Slide 1: 1H 25 Financial Results Presentation
1H 25 FINANCIAL RESULTS PRESENTATION Dr Peter Meintjes Chief Executive Officer Grant Gibson Chief Financial Officer 26 November 2024
Slide 2: Important Notice and Disclaimer
IMPORTANT NOTICE AND DISCLAIMER This presentation has been prepared by Pacific Edge Limited (PEL) solely PEL’s current views with respect to future events. Forward-looking Investment risk to provide interested parties with further information about PEL and its statements, by their very nature, invol
Slide 3: Agenda
AGENDA 1. HIGHLIGHTS 2. STRATEGIC DELIVERY 3. FINANCIAL PERFORMANCE 4. OUTLOOK 5. QUESTIONS 3
Slide 4: 1H 25 Highlights: Focused on Catalysts for Medicare Coverage Certainty
1H 25 HIGHLIGHTS: FOCUSED ON CATALYSTS FOR MEDICARE COVERAGE CERTAINTY 1.1% 3.2% 1.4% ($14.5M) GLOBAL TESTS COMMERCIAL OPERATING NET LOSS AFTER $35.9M (TLT1) on 2H 24 TEST VOLUMES REVENUE on TAX CASH, CASH -22.0% on 1H 24 on 2H 24 2H 24 Up 1.5% on 2H 24 EQUIVALENTS2 -20.0% on 1H 24 -16.3% on 1H 24 -
Slide 5: Value Creation Through Three Pillars
VALUE CREATION THROUGH THREE PILLARS INPUTS OUTPUTS EXCELLENT PATIENT EXPERIENCE OUR PEOPLE AND ACCURATE RESULTS OUR IP, KNOWLEDGE EARLY DETECTION AND AND EXPERIENCE CLINICALLY ACTIONABLE CARE OUR PROCESSES INNOVATION PIPELINE FOR CLINICAL APPLICATIONS OUR CLINICAL STUDIES INCLUSIVE WORKPLACE PARTNE
Slide 6: Test Volumes Steady Against 2H 24 Amid Medicare Uncertainty
TEST VOLUMES STEADY AGAINST 2H 24 AMID MEDICARE UNCERTAINTY 1H 25 TOTAL LAB THROUGHPUT (TLT*) TEST VOLUMES BY TYPE (TLT*) • Global TLT of 14,233 for 1H 25 steady (-1.1%) on 2H 24 and down 22% on 1H 24 amid ongoing Medicare coverage uncertainty and 17% 19% 23% reduced reach of the sales force 33% • G
Slide 7: Foundations for Growth - US Test Volumes Steady
FOUNDATIONS FOR GROWTH - US TEST VOLUMES STEADY KAISER PERMANENTE GAINS PARTIALLY OFFSET MEDICARE UNCERTAINTY US TOTAL TEST VOLUME* • US TLT in Q2 25 relatively stable on the prior quarter (Q1 25) 9,000 • Strong performance from the Southern California Permanente 8,627 8,000 Medical Group and sustai
Slide 8: Foundations for Growth – Performance Improvements Sustained
FOUNDATIONS FOR GROWTH – PERFORMANCE IMPROVEMENTS SUSTAINED SALES TEAM FOCUSED ON KEY PERFORMANCE INDICATORS US SALES FORCE EFFICIENCY 80 381 394 379 400 • Sales FTE down to an average of 15.0 in Q2 25 from 32.7 in 70 350 Q4 23 as we focused on cash conservation: 288 292 VOLUME /SALES FTE 265 AVERAG
Slide 9: Foundations for Growth - US Cash Collections Improve
FOUNDATIONS FOR GROWTH - US CASH COLLECTIONS IMPROVE REIMBURSEMENT & CASH COLLECTIONS – A CORE COMPETENCY US COMMERCIAL TEST VOLUMES AND ASP* (US$) • Average Sales Price (ASP*) per test increased to US$618 from $700 16,000 US$613 in 2H 24 and US$519 in 2H 23 lifted by: $613 $618 • Enhanced Patient R
Slide 10: Driving Growth in Asia Pacific and Consolidating New Zealand
DRIVING GROWTH IN ASIA PACIFIC AND CONSOLIDATING NEW ZEALAND APAC TOTAL TEST VOLUMES* 1,600 1,400 1,200 1,363 1,283 1,199 TEST VOLUMES 1,000 1,165 1,139 1,142 1,111 1,061 1,079 983 800 600 400 200 - Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 • Quarterly total test volumes benefit fr
