Financial Results for the Half Year to 30 September 2023
23 November 2023
UNAUDITED FINANCIAL RESULTS FOR THE HALF YEAR TO 30 SEPTEMBER 2023
STRONG RISE IN REVENUE DESPITE MEDICARE UNCERTAINTY
FINANCIAL AND PERFORMANCE HIGHLIGHTS
1
• Operating revenue increases 50% to $13.1 million; total revenue increases 22% to $16.6
million lifted by a 28% rise in commercial Cxbladder test volumes in the US market.
• Total laboratory throughput
2
(TLT) of Cxbladder tests increases 22% to 18,229 tests,
commercial tests increase to 15,401 tests; US ordering clinicians grow to 1,147, up 17.3%
from the 978 at the end of Q2 23.
• Net loss after tax increases to $15.1 million from $10.2 million as the company had been
investing to focus on top line growth. Expense growth has since been tempered through
the restructure implemented in late Q2 24 that is not yet evident in operating expenditure.
• Cash and cash equivalents and short-term deposits at $62.2 million from $77.8 million at
the end of March 2023. Pacific Edge expects the available cash to be sufficient to support
the company through to regaining coverage in the event of a Medicare non-coverage
determination, a process that may take up to four years.
STRATEGIC HIGHLIGHTS
• Cxbladder testing volumes continued their growth trajectory despite uncertainty over
continued Medicare coverage.
• Restructured the commercial organization to focus on profitable sales territories, alternative
revenue streams and cash preservation over top line revenue growth alone.
• Cxbladder went live in Kaiser Permanente’s electronic medical record (EMR) systems on
14 November (US time) across all urology medical centers in the Southern California
Permanente Medical Group, which is expected to support test volumes in 2H 24.
• Developing a protocol for CREDIBLE – a randomized clinical trial focused on generating
clinical utility evidence for Detect
+
for guideline inclusion and increased coverage certainty.
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today
reports strong growth in operating revenue in the half year to the end of September - up 50%
to $13.1 million from $8.7 million in the same period a year ago - as it benefited from growing
demand for its suite of Cxbladder tests.
Total revenue, which includes interest income on cash reserves and government grants,
increased 22% to $16.6 million from $13.6 million in the same period a year ago. The net loss
for the half year of $15.1 million was wider than the $10.2 million loss in the same period in the
prior year. Restructuring and capital preservation initiatives implemented late in 2Q 24 are not
yet evident in 1H 24 operating expenditure, which still reflects the company’s prior orientation
towards revenue growth. Additionally, the company incurred extra costs defending its coverage
by Medicare.
1
All comparisons are to the same period of the prior financial year unless otherwise stated.
2
Total Laboratory Throughput includes commercial, pre-commercial and clinical studies testing.
Pacific Edge has maintained a strong balance sheet with cash and cash equivalents of $62.2
million. In the event of a Medicare non-coverage determination, the company expects the
available cash to be sufficient to support the company through to regaining coverage, a process
that may take up to four years, with interim coverage attempts with every piece of new clinical
evidence. In the six-month period the company recorded a cash outflow of $15.6 million,
reducing its reserves from the $77.8 million recorded at the end of March 2023.
Chairman Chris Gallaher said: “Pacific Edge has continued to grow test volumes and revenue
through the first half of the 2024 financial year amid the ongoing uncertainty over Medicare
coverage of Cxbladder. However, the company has adapted and will manage its capital
reserves to weather a Medicare non-coverage decision, the most adverse outcome of the
range of alternatives now possible.”
Chief Executive Dr Peter Meintjes said: “We are proud of our achievements for the first half of
the 2024 financial year despite the well documented headwinds we’ve faced. The
reorganization and other cost control measures have appropriately lowered our expense base,
while continuing to focus on driving test throughput and revenue.”
STRATEGY REFINEMENT
Pacific Edge has refined its sales strategy to prioritize profitable sales territories, alternative
revenue streams and cash preservation over top line revenue growth alone. It has aligned its
sales messaging to embed the clinical value of Cxbladder to the physician and patient, and its
economic value to health systems and payers. These benefits include a reduction in the
number of unnecessary invasive cystoscopies and imaging, increasing access to specialist
care for higher risk patients, and reduced healthcare payer expenditure on patients presenting
with hematuria or in surveillance for bladder cancer recurrence.
It has reconfigured its evidence generation program within a structured framework for
Analytical Validity (AV), Clinical Validity (CV) and Clinical Utility (CU). The current studies are
orientated on defined patient populations, conventional end points and sample sizes that are
sufficient for guidelines inclusion and coverage. The Medical Team is developing a protocol for
a new randomized clinical trial called CREDIBLE (Cystoscopic REDuction In BLadder
Evaluations for micro-hematuria) which is expected to generate the clinical utility evidence for
Cxbladder Detect
+
, needed for guidelines inclusion.
“Pacific Edge is also continuing its investment in digital systems that enhance the customer
experience. The integration of Cxbladder into the EMR system of Kaiser Permanente, is the
best example of these efforts. Having completed this effort, the company will now focus on
scaling the digital customer experience with an EMR Program that includes bespoke solutions
and a more generically deployable customer portal,” Dr Meintjes said.
“We expect these changes to allow a resumption of growth for the remainder of the financial
year, assuming no change to our Medicare coverage status and to continue our focus on AV,
CV and CU evidence generation in the event of a Medicare non-coverage decision.”
Finally, the company’s research and development efforts have been orientated toward the
launch of the tests enhanced by DNA markers Detect
+
and Monitor
+
. A key focus has been to
ensure laboratory operations are optimised to reduce technician time, turnaround time and
lower the cost of goods sold.
OUTLOOK
Dr Meintjes said the finalization of the ‘Genetic testing for oncology’ Local Coverage
Determination (DL39365) is the single biggest determinant of the company’s prospects in the
coming 12 months, with a decision due by 26 July 2024 (US Time).
“A non-coverage determination is likely to impact US volumes with the company considering
processes that will see Medicare patients assuming responsibility for the payment for
Cxbladder. Under such a scenario Pacific Edge, supported by its strong balance sheet, would
continue to work towards regaining coverage within four years, with attempts made for re-
coverage with every piece of new clinical evidence.
“Conversely, an affirmation of our status as covered by Medicare will be a catalyst for our US
commercial operations, supported by a sales force that is now firmly focused on the Cxbladder
proposition,” Dr Meintjes said.
“Meanwhile, and irrespective of the Medicare outcome, we continue to expect an increase in
volume from Kaiser Permanente, ex-US business serviced from our US laboratory and APAC
business serviced from our New Zealand laboratory. We are continuing to work towards a
national contract with Te Whatu Ora – Health New Zealand and to grow international testing
volume in the medium term from our distribution agreements and growth markets in Australia,
Latin America, Israel and Southeast Asia.
“We look forward to providing a further update in the New Year,” Dr Meintjes said.
CONFERENCE CALL
Pacific Edge is holding an investor briefing at 11.00am (NZT) today. It is available through the
following like: www.virtualmeeting.co.nz/pebhy23 or by phone on the following toll-free
numbers:
• New Zealand: 0800 449 170
• Australia: 1800 896 574
Released for an on behalf of Pacific Edge by Grant Gibson, Chief Financial Officer.
For more information:
Investors: Media:
Dr Peter Meintjes Richard Inder
Pacific Edge, Chief Executive The Project
P: +64 22 032 1263 P: +64 21 645 643
OVERVIEW
Pacific Edge: www.pacificedgedx.com
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.
Cxbladder: www.cxbladder.com
Cxbladder is a urine-based genomic biomarker test optimized for the detection and surveillance
of bladder cancer. The Cxbladder evidence portfolio developed over the past 14 years includes
more than 20 peer reviewed publications for primary detection, surveillance, adjudication of
atypical urine cytology and equivocal cystoscopy. Cxbladder is the focal point of numerous
ongoing and planned clinical studies to generate an ever-increasing body of clinical utility
evidence supporting adoption and use in the clinic to improve patient health outcomes.
Cxbladder has been trusted by over 4,400 US urologists in the diagnosis and management of
more than 100,000 patients, including the option for in-home sample collection. In New
Zealand, Cxbladder is accessible to 75% of the population via public healthcare and all
residents have the option of buying the test online.
