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Financial Results for the Half Year to 30 September 2022

Half Year Results23 November 2022PEBHealthcare

Company Announcement
24 November 2022


FINANCIAL RESULTS FOR THE HALF YEAR TO 30 SEPTEMBER 2022

PACIFIC EDGE INVESTMENT FOR GROWTH DELIVERS EARLY RESULTS


HIGHLIGHTS

• Operating revenue from test sales increases 62% to $8.7 million when compared to the same period

of the prior year (1H22); total revenue increases 102% to $13.6 million when compared with 1H22,

with increases from commercial test volume growth boosted by foreign exchange gains

• Total laboratory throughput rises 34% to 14,917 in line with analyst expectations, lifted by a 35%

increase in commercial test volumes to 12,422, with growth led by the US market

• Investments driving Cxbladder adoption and lifting US clinician engagement; staff numbers increase

from 86 at the end of March 2022 to 100 full-time-equivalents (FTE) at 30 September 2022

• Kaiser Permanente using Cxbladder Triage at 11 sites, two of which are in the Top 20 sites by volume

during 1H23

• Net losses after tax increased to $10.6 million, from $9.0 million in 1H22 as Pacific Edge continues to

invest for growth

• Cash, cash equivalents and short-term deposits of $93.5 million as at 30 September 2022, down from

$105.4 million at 31 March 2022, provides strong foundation for continued investment

• Optimistic outlook tempered by proposed LCD from Novitas and the potential to affect Medicare

reimbursement.

DUNEDIN, New Zealand – Pacific Edge (NZX, ASX PEB), today announces strong growth in revenue for the

half year to the end of September 2022 as new growth investments begin to accelerate the adoption of

Cxbladder, the company’s suite of advanced genomic bladder cancer diagnostic tests.

Total operating revenue, the income generated from Cxbladder test sales, increased 62% to $8.7 million

from $5.4 million in 1H22. Revenue growth resulted from a 35% increase in commercial tests to 12,422

from 9,192 tests in 1H22, and the sharp weakening New Zealand dollar against the US dollar. As reported

in Pacific Edge’s October quarterly shareholder update, total test volumes rose to 14,917, a 34% increase

on the 11,136 tests processed in 1H22.

Total revenue, which includes government grants and other income, increased 102% to $13.6 million from

$6.7 million in the same period of the prior year, assisted by a $3.0 million foreign exchange gain on the

mark to market of USD cash balances and increased interest income accruing on cash balances.

The half year net loss after tax increased to $10.6 million, from $9.0 million in 1H22, as Pacific Edge

accelerated its investment to drive the adoption of tests. Net operating expenses increased to $24.2

million from $15.7 million as the company invested for growth particularly in the US market. Expenses

were also lifted by $1.7m due to the translation impact of a weaker New Zealand dollar.

Company Announcement
24 November 2022

Cash, cash equivalents and short-term deposits at 30 September 2022 were $93.5 million compared to

$105.4 million at 31 March 2022 following a net cash outflow of $12.0 million over the six months to the

end of September 2022.

Pacific Edge Chairman Chris Gallaher said, “Over the last six months Pacific Edge has carefully invested in

line with the program we outlined in May to drive the adoption of our tests around the world.

“We are starting to see the benefits of this program, particularly in the US market. Awareness of the role

Cxbladder can play in the diagnosis and management of bladder cancer is growing and we are seeing early

signs of an acceleration in the adoption of our tests by clinicians and healthcare providers.

“These successes have been tempered by the uncertainty over the continued reimbursement of our tests

by the US Centers for Medicare & Medicaid Services (CMS), from which the company receives most of its

US revenues.

“We are working to resolve this uncertainty, which followed the July release of a proposed Local Coverage

Determination (LCD)

1

by Novitas, the Medicare Administrative Contractor (MAC) with jurisdiction for

Pacific Edge’s US laboratory.

“Notwithstanding this possibility, given our technological leadership and the growing awareness for how

Cxbladder improves clinical practice, we remain confident that our tests will, over the longer term, be

integrated into global standards of bladder cancer care including those used by the key US market. Our

company is well funded and remains well placed to deliver on these growth ambitions.”

STRATEGIC PROGRESS

Pacific Edge Chief Executive Dr Peter Meintjes said the company had made good progress on its strategic

objectives.

“We have introduced new capability and energy into the business with the establishment of our new

Medical Affairs and Virtual Sales teams and the recruitment of new account executives, marketing

personnel and a VP of Market Access. Our global team has risen to 100 FTEs at the end of September from

86 at the end of March.

“These investments are aligned with the strategies for value creation that we outlined in May. As

expected, they have resulted in an increase in cash outflow and a larger loss for the half year period as

we continue to build capability and capacity that will underpin the next phase of success for Pacific Edge.

“As we look towards the long-term, the proposed LCD from Novitas has been factored into the phasing of

our investment program. At present, we continue to be reimbursed by Medicare for our tests and have

not seen any reduction in demand for Cxbladder since the release of the proposed LCD. Pacific Edge


1

LCDs are decisions made by a Medicare Administrative Contractor (MAC) whether to cover a particular item or service in a

MAC’s jurisdiction (region) in accordance with section 1862(a)(1)(A) of the US Social Security Act.

Company Announcement
24 November 2022

maintains that in the absence of any adverse reporting event on the performance of Cxbladder, it would

be unprecedented to lose CMS coverage.

“We therefore continue to invest prudently and do so with clear targets for the adoption of our tests and

operating revenue. We remain confident that these investments set the company up to capitalize on the

significant opportunities the company enjoys in both in the US and further afield,” Dr Meintjes said.

The new Medical Affairs team is at the heart of our strategy to use the expanding body of clinical evidence

that supports the validity and utility of Cxbladder to influence healthcare providers’ and payers' to adopt

and cover of our tests while working to have Cxbladder accepted into global standards of care.

The Medical Affairs and Marketing teams have expanded our Key Opinion Leader (KOL) engagement

program and placed clinical evidence generation at the core of how we engage with KOLs,” Dr Meintjes

said. At the upcoming Society for Urologic Oncology (SUO) meeting in late 2022, Pacific Edge will run its

first in-person Principle Investigator Meeting for STRATA, hold its first Clinical Advisory Board Meeting

and will sponsor a Symposium Session titled: Real life impact of Cxbladder tests on the diagnosis and

surveillance of bladder cancer moderated by VP of Medical Affairs, Dr. Tamer Aboushwareb featuring

presentations from the following KOLs:

• Dr. Sia Daneshmand: Overview, bladder biomarkers

• Dr. Sima Porten: Use of Cxbladder in-home sampling during COVID

• Dr. John Stafkianos: Cxbladder CU and real-life value in practice

REGIONAL PERFORMANCE

USA

The US business has made strong progress. For the six-month period, US test volumes were up 42% on

the same period a year ago to 12,769, while commercial tests increased 42% to 10,622 from 7,476 in the

same period of the prior year. The number of clinicians ordering our tests has meanwhile increased to

979 in the second quarter of FY23, a 42% increase on the 689 ordering clinicians at the same time a year

ago and 10% ahead of the 894 ordering clinicians for the quarter ending June 2022.

