Mauna Kea Technologies Sa Class O · EURONEXT:ALMKT
Mauna Kea Technologies Sa Class O — Investor Presentation (February 2025)
34 slides from Mauna Kea Technologies Sa Class O's investor presentation, February 2025
Slide 1: Corporate Presentation February 2025
Corporate Presentation February 2025 See cells. Change lives.
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: Mauna Kea has pioneered groundbreaking medical technologies
True to its namesake, Mauna Kea has pioneered groundbreaking medical technologies that transform how physicians explore and treat the human body. 3
Slide 4: Cellvizio addresses critical unmet medical needs
Cellvizio addresses critical unmet medical needs by providing unmatched clinical value and robust health economics that align incentives for all stakeholders. 4
Slide 5: 100,000 patients and counting
100,000 patients and counting HELPING PHYSICIANS SAVE LIVES, ONE PATIENT AT A TIME Discovering pre-cancerous mucosal changes in the esophagus or the stomach before they become cancer can save the patient’s life. Avoiding a near-miss in a peripheral lung nodule and thus diagnosing lung cancer at an e
Slide 6: Cellvizio
CELLVIZIO® THE WORLD'S SMALLEST MICROSCOPE, WITH A REVOLUTIONARY IMPACT: TRANSFORMING PATIENT LIVES EVERY DAY ULTRA-MINIATURIZED FIBER OPTIC MINIPROBES CELLVIZIO PLATFORM Proprietary cutting-edge opto-mechatronics and image processing software ‣ 238 patents ‣ 1,200 clinical papers REAL-TIME VISUALIZ
Slide 7: Markets
MARKETS TECHNOLOGY USED ACROSS A WIDE RANGE OF SPECIALTIES REPRESENTING A MULTI-BILLION DOLLAR ANNUAL OPPORTUNITY Gastroenterology Interventional oncology GI ENDOSCOPY (Barrett’s Esophagus, Interventional Stomach cancer, Pulmonology GI - IBS pancreatic cysts) (Food Intolerance) $1B Neurology/ $0.5B
Slide 8: Unit Economics / Business Model
UNIT ECONOMICS / BUSINESS MODEL HIGH GROSS MARGIN PROFILE Gross Margin CELLVIZIO PORTFOLIO OF FIBER PLATFORM OPTIC MINIPROBES SYSTEM 90% Reusable CAPITAL PROBES 85% SALE SERVICES HOSPITAL 95% PAY-PER-USE1 10 models of miniprobes designed for every ASC 75% application 1. Gross margin on probes 8
Slide 9: Key Focus Application: Pancreatic Cysts Diagnosis
KEY FOCUS APPLICATION: PANCREATIC CYSTS DIAGNOSIS PROVEN SOLUTION TO AVOID UNNECESSARY SURGERY CELLVIZIO ENABLES NEAR-PERFECT ACCURACY OF CHARACTERIZATION OF SOLITARY CYSTS 3-10% of adults have pancreatic cysts For benign 30% of cysts are indeterminate after endoscopic 97% Accuracy vs malignant clas
Slide 10: Pancreatic Cysts: CLIMB Study
PANCREATIC CYSTS: CLIMB STUDY MAJOR PIVOTAL STUDY TO VALIDATE CELLVIZIO’S SUPERIORITY AND BUILD STRONG MOMENTUM Univ. Mich. BIDMC, Boston, Ann Arbor, MI MA Parkview Fort Wayne, IN Yale, New Haven, CT ‣ Investigator Initiated Study (Ohio State University) UC Davis Mt Sinai, (Davis, CA) New York, NY ‣
Slide 11: Pancreatic Cyst Characterization
PANCREATIC CYST CHARACTERIZATION 10 YEARS OF FAST-PACED DEVELOPMENT WITH MAJOR MILESTONES TO BE ACHIEVED IN THE COMING WEEKS AND MONTHS 2024-25 2020-22 2018 Completion of CLIMB study, a major clinical 2014 AI + Cellvizio for pancreatic milestone cyst publication from Ohio Prospective CONTACT 2 study
Slide 12: Pancreatic Cysts: A Large and Growing Market Opportunity
PANCREATIC CYSTS: A LARGE AND GROWING MARKET OPPORTUNITY A MIX BETWEEN CAPITAL EQUIPMENT AND RECURRING REVENUE Hospitals in the US 1,000 performing EUSFNA €400-500m Capital equipment Procedures /year that would 75,000 benefit from Cellvizio nCLE $200,000 per system €200-300m Annual Recurring revenue
Slide 13: Key Focus Application: Esophageal and Gastric Cancers
