Mauna Kea Technologies Sa Class O · EURONEXT:ALMKT
Mauna Kea Technologies Sa Class O — Investor Presentation (September 2025)
47 slides from Mauna Kea Technologies Sa Class O's investor presentation, September 2025
Slide 1: Corporate Presentation September 2025
Corporate Presentation September 2025 See cells. Change lives. 1
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: Your Presenters Today
YOUR PRESENTERS TODAY Sacha Loiseau, Ph.D. Côme de La Tour du Pin Chairman and CEO, Founder Chief Financial Officer A SEASONED MEDTECH ENTREPRENEUR AND INVESTOR A KEY BUSINESS PARTNER WITH A SOLID EXPERIENCE IN FINANCE AND IR Founder and CEO of Mauna Kea from 2000 to 2018, then Non- Exec Chairman un
Slide 4: Company Snapshot / Executive Summary
COMPANY SNAPSHOT / EXECUTIVE SUMMARY 4
Slide 5: Mauna Kea Technologies, Inventors of Cellvizio
MAUNA KEA TECHNOLOGIES, INVENTORS OF CELLVIZIO A REMARKABLE ENTREPRENEURIAL 800+ STORY – Like so many disruptive > 100 k 1,200+ systems technologies, Cellvizio was way ahead procedures clinical papers installed of its time. NOW IS THE TIME – 20+ Cellvizio is recognized as a must-have 238 Cat I CPT F
Slide 6: The Power of Cellvizio Vision
Seeing is knowing The Power of Cellvizio Vision ® Cellvizio provides physicians with the super- power to visualize tissues at the cellular level, in real time, during their procedures. Cellvizio addresses critical unmet medical needs by providing unmatched clinical value and robust health economics
Slide 7: Cellvizio: The World's Smallest In Vivo Microscope
CELLVIZIO®: THE WORLD’S SMALLEST IN VIVO MICROSCOPE DELIVERING REAL-TIME CELLULAR IMAGING REAL-TIME INSIGHT INTO CELLULAR STRUCTURE FOR IMMEDIATE DECISIONS Hundreds of real-time cellular images per minute enable TARGETED DIAGNOSTIC AND TREATMENT MINIPROBES Ultra miniaturized fiber optic miniprobes C
Slide 8: Commercial & Partnered Pipeline Addressing an $8B Annual TAM
COMMERCIAL & PARTNERED PIPELINE ADDRESSING AN $8B ANNUAL TAM COMMERCIAL DEVELOPMENT GASTROENTEROLOGY INTERVENTIONAL ONCOLOGY $1B $6B $0.3B GI ENDOSCOPY (Barrett’s Esophagus, Neurology/ $0.5B neurosurgery Stomach cancer, Interventional pancreatic cysts) Pulmonology GI - IBS (Food Intolerance) $0.5B H
Slide 9: High-Margin Business Model Across Multiple Revenue Streams
HIGH-MARGIN BUSINESS MODEL ACROSS MULTIPLE REVENUE STREAMS PAY-PER- CAPITAL PROBE USE / SALES SALES RENTAL ‣ One-time revenue stream ‣ 10 models of miniprobes for ‣ Pay-per-Use (PPU): free with high upfront value broad clinical versatility placement, usage-based revenue ‣ Financial leasing offered v
Slide 10: Seasoned, Connected and Battle-Tested Leadership Team
SEASONED, CONNECTED AND BATTLE-TESTED LEADERSHIP TEAM Executive Team Sacha Loiseau, Ph.D. Chairman and CEO, Founder Board of Directors Nathalie Lecoq Côme de La Tour du Pin Chief Operating Officer Chief Financial Officer Christopher McFadden Molly O'Neill Director Director Managing Director, Apollo
Slide 11: Two Key Shareholders in Our Capital Structure
