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Pacific Edge Presents at Bell Potter Healthcare Conference

Investor Presentation10 November 2021PEBHealthcare

PACIFIC EDGE
BELL POTTER HEALTHCARE

CONFERENCE

10NOVEMBER 2021

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Safe HarbourStatement and Disclaimer

MOLECULAR DIAGNOSTICS
making a difference globally

We are a globally focused cancer

diagnostics company specialising in

developing and commercialising

molecular diagnostic tests that

address large unmet needs in the

detection and management

of cancer.

PACIFIC EDGE IS DELIVERING ON THE STRATEGY
A GLOBAL CANCER MOLECULAR DIAGNOSTICS COMPANY

Validated and class leading suite of Cxbladder products

•Four urine-based diagnostic tests (Cxbladder) for the detection and

management of Urothelial Cancer (UC)

•First new diagnostic tests to be commercially available for UC in 19 years

•Commercial sales in New Zealand, Australia, Singapore and the U.S.

•CMS reimbursement and product specific CPT codes for Cxbladder Detect

and Cxbladder Monitor

Portfolio of intellectual property and clinical evidence

•Products are underpinned by extensive clinical evidence published in top-

tier international journals

•Potential to leverage existing intellectual property into new product

development for the detection and management of other cancers that can

be detected in urine

Compelling growth opportunity

•The Annual Addressable Market (AAM) for Cxbladder in the U.S. estimated

to be more than US$3.5b

*

•Laboratory infrastructure in place in New Zealand and the U.S. with a

combined design capacity for 300k tests per annum

•Dedicated and growing US sales force in place to drive test growth

* Pacific Edge estimate, discussed further on slide 19

4

UROTHELIAL CANCER (UC)
A SIGNIFICANT GLOBAL HEALTHCARE CHALLENGE

•~ 550,000 new cases in 2018

1

•~ 200,000 deaths annually

1

•10th most common cancer globally, 6th most common

in men

1

and the 5th most common in the US

•The disease is characterisedby haematuriablood in the

urine

•High recurrence rates ( with 70% recurrence following

treatment). Requires regular monitoring

•High detection and management costs with invasive

tests and procedures

•Patient compliance low ~40% leading to an increase in

disease progression

5%

are upper

tract (not

including

kidney)

95%

are bladder

cancer

Ureter

Bladder

Kidney

Urothelial Cancer

1. Bray et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality

worldwide for 3 cancers in 185 countries. Ca Cancer J Clin. 2018;68:394-424

5

CLINICAL PATHWAY FOR UROTHELIAL CANCER
Primary Detection of UC -HematuriaSurveillance

MONITORING

FULL

EVALUATION,

DIAGNOSIS

AND

TREATMENT

REFERRAL

TO A

SPECIALIST

EVALUATION

BY PRIMARY

PHYSICIAN

Trad i t i o n al test s are expensive, invasive and have poor relative performance ... providing

significant opportunities for new diagnostic tests that are cheaper, non-invasive and accurate.

The Cxbladder suite of products from Pacific Edge provides better care for patients, better

utility for urologists and savings for healthcare payers.

CXBLADDER REVOLUTIONISES HOW UROLOGISTS
DETECT AND MANAGE UROTHELIAL CANCER

1. U.S. commercial launch of Cxbladder Resolve will be initiated in FY22

7

Four class leading, urine based diagnostic tests for UC addressing multiple unmet needs across

the clinical pathway:

Cxbladder Resolve

1

(CxbR): Segregates High ImpactTumours(HIT) from

Low ImpactTumours(LIT) enabling a prioritisation of patients with cancer

Cxbladder Detect (CxbD): For use by urologists for patients who have

been referred for a full UCworkup to detect cancers

Cxbladder Triage (CxbT): Front line test for use in the primary evaluation

of haematuria to rule out patients who do not have cancer

Cxbladder Monitor (CxbM): Provides front line identification for urothelial

cancer patients being monitored for recurrence of the disease

Integrated into standards of care and guidelines for a number of healthcare providers in New Zealand and the

NCCN guidelines in the U.S.

