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Quarterly Investor Update – Q3 FY23 Test Volumes rise 36%

Quarterly Update18 January 2023PEBHealthcare

INSIDE
Letter from the CEO 2

Sustaining strong performance 3

Targeting national accounts 4

Cxbladder Monitor’s day in the sun 5

Extending our tech leadership 6

Profiling our new COO 8

INVESTOR

UPDATE

JANUARY 23

PACIFIC EDGE LIMITED INVESTOR UPDATE | JANUARY 2023
2

Dear Investors,

In this third quarter update, I

am pleased to advise that we

are continuing to deliver on our

growth objectives. Pacific Edge

closed out 2022 confident the

new approach we are taking to

drive increased adoption and use

of Cxbladder is delivering on its

goals.

Test volumes for the third

quarter of the 2023 financial year

are up 36% on the same period in

the prior financial year to 7,768.

Consistent with prior years, we

observed a seasonal slowdown

that comes with the Thanksgiving,

Christmas, and New Year holiday

season (see page 3).

Throughput remained flat on

the 7,864 achieved in the second

quarter of the current financial

year, though notably the number

of unique ordering clinicians

increased.

In the previous quarter, we

added two new sales roles with a

focus on National Accounts (see

page 4). With these appointments,

we have now largely put in place

the size and diversity of roles in the

commercial team that we need for

our next phase of growth. We are

looking towards the 2024 financial

year when we expect these

initiatives to start to demonstrate

a return by increasing the number

of tests per ordering clinician, while

continuing our upward momentum

on the number of ordering

clinicians and revenue.

As we highlighted at our 1H23

results in November, we are seeing

similar encouraging signs across

the initiatives we announced in May.

Our new Direct Sales team

members are gaining confidence

and knowledge in their territories.

To support the expected volume

growth, we have added to our

laboratory, scientific and customer

support staff.

In the previous quarter, our

Medical Affairs team have also

begun to demonstrate the value

they bring to the business.

Communicating the portfolio of

evidence supporting Cxbladder to

clinical and commercial decision

makers is no small task. Ultimately,

it requires our people to be able

to engage with them as equals,

and to be able to answer nuanced

questions of science or clinical

practice confidently and with

conviction.

“We have now largely

put in place the size

and diversity of roles

... for our next phase of

growth.”



At the Society for Urologic

Oncology (SUO) meeting in

San Diego in December, and in

meetings following the conference

(see page 5), various key opinion

leaders (KOLs) from the urology

community regularly acknowledged

that the Medical Affairs team was

bringing a new sense of purpose by

putting Pacific Edge and Cxbladder

at the center of conversations

around innovation in biomarkers

– a key feature of international

conferences.

Decision makers are not only

talking to Pacific Edge about

the evidence and the clinical

utility of the products. More and

more they are now talking to one

another on the value of integrating

Cxbladder into their practice. We

are also seeing a new enthusiasm

for clinicians to be involved in

upcoming clinical trials.

Finally, we were excited

to announce in December

acceptance for publication in the

Journal of Urology new research

demonstrating that the addition of

DNA biomarkers to Cxbladder can

deliver significant improvements in

test performance (see page 6). The

study and the enhanced test that we

are commercializing on the back of

it, Cxbladder Detect

+

, positions the

company to extend our leadership

in best-in-class diagnostic tools for

the detection and management of

bladder cancer.

Cxbladder Detect

+

represents

an exciting evolution for the

company. As a single product

for hematuria evaluation with

significantly enhanced performance

characteristics, it allows us to offer

new solutions to the clinicians,

healthcare funders and providers

and those who set global standards

of care.

We continue to actively engage

with our legal advisors, our industry

coalition partners and with all

appropriate formal channels

with Novitas and CMS regarding

the proposed LCD and remain

confident that our feedback will be

incorporated into revisions to the

proposal that will benefit patients,

payors and diagnostics companies,

including continued reimbursement

for Cxbladder.

On behalf of the entire Pacific

Edge team, I wish you all a good

start to the New Year.

Ngā mihi,

Dr Peter Meintjes

LETTER FROM THE CEO

DELIVERING ON OUR

GROWTH OBJECTIVES

PACIFIC EDGE LIMITED INVESTOR UPDATE | JANUARY 2023
3

TEST VOLUMES

SUSTAINING STRONG THROUGHPUT

Cxbladder tests processed at Pacific Edge’s

laboratories in the US and New Zealand have

sustained the strong performance of prior quarters

despite the seasonal headwinds of holidays with

reduced laboratory operating days and reduced

physician schedules.

