Pacific Edge Limited · NZX:PEB
Pacific Edge — Shareholder Meeting (July 2023)
52 slides from Pacific Edge's shareholder meeting presentation, Jul 27, 2023
Slide 1: Pacific Edge Annual Shareholders Meeting
Pacific Edge Annual Shareholders Meeting Link Market Services Auckland 27 July 2023 Pacific Edge’s ordinary shares trade on the NZX and the ASX under the ticker code: PEB
Slide 2: Chris Gallaher, Chairman
be CHRIS GALLAHER Chairman a biadder 7 PACIFIC EDGE ANCER DIAGNOSTICS COMPAN
Slide 3: Important Notice and Disclaimer
IMPORTANT NOTICE AND DISCLAIMER This presentation has been prepared by Pacific Edge Limited (PEL) solely uncertainties. Many of those risks and uncertainties are matters which PEL does not guarantee any particular return or the performance of PEL. to provide interested parties with further informati
Slide 4: Directors
DIRECTORS SARAH PARK ANATOLE MASFEN BRYAN WILLIAMS ANNA STOVE MARK GREEN TONY BARCLAY
Slide 5: Meeting Agenda
MEETING AGENDA 1. PRESENTATIONS 2. SHAREHOLDER DISCUSSION 3. RESOLUTIONS 4. ORDINARY BUSINESS 5. MEETING CLOSE
Slide 6: FY23 Highlights: Strong Performance Follows Strategic Execution
FY 23 HIGHLIGHTS: STRONG PERFORMANCE FOLLOWS STRATEGIC EXECUTION PACIFIC EDGE GLOBAL TEST VOLUMES1 PACIFIC EDGE OPERATING REVENUE 35,000 $20,000 $19,616 $17,500 30,000 37% 31,565 $15,000 71% 25,000 $12,500 23,086 20,000 $(000) $10,000 $11,445 TESTS 15,000 16,861 $7,500 15,814 $7,701 10,000 $5,000 $4
Slide 7: Pacific Edge's Medicare Journey
PACIFIC EDGE’S MEDICARE JOURNEY July ‘20 July - Sep ‘22 Jan ‘23 June - July ‘23 TODAY Novitas informs Open Meetings, Public Triage gains coding We pursue all legal Preparing for notice Pacific Edge that Comment. Support from and then coverage and political and comment, open Cxbladder is industry, pa
Slide 8: Preserving Capital and Continuing to Create Shareholder Value
PRESERVING CAPITAL AND CONTINUING TO CREATE SHAREHOLDER VALUE Pacific Edge is continuing to review scenario planning, strategy and our risk management framework COMMITTED TO MAINTAINING A STRONG BALANCE SHEET • Pacific Edge expects to manage cash reserves - in the event of an adverse Medicare covera
Slide 9: Dr Peter Meintjes, Chief Executive Officer
Dr PETER MEINTJES Chief Executive Officer
Slide 10: Novitas Determination Is a Company Defining Moment
NOVITAS DETERMINATION IS A COMPANY DEFINING MOMENT An unexpected, unprecedented and flawed decision NOVITAS SUMMARY CONCLUSIONS MEDICARE IS OUR LARGEST CUSTOMER Finalized LCD ‘Genetic Testing for Oncology’ (L39365) noted • Cxbladder has a majority Medicare and Medicare Advantage Cxbladder tests ‘not
Slide 11: Navigating Coverage Uncertainty
NAVIGATING COVERAGE UNCERTAINTY Clinical evidence development remains a priority Cxbladder is well supported by the US urological community with >1,200 separate clinicians (representing >10% of practicing LCD TIMELINE US urologists1) ordering >8,600 tests2 in the US in Q1 24 NOVITAS REPUBLISHES LCD
Slide 12: Despite LCD Uncertainty in FY23 We Delivered Stand-Out Growth
DESPITE LCD UNCERTAINTY IN FY 23 WE DELIVERED STAND-OUT GROWTH WE HAVE SHOWN ABILITY TO EXECUTE DESPITE CHALLENGING MARKET CONDITIONS FY 23 TOTAL LAB THROUGHPUT (TLT*) TEST VOLUMES BY TYPE (TLT*) • Global TLT increased 37% to 31,565 tests • Global Commercial test volumes increased 39% to 26,691 25%
Slide 13: Coverage Uncertainty Has Affirmed Our Strategy
COVERAGE UNCERTAINTY HAS AFFIRMED OUR STRATEGY CLINICAL EVIDENCE AND STRONG UROLOGICAL RELATIONSHIPS ARE FUNDAMENTAL TO SUCCESS 13
Slide 14: Refining Our Focus: Adoption, Retention and Revenue Generation
