Slide 1: Pacific Edge 2019 Annual Meeting
PACIFIC EDGE 2019 ANNUAL MEETING
Slide 2: Board of Directors
BOARD OF DIRECTORS GOVERNANCE Chris Gallaher Independent Director, Chairman David Darling Executive Director and Chief Executive Officer Board of Directors John Duncan Independent Director Experience in governance, finance, sales management cancer research, David Levison Independent Director (US-bas
Slide 3: Meeting Agenda
MEETING AGENDA • Presentations: • Address from the Chair, Chris Gallaher • Address from the Chief Executive Officer, David Darling • Shareholder Discussion • Resolutions as per Notice of Meeting: • Re-election of Chris Gallaher and David Levison • Election of Sarah Park and John Duncan • Authorise t
Slide 4: Chairman
PACIFIC EDGE Cancer Diagnostic Company » —s\ CHAIRMAN Chris Gallaher
Slide 5: First Mover Advantage in a Global Opportunity in Haematuria and Bladder Cancer
FIRST MOVER ADVANTAGE IN A GLOBAL OPPORTUNITY IN HAEMATURIA AND BLADDER CANCER The USA and NZ markets dominate our commercial focus 9th most common 79,000+ new bladder cancer in the world; 17 years of R&D and 4th most common in cancer cases in USA every year validation “Pacific Edge’s annual men add
Slide 6: Board Report for FY19
BOARD REPORT FOR FY19 • Board oversight of strategy implementation following detailed strategic review in February 2018. • Now starting to realise the revenue potential of our company – in early stages in the USA. • Key milestones being achieved, although taking longer than anticipated to gain wides
Slide 7: Chief Executive Officer
CHIEF EXECUTIVE OFFICER David Darling
Slide 8: FY19 Highlights and Milestones
FY19 HIGHLIGHTS AND MILESTONES • Growth in commercial sales and billable test volumes: - Strong growth in NZ and US commercial sales, particularly in Q4 FY19. • Two of three US reimbursement milestones successfully attained: - National price for all Cxbladder tests (US$760 per test) - National produ
Slide 9: FY19 Financial Result Snapshot
FY19 FINANCIAL RESULT SNAPSHOT % (NZ$’000) FY19 FY18 Change ü Operating revenue from test sales up 12% y/y Operating Revenue1 (test sales) 3,817 3,400 12% to $3.8m, with total revenue for the period of $5.1m Other Revenue 1,312 1,602 (18%) ü Total operating expenses reduced to $23.0m Total Revenue 5
Slide 10: FY19 Key Metrics – Laboratory Throughput
FY19 KEY METRICS – LABORATORY THROUGHPUT Total Laboratory Throughput Total Laboratory Throughput LABORATORY THROUGHPUT (by region) (by test type) (Commercial tests and User Programmes) 81% of FY19 tests were billable Triage ROW 20% 20% USA Detect 16 80% Monitor 57% 14 23% 12 10 (000s) 8 Regional Thr
Slide 11: Commercial Progress by Region in FY19
COMMERCIAL PROGRESS BY REGION IN FY19 2019 Annual Meeting 11
Slide 12: Growing Commercial Adoption in Home Market (New Zealand)
GROWING COMMERCIAL ADOPTION IN HOME MARKET (NEW ZEALAND) • New Zealand’s public healthcare providers are leading the global adoption of Cxbladder. • Majority have now adopted Cxbladder into their standard of care and, in some cases, their clinical guidelines, replacing the gold standard cystoscopy •
Slide 13: Continued Reimbursement Progress in the US
CONTINUED REIMBURSEMENT PROGRESS IN THE US Two of three milestones required for national public reimbursement in the US were completed in FY19: • Receipt of Product Specific CPT codes for Cxbladder Detect and Allows Pacific Edge to Cxbladder Monitor (January 2019) move into contract negotiations wit
Slide 14: Focus on Institutional Healthcare Organisations in All Markets
FOCUS ON INSTITUTIONAL HEALTHCARE ORGANISATIONS IN ALL MARKETS • Building on success achieved with large public healthcare providers in New Zealand. • Ongoing commercial negotiations and start up processes with multiple targeted institutional customers in the USA. • FY19 commenced commercial evaluat
Slide 15: Institutions in Southeast Asia and the USA Using or Evaluating Cxbladder
INSTITUTIONS IN SOUTHEAST ASIA AND THE USA USING OR EVALUATING CXBLADDER USA USA Singapore • Carolina Urologic Research • University of California-San Diego • Singapore General Hospital Center • University of California-San Francisco • Tan Tock Seng • City of Hope • University of Chicago • Khoo Tech
Slide 16: Growing Clinical Evidence for Cxbladder
GROWING CLINICAL EVIDENCE FOR CXBLADDER • Publication of peer-reviewed papers is key to gaining coverage and positive reimbursement decisions. • Library of comprehensive clinical evidence for physicians, healthcare payers (reimbursement) and healthcare providers alike. • Application to have Cxbladde
Slide 17: Commercial Progress in Line with Peers
COMMERCIAL PROGRESS IN LINE WITH PEERS Cxbladder’s commercial progress is currently in line with peers in the diagnostics world; gaining Test Volume of Various Diagnostics Post Launch coverage and reimbursement decisions will be key 50,000 to driving volume. 45,000 40,000 Inclusion in ASCO and 35,00