CXBLADDER’S CLASS LEADING PERFORMANCE METRICS:
SENSITIVITY, SPECIFICITY AND NEGATIVE PREDICTIVE VALUE (NPV)

8

Primary Detection of UC -Haematuria

Cxbladder TriageCxbladder DetectCxbladder ResolveCxbladder Monitor

Sensitivity 95%

NPV 99%

Sensitivity 82%

Specificity 85%

NPV 97%

Sensitivity (HIT) 92%

Specificity (HIT) 94%

NPV 99%

Sensitivity 93%

NPV 97%

Surveillance of UC

Cxbladder’sclass leading performance metrics provides the confidence for physicians to:

1.Safely rule out patients who do not have disease,

2.significantly reduce the need for expensive, invasive tests

3.identify high impact tumoursfor immediate prioritization

4.Non-invasive test increases patient’s compliance with physicians clinical recommendations

HIT

: High Impact Tumours; T1-T4, Cis, Ta HG

FIRST MOVER ADVANTAGE WITH SIGNIFICANT COMPETITIVE
ADVANTAGE

9

10
OUR LONG TERM GROWTH OBJECTIVES REMAIN

CONSISTENT OVER TIME

Drivecommercial use with large scale

institutional accounts in each targeted

market

Positively shiftour commercial customers

to progress to include multipleCxbladder

products in their standard of care and

commercial use

Gain greater recognition in urology

guidelines globally to enhance adoption

Trigger commercial activity in Australia

and South East Asia following publication

of SEA User Programme evidence

LAUNCH AND
COMMERCIALISE ALL

FOUR CXBLADDER

PRODUCTS IN OUR

TARGETED MARKETS

GLOBALLY

üCxbladder remains the only suite of products

which cover the clinical pathway for urothelial

cancer

üSuite of four Cxbladder products -three

products commercially available in the U.S.

•Fourth product –Cxbladder Resolve -to

commencecommercial launch in U.S. in FY22

•Strong adoption of Cxbladder is underway in NZ;

acceleratingmomentum in U.S. and progression

of User Programmes in Singapore and Australia

•Gain greater recognition in national guidelines

to deepen and accelerate commercial use of

Cxbladder

Achieved

Forward focus

11

COMMERCIAL ADOPTION IN NZ LEADS THE WORLD
12

•More than 70% of New Zealand’s

population now have access to Cxbladder

through contract coverage by their public

healthcare providers, who have adopted

Cxbladder into commercial mainstream use

and their standard of care

•New electronic guideline ‘Health Pathways’

with Cxbladder Triage and imaging for all

haematuria patients -replacing previous

gold standard cystoscopy and other tests

and procedures

13
TriageDetectMo nitor

TLT by Test Type

(as at 31 March 2021)

PRIMARY REVENUE GENERATION FOCUS

REMAINS UNITED STATES

USRest of World

Total Laboratory Throughput

(TLT) by Region

(as at 31 March 2021)

UNITED STATES

75% FY21 Total Laboratory Throughput

SOUTH EAST ASIA

AUSTRALIA

NEW ZEALAND

Pacific Edge’s perspective on the relative size of the market opportunity

14
SIGNIFICANT U.S. TOTAL ADDRESSABLE MARKET

> US$3.5 BILLION OPPORTUNITY FOR CXBLADDER PRODUCTS IN BOTH THE

EVALUATION OF HAEMATURIA AND MONITORING FOR DISEASE RECURRENCE

U.S. ANNUAL

ADDRESSABLE

MARKET

MORE THAN 5 MILLION

CXBLADDER TEST

OPPORTUNITIES PER

YEAR WITH AN

ESTIMATED ANNUAL

REVENUE POTENTIAL OF

MORE THAN

US$ 3.5 BILLION*

* Pacific Edge estimate

SUSTAIN THE GLOBAL FIRST
MOVER ADVANTAGE;

MAKE CXBLADDER THE

PREFERRED GO-TO

DETECTION AND

MANAGEMENT TESTS FOR

UROTHELIAL CANCER

üStrong competitive advantages –first mover

position, leader in the field, years of

investment into development and validation,

IP protection

üIncreasing coverage by U.S. payers (insurers)

üSignificant portfolio of peer-reviewed

published papers supporting superior

performance of Cxbladder products

üConcluded major U.S. reimbursement and

commercial milestones

üIncluded under the NCCN guidelines for

monitoring for recurrence

üKaiser Permanente signed up and now

commercially using both CxbladderMonitor

and CxbladderTriage

Achieved

15

üCMS* reimbursement coverage for Cxbladder Detect
and Cxbladder Monitor from 1 July 2020 at US$760