In the three months to the end of December 2022

(Q3 23), the team processed 7,768 tests, a 36% increase

over Q3 22. This growth rate is in line with the year-on-

year growth rates we achieved in Q2 23 and ahead of

the year-on-year growth rate of 32% achieved in Q1 23.

Volumes were flat on the Q2 23’s 7,864

1

tests

reflecting the seasonal slowdown we see from

Thanksgiving through to the New Year and the start

of the fourth quarter as urologists and patients take

holidays. As we have seen in prior years, we expect a

return to quarter-on-quarter growth in the last three

months of the financial year.

US test volumes for Q3 23 were 6,629, a 44%

improvement on the 4,591 in Q3 22, but flat on the 6,699

tests in the Q2 23. The number of unique US ordering

clinicians has continued to grow to 1,076 at the end of

the Q3 23, up 45% on Q3 22 and up 10% on Q2 23.

In line with the seasonal trends observed in the prior

years, tests per physician in Q3 23 fell to 6.2 from 6.8 in

Q2 23.

Q3 23 APAC volumes were up 2% on Q3 22 at 1,139

and flat on the 1,165 in Q2 23, with the relatively mature

New Zealand market dominating throughput.

UNIQUE ORDERING CLINICIANS: US

-

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000


Q1 23Q2 23Q4 22Q3 22Q2 22Q1 22Q4 21Q3 21Q2 21Q1 21

Test volume

USNZ

2,791

3,110

3,824

4,277

4,706

4,591

5,290

6,073

6,699

1,073

1,079

1,074

1,117

952

983

1,165

Q3 23

6,629

1,139

943

1,088

2,133

852

38%

CAGR

-

200

400

600

800

1,000

1,200


Q1 23Q2 23Q4 22Q3 22Q2 22Q1 22Q4 21Q3 21

Physicians

44%

CAGR

516

530

Q2 21Q1 21

411

462

657

689

740

782

894

979

Q3 23

1,076

TOTAL TEST VOLUMES: GROUP

1

Test numbers in Q1 23 and Q2 23 are respectively one and three more than previously reported due to the reclassification of tests arising from the clarification

of information required to support test results.

NATIONAL ACCOUNTS
TAPPING THE LARGEST POOLS OF

CXBLADDER DEMAND

As a continued enhancement to

Pacific Edge’s sales strategy, the

PEDUSA team now has a small

and dedicated team to work

with national accounts.

National Accounts are

those institutions and practices

that have larger influence on

the practice of urology either

through their ability to influence

clinical standards and practice,

or through their scope, size, and

reputation.

Pacific Edge has always had

strong relationships with these

National Accounts, managed by

the sales and executive teams,

and believe this new focus will

enhance these relationships.

These National Accounts will

initially total approximately 50

institutions in the US, but this

focus can be expanded as we

prove our selling model.

National Accounts are

expected to have longer sales

cycles and complex decision-

making processes. However, they

are expected to standardize and

systematize their technology

adoption, which increases the

“stickiness” as they look to establish protocols for the appropriate use

of Cxbladder in their patient population.

To help lead this initiative, we have appointed an experienced

and award-winning sales leader, Melissa Garcia, as our new National

Account Director. Joining her in the National Accounts Team is Joe

Swanson – a top performer among our Account Executives. The new

team will work closely with our Medical Affairs, Market Access, and

field sales teams to establish our National Accounts strategy, and

refine it in response to market dynamics.

We expect the new team to be a performance driver in the 2024

financial year.

PACIFIC EDGE LIMITED INVESTOR UPDATE | JANUARY 2023

4

Pacific Edge is now confident we have largely recruited the people we need to deliver on the next

leg of our growth plan.

With the team set, our focus is now on execution to realize our throughput and revenue goals

while assessing the effectiveness of our expansions and initiatives in FY23.

Since the end of September our global team has grown by 15 people to around 115 and we now

expect it to stabilize at this level for our next phase of growth. We are targeting the 2024 financial

year where this investment in people should be driving a meaningful contribution to Pacific Edge’s

financial and operational performance.

Key achievements in the US include the recruitment of a new Director of National Accounts

(see above), stabilizing the number of territories for the Direct Sales Team and rounding out the

Medical Affairs Team. In New Zealand we have built out the back-office, laboratory and research

and development teams to ensure we are positioned to deliver seamless service to our global

customers and our clinical research partners as we grow.

