Pacific Edge Limited · NZX:PEB
Pacific Edge — Shareholder Meeting (September 2024)
53 slides from Pacific Edge's shareholder meeting presentation, Sep 24, 2024
Slide 1: Annual Shareholders Meeting
Pacific Edge ANNUAL SHAREHOLDERS MEETING 24 September 2024 Auckland Pacific Edge’s ordinary shares trade on the NZX and the ASX under the ticker code: PEB
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: Chris Gallaher, Chairman
i CHRIS GALLAHER Chairman PACIFIC EDGE ‘CANCER DIAGNOSTICS COMPANY x SY Capiadder 8
Slide 4: Directors
DIRECTORS SARAH PARK ANATOLE MASFEN BRYAN WILLIAMS ANNA STOVE MARK GREEN TONY BARCLAY 4
Slide 5: Agenda
AGENDA 1. CHAIRMAN’S ADDRESS 2. CHIEF EXECUTIVE’S ADDRESS 3. QUESTIONS 4. US OPERATIONS 5. OUR CLINICAL PROGRAM 6. QUESTIONS 7. RESOLUTIONS 8. VOTING AND GENERAL BUSINESS 9. MEETING CLOSE
Slide 6: 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 7: FY24 - Conserving Cash Amid Coverage Uncertainty
FY 24 - CONSERVING CASH AMID FY 25 - CATALYSTS FOR GROWTH COVERAGE UNCERTAINTY POSITIONED FOR GROWTH • Commercial operations focused on profitable territories, non-Medicare revenue 32,633 streams and selling the clinical and economic value of Cxbladder • Direct sales team efficiency improves - opera
Slide 8: Dr Peter Meintjes, Chief Executive Officer
Dr PETER MEINTJES Chief Executive Officer 8
Slide 9: Pacific Edge Is Founded on Delivering Positive Outcomes for Society
PACIFIC EDGE IS FOUNDED ON DELIVERING POSITIVE OUTCOMES FOR SOCIETY WE CREATE VALUE BY PRIORITISING OUR PATIENTS, OUR PHYSICIANS AND OUR PEOPLE Our Vision A world where the early diagnosis and better treatment of cancer is within reach of everyone Our Values: Our Sustainability Priorities: 9
Slide 10: 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 11: Growth Slowed Amid Medicare Draft
GROWTH SLOWED AMID MEDICARE DRAFT FY 24 TOTAL LAB THROUGHPUT (TLT*) TEST VOLUMES BY TYPE (TLT*) • Global TLT increased 3% to 32,633 with test demand moderating amid proposed Medicare coverage changes & sales force reductions • Global Commercial test volumes increased 2%. Global TLT is driven 22% 22%
Slide 12: Foundations for Growth – US Sales Team Performance Improves
FOUNDATIONS FOR GROWTH – US SALES TEAM PERFORMANCE IMPROVES US SALES TEAM REDUCTIONS TO CONSERVE CASH DAMPEN VOLUME GROWTH IN FY24 US SALES FORCE EFFICIENCY • Commercial volumes stabilizing with a focus on profitable 100 381 403 sales territories and non-Medicare revenue streams (Kaiser 400 AVERAGE
Slide 13: Driving Growth in Asia Pacific and Consolidating New Zealand
DRIVING GROWTH IN ASIA PACIFIC AND CONSOLIDATING NEW ZEALAND APAC TOTAL TEST VOLUMES* 1,400 1,283 1,165 1,199 1,200 1,139 1,142 1,111 1,061 1,079 983 APAC TEST VOLUME 1,000 800 600 400 200 - Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q2 24 Q3 24 Q424 Q1 25 • Quarterly total test volumes benefit from: • Fewer eva
Slide 14: Extending Our Reach Through Global Distribution Agreements
EXTENDING OUR REACH THROUGH GLOBAL DISTRIBUTION AGREEMENTS 14
Slide 15: STRATA – The Strongest Evidence Yet for Guidelines Inclusion
STRATA1 – THE STRONGEST EVIDENCE YET FOR GUIDELINES INCLUSION A MILESTONE IN OUR DRIVE FOR MEDICARE COVERAGE CERTAINTY PARADIGM-SHIFTING STUDY DEMONSTRATES CLINICAL UTILITY OF TRIAGE USING CLINICAL EVIDENCE TO DRIVE CXBLADDER ADOPTION • STRATA is the first ever randomized controlled trial of a urine
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 • Our Chief Medical Officer Dr Tamer Abous
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 have submitted an abstract to the Western Section AUA conference rega
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 DETECT+ AND MONITOR+ • Ensure R&D, Digital and Lab Operations focus on the launch of Detect+ and Monitor+ • Simplifying Cxbladder: • Aim to reduce technician time, lower cost of goods, lower turnaround time, increase
Slide 22: Pacific Edge USA - Operations