The company is pleased with the progress it is making with Kaiser Permanente. During 1H FY23, Cxbladder

tests were ordered from 11 of the 30 Kaiser Permanente Urology Centers in Southern California (SoCal),

and of these clinics, two now count among our top 20 accounts.

From an operations standpoint, we have made meaningful progress implementing Cxbladder ordering

and resulting from within Kaiser’s Electronic Medical Records (EMR) system, a move that is expected to

accelerate Kaiser’s adoption of Cxbladder when the project is completed in the coming months. In support

of this initiative, Kaiser has a dedicated project team with whom Pacific Edge meets weekly. This helps to

provide good visibility into the organization.

We also continue to advance our strategy for the US Veterans Affairs (VA), the second largest integrated

healthcare provider in the US. Our goal is to develop clinical evidence for medical policy within the VA

Company Announcement
24 November 2022

system with the DRIVE clinical study and to transition early adopting PIs from evaluation and clinical trials

to broader adoption across the more than nine million veterans it covers.

ASIA PACIFIC

In the Asia Pacific, where test numbers are dominated by the relatively mature New Zealand market, total

laboratory throughput volumes were flat versus the same period a year ago at 2,148 tests. Commercial

test volumes increased 5% to 1,800 tests.

To increase test adoption, we continue to advocate for Cxbladder to be deployed in the New Zealand

primary care setting. Te Whatu Ora Te Pae Hauora o Ruahine o Tararua MidCentral and Te Whatu Ora

Whanganui are the latest New Zealand regional public healthcare providers to adopt Cxbladder in primary

care.

Pacific Edge believes Cxbladder represents a compelling case for the newly-established Te Whatu Ora –

Health New Zealand and Te Aka Whai Ora, the new Māori Health Authority, as they seek to improve access

to healthcare for all New Zealanders. There is clear evidence

2

from within the New Zealand healthcare

system that the deployment of Cxbladder in primary care allows clinicians to reliably and safely identify

patients that can be assessed in primary care with fewer referrals to secondary care and fewer invasive

procedures.

Finally, the company has also taken further steps into new markets such as Australia and Singapore. We

have seen a small number of tests beginning to flow out of Australia, while the company has recruited a

new business development manager for Southeast Asia, based in Singapore.

OUTLOOK

Dr Meintjes said Pacific Edge is looking towards the final four months of the financial year with cautious

optimism. The primary uncertainty is the range of potential outcomes from the proposed Novitas LCD.

“Our focus for the moment is continuing to cautiously execute on our strategy until we have certainty of

continued CMS reimbursement. And while the loss of coverage would likely require a slowing in our

intended hiring plan, we have identified a clear path to re-establish CMS coverage. In short, we remain

confident, over time, of our success in the world’s largest healthcare market.

“Pacific Edge has a strong balance sheet and world leading technology for the evaluation of hematuria

and the diagnosis and management of bladder cancer. Our Cxbladder tests are gaining traction in the US

market and further afield while the evidence supporting their adoption continues to grow.

Released for and on behalf of Pacific Edge by Grant Gibson Chief Financial Officer.





2

Davidson P, McGeoch G, Shand B. Assessment of a clinical pathway for investigation of haematuria that reduces the need

for cystoscopy. NZ Med J 2020. 133:1527

Company Announcement
24 November 2022

For more information:

Investors Media

Dr Peter Meintjes Richard Inder

Chief Executive The Project

Pacific Edge P: +64 21 645 643

P: +6422 032 1263



OVERVIEW www.pacificedgex.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.


About Cxbladder: www.cxbladder.com

Cxbladder is a non-invasive genomic urine test optimized for the detection and management 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 is reimbursed by CMS and has been trusted by over 2,000 US urologists

in the diagnosis and management of more than 80,000 patients, including the option for in-home sample collection. In New

Zealand, Cxbladder is accessible to 70% of the population via public healthcare and all residents have the option of buying the

test online.

---

PACIFIC EDGE
1H FY 23 Investor Presentation

24 November 2022

IMPORTANT NOTICE AND DISCLAIMER
ImportantNotice

This presentation has been prepared by Pacific Edge Limited (PEL) solely

to provide interested parties with further information about PEL and its

activities at the date of this presentation.

Information of a general nature

The information in this presentation is of a general nature and does not

purport to be complete nor does it contain all the information which a

prospective investor may require in evaluating a possible investment in

PEL or that would be required in a product disclosure statement,

prospectus or other disclosure documentfor the purposes of the New

Zealand Financial Markets Conduct Act 2013 (FMCA) or the Australian

Corporations Act. PEL is subject to a disclosure obligation that requires it

to notify certain material information to NZX Limited (NZX) and ASX

Limited (ASX) forthe purpose of that information being made available

to participants in the market and that information can be found by

visiting www.nzx.com/companies/PEBand

www2.asx.com.au/markets/company/PEB.This presentation should be

read in conjunction with PEL’s other periodic and continuous disclosure

announcements released to NZXand ASX.

Not an offer

This presentation is for information purposes only and is not an

invitation or offer of securities for subscription, purchase or sale in any

jurisdictionwhere such offer purchase or sale would not be permitted.

Not financial product advice

This presentation does not constitute legal, financial, tax, financial

product advice or investment advice or a recommendation to acquire

PEL securities, and has been prepared without taking into account the

objectives, financial situation or needs of investors. Before making an

investment decision, prospective investors should consider the

appropriateness of the information having regard to their own

objectives, financial situation and needs and consult an NZX Firm,

solicitor, accountant or other professional advisor if necessary.

Forward-looking statements

This presentation may contain forward-looking statements that reflect

PEL’s current views with respect to future events. Forward-looking

statements, by their very nature, involve inherent risks and

uncertainties. Many of those risks and uncertainties are matters which

are beyond PEL’s control and could cause actual results to differ from

those predicted. Variations could either be materially positive or

materially negative. The information is stated only as at the date of this

presentation. Except as required by law or regulation (including the NZX

Listing Rulesand ASX Listing Rules), PEL undertakes no obligation to

update or revise any forward-looking statements, whether as a result of

new information, future events or otherwise. To the maximum extent

permitted by law, the directors of PEL, PEL and any of its related bodies

corporate and affiliates, and their respective officers, partners,

employees, agents, associates and advisers do not make any

representation or warranty, express or implied, as to the accuracy,

reliability or completeness of such information, or the likelihood of

fulfilment of any forward-looking statement or any event or results

expressed or implied in any forward-looking statement, and disclaim all

responsibility and liability for these forward-looking statements

(including, without limitation, liability for negligence).

Financial data

All dollar values are in New Zealand dollars unless otherwise stated. This

presentation should be read in conjunction with, and subject to, the

explanations and views of future outlook on market conditions, earnings

and activities given in the announcements relating to the results, and

interimreport, for the six months ended 30 September 2022.

Effect of rounding

A number of figures, amounts, percentages, estimates, calculations of

value and fractions in this presentation are subject to the effect of

rounding. Accordingly, the actual calculation of these figures may differ

from the figures set out in this presentation.