Slide 11: Simplifying the Cxbladder Value Proposition – Triage Plus
SIMPLIFYING THE CXBLADDER VALUE PROPOSITION – TRIAGE PLUS TRIAGE PLUS NAMING ALIGNS WITH CLINICAL POSITIONING AND STRATA1 EVIDENCE TRIAGE PLUS – THE ADDITION OF DNA BIOMARKERS LIFTS PERFORMANCE3 Performance3 Sens Spec NPV PPV ROR • Triage Plus combines the value propositions of the existing Triage a
Slide 12: Preparing for the Commercialization of Triage Plus
PREPARING FOR THE COMMERCIALIZATION OF TRIAGE PLUS EXPANDING AND EXTENDING OUR LEADERSHIP POSITION IN HEMATURIA EVALUATION ESSENTIAL PRE-CONDITIONS TO LAUNCHING TRIAGE PLUS • Pricing that reflects the clinical value and economic benefit of the test • Reliable Medicare reimbursement via (existing) co
Slide 13: Triage Plus Pricing Stands to Bolster Pacific Edge's Economics
TRIAGE PLUS PRICING STANDS TO BOLSTER PACIFIC EDGE’S ECONOMICS PRICING OF TRIAGE PLUS IS THE NEXT STEP IN THE COMMERCIALISATION PROGRAM • Determining a CMS price for Triage Plus (0420U) is the next step in establishing reimbursement • Advisory Panel and CMS have recommended Gapfill for Triage Plus •
Slide 14: Selling Cxbladder's Clinical, Economic and Patient Value
SELLING CXBLADDER’S CLINICAL, ECONOMIC AND PATIENT VALUE Pacific Edge’s budget impact modelling shows Cxbladder offers better care, avoids unnecessary procedures and improves workflow when used to intensify or de-intensify hematuria evaluation or in the surveillance for the recurrence of bladder can
Slide 15: Strengthening Our Customer Experience
STRENGTHENING OUR CUSTOMER EXPERIENCE DRIVING ‘STICKINESS’ AND LONG-TERM MARKET SHARE THE BEST AND MOST CUSTOMER-FRIENDLY TEST • Give customers options to connect with Pacific Edge to fit their needs with easy-to-use digital workflows • Electronic Medical Record (EMR) integrations (Kaiser) • Pacific
Slide 16: AUA Hematuria Guidelines – A Comprehensive Review
AUA HEMATURIA GUIDELINES – A COMPREHENSIVE REVIEW AN APPROACH THAT SUPPORTS OUR DRIVE FOR GUIDELINE INCLUSION • The AUA has commenced a review of the microhematuria guideline and has asked for professional comment on its initial draft; no timeframe provided • The clinical utility of Cxbladder Triage
Slide 17: 'Genetic Testing for Oncology' LCD Process Extended
‘GENETIC TESTING FOR ONCOLOGY’ LCD PROCESS EXTENDED CMS1 APPROVED THE EXTENSION TO GIVE NOVITAS1 TIME TO RESPOND TO ALL COMMENTS EXTENSION INCREASES CONFIDENCE TOWARDS MEDICARE COVERAGE CERTAINTY 27 July 2023 • Cxbladder continues to receive reimbursement from Medicare and Medicare Novitas1 republis
Slide 18: Clinical Evidence Catalysts for Coverage Certainty
CLINICAL EVIDENCE CATALYSTS FOR COVERAGE CERTAINTY MEDICARE RECONSIDERATION AND GUIDELINE INCLUSION REQUESTS (Novitas1 typically handles reconsideration requests on existing LCDs within three months of submission) Catalyst Test and evidence standard (2) Expected date of reconsideration request (3) 1
Slide 19: Independent Real-World Evidence of Cxbladder's Clinical Utility