PACIFIC EDGE USA - OPERATIONS DAVID LEVISON President Pacific Edge Diagnostics USA 22
Slide 23: Medicare & Medicaid – The Largest Volume from Single Decision
MEDICARE & MEDICAID – THE LARGEST VOLUME FROM SINGLE DECISION HEALTH INSURANCE IN THE US MARKET – SERVING 335 MILLION PEOPLE1 US HEALTH INSURANCE COVERAGE1 PUBLIC FUNDED INSURNCE: Medicare, Medicaid, Veterans Admin, etc. 70% 65.6% • Limited options for plan design • Little or no out of pocket expens
Slide 24: Focusing Our Efforts on Concentrations of Demand
FOCUSING OUR EFFORTS ON CONCENTRATIONS OF DEMAND HOW THESE MARKET FEATURES INFLUENCE OUR EFFORTS UROLOGISTS PLACE OF WORK1 • We serve a population of 14,176 US practicing urologists1 4,500 3,968 3,881 4,000 • >60% of those urologists practice in small, private groups 3,500 3,000 UROLOGISTS • Consist
Slide 25: Selling Cxbladder's Clinical, Economic and Patient Value
SELLING CXBLADDER’S CLINICAL, ECONOMIC AND PATIENT VALUE For clinicians and patients, Cxbladder offers better care, avoids unnecessary procedures & improves workflow. For healthcare payers it offers substantial total cost savings per patient when used to intensify or de-intensify hematuria evaluatio
Slide 26: Pacific Edge USA Functional Capabilities
PACIFIC EDGE USA FUNCTIONAL CAPABILITIES ACTIVITIES THAT TRAVERSE SALES AND MEDICAL AFFAIRS TO LAB OPERATIONS AN AVERAGE WEEK • ~1,000 direct sales interactions MEDICAL AFFAIRS SALES MARKETING - Clinical education - Growing test volume - Sales support • 400-500 samples processed - Sales support - Di
Slide 27: Simplifying the Cxbladder Value Proposition – Detect+ & Monitor+
SIMPLIFYING THE CXBLADDER VALUE PROPOSITION – DETECT+ & MONITOR+ ADDITION OF DNA BIOMARKERS ENHANCES TEST PERFORMANCE3 Performance3 Sensitivity Specificity NPV PPV ROR HEMATURIA EVALUATION TEST PERFORMANCE CxbDetect+ 97% 90% 99.7% 44% 83% The improved performance characteristics of Detect+ mean it c
Slide 28: Preparing for Detect+ Commercialization
PREPARING FOR DETECT+ COMMERCIALIZATION EXPANDING AND EXTENDING OUR LEADERSHIP POSITION IN HEMATURIA EVALUATION ESSENTIAL PRE-CONDITIONS TO LAUNCHING DETECT+ • Pricing that reflects the clinical value and economic benefit of the test • Reliable Medicare reimbursement via (existing) coverage of our t
Slide 29: Detect+ Pricing Stands to Bolster Pacific Edge's Economics
DETECT+ PRICING STANDS TO BOLSTER PACIFIC EDGE’S ECONOMICS PRICING OF DETECT+ IS THE NEXT STEP IN THE COMMERCIALISATION PROGRAM • Pricing of Detect+ is the next step in establishing reimbursement • The Crosswalk strategy for pricing of Detect+ is based on technological similarities to previously pri
Slide 30: 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 • Pacific Edge Cus
Slide 31: Our Customer Portal – Streamlining the Customer Experience
OUR CUSTOMER PORTAL – STREAMLINING THE CUSTOMER EXPERIENCE Please click the image above to launch the customer portal video 31
Slide 32: EMR Supporting Adoption at Kaiser Permanente
EMR SUPPORTING ADOPTION AT KAISER PERMANENTE • EMR integration went live in Nov 2023 across Kaiser’s Southern California Permanente Medical Group streamlining sample collection, test ordering and test resulting for Triage and Monitor • All 15 Kaiser SoCal sites are now ordering and volumes increasin
Slide 33: Lumea – Establishing Digital Links with Clinics
LUMEA – ESTABLISHING DIGITAL LINKS WITH 450 CLINICS ALIGNING OUR SYSTEMS WITH PRE-EXISTING EMRS AND CUSTOMER PORTALS • Lumea BxLink is a Digital Pathology Lab Information System for pathology labs that is integrated with approximately 450 clinics (not all of which are urology) • Approximately 200 of
Slide 34: Strengthening Our Foundations – Operational Excellence
STRENGTHENING OUR FOUNDATIONS – OPERATIONAL EXCELLENCE DIGITALIZATION, AUTOMATION & CUSTOMER EXPERIENCE Readying our operations to scale • Improve Lab Operations and Customer Service with focus on increasing automation and reducing turn around time • An operational plan to scale to more than 250k sa