per test

üCMS related tests (Medicare and Medicare

Advantage) accounted for 67% of U.S. commercial

test volumes in FY21

üCxbladder Detect and Cxbladder Monitor accounted

for the majority of U.S. commercial test volumes in

FY21

üInclusion in the CMS’s Local Coverage Determination

(LCD) has resulted in a significant increase in

recognised revenue and cash receipts –with CMS

tests paid in approximately 30 days

üMany global healthcare providers regard CMS

reimbursement as a significant validation –which is

expected to pave the way for wider adoption

The successful LCD decision has allowed Pacific

Edge to start recognising revenue (under NZ IFRS

15) for tests that are performed on CMS patients

(Medicare and Medicare Advantage) in the US at

the CMS price of US$760 per test for Medicare

REIMBURSEMENT

COVERAGE BY THE CMS

PROVIDES A SIGNIFICANT

VALIDATION AND

COMMERCIAL MILESTONE

16

* Centers for Medicare and Medicaid Services is the US National

insurance payer for all US citizens over 65 years of age

Achieved

17
PIVOTAL CLINICAL PAPER

HIGHLIGHTS SIGNIFICANT BENEFIT FROM

USE OF MULTIPLE CXBLADDER PRODUCTS

§Co-authored by leading U.S. urologists and accepted for

publication in the Journal of Urology

*

§Demonstrates the significant clinical and patient benefits

from the use of a combination of Cxbladder products to:

§Firstly rule out those who do not have cancer;

§Then accurately identify those with cancer; and

§Finally, segregate out those with high-impact

tumours for priority investigation.

§Highlights the enhanced clinical resolution from the

integrated use of Cxbladdertests to provide 4.8x higher

efficacy in the segregation of patients by risk class, than

the latest American Urological Association (AUA)

guidelines

The Journal of Urology is the official journal of the American Urological Association (AUA) and the most

widely read and highly cited journal in the field of Urology. The paper publication on 8 July 2021

18
RECENT PUBLISHED EVIDENCE SUPPORTS

OUTPERFORMANCE OF CXBLADDER PRODUCTS

Real world use of the Patient –In-Home-Sampling-System for patients at home in the

US during the Covid-19 pandemic

American Urological Association’s (AUA) Journal of Urology -“real world lookback study” highlighting

the clinical utility of Cxbladder Monitor being used in the Covid setting for managing patients outside

the clinic

The publication concluded that the use of Cxbladder Monitor and Pacific Edge’s Patient-In-Home

Sampling System:

-Could be used to further stratify low risk patients for decreased surveillance during the pandemic

and beyond;

-Reduced the number of cystoscopies required; and

-Was feasible and safe for patients being monitored for urothelial cancer during the Covid-19

pandemic.

The clinical paper was authored by CarrisaChu, Kevin Li, Maxwell Meng and SimaPortenfrom the Department of Urology at the

University of California San Francisco. The paper published Journal of Urology September 2021

GUIDELINES INCLUSION WILL ACCELERATE GROWTH
Inclusion in guidelines is a progressive process

requiring substantive clinical evidence and

generally follows post mainstream adoption by

healthcare providers.

Cxbladder has been included in:

•New Zealand’s national standard of care and

many of the local guidelines, replacing the

gold standard cystoscopy

•The U.S.’s NCCN Guidelines with a 2b

recommendation for patients being

monitored for recurrence of urothelial

cancer

•The publication of additional

peer reviewed evidence

highlighting the validation

and clinical utility of the

Cxbladder products in our

target markets

•Changes are now being seen

in both AUA and EAU 2020

guidelines wording that could

help facilitate our inclusion

Our focus will continue on:

19

GROW THE ADOPTION
OF CXBLADDER BY

LARGE SCALE

INSTITUTIONAL

HEALTHCARE

CUSTOMERS, FOR

MULTIPLE TARGETED

CLINICAL NEEDS

üInclusion in LCD for CMS reimbursement

üCommercial agreement with Kaiser

Permanente

üGrowing adoption and use by large

scale, highly reputable healthcare

organisations

üMore than 70% of NZ’s population

under coverage by public healthcare

providers

Our focus on obtaining agreements for

commercial use of Cxbladder by large

institutional accounts has been shown to be

successful in NZ and now the U.S.

Achieved

20

ADOPTION OF MULTIPLE CXBLADDER PRODUCTS
§Increasing awareness of Cxbladder as a

proposition to better manage urology patients in

the global Covid pandemic

§Allows urologists and healthcare providers to

manage patient care from home and reduce

number of patients coming into clinics

§New Zealand leading the world in adoption and

commercial use of multiple Cxbladder products,

and inclusion in standards of care

§Kaiser Permanente moving to commercial use of

second Cxbladder product, Cxbladder Triage

§Pivotal Cxbladder clinical performance paper

published in high profile urology journal;

highlighting benefits and clinical utility from

multiple product use

21

KAISER PERMANENTE:
LARGE COMMERCIAL CUSTOMER

FOR

CXBLADDER AND PROVIDES SIGNIFICANT

VA L I DAT I O N

•Kaiser is the largest non-profit healthcare provider in the U.S. with

over 12 million members (approximately 3.8% of the U.S.

population), 39 hospitals and approximately 23,000 physicians.

