Quarterly Investor Update – Q2 FY23 Test Volumes rise 36%

OCTOBER 2022
INSIDE
From the CEO 2
Test Volumes 3
Primary Care 4
Novitas Proposal 4
National Sales Meeting 5
Evidence Coverage and Guidelines 6
US Leadership 7

PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2022
2
Dear Shareholders,
In this second quarter shareholder
update, I am pleased to report the
investments we are making to drive
the adoption of Cxbladder tests
globally are delivering early results.
As we detail on page 3,
the volume of Cxbladder tests
processed at our US and New
Zealand laboratories has risen
strongly against the first quarter
and the prior year, with the increase
in throughput being mirrored by
an increase in the number of US
clinicians ordering our tests.
We have on-boarded 14 new
people since the end of March,
bringing our global team to 100
at the end of September. Most
of the new hires are charged
with advancing our revenue
growth objectives and increasing
awareness of the peer-reviewed
clinical evidence that underpins the
clinical value of Cxbladder.
We have hired effectively
against plan with the recruitment of
new Account Executives (AEs) and
marketing hires, while establishing
our new Medical Affairs Team
and new Virtual Sales Team. The
Virtual Sales team, responsible for
growing our sales pipeline through
prospecting activities, while
enhancing the Cxbladder customer
experience with streamlined
service, ordering, and delivery of
test results, is the first among these
new hires to have a clear impact.
We expect all commercial hires
to build further momentum in the
quarters ahead.
Our US National Sales Meeting
(see page 5), held in September
under the banner of ‘Unlocking Our
Potential’, was a key step towards
this goal. We assembled all staff
across the broader commercial
team and focused our training on
a standardized selling process,
maturing our new AEs, and
upskilling our tenured AEs, while
creating opportunities to share
successes, and reinforcing a culture
that celebrates excellence at Pacific
Edge.
“The increase in
throughput is being
mirrored by an increase
in the number of US
clinicians ordering our
tests”


In the New Zealand market,
we continue to make progress in
encouraging healthcare providers
to use Cxbladder earlier in the
patient care pathway (see page
4). We have also made further
steps into new markets such as
Australia and Singapore, including
the recruitment of a new business
development manager for
Southeast Asia, based in Singapore.
We continue to advance our
clinical evidence generation
program to strengthen the case
for Cxbladder to be included in
global standards of care and gain
coverage by healthcare payors.
Patient recruitment is steadily rising
for studies already underway, while
the more-recently initiated studies
are navigating key administrative
milestones (see page 6).
This important progress
continues despite the release
for public comment in July of a
proposed new Local Coverage
Determination (LCD) from Novitas,
the Medicare Administrative
Contractor with jurisdiction for our
US laboratory. If accepted without
change, this proposed LCD would
result in a loss of coverage for
Cxbladder tests by the US Centers
for Medicare & Medicaid Services
(CMS).
As demonstrated by the
continued increase in Cxbladder
testing volume, the proposal has
had little to no impact on demand
for our tests. Cxbladder remains
a covered test while submissions
on the proposed LCD are being
considered, and feedback from our
sales force is that it is not on the
radar of our key US customers and
physicians.
Pacific Edge maintains that in the
absence of any adverse reporting
event about the performance
of Cxbladder, it would be
unprecedented to lose coverage. To
this end, we have offered comments
on the proposal (see page 4). We
maintain our position that the
proposed LCD is unlikely to survive
in its current form and continue to
responsibly plan for all eventualities.
We look forward to providing
a further update when we release
our half year financial results on 24
November 2022.
Dr Peter Meintjes
Chief Executive
FROM THE CEO
BUILDING MOMENTUM IN
OUR MARKETS

PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2022
3
TEST VOLUMES
INVESTMENTS IN US SALES AND MARKETING
DRIVING RESULTS
Cxbladder tests processed at
Pacific Edge’s laboratories
in the US and New Zealand
have set another record in an
early demonstration that our
investments to drive adoption are
delivering results.
In the three months to the
end of September 2022, the
team processed 7,861 tests, a 36%
improvement on the 5,780 tests
processed in the same quarter
in the prior financial year and an
11% increase on the 7,055 tests
processed in the three months to
the end of June 2022. For the six-
month period, test volumes reached
14,916, a 34% increase on the 11,136
tests processed in the same period
in the prior financial year.
US test volumes for the latest
three-month period increased to
6,696, a 42% improvement on the
4,706 in the same period a year ago
and up 10% on the 6,073 processed
in the three months to the end of
June. For the six-month period,
US test volumes were also up 42%
on the same period a year ago to
12,769.
We have also seen an increase
in US clinicians ordering our tests
to 979, a 42% increase on the 689
ordering clinicians at the same time
a year ago and 10% ahead of the
894 ordering clinicians at the end of
June 2022.
Our internal metrics show that
this increase in ordering clinicians
reflects an important contribution
from the new Virtual Sales Team,
a key element of the investment
program to drive growth we set
out in May 2022. This team has
had an immediate impact through
prospecting activities, and by
assisting on-the-ground teams with
the on-boarding of new clinicians
and urology practices, while
ensuring the streamlined ordering of
tests and results delivery.
We continue to prudently invest
in line with the investment program,
which as we mentioned in May is
linked to the achievement of certain
revenue milestones. In addition to
the hiring of a new Virtual Sales
team, our recruitment program
has included hiring of account
and marketing executives and the
establishment of a new Medical
Affairs team.
We are confident that these
investments will continue to build
sales momentum. The Account
Executives we hired last year are
beginning to hit their stride, while
new hires are learning the ropes
and bringing fresh insights and
energy to the team.
We are seeing early results with
opportunities emerging in previously
uncovered territories. Similarly,
our Medical Science Liaison team
is quickly upskilling, developing
strategies to drive enrolment in our
clinical studies and support our sales
efforts.
In the Asia Pacific, where test
numbers are dominated by the
relatively mature New Zealand
market, volumes in the three-month
period were 1,165, an 8% increase
on the same period a year ago and
a 19% increase on the June 2022
quarter. For the six-month period,
New Zealand test volumes were
largely flat on the same period a
year ago at 2,147 tests.
UNIQUE ORDERING CLINICIANS (US)
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000

Q1 FY23Q2 FY23Q4 FY22Q3 FY22Q2 FY22Q1 FY22Q4 FY21Q3 FY21Q2 FY21
Test volume
USNZ
42%
CAGR
2,791
3,110
3,824
4,277
4,706
4,591
5,290
6,073
6,696
1,073
1,079
1,074
1,117
952
982
1,165
943
1,088
-
200
400
600
800
1,000
1,200

Q1 FY23Q2 FY23Q4 FY22Q3 FY22Q2 FY22Q1 FY22Q4 FY21Q3 FY21Q2 FY21
Physicians
46%
CAGR
462
516
530
657
689
740
782
894
979
TOTAL TESTING VOLUME (PACIFIC EDGE GROUP)

PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2022
4
PRIMARY CARE
CXBLADDER BUILDS MOMENTUM
IN THE COMMUNITY
NOVITAS PROPOSAL
SEEKING US REIMBURSEMENT CERTAINTY
Te Whatu Ora Te Pae Hauora o
Ruahine o Tararua MidCentral and
Te Whatu Ora Whanganui have
become the latest New Zealand
regional public healthcare providers
to adopt Cxbladder in the primary
care setting.
From the end of September
General Practitioners in Palmerston
North, the Horowhenua, Manawatu,
Otaki and the Whanganui districts
have been able to use Cxbladder
Triage (CxbT), together with
imaging to assist them to safely
rule out bladder cancer in patients
presenting with hematuria.
By identifying these patients
in primary care, CxbT reduces
the need for urology referral and
further invasive testing, such as
a cystoscopy. This new primary
care pathway offers a streamlined
standard of care and is receiving
increasing attention from patient
advocacy groups, as it provides
patients with greater comfort and
peace of mind.
The approach was pioneered in
Canterbury and was supported by a
clinical review published in the New
Zealand Medical Journal in 2020
1
.
The review showed fewer patients
were referred to secondary care
and required invasive procedures.
When cancer was diagnosed the
time to treatment was also reduced.
Meanwhile those who received a
negative CxbT test gained early
reassurance (within a couple of
weeks) that they did not have
bladder cancer.
More than 70% of New Zealand’s
population now has access to
Cxbladder through the public
health system and we are actively
engaging with the national system,
Te Whatu Ora – Health New Zealand
and Te Aka Whai Ora, the new Māori
Health Authority, to expand access
for the remainder of the population.
Pacific Edge has seen no disruption
to demand for Cxbladder and it
remains a covered and reimbursed
test by the Centers for Medicare &
Medicaid Services (CMS), despite
the proposed Local Coverage
Determination (LCD) that would
see Cxbladder Detect and
Cxbladder Monitor lose coverage if
implemented without any changes.
Novitas, the Medicare
Administrative Contractor with
jurisdiction for Pacific Edge’s
laboratory in Hershey Pennsylvania,
issued and sought public comment
on the LCD in July. Pacific Edge
submitted written comments
for consideration supported by
multiple Key Opinion Leading
customers, the patient advocacy
group BCAN (Bladder Cancer
Advocacy Network) and our
industry partner the Coalition
for 21st Century Medicine (C21),
which also coordinated with other
affected companies in its response.
Subsequent to the comment
period closing on 6 September
2022, Pacific Edge has requested
meetings with Novitas directly
and with the CEOs of Guidewell
(Novitas’ parent company)
and CMS with assistance and
coordination from C21.
Our view remains that
the proposed LCD contains
inconsistencies, unintended
consequences and a methodology
that may violate Medicare’s rules.
Most notably, the proposed
LCD appears focused on tests
for guiding therapeutic decisions
after a confirmed diagnosis (PGx
or Pharmacogenomics testing),
apparently excluding diagnostic
biomarker tests from clinical tool
kits. The LCD also takes the highly
unusual step of ‘outsourcing’
coverage determinations to third
party databases.
We have yet to hear how our
submissions have been received
and do not know when we will get
a response. However, we will get 45
days’ notice of the adoption of a
new LCD.
Meanwhile, a proposed LCD
must be withdrawn or adopted
within a year of the closure of
public comment. So, if Novitas
issues a new draft LCD the clock
starts again. We are looking
forward to gaining certainty from
Novitas.
1
Davidson P, McGeoch G, Shand B. Assessment of a clinical pathway for investigation of haematuria that reduces the need for cystoscopy. NZ Med J 2020. 133:1527
CMS delegates administrative authority to
Medicare Administrative Contractors (MACs)
NOVITAS is the MAC with jurisdiction for
Pacific Edge’s US Laboratory

PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2022
5
NATIONAL SALES MEETING
UNLOCKING OUR POTENTIAL
“Unlocking Our Potential” was
the theme of the Pacific Edge
Diagnostics USA (PEDUSA)
national sales meeting held in
Hershey, PA in mid-September.
Traditionally an annual event,
COVID restrictions forced us to
cancel two previous meetings,
so this was the first in-person
gathering of the entire sales
force in over three years.
The meeting was a key
initiative of our strategy to
build capability and capacity
within Pacific Edge to drive
the adoption of Cxbladder and
accelerate revenue growth. It
helped to build relationships
within the commercial team and
was a significant step towards
standardizing process and
training new hires, ensuring
new account executives benefit
from the insights of tenured
executives and they in turn
benefit from the energy and
insights new team members
bring to the company.
Over the course of three
productive days, the US sales,
and executive teams, with some
customer service, and laboratory
team involvement as well, were
able to interact and discuss ways
that we can better help clinicians
and patients in the diagnosis of
bladder cancer. The focus on
unlocking our potential reflected
our understanding that impactful
insights delivered at the right
moment can help solidify the
value that Cxbladder offers to
clinicians and patients.
“The meeting was
a key initiative to
build capacity and
capability”


To that end, the team heard
from a practicing urologist that
uses Cxbladder, a bladder cancer
patient, and a broad array of
Pacific Edge experts on how to
lead sales conversations with
impactful insights. We also
discussed the existing high-
quality peer reviewed evidence
for Cxbladder that answers the
range of questions that patients
and our customers regularly
face and how to present this
information in a meaningful
way that leads to increased
Cxbladder utilization at the
earliest point in patient care.
The sessions – along with a
team scavenger hunt around
Hershey and an evening event to
celebrate our retiring PEDUSA
Chief Executive Jackie Walker
– renewed and re-energized
relationships across the entire US
based Pacific Edge team. It was
also a great opportunity for staff
to meet the new team members
who have joined PEDUSA since
our last meeting three years ago.
Of course, all good sales reps
know that what matters from
here is the follow up – we will
be tracking their progress and
continuing to reinforce the new
enhanced selling model until a
review of the implementation in
early 2023.

PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2022
6
EVIDENCE COVERAGE AND GUIDELINES
CLINICAL EVIDENCE PROGRAM ADVANCES
Clinical evidence fundamentally underpins commercial success in healthcare and consequently is one of the key
pillars of our investment program. High-quality clinical evidence is needed by clinicians to make the decision to
adopt Cxbladder in clinical practice and by healthcare payors to make decisions to cover and reimburse a Cxbladder
test. The guidelines committees of professional medical societies, including the American Urological Association
(AUA), the National Comprehensive Cancer Network (NCCN) and the European Association of Urology (EAU), also
need the evidence to support embedding Cxbladder as a standard of care. All our studies made progress during the
last quarter.
STUDY ENROLLED SITES
AND LOCATIONS
Q2* FY23 PROGRESS AND TARGETS
US and Singapore studiesComplete
- Enrolment and analysis complete, under peer
review and pending publication
STRATA
(Safe Testing of Risk for
Asymptomatic Microhematuria)
11
USA and Canada
- Enrolment total is 412, including 100 ‘low risk’
subjects that are the focus of the study
- Target (Q4 2023) 600 subjects, including 120
low risk subjects randomized to test arm
DRIVE
(Detection and Risk Stratification in
Veterans Presenting with Hematuria)
10
USA
- Enrolment total is 491
- Target (Q2 2025) ~600 patients
LOBSTER
(Longitudinal Bladder Cancer Study
for Tumor Recurrence)
2/10
- Two sites are open and another 8 are at
pre-activation. Enrolment is now 27 patients.
- Each site will enroll 100 patients within 12
months and follow up for another 12 months
DEDUCT
(Detection of Disease in the Upper
Tract)
1/3
- One site is open for this pilot study and the
first patient in is expected by Dec 2022
MONSTER
(Monitoring Study of Post-Treatment
Effectiveness for Residual Disease)
0/1
New Zealand
- Finalizing protocol documentation and
commenced engagement with ethics
committee
- Target (Q1 2023) first patient
*Dates are calendar year not financial years
THE STRATEGIC RATIONALE OF OUR STUDIES
Our clinical studies are principally aimed at delivering two types of evidence: clinical validity evidence (evidence that Cxbladder accurately
identifies a patient’s clinical status in an independent patient cohort) and clinical utility evidence (evidence that Cxbladder is clinically useful for
physicians for a defined population and indication). We are also undertaking studies to deliver analytical validity evidence (evidence that a test is
repeatable in laboratory conditions).
US and Singapore Studies – studies to further develop the clinical validity of Cxbladder tests in facilitating the early detection, intensifying or de-
intensify hematuria evaluation and assistance in adjudicating equivocal cystoscopy.
ST R ATA – a study to further demonstrate the clinical utility of Cxbladder in safely risk-stratifying patients presenting with hematuria into those
that may receive a less intense evaluation for the presence of urothelial cancer and those that should continue with a standard evaluation. The
aim is to show how Cxbladder can safely de-intensify evaluation for a significantly higher proportion of low risk patients than the current AUA
guidelines.
DRIVE – a study underway in partnership with the US Veterans Health Administration (VA). It seeks to demonstrate to VA urologists the clinical
validity of Cxbladder in a cohort of VA patients, but it is also relevant to Pacific Edge’s drive for the inclusion of Cxbladder in the AUA guidelines
for the evaluation of patients with gross hematuria and micro hematuria.
LOBSTER – a study aimed at further demonstrating the clinical validity of Cxbladder in assisting clinicians to reduce the frequency of cystoscopies
for patients under surveillance for the recurrence of urothelial cancer. Like the STRATA study, LOBSTER aims to further demonstrate Cxbladder
can reduce the burden of invasive and expensive cystoscopy evaluations, spare patients the potential risks, discomfort, and anxiety from
cystoscopy and potentially overcome entrenched patient noncompliance with management and surveillance regimes.
DEDUCT – a study to demonstrate the clinical validity of Cxbladder for the detection of urothelial carcinoma in the urinary upper tract (UTUC)
where the ureters connect the bladder to the kidney. It is aimed at evaluating Cxbladder’s potential to safely avoid ureteroscopy, risk-stratify
patients suspected to have UTUC and avoid unnecessary ureteroscopy and radiation exposure through imaging. It is foundational evidence
necessary for the inclusion of Cxbladder in AUA guidelines for the treatment of UTUC.
MONSTER – a pilot study to analytically validate the performance characteristics of Cxbladder against white light cystoscopy during the
surveillance of urothelial cancer. This is a study to determine the presence of a tumor and safely risk-stratify patients for residual disease prior to
the 6-week re-resection for high grade patients or the 3-month flexible cystoscopy check for all patients. The study could be expanded to the US
depending on the outcome of the pilot.