---
Pacific Edge’s ordinary shares trade on the
NZX and the ASX under the ticker code: PEB
Pacific Edge
1H 24 FINANCIAL RESULTS
INVESTOR PRESENTATION
Dr Peter Meintjes
Chief Executive Officer
Grant Gibson
Chief Financial Officer
23 November 2023
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By receiving this presentation, you agree to the above terms and
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2
1.1H 24 HIGHLIGHTS
2.STRATEGY DELIVERY
3.FINANCIAL PERFORMANCE
4.OUTLOOK
5.QUESTIONS
AGENDA
1H 24 HIGHLIGHTS: BUILDING TEST VOLUMES IN THE US DESPITE UNCERTAINTY
($15.1M)
NET LOSSAFTER
TA X
Global TLT of 18,229
US TLT increase 25% on 1H 23
to 15,962 tests
Increase from ($10.2M) on
1H 23 lifted by investments
for future growth and
Medicare objections
Operating revenue $13.1M
To t a l re v e n u e o f $ 1 6 . 6 M u p
22% on 1H 23
$62.2M
CASH, CASH
EQUIVALENTS
3
Strong Balance Sheet
$15.6M reduction in cash &
cash equivalents
3
on Mar 23
24%
COMMERCIAL
TEST VOLUMES
on 1H 23
22%
1
GLOBAL TESTING
VOLUMES
(TLT
2
) on 1H 23
50%
GROWTH IN
OPERATING
REVENUE on
1H 23
Commercial Tests of 15,401
US Commercial Tests rise
28% on 1H 23 to
13,550tests
1.All comparisons are to the same period in the prior year unless otherwise stated
2.TLT is the Total Laboratory Throughput including commercial, pre-commercial and clinical studies testing
3.Cash, short-term deposits and term deposits
4.EPR/PAP is the Enhanced Patient Responsibility / Patient Assistance Program
4
•Volume growth tempered by reorganisation in 2Q 24 in response to Novitas’ draft LCD & risk to Medicare coverage
•Immediate focus on profitable sales territories, alternative revenue streams and cash preservation over top line
revenue growth alone
•Longer-term focus on clinical evidence development for guidelines inclusion and coverage certainty
•Sales messaging emphasis on clinical value proposition to support EPR/PAP
4
, health economics, strategic accounts
VALUE CREATION THROUGH THREE PILLARS
OUR PEOPLE
OUR PROCESSES
OUR IP, KNOWLEDGE
AND EXPERIENCE
OUR CLINICAL STUDIES
PARTNER SITES
OUR INVESTORS
EARLY DETECTION AND
CLINICALLY ACTIONABLE CARE
INNOVATION PIPELINE FOR
CLINICAL APPLICATIONS
INCLUSIVE WORKPLACE
DRIVEN BY OUTCOMES
INCREASED LONG-TERM
SHAREHOLDER VALUE
EXCELLENT PATIENT EXPERIENCE
AND ACCURATE RESULTS
INPUTSOUTPUTS
A VALUES-DRIVEN, DIVERSE, RESULTS-FOCUSED CULTURE
SCALABLE PROCESSES, AUTOMATED OPERATIONS, CONTINUOUS IMPROVEMENT
DIGITALIZED ARCHITECTURE, SEAMLESS VIRTUAL COLLABORATION, REAL-TIME ANALYSIS
EVIDENCE,
COVERAGE AND
GUIDELINES
RESEARCH
AND
INNOVATION
ADOPTION,
RETENTION AND
REVENUE
GENERATION
6,573
5,591
9,192
12,422
15,401
7,054
7,385
10,004
14,269
-
5,000
10,000
15,000
20,000
25,000
30,000
FY20FY21FY22FY23FY24
TESTS
8,147
6,864
11,136
14,920
18,229
8,714
8,950
11,950
16,645
-
5,000
10,000
15,000
20,000
25,000
30,000
35,000
FY 20FY 21FY 22FY 23FY 24
TESTS
19%
56%
25%
DEVELOPING A TRACK RECORD OF GROWTH
ABILITY TO EXECUTE DESPITE CHALLENGING MARKET HEADWINDS
1H 23
TEST VOLUMES BY TYPE (TLT*)
GLOBAL COMMERCIAL TEST VOLUMES (TLT*)
GLOBAL TOTAL TEST VOLUMES (TLT*)
1H 24 TOTAL LAB THROUGHPUT (TLT*)
•Global TLT increased 22% to 18,229 tests
•Global Commercial test volumes increased 24% to 15,401 tests
•Global TLT is driven by US growth in the US (predominantly Detect)
•Hematuria evaluation (Triage & Detect) is the largest market
opportunity, ~3x the size of bladder cancer surveillance (Monitor)
23,086
15,814
16,861
*TLT is the Total Laboratory Throughput including commercial, pre-commercial and clinical studies testing
1H 24
▲
24%
▲
22%
31,565
19,196
12,976
13,627
26,691
6
1H
2H
1H
2H
17%
60%
23%
7
MEDICARE: ‘GENETIC TESTING FOR ONCOLOGY’ (DL 39365) RESPONSE
PACIFIC EDGE AND INDUSTRY DELIVERED A POINT-BY-POINT REBUTTAL
INDUSTRY AND UROLOGY KEY OPINION LEADERS UNITED TO OVERTURN DL39365
•Pacific Edge engaged with oncology diagnostics industry & urology community during
the ‘Review and Comment’ period to assemble the strongest possible support
•Our representations to Novitas were strongly supported by:
•The leading professional societies in urology - AUA, LUGPA and AACU
1
•Industry partners, the Coalition for 21st Century Medicine (C21), the American
Clinical Laboratory Association (ACLA) and by many other key urologic opinion
leaders
•More than a dozen Urology Key Opinion Leaders (KOLs) wrote a response to
Novitas that will be published in the Journal of Bladder Cancer
2
rallying against
Novitas’ approach
•Awaiting finalization before considering other legal/regulatory options
REPUBLISHED DRAFT LCD
(27 July 2023)
3
REVIEW AND COMMENTPERIOD
(Closed 9 September 2023)
2
DECISION
Novitas must withdraw or finalize the LCD by 26
July 2024
3
LCD becomes effective (assuming no further
protest) a minimum of 45 days after finalization
PACIFIC EDGE’S LARGEST PAYER
•Medicare and Medicare Advantage is the largest global opportunity in
bladder cancer diagnostics from a single coverage decision
•In 1H 24 Medicare and Medicare Advantage delivered ~7,850 commercial
tests (~58% of US commercial tests) and ~$9.9 m NZD in total operating
revenue (~75%)
1.AUA: American Urological Association, LUGPA: Large Urology Group Practice Association, AACU: American Association of Clinical Urologists
2.A copy of the accept manuscript is available at https://www.pacificedgedx.com/assets/Investor-Files/Lotan-et-al-Commentary-on-Novitas-LCD-DL39365.pdf
3.All dates in this graphic refer to US Dates
8
BUILDING RESILIENCE TO WEATHER A MEDICARE NON-COVERAGE DECISION
PRESERVING CAPITAL, DIVERSIFYING REVENUE SOURCES, DRIVING PROFITABLE SALES OPERATIONS
COMMITTED TO MAINTAINING A STRONG BALANCE SHEET
•Pacific Edge expects to manage its cash reserves in the event of an
adverse Medicare coverage decision until we regain coverage, a
process that could take up to 4 years with several earlier
opportunities for re-coverage with new evidence
PEDUSA STRATEGIC RESPONSE
•Restructured US sales operations and introduced patient
responsibility
•Deeper focus on larger or value-based institutional accounts and
capitated systems (pop: ~13.2 million patients)
•Refocused clinical evidence development, coverage and guidelines
for coverage certainty
•Ex-US opportunities through distributors: ProGenetics (Israel) and
SouthGenetics (various LATAM countries)
•Considering alternative Medicare Administrative Contractor, LCD
Challenge & new LCDs
EXTENDING OUR REACH THROUGH DISTRIBUTION AGREEMENTS
APAC & HEAD OFFICE STRATEGIC RESPONSE
•R&D investment weighted to Detect
+
and Monitor
+
launches
•Development of growth markets in Australia and Asia
•Distribution agreements Transviet (Vietnam), Hi-Precision (Philippines) and
WellSpring (Malaysia)
9
A FLEXIBLE AND GOAL FOCUSED SALES FORCE
REORGANISATION DISRUPTS SALES IN Q2 24
WE HAVE REVIEWED OUR APPROACH TO THE US MARKET
•Sales territories reduced from 29 to 17
•Sales initiatives focused on clinical value, economic value and
patient value
•Increased expectations of throughput per sales force headcount
•Accelerate our clinical evidence generation program where possible
with a focus on monitoring
ENHANCED PATIENT RESPONSIBILITY AND SALES FORCE EFFICIENCY
•Patients with non-contracted private insurance (i.e. non-Kaiser) to
sign patient responsibility notice
•Provides Pacific Edge with increased means to collect payment
from the patient, as the patient acknowledges liability
•Patient Assist Program will offer customers discounts based on
income benchmarked against US federal policy guidelines
US TEST VOLUMES (TLT*) AND ORDERING CLINICIANS
4,277
4,706
4,591
5,290
6,073
6,699
6,629
7,816
8,627
7,335
657
690
741
789
895
978
1,082
1,150
1,232
1,147
-100
100
300
500
700
900
1,100
1,300
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
Q1 22Q2 22Q3 22Q4 22Q1 23Q2 23Q3 23Q4 23Q1 24Q2 24
UNIQUE CLINICIANS
US TEST VOLUME
US ORDERING CLINICIANS (RHS)
Commercial tests represent 84% of TLT in 1H 24
*
1H 24 Total Laboratory Throughput including commercial, pre-commercial and clinical studies testing
10
For healthcare payers Cxbladder Detect offers substantial total cost savings per patientwhen used to
intensify or de-intensify hematuria evaluation in patients presenting with microhematuria
1
1
Pacific Edge has developed a detailed budget impact model to understand costs to private practice, healthcare institutions and payers, over and
above the Cxbladder test price of US $760/test focused on microhematuria patients. Budgetary Impact of Including the Urinary Genomic Marker
Cxbladder Detect in the Evaluation of Microhematuria Patients - PubMed (nih.gov)
SELLING CXBLADDER’S CLINICAL, ECONOMIC AND PATIENT VALUE
Pacific Edge
modelling
1
suggests avoided
procedures could
save >US$500 per
patient with
microhematuria
CURRENT PRACTICE (AUA GUIDELINES)CXBLADDER INTRODUCED TO STANDARD OF CARE
DRIVING GROWTH IN ASIA PACIFIC AND CONSOLIDATING NEW ZEALAND
*
APAC TEST VOLUMES
*
*
1H 24 Total Laboratory Throughput including commercial, pre-commercial and clinical studies testing, APAC generating ~12% of test volume
NEW ZEALAND IS A MATURE MARKET
•Cxbladder is covered in 15 of the 20 new Te Whatu Ora - Health New
Zealand health regions, representing >75% of the population
•Te Whatu Ora Nelson/Marlborough has advised Pacific Edge that it is
introducing Cxbladder Triage in primary care
•We are seeking a national contract with Te Whatu Ora working
through NZ KOLs
AUSTRALIA & ASIA PACIFIC
•Australia and Southeast Asia are still in business development
•Initial commercial testing volume direct or via distributors in
Singapore, Malaysia, India (Eval) and the Philippines (Eval)
11
Commercial tests represent 84% of TLT in 1H 24
1,079
1,074
1,117
952
983
1,165
1,139
1,061
1,077
1,190
-
200
400
600
800
1,000
1,200
1,400
Q1 22Q2 22Q3 22Q4 22Q1 23Q2 23Q3 23Q4 23Q1 24Q2 24
APAC TEST VOLUME
12
STRENGTHENING OUR FOUNDATIONS: PERFORMANCE EXCELLENCE
DIGITALIZATION, AUTOMATION & CUSTOMER EXPERIENCE
Customer facing systems
•Give customers options to connect with Pacific Edge to
fit their needs and smooth workflows
•Electronic Medical Record (EMR) integrations
•Customer Portal
•Improvement of end-to-end experience for patients and
customers supported by digital workflows
Internal systems
•Improve Lab Operations and Customer Service with
focus on increasing automation and reducing turn
around time
•Organization-wide data warehouse for storage, access
and reporting of all commercial data
•Customer Relationship Management (CRM) rollout
expanded beyond sales to all commercial teams
•EMR integration went live 14 November 2023 (US Time) that streamlines
sample collection, test ordering and resulting
•Cxbladder Triage and Monitor introduced into Southern California
Permanente Medical Group (Kaiser SoCal); 15 sites now eligible to order
Cxbladder electronically
•Large opportunity to reduce unnecessary cystoscopies for the evaluation
of bladder cancer in hematuria patients and NMIBC patients
•Kaiser SoCal represents ~37% of the >12.6 million members covered by
the Kaiser Health Plan nationally
CXBLADDER NOW LIVE IN KAISER PERMANENTE’S EMR
Achievement expected to drive volume in 2H 24
1. RDM: Residual Disease Monitoring,
2. TRM: Therapeutic Response Monitoring
3. Lotan et al ‘Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification’
13
OUR
FUTURE
SIMPLIFYING THE CXBLADDER PROPOSITION – DETECT
+
AND MONITOR
+
LEVERAGING EVIDENCE SHOWING THE ADDITION OF DNA BIOMARKERS ENHANCES TEST PERFORMANCE
3
CLINICAL EVIDENCE UNDERPINS COVERAGE AND GUIDELINES DECISIONS
Recognition in national guidelines is the best way to entrench Medicare coverage of Cxbladder and its
adoption by other independently contracted healthcare systems
•Leading urologic authority in Europe and
globally influential
•Relevant standards of care: non-muscle
invasive bladder cancer
•Review period: with new evidence, last
updated in March 2023
•US-based not-for-profit alliance of 32
leading US cancer centres
•Relevant standards of care: High-risk
non-muscle-invasive bladder cancer
•Review period: annual submission every
August
www.auanet.orgwww.nccn.orgwww.uroweb.org
•Globally the most influential and largest
urologicalassociation
•Relevant standards of care: Hematuria,
microhematuria management and non-
muscle invasive bladder cancer
•Review period: with new evidence, last
updated in 2020
PACIFIC EDGE’S CLINICAL STUDY PROGRAM
microDRIVE
Detection and
RIsk Stratification
in VEterans
Presenting with
Microhematuria
POOLED
ANALYSIS
Pooled-analysisof
Detect
+
from
multiple studies
AUSSIE
Australian
Urologic risk
Stratification of
patientS wIth
hEmaturia
DRIVE
Detection and
RIsk stratification
in VEterans
presenting with
hematuria
STRATA
Safe Testing of
Risk for
AsymptomaTic
microhematuriA
LOBSTER
LOngitudinal
Bladder Cancer
Study for Tumor
REcurRence
CREDIBLE
Cystoscopic
REDuction In
BLadder Evalu-
ations for micro-
hematuria
FIVE YEAR CXBLADDER CLINICAL STUDY ROAD MAP
PACIFIC EDGE WILL SEEK GUIDELINE INCLUSION AS NEW EVIDENCE PRODUCED
15
16
*US CU-Surv – proposed study that will focus on clinical utility of Monitor
+
in surveillance NMIBC patients
FIVE YEAR CXBLADDER CLINICAL STUDY ROAD MAP (continued)...