TWO KEY SHAREHOLDERS IN OUR CAPITAL STRUCTURE 15% 14% 8% Management + ESOP/Free Shares 8% Other Institutional investors 55% Individual investors 3 MAJOR EQUITY ‣ Telix Pharmaceuticals invested €6M in 2023 INVESTMENTS ‣ Johnson & Johnson invested twice in 2019 SINCE 2019 and 2021 for a total of €15M
Slide 12: An Opportunity to Fund a De-Risked Turnaround at an Attractive Valuation
AN OPPORTUNITY TO FUND A DE-RISKED TURNAROUND AT AN ATTRACTIVE VALUATION FINANCIAL CATALYST: 70% DEBT REDUCTION BUSINESS MOMENTUM: KEY GROWTH DRIVERS Enterprise value (in €M) 60 ‣ High-Growth U.S. Engine: Driving toward 12 profitability, fueled by record sales productivity 40 40 exceeding $900k/rep
Slide 13: Key Commercial Indications
KEY COMMERCIAL INDICATIONS 13
Slide 14: Pancreatic Cysts
PANCREATIC CYSTS HIGH DIAGNOSTIC UNCERTAINTY LEADING TO UNNECESSARY SURGERY AND COSTS 3-10% OF ADULTS HAVE PANCREATIC CYSTS CURRENT DIAGNOSTIC CLINICAL IMPACT LIMITATIONS ‣ ~50% of patients with benign ‣ No cellular-level biopsy possible cysts undergo unnecessary ‣ 30% of cysts remain surgery indete
Slide 15: Pancreatic Cysts: Real Time, Near-Perfect Characterization
PANCREATIC CYSTS CELLVIZIO ENABLES REAL TIME, NEAR-PERFECT CHARACTERIZATION OF PANCREATIC CYSTS AQ-Flex probe introduced through Detailed live microscopic imaging of the the EUS-guided FNA needle pancreatic cyst wall and internal features ‣ 95% accuracy in benign vs malignant classification Serous C
Slide 16: Cellvizio Outperforms All Other Modalities for Cyst Characterization
PANCREATIC CYSTS CELLVIZIO OUTPERFORMS ALL OTHER MODALITIES FOR CYST CHARACTERIZATION Cellvizio (nCLE) NGS CEA + Cytology + Glucose Direct microscopic imaging Genetic mutation profiling Modality Analysis of cyst fluid of cyst wall of cyst fluid Sensitivity ✅ High – 98% ❌ Low – 76% ❌ Low – 77% Specif
Slide 17: CLIMB Study: The Landmark Multi-Center Pivotal Trial
PANCREATIC CYSTS CLIMB STUDY: THE LANDMARK MULTI-CENTER PIVOTAL TRIAL THAT CHANGED EVERYTHING ‣ Prospective, multi-center study comparing Cellvizio to all standard Univ. Mich. Ann Arbor, MI BIDMC, Boston, techniques MA Parkview Fort Wayne, IN Yale, New ‣ 14 leading sites activated, including Haven,
Slide 18: Irritable Bowel Syndrome: A Massive, Underserved Market in GI
IRRITABLE BOWEL SYNDROME A MASSIVE, UNDERSERVED MARKET IN GI TOTAL MARKET #1 DIAGNOSIS IN GI - YET POORLY MANAGED 10-15% Worldwide population $94B Global IBS HIGH UNMET NEED CURRENT TOOLS FALL SHORT therapeutics (2023) ‣ 64% patients suffer >10 years ‣ < 50% patients receive clear diagnosis ‣ 34% of
Slide 19: CellTolerance: A Breakthrough Program with Physician Buy-In
IRRITABLE BOWEL SYNDROME CELLTOLERANCE: A BREAKTHROUGH PROGRAM WITH PHYSICIAN BUY-IN AND LOW BARRIERS TO ADOPTION ‣ 10-15% worldwide population have been told they have IBS ‣ 50% of all consultations in gastroenterology ‣ #1 diagnosis in GI, #7 in medicine LEADING PHYSICIANS HAVE SHOWN THAT 50% OF I
Slide 20: Cellvizio: The Only Tool That Visualizes Functional Gut Reactions