STAFFED FOR THE NEXT PHASE OF GROWTH

CONFERENCES
MONITOR’S DAY IN THE SUN

Cxbladder Monitor and our freshly

minted Medical Affairs Team were

front and center at the Society of

Urologic Oncology (SUO) meeting

in San Diego at the start of

December.

The conference is a premier

gathering for clinicians who

manage patients already diagnosed

with bladder cancer. For these

clinicians, having treated the

cancer, Cxbladder Monitor (CxbM)

is of intense interest due to its

potential to reduce the frequency

of surveillance cystoscopy, and

therefore improve compliance with

surveillance for recurrent bladder

cancer.

A highlight of the conference,

attended by about 1000 clinicians

and industry professionals was a

Cxbladder Breakfast Symposium

on the real-life impacts of

Cxbladder tests for the diagnosis

and surveillance of bladder cancer.

The event featured three leading

urologists – Dr Sia Daneshmand,

Dr Sima Porten, and Dr John

Sfakianos and was chaired by

Pacific Edge’s VP of Medical Affairs

Dr Tamer Aboushwareb.

Key successes of the

symposium, and the conference at

large, included the endorsement

by independent clinicians of

CxbM’s clinical utility, the evidence

to support its use, and how - by

offering options to reduce the

number of cystoscopies – CxbM

helped to overcome patient

reticence towards surveillance

regimes for cancer recurrence.

In a sign of the success of our

new Medical Affairs team, Pacific

Edge was roundly praised for its

research and its commitment to

a full clinical evidence generation

program and has set a new

template for engagement at similar

events in the future.

Medical Affairs led podium

presentations, side line

conversations with clinicians, and

formal sessions. A key initiative was

the Principle Investigator Meeting

for STRATA which was attended

by all principle investigators and

coordinators in the STRATA trial

(see page 7) to discuss challenges

and drive faster enrolment of

appropriate patients for the trial.

We plan to hold PI meetings for

other clinical studies at similar

conferences going forward.

Finally, the SUO conference

also hosted the first meeting of

Pacific Edge’s Clinical Advisory

Board (CAB). This body, a panel

of our most trusted advisors from

renowned academic centers,

includes leading urologists from

around the US, four of whom sit on

the AUA guidelines committees.

The CAB provided us with highly

useful insights in how to drive

our product development and

clinical study program. It was also

supportive of our test validation

roadmap for Detect

+

(see page 6).

STRENGTHENING

KAISER CLINICIAN

RELATIONSHIPS

PACIFIC EDGE LIMITED INVESTOR UPDATE | JANUARY 2023

5

Cxbladder remains on track

to be integrated within the

Kaiser Permanente electronic

medical record (EMR) system

with the rollout starting with

Southern California (SoCal).

As a partner in this project,

Pacific Edge was invited to

attend a Kaiser Permanente

internal conference for

urologists in October and

had the opportunity to raise

awareness of the rollout

to a number of urologists

not already familiar with

the internal developments.

In December, Pacific Edge

Medical Affairs and Senior

Management were invited

to address the SoCal

organization’s 13 urology

chiefs over dinner and

received positive confirmation

on the performance of

Cxbladder and the desire to

rollout systematically via EMR.


“We are confident

of ... the successful

conclusion of this

project before the

end of March 2023.”

These opportunities reinforce

Pacific Edge’s position as an

innovation partner for Kaiser

Permanente, underpinned

by a shared desire to reduce

unnecessary cystoscopies

during hematuria evaluation

and surveillance, and to

ultimately move towards

proactive routine testing

of “At Risk” populations

defined by age, smoking

history and other clinical

factors in the EMR. We remain

encouraged that we will be

able to announce a successful

conclusion to the integration

project prior to the end of the

financial year.

RESEARCH AND INNOVATION
EXTENDING OUR DIAGNOSTIC LEAD

DNA MARKERS LIFT CXBLADDER PERFORMANCE

2

An enhanced version of Cxbladder

Detect (CxbD) is set to extend

Pacific Edge’s first mover

advantage in providing best-

in-class diagnostic tools for the

detection and management of

bladder cancer.

In December we announced

new peer-reviewed evidence that

demonstrates the addition of DNA

biomarkers to Cxbladder Triage

(CxbT) and CxbD, Pacific Edge’s

products for hematuria evaluation,

deliver significant performance

improvements.