Past performance

Investors should note that past performance, including past share price

performance, cannot be relied upon as an indicator of (and provides no

guidance as to) future PEL performance, including future financial

position or share price performance.

Investment risk

An investment in securities of PEL is subject to investment risk and other

known and unknown risks, some of which are beyond the control of PEL.

PEL does not guarantee any particular return or the performance of PEL.

Disclaimer

None of PEL or PEL’s advisers or any of their respective affiliates, related

bodies corporate, directors, officers, partners, employees and agents,

have authorised, permitted or caused the issue, submission, dispatch or

provision of this presentation and, except to the extent referred to in

this presentation, none of them makes or purports to make any

statement in this presentation and there is no statement in this

presentation which is based on any statement by any of them.

To the maximum extent permitted by law, none of PEL and its advisers,

affiliates, related bodies corporate, nor their respective directors,

officers, partners, employees and agents makes any representation or

warranty, express or implied, as to the currency, accuracy, reliability or

completeness of information in this presentation; and none of them shall

have any liability (including for negligence) for:

•any errors or omissions in this presentation; or

•any failure to correct or update this presentation, or any other

written or oral communications provided in relation to this

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•any claim, loss or damage (whether foreseeable or not) arising from

the use of any information in this presentation or otherwise arising in

connection with this presentation or the information contained in it.

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

conditions.

DR PETER MEINTJES
Chief Executive Officer

GRANT GIBSON

Chief Financial Officer

1.1H FY 23 HIGHLIGHTS
2.PACIFIC EDGE SNAPSHOT

3.DELIVERING ON STRATEGY

4.FINANCIAL RESULTS DETAIL

5.OUTLOOK

AGENDA

1H FY23 HIGHLIGHTS: BUILDING MOMENTUM DESPITE CMS UNCERTAINTY
($10.6M)

NET LOSSAFTER

TAX

Global TLT of 14,917

US TLT increase 42% on

1H22 to 12,769 tests

Increase from ($9.0M) in

1H22 amid investment for

future growth

Operating revenue $8.7M

To t a l re v e n u e o f $ 1 3 . 6 M u p

102% on 1H22

$93.5M

CASH, CASH

EQUIVALENTS

3

Strong Balance Sheet

$12.0M reduction in cash &

cash equivalents

3

in 1H23

35%

COMMERCIAL

TEST VOLUMES

on 1H22

34%

1

GLOBAL TESTING

VOLUMES

(TLT

2

) on 1H22

62%

GROWTH IN

OPERATING

REVENUE on

1H22

Commercial Tests of 12,422

US Commercial Tests rise

42% on 1H22 to 10,622

tests

PACIFIC EDGE IS DELIVERING ON ITS STRATEGY

•RESEARCH AND INNOVATION

•EVIDENCE, COVERAGE AND GUIDELINES

•ADOPTION, RETENTION & REVENUE GENERATION

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

PACIFIC EDGE AT A GLANCE: GROWING GLOBALLY
Commercial markets with

customers and clinical study partnerships

Markets with clinical study partnerships

USA

CANADA

Pacific Edge Diagnostics USA

Hershey, Pennsylvania

AUSTRALIA

NEW ZEALAND

SINGAPORE

Pacific Edge HQ, Dunedin

FROM IP DEVELOPMENT TO PATIENT

~300K

Annual

laboratory test

capacity

1.Figures are cumulative across company history and represent unique patients

•IP: 4x patent families in bladder cancer, with >80 patents including RNA

biomarkers and their analysis algorithms

•Cxbladder: Advanced genomic biomarker tests from a non-invasive urine

sample for the early detection and management of bladder cancer

•Clinical Evidence: Peer-reviewed clinical validity and utility data that

shows Cxbladderoutperforms Standard of Care (SoC)

•Reimbursement: Cxbladdertests reimbursed by Medicare and Kaiser

Health Plan in the USA

•Patient Empowerment: Non-invasive efficacious testing offers

opportunity for increased patient compliance with surveillance and

management regimes

100 FTE

60% based in US

40% APAC

>80,000

1

Patients have

used Cxbladder

CXBLADDER IN THE PATIENT CARE PATHWAY
Primary Care Physician

Patient presents with

hematuria and clinician

cannot rule out cancer.

Patient referred to

urologist

Urologist

Current guidelines for

hematuria evaluation

recommend ~95%get

cystoscopy

1

ahead of

diagnosis & treatment

Urologist

Monitor for recurrence

with cystoscopy,

frequency varies

according to patient

presentation

Typical

standard of

care on the

patient care

pathway

For use by

SPECIALISTS to detect

the presence of

urothelial cancer and

adjudicate diagnostic

dilemmas

For use in the PRIMARY CARE and SPECIALIST

settings to de-intensify hematuria workup or rule out

urothelial cancer (UC)

For use by SPECIALISTS

to monitor for recurrence

at a frequency proportional

to risk

TRIAGE

DETECT

MONITOR

Cxbladder

TRIAGE

(CxbT)

Cxbladder

DETECT

(CxbD)

Cxbladder

MONITOR

(CxbM)

VALUE PROPOSITION

Assists clinicians to safely de-intensify

hematuria evaluation from low incidence

populations

Sensitivity 95% / NPV 99%

Assists clinicians to adjudicatediagnostic

dilemmas (e.g., equivocal cystoscopy &

atypical cytology) in any patient population

Sensitivity 82% / Specificity 85% / NPV 97%

Assists clinicians in monitoring for UC

recurrence. Intended to reduce the

frequency of surveillance cystoscopy and

improve patient compliance

Sensitivity 93% / NPV 97%

Sensitivity: the likelihood of the test to be positive in a patient with the disease Specificity: the likelihood of the test to

be negative when the patient does not have the disease; NPV:the likelihood of a negative test being a true negative.

1

AUA Guidelines and WolduSL, Ng CK, Loo RK, Slezak JM, Jacobsen SJ, Tan WS, et al. (2021a). "Evaluation of the New American Urological Association Guidelines

Risk Classification forHematuria."JUrol205(5): 1387-1393.

BLADDER CANCER
IS A SIGNIFICANT GLOBAL HEALTHCARE CHALLENGE

•Hematuria evaluation for suspected urothelial cancer has

high detection and surveillance costs

2

•Current American Urological Association guideline leads to recommendation

for >90%cystoscopy of patients presenting with hematuria

3

•Under guidelines in the US, 3.4 million patients should be worked

up for cystoscopy, but only 1 million undergo the procedure

4

•Only 40% of patients comply with existing standards of care due

to invasive and high-cost diagnostic procedures

5

1. Bray et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 3 cancers in 185 countries.CaCancer J Clin. 2018;68:394-424

2. Bottermanet al. The health economics of bladder cancer: a comprehensive review of the published literature. Pharmacoeconomics 2003;21(18):1315-30.

3.AUA Guideline andWolduSL, Ng CK, Loo RK, Slezak JM, Jacobsen SJ, Tan WS, et al. (2021a). "Evaluation of the New American Urological Association Guidelines Risk Classification for Hematuria." J Urol205(5): 1387-1393.