REFINING OUR FOCUS: ADOPTION, RETENTION AND REVENUE GENERATION FOCUS AREAS: 1. NEW: Dimensioning the US business to reflect increased probability of future adverse Medicare determination I. National Accounts and Virtual Teams to support Kaiser, VA, Capitated Systems II. Enhanced Patient Responsibili
Slide 15: Driving Growth in Asia Pacific and Consolidating New Zealand
DRIVING GROWTH IN ASIA PACIFIC AND CONSOLIDATING NEW ZEALAND APAC GENERATING ~14% OF TEST VOLUME1 NEW ZEALAND IS A MATURE MARKET APAC TEST VOLUMES1 • Cxbladder is covered in 15 of the 20 new Te Whatu Ora, Health Commercial tests represent 83% of TLT in FY 23 for APAC New Zealand, representing >75% o
Slide 16: Evidence, Coverage and Guidelines: Changing Clinical Practice
EVIDENCE, COVERAGE AND GUIDELINES: CHANGING CLINICAL PRACTICE FOCUS AREAS: 1. Generate high-quality clinical validity and utility evidence through clinical studies 2. NEW: Reconfigure evidence program to focus on: I. Hematuria evaluation and surveillance (Detect+ and Monitor+) II. The end points tha
Slide 17: Research and Innovation: Understanding the Commercialisation Pathway
RESEARCH AND INNOVATION: UNDERSTANDING THE ENTIRE COMMERCIALISATION PATHWAY RESEARCH & INTELLECTUAL TECHNOLOGY PRODUCT INNOVATION PROPERTY COMMERCIALISATION FOCUS AREAS: 1. NEW: Ensure R&D, Digital and Lab Operations focus on the launch of Detect+ and Monitor+ 2. NEW: Working to ensure Cxbladder is
Slide 18: ESG: Pacific Edge Is Founded on Improving Social Outcomes
ESG: PACIFIC EDGE IS FOUNDED ON IMPROVING SOCIAL OUTCOMES Pacific Edge is delivering actionable information that can contribute to clinically meaningful improvements in cancer treatment, improving lives, improving healthcare equity across populations and healthcare outcomes for patients GOVERNANCE •
Slide 19: Outlook: Focused on FY24 Execution
OUTLOOK: FOCUSED ON FY24 EXECUTION • Pacific Edge expects to manage cash reserves - in the event of an adverse Medicare coverage decision - until it regains coverage, a process we would expect to take around 4 years. • We expect to re-focus the business on clinical development for guidelines inclusi
Slide 20: David Levison, President Pacific Edge Diagnostics USA
DAVID LEVISON President Pacific Edge Diagnostics USA
Slide 21: PEDUSA – Adoption Retention and Revenue Generation
PEDUSA – ADOPTION RETENTION AND REVENUE GENERATION FOCUSED ON MEDICARE COVERAGE AND SELLING THE CLINCAL VALUE OF CXBLADDER FOCUS AREAS: 1. NEW: Dimensioning the US business to reflect increased probability of future adverse Medicare determination I. National Accounts and Virtual Teams to support Kai
Slide 22: Molecular Diagnostics Value Chain: Patient Journey
MOLECULAR DIAGNOSTICS VALUE CHAIN: PATIENT JOURNEY GENETIC RISK DISEASE SYMPTOMS SURGICAL OR AT BIRTH MANIFESTS ONSET THERAPEUTIC INTERVENTION GENOMIC SCREENING ASYMPTOMATIC SCREENING PATIENT/DISEASE MANAGEMENT SURVEILLANCE (PERSONALIZED GENETIC RISK) (EARLY DETECTION) (CLINICAL DECISION MAKING) (RD
Slide 23: Hematuria Evaluation and Surveillance in the US Market
HEMATURIA EVALUATION AND SURVEILLANCE IN THE US MARKET VALUE PROPOSITION Cxbladder Cxbladder Cxbladder TRIAGE DETECT MONITOR 90% US$191K US$9.4B Five-year survival Average lifetime Annual US spend on rate for NMIBC if cost per patient2 bladder cancer3 detected early1 Patient care pathway Primary Car
Slide 24: Health Economics – The Economic Value of Cxbladder Detect
HEALTH ECONOMICS – THE ECONOMIC VALUE OF CXBLADDER DETECT Cxbladder Detect offers substantial total cost savings/patient when used to intensity or de-intensify hematuria evaluation in patients presenting with microhematuria1 AUA guidelines >1m cystoscopies are Pacific Edge modelling recommend all hi
Slide 25: Differentiated Sales Roles Focussed on Different Customer Types
