Slide 1: 1H 24 Financial Results Investor Presentation
Pacific Edge 1H 24 FINANCIAL RESULTS INVESTOR PRESENTATION Dr Peter Meintjes Chief Executive Officer Grant Gibson Chief Financial Officer 23 November 2023 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: Agenda
AGENDA 1. 1H 24 HIGHLIGHTS 2. STRATEGY DELIVERY 3. FINANCIAL PERFORMANCE 4. OUTLOOK 5. QUESTIONS
Slide 4: 1H 24 Highlights: Building Test Volumes in the US Despite Uncertainty
1H 24 HIGHLIGHTS: BUILDING TEST VOLUMES IN THE US DESPITE UNCERTAINTY 22%1 24% 50% ($15.1M) $62.2M GLOBAL TESTING COMMERCIAL GROWTH IN NET LOSS AFTER CASH, CASH VOLUMES TEST VOLUMES OPERATING TAX EQUIVALENTS3 (TLT2) on 1H 23 on 1H 23 REVENUE on 1H 23 Global TLT of 18,229 Commercial Tests of 15,401 O
Slide 5: Value Creation Through Three Pillars
VALUE CREATION THROUGH THREE PILLARS INPUTS OUTPUTS ADOPTION, RETENTION AND EXCELLENT PATIENT EXPERIENCE OUR PEOPLE REVENUE AND ACCURATE RESULTS GENERATION EARLY DETECTION AND OUR PROCESSES CLINICALLY ACTIONABLE CARE OUR IP, KNOWLEDGE INNOVATION PIPELINE FOR AND EXPERIENCE CLINICAL APPLICATIONS OUR
Slide 6: Developing a Track Record of Growth
DEVELOPING A TRACK RECORD OF GROWTH ABILITY TO EXECUTE DESPITE CHALLENGING MARKET HEADWINDS 1H 24 TOTAL LAB THROUGHPUT (TLT*) TEST VOLUMES BY TYPE (TLT*) • Global TLT increased 22% to 18,229 tests • Global Commercial test volumes increased 24% to 15,401 tests 23% 25% • Global TLT is driven by US gro
Slide 7: Medicare: Genetic Testing for Oncology (DL 39365) Response
MEDICARE: ‘GENETIC TESTING FOR ONCOLOGY’ (DL 39365) RESPONSE PACIFIC EDGE AND INDUSTRY DELIVERED A POINT-BY-POINT REBUTTAL INDUSTRY AND UROLOGY KEY OPINION LEADERS UNITED TO OVERTURN DL39365 • Pacific Edge engaged with oncology diagnostics industry & urology community during REPUBLISHED DRAFT LCD th
Slide 8: Building Resilience to Weather a Medicare Non-Coverage Decision
BUILDING RESILIENCE TO WEATHER A MEDICARE NON-COVERAGE DECISION PRESERVING CAPITAL, DIVERSIFYING REVENUE SOURCES, DRIVING PROFITABLE SALES OPERATIONS COMMITTED TO MAINTAINING A STRONG BALANCE SHEET APAC & HEAD OFFICE STRATEGIC RESPONSE • Pacific Edge expects to manage its cash reserves in the event
Slide 9: A Flexible and Goal Focused Sales Force
A FLEXIBLE AND GOAL FOCUSED SALES FORCE REORGANISATION DISRUPTS SALES IN Q2 24 US TEST VOLUMES (TLT*) AND ORDERING CLINICIANS WE HAVE REVIEWED OUR APPROACH TO THE US MARKET Commercial tests represent 84% of TLT in 1H 24 • Sales territories reduced from 29 to 17 10,000 1,232 1,300 • Sales initiatives
Slide 10: Selling Cxbladder's Clinical, Economic and Patient Value
SELLING CXBLADDER’S CLINICAL, ECONOMIC AND PATIENT VALUE For healthcare payers Cxbladder Detect offers substantial total cost savings per patient when used to intensify or de-intensify hematuria evaluation in patients presenting with microhematuria1 CURRENT PRACTICE (AUA GUIDELINES) CXBLADDER INTROD
Slide 11: Driving Growth in Asia Pacific and Consolidating New Zealand
DRIVING GROWTH IN ASIA PACIFIC AND CONSOLIDATING NEW ZEALAND* NEW ZEALAND IS A MATURE MARKET APAC TEST VOLUMES* • Cxbladder is covered in 15 of the 20 new Te Whatu Ora - Health New Commercial tests represent 84% of TLT in 1H 24 Zealand health regions, representing >75% of the population 1,400 • Te W
Slide 12: Strengthening Our Foundations: Performance Excellence
STRENGTHENING OUR FOUNDATIONS: PERFORMANCE EXCELLENCE DIGITALIZATION, AUTOMATION & CUSTOMER EXPERIENCE CXBLADDER NOW LIVE IN KAISER PERMANENTE’S EMR Customer facing systems Achievement expected to drive volume in 2H 24 • Give customers options to connect with Pacific Edge to fit their needs and smoo
Slide 13: Simplifying the Cxbladder Proposition – Detect+ and Monitor+
SIMPLIFYING THE CXBLADDER PROPOSITION – DETECT+ AND MONITOR+ LEVERAGING EVIDENCE SHOWING THE ADDITION OF DNA BIOMARKERS ENHANCES TEST PERFORMANCE3 OUR FUTURE 1. RDM: Residual Disease Monitoring, 2. TRM: Therapeutic Response Monitoring 3. Lotan et al ‘Urinary Analysis of FGFR3 and TERT Gene Mutations
Slide 14: 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 adoption by other independently contracted healthcare systems www.auanet.org www.nccn.org www.uroweb.org • Globally the most influential
Slide 15: Five Year Cxbladder Clinical Study Road Map
FIVE YEAR CXBLADDER CLINICAL STUDY ROAD MAP PACIFIC EDGE WILL SEEK GUIDELINE INCLUSION AS NEW EVIDENCE PRODUCED 15