STUDIES FOR DETECT
+
AND MONITOR
+
*
AMPLIFYING OUR EVIDENCE WITH UROLOGY OPINION LEADERS
CLINICAL DOSSIER DEVELOPMENT
•Contains all published Cxbladder data; externally reviewed
•Used to engage with guideline committees, private payors, government
payers, value-based clinician groups, ex-US distributors, etc
•Annual National Comprehensive Cancer Network (NCCN) submission of
new evidence
PODIUMS, PRESENTATIONS, POSTERS AND PUBLICATIONS
•Increase “share of voice” by presenting data on Cxbladder utility in
multiple forums (AUA, SUO, ASCO GU
1
), clinicians, academic institutions
•Publications – support for data generated and published by our users
and KOLs
•Speakers Bureau – trained, external KOLs and senior Medical Science
Liaison team members
BUILDING KOL RELATIONSHIPS
•Academics, clinical leads in private practice, guidelines committees and
other influential clinicians
•Educational events, journal clubs, and resident training for large
institutions
17
VIDEO VIEWS
PUBLISHED
12/2/22
4102
1.AUA: American Urological Society, SUO: Society for Urologic Oncology, ASCO GU: American Society of Clinical Oncology Genitourinary
18
WE ARE PREPARED SHOULD FDA REGULATE LAB DEVELOPED TESTS
FDA REGULATION FACES HURDLES
•FDA has proposed LDTslike Cxbladder that are performed within a “single lab” as a
CLIA/LDT are within its remit to regulate under the Medical Device Amendments
of 1976
•60-day comment period is expected to close on 4 December 2023 (US time),
but delays are widely anticipated as a result of legal action from industry
groups
•Proposed four-year phase in period, with a registry of all tests as the first
step, with 510k/PMA
1
in the later years offers time to adapt
•Pacific Edge supports and welcomes FDA regulation through an act of
Congress, e.g. VALID
2
Act (failed to pass Congress in 2022)
•Pacific Edge does not support regulation under the Medical Device
Amendments of 1976
•Pacific Edge is prepared
•While some requirements will be specific to the FDA, most are captured by
other regulatory bodies (CLIA, CAP & NYS
3
) with which we already comply
•Achieving FDA-approved status may make it more difficult for competitors
to develop parity with Cxbladder’s level of evidence
•Pacific Edge actively resources its R&D, clinical development, digital
development and clinical operations to maintain compliance with all
regulatory requirements
1.PMA is pre-market approval. 510k is a similar, but slightly shorter process in
which the process follows a previously approved “predicate device”
2.VALID: Verifying Accurate Leading-edge IVCT Development Act
3.CLIA: Clinical Laboratory Improvement Amendments, CAP: College of American
Pathologists, NYS: New York State
RESEARCH & INNOVATION – FOCUSED ON DNA ENHANCED PRODUCTS
READYING FOR THE LAUNCH OF NEW DETECT
+
AND MONITOR
+
•Ensure R&D, Digital and Lab Operations focus on the launch of Detect
+
and Monitor
+
•Simplifying Cxbladder to reduce technician time, lower cost of goods,
lower turnaround time, increase throughput and increase automation
•Develop sufficient documentation for in-vitro diagnostic (IVD)
regulation associated with product development and analytical
validation of our next generation tests
•Continued engagement with industry and academic research and
development collaborations to address unmet clinical needs in bladder
cancer diagnosis and management
19
1H 24 FINANCIAL PERFORMANCE
$2,285
$3,326
$5,378
$8,707
$13,095
$2,085
$4,375
$6,067
$10,909
$0
$5,000
$10,000
$15,000
$20,000
$25,000
FY 20FY 21FY 22FY 23FY 24
$(000)
1H2H
21
US COMMERCIAL TEST VOLUME GROWTH DRIVING REVENUE
RATE OF REVENUE GROWTH IN 2Q 24 EASES AMID SALE FORCE REORGANIZATION
PACIFIC EDGE OPERATING REVENUE
$4,370
$7,701
$11,445
$19,616
1H 23
1H 24
REGIONAL REVENUE CONTRIBUTION
5%
95%
APAC
AMERICAS
▲
50%
22
REVENUE GROWS WITH INCREASED ADOPTION OF CXBLADDER
LOSSES REFLECT INVESTMENTS FOR TOP LINE REVENUE GROWTH IN FY23
•Operating revenue rises with increased volumes
and an increase in average receipts
•Total revenue includes FX gains of $0.7m 1H 24,
lower than the$3.0m in 1H 23
•Interest revenue of $1.9m in 1H 24 up on
the$1.6m in 2H 23 and $1.1m in 1H 23
•Increase in operating expenses driven by
increased headcount as investments made for
revenue growth in FY 23, and increased
expenses relating tovolume growth
•Reorganisation with reduction insales
territorieslate1H 24 will flow through in 2H 24
•Balance sheet remains strong
Half year to 30 September
1H 242H 23 1H 23
1H 24
vs. 1H 23
1H 24
vs. 1H 23
$(000)$(000)$(000)
△
$(000)
△%
Operating revenue $13,095$10,909$8,707$4,38850%
To t a l re v e n u e $16,580$12,531$13,593$2,98722%
Operating expenses $31,832$28,925$24,164$7,66832%
Totalcomprehensive loss -$15,054-$16,873-$10,191-$4,86348%
Cash receipts from customers $13,576$11,152$7,316$6,26086%
Net operating cash outflow $14,992$11,603$13,972$1,0207%
Net cash, cash equivalents and
short-term deposits
$62,174$77,791$93,455-$31,281-33%
23
OPERATING EXPENSES RISE REFLECTING GROWTH CONFIGURATION
2Q 24 REFOCUS ON PROFITABLE SALES, NEW REVENUE AND CASH PRESERVATION TO MODERATE EXPENSES
•Lab operating expenses rise with increased
testvolumes and higher freight costs
•Research expenses reflect increased clinical
study expenditure with commencement of
microDRIVE
•Sales and marketing expenses reflect the
impact of prior appointments focused on
growth. Sales expenses tomoderate in 2H 24
following reorganisation
•G&A expenditure in 1H 24 includes elevated
legal fees related to the objections of the
proposedMedicare loss ofcoverage
FINANCIAL PERIOD
(March year-end)
1H 242H 231H 23
1H 24
vs. 1H 23
1H 24
vs. 1H 23
$(000)$(000)$(000)
△
$(000)
△%
Laboratory operations $6,141$4,882$4,467-$1,67437%
Research $5,487$4,774$3,710-$1,77748%
Sales and marketing $14,339$13,748$11,375-$2,96426%
General and administration $5,865$5,521$4,612-$1,25327%
Total operating expenses$31,832$28,925$24,164-$7,66832%
24
ESG: PACIFIC EDGE IS FOUNDED ON IMPROVING SOCIAL OUTCOMES
GOVERNANCE
•Integrating oversight of Environmental, Social and Governance (ESG)
matters, including carbon reporting, into the Audit and Risk Committee
Charter
AOTEAROA NEW ZEALAND CLIMATE STANDARDS
•Measured carbon emissions (Scope 1, 2, 3) in FY 23 and positioned to
provide base year data in FY 24
•Working closely with expert advisors to accurately audit and measure
our greenhouse gas emissions, as we work towards achieving
certification in respect of FY 24
•Developing strategies and policies and evolving our risk management
framework to meet our reporting requirements
ATTRACTING AND RETAINING TALENT AT PACIFIC EDGE
•We actively promote diversity, inclusion, engagement and fair
remuneration
Cxbladder delivers actionable information that can: contribute to clinically meaningful improvements in cancer treatment;
improve patient lives; healthcare equity and outcomes; and healthcare payer operating expenditure savings
1,2
PROMOTING HEALTH CARE EQUITY
Following the introduction of Cxbladder into primary care in Te
Whatu Ora Canterbury, referrals to urologists were safely reduced,
urological waiting lists fell by 25%
2
1. Budgetary Impact of Including the Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients - PubMed (nih.gov)
2. Davidson, Peter; Presentation to Urofair, 2022, time to first specialist assessment.
OUTLOOK: FOCUSED ON FY24 EXECUTION
•Pacific Edge expects the available cash to be sufficient to support the company
in the event of an adverse Medicare coverage decision through to regaining
coverage - a process that may take up to four years with interim coverage
attempts with every piece of new evidence
•We have re-focused the business on clinical development for guidelines
inclusion and increased coverage certainty for Detect
+
& Monitor
+
•Selling focus on clinical value as the driver of higher throughput/headcount and
throughput/clinician
•HEADWINDS:
•Possible non-coverage determination from Novitas on a new proposed
LCD after following appropriate procedure
•Possible negative physician or patient response to enhanced patient
responsibility for commercially insured patients
•CATALYSTS:
•Possible re-coverage determination from Novitas on new proposed LCD
after following appropriate procedure
•Possible Te Whatu Ora national contract
•New clinician-generated CU evidence as studies completed
•We have world-leading technology, a strong balance sheet, are effectively
navigating headwinds in the US and establishing footholds in new markets
25
APPENDIX
26
Mission
To help improve people’s lives and
patient outcomes by providing leading
solutions for the early detection and
management of cancer
Vision
A world where the early diagnosis and
better treatment of cancer is within
reach of everyone
27
PACIFIC EDGE: RESEARCH, INNOVATION, COMMERCIALIZATION
2001
2001
Pacific Edge
established
2007
2007
Commercial
pivot to
focus on
urothelial
cancer
diagnostics
2008
Holyoake et al: Urine-
based RNA detection
of urothelial cancer.