4. Kenigsberg, A, et al. The Economics of Cystoscopy: A Microcost Analysis, Urology 157: 29−34, 2021.

5. Schrag, D et al. Adherence to Surveillance Among Patients With Superficial Bladder Cancer JNIC, Volume 95, Issue 8, 16 April 2003.

6. TAM is the Total Addressable Market based on Pacific Edge estimates.

~550K

Annual cases

and growing

1

~200K

Annual

deaths

1

6TH

Most common

cancer in men

1

~70%

Recurrence

USA –TAM

6

US$3.5b

Americas (non-US) –TAM US$0.5b

EMEA (w/o most of Africa) –TAM US$1.4b

APAC (w/o China) –TAM US$2.2b

OUR INVESTMENT PROGRAM FOR GROWTH
Mission

To help improve

lives and patient

outcomes by

providing leading

solutions for the

early detection

and management

of cancer.

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

ADOPTION,

RETENTION AND

REVENUE

GENERATION

EVIDENCE,

COVERAGE AND

GUIDELINES

RESEARCH

AND

INNOVATION

Vision

A world where the early

diagnosis and better treatment

of cancer is within the reach of

every patient

A DIVERSE AND INCLUSIVE VALUES-DRIVEN CULTURE WHERE ALL EMPLOYEES CAN GROW AND THRIVE.

OUR FOUNDATIONS

EXCELLENT PATIENT EXPERIENCE

AND ACCURATE RESULTS

INPUTSOUTPUTS

8,147
6,864

11,136

14,917

8,714

8,950

11,950

-

5,000

10,000

15,000

20,000

25,000

FY20FY21FY22FY23

TESTS

1H2H

6,573

5,591

9,192

12,422

7,054

7,385

10,004

-

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

20,000

22,000

FY20FY21FY22FY23

TESTS

1H2H

19%

56%

25%

17%

61%

22%

GLOBAL: COMMERCIAL TESTS GROWING STRONGLY AS US ACCELERATES

1H22

Testing Volumes (TLT) by Type

PEL: Global Commercial Testing Volumes

PEL: Global Testing Volumes (TLT*)

Total Lab Throughput (TLT) has increased 34% to 14,917 tests in 1H23

•US market driving growth in commercial test volumes with new hires

building momentum in test throughput

•APAC volumes steady as we drive adoption in the primary care

setting

•Growth in CxbladderDetect in test mix reflects growing US test

volumes

23,086

15,814

16,861

19,196

12,976

13,627

*TLT is the Total Laboratory Throughput including commercial, pre-commercial and clinical studies testing

1H23


35%


34%

STRONG GROWTH IN THE US: PACIFIC EDGE’S LARGEST MARKET
USA test volumes

1

1

Total Laboratory Throughput including commercial, pre-commercial and clinical studies testing

6,251

4,924

8,983

12,769

6,989

6,934

9,881

-

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

20,000

FY20FY21FY22FY23

TESTS

1H2H

13,240

18,864

11,858

83%of TLT in 1H23 performed in the USA

KEY US PAYORS ACTIVATED

•The Kaiser Health Plan covers over 12.5m members, with

>85% of those members in California

•2 Kaiser accounts in PEB’s Top 20 Accounts. 11 Kaiser

sites across Southern California ordering in 1H23

•EMR integration on track with Kaiser dedicating a project

team to the implementation

•The Veterans Administration (VA) is the second largest

integrated healthcare system in the US serving >9m

veterans each year

•DRIVE clinical study, has enrolled 80% of target patients.

It is an important engagement with VA urologists to

determine utility in a cohort of VA patients

•Centers for Medicare & Medicaid Services (CMS) covers

more than 61.5m US citizens over 65and people on low

incomes

•CMS continues to reimburse despite proposed LCD

•Focus on selling to urologists who order based on

medical necessity


42%

INVESTMENTS ALREADY DRIVING US ADOPTION AND RETENTION
Unique physicians ordering Cxbladder

FY 21FY 22 FY 23

462

516

530

657

689

740

782

894

979

0

200

400

600

800

1000

1200

Q2 FY21Q3 FY21Q4 FY21Q1 FY22Q2 FY22Q3 FY22Q4 FY22Q1 FY23Q2 FY23

PHYSICIANS


46%

CAGR

Distribution of Current

U.S. Customers

Pacific Edge Diagnostics

USA, Hershey,

Pennsylvania

INVESTMENTS ALREADY DRIVING US ADOPTION AND RETENTION
Prudent implementation of May 2022 investment program*

COMMERCIAL DEPARTMENTHIRING PLAN

Sales

-Account Executives, Regional Sales Directors, National Accounts & Virtual Sales (contractors) [+9]

Marketing and Sales Support

-Event Management, Product Marketing, Product Management, Sales Training & Sales Operations [+3]

Medical Affairs

-VP Medical Affairs and MSLs [+4]

Market Access and Reimbursement

-VP Market Access [+1]

*All appointments linked to the achievement of revenue milestones

DIRECT SALES AND MARKETING

MEDICAL AFFAIRS & MARKET ACCESS

BUILDING THE CXBLADDER BRAND WITH CLINICIANS AND HEALTHCARE PROVIDERS
13,790

Practicing

urologists

1

1,900

Large urology

group practice

sites

2

TARGET US RELATIONSHIPS

1

American Urological Assn Census 2021,

2

BHN Network

SUO, San Diego Nov-Dec 2022 (upcoming)

Leading event in the urological calendar

•Meeting of Clinical Advisory Board

•Breakfast symposium on the use of biomarkers

for cancer diagnosis

50

Urology

conferences

across the US

and APAC

AUA Annual Meeting, New Orleans May 2022

Largestand most prestigiousevent in the global

urological calendar

•SponsorshipofInternational Bladder Cancer

Group Expert Forum,VAsessions

•Event and venue sponsorship, advertising

Mike, can you source

the higher res pic?

BCAN Think Tank, Denver Aug 2022

Unique in bringing together patients/ patient

advocates,researchers, and urologists

•Event sponsorship

IBCN, Barcelona Sept-Oct 2022

Leading global event dedicated to bladder cancer

research and care

•Breakout session focused on biomarkers in

the diagnosis and surveillance of bladder

cancer

•Event sponsorship

Medical Affairs Team now supporting Sales at leading events as

we targetpodium presentations and host/sponsor focused

breakout sessions.