The study, to be published

in the prestigious American

Urological Association’s Journal

of Urology, showed the enhanced

test Cxbladder Detect

+

(CxbD

+

)

delivered Sensitivity of 97% (+23%

compared with CxbD), Specificity

of 90% (+8%), Negative Predictive

Value of 99.7% (+2.5%), Positive

Predictive Value of 44% (+19%)

and Rule-out Rate of 83% (+5%).

The study is available for review on

the Cxbladder website.

By adding DNA biomarkers, we

have developed CxbD

+

, as a single

product for hematuria evaluation

that can assist clinicians to risk

stratify patients to rule in and

safely rule out the presence of

bladder cancer for any hematuria

patient at any point in the patient

care pathway. CxbD

+

is the first

combined RNA and DNA biomarker

test for detection of bladder cancer.

The study enrolled 804 patients

from two cohorts (344 from the

US and 460 from Singapore).

The study validates the use of

Cxbladder in a Southeast Asian

patient population, further

strengthening the evidence

for genomic biomarker tests in

genetically diverse populations.

CxbD

+

will require its own

coding, coverage, and pricing

decisions to ultimately establish

reimbursement. However, given

the increased performance it could

potentially receive a higher price.

We expect no negative impact

to revenue from existing products

- commercial Triage and Detect

customers will only be transitioned

to CxbD

+

after reimbursement

is established. The company will

continue to explore whether DNA

markers will have a similar impact

on the performance of Cxbladder

Monitor for surveillance of

recurrence of disease.

Te s tSensitivitySpecificity NPVPPVROR

Cxbladder tests enhanced with DNA biomarkers

CxbT

+

95%78%99.5%26%73%

CxbD

+

97%90%99.7%44%83%

Existing Cxbladder tests

CxbT89%63%99%16%59%

CxbD74%82%97%25%78%

2

Lotan et al ‘Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification’ Journal of Urology

2022 Dec 30;101097JU0000000000003126. doi: 10.1097/JU.0000000000003126 online ahead of print.

PACIFIC EDGE LIMITED INVESTOR UPDATE | JANUARY 2023

6

A CxbD

+

negative patient has a low probability of Urothelial Carcinoma because CxbD

+

combines the

characteristics of high Sensitivity (97%), NPV (99.7%) and Specificity (90%) with a Rule out rate (ROR) of 83%.

A CxbD

+

positive patient conversely has a higher probability of urothelial cancer for the same reasons. A positive

test therefore can be used to justify an intensification of urologic evaluation and assist the adjudication of

diagnostic dilemmas such as equivocal cystoscopy or urine cytology.

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 standard of care).

Positive Predictive Value (PPV) - the percentage of positive tests being true positives (by standard of care).

Rule-out Rate (ROR) - the percentage of tests that return a negative result.

RESEARCH AND INNOVATION
ONGOING STUDY PROGRAMENROLLED SITES

AND LOCATIONS

PROGRESS AND TARGETS*

STRATA - Safe Testing of Risk for

AsymptomaTic MicrohematuriA

11/11

USA and Canada

- Enrolment total is 430, including 106 ‘low risk’

subjects that are the focus of the study

- Target ~600 subjects, including 120 low risk

subjects randomized to test arm

- Last patient in Q2 2023

- Follow up until Q2 2024

DRIVE - Detection and RIsk Stratification

in VEterans Presenting with Hematuria

7/11 (VA)

USA

- Enrolment total is 513

- Target (Q2 2025) ~600 patients

- Last patient in: Q2 2023

- Follow up: until Q2 2025

AUSSIE - Australian Urologic risk

Stratification of patientS wIth hEmaturia

1/1

Australia

- Enrolment due to start in March 2023

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

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

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

PACIFIC EDGE LIMITED INVESTOR UPDATE | JANUARY 2023

7

Visit the Pacific Edge website to learn more about the strategic rationale for our studies.

Analytical validity: Develop a test that is repeatable in the lab for a given indication and population.

Clinical validity: Make sure the test works in the same way on an independent eligible population for the given indication.

Clinical utility: Put the test in the hands of a physician to establish that it can usefully change patient management within

the context of care for the defined population and indication.