IRRITABLE BOWEL SYNDROME CELLVIZIO: THE ONLY TOOL THAT VISUALIZES FUNCTIONAL GUT REACTIONS IN REAL TIME STEP 1 : Food prepared and STEP 2 : Gut barrier STEP 3: Real-time gut barrier sprayed applied directly onto visualization reaction the duodenum mucosa Normal barrier Broken barrier Negative Positi
Slide 21: CellTolerance Outperforms All Other Diagnostic Methods
IRRITABLE BOWEL SYNDROME CELLTOLERANCE OUTPERFORMS ALL OTHER DIAGNOSTICS METHODS CellTolerance IgG Blood Test Skin Test Low FODMAP diet Real-time microscopic Measures IgG Extremely stringent Detects IgE-mediated Assessment Type imaging of the gut antibodies to various diet very hard to allergic skin
Slide 22: Excellent Clinical Results
IRRITABLE BOWEL SYNDROME EXCELLENT CLINICAL RESULTS NO ALTERNATIVES The only tool that visualizes real-time gut function ‣ 60% of patients have at least one NO INTERPRETATION positive reaction during the Instant visual confirmation - clear, binary results Cellvizio / CellTolerance Procedure THERAPEU
Slide 23: Global Network Expansion Driven by Key Opinion Leaders
IRRITABLE BOWEL SYNDROME GLOBAL NETWORK EXPANSION DRIVEN BY STRONG SUPPORT FROM KEY OPINION LEADERS Clinique de Clinique du Children’s Bercy Praxisklinik für Clinique des Trocadero Hospital & Gastroenterologie Champs Elysées Frankfurt Medical Center Asklepios Klinikum Schwalmstadt Stanford Universit
Slide 24: Esophageal Cancer: A Deadly Disease Driven by Missed Diagnosis of Barrett's
ESOPHAGEAL CANCER: A DEADLY DISEASE DRIVEN BY MISSED DIAGNOSIS OF BARRETT’S, A CURABLE PRECURSOR BARRETT’S ESOPHAGUS 50M U.S. PATIENTS AT RISK A MAJOR CANCER DUE TO MISSED DIAGNOSIS ‣ 18-27% of U.S. adults have GERD, a key risk factor Chronic Acid Reflux (GERD) ‣ 91% of esophageal cancer cases had n
Slide 25: Cellvizio Transforms Barrett's Detection
BARRETT’S ESOPHAGUS CELLVIZIO TRANSFORMS BARRETT’S DETECTION - HIGHER ACCURACY, EARLIER INTERVENTION 9 INDEPENDENT STUDIES ‣ Cellvizio evaluated as adjunct to standard biopsy during 688 PATIENTS Upper GI endoscopy 1,299 LESIONS ‣ Proven superior detection of dysplasia and early cancer 98% 96% 93% Ne
Slide 26: Cellvizio Outperforms All Other Diagnostic Tools in Barrett's
BARRETT’S ESOPHAGUS CELLVIZIO OUTPERFORMS ALL OTHER DIAGNOSTIC TOOLS IN ACCURACY AND HEALTH SYSTEM EFFICIENCY HD-WLE + Seattle NBI Cellvizio (pCLE) WATS-3D Protocol Biopsy Narrow Band Imaging In vivo real-time cellular Randomized 4-quadrant Enhanced surface Brushed sample + 3D Assessment Type imagin
Slide 27: CMS Coverage: Strong Financial Incentive to Use Cellvizio
CMS COVERAGE: STRONG FINANCIAL INCENTIVE TO USE CELLVIZIO BARRETT’S ESOPHAGUS IN BARRETT’S, EVEN WITH 2024 REIMBURSEMENT REDUCTION CPT code 43252 for Cellvizio can be billed in addition to other CPT codes for upper GI endoscopy (EGD) and EUS-FNA (pancreatic cyst characterization) CMS COVERAGE ASC Ho
Slide 28: Financials
FINANCIALS 28
Slide 29: Financial Turnaround Hampered by the Debt Legacy
FINANCIAL TURNAROUND HAMPERED BY THE DEBT LEGACY 2019 - 2021 2022 - 2024 - New Team EBITDA excluding non-cash elements (in €K) ‣ Period of significant cash 0 ‣ Substantial loss reduction (3 (3 consumption EBITDA losses narrowed by -2000 (6 -4000 two-thirds since 2022 -6000 (10 (9 ‣ Low commercial sa