INDEPENDENT REAL-WORLD EVIDENCE OF CXBLADDER’S CLINICAL UTLITY CLINICAL UTILITY EVIDENCE OF CXBLADDER TRIAGE THAT SUPPORTS MEDICARE COVERAGE KAISER PERMANENTE ABSTRACT SHOWS CLINICAL VALUE IN REAL WORLD SETTING • Kaiser Permanente presented an abstract to the Western Section AUA conference regarding
Slide 20: Strategic Responses to the Impending Medicare Determination
STRATEGIC RESPONSES TO THE IMPENDING MEDICARE DETERMINATION OUR RESPONSE TO AN AFFIRMATION OF COVERAGE • Strategic review to accelerate the US adoption of Cxbladder among patients, clinicians, and healthcare payers OUR RESPONSE TO A LOSS OF COVERAGE • Explore legal options supported by customers,
Slide 21: Research & Innovation – Focused on DNA Enhanced Products
RESEARCH & INNOVATION – FOCUSED ON DNA ENHANCED PRODUCTS READYING FOR THE LAUNCH OF TRIAGE PLUS AND MONITOR PLUS • Ensure R&D, Digital and Lab Operations focus on the commercial scaling of Triage Plus and Monitor Plus • Simplifying Cxbladder: • Aim to reduce technician time, lower cost of goods, low
Slide 22: Financial Performance
FINANCIAL PERFORMANCE [sx PacificEdge’ CANCER DIAGNOSTICS.
Slide 23: US Commercial Test Volume Growth Driving Revenue
US COMMERCIAL TEST VOLUME GROWTH DRIVING REVENUE LOOKING TO US CATALYSTS TO DRIVE A RECOVERY IN REVENUE GROWTH PACIFIC EDGE OPERATING REVENUE REGIONAL REVENUE CONTRIBUTION $25,000 $23,907 92% $20,000 $19,616 1H 25 8% $10,812 $15,000 $10,909 -16.3% APAC $(000) $11,445 vs 1H 24 AMERICAS $10,000 $7,701
Slide 24: Cash and Cash Equivalents: A Strong Balance Sheet
CAPITAL FOCUSED ON EVIDENCE GENERATION FOR RELIABLE REIMBURSEMENT A STRONG BALANCE SHEET $15,664 $15,617 $16,000 $120,000 $14,330 • Cash, cash equivalents and short-term $14,000 deposits of $35.9M vs. $50.3M as at 31 CASH AND CASH EQUIVALENTS (NZ$000) $100,000 $105,412 $11,957 $11,913 March 2024 $12
Slide 25: Revenue Steady; Increase in ASP Offsets the Impact of Lower Volume
REVENUE STEADY; INCREASE IN ASP OFFSETS THE IMPACT OF LOWER VOLUME • Operating revenue increases 1.4% on 2H 24 despite 1H 25 1H 25 lower volumes following lift in ASP1 to US$618 vs. vs. vs. US$613 in 2H 24 FINANCIAL PERIOD 1H 25 2H 24 1H 24 FY24 1H 24 2H 24 • Total revenue includes FX loss of $0.4M,
Slide 26: Operating Expenses Steady on Prior Half
OPERATING EXPENSES STEADY ON PRIOR HALF INVESTMENT NOW FOCUSSED ON LONG-TERM STRATEGIC INITIATIVES 1H 25 1H 25 • Operating expenses are steady on 2H 24 1H 25 2H 24 1H 24 FY24 vs. vs. • The 16.3% reduction vs. 1H 24 is due to FINANCIAL PERIOD 1H 24 2H 24 the shift in focus to preserve cash while enha
Slide 27: Summary and Outlook
SUMMARY AND OUTLOOK [sx PacificEdge’ CANCER DIAGNOSTICS.
Slide 28: Ready for All Outcomes
READY FOR ALL OUTCOMES • We continue to manage our cash prudently while we seek to maintain reliable reimbursement for existing products and establish reimbursement for future products • We will continue to: • Engage directly and through industry partners with CMS/Novitas to preserve reimbursement o
Slide 29: Appendix
APPENDIX px | PacificEdge’ CANCER DIAGNOSTICS.