Clin Cancer Res
2008
2010
2010
Pacific Edge
Diagnostics
New Zealand
(PEDNZ)
established
2012
2012
O’Sullivan et al:
Cxbladder Detect
performance
validation.
Journal of Urology
Dec 2012
Launch of Pacific Edge
Diagnostics USAand
Cxb Detect
2013
Mar 2013
PEDUSA receives
CLIA
accreditation
May 2013
First commercial
sale (Cxb Detect)
for PEDNZ
Mar 2013
First commercial
sale (Cxb Detect)
for PEDUSA
2014
Dec 2014
Launch of Cxbladder
Triage
2015
Mar 2015
Kavalieris et al:
Cxb Triage
performance
validation. BMC
Urology
Dec 2015
Launch of
Cxbladder
Monitor
2016
Nov 2016
Clinical trials
commence in
Singapore
2018
Feb 2018
Cxb Triage
adopted into
Canterbury
Community Health
Pathways with
primary care
referral
2019
Aug 2019
Konety et al: Clinical
Utility of Cxb Detect
in adjudicating
atypical cytology and
equivocal
cystoscopy.European
Urology
2020
Apr 2020
Patient in-home
sampling initiated in
the US
Jun 2020
Kaiser Permanente,
approves commercial
use of Cxbladder
Jul 2020
CMS confirms
reimbursement of
Cxbladderat
$760/test
2021
Aug 2021
Cxbladder reaches
70% public
healthcare
coverage in NZ
Oct 2021
PEB raises
$103.5m
(~US$72.5m)
Dec 2021
First commercial
sale of Cxbladder
in Australia
2003
Listed on
the NZX
Cxbladder
TRIAGE
Cxbladder
DETECT
Cxbladder
MONITOR
2022
Dec 2022
Lotan et al:
Enhanced
Cxbladder
Tests Deliver
Improved
Performance.
Journal of
Urology
28
MONITOR FOR
RECURRENCE
SURVEILLANCE
(RDM
1
, TRM
2
, RECURRENCE)
PATIENT/DISEASE MANAGEMENT
(CLINICAL DECISION MAKING)
MOLECULAR DIAGNOSTICS VALUE CHAIN:
PATIENT JOURNEY
GENOMIC SCREENING
(PERSONALIZED GENETIC RISK)
ASYMPTOMATIC SCREENING
(EARLY DETECTION)
1.RDM: Residual Disease Monitoring
2.TRM: Therapeutic Response Monitoring.
29
INTENSIFY/DE-INTENSIFY
WORKUPS
SURGICAL OR
THERAPEUTIC
INTERVENTION
SYMPTOMS
ONSET
GENETIC RISK
AT BIRTH
DISEASE
MANIFESTS
ADJUDICATE DIAGNOSTIC
DILEMMAS
BLADDER CANCER
A SIGNIFICANT GLOBAL HEALTHCARE CHALLENGE
1. World Cancer Research Fund Annual case figure is 2020.
2. American Society of Clinical Oncology Annual death figure is 2020.
3. Average recurrence for low grade cancer
4. International Agency for Research on Cancer
30
10
th
Most common
cancer world-
wide
1
~70%
Recurrence
3
~573K
Annual cases
and growing
1
>212K
Annual
deaths
2
6
th
Most common
cancer in men
1
17
th
Most common
cancer in women
1
<1.7 1.7 to 2.7 2.7 to 5.3 5.3 to 8.6 >8.6
INCIDENCE PER 100,000 OF THE POPULATION
4
1. Pacific Edge estimates
USA – To t a l A d d re s s a b l e M a r ke t ( TA M ) U S $ 3 . 5 b
Americas (non-US) – TA M US$ 0 .5 b
EMEA (w/o most of Africa) – TA M US$ 1 .4 b
APAC (w/o China) – TA M US$ 2 .2 b
US$7.6b
Total
Addressable
Market
1
31
CXBLADDER IS A GLOBAL OPPORTUNITY
•US is the focus of our growth efforts
•New Zealand is a mature market
•APAC in business development
•Distribution considered in other markets
on a case-by-case basis
GLOBAL COMMERCIALIZATION
HEMATURIA EVALUATION AND SURVEILLANCE IN THE US MARKET
90%
Five-year survival
rate for NMIBC if
detected early
1
US$191K
Average lifetime
cost per patient
2
US$9.4B
Annual US spend on
bladder cancer
3
The US has >55m
men and >63m
women aged 50+
~7m
present with
hematuria
4
~3.4m
referred for
clinical
workup
7
>1.0m
patients
receive a
cystoscopy
5
~82k
Annual cases of
bladder cancer
6
~725k
patients living with
bladder cancer
~1.5Cxb Monitor/yr
6
US$3.5B
opportunity
7
(hematuria,
surveillance)
1. National Cancer Institute SEER.
2. Aly A et al. (2020) The Real-World Lifetime Economic Burden of Urothelial Carcinoma by Stage at Diagnosis. J Clin Pathw. 2020 May; 6(4):51-60
3. National Cancer Institute: Cancer Progress Trends Report
4. Journal of the American Medical Association
5. Kenigsberg, A, et al. The Economics of Cystoscopy: A Microcost Analysis, Urology 157: 29−34, 2021.
6. National Cancer Institute SEER.
7. Pacific Edge Estimate, opportunity estimated at US$760/Per test
VALUE PROPOSITION
Primary Care Physician
Urologist/Specialist
Patient care
pathway
Cxbladder
TRIAGE
Cxbladder
DETECT
Cxbladder
MONITOR
32
>4.5M CXBLADDER TESTOPPORTUNITIES
THE PRINCIPLES OF PACIFIC EDGE’S CLINICAL STUDY DESIGN PROGRAM
33
STUDYGOAL*USE CASE / INDICATIONPOPULATION
STRATA
•CU of Triage
•CV of Detect
+
(retrospective)
•Risk stratification•Microhematuria
DRIVE
•CV of Detect
+
•CV of Triage
•Data for pooled-analysis
•Risk stratification•Microhematuria and gross
hematuria
AUSSIE
•CVof Detect
+
with an Australian cohort
•Data for pooled analysis
•Risk stratification•Microhematuria and gross
hematuria
microDRIVE
•CV of Detect
+
•Data for pooled analysis
•Risk stratification•Microhematuria
POOLED ANALYSIS
(two groups)
•CV of Detect
+
•Risk stratification•Microhematuria / gross hematuria
LOBSTER
•CV of Monitor/Monitor
+
•Risk stratification•Surveillance
CREDIBLE
•CU of Detect
+
•Risk stratification •Microhematuria
*CU - Clinical Utility, CV - Clinical Validity, AV - Analytical validity. For a detailed definition of these terms please see the glossary on
page 38 of this presentation.
Pacific Edge will attempt to gain guideline inclusion (and coverage) with every new piece of clinical or economic
evidence supporting the adoption of Cxbladder
SUMMARY OF CLINICAL EVIDENCE
StudyPop.TypeSensitivity (Sn)NPVSpecificity (Sp)Comment
Detect+
AVLotan et al., 2022MH + GH*97%99.7%90%Pooled data from US and Singapore cohorts (n=804)
CV
DRIVE (unpublished) (1)MH + GH*Study in progress
AUSSIE (unpublished) (4)MH + GH*Study to start this year
microDRIVE(unpublished) (5)MH*Study to start this year
CUCREDIBLE (not started)(6)MHProtocol in final development stages, site selection starting by the end of year.
Triage
AVKavalieris et al., 2015MH + GH*95.10%98.50%45%Sn, Sp, NPV values when test-negative rate is 40%
CV
Davidson et al., 2019MH + GH*95.5% (1)98.6% (1)34.3%GH only: Sn (95.1%), NPV(98%), Sp(32.8%); MH only: Sn (100%), NPV (100%), Sp (42.6%)
Konety et al., 2019(2)100%
Cxbladder (3) correctly adjudicated all UC confirmed patients (n=26) with atypical urine cytology
results (n=153, 4)
Lotan et al., 2022MH + GH*89%99%63%Pooled data from US and Singapore cohorts (n=804)
CU
Davidson et al., 2020MH + GH*89.4% (5)98.9% (5)59% (5)
39% of patients testing negative for Cxb Triage & imaging did not get cystoscopy & were
managed at primary care (6)
STRATA (unpublished) (7)MH + GH*Study in progress
Detect
AVO'Sullivan et al., 2012GH*81.8%97%85.1%Cxb Detect detected 97% of HG tumors & 100% of Stage 1 or greater tumors.
CV
Lotan et al., 2022MH + GH*74%97%82%Pooled data from US and Singapore cohorts (n=804)
DRIVE (unpublished) (1)MH + GH*Study in progress
Monitor
AVKavalieris et al., 2017(1)88% (2)97% (2)N/A(3)
CVKonety et al., 2019(4)100%
Cxbladder (5) correctly adjudicated all UC confirmed patients (n=26) with atypical urine cytology
results (n=153, 6)
CUKoya et al., 2020(7)
Integration of Cxb Monitor into the surveillance schedule reduced annual cystoscopies (39%)
(8,9)
CULi et al., 2023(7)
Cxbladder Monitor safely postpones a patient’s next scheduled cystoscopy, the current ‘gold
standard’ for bladder cancer surveillance.