KEY FOCUS APPLICATION: ESOPHAGEAL AND GASTRIC CANCERS ACCURATE DIAGNOSIS OF BARRETT’S ESOPHAGUS TO PREVENT THE DEVELOPMENT OF CANCER of American adults have 18-27% GERD potentially leading Chronic Acid Reflux (GERD) THE ADJUNCT USE OF CELLVIZIO DURING to esophageal cancer1 ENDOSCOPY SIGNIFICANTLY IN
Slide 14: Esophageal Cancer
ESOPHAGEAL CANCER A META ANALYSIS1 DEMONSTRATING THE HIGH DETECTION ACCURACY RATE OF BARRETT’S ESOPHAGUS WHEN CELLVIZIO IS USED DURING ENDOSCOPY 9 studies for a total of 688 patients and 1,299 lesions assessed the benefits of Cellvizio as an adjunct to random 4-quadrant biopsies in the surveillance
Slide 15: Strong Economic Benefits
STRONG ECONOMIC BENEFITS INCREASING REVENUE, OPTIMIZING HEALTHCARE RESOURCE UTILIZATION AND ENHANCING PATIENT SATISFACTION ‣ Proven solution with enhanced diagnostic accuracy and reimbursement with Category 1 CPT code 43252 ‣ Used during an Upper GI Endoscopy ‣ Adds only a few minutes to the procedu
Slide 16: U.S. CMS Coverage
U.S. CMS COVERAGE SIGNIFICANT FINANCIAL INCENTIVE TO USE CELLVIZIO IN BARRETT’S AND PANCREATIC CYSTS Specific CPT code 43252 to Cellvizio can be added to other CPT codes in upper GI endoscopy and EUSFNA (pancreatic cyst characterization) ASC Hospital 2023 rule BARRETT’S - EGD without Cellvizio $470
Slide 17: Food Intolerance Detection for Patients with IBS
FOOD INTOLERANCE DETECTION FOR PATIENTS WITH IBS A BREAKTHROUGH SOLUTION ENABLING BOTH DETECTION AND TREATMENT CELLVIZIO IS THE ONLY TECHNOLOGY ENABLING FUNCTIONAL VISUALIZATION OF THE GUT BARRIER AN UNMET NEED WITHIN A $100B THERAPEUTIC MARKET, AND FOOD INTOLERANCE DETECTION AS MILLIONS OF PATIENTS
Slide 18: Endoluminal Robotics for Pulmonology
ENDOLUMINAL ROBOTICS FOR PULMONOLOGY GIVING SIGHT TO BLIND NEEDLES TO IMPROVE DIAGNOSTIC YIELD FOR LUNG CANCER CELLVIZIO ALLOWS SAFE AND ACCURATE DETECTION of lung nodules located OF DIFFICULT-TO-ACCESS LUNG NODULES 80% outside the airways with no direct visualization 90% Accuracy in detecting malig
Slide 19: Robotic Surgery
ROBOTIC SURGERY CELLVIZIO ENABLES PRECISE MARGIN DELINEATION DURING MINIMALLY INVASIVE ROBOTICS-ASSISTED SURGERIES TRANSORAL ROBOTICS SURGERY (TORS) LIMITATIONS OF CURRENT STANDARD OF CARE Preservation of larynx / pharynx ‣ General consensus on advanced visualization being central function with R0 r
Slide 20: 2024 Financial Results
2024 FINANCIAL RESULTS CONTINUED REDUCTION IN LOSSES DESPITE LOWER SALES DUE TO SPECIFIC 2024 HEADWINDS Initial Sales (in €K) 10 2024 plan ‣ Strong 2024 sales plan with a €2.5m increase in sales ‣ Undermined by €2m loss due to Tasly JV’s failure to fullfill 7 7 7 its contractual obligations 6 ‣ Nega
Slide 21: 2025 - 2026 Plan
2025 - 2026 PLAN MAUNA KEA IS AT A STRATEGIC INFLECTION POINT 1 GI Endoscopy 2 CellTolerance 3 AI Platform 4 Pulmonology Barrett’s Esophagus A large and untapped market AI Lab infrastructure Excellent clinical results and ‣ IBS prevalence: 10-15% of progress on CLEVER study ‣ Sustained PPU volume de
Slide 22: 2025 - 2026 Plan: Upcoming Momentum
2025 - 2026 PLAN LEVERAGING THE STRONG UPCOMING MOMENTUM OF MATURE GI INDICATIONS Inclusion in EU CLIMB French PANCREATIC guidelines results reimbursement ‣ New capital sales CYSTS Q2 2025 Q2 2025 Q3 2025 CMS 2026 Reimbursement Opening of ‣ Higher PPU price BARRETT’S Rule back to Level 3 new ASCs ‣
Slide 23: Building a Strong and Efficient Commercial Team
2025 - 2026 PLAN BUILDING A STRONG AND EFFICIENT COMMERCIAL TEAM ‣ Through our 10+ years of commercial experience, we have developed a strong understanding of the requirements, competencies, and needs of an optimal and efficient commercial and marketing team. ‣ Unfortunately, in recent years, we hav