•Kaiser is reported to manage ~2% of U.S. urology patients

•Around 800,000 people in the U.S. are reportedly monitored for

urothelial cancer, up to 4 times per year for 5 years

•National agreement with Pacific Edge for all Cxbladder products

•Utilising Cxbladder’s Patient In-Home Sampling System for its

patients, with the process managed by Pacific Edge

•Kaiser reported approximately 15% of consultations were telehealth

prior to Covid-19. The proportion of telehealth consultations are

reported by Kaiser to have increased to around 95% during Covid-

19

22

COMMERCIAL USE OF CXBLADDER BY KAISER
PERMANENTE

•Commercial use of Cxbladder Monitor progresses, however, pace of roll-out still hampered by

Covid-19

•Commitment to start commercial use of Cxbladder Triage commenced in August of 2021 well ahead

of expected schedule. CxbTwill add volume to the use of CxbladderMonitor

•Growth in the commercial use of Cxbladderis expected to grow progressively in Kaiser Permanente

over the latter part of FY22/early FY23 as Covid restrictions ease and electronic management of

processes are concluded

23

CONTINUING EVALUATION AND USE OF CXBLADDER
BY LARGE HEALTHCARE INSTITUTIONS

USAUSASOUTH EAST ASIA

•Kaiser Permanente (Completed)

•Carolina Urologic Research

Center

•City of Hope

•Cleveland Clinic

•Cornell

•Fox Chase CC

•Johns Hopkins CC

•MD Anderson

•Moffitt CC

•Ohio State University CC

•Penn State Milton S. Hershey

Medical Center

•Rush University

•Thomas Jefferson University

•TriStar Medical Center

•UCLA

•University of California-San

Diego

•University of California-San

Francisco

•University of Chicago

•University of Colorado

•University of Michigan

•University of Minnesota

•University of Oklahoma

•University of Pennsylvania

•University of Southern

California

•UT Southwestern

•VA Accounts

•Wellstar

•Singapore General Hospital

•Tan Tock Seng

•Khoo Tech PuatHospital

•KK Women’s and Children’s

Hospital

•National University Hospital

•Raffles Medical Group

•Gleneagles Private Hospital

AUSTRALIA/NEW ZEALAND

•AUS: Multiple large public

hospitals across Australia

•NZ: Majority of public

healthcare providers

24

GROWING REIMBURSEMENT BY U.S. HEALTHCARE
PROVIDERS AND PAYERS

FACEY MEDICAL GROUP

•Multi-specialty medical group with

over 180 physicians providing care

to more than 170,000 patients in

California

•Affiliated with, or owned by

Providence Health & Services, one

of the largest health systems in the

Western United States.

•Agreement covers the use of

CxbladderDetect and Cxbladder

Monitor for Facey Medical Group

patients.

UNITED HEALTHCARE COVERAGE

•The largest private health insurer in the

U.S 50 million members with more than

5.7 million Medicare Advantage

members

•Coverage has facilitated reimbursement

for Cxbladder Detect and Cxbladder

Monitor tests performed on United

Healthcare patients (Medicare

Advantage policy holders) from 1April

2021 at US$760 per test

25

FY21 AND FY22 YTD
PERFORMANCE

26

OUR CHANGING WORLD:
COVID HAS PRESENTED CHALLENGES AND OPPORTUNITIES FOR PACIFIC EDGE

•The value of a robust healthcare system and enduring infrastructure has become

evident

•The pandemic accelerated the deployment of innovative technologies and

platforms, in particular telemedicine

•Adoption accelerated from the lifting of barriers, increase in CMS reimbursement

rate

•Telemedicine is becoming a sustained channel in the healthcare sector, during

and post-Covid19

•Drivers to changing established physician and healthcare provider behaviour –

education and publication of peer reviewed high performance evidence

27

•Pacific Edge’s U.S. reimbursement milestones in
place

•Commercial agreement with largest single

validation customer in U.S. –Kaiser

Permanente

•Existing system in place for in-home sampling;

tested and proven by Kaiser Permanente study

•Simple and effective solution for urologists

•New Zealand urologists leading the way

globally

Pacific Edge, our Cxbladder products and urine sampling system were identified by

many customers and urologists as being central to enabling telemedicine, in the

urology space, when the Covid-19 pandemic took hold:

28

FY21 WAS A YEAR OF ACHIEVEMENT
IN A DIFFICULT GLOBAL ENVIRONMENT

üCMS coverage for Cxbladder Detect and Cxbladder

Monitor

üCommercial agreement with Kaiser Permanente for

all four Cxbladdertests

üPublication of additional clinical evidence

highlighting the clinical utility of Cxbladder

üScale up of U.S. operations to accelerate revenue

growth

üCommercial agreements with NZ public healthcare

providers for more than two thirds of NZ’s

population

üInclusion in S&P/NZX 50 Index

29

0
5

10

15

20

25

Total RevenueOperating

Revenue

Cash ReceiptsCash &

equivalents

$Millions

FY20FY21

FY21 DELIVERED STRONG IMPROVEMENT

ACROSS OUR KEY FINANCIAL METRICS

Financial Milestones

ü76% increase in operating revenue

ü52% increase in cash reimbursement

ü25% decrease in net loss after tax

ü56% increase in net cash, cash

equivalents and short term deposits

30

GROWTH CONTINUES IN FY22
Q1 FY22 was a record quarter for Cxbladdertest volumes and cash receipts

Q1 FY22 Total Laboratory Throughput:

•Up 79% on Q1 FY21

•Up 9% on Q4 FY21

•Up 35% on quarterly average from

FY21

•Q1 FY22 Cash Receipts:

•Up 142% on Q1 FY21

•Up 21% on Q4 FY21

•Up 50% on quarterly average in FY21

5356

2,000

3,000

4,000

5,000

6,000

Q1 21Q2 21Q3 21Q4 21Q1 22

Test Numbers

Total Laboratory Throughput

31

POSITIVE GROWTH
OUTLOOK

32

33
STRONG PLATFORM TO ACCELERATE GROWTH

•Four class leading products for the detection and management of Urothelial

Cancer (UC), addressing a large, under-served global market opportunity -AAM

for Cxbladder in the U.S. estimated to be more than US$3.5b

•Reimbursement milestones achieved in U.S. –CMS coverage and United

Healthcare coverage for CxbladderDetect and CxbladderMonitor

•Commercial agreement with largest single validation customer in U.S. –Kaiser

Permanente with 12.8 million people covered

•The majority of the public healthcare providers signed up in New Zealand

covering more than 70% of the national population

•Two proprietary CAP-accredited, CLIA certified laboratories with a combined

design capacity for approximately 300k tests per annum

•Recent ASX dual listing and $103.5m capital raise provided funding to execute

growth strategy and accelerate commercial opportunities

•U.S. Laboratory design capacity: 260,000 tests p.a
•Building US sales team to accelerate the adoption of Cxbladder: 28

account managers as at 31 October 202

•Expanding new and existing sales territories

•Expansion of customer services team to drive Patient In-Home Sampling

System program for Kaiser and others

SCALE-UP OF U.S. COMMERCIAL OPERATIONS DRIVING

GROWTH

34

•Growing portfolio of published, clinical evidence in tier 1 clinical journals

is driving adoption and inclusion in guidelines

28

OUTLOOK
The U.S. remains Pacific Edge’s primary near

term focus:

§An increasing number of

commercially reimbursed tests from

CMS and Kaiser Permanente covered

patients are currently expected to

underpin strong revenue growth and

growth in cash receipts in FY22 and

beyond;

§Positive results from the recent scale-

up of U.S. commercial operations are

now starting to be seen;

§United Healthcare* coverage

provides validation supporting the

potential adoption and coverage of

Cxbladder with other private payers

in the U.S.

§Strong growth continues in New Zealand with

customers moving to multiple Cxbladder products

in mainstream use

§Southeast Asia has the potential to become a

market of scale over time with an accessible

population base larger than the U.S.

§Australia is in the early stages of commercial take-

up and there exists an opportunity to deliver sales

and volume growth

§Potential to develop and grow new product

opportunities by leveraging the company’s

intellectual property across other cancers that can

be detected in urine

* Currently Medicare Advantage policyholders

“Pacific Edge has an exciting and profitable future ahead. We
have a proven team delivering on a huge market opportunity

for our Cxbladder products and we are just starting to scratch

the surface. We are now well positioned to accelerate our

momentum and grow adoption of our novel and world

leading products.”

36

David Darling CEO Pacific Edge

November 2021

DISCUSSION
37

Data sourced from publicly available filings. Our datasets may not be complete. Automated analysis can produce errors. If you believe any data on this page is incorrect, please contact us at hello@nzxplorer.co.nz. For informational purposes only. Not investment advice.