*Referred patients.
Definitions - MH: Microhematuria, GH: Gross Hematuria. For Sensitivity, NPV and Specificity please see page 38 of this presentation
34
FOOTNOTES FOR CLINICAL EVIDENCE SUMMARY
Footnotes
Detect
+
1Observational study to validate performance characteristics and clinical utility of Cxbladder tests (Cxb Triage, Cxb Detect, CxbDetect
+
).
2Observational study to validate performance characteristics of Cxb Detect
+
in patients with UC of the upper tract.
3Patients with suspected upper tract UC (UTUC) or surveillance patients with a history of UTUC.
4Observational study to validate performance characteristics and clinical utility of Cxbladder tests (Cxb Triage, Cxb Detect, CxbDetect
+
).
5Observational study to validate performance characteristics of CxbDetect
+
in microhematuria(MH) patients.
6Clinical utility study comparing the reduction of cystoscopy use when implementing the new clinical pathway to SOC in a defined MH population.
Triage
1CxbTriage performance; CxbTriage & imaging combined performance had a Snof 97.7% & NPVof 99.8%.
2Patients included hematuria evaluation (n=436) or surveillance previously diagnosed with UC (n=416) with both Cxbladder & urine cytology results.
3Cxbladder includes Cxbladder Triage & Cxbladder Monitor.
4This included n=70 for patients with hematuria & n=83 for patients with previously diagnosed UC and overall test negative rate of 30.7%.
5Cxb Triage performance; Cxb Triage & imaging combined performance had a Snof 98.1%,NPV of 99.9% & Spof 98.4%.
6Cxb Triage negative rate was 53%; Follow-up period of 21-months showed no missed cancers, demonstrating safety.
7The intent of STRATA is to show that it is safe to risk stratify low risk microhematuria patients and not undertake cystoscopy.
Detect
1
Observational study to validate performance characteristics and clinical utility of Cxbladder tests (Cxb Triage, Cxb Detect, CxbDetect
+
).
Monitor
1Surveillance patients previously diagnosed with primary or recurrent UC.
2CxbMonitor performance characteristics on surveillance patients diagnosed with primary UC; CxbMonitor had a Snof 93% and NPV of 94% on patients with recurrent UC.
3Using Kavalieris et al., (2017) data set, Lotan et al., (2017) compared relative performance of Cxb Monitor against NMP22 ELISA,NMP22 BladderChek and urine cytology.
4Patients included hematuria evaluation (n=436) or previously diagnosed UC (n=416) with both Cxbladder & urine cytology results.
5Cxbladder includes Cxbladder Triage & Cxbladder Monitor.
6This included n=70 for patients with hematuria & n=83 for patients with previously diagnosed UC; test negative rate of 30.7%.
7All patients were being evaluated for recurrence of UC (n=309 providing 443 samples).
8Cxb Monitor identified all seven confirmed recurrence events idnetified on the first cystoscopy.
9Patients returning negative CxbMonitor results (n=235) had no pathology-confirmed recurrence at 1st cystoscopy
35
REFERENCES SUMMARY OF CLINICAL EVIDENCE
References
Detect
+
Lotan et al., (2022). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification.The Journal of Urology, 10-1097.
Triage
Davidson et al., (2019). Inclusion of a molecular marker of bladder cancer in a clinical pathway for investigation of haematuria may reduce the need for cystoscopy.NZ Med J,132(1497), 55-64.
Davidson et al., (2020). Assessment of a clinical pathway for investigation of haematuria that reduces the need for cystoscopy.The New Zealand Medical Journal (Online),133(1527), 71-82.
Kavalieris et al., (2015). A segregation index combining phenotypic (clinical characteristics) and genotypic (gene expression) biomarkers from a urine sample to triage outpatients presenting with hematuria who
have a low probability of urothelial carcinoma.BMC urology,15(1), 1-12.
Konety et al., (2019). Evaluation of cxbladder and adjudication of atypical cytology and equivocal cystoscopy.European urology,76(2), 238-243.
Lotan et al., (2022). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification.The Journal of Urology, 10-1097.
Detect
Lotan et al., (2022). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification.The Journal of Urology, 10-1097.
O'Sullivan et al., (2012). A multigene urine test for the detection and stratification of bladder cancer in patients presenting with hematuria.The Journal of urology,188(3), 741-747.
Monitor
Kavalieris et al., (2017). Performance characteristics of a multigene urine biomarker test for monitoring for recurrent urothelial carcinoma in a multicenter study.The Journal of Urology,197(6), 1419-1426.
Konety et al., (2019). Evaluation of cxbladder and adjudication of atypical cytology and equivocal cystoscopy.European urology,76(2), 238-243.
Koya et al., (2020). An evaluation of the real-world use and clinical utility of the Cxbladder Monitor assay in the follow-up ofpatients previously treated for bladder cancer.BMC urology,20(1), 1-9.
Lotan et al., (2017). Clinical comparison of non-invasive urine tests for ruling out recurrent urothelial carcinoma. Urologic Oncology: Seminars and Original Investigations, 35 (8), 531-539.
Li et al., (2023). Cxbladder Monitor testing to reduce cystoscopy frequency in patients with bladder cancer. Urologic Oncology: Seminars and Original Investigations, 41 (7), 326.e1 –326.38.
36
INDEPENDENT DIRECTORS
SARAH PARK
ANATOLE MASFEN
BRYAN WILLIAMS
ANNA STOVE
MARK GREEN
TONY BARCLAY
CHRIS GALLAHER
Chairman
Chris has held senior positions in
both CEO and CFO roles with large
international companies and was a
partner in Arthur Young, Chartered
Accountants. Prior to retiring from
full time corporate life, he was CFO
of Fulton Hogan, a large New
Zealand civil contractor
DR PETER MEINTJES
Chief Executive Officer
Peter is a molecular diagnostics and
genomics leader focused on
nascent market development of
disruptive innovations to drive
commercial success. Prior to joining
Pacific Edge, he was based in
Boston in a succession of diagnostic
leadership roles. Most recently he
was the Chief Commercial Officer
at Eurofins Transplant Genomics
and before that he was CEO at
Omixon
SENIOR LEADERSHIP TEAM
GRANT GIBSON DAVID LEVISON DR TAMER ABOUSHWAREB
Chief Financial Officer President Pacific Edge Diagnostics USA Chief Medical Officer
GLEN COSTIN DARELL MORGAN DR JUSTIN HARVEY
President Asia Pacific Chief Operating Officer Chief Technology Officer
ANDY MCINTOSH PROFESSOR PARRY GUILFORD
Chief Digital Officer Chief Scientific Officer
PACIFIC EDGE BOARD AND MANAGEMENT
37
GLOSSARY
•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.
•Evidence definitions:
•Analytical validity: Evidence that a test is repeatable in the lab for a given indication and population.
•Clinical validity: Evidence a test works in the same way on an independent eligible population for a given indication.
•Clinical utility: Evidence that a test in the hands of a physician can usefully change patient management within the context of
care for the defined population and indication.
38
FOR MORE INFORMATION:
Dr. Peter Meintjes
Chief Executive Officer
email: peter.meintjes@pelnz.com
Grant Gibson
Chief Financial Officer
email: grant.gibson@pelnz.com
Pacific Edge
87 St David Street, PO Box 56, Dunedin, New Zealand
P +64 3 479 5800 F +64 3 479 5801
email: investors@pacificedge.co.nz
www.pacificedgedx.com
39
---
CONSOLIDATED
INTERIM FINANCIAL
STATEMENTS
FOR THE SIX MONTHS ENDED
30 SEPTEMBER 2023
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2023PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2023
Note: These Financial Statements are to be read in conjunction with the Notes to the Financial Statements.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2023
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
NOTES
UNAUDITED
SEPT 2023
6 MONTHS
($000)
UNAUDITED
SEPT 2022
6 MONTHS
($000)
AUDITED
MARCH 2023
12 MONTHS
($000)
REVENUE
Operating Revenue 4 13,095 8,707 19,616
Total Operating Revenue 13,095 8,707 19,616
Other Income4 859 761 1,417
Interest Income 1,892 1,099 2,761
Foreign Exchange Gain 734 3,026 2,330
Total Revenue and Other Income 16,580 13,593 26,124
OPERATING EXPENSES
Laboratory Operations 6,141 4,467 9,349
Research 5,487 3,710 8,484
Sales and Marketing 14,339 11,375 25,123
General and Administration5,865 4,612 10,133
Total Operating Expenses5 31,832 24,164 53,089
NET LOSS BEFORE TAX (15,252) (10,571) (26,965)
Income Tax Expense - - -
LOSS FOR THE YEAR AFTER TAX (15,252) (10,571) (26,965)
Items that may be reclassified to profit or loss:
Translation of Foreign Operations 198 380 (99)
TOTAL COMPREHENSIVE LOSS atttributable
to equity holders of the Company
(15,054) (10,191) (27,064)
Earnings per share for loss attributable to the
equity holders of the Company during the year
Basic and Diluted Earnings per share (0.019) (0.013) (0.033)
Consolidated Interim Financial Statements
Consolidated Statement of Comprehensive Income 3
Consolidated Statement of Changes in Equity 4
Consolidated Balance Sheet 6
Consolidated Statement of Cash Flows 7
Notes to the Financial Statements
1. Summary of Accounting Policies 8
2. Investment and Advances in Subsidiaries 10
3. Dividends 10
4. Revenue and Other Income 10
5. Operating Expenses 11
6. Segment Information 12
7. Share Capital 16
8. Reconciliation of Cash Flows to Operating
Activities with Operating Net Loss 16
9. Contingent Liabilities 17
10. Capital Commitments 17
11. Subsequent Events 17
12. Related Parties 17
13. Proposed Local Coverage Determination (LCD)
Changes – Potential Impact on Revenue 17
14. Net Tangible Assets 18
3 2
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2023PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2023
Note: These Financial Statements are to be read in conjunction with the Notes to the Financial Statements.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2023
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
NOTES
SHARE
CAPITAL
ACCUMULATED
LOSSES
SHARE BASED
PAYMENTS
RESERVE
FOREIGN CURRENCY
TRANSLATION
RESERVE
TOTAL
EQUITY
($000)($000)($000)($000)($000)
UNAUDITED 6 MONTHS TO 30 SEPT 2022
Balance as at 31 March 2022 294,139 (189,849) 3,145 941 108,376
Loss After Tax - (10,571) - - (10,571)
Other Comprehensive Income - - - 380 380
Total Comprehensive Loss atttributable to equity holders of the Company - (10,571) - 380 (10,191)
Transactions with owners in their capacity as owners:
Issue of Share Capital7 (2) - - - (2)
Share Based Payments - Employee Remuneration7 93 - - - 93
Share Based Payment - Employee Share Options7 - - 567 - 567
Balance as at 30 September 2022 294,230 (200,420) 3,712 1,321 98,843
UNAUDITED 6 MONTHS TO 30 SEPT 2023
Balance as at 31 March 2023 294,317 (216,814) 4,418 842 82,763
Loss After Tax - (15,252) - - (15,252)
Other Comprehensive Income - (8) - 206 198
Total Comprehensive Loss atttributable to equity holders of the Company - (15,260) - 206 (15,054)
Transactions with owners in their capacity as owners:
Issue of Share Capital7 - - - - -
Share Based Payments - Employee Remuneration7 38 - - - 38
Share Based Payment - Employee Share Options7 - - 555 - 555
Balance as at 30 September 2023 294,355 (232,074) 4,973 1,048 68,302
AUDITED 12 MONTHS TO 31 MARCH 2023
Balance as at 31 March 2022 294,139 (189,849) 3,145 941 108,376
Loss After Tax - (26,965) - - (26,965)
Other Comprehensive Income - - - (99) (99)
Total Comprehensive Loss atttributable to equity holders of the Company - (26,965) - (99) (27,064)
Transactions with owners in their capacity as owners:
Issue of Share Capital7 (4) - - - (4)
Share Based Payments - Employee Remuneration7 182 - - - 182
Share Based Payment - Employee Share Options7 - - 1,273 - 1,273
Balance as at 31 March 2023 294,317 (216,814) 4,418 842 82,763
5 4
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2023PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2023
Note: These Financial Statements are to be read in conjunction with the Notes to the Financial Statements.