APAC: NEW ZEALAND AT THE FOREFRONT WITH ADOPTION BY PRIMARY CARE
Commercial tests represent 84%of TLT in 1H23 for APAC

APAC QUARTERLY TEST VOLUMES

1

1

Total Laboratory Throughput including commercial, pre-commercial and clinical studies testing

Pacific Edge has Cxbladder coverage in 14 of the 20 new Te

Whatu Ora, Health New Zealand, regions, representing >70%

of the country’s population

1,896

1,940

2,153 2,148

1,725

2,016

2,069

-

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

4,500

FY20 FY21 FY22 FY23

Test volumes

1H2H

(0.2%)


•Volumes unchanged in APAC driven by slower growth in NZ

•MidCentraland Whanganui district health regions adopted

Cxbladderin the primary care setting (Sept, 2022)

•Australia and Southeast Asia still in business development

•New SEA BDM (+1 FTE, hired in Sept, 2022)

•User experience studies initiated in Australia and Singapore

MEDICARE COVERAGE UPDATE
NovitasProposed LCD (released on July 28, 2022 in the USA)

1.Outlines a new methodology for covering molecular biomarker tests

2.Mentions codes for CxbladderDetect and Monitor as ‘not covered’

3.If adopted Pacific Edge will receive 45 days' notice of its effect

4.May be withdrawn by Novitasat any time or expire after 12 months

1

5.Pacific Edge provided oral & written comments to Novitasprior to the close of public comment on Sept 6, 2022

6.Pacific Edge have yet to receive feedback or update from Novitasand do not have a timeline for response

Key Messages for Investors

1.Cxbladdercurrentlyremains covered by Novitas, and we have seen no reduction in demand for Cxbladder

2.Cxbladderhas not been singled out in the LCD and there is no “adverse reporting event”associated with

Cxbladder(it would be highly unusual for a test to lose coverage without an “adverse reporting event”)

3.The Proposed LCD contains inconsistencies, unintended consequencesand a methodology that may violate

Medicare’s rules

4.The Proposed LCD appears focused on SNP-based PGx tests

2

for guiding therapeutic decisions after a

confirmed diagnosis, apparently excluding diagnostic biomarker tests from clinical tool kits

5.The LCD takes the highly unusual step of ‘outsourcing’ coverage determinations to third party databases

6.Pacific Edge has the leadership team and the relationships with lawyers, coalitions, lobbyists, professional

societies, physicians and patient advocacy groups to affect a positive outcome

7.We maintain our position that the proposed LCD is unlikely to survive in its current form and continue to

responsibly plan for all eventualities

CMS delegates

administrative

authority to Medicare

Administrative

Contractors (MACs)

NOVITAS is the

MAC with

jurisdiction for

Pacific Edge’s

US Laboratory

1

Pacific Edge understands the Proposed LCD expires if it is not notified within 12 months of the date of proposal on July 28

th

, 2022. Pacific Edge

previously understood this was 12 months after the close of comments on Sept 6

th

, 2022

2

The Single Nucleotide Polymorphism-based Pharmacogenetic (PGx) tests.

GLOBAL GUIDELINES PIVOTAL TO THE WIDESPREAD ADOPTION OF CXBLADDER
Recognition in national guidelines deepens and accelerates commercial use of Cxbladder tests and entrenches

coverage by nationally relevant healthcare institutions.

•Most influential and largest

urologicalassociation in the world

•U.S. based -23,000 members worldwide.

•Standards of care relevant to Cxbladder:

•Hematuria and micro-hematuria

management

•Non-muscle invasive bladder

cancer (NMIBC). (Standard makes

an allowance for the use of

biomarkers in surveillance)

•Guidelines reviewed as new evidence

emerges

•Pacific Edge can influence this process by

publishing new clinical evidence

www.auanet.org

•Leading urologic authority in Europe

•Netherlands-based, 18,000 members

•Standards relevant to Cxbladder

•Non-muscle invasive bladder

cancer (NMIBC)

•Guidelines loosely followed in New

Zealand, Australia and Singapore,

but localised at a national and

regional level

•Guidelines recently reviewed with

favourable biomarkerlanguage and are

updated regularly

www.uroweb.org

•US-based not-for-profit alliance of 32

leading US cancer centres

•Bladder cancer standard suggests

biomarkers may be considered during

surveillance of high-risk non-muscle-

invasive bladder cancer

•Guidelines reviewed annually. PEB will

resubmit in every year where there is new

peer-reviewed evidence for Cxbladder

•Clinical Dossier updated for next review in

April 2023

www.nccn.org

CLINICAL EVIDENCE GENERATION TOWARDS GUIDELINE INCLUSION (1/2)
STUDYAIMLOCATIONSENROLLED SITES*STATUS**

US Primary

Study

Prospective, single-arm, observational study to develop clinical evidence for

Cxbladder tests, accurate risk stratification, intensifying or de-intensify hematuria

evaluation and assistance in adjudicating equivocal cystoscopy or urine cytology

USA12/12-Enrolment complete

-Analysis complete

-Publication pending

Singapore StudyProspective, single-arm, observational study to develop clinical evidence

forCxbladdertests, accurate risk stratification, intensifying or de-intensify

hematuriaevaluation and assistance in adjudicating equivocal cystoscopy or urine

cytology

Singapore4 / 4-Enrolment complete

-Analysis complete

-Publication pending

STRATASafe Testing of Risk for AsymptomaTIc MicrohematuriA

Demonstrate the clinical utility of Cxbladder using a prospective, two-arm

randomizeddesign to safely risk-stratify patients and rule out from further

hematuriaevaluation

•Safely risk stratifying patients in order to rule out from cystoscopy

•Demonstrate the clinical utility of Cxbladder against the AUA guidelines

USA

Canada

11 / 11-Enrolment total is 421, including 103 ‘low

risk’ subjects that are the focus of the study

-Target enrolment: ~600 patients, including

120 low risk subjects randomized to test arm

-Last patient in:Q2 2023

-Follow up: until Q2 2024

DRIVE

Detection and RIsk Stratification in VEterans Presenting with Hematuria

Prospective, single-arm, observational study to demonstrate the clinical validity &

utility of Cxbladder tests in risk stratifying Veterans presenting with hematuria

•Demonstrate performance with Veterans and contribute to commercial

adoption of Cxbladder for use with Veterans

•Critical for adoption of Cxbladder by VA. Contributes to AUA Guidelines

•Recruitment re-started after COVID-related delays

•Targeting inclusion of all veterans presenting for evaluation of hematuria

VA Sites

(USA)

10 / 11-Enrolment total is 507

-Target enrolment: ~600 patients

-Last patient in: Q2 2023

-Follow up: until Q2 2025

*Estimated number of enrolled sites

**All dates are best-case estimates and subject to change

STUDYAIMLOCATIONSENROLLED
SITES*

STATUS**

DEDUCT

DEtection of Disease in the Upper traCT

Prospective, single-arm, observational study to validate performance of Cxbladder for the

detection of urothelial carcinoma (UC) in the upper tract (UTUC)

•Evaluate Cxbladder to safely avoid ureteroscopy

•Safely risk stratify patientssuspected to have UTUC and avoid unnecessary ureteroscopy

and radiation exposure through imaging

•Targeting inclusion of Cxbladder utility for UTUC in AUA guidelines

USA1 / 3-One site is open for this pilot

study and the first patient in is

expected by Dec 2022

LOBSTERLOngitudinal Bladder Cancer Study for Tumor REcurRence

Prospective, single-arm, observational study to evaluate the performance characteristics and

clinical utility of CxbM in a new surveillance protocol vs standard of care over four visits

•Safely risk stratify patients under surveillance for recurrence of UC

•Safely alternate CxbM with cystoscopy for intermediate and high-risk patients under

surveillance for recurrence of UC

•Targeting AUA guidelines inclusion for biomarkers as an alternative to cystoscopy in a

surveillance setting

USA (including

some VA sites)

Australia

2 / 10-Two sites are open and another 8

are at pre-activation. Enrolment

is now 27 patients.

