Pacific Edge Presents at Bell Potter Healthcare Conference
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.