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Financial Results for the Half Year to 30 September 2023

Half Year Results22 November 2023PEBHealthcare

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

IMPORTANT NOTICE AND DISCLAIMER
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A number of figures, amounts, percentages, estimates, calculations of

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Investors should note that past performance, including past share price

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•any errors or omissions in this presentation; or

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By receiving this presentation, you agree to the above terms and

conditions.

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.