US LEADERSHIP
NAVIGATING KNOWN CHALLENGES
David Levison assumed the new role of Pacific Edge Diagnostics USA (PEDUSA) President from the start of
September, taking direct strategic and operational control of our largest and fastest growing operations.
David brings to the business more than 25 years in the healthcare industry, working across a range of sectors from
pharmaceuticals to services and diagnostics. He has been the founder and CEO of several high growth medical
and medical technology businesses and for the four years until November 2020 was a Non-Executive Director on
the Pacific Edge Board.
You have moved from being Executive Chairman of PEDUSA to President
Americas; why have you taken on the role?
The investments that we have made in Pacific Edge recently and have
planned for the future will allow the global organization to attain new
levels of clinical acceptance and financial progress. In the US, the addition
of Medical Affairs, Market Access and Reimbursement teams, and local
clinical evidence development capabilities are solidifying the foundation for
our future growth. I am excited by the opportunity to make the Cxbladder
products a more important tool for all US based urologists.
What gives you confidence that you can drive the adoption of Pacific
Edge’s technologies in the world’s largest healthcare market?
The current standard of care for both hematuria evaluation and bladder
cancer surveillance has not been optimized for the advances in molecular
diagnostic signatures like Cxbladder. Established procedures and tests, like
cystoscopy and cytology, were introduced many years ago as stand-alone
products before the development of molecular medicine. When integrated
into clinical pathways, Cxbladder can help clinicians target the specific
patients that are likely to benefit from a full urology work-up as well as
those patients that can be spared the time, expense, and discomfort.
Our customer Kaiser Permanente, known for its innovative approach to
healthcare, is adopting Cxbladder in this integrated way and we believe will
serve as a model for further clinical adoption.
What do you see as the biggest challenges?
The good news is that our challenges are known, and we have plans in
place for overcoming them. Our products have historically not had the
level of published clinical evidence that is required to drive adoption and
be included in standard of care guidelines. The pipeline of clinical evidence
that is in development will allow us to show urologists the full range of
benefits they can derive from the use of Cxbladder products.
What is the professional experience that has been most helpful to you in
this role?
There have been multiple. Having been the founding CEO of molecular
diagnostics companies, from start-up to full commercialization, helps me
understand the road that Pacific Edge is traveling and anticipate the next
twist and turn of our journey. Having worked with the Centers for Medicare
& Medicaid Services, commercial insurance companies, and the US Food
and Drug Administration has provided me with insights into the transition
from scientific insights to commercial success. And lastly, having been
on the Board of Directors of both Pacific Edge as well as other firms, I
understand the importance of effective communication with investors,
Directors, and the wide variety of parties interested in the success of
Pacific Edge.
Where are you most likely to be found on a Saturday afternoon?
I am likely to be doing some combination of the following: working in our
fruit and vegetable garden, cooking a meal for family and friends, visiting
with one of our five children, or trying to fit in a run or walk for some
exercise.
PACIFIC EDGE LIMITED INVESTOR UPDATE | OCTOBER 2022
7
DAVID LEVISON
- Pacific Edge Diagnostics
USA – President Americas
Former roles:
- Pacific Edge -
Non-Executive Director
- Qlarity Imaging -
Chief Executive Officer
- CardioDx – Director Chief
Executive Officer and Chief
Strategic Officer
- CareDx - Board member
- Texas Pacific Ventures -
Venture Partner
- iScribe - Founder,
President, and Director
Education:
- B.A. (Williams)
- MBA (Stanford)

ABOUT US
Pacific Edge Limited (NZX/ASX: PEB) is a
global cancer diagnostics company leading the
way in the development and commercialization
of bladder cancer diagnostic and prognostic
tests for patients presenting with hematuria
or surveillance of recurrent disease.
Headquartered in Dunedin, New Zealand, the
company provides its suite of Cxbladder tests
globally through its wholly owned, and CLIA
certified, laboratories in New Zealand and the
USA.
VISIT US ONLINE:
www.pacificedgedx.com
www.cxbladder.com
FOLLOW US ON SOCIAL MEDIA:
www.facebook.com/PacificEdgeLtd
www.facebook.com/Cxbladder
www.twitter.com/PacificEdgeLtd
www.twitter.com/Cxbladder
www.linkedin.com/company/pacific-edge-ltd
CONTACT US:
Centre for Innovation
87 St David Street
PO Box 56
Dunedin 9016, New Zealandd
T: +64 3 479 5800
E: investors@pacificedge.co.nz