DIFFERENTIATED SALES ROLES FOCUSSED ON DIFFERENT CUSTOMER TYPES Regional Sales National Account Director Manager Role: Manager Role: Strategic sale Target: Key clini- Target: KOL's, large cians and users institutions Focus: Escalation, Focus: Clinical coordination value, execution Account Executive
Slide 26: Redimensioning Our Sales Force with Strategic Change
REDIMENSIONING OUR SALES FORCE WITH STRATEGIC CHANGE IMPACT ON TEST DEMAND AND REVENUE UNKNOWN REVIEWING OUR APPROACH TO MARKET • Focus on larger or value-based institutional accounts • Sales initiatives focused on clinical value, economic value and patient value • Increase expectations of throughpu
Slide 27: Enhanced Customer Experience and Growing Global Footprint
ENHANCED CUSTOMER EXPERIENCE AND GROWING GLOBAL FOOTPRINT DIGITALIZATION & CUSTOMER EXPERIENCE The Kaiser Health Plan covers >12.5m • EMR integrations and Customer Portal members • Investment to upgrade older hardware and IT systems • 2 Kaiser sites in PEB’s Top 20 Accounts. 14 Kaiser sites across •
Slide 28: Simplifying the Cxbladder Proposition – Detect+ and Monitor+
SIMPLIFYING THE CXBLADDER PROPOSITION – DETECT+ AND MONITOR+ LEVERAGING EVIDENCE SHOWING THE ADDITION OF DNA BIOMARKERS ENHANCES TEST PERFORMANCE 1 RDM: Residual Disease Monitoring, 2. TRM: Therapeutic Response Monitoring 3. Lotan et al ‘Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Per
Slide 29: Dr Tamer Aboushwareb, Chief Medical Officer
Dr Tamer Aboushwareb, MD, PhD Chief Medical Officer Pacific Edge Diagnostics USA
Slide 30: Drive Evidence-Based Clinical Practice Change and Maintain Leadership
DRIVE EVIDENCE-BASED CLINICAL PRACTICE CHANGE AND MAINTAIN LEADERSHIP FOCUS AREAS: 1. NEW: Reconfigure evidence program to focus on: I. Hematuria evaluation (Detect+) and surveillance (Monitor+) II. The clinical end points that matter most to guidelines committees III. Specific patient populations r
Slide 31: How Clinical Evidence Generates Shareholder Value
HOW CLINICAL EVIDENCE GENERATES SHAREHOLDER VALUE CLINICAL EVIDENCE GENERATION IS A CORE ELEMENT OF OUR STRATEGY AND WILL CONTINUE TO BE BEFORE GUIDELINE AFTER INCLUSION INCLUSION INCLUSION Clinical evidence drives early adoption Evidence strengthens the language of Cxbladder and builds momentum for
Slide 32: Clinical Evidence Underpins Coverage and Guidelines Decisions
CLINICAL EVIDENCE UNDERPINS COVERAGE AND GUIDELINES DECISIONS Recognition in national guidelines is the best way to entrench Medicare coverage of Cxbladder and its use and adoption by other independent contracted healthcare systems. www.auanet.org www.nccn.org www.uroweb.org • Globally the most infl
Slide 33: Principles of Pacific Edge's Clinical Study Design Program
THE PRINCIPLES OF PACIFIC EDGE’S CLINICAL STUDY DESIGN PROGRAM We will attempt to gain guideline inclusion (and coverage) with every new piece of clinical or economic evidence, and through reframing our evidence with urology key opinion leaders • Studies developing Clinical Validity (CV) evidence an
Slide 34: Proposed Studies for Clinical Utility of Detect+
PROPOSED STUDIES FOR CLINICAL UTILITY OF DETECT+ NOT REPORTED REPORTED • US CU study-hem – will focus on producing clinical utility data for Detect+ in microscopic hematuria patients (ABOVE) • US CU-surveillance – will follow the CU for hematuria and focus on clinical utility of Monitor+ 34
Slide 35: Five Year Cxbladder Clinical Study Road Map
FIVE YEAR CXBLADDER CLINICAL STUDY ROAD MAP 35
Slide 36: Five Year Cxbladder Clinical Study Road Map (continued)
FIVE YEAR CXBLADDER CLINICAL STUDY ROAD MAP (continued)… * * *Proposed studies 36
Slide 37: Increasing Coverage Indications with Detect+ and Monitor+
