Quarterly Investor Update – Q3 FY23 Test Volumes rise 36%
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
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.
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