicable Partnership Development Process in Place
We Have a Replicable Partnership Development Process in Place STAGE 1 Application Where Cellvizio provides a clear differentiated Clear focus on market-pull indications solution to major clinical conundrums. Market Large addressable markets in key 2 Evaluate market size and hurdles to adoption in ge
Slide 12: We Have Built a Solid Pipeline for Cellvizio Partnerships
We Have Built a Solid Pipeline for Cellvizio Partnerships CLINICAL GRANTED REG. COMMERCIAL APPLICATION ECOSYSTEM STAGE IN MARKET DEVELOPMENT APPROVAL PARTNERSHIPS NEUROLOGIC CANCER #surgery 4 US #navigation LUNG CANCER #endoluminal robotics 3 GLOBAL GLOBAL OPEN #molecular imaging IBD / IBS #endoscop
Slide 13: Our Cellvizio Development Roadmap is Fully Aligned with Our Partners' Key Needs
Our Cellvizio Development Roadmap is Fully Aligned with Our Partners' Key Needs MOLECULAR CANCER IMAGING ROBOTIC ASSISTED IMAGING ARTIFICIAL INTELLIGENCE BUILD CELLVIZIO IMAGING DATASETS • Integrated navigation • Advanced prototype • In vivo endoscopic and data capture developed for various • Cellvi
Slide 14: We Are Already Validating Our New Business Strategy
We Are Already Validating Our New Business Strategy JV and Licensing agreement with Tasly Pharmaceutical $10 million upfront cash contribution to Mauna Kea JV now incorporated in Zhejiang province with $35m registered capital Mauna Kea to own 44% of JV in exchange of certain IP rights and licenses E
Slide 15: 1. Expanding the Chinese Market
1. Expanding the Chinese Market Installed base in China Building on solid installed base of 46 Liaoning - 2 Beijing & Tianjin - 7 systems in Eastern China and strong Shandong - 2 KOL support Inner Mongolia - 1 Hubei - 2 Expansion to entire territory with Tasly Shanxi - 1 Sichuan & Chongqing - 3 Acce
Slide 16: 2. Launching a Dedicated Cellvizio Platform for Neurosurgery
2. Launching a Dedicated Cellvizio Platform for Neurosurgery A key application 10 years in the making Zeiss launches the Publication by Pr. Guyotat et al on Convivo Confocal Neuro-endomicroscope 2023 stereotactic neurologic applications of Cellvizio 2022 2020 2021 Tasly Mauna Kea Medical Engineering
Slide 17: Illustrative Cellvizio cases
Illustrative Cellvizio cases Cellvizio for lung cancer © 2022 Mauna Kea Technologies 17
Slide 18: Lung Cancer Diagnosis: Fighting the Numbers
Lung Cancer Diagnosis: Fighting the Numbers 1 million lung biopsies performed annually worldwide But Only 6% of lung cancer cases diagnosed at an early stage Lung cancer responsible for more deaths than colon, breast, and prostate cancers combined. 1. American Lung Association, State of Lung Cancer
Slide 19: Navigation and Robotics Suffer from Low Diagnostic Yield
Navigation and Robotics Suffer from Low Diagnostic Yield 1. 3. 80% of lung nodules located outside the airways with no direct visualization Near-miss of target nodule caused by blindly used 2. Lack of direct visualization and CT- biopsy needles to-body divergence strongly limit Advanced Navigation a
Slide 20: The Cellvizio Solution: Giving Sight to Blind Needles
The Cellvizio Solution: Giving Sight to Blind Needles Cellvizio captures in situ images in real-time, and can provide in vivo guidance for targeted biopsy during manual and robotics-assisted bronchoscopies with the following benefits: Needle positioning for tool-in-lesion Assurance of lesion-in-tool
Slide 21: Building on 8 Years of Product and Clinical Development in Interventional Pulmonology
We are Building on 8 years of Product and Clinical Development in Interventional Pulmonology Start of Enrollment in CLEAR peripheral lung cancer multi- Strategic Equity Investment center clinical trial of €6M by Johnson & Johnson Innovation Strategic Equity Investment of €7.5M by 2023 2022 First cli
Slide 22: Cellvizio for Pancreatic Cysts
Illustrative Cellvizio cases Cellvizio for Pancreatic Cysts © 2022 Mauna Kea Technologies 22
Slide 23: Cellvizio nCLE is a Paradigm Shift for Pancreatic Cyst Characterization
Cellvizio Needle-based Endomicroscopy (nCLE) is a Paradigm Shift for Pancreatic Cyst Characterization 3-10% prevalence of Pancreatic Cysts, often detected incidentally during radiology Low diagnostic yield of Radiology Cellvizio miniprobe inspecting the cyst wall through a needle during EUS-FNA proc
Slide 24: The CLIMB Pivotal Study for Cellvizio in Pancreatic Cysts
The CLIMB Pivotal Study for Cellvizio in Pancreatic Cysts CLIMB STUDY CENTERS Swedish Univ. Mich. Seatle, WA Univ. of Illinois Ann Arbor, MI Chicago, IL Parkview Fort Wayne, IN Investigator Initiated Study (Ohio State University) Yale, New with a grant from NIH and Mauna Kea : 10 Haven, CT centers,
Slide 25: 10 Years of Clinical and Product Development in Pancreatic Cysts