For and on behalf of the Board of Directors
Director Director
Dated 22nd day of November 2023
AS AT 30 SEPTEMBER 2023
CONSOLIDATED BALANCE SHEET
NOTES
UNAUDITED
SEPT 2023
6 MONTHS
UNAUDITED
SEPT 2022
6 MONTHS
AUDITED
MARCH 2023
12 MONTHS
($000)($000)($000)
CURRENT ASSETS
Cash and Cash Equivalents 20,469 37,989 33,229
Short Term Deposits 41,705 55,466 44,562
Receivables 5,239 6,017 5,493
Inventory 1,676 1,507 1,287
Other Assets 1,688 1,734 1,400
Total Current Assets 70,777 102,713 85,971
NON-CURRENT ASSETS
Property, Plant and Equipment 2,945 1,753 2,768
Right of Use Assets 1,376 1,507 1,143
Intangible Assets 1,156 784 1,031
Total Non-Current Assets 5,477 4,044 4,942
TOTAL ASSETS 76,254 106,757 90,913
CURRENT LIABILITIES
Payables and Accruals 6,539 5,983 6,928
Lease Liabilities 529 1,267 811
Total Current Liabilities 7,068 7,250 7,739
NON-CURRENT LIABILITIES
Lease Liabilities 884 664 411
Total Non-Current Liabilities 884 664 411
TOTAL LIABILITIES 7,952 7,914 8,150
NET ASSETS 68,302 98,843 82,763
Represented by:
EQUITY
Share Capital7 294,355 294,230 294,317
Accumulated Losses (232,074) (200,420) (216,814)
Share Based Payments Reserve 4,973 3,712 4,418
Foreign Translation Reserve 1,048 1,321 842
TOTAL EQUITY 68,302 98,843 82,763
FURTHER INFORMATION:
Net Tangible Assets Per Share ($)14 0.083 0.121 0.101
Note: These Financial Statements are to be read in conjunction with the Notes to the Financial Statements.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2023
CONSOLIDATED STATEMENT OF CASH FLOWS
NOTES
UNAUDITED
SEPT 2023
6 MONTHS
UNAUDITED
SEPT 2022
6 MONTHS
AUDITED
MARCH 2023
12 MONTHS
($000)($000)($000)
CASH FLOWS TO OPERATING ACTIVITIES
Cash was provided from:
Receipts from Customers 13,576 7,316 18,468
Receipts from Grant Providers 1,371 404 1,066
Interest Received 1,228 908 2,716
16,175 8,628 22,250
Cash was disbursed to:
Payments to Suppliers and Employees 31,080 22,611 47,869
Net GST outflow (inflow) 87 (11) (44)
31,167 22,600 47,825
Net Cash Flows To Operating Activities8 (14,992) (13,972) (25,575)
CASH FLOWS FROM INVESTING ACTIVITIES:
Cash was provided from:
Proceeds from Short Term Deposits 35,703 71,784 143,490
35,703 71,784 143,490
Cash was disbursed to:
Purchase of Short Term Deposits 32,846 57,310 118,107
Capital Expenditure on Plant and Equipment 487 504 1,870
Capital Expenditure on Intangible Assets 302 487 1,039
33,635 58,301 121,016
Net Cash Flows From Investing Activities 2,068 13,483 22,474
CASH FLOWS (TO) FINANCING ACTIVITIES:
Cash was received from:
Proceeds from Borrowings - 314 -
Ordinary Shares Issued7 - - (4)
- 314 (4)
Cash was disbursed to:
Repayment of Leases - Principal 675 553 1,195
Repayment of Leases - Interest 32 46 83
Issue Expenses7 - 2 -
707 601 1,278
Net Cash Flows (To) Financing Activities (707) (287) (1,282)
Net (Decrease) in Cash Held (13,631) (776) (4,383)
Add Opening Cash Brought Forward 33,229 35,412 35,412
Effect of Exchange Rate Changes on Net Cash 871 3,353 2,200
Ending Cash Carried Forward 20,469 37,989 33,229
7 6
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2023PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2023
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2023
NOTES TO THE FINANCIAL STATEMENTS
1 . SUMMARY OF ACCOUNTING POLICIES
The unaudited consolidated interim financial statements (“Interim Financial Statements”)
presented are those of Pacific Edge Limited (“Company”) and its subsidiaries (“Group”).
The Company is registered and domiciled in New Zealand. The Group’s purpose is to
research, develop and commercialise new diagnostic and prognostic tools for the early
detection and management of cancers. Pacific Edge Diagnostics New Zealand Limited and
Pacific Edge Diagnostics USA Limited manage and operate the laboratories used for the
detection of bladder cancer. Pacific Edge (Australia) Pty Limited’s purpose is to research
and develop the Cxbladder products and other prognostic tools. Pacific Edge Diagnostics
Singapore Pte Limited’s purpose is sales and marketing of bladder cancer products and
assisting with research and development. Pacific Edge Analytical Services Limited is a
dormant entity.
The Company is a for profit entity, registered in New Zealand under the Companies Act
1993 and is a reporting entity for the purposes of the Financial Markets Conduct Act
2013. The Company is dual listed, with its primary listing of ordinary shares quoted in New
Zealand on the NZX Main Board, and a secondary listing in Australia as a Foreign Exempt
Entity on the ASX.
a) Basis of Preparation
The Interim Financial Statements for the six months ended 30 September 2023 have
been prepared in accordance with New Zealand Generally Accepted Accounting Practice
(GAAP) and the Financial Markets Conduct Act 2013. They comply with the New Zealand
Equivalents to International Financial Reporting Standards (NZ IFRS) and other guidance as
issued by the External Reporting Board, as appropriate for entities, and with International
Financial Reporting Standards.
The Interim Financial Statements have been prepared in accordance with NZ IAS 34 -
Interim Financial Reporting. In complying with NZ IAS 34, these consolidated Interim
Financial Statements also comply with IAS 34 - Interim Financial Reporting and should
be read in conjunction with the Company’s 2023 Annual Report. The Interim Financial
Statements for the six months ended 30 September 2023 are unaudited. Comparative
balances for 30 September 2022 are unaudited, whilst the comparative balances for 31
March 2023 are audited.
The Interim Financial Statements are prepared on the basis of historical cost, except where
otherwise identified. The presentational currency used in the preparation of the financial
statements is New Zealand dollars and all values are rounded to the nearest thousand
dollars ($000).
b) Accounting Policies
All significant accounting policies have been applied on a basis consistent with those used
in the audited financial statements of Pacific Edge Limited for the year ended 31 March
2023.
c) Authorisation
The Interim Financial Statements were authorised by the Board of Directors on
22 November 2023. The Annual Financial Statements for the year ended 31 March 2023
were authorised by the Board of Directors on 24 May 2023.
d) Audit
The Interim Financial Statements have not been audited. The comparative full year
financial results for the year ended 31 March 2023 have been audited.
e) Basis of Consolidation
The following entities and the basis of their inclusion for consolidation in these Interim
Financial Statements are as follows:
Ownership Interests
& Voting Rights
Name of Subsidiary
Place of
Incorporation
(or registration)
and Operation
Principal Activity
30 Sept
2023
(%)
30 Sept
2022
(%)
Pacific Edge Diagnostics
New Zealand Limited
New Zealand
Commercial Sales and
Diagnostic Laboratory
Operation
100100
Pacific Edge (Australia)
Pty Limited
Australia
Commercial Sales and
Biotechnology Research
& Development
100100
Pacific Edge Diagnostics
USA Limited
USA
Commercial Sales and
Diagnostic Laboratory
Operation
100100
Pacific Edge Singapore
Pte Limited
Singapore
Commercial Sales and
Biotechnology Research
& Development
100100
Pacific Edge Analytical
Services Limited
New ZealandDormant Company100100
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2023
NOTES TO THE FINANCIAL STATEMENTS
9 8
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2023PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2023
2. INVESTMENT AND ADVANCES IN SUBSIDIARIES
The consolidated Interim Financial Statements incorporate the assets and liabilities and
results of Pacific Edge Diagnostics New Zealand Limited, Pacific Edge (Australia) Pty
Limited, Pacific Edge Diagnostics USA Limited, Pacific Edge Diagnostics Singapore Pte
Limited and Pacific Edge Analytical Services Limited, all of which are 100% owned by the
Company. Subsidiaries have a 31 March balance date. The investments in and advances to
subsidiaries are eliminated on consolidation in the Group financial statements.
3. DIVIDENDS
The Company does not propose to pay dividends to shareholders similar to previous years.
This policy continues.