INCREASING COVERAGE INDICATIONS WITH DETECT+ AND MONITOR+ FOCUSING RESOURCES DETECT+ AND MONITOR+ TEST SUPPORTING EVIDENCE • HEMATURIA EVALUATION Ongoing studies • Detect and Triage tests to be superseded by Detect+ as single - DRIVE product for hematuria evaluation - AUSSIE - microDRIVE • Clinical
Slide 38: Amplifying Our Evidence with Urology Opinion Leaders
AMPLIFYING OUR EVIDENCE WITH UROLOGY OPINION LEADERS CLINICAL DOSSIER DEVELOPMENT • Contains all published Cxbladder data; externally reviewed • Used to engage with guideline committees, private payors, government payers, value-based clinician groups, ex-US distributors, etc. • Annual NCCN submissio
Slide 39: Research & Innovation – Focused on Commercialisation
RESEARCH & INNOVATION – FOCUSED ON COMMERCIALISATION READYING FOR THE LAUNCH OF DETECT+ AND MONITOR+ • Ensure R&D, Digital and Lab Operations focus on the launch of Detect+ and Monitor+ • Develop higher level of documentation associated with product development and analytical validation of our next
Slide 40: Shareholder Questions
SHAREHOLDER QUESTIONS CHRIS GALLAHER Chairman
Slide 41: Appendix
FIC EDGE aca 2 bladder
Slide 42: Mission and Vision
Mission To help improve people’s lives and patient outcomes by providing leading solutions for the early detection and management of cancer. Vision A world where the early diagnosis and better treatment of cancer is within reach of everyone. “Nobody should die of cancer” 42
Slide 43: Pacific Edge: Research, Innovation, Commercialization
PACIFIC EDGE: RESEARCH, INNOVATION, COMMERCIALIZATION Aug 2021 Cxbladder reaches 70% public healthcare 2012 Aug 2019 coverage in NZ O’Sullivan et al: Cxbladder Detect Konety et al: Clinical performance Utility of Cxb Detect Oct 2021 2008 validation. in adjudicating PEB raises Holyoake et al: Urine-
Slide 44: Pacific Edge: Our Global Footprint
PACIFIC EDGE: OUR GLOBAL FOOTPRINT 44
Slide 45: Clinical Evidence Generation Towards Guideline Inclusion (1/2)
CLINICAL EVIDENCE GENERATION TOWARDS GUIDELINE INCLUSION (1/2) STUDY AIM LOCATIONS ENROLLED STATUS** SITES* STRATA Safe Testing of Risk for AsymptomaTIc MicrohematuriA USA 12 / 13 - Enrolment total is 545 Demonstrate the clinical utility (CU) of Cxbladder using a prospective, two-arm randomized desi
Slide 46: Clinical Evidence Generation Towards Guideline Inclusion (2/2)
CLINICAL EVIDENCE GENERATION TOWARDS GUIDELINE INCLUSION (2/2) STUDY AIM LOCATIONS ENROLLED STATUS** SITES* Microhematuria Pooled-analysis of Cxbladder Detect+ performance from multiple studies involving prospectively recruited USA, Aus N/A - DRIVE underway, AUSSIE and Pooled-analysis patients from
Slide 47: Summary of Clinical Evidence
SUMMARY OF CLINICAL EVIDENCE Study Pop. Type Sensitivity (Sn) NPV Specificity (Sp) Comment AV Lotan et al., 2022 MH + GH* 97% 99.7% 90% Pooled data from US and Singapore cohorts (n=804) DRIVE (unpublished) (1) MH + GH* Study in progress Detect+ AUSSIE (unpublished) (4) MH + GH* Study to start this y
Slide 48: 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 49: References Summary of Clinical Evidence
REFERENCES SUMMARY OF CLINICAL EVIDENCE References 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- Detect+ 1097. Davidson et al., (2019). Inclusion of a molecular mar
Slide 50: 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 51: Glossary
GLOSSARY • Sensitivity - the frequency with which a test correctly identifies patients with a disease. • Specificity - the frequency with which a test correctly identifies patients without a disease. • Negative Predictive Value (NPV) - the percentage of negative tests being true negatives (by standa
Slide 52: 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 3 479 5800 F +64 3 479 5801 email: investors@pacificedge.co.nz ww