With the delivery of new and exciting evidence showing the analytical validity of Cxbladder Detect

+

(CxbD

+

),

we have modified our existing clinical evidence generation program to optimize the path to coverage for

Detect

+

. Specifically, the primary endpoint of the DRIVE study has been updated to Detect

+

alongside Triage.

Specifically, the DRIVE study will generate clinical validity evidence for CxbD

+

. The STRATA study will offer

clinical utility evidence for CxbD

+

as a secondary objective. Additionally, we will launch the AUSSIE study to

develop clinical validity evidence for CxbD

+

in an Australian healthcare system for accurate risk stratification

to intensify or de-intensify hematuria evaluation. We will announce additional clinical studies as part of our

medical communications program as those plans mature.

DETECT

+

DRIVES EVIDENCE PROGRAM CHANGE

THE PACIFIC EDGE TEAM
DRIVING PERFORMANCE EXCELLENCE

Darrell Morgan joined Pacific Edge in October as Chief Operating Officer. In this role he is overseeing the

company’s global laboratory operations, manufacturing, logistics and inventory management. Based in

Dunedin, he is also charged with driving the quality and compliance functions and operationalizing people

and culture initiatives.

Darrell has more than 37 years’ experience in senior roles in the UK, Europe, and New Zealand. They have included

pharmaceutical research and development, immunodiagnostics, and device development for drug delivery across

human and animal health. He has also held technical operations and customer-facing roles.

DARRELL MORGAN

October 2022 – present

Chief Operating Officer –

Pacific Edge

Former roles:

Argenta (Animal Health

Contract Research and

Development)

2013 - October 2022 - Product

Development Director with

earlier senior roles in product

and business development and

research and development.

UCB (Pharmaceutical

Manufacturing)

2004 - 2012 – Director, Head of

Patient Solution Technologies,

Life Cycle Management with

earlier roles in sterile drug

product/device development

and industrialisation.

Oxford GlycoSciences

(Biopharmaceutical Research

and Development)

1999 - 2003 – Pharmaceutical

Development Manager

Fisons/Rhone-Poulenc Rorer

(Pharmaceutical Research,

Development and Manufacture)

1990-1999

Amersham International

(Immunodiagnostic

Manufacture)

1985-1990

3

Oligoprimers are synthesised chains of DNA and RNA that Pacific Edge uses to copy or amplify the gene

signatures that are the focus of Cxbladder tests.

PACIFIC EDGE LIMITED INVESTOR UPDATE | JANUARY 2023

8

What attracted you to working at Pacific Edge?

My career in human health has been driven by a passion to make a positive

impact on patient health and wellbeing. At Pacific Edge I can help our

patients through their bladder cancer diagnosis journey, providing world class

clinical diagnostics with class leading customer service. I want patients to be

confident that whatever their Cxbladder result, that the result is accurate, will

be provided in a timely fashion and backed-up by Pacific Edge’s experts in

customer care.

You have now been in the role for three months – what do you see as your

priorities for the year ahead?

The first three months has given me insights into where I need to focus.

These are:

• Continuing to build a world class team of manufacturing scientists, supply

chain experts, quality managers and molecular diagnostic specialists.

• Performance Excellence – developing a Lean 6-Sigma approach to

reagent manufacture, clinical diagnostic assay work-streams, inventory

management and customer service.

• Scale-Up and growth. Pacific Edge’s growth strategy will be underpinned

by right sized manufacturing, testing and clinical diagnostic capabilities.

The next year will see increased capability in reagent manufacture,

automated solutions for tube filling and labelling, and increased capacity to

match forecast volume growth from new market opportunities and product

updates.

“At Pacific Edge I can help patients through their

bladder cancer journey.”

What is one of the biggest challenges you are now facing?

The war in Ukraine and COVID-19 in China continue to cause significant

disruption to supply chains, especially with laboratory consumables or

highly specialized equipment or molecular diagnostic grade chemicals/PCR

enzymes. Our team has done a magnificent job over the last 3 years, but we

still see daily issues with freight delays, long lead times for oligoprimers

3

and

primary closures for our reagents.

Outside of your work at Pacific Edge describe to us your most memorable

day of 2022?

My family and I are relocating from Auckland to Dunedin. We sold our house

at auction in November which was both fascinating and terrifying! It was

memorable in that we could see the result of the hard work in getting the

house ready for auction, but also stressful - not knowing if the house would

sell or not and what the price would be. The auction was successful and

allows us to be in our new home in Dunedin in time for Christmas.

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

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