-Each site will enroll 100 patients

within 12 months and follow up

for another 12 months

CLINICAL EVIDENCE GENERATION TOWARDS GUIDELINE INCLUSION (2/2)

*Estimated number of enrolled sites

**All dates are best-case estimates and subject to change

Clinical Development headcount +1 since May. Expecting further +2 headcount before EOFY

IIT Study AimSitesPublications
Hematuria Evaluation: Local clinical validity evidence for internal hospital guidelines and budget development62x Conference Abstracts

Surveillance: Local clinical validity evidence for internal hospital guidelines and budget development72x Conference Abstracts

CU of Cxbladder to identify subclinical tumors in white light negative patients, confirmed by blue light1Pending

Risk-based hematuria evaluation of microhematuria patients by Cxbladder1Pending

Risk-stratification of surveillance patients for prioritization of post-TURBT care by Cxbladder21x Conference Abstract

INVESTIGATOR INITIATED TRIALS –SUPPLEMENTING OUR EVIDENCE PROGRAM

•Investigator Initiated Studies (IITs) are proposed by investigators

and supported by Pacific Edge

•IITs typically provide clinical utility evidence at modest scale

•They promote familiarity and confidence with Cxbladder, the test

result and how Cxbladdercan be used to manage patients

•Supports local data development for market access and adoption

Left to right -Royal Prince Alfred Hospital (Sydney), UT Southwestern (Dallas), Canberra Hospital (ACT)

What are Investigator Initiated Trials?

•Return on investment is expected in the form of publications, abstracts and presentations from Principle Investigators of an IIT

RESEARCH AND INNOVATION
DRIVING IP TO TECHNOLOGY

•Evaluate ‘product concepts’ to address unmet clinical needs

•+2 scientists to explore market potential of various product concepts

including:

•Prognostics or companion diagnostics in urology

•Adjacent disease (with molecular signal in the urine)

•+2 developers and bioinformaticians to improve platforms, integrations and

analysis capabilities

•MONSTER Study

•Examining new markers of Minimum Residual Disease(MRD)

•Surveillance for bladder cancer immediately following surgical

intervention (vs CxbMwhich is used six months after intervention for

recurrence)

MONSTER

MONitoringStudy of post-Treatment Effectiveness for Residual Disease

Single-arm, observational study to validate the performance characteristics of Cxbladder

against white light cystoscopy during surveillance of UC

•Christchurch study to measure residual disease

•To s a fe l y r i s k s t ra t i f y p a t i e n t s fo r re s i d u a l d i s e a s e p r i o r t o t h e 6-week re-resection for

high grade patients or the 3-month flexible cystoscopy check for all patients

-Finalizing protocol

documentation and commenced

engagement with ethics

committee

-Ta rge t ( Q 1 2 0 2 3 ) f i rs t p at i e nt

Christchurch

Hospital

FINANCIAL RESULTS OVERVIEW

5%
95%

$1,425

$2,033

$2,285

$3,326

$5,378

$8,707

$1,975

$1,784

$2,085

$4,375

$6,067

$-

$2,000

$4,000

$6,000

$8,000

$10,000

$12,000

$14,000

FY18FY19FY20FY21FY22FY23

$(000)

1H2H

US TEST COMMERCIAL TEST VOLUME GROWTH AND FX DRIVING REVENUES

$11,445

$7,701

$4,370

$3,817

$3,400

1H23

Pacific Edge Operating RevenueRegional Revenue Split

1H22

•Operating Revenue grew $3.3m, with $2.4m driven by the 35% increase in

commercial tests (42% increase in the US) and $0.9m of the growth due to the

weakening of the New Zealand dollaragainst the United States Dollar

•US continues to grow share of total revenue


62%

USA APAC

7%

93%

Half yearto 30 September20222021VarianceChange
$000$000$000%

Operating revenue$8,707$5,378$3,32962%

Total revenue$13,593$6,730$6,863102%

Operating expenses$24,164$15,715$8,44954%

Total comprehensive loss-$10,571-$8,985-$1,58618%

Cash receipts from customers$7,316$5,370$1,94636%

Net operating cash outflow-$13,972-$8,616-$5,35662%

Net cash, cash equivalents and short term

deposits

$93,455$91,586$1,8692%

US TEST VOLUME GROWTH AND FX GAINS LIFT REVENUE

STRONG BALANCE SHEET SUPPORTS GROWTH INVESTMENTS

•Total income lifted by increase in interest

income and FX gains on mark to market

of US cash balances (~$3.0m)

•Expense rise lifted by investments for

growth, led by sales and marketing and

the translation effect of a weaker NZD

(~$1.7m)

•At constant currency, expenses would

have increased 43%

•APAC expenses up 20% 1H23 over 1H22

•Operating cash outflow in 1H23 of

$14.0m

•Cash and cash equivalents of $93.5m

1

down $12.0m on $105.4m in March

FY2022

1

30 September 2022

OPERATING COSTS RISE AS INVESTMENT FOR GROWTH CONTINUES
Operating Expenses

Half year to 30 September

2022

$000

2021

$000

Variance

$000

Change

%

Laboratory operations$4,467$3,076$1,39145%

Research$3,710$2,572$1,13844%

Sales and marketing$11,375$6,179$5,19684%

General and

administration

$4,612$3,888$72419%

Total operating expenses$24,164$15,715$8,44954%

INVESTING IN FY23 TO DELIVER IN FY24

•Investment in people accounted for ~56%

of the uplift in expenses (headcount, salary

increases and recruitment costs) with

investment weighted to the commercial

teams

•Sales and Marketing investment accounted

for ~61% of operating expense increase

•Laboratory operations expenses follow

higher throughput and freight costs

•Research increase reflects the increased

investment in the clinical evidence

generation program (including a minority

share of Medical Affairs)

OUTLOOK
•CautiousoptimismforthefinalfourmonthsofFY23as

wecontinuetoimplementourstrategyrecognizingthe

potentialfordisruption

•Wearedeliveringgrowthinlinewithourexpectations

andinvestingprudently

•TheproposedNovitasLCDhasnotimpactedcommercial

orclinicaltrialthroughput

•EvenintheeventofanadverseLCD,PacificEdgehasa

pathtore-establishcoverage

•We have world-leading technology, a strong balance

sheet and we are building momentum in the world’s

most important market

QUESTIONS

APPENDIX

STRATEGY: ADOPTION, RETENTION AND REVENUE GENERATION
ADOPTION,

RETENTION AND

REVENUE

GENERATION

FOCUS AREAS:

