Pacific Edge Limited · NZX:PEB
Pacific Edge — Corporate Update (January 2025)
18 slides from Pacific Edge's corporate update, Jan 13, 2025
Slide 1: Novitas LCD Investor Presentation
NOVITAS LCD INVESTOR PRESENTATION Chris Gallaher Chairman Dr Peter Meintjes Chief Executive Officer 13 January 2025
Slide 2: Important Notice and Disclaimer
IMPORTANT NOTICE AND DISCLAIMER This presentation has been prepared by Paci fic Edge Limited (PEL) solely PEL’s current views with respect to future events. Forward-looki ng Investm ent risk to provide interested parties wi th further information about PEL and its statements, by their very nature, i
Slide 3: Pacific Edge's Medicare Journey
PACIFIC EDGE’S MEDICARE JOURNEY July ’20 July - Sep ’22 Jan ’23 June - July ’23 Aug ’23 – May ’24 Aug ’24 Jan ’25 Novitas informs Open Meetings, Triage gains We pursue all legal Participated in Published AV Novitas finalizes Pacific Edge that Public Comment. coding and and political Novitas’ open no
Slide 4: 'Genetic Testing in Oncology: Specific Tests' (L39365)
‘GENETIC TESTING IN ONCOLOGY: SPECIFIC TESTS’ (L39365) FINDINGS US COMMERCIAL TEST VOLUMES AND ASP* (US$) • Finalized LCD no longer relies on 3rd party databases/compendia $700 16,000 • Finalized LCD no longer preemptively non-covers non-commercial tests $613 $618 • Finalized LCD has been reduced to
Slide 5: Novitas Continues to Misunderstand the Value of Cxbladder
NOVITAS CONTINUES TO MISUNDERSTAND THE VALUE OF CXBLADDER • Appears to misunderstand the intended patient population and the important role that biomarkers can play in risk stratifying hematuria patients • Appears to assume Cxbladder products are a screening test • Fails to consider new peer reviewe
Slide 6: Value Creation Through a Focus on Three Pillars
VALUE CREATION THROUGH A FOCUS ON THREE PILLARS WE PREPARED FOR THIS OUTCOME • We have re-focused the business on clinical development for guidelines inclusion and increased coverage certainty for Detect Plus & Monitor Plus • We have restructured our commercial operations to focus on profitable terr
Slide 7: Setting a Route to Regaining Medicare Coverage
SETTING A ROUTE TO REGAINING MEDICARE COVERAGE ACTIVATING OUR CONTINGENCY PLANS • Potential legal challenge to the LCD on procedural and fairness grounds • Further review the structure of our operations and our strategy to reduce cash burn in line with our plan to regain Medicare coverage • Submit a
Slide 8: 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 9: 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 10: 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 11: Summary and Outlook
SUMMARY AND OUTLOOK ge PacificEdge’ CANCER DIAGNOSTICS
Slide 12: Outlook: More Catalysts Than Headwinds
OUTLOOK: MORE CATALYSTS THAN HEADWINDS • We are disappointed with this decision, but have prepared for it • We will focus on the available legal and appeals avenues in the next 45 days • We will continue our evidence generation focus until re-coverage • The company is well placed to fund the re-cove
Slide 13: Appendix
APPENDIX ge PacificEdge’ CANCER DIAGNoSTICS.
Slide 14: 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 15: 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 16: 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 17: 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 18: 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