Slide 18: Diagnostic Outperformance Published in World #1 Clinical Journal
DIAGNOSTIC OUTPERFORMANCE PUBLISHED IN WORLD #1 CLINICAL JOURNAL DEMONSTRATES SIGNIFICANT CLINICAL UTILITY OF CXBLADDER • Diagnostic outperformance published in global number one* ranked urology journal, European Urology, in May 2019. Results: • Use of Cxbladder resulted in 35% of patients avoiding
Slide 19: Compelling Results from Clinical Look-Back Study
COMPELLING RESULTS FROM CLINICAL LOOK-BACK STUDY ARTICLE SUPPORTS THE INCLUSION OF CXBLADDER IN A CLINICAL PATHWAY FOR THE INVESTIGATION OF HAEMATURIA Inclusion of a molecular marker of bladder cancer in a clinical pathway for Published by the Canterbury District Health Board (CDHB) in the New Zeala
Slide 20: The Opportunity for Cxbladder
THE OPPORTUNITY FOR CXBLADDER
Slide 21: Detecting and Managing Urothelial Cancer Creates a Significant Healthcare Challenge
DETECTING AND MANAGING UROTHELIAL CANCER (UC) CREATES A SIGNIFICANT HEALTHCARE CHALLENGE GLOBALLY UC is a major global health problem: • 500,000 new cases annually • 200,000 deaths annually Kidney • 9th most prevalent cancer but 4th in men • Highest recurrence rates of any cancer 5% are upper tract
Slide 22: Clinical Pathway for UC/Bladder Cancer in USA
CLINICAL PATHWAY FOR UC/BLADDER CANCER IN USA HISTORICAL TESTING STANDARD OF CARE CXBLADDER EVALUATION BY PRIMARY Historically, diagnosis and Cxbladder Triage PHYSICIAN monitoring of bladder cancer Primary evaluation of haematuria has involved an arduous regime of invasive and REFERRAL TO A SPECIALI
Slide 23: Patients Don't Like Invasive Tests
PATIENTS DON’T LIKE INVASIVE TESTS PATIENT FEEDBACK REGARDING CYSTOSCOPY: BCAN SURVEY IN OVER 900 US PATIENTS WITH UC PATIENT COMMENTS CYSTOSCOPY PATIENTS REPORTED MODERATE TO SEVERE: • “I recommend being put to sleep. Dealing with these while awake ANXIETY was horrible.” • “Asked doc for valium to
Slide 24: Cxbladder: Filling an Unmet Clinical Need
CXBLADDER: FILLING AN UNMET CLINICAL NEED The suite of non-invasive Cxbladder tests represents a paradigm shift in performance offering physicians, patients and payers significant increases in utility and outcomes PROBLEM: CXBLADDER: • Existing detection and management of UC involves expensive and i
Slide 25: FY20 Outlook
FY20 OUTLOOK —s\ ancer Diagnostic Company
Slide 26: Key Objectives Going Forward
KEY OBJECTIVES GOWING FORWARD SUCCESS WITH THESE OBJECTIVES WILL ADD SIGNIFICANT GROWTH TO OUR BUSINESS: • GLOBAL REACH: Grow the number of large institutional healthcare customers globally and build on initial sales to these organisations. • USA: Successfully achieve the third and final USA reimbur
Slide 27: Our Primary Focus Remains the USA Market
OUR PRIMARY FOCUS REMAINS THE USA MARKET A SCALE OPPORTUNITY IN BOTH THE EVALUATION OF HAEMATURIA AND MONITORING FOR RECURRENCE UROTHELIAL AND BLADDER CANCER IN THE US 5 January 2019 *EY-Parthenon business review of the US market opportunity 2019 Annual Meeting 27
Slide 28: Positive Growth Outlook for Pacific Edge
POSITIVE GROWTH OUTLOOK FOR PACIFIC EDGE FY20 expectations are for: • Continued growth in commercial sales from new and existing customers. • Demand from public healthcare providers in New Zealand to grow strongly and positively impact on laboratory throughput volumes. • New Zealand business to be c
Slide 29: Shareholder Discussion
SHAREHOLDER DISCUSSION 2019 Annual Meeting 29
Slide 30: Business of the Meeting
BUSINESS OF THE MEETING 2019 Annual Meeting 30
Slide 31: Resolutions
RESOLUTIONS Resolution 1: That Chris Gallaher, who retires by rotation and is eligible for re-election, be re- elected as a Director of the Company. Resolution 2: That David Levison, who retires by rotation and is eligible for re-election, be re- elected as a Director of the Company. Resolution 3: T
Slide 32: Proxies and Voting
PROXIES AND VOTING We have received the following valid votes and proxies: PROXIES AND POSTAL VOTES FOR AGAINST DISCRETIONARY VALID % OF TOTAL VOTES/PROXIES ISSUED CAPITAL RECEIVED 1 Re-election of Chris Gallaher 192,616,683 2,365,098 3,129,581 198,111,362 38.78% 2 Re-election of David Levison 192,7
Slide 33: Other Business
OTHER BUSINESS 2019 Annual Meeting 33
Slide 34: Close of the Meeting
CLOSE OF THE MEETING Presentations are available at www.pacificedgedx.com David Darling Chief Executive Officer Pacific Edge Limited www.pacificedge.co.nz Tel: +64 3 479 5802 Mobile: +64 21 797981 www.cxbladder.com Email: david.darling@pelnz.com www.pacificedgedx.com
Slide 35: Disclaimer
DISCLAIMER Information The information in this presentation is an overview and does not contain all information necessary to make an investment decision. It is intended to constitute a summary of certain information relating to the performance of Pacific Edge Limited . The information in this presen