Slide 16: Five Year Cxbladder Clinical Study Road Map (continued)
FIVE YEAR CXBLADDER CLINICAL STUDY ROAD MAP (continued)… STUDIES FOR DETECT+ AND MONITOR+ * *US CU-Surv – proposed study that will focus on clinical utility of Monitor+ in surveillance NMIBC patients 16
Slide 17: 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 National Compre
Slide 18: We Are Prepared Should FDA Regulate Lab Developed Tests
WE ARE PREPARED SHOULD FDA REGULATE LAB DEVELOPED TESTS FDA REGULATION FACES HURDLES • FDA has proposed LDTs like Cxbladder that are performed within a “single lab” as a CLIA/LDT are within its remit to regulate under the Medical Device Amendments of 1976 • 60-day comment period is expected to close
Slide 19: Research & Innovation – Focused on DNA Enhanced Products
RESEARCH & INNOVATION – FOCUSED ON DNA ENHANCED PRODUCTS READYING FOR THE LAUNCH OF NEW DETECT+ AND MONITOR+ • Ensure R&D, Digital and Lab Operations focus on the launch of Detect+ and Monitor+ • Simplifying Cxbladder to reduce technician time, lower cost of goods, lower turnaround time, increase th
Slide 20: 1H 24 Financial Performance
1H 24 FINANCIAL PERFORMANCE PACIFIC EDGE Cbiadcer <Y | PACIFIC EDGE
Slide 21: US Commercial Test Volume Growth Driving Revenue
US COMMERCIAL TEST VOLUME GROWTH DRIVING REVENUE RATE OF REVENUE GROWTH IN 2Q 24 EASES AMID SALE FORCE REORGANIZATION PACIFIC EDGE OPERATING REVENUE REGIONAL REVENUE CONTRIBUTION $25,000 5% $19,616 $20,000 1H 24 ▲ $15,000 50% $10,909 $(000) $11,445 95% APAC AMERICAS $10,000 $7,701 $6,067 $13,095 $5,
Slide 22: Revenue Grows with Increased Adoption of Cxbladder
REVENUE GROWS WITH INCREASED ADOPTION OF CXBLADDER LOSSES REFLECT INVESTMENTS FOR TOP LINE REVENUE GROWTH IN FY23 • Operating revenue rises with increased volumes 1H 24 1H 24 and an increase in average receipts 1H 24 2H 23 1H 23 Half year to 30 September vs. 1H 23 vs. 1H 23 • Total revenue includes
Slide 23: Operating Expenses Rise Reflecting Growth Configuration
OPERATING EXPENSES RISE REFLECTING GROWTH CONFIGURATION 2Q 24 REFOCUS ON PROFITABLE SALES, NEW REVENUE AND CASH PRESERVATION TO MODERATE EXPENSES 1H 24 1H 24 • Lab operating expenses rise with increased FINANCIAL PERIOD 1H 24 2H 23 1H 23 test volumes and higher freight costs vs. 1H 23 vs. 1H 23 (Mar
Slide 24: ESG: Pacific Edge Is Founded on Improving Social Outcomes
ESG: PACIFIC EDGE IS FOUNDED ON IMPROVING SOCIAL OUTCOMES Cxbladder delivers actionable information that can: contribute to clinically meaningful improvements in cancer treatment; improve patient lives; healthcare equity and outcomes; and healthcare payer operating expenditure savings1,2 GOVERNANCE
Slide 25: Outlook: Focused on FY24 Execution
OUTLOOK: FOCUSED ON FY24 EXECUTION • Pacific Edge expects the available cash to be sufficient to support the company in the event of an adverse Medicare coverage decision through to regaining coverage - a process that may take up to four years with interim coverage attempts with every piece of new e
Slide 26: Appendix
5 SS & PACIFIC, EDGE = Choiadder att amen
Slide 27: 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 27
Slide 28: 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 29: 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 30: 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 31: 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 32: 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 33: The Principles of Pacific Edge's Clinical Study Design Program
THE PRINCIPLES OF PACIFIC EDGE’S CLINICAL STUDY DESIGN PROGRAM Pacific Edge will attempt to gain guideline inclusion (and coverage) with every new piece of clinical or economic evidence supporting the adoption of Cxbladder STUDY GOAL* USE CASE / INDICATION POPULATION STRATA • CU of Triage • Risk str
Slide 34: 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+ CV AUSSIE (unpublished) (4) MH + GH* Study to start thi
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 Detect+). 2 Observational study to validate performance characteristics of Cxb Detect+ in patients with UC of the upper
Slide 36: 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 37: 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 38: 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 39: 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