Slide 30: Profitability Objective by 2027
PROFITABILITY OBJECTIVE BY 2027 23 18 Initial 2024 1 plan 14 A REASONABLE SALES RAMP 2 Licence Sales UP BUILT ON CURRENT 11 4 COMMERCIAL MOMENTUM 7 2 2 8 7 6 6 5 5 2020 2021 2022 2023 2024 2025E 2026E 2027E 2028E 2029E 2030E 6000 4000 EBITDA (excluding IFRS 2, in €k) 2000 0 410 597 2 4 -2000 (3 (3 (
Slide 31: Focus on U.S. Commercial Plan in 2025-2030
FOCUS ON U.S. COMMERCIAL PLAN IN 2025-2030 Sales in $k 20 000 25 000 19 559 PILLARS OF GROWTH ‣ Installed base of 200+ systems 15 595 15 000 18 750 ‣ 1,000+ target centers (out of 10,000 hospitals) 12 436 ‣ Attractive reimbursement (CPT 43252): x2–2.6x higher with Cellvizio compared to the standard
Slide 32: Commercial Plan in Europe/RoW in 2025-2030
COMMERCIAL PLAN IN EUROPE/ ROW IN 2025-2030 Sales in $k 20 000 ACCELERATION OF SALES FROM 2027 WITH OUR CELLTOLERANCE AND PANCREATIC CYST INDICATIONS 15 000 ‣ Capitalizing on initial successes of CellTolerance in Germany / France / Italy to open new centers in Europe ‣ Expansion of CellTolerance int
Slide 33: U.S. Commercialization Leveraging Installed Base
U.S. COMMERCIALIZATION LEVERAGING OUR SIGNIFICANT INSTALLED BASE AND PORTFOLIO OF GI APPLICATIONS POTENTIAL MID-TERM REVENUE CAPITAL UPSELL $15M - $20M ‣ Upgrade 50+ sites to Gen3 ~$200–250K per upgrade (e.g. Ohio State, HCA) Short /midterm opportunity $10M ARR CROSS-SELL ~$100–250K pay-per-use ‣ St
Slide 34: Strong U.S. Sales Momentum with Sustained Productivity Gains
2025 U.S. SALES STRONG U.S. SALES MOMENTUM WITH SUSTAINED PRODUCTIVITY GAINS Sales in the U.S. in H1 2024-2025 ($K) +31% ‣ U.S. sales productivity doubled exceeding +23% $800K (annualized) per sales representative 1 294 1 300 1 183 ‣ Strong capital sales momentum driven by robust systems, probes, an
Slide 35: Transforming the U.S. into a High-Margin Growth Engine
TRANSFORMING THE U.S. INTO A HIGH-MARGIN GROWTH ENGINE Sales per Rep in the U.S. Path to $1M sales/rep (in $K) based on targeted model 1 000 A SOLID FOUNDATION TO ACCELERATE IN THE UNITED STATES ‣ 4 M$ in revenue in 2024 > $626k 750 ‣ Team restructured in 2021, now composed of 6 reps ‣ Productivity
Slide 36: Rebuilding Momentum on PPU Volume
U.S. COMMERCIALIZATION REBUILDING MOMENTUM ON PPU VOLUME Average U.S. PPU procedures (logs) / active account / month ‣ 2023 marked a significant inflection point 15 9M 2025 driven by rationalization of the customer base ~2,500 logs and improved focus on community hospitals 10 logs /month and ambulat
Slide 37: CMS Coverage: Proposed 2026 Rule Strengthens Economic Value
CMS COVERAGE: PROPOSED 2026 RULE STRENGTHENS ECONOMIC VALUE OF CELLVIZIO CMS Proposed ASC Hospital 2026 Rule 2025 2026 Variation 2025 2026 Variation Barrett’s – EGD $503 $501 -0.6 % $938 $937 -0.1 % WITHOUT Cellvizio x2.3 x2.6 Barrett’s – EGD $1,116 $1,149 +3.0% $2,366 $2,444 +3.3% WITH Cellvizio ‣
Slide 38: EU & RoW Commercialization Driven by CellTolerance and Distribution