10 Years of Clinical and Product Development in Pancreatic Cysts Imaging and Characterization 2023-24 2020-22 Completion of 2018 CLIMB study, a major clinical milestone 2014 Prospective CONTACT 2 study by AI + Cellvizio for panc cyst publication from Ohio State Dr Bertrand Napoleon on University 201
Slide 26: Cellvizio for Inflammatory Bowel Disease (IBD)
Illustrative Cellvizio cases Cellvizio for Inflammatory Bowel Disease (IBD) © 2022 Mauna Kea Technologies 26
Slide 27: Inflammatory Bowel Disease: Introducing a New Key Therapeutic Endpoint with Cellvizio
Inflammatory Bowel Disease: Introducing a New Key Therapeutic Endpoint with Cellvizio 6-8 million 187,000 patients suffering from Hospitalizations in the US per IBD in the US and EU year for Crohn’s disease Patients with Ulcerative Colitis or Crohn’s Disease in remission undergo $21B Drug prescripti
Slide 28: Intestinal Barrier Healing, Visualized with Cellvizio, is a Far Superior Predictor
Intestinal Barrier Healing, Visualized Functionally with Cellvizio, is a Far Superior Predictor Long term study published in Gastroenterology demonstrates that Intestinal Barrier Healing by far outcompetes all other predictors of relapse / remission Cellvizio is the only available imaging platform t
Slide 29: Building on a Decade of Clinical Development in IBD
Building on a Decade of Clinical Development in IBD with Leading Teams Around the World 2023 2022 2017 Launch of business development initiatives 2012 around IBD More than 2,000 Intestinal Barrier patients enrolled Healing emerges as key In 41 published therapeutic endpoint clinical studies PUBLICAT
Slide 30: Financial Metrics
Financial Metrics © 2022 Mauna Kea Technologies 30
Slide 31: First 9 Months 2022 Sales and Revenue
First 9 Months 2022 Sales and Revenue Global Sales and Total Revenue €9,000 €839 Sales for the first nine months of 2022 decreased by €1,416 €1,303 €275K, or -5% year-on-year, to €4,812K. €6,750 €1,113 9 months Systems sales at €1,628K, -17%. €318 €3,204 Sales of consumables at €2,167K, -5%. €4,500
Slide 32: 9m 2022 Sales by Geography Show Solid US Progress
9m 2022 Sales by Geography Show Solid US Progress €6,000 Solid 23% growth in the US -5% Impact of COVID-19 and Tasly deal in China €5,087 €4,812 €4,500 Overall, relative stability of sales revenue according to plan US: +23% €3,000 €3,048 9m 2022 sales geographical split €2,478 EMEA & ROW €1,500 €1,5
Slide 33: Cellvizio U.S. Revenue per Headcount is Showing Significant Growth
Cellvizio U.S. Revenue per Headcount is Showing Significant Growth €5,000 U.S. consumable (probe) and PPU revenue €4,182 demonstrate adoption of Cellvizio in the €4,000 targeted market segment €3,586 9 months €3,432 Launch of next-generation Cellvizio has €3,048 rekindled capital sales initiatives €
Slide 34: H1 2022 Income Statement
H1 2022 Income Statement In €k - IFRS Standards 30/06/2022 30/06/2021 Variation % • Increase in the gross margin of €0.1m or Sales 3 391 3 314 77 2% 2% Gross Profit 2 480 2 343 137 6% % Gross Margin 73% 71% Other Income 318 548 (230) -42% • EBITDA improved by €1.3m following the company's reorganiza
Slide 35: Simplified Balance Sheet
Simplified Balance Sheet • Trade receivables decreased in line with sales volume. • Other current asssets including R&D tax credit €0,3m • Non-current provisions decreased with payments linked to restructuring. • Long-term debt remained stable, mainly including - EIB loan: €19m and Guaranteed loan b
Slide 36: Cash Flow Statement
Cash Flow Statement • R&D tax credit and equity line were activated during the second half of the year • Capex decreased as the commercialization of next-generation platform started in Q3 2021 and lower capitalization of R&D expenses in 2022 • Cash at the end of June 2022 was 5.3M€ • Cash position i
Slide 37: Stock and Shareholding Information
Stock and Shareholding Information Stock Market Data Analyst Coverage Shareholders Structure • Listed on Euronext Paris GILBERT DUPONT regulated market, Guillaume Cuvillier Founders & Other Institutionals Management ESOP Compartment C ODDO BHF • Initial listing: 9% 11% Damien Chaplain July 6, 2011 •
Slide 38: Our Growth Strategy Benefits from 15 Years of Global Multidisciplinary Clinical Community Building
Our Growth Strategy Benefits from 15 years of Global Multidisciplinary Clinical Community Building. © 2022 Mauna Kea Technologies 38
Slide 39: Investment Summary
✓ 2021 new strategy validated with recent Tasly Pharmaceutical partnership ✓ Multi-billion market opportunities addressed by proprietary Cellvizio Investment platform ✓ Strong pipeline of strategic partners to address large additional Summary markets based on portfolio of regulatory / clinical / pro
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