4. REVENUE AND OTHER INCOME
Unaudited
Sept 2023
6 Months
($000)
Unaudited
Sept 2022
6 Months
($000)
Audited
March 2023
12 Months
($000)
Cxbladder SalesCxbladder Sales
- US - Accrual Accounting- US - Accrual Accounting 11,403 11,403 7,3837,383 16,362 16,362
- US - Cash Accounting- US - Cash Accounting 1,062 1,062 916916 2,388 2,388
- Total US Sales- Total US Sales 12,465 12,465 8,2998,299 18,750 18,750
- Rest of World- Rest of World 630 630 408408 866 866
Total Operating Revenue Total Operating Revenue 13,095 13,095 8,7078,707 19,616 19,616
Other IncomeOther Income
Grant IncomeGrant Income 3 3 300300 44 44
Research Rebates and Tax IncentivesResearch Rebates and Tax Incentives 856 856 461461 1,373 1,373
Total Other IncomeTotal Other Income 859 859 761761 1,417 1,417
Refer to note 13 for details on a proposed Local Coverage Determination change that has
the potential to negatively impact future revenue.
5. OPERATING EXPENSES
The note below highlights total expenses shown within total operating expenses. These
items are then split across functions laboratory, research, sales and marketing and general
and administration as reported in the annual report.
Unaudited
Sept 2023
6 Months
($000)
Unaudited
Sept 2022
6 Months
($000)
Audited
March 2023
12 Months
($000)
Operating ExpensesOperating Expenses
AmortisationAmortisation 178 178 123123 427 427
Auditors Remuneration Auditors Remuneration
- Group year end financial statements- Group year end financial statements 97 97 6969 184 184
- Half year review of financial statements- Half year review of financial statements 34 29 30
- Foreign statutory financial statements 25 13 12
Total Auditors RemunerationTotal Auditors Remuneration
156 111 226
Consultant CostsConsultant Costs 1,366 858 2,019
DepreciationDepreciation 370 206 527
Depreciation on Right of Use AssetsDepreciation on Right of Use Assets 635 635 569569 1,179 1,179
Directors FeesDirectors Fees 247 247 495
Employee BenefitsEmployee Benefits15,70015,70010,79710,79726,10726,107
Employee Share Scheme ExpensesEmployee Share Scheme Expenses 38 38 9393 182 182
Employee Share OptionsEmployee Share Options 555 555 567567 1,273 1,273
Interest on Lease LiabilitiesInterest on Lease Liabilities 32 32 4646 83 83
Legal ExpensesLegal Expenses 620 620 388388 695 695
NZX / ASX / Registry FeesNZX / ASX / Registry Fees 146 146 225225 305 305
Rental and Lease ExpenseRental and Lease Expense 68 38 122
Site Fees - Clinical StudiesSite Fees - Clinical Studies 1,358 636 1,094
Other Operating ExpensesOther Operating Expenses10,36310,3639,2609,26018,35518,355
Total Operating ExpensesTotal Operating Expenses 31,832 31,832 24,16424,164 53,089 53,089
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2023
NOTES TO THE FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2023
NOTES TO THE FINANCIAL STATEMENTS
11 10
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2023PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2023
Employee Share Scheme
Employee Share Scheme Expenses are a non-cash expense. These relate to shares issued
to employees in lieu of cash bonuses.
Employee Share Scheme Options
Employee Share Options are a non-cash expense. Refer to Note 8 of the Annual Report for
details of the accounting policy for Employee Share Schemes.
Other Operating Expenses
The major categories of expenditure which make up operating expenses, but are not
disclosed separately above: Laboratory costs, Information Technology costs, Compliance
and Regulatory costs, Investor Relations costs.
6. SEGMENT INFORMATION
Operating segments are reported in a manner consistent with the internal reporting
provided to the chief operating decision-maker. The chief operating decision-maker,
who is responsible for allocating resources and assessing performance of the operating
segments, has been identified as the Chief Executive Officer who makes strategic
decisions.
There are two operating segments at balance date:
1. Commercial: The sales, marketing, laboratory and support operations to run the
commercial businesses worldwide; and
2. Research: The research and development of diagnostic and prognostic products for
human cancer.
The reportable operating segment Commercial derives its revenue primarily from sales
of Cxbladder tests and the reportable operating segment Research derives its revenue
primarily from grant income. The Chief Executive Officer assesses the performance of the
operating segments based on net loss for the period.
Segment income, expenses and profitability are presented on a gross basis excluding
inter-segment eliminations to best represent the performance of each segment operating
as independent business units. The segment information provided to the Chief Executive
Officer for the reportable segments described above, for the six months ended
30 September 2023, is shown on the following page.
Unaudited 6 Months
to 30 September 2023
Commercial
($000)
Research
($000)
Less:
Eliminations
($000)
Total
External
Income
($000)
Income
Operating Revenue - External13,095 - - 13,095
Other Income 2761,403 (820)859
Interest Income141,878 - 1,892
Foreign Exchange Gain-734 - 734
Total Income13,3854,015 (820)16,580
Expenses
Expenses21,7919,678 (820)30,649
Depreciation & Amortisation 801 382 - 1,183
Total Operating Expenses22,59210,060 (820)31,832
Loss Before Tax (9,207) (6,045) - (15,252)
Income Tax Expense - - - -
Loss After Tax (9,207) (6,045) - (15,252)
Net Cash Flow to Operating Activities (9,114) (5,878) - (14,992)
Audited 12 Months
to 31 March 2023
Commercial
($000)
Research
($000)
Less:
Eliminations
($000)
Total
External
Income
($000)
Income
Operating Revenue - External 19,616 - - 19,616
Other Income 467 2,245 (1,295) 1,417
Interest Income 18 2,743 - 2,761
Foreign Exchange Gain 5 2,325 - 2,330
Total Income 20,106 7,313 (1,295) 26,124
Expenses
Expenses 35,891 16,360 (1,295) 50,956
Depreciation & Amortisation 1,311 822 - 2,133
Total Operating Expenses 37,202 17,182 (1,295) 53,089
Loss Before Tax (17,096) (9,869) - (26,965)
Income Tax Expense - - - -
Loss After Tax (17,096) (9,869) - (26,965)
Net Cash Flow to Operating Activities (15,908) (9,667) - (25,575)
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2023
NOTES TO THE FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2023
NOTES TO THE FINANCIAL STATEMENTS
13 12
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2023PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2023
Unaudited 6 Months
to 30 September 2022
Commercial
($000)
Research
($000)
Less:
Eliminations
($000)
Total
External
Income
($000)
Income
Operating Revenue - External 8,707 - - 8,707
- Internal - - - -
Other Income 237 1,287 (763) 761
Interest Income 3 1,096 - 1,099
Foreign Exchange Gain 8 3,018 - 3,026
Total Income 8,955 5,401 (763) 13,593
Expenses
Expenses 16,280 7,749 (763) 23,266
Depreciation & Amortisation 594 304 - 898
Total Operating Expenses 16,874 8,053 (763) 24,164
Loss Before Tax (7,919) (2,652) - (10,571)
Income Tax Expense - - - -
Loss After Tax (7,919) (2,652) - (10,571)
Net Cash Flow to Operating Activities (8,478) (5,494) - (13,972)
Eliminations
These are the intercompany transactions between the subsidiaries and the Parent. These
are eliminated on consolidation of Group results. The Research segment of the business
utilise consumables and other components that are purchased by the Commercial
segments of the business, with the costs of these components allocated to Research
segment, and the Commercial segment recognising revenue from the sale.
Total Laboratory Throughput:
Unaudited
Commercial
# Tests
Research
# Tests
Total
# Tests
6 months ended 30 September 2023 15,401 2,828 18,229
12 months ended 31 March 2023 26,691 4,874 31,565
6 months ended 30 September 2022 12,422 2,495 14,917
Laboratory Throughput is a key metric for the Group: Laboratory Throughput provides
evidence of the usage of Cxbladder products globally and the rates of adoption between
different customer segments. Total Laboratory Throughput includes commercial tests,
which are invoiced to customers, and research tests which are not considered to be
billable as these tests relate to user programs or other non-chargeable activities.
Commercial test numbers are also a key metric for the Group. Commercial Tests are those
tests for which the Company is actively seeking reimbursement and cash receipts, and
tests performed at no charge in order to gain new customers.
Segment Assets and Liabilities Information:
Unaudited as at 30 September 2023
Commercial
($000)
Research
($000)
Total
($000)
Total Assets 8,152 68,102 76,254
Total Liabilities 4,585 3,367 7,952
Audited as at 31 March 2023
Commercial
($000)
Research
($000)
Total
($000)
Total Assets 9,375 81,538 90,913
Total Liabilities 5,853 2,297 8,150
Unaudited as at 30 September 2022
Commercial
($000)
Research
($000)
Total
($000)
Total Assets 8,906 97,851 106,757
Total Liabilities 5,990 1,924 7,914
Additions to non current assets for the period include:
Commercial
($000)
Research
($000)
Total
($000)
Property, Plant & Equipment 479 10 489
Right of Use Assets 873 - 873
Intangible Assets 298 4 302
Total Additions to Non Current Assets 1,650 14 1,664
The amounts provided to the Chief Executive Officer with respect to total assets and total
liabilities are measured in a manner consistent with that of the financial statements. These
assets and liabilities are allocated based on the operation of the segment and the physical
location of the asset.
There are no unallocated assets or liabilities.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2023
NOTES TO THE FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2023
NOTES TO THE FINANCIAL STATEMENTS
15 14
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2023PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2023
7. SHARE CAPITAL
Sept 2023
6 Months
Shares (000)
Unaudited
Sept 2023
6 Months
($000)
Unaudited
Sept 2022
6 Months
($000)
Audited
March 2023
12 Months
($000)
Opening Balance 810,365 294,317 294,139 294,139
Issue of Ordinary Shares
- Employee Remuneration
1
352 38 93 182
Less: Issue Expenses - (2) (4)
Movement 352 38 91 178
Closing Balance 810,717 294,355 294,230 294,317
1
During the period 351,894 shares were issued as part of employees remuneration in lieu of cash payments
at an average price of $0.107 per share. (2023: 277,985 at $0.65).
There are 810,717,112 (September 2022: 810,180,218 and March 2023: 810,365,218) ordinary
shares on issue. All fully paid shares in the Company have equal voting rights and equal
rights to dividends. All Ordinary Shares are fully paid and have no par value.