Slide 24: EU & RoW: Commercial Expansion Driven by CellTolerance
EU & ROW COMMERCIAL EXPANSION DRIVEN BY CELLTOLERANCE ‣ EU & RoW commercial expansion driven mainly by CellTolerance’s PPU business ‣ Some specific capital sales for pancreatic cysts through distributors ‣ New GTM solution to be engineered in China CELLTOLERANCE COMMERCIAL EXPANSION 1st Phase From F
Slide 25: EU & RoW: Total Sales to Exceed €10M by 2028
EU & ROW TOTAL SALES TO EXCEED €10M BY 2028 Total EU & RoW sales (in €K) 11 000 ~€10m+ sales 2024 ‣ Majority of sales in the legacy GI business ‣ Limited sales in food intolerance with already 8 250 15 existing centers in Germany 42 2025-2028 5 500 ‣ Capital sales growth in pancreatic cysts mainly v
Slide 26: U.S. Commercial Expansion Focused on Legacy GI
U.S. COMMERCIAL EXPANSION FOCUSED ON LEGACY GI ‣ Targeting of 1,000 ASCs and Community Hospitals with high volume interventional endoscopy activity for pancreatic cysts ‣ Partnering with with commercial platform to accelerate market penetration LEGACY GI COMMERCIAL EXPANSION Density of ASCs by U.S.
Slide 27: U.S. Total Sales to Exceed €40M by 2028
U.S. TOTAL SALES TO EXCEED €40M BY 2028 Total U.S. sales (in $K) 50 000 2024 ‣ All sales in the legacy GI business ~$40m+ sales ‣ 40% of sales in PPU with 4,000 annual 37 500 procedures 42 2025-2028 25 000 ‣ New momentum in capital sales for pancreatic cysts ‣ Acceleration of PPU sales with increasi
Slide 28: A Strategic Process with Active Discussions Underway
A STRATEGIC PROCESS WITH ACTIVE DISCUSSIONS UNDERWAY TARGETING FINALIZATION OF ONE OR MORE OPTIONS BY MID-2025 # of institutional targets 20% 40% ‣ Process started end-2024 ‣ Strong traction since mid-January post JPM Conference 40% ‣ All options including M&A, PE-backed take private, licensing ‣ Mo
Slide 29: Strategic Product Development Roadmap
STRATEGIC PRODUCT DEVELOPMENT ROADMAP ALIGNED TO VALUE CREATION MANDATE CELLVIZIO IMAGING DATASETS ARTIFICIAL INTELLIGENCE ROBOTIC MOLECULAR ASSISTED IMAGING CANCER IMAGING ‣ In situ / In vivo endomicroscopic imaging data for multimodal datasets ‣ Advanced prototype ‣ Development of developed for va
Slide 30: Leadership Team
LEADERSHIP TEAM SEASONED, CONNECTED AND BATTLE-TESTED Sacha Loiseau, Ph.D. Chairman and CEO, Founder Nathalie Lecoq Côme de La Tour du Pin Chief Operating Officer Chief Financial Officer Christopher McFadden Molly O'Neill Director Director Managing Director, Apollo Global Chief Strategic Partnership
Slide 31: Shareholding
SHAREHOLDING TWO MAJOR STRATEGIC SHAREHOLDERS WITH STRONG INTEREST IN THE TECHNOLOGY ‣ Interventional ‣ Urologic oncologic 18% pulmonology / robotics surgery endoluminal robotics 17% 8% Management + ESOP/Free Shares 8% Other Institutional 49% investors Individual investors 3 MAJOR EQUITY INVESTMENTS
Slide 32: Balance Sheet
BALANCE SHEET A €21.7M EIB LOAN RESTRUCTURED IN 20241 EIB loan maturities1 (in €K) ‣ Total of €17.5m split into 2 tranches with maturities of July 15000000 15,000 14000000 2024 and July 2025 12000000 ‣ Interests of 5% (Tranche A, PIK) and 7% (Tranche B, PIK and 10000000 cash) 10,000 8000000 ‣ Restru
Slide 33: Why Mauna Kea?
WHY MAUNA KEA? A UNIQUE AND UNPARALLELED TECHNOLOGY POISED FOR STRONG SHORT TERM MOMENTUM AND GROWTH ‣ Cellvizio® proven proprietary cutting-edge opto-mechatronics and image DIFFERENTIATED processing software TECHNOLOGY ‣ Leading the global adoption of real-time cellular imaging UNIQUE IP ‣ 200+ iss
Slide 34: Outlook and Value Creation
V OUTLOOK AND VALUE CREATION 34
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