EU & ROW COMMERCIALIZATION DRIVEN BY CELLTOLERANCE AND STRATEGIC DISTRIBUTION AGREEMENTS MID-TERM POTENTIAL ARR DIRECT SALES $10M - $15M ‣ 50 new CellTolerance account across ~$200–250K pay-per-use top EU markets revenue per account DISTRIBUTORS ‣ Direct presence: France, Germany Italy, ‣ 10 strateg
Slide 39: Rigorous Management of Operating Expenses
RIGOROUS MANAGEMENT OF OPERATING EXPENSES, CONSISTENTLY DECREASING SINCE 2021 Operating expenses (in thousands of euros) 10000 - 40% ‣ Optimization of sales and 9 170 marketing expenses for greater 7 598 7 506 efficiency and productivity. 6 823 ‣ Significant reduction in general 5 537 and administra
Slide 40: H1 2025 Results: A 32% Reduction in Current Operating Loss
H1 2025 RESULTS: A 32% REDUCTION IN CURRENT OPERATING LOSS In K€ H1 2025 H1 2024 Change (%) REVENUE Sales growth in the U.S. offsetting the Revenue 3,692 3,871 -5% temporary slowdown in activity in the Other revenues 339 396 - 15 % rest of the world Total revenue 4,031 4,269 -6% OPERATING COSTS Gros
Slide 41: Debt Restructuring
DEBT RESTRUCTURING 41
Slide 42: Excessive Debt Burden Crushing Equity Value
EXCESSIVE DEBT BURDEN CRUSHING EQUITY VALUE Market capitalization Total debt (€M)2 (€M) 40 M€ ‣ Total Debt of €40M: Over 75% is owed to the 40 000 40000 European Investment Bank (EIB) ‣ EIB Debt of €31M: This includes a €17.5M loan contracted in 2019-2020, €5.5M in capitalized 30 000 interest, and €
Slide 43: A Massive 70% Debt Reduction Plan Approved by a Majority of Classes
A MASSIVE 70% DEBT REDUCTION PLAN APPROVED BY A MAJORITY OF CLASSES % Exposure by class Before Haircut After ‣ Waiver of 55% of the EIB debt 1. Public creditors €1.3M 0% €1.3M principal and interest, and 100% of sales royalties 2. EIB €31.0M 67 % €10.3M 3. Lessor €0.1M 80 % €0.0M ‣ Conversion of a p
Slide 44: A 10-Year Timeline Providing Visibility for the Plan's Execution
A 10-YEAR TIMELINE PROVIDING THE VISIBILITY NEEDED FOR THE PLAN'S EXECUTION Financial Debt Repayment Schedule (€ in thousands) 15 000 14 368 12 000 9 000 6 555 5 996 70% of repayments are now 6 000 scheduled after 2030 3 890 3 826 3 046 3 000 2 459 2 129 2 115 1 630 1 621 1 117 1 066 497 601 184 0 2
Slide 45: A Key Financing to Secure the Restructuring & Unlock Value
A KEY FINANCING TO SECURE THE RESTRUCTURING & UNLOCK VALUE ‣ New financing is the final condition required by the court to approve the debt restructuring plan ‣ Size: €5M - €8M with warrants attached to provide a clear runway to profitability and positive cash flow A PROTECTED & COMPELLING INVESTMEN
Slide 46: Indicative Timeline
INDICATIVE TIMELINE September 12 ‣ Notification of the safeguard plan to creditors and shareholders Need to secure investment commitments of min. €5M before September 25 - October 2 Sept 25 to secure creditors’ vote ‣ Launch of creditors’ vote on the safeguard plan October 2 ‣ H1 Financial Results O
Slide 47: 9 rue d’Enghien 75010 Paris France
9 rue d’Enghien 24 Denby Road 75010 Paris Allston, MA 02134 47 France USA
Mauna Kea Technologies — Investor Presentation (September 2025) on 6ix