Slide 35: Our Clinical Research Program
OUR CLINICAL RESEARCH PROGRAM Dr TAMER ABOUSHWAREB Chief Medical Officer Pacific Edge Diagnostics USA 35
Slide 36: 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 37: Focused on Clinical Evidence for Detect+ and Monitor+
FOCUSED ON CLINICAL EVIDENCE FOR DETECT+ AND MONITOR+ DELIVERING CLINICAL EVIDENCE THAT DRIVES BEHAVIOR CHANGE AND GUIDELINES INCLUSION EVIDENCE STANDARD DEMONSTRATED1 PROGRAM TARGETS CU AND CV OF DETECT+ ANALYTICAL CLINICAL CLINICAL • Cxb Triage, Detect and Monitor are already well established in c
Slide 38: Pacific Edge's Program Supplemented by Independent Research
PACIFIC EDGE’S PROGRAM SUPPLEMENTED BY INDEPENDENT RESEARCH INDEPENDENT STUDIES UNDERWAY TEST AND EVIDENCE EXPECTED STUDY INSTITUTION/LOCATION STANDARD PUBLICATION Patient preference and satisfaction of “bio-markers vs cystoscopy” Mayo Clinic, US Monitor – CU 2025 Review of the Canterbury experience
Slide 39: Engaging Key Opinion Leaders for Clinical Excellence and Advocacy
ENGAGING KEY OPINION LEADERS FOR CLINICAL EXCELLENCE AND ADVOCACY • Managing Key Opinion Leaders is a core responsibility of the Medical Affairs Team • All members of the team are non-practicing physicians, or have similar qualifications like PhDs in biology or a Pharm D • We engage our KOLs to: • R
Slide 40: 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 41: Dr Peter Meintjes, Chief Executive Officer
Dr PETER MEINTJES Chief Executive Officer 41
Slide 42: Summary and Outlook: Ready for All Outcomes
SUMMARY AND OUTLOOK: READY FOR ALL OUTCOMES • We continue to manage our cash prudently while we establish coverage certainty • We will continue to: • Preserve reimbursement of our existing portfolio of tests • Focus on the clinical development of Detect+ and Monitor+ for guidelines inclusion and inc
Slide 43: Appendix
APPENDIX
Slide 44: Bladder Cancer
BLADDER CANCER A SIGNIFICANT GLOBAL HEALTHCARE CHALLENGE INCIDENCE PER 100,000 OF THE POPULATION4 10th <1.7 1.7 to 2.7 2.7 to 5.3 5.3 to 8.6 >8.6 Most common cancer world- wide1 6th 17th Most common Most common cancer in men1 cancer in women1 >212K Annual deaths2 ~573K Annual cases ~70% and growing1
Slide 45: Cxbladder Is a Global Opportunity
CXBLADDER IS A GLOBAL OPPORTUNITY US$7.6b Total Addressable Market1 GLOBAL COMMERCIALIZATION • US is the focus of our growth efforts • New Zealand is a mature market • APAC in business development • Distribution considered in other markets on a case-by-case basis USA – Total Addressable Market (TAM)
Slide 46: Pacific Edge Five Year Clinical Study Road Map
PACIFIC EDGE FIVE YEAR CLINICAL STUDY ROAD MAP 54
Slide 47: Pacific Edge Five Year Clinical Study Roadmap (continued)
PACIFIC EDGE FIVE YEAR CLINICAL STUDY ROADMAP (continued…) 55
Slide 48: FY24: Revenue Grows with Increased Adoption of Cxbladder
FY 24: REVENUE GROWS WITH INCREASED ADOPTION OF CXBLADDER GROWTH MODERATES IN 2H 24 WITH REORGANIZATION CRIMPING SALES 2H 24 1H 24 FY24 FY 23 FY 24 vs. 2H 24 vs. • Operating revenue increased 22% in FY 24 vs FY 23 with increased volumes and an increase in FINANCIAL PERIOD FY 23 1H 24 average receipt
Slide 49: 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) concept DRIVE (unpublished) (1) MH + GH* Study in progress Detect+ CV AUSSIE (unpublished) (4) MH + GH* Stud
Slide 50: 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 Detect+). 2 Observational study to validate performance characteristics of Cxb Detect+ in patients with UC of the upper
Slide 51: References Summary of Clinical Evidence
REFERENCES SUMMARY OF CLINICAL EVIDENCE References + Detect Lotan et al., (2022). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification. The Journal of Urology, 10-1097. Davidson et al., (2019). Inclusion of a molecular mar
Slide 52: 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 53: 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 555 562 email: investors@pacificedge.co