1.Diversify sales process to target Strategic

Accounts differently, including education and

Key Opinion Leader (KOL) engagement activities

by our Medical Affairs team

2.Drive protocolized adoption of Cxbladder at the

earliest point in the patient care pathway

3.Increase event marketing, sponsorship and

marketing communications to amplify our

clinical evidence generation within the urology

and oncology communities

4.Establish “in-network” or contracted

relationships for the reimbursement of

Cxbladder with government healthcare funders

and private payors

5.Empower patients through patient awareness

and patient advocacy initiatives through

established societies and our Cxbladder website

BLADDER CANCER IN THE US MARKET
90%

Five-year survival

rate if detected

early

1

US$220,000

Average lifetime

cost

2

per patient

US$4.9B

Forecast direct costs

associated with

urothelial cancer

in 2020

2

The US has >55m

men and >63m

women aged 50+

~7m

present with

Hematuria

2

~3.4m

require

clinical

workup

2

>1.0m

patients

receive a

cystoscopy

3

~81k

Annual cases of

bladder cancer

4

~800k

monitored for recurrence

Avg1.5CxbM/yr

5

US$3.5B

opportunity

6

(hematuria,

surveillance)

1

Bladder Cancer Advocacy Network

2

Presentation from Dr Sia Daneshmand (Director of Urologic Oncology and Clinical Research, USC) July 2019

3

Konigsberg, A, et al. The Economics of Cystoscopy: A Microcost Analysis, Urology 157: 29−34, 2021.

4

National Cancer Institute 2021 forecast

5

Pacific Edge Estimate

6

Pacific Edge estimates at US$760/Per test

> 4.6M TESTOPPORTUNITIES

VALUE PROPOSITION

Primary Care Physician

Urologist

Patient care

pathway

Cxbladder

TRIAGE

(CxbT)

Cxbladder

DETECT

(CxbD)

Cxbladder

MONITOR

(CxbM)

STRATEGY: EVIDENCE, COVERAGE AND GUIDELINES
CHANGE CLINICAL PRACTICE

FOCUS AREAS:

Generate high-quality clinical validation and utility evidence

through clinical studies

Use Clinical Utility evidence to:

•Drive the adoption of Cxbladder by clinicians,

insurers and hospitals ahead of guideline inclusion

•Pursue inclusion of Cxbladder in globally-relevant

standards and guidelines of clinical care across the

breadth of patient pathways

•Foster trusted relationships with key opinion

leaders, relevant uro-oncology centres of

excellence, professional societies and patient

advocacy networks to drive a broader awareness

and demand for Cxbladder

•Develop the scientific and clinical credibility of the

Cxbladder brand

EVIDENCE

COVERAGE AND

GUIDELINES

STRATEGY: RESEARCH AND INNOVATION:
UNDERSTANDING THE ENTIRE COMMERCIALISATION PATHWAY

RESEARCH &

INNOVATION

INTELLECTUAL

PROPERTY

TECHNOLOGYPRODUCT

COMMERCIALISATION

FOCUS AREAS:

1.Evaluate ‘product concepts’ to address unmet clinical needs through market research and scientific/clinical advisory boards

2.Evaluate cutting-edge technologies to meet the market requirements of desired product concepts

3.Continue to build a patent portfolio for novel clinical applications of cutting-edge molecular technologies

4.Turn patented technology into clinically-validated molecular diagnostic tools that address an unmet clinical need

PACIFIC EDGE: A HISTORY OF RESEARCH-LED INNOVATIONAND GROWTH
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

2011

2011

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

CxbD

2013

Mar 2013

PEDUSAreceives

CLIA

accreditation

May 2013

First commercial

sale (CxbD) for

PEDNZ

Mar 2013

First commercial

sale (CxbD) for

PEDUSA

2014

Dec 2014

Launch of Cxbladder

Triage

2015

Mar 2015

Kavalieris et al:

CxbT

performance

validation BMC

Urology

Dec 2015

Launch of

Cxbladder

Monitor

2016

Nov 2016

Clinical trials

commence in

Singapore

2018

Feb 2018

CxbT adopted

into Canterbury

Community

Health Pathways

with primary care

referral

2019

Aug 2019

Konety et al:

Clinical Utility of

CxbD 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

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

---

CONSOLIDATED
INTERIM FINANCIAL

STATEMENTS

FOR THE SIX MONTHS

ENDED 30 SEPTEMBER 2022

PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022
Note: These Financial Statements are to be read in conjunction with the Notes to the Financial Statements

FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2022

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

NOTES

UNAUDITED

SEPT 2022

6 MONTHS

($000)

UNAUDITED

SEPT 2021

6 MONTHS

($000)

AUDITED

2022

12 MONTHS

($000)

REVENUE

Operating Revenue 4 8,707 5,378 11,445

Total Operating Revenue 8,707 5,378 11,445

Other Income4 761 747 1,691

Interest Income 1,099 108 549

Foreign Exchange Gain 3,026 497 193

Total Revenue and Other Income 13,593 6,730 13,878

OPERATING EXPENSES

Laboratory Operations4,467 3,076 6,498

Research3,710 2,572 5,135

Sales and Marketing11,375 6,179 14,277

General and Administration4,612 3,888 7,756

Total Operating Expenses524,164 15,715 33,666

NET LOSS BEFORE TAX(10,571) (8,985) (19,788)

Income Tax Expense - - -

LOSS FOR THE PERIOD AFTER TAX(10,571) (8,985) (19,788)

Items that may be reclassified to profit or loss:

Translation of Foreign Operations 380 - 114

TOTAL COMPREHENSIVE LOSS atttributable

to equity holders of the Company

(10,191) (8,985) (19,674)

Earnings per share for loss attributable to the

equity holders of the Company during the period

Basic and Diluted Earnings per share(0.013) (0.012)(0.026)

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 Consolidated Interim Financial Statements

1. Summary of Accounting Policies 8

2. Investments In and Advances To Subsidiaries 9

3. Dividends 10

4. Revenue and Other Income 10

5. Operating Expenses 11

6. Segment Information 12

7. Share Capital 17

8. Reconciliation of Cash Used In Operating

Activities with Operating Net Loss 18

9. Contingent Liabilities 18

10. Capital Commitments 18

11. Subsequent Events 18

12. Related Parties 19

13. Proposed Local Coverage Determination (LCD)

Changes – Potential Impact on Revenue 19

14. Net Tangible Assets 20

3 2

PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2022

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 2021

Balance as at 31 March 2021 190,305 (170,061) 4,038 827 25,109

Loss After Tax - (8,985) - - (8,985)

Other Comprehensive Income - - - - -

TOTAL COMPREHENSIVE LOSS atttributable to equity holders of the Company - (8,985) - - (8,985)

Transactions with owners in their capacity as owners:

Issue of Share Capital7 76,045 - - - 76,045

Share Based Payments - Employee Remuneration7 172 - - - 172

Share Based Payments - Employee Share Options7 1,175 - (121) - 1,054

Balance as at 30 September 2021 267,697 (179,046) 3,917 827 93,395

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 Payments - Employee Share Options7 - - 567 - 567

Balance as at 30 September 2022294,230(200,420) 3,712 1,32198,843

AUDITED 12 MONTHS TO 31 MARCH 2022

Balance as at 31 March 2021 190,305 (170,061) 4,038 827 25,109

Loss After Tax - (19,788) - - (19,788)