Slide 30: Pacific Edge's Global Reach
PACIFIC EDGE’S GLOBAL REACH 30
Slide 31: Pacific Edge's Evidence Program Seeks to Change Clinical Practice
PACIFIC EDGE’S EVIDENCE PROGRAM SEEKS TO CHANGE CLINICAL PRACTICE STRUCTURED CLINICAL EVIDENCE DEVELOPMENT • Pacific Edge’s clinical study program is focused on developing clinical evidence for Cxbladder tests in a structured framework • Analytical Validity (AV): Evidence that a test is repeatable i
Slide 32: Hematuria Evaluation Five Year Clinical Studies Roadmap
HEMATURIA EVALUATION FIVE YEAR CLINICAL STUDIES ROADMAP Calendar Pre 2023 2024 2025 2026 2027 2028 year 2023 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 STRATA * DBL DRIVE * DBL AUSSIE * microDRIVE * Pooled CV CREDIBLE * Legend: Pre-activation (docs, CTA etc) Publication Submit
Slide 33: Surveillance Five Year Clinical Studies Roadmap
SURVEILLANCE FIVE YEAR CLINICAL STUDIES ROADMAP Calendar Pre 2023 2024 2025 2026 2027 2028 year 2023 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 “The 1800” LOBSTER * US CU Surv 33
Slide 34: Summary of Clinical Evidence
SUMMARY OF CLINICAL EVIDENCE Study Pop. Type Sensitivity (Sn) NPV Specificity (Sp) Comment Proof of Lotan et al., 2022 MH + GH* 97% 99.7% 90% Pooled data from US and Singapore cohorts (n=804). Called Detect+ in publication. concept DRIVE (unpublished) (1) MH + GH* Study in progress Triage Plus CV AU
Slide 35: Footnotes for Clinical Evidence Summary
FOOTNOTES FOR CLINICAL EVIDENCE SUMMARY Footnotes 1 Observational study to validate performance characteristics and clinical utility of Cxbladder tests (Cxb Triage, Cxb Detect, Cxb Triage Plus). 2 Observational study to validate performance characteristics of Cxb Triage Plus in patients with UC of t
Slide 36: References Summary of Clinical Evidence
REFERENCES SUMMARY OF CLINICAL EVIDENCE References Triage Plus Lotan et al., (2022). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification1. The Journal of Urology, 10-1097. Davidson et al., (2019). Inclusion of a molecular
Slide 37: Key Clinical Advisors and Consultants
KEY CLINICAL ADVISORS AND CONSULTANTS Professor Yair Lotan, MD Associate Professor Katie Murray, DOMS, FACS Institution: UT Southwestern Medical Center Institution: NYU Langone Relationship: Consultant, CAB member, IIT PI, CT PI Relationship: Consultant, CAB member, Brief Bio: Published >500 article
Slide 38: Pacific Edge – Taking New Zealand Innovation Global
PACIFIC EDGE – TAKING NEW ZEALAND INNOVATION GLOBAL Aug 2021 Cxbladder reaches 70% public healthcare coverage in NZ Nov 2023 Oct 2021 Kaiser PEB raises Permanente Dec 2012 Dec 2014 $103.5m EMR Launch of Pacific Edge Launch of (~US$72.5m) integration Diagnostics USA and Cxbladder goes live Cxb Detect
Slide 39: Pacific Edge Board and Management
PACIFIC EDGE BOARD AND MANAGEMENT CHRIS GALLAHER DR PETER MEINTJES Chairman Chief Executive Officer Chris has held senior positions in Peter is a molecular diagnostics and both CEO and CFO roles with large genomics leader focused on international companies and was a nascent market development of par
Slide 40: For More Information
FOR MORE INFORMATION: Dr. Peter Meintjes Chief Executive Officer email: peter.meintjes@pelnz.com Grant Gibson Chief Financial Officer email: grant.gibson@pelnz.com Pacific Edge 87 St David Street, PO Box 56, Dunedin, New Zealand P +64 3 577 6733 Within NZ 0800 555 563 email: investors@pacificedge.co