8. RECONCILIATION OF CASH FLOWS TO OPERATING ACTIVITIES WITH
OPERATING NET LOSS
Unaudited
Sept 2023
6 Months
($000)
Unaudited
Sept 2022
6 Months
($000)
Audited
March 2023
12 Months
($000)
Net Loss for the PeriodNet Loss for the Period (15,252) (15,252) (10,571) (10,571) (26,965) (26,965)
Add Non Cash Items:Add Non Cash Items:
DepreciationDepreciation 370 370 206 206 527 527
Loss on disposal of Property, Plant and EquipmentLoss on disposal of Property, Plant and Equipment 2 2 16 16 24 24
AmortisationAmortisation 178 178 123 123 427 427
Employee Share options 555 567 1,273
Employee bonuses paid in shares in lieu of cash 38 93 182
Depreciation on right of use assets 635 569 1,179
Interest on finance leases shown in lease
repayments
32 46 83
Total Non Cash Items 1,810 1,620 3,695
Add Movements in Other Working Capital items: (37) (2,493) (1,641)
(Increase) in Receivables and Other Assets (389) (500) (280)
(Increase) Decrease in Inventory (390) 998 1,946
Increase in Payables and Accruals (734) (3,026) (2,330)
Total Movement in Other Working CapitalTotal Movement in Other Working Capital (1,550) (1,550) (5,021) (5,021) (2,305) (2,305)
Net Cash Flows to Operating ActivitiesNet Cash Flows to Operating Activities (14,992) (14,992) (13,972) (13,972) (25,575) (25,575)
9. CONTINGENT LIABILITIES
There were no known contingent liabilities at 30 September 2023 (September 2022: Nil
and March 2023: Nil). The Company and Group have not granted any securities in respect
of liabilities payable by any other party whatsoever.
10. CAPITAL COMMITMENTS
There are no capital commitments at 30 September 2023 (September 2022: Nil and March
2023: Nil).
11. SUBSEQUENT EVENTS
There are no subsequent events.
12. RELATED PARTIES
Details of all related party relationships have been disclosed in the annual report for the
year ended 31 March 2023. No new transactions with directors occurred that would be
considered a related party.
13. PROPOSED LOCAL COVERAGE DETERMINATION (LCD) CHANGES -
IMPACT ON REVENUE
On 2 June 2023* Novitas, the Medicare Administrative Contractor (MAC) with jurisdiction
for Pacific Edge’s US laboratory issued a final Local Coverage Determination (LCD)
L39365 that governs the reimbursement of Cxbladder in the US by the US Centres for
Medicare & Medicaid Services (CMS). The LCD determined that Cxbladder would not
qualify for coverage from Novitas for tests reimbursed by the CMS from 17 July 2023.
These tests represent a significant portion of current Cxbladder testing revenue. Multiple
companies that had existing coverage or are seeking coverage, were similarly impacted by
this proposal.
On 6 July 2023* Pacific Edge Limited received notification that LCD L39365 would not
become final and Novitas would propose it again as a draft LCD DL39365. The new draft
would be subject to ‘notice and comment for 45 days including an open public meeting
and a written comment submission period.
On 27 July 2023* Pacific Edge Limited became aware that Novitas had published the LCD
(DL39365) without any changes from LCD L39365, which if approved without further
changes would mean Cxbladder (and multiple other products from various companies)
would not qualify for coverage from Novitas for tests reimbursed by the CMS.
Novitas provided for the statutory requirement for a 45-day notice and comment period
commencing 27 July 2023* and finishing 9 September 2023*, during which time all
interested stakeholders were able to submit comments to Novitas. Pacific Edge, and a
number of impacted parties submitted written submissions that argue Cxbladder Triage,
Detect and Monitor tests should retain Medicare coverage based on the clinical value they
offer to patients, clinicians, and healthcare payers.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2023
NOTES TO THE FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2023
NOTES TO THE FINANCIAL STATEMENTS
17 16
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2023
Novitas may take up to 365 days from the original publication date (27 July 2023*) to
withdraw or finalize the LCD including a response to those comments. When finalized,
Novitas must provide a minimum of 45 days’ notice before the LCD becomes effective.
Pacific Edge received payment in line with the existing LCD/LCA (Local Coverage Article)
for the six months ended 30 September 2023, and to the date of approval of these
Consolidated Financial Statements. However, the Company is unable to determine the
future impact, if any, at the date of approval of these Consolidated Financial Statements.
Refer to the Pacific Edge Limited 2023 Annual report issued 22 June 2023 for further
history of the proposed Local Coverage Decision up to 22 June 2023.
*All dates with an Asterix refer to US dates
14. NET TANGIBLE ASSETS
Net Tangible Assets per share is a non-GAAP measure that is required to be disclosed by
the NZX Listing Rules. The calculation of the Group’s Net Tangible Assets per share and it’s
reconciliation to the consolidated balance sheet is presented below.
Unaudited
Sept 2023
6 Months
($000)
Unaudited
Sept 2022
6 Months
($000)
Audited
March 2023
12 Months
($000)
Total AssetsTotal Assets 76,254 76,254 106,757106,757 90,913 90,913
Less Intangible AssetsLess Intangible Assets 1,156 1,156 784784 1,031 1,031
Less Total LiabilitiesLess Total Liabilities 7,952 7,952 7,9147,914 8,150 8,150
Net Tangible Assets 67,146 98,059 81,732
Number of Shares Issued (000’s) 810,717 810,180 810,365
Net Tangible Assets Per ShareNet Tangible Assets Per Share $0.083 $0.083 $0.121 $0.121 $0.101 $0.101
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2023
NOTES TO THE FINANCIAL STATEMENTS
18
Independent auditor’s review report
To the shareholders of Pacific Edge Limited
Report on the consolidated interim financial statements
Our conclusion
We have reviewed the consolidated interim financial statements of Pacific Edge Limited (the
Company) and its subsidiaries (the Group), which comprise the consolidated balance sheet as at
30 September 2023, and the consolidated statement of comprehensive income, the consolidated
statement of changes in equity and the consolidated statement of cash flows for the six months ended
on that date, and significant accounting policies and other explanatory information.
Based on our review, nothing has come to our attention that causes us to believe that the
accompanying consolidated interim financial statements of the Group do not present fairly, in all
material respects, the financial position of the Group as at 30 September 2023, and its financial
performance and cash flows for the six months then ended, in accordance with International
Accounting Standard 34 Interim Financial Reporting (IAS 34) and New Zealand Equivalent to
International Accounting Standard 34 Interim Financial Reporting (NZ IAS 34).
Basis for conclusion
We conducted our review in accordance with the New Zealand Standard on Review Engagements
2410 (Revised) Review of Financial Statements Performed by the Independent Auditor of the Entity
(NZ SRE 2410 (Revised)). Our responsibilities are further described in the Auditor’s responsibilities for
the review of the consolidated interim financial statements section of our report.
We are independent of the Group in accordance with the relevant ethical requirements in New
Zealand relating to the audit of the annual financial statements, and we have fulfilled our other ethical
responsibilities in accordance with these ethical requirements. In addition to our role as auditor, our
firm carried out other services for the Group in the area of generic treasury training. The provision of
these other services has not impaired our independence.
Responsibilities of the Directors for the consolidated interim financial statements
The Directors of the Company are responsible on behalf of the Company for the preparation and fair
presentation of these consolidated interim financial statements in accordance with IAS 34 and NZ IAS
34 and for such internal control as the Directors determine is necessary to enable the preparation and
fair presentation of the consolidated interim financial statements that are free from material
misstatement, whether due to fraud or error.
Auditor’s responsibilities for the review of the consolidated interim financial statements
Our responsibility is to express a conclusion on the consolidated interim financial statements based on
our review. NZ SRE 2410 (Revised) requires us to conclude whether anything has come to our
attention that causes us to believe that the consolidated interim financial statements, taken as a whole,
are not prepared in all material respects, in accordance with IAS 34 and NZ IAS 34.
A review of consolidated interim financial statements in accordance with NZ SRE 2410 (Revised) is a
limited assurance engagement. We perform procedures, primarily consisting of making enquiries,
primarily of persons responsible for financial and accounting matters, and applying analytical and other
review procedures. The procedures performed in a review are substantially less than those performed
in an audit conducted in accordance with International Standards on Auditing and International
Standards on Auditing (New Zealand) and consequently does not enable us to obtain assurance that
we might identify in an audit. Accordingly, we do not express an audit opinion on these consolidated
interim financial statements.
PricewaterhouseCoopers, PwC Centre, 60 Cashel Street, PO Box 13-244, Christchurch 8141 New Zealand
T: + 64 3 374 3000, pwc.co.nz
Who we report to
This report is made solely to the Company’s shareholders, as a body. Our review work has been
undertaken so that we might state those matters which we are required to state to them in our review
report and for no other purpose. To the fullest extent permitted by law, we do not accept or assume
responsibility to anyone other than the shareholders, as a body, for our review procedures, for this
report, or for the conclusion we have formed.
The engagement partner on the review resulting in this independent auditor’s review report is Maxwell
John Dixon.
For and on behalf of:
Chartered Accountants Christchurch
22 November 2023
PwC 2
87 St David Street, PO Box 56, Dunedin, New Zealand
P +64 3 577 6733 (overseas) | 0800 555 563 (NZ)
F +64 3 974 9393
www.pacificedgedx.com/
---
Template
Results announcement
(for Equity Security issuer/Equity and Debt Security issuer)
Updated as at June 2023
Please do not amend or delete individual rows. As this template relates to prescribed content, changes to content
should only be made where it is clearly indicated that this is permitted, otherwise, if an Issuer considers a particular
element does not apply, mark the row as N/A, Any other changes to this prescribed form must first be approved by
NZX as required under NZX Listing Rule 3.26.1.
Results for announcement to the market
Name of issuer Pacific Edge Limited
Reporting Period 6 months to 30 September 2023
Previous Reporting Period 6 months to 30 September 2022
Currency NZD (New Zealand Dollar)
Amount (000s) Percentage change
Revenue from continuing
operations
Operating revenue $13,095
Other income $3,485
Operating revenue 50% increase
Other income 29% decrease
Total Revenue $16,580 22% Increase
Net profit/(loss) from continuing
operations
($15,252) 44% Increase in Loss
Total net profit/(loss) ($15,252) 44% Increase in Loss
Interim/Final Dividend
Amount per Quoted Equity
Security
The Company does not propose to pay dividends to shareholders
Imputed amount per Quoted
Equity Security
Not Applicable
Record Date Not Applicable
Dividend Payment Date Not Applicable
Current period Prior comparable period
Net tangible assets per Quoted
Equity Security
$0.083 $0.121
A brief explanation of any of the
figures above necessary to
enable the figures to be
understood
For commentary on the results, please refer to the commentary in the
accompanying NZX release. Further information is also set out in the
unaudited financial statements of the Company for the 6 months to 30
September 2023 which accompany this Results Announcement.
Authority for this announcement
Name of person authorised to
make this announcement
Grant Gibson – Chief Financial Officer
Contact person for this
announcement
Grant Gibson
Contact phone number 0800 555 563
Contact email address grant.gibson@pelnz.com
Date of release through MAP 23/11/2023
Unaudited financial statements accompany this announcement.
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.