Other Comprehensive Income - - - 114 114

TOTAL COMPREHENSIVE LOSS atttributable to equity holders of the Company - (19,788) - 114 (19,674)

Transactions with owners in their capacity as owners:

Issue of Share Capital7 99,622 - - - 99,622

Share Based Payments - Employee Remuneration7 172 - - - 172

Share Based Payments - Employee Share Options7 4,040 - (893) - 3,147

Balance as at 31 March 2022 294,139 (189,849) 3,145 941 108,376

Note: These Financial Statements are to be read in conjunction with the Notes to the Financial Statements

5 4

PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022
For and on behalf of the Board of Directors

Director Director

Dated 23rd day of November 2022

AS AT 30 SEPTEMBER 2022

CONSOLIDATED BALANCE SHEET

NOTES

UNAUDITED

SEPT 2022

6 MONTHS

UNAUDITED

SEPT 2021

6 MONTHS

AUDITED

MARCH 2022

12 MONTHS

($000)($000)($000)

CURRENT ASSETS

Cash and Cash Equivalents 37,989 80,081 35,412

Short Term Deposits 55,466 11,505 70,000

Receivables6,017 2,978 4,012

Inventory 1,507 956 1,007

Other Assets1,734 930 1,183

Total Current Assets102,713 96,450 111,614

NON-CURRENT ASSETS

Property, Plant and Equipment1,753 908 1,404

Right of Use Assets 1,507 2,381 1,830

Intangible Assets 784 231 434

Total Non-Current Assets4,044 3,520 3,668

TOTAL ASSETS106,757 99,970 115,282

CURRENT LIABILITIES

Payables and Accruals5,983 4,227 4,983

Lease Liabilities1,267 1,033 1,072

Total Current Liabilities7,250 5,260 6,055

NON-CURRENT LIABILITIES

Lease Liabilities 664 1,315 851

Total Non-Current Liabilities 664 1,315 851

TOTAL LIABILITIES7,914 6,575 6,906

NET ASSETS98,843 93,395 108,376

Represented by:

EQUITY

Share Capital7294,230 267,697 294,139

Accumulated Losses(200,420) (179,046) (189,849)

Share Based Payments Reserve 3,712 3,917 3,145

Foreign Currency Translation Reserve1,321 827 941

TOTAL EQUITY98,843 93,395 108,376

FURTHER INFORMATION

Net Tangible Assets per share ($)140.121 0.118 0.133

FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2022

CONSOLIDATED STATEMENT OF CASH FLOWS

NOTES

UNAUDITED

SEPT 2022

6 MONTHS

UNAUDITED

SEPT 2021

6 MONTHS

AUDITED

MARCH 2022

12 MONTHS

($000)($000)($000)

CASH FLOWS TO OPERATING ACTIVITIES

Cash was provided from:

Receipts from Customers7,316 5,370 10,942

Receipts from Grant Providers 404 469 1,413

Interest Received 908 242 365

8,628 6,081 12,720

Cash was disbursed to:

Payments to Suppliers and Employees22,611 14,683 30,198

Net GST cash (inflow) outflow (11) 14 74

22,600 14,697 30,272

Net Cash Flows To Operating Activities8(13,972) (8,616) (17,552)

NET CASH FLOWS FROM (TO) INVESTING ACTIVITIES:

Cash was provided from:

Proceeds from Short Term Deposits 71,784 17,000 51,837

71,784 17,000 51,837

Cash was disbursed to:

Purchase of Short Term Deposits 57,310 9,505 102,837

Capital Expenditure on Plant and Equipment504 298 713

Capital Expenditure on Intangible Assets 487 108 413

58,301 9,911 103,963

Net Cash Flows From (To) Investing Activities13,483 7,089 (52,126)

CASH FLOWS (TO) FROM FINANCING ACTIVITIES:

Cash was received from:

Proceeds from Borrowings314--

Ordinary Shares Issued7 - 80,000 103,488

Exercising of Share Options-657 2,306

314 80,657 105,794

Cash was disbursed to:

Repayment of Leases - Principal 553 506 1,147

Repayment of Leases - Interest 46 69 126

Issue Expenses7 2 3,099 3,865

601 3,674 5,138

Net Cash Flows (To) From Financing Activities(287) 76,983 100,656

Net (Decrease) Increase in Cash and Cash

Equivalents Held

(776) 75,456 30,978

Add Opening Cash Brought Forward 35,412 4,129 4,129

Effect of exchange rate changes on net cash3,353 496 305

Ending Cash and Cash Equivalents Carried

Forward

37,989 80,081 35,412

Note: These Financial Statements are to be read in conjunction with the Notes to the Financial StatementsNote: These Financial Statements are to be read in conjunction with the Notes to the Financial Statements

7 6

PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2022

NOTES TO THE CONSOLIDATED INTERIM 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 for the purpose of developing

and commercialising innovative 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 of Financial Statements

The Interim Financial Statements for the six months ended 30 September 2022 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 2022 Annual Report. The Interim Financial

Statements for the six months ended 30 September 2022 are unaudited. Comparative

balances for 30 September 2021 are unaudited, whilst the comparative balances for

31 March 2022 are audited.

The Interim Financial Statements are prepared on the basis of historical cost, except where

otherwise identified. The presentation 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 and Accounting Estimates

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 2022.

The Interim Financial Statements were authorised by the Board of Directors on

23 November 2022. The Annual Financial Statements for the year ended 31 March 2022

were authorised by the Board of Directors on 25th May 2022.

c) Audit

The Interim Financial Statements have not been audited. The comparative full year

financial results for the year ended 31 March 2022 have been audited.

d) 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

2022

(%)

30 Sept

2021

(%)

Pacific Edge Diagnostics

New Zealand Limited

New Zealand

Commercial Sales and

Diagnostic Laboratory

Operation

100100

Pacific Edge (Australia)

Pty Limited

Australia

Biotechnology Research

& Development

100100

Pacific Edge Diagnostics

USA Limited

USA

Commercial Sales and

Diagnostic Laboratory

Operation

100100

Pacific Edge Diagnostics

Singapore Pte Limited

Singapore

Commercial Sales and

Biotechnology Research

& Development

100100

Pacific Edge Analytical

Services Limited

New ZealandDormant Company100100

2. INVESTMENTS IN AND ADVANCES TO 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.

FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2022

NOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTS

9 8

PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022
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 2022

6 Months

($000)

Unaudited

Sept 2021

6 Months

($000)

Audited

March 2022

12 Months

($000)

Cxbladder SalesCxbladder Sales

US - Accrual Accounting US - Accrual Accounting7,3837,383 4,537 4,537 9,687 9,687

US - Cash Accounting US - Cash Accounting 916 916 445 445 953 953

Total US SalesTotal US Sales8,2998,299 4,982 4,982 10,640 10,640

Rest of World Rest of World 408 396 805

Total Operating Revenue Total Operating Revenue 8,7078,707 5,378 5,378 11,445 11,445

Other IncomeOther Income

Grant RevenueGrant Revenue 300 300 295 295 321321

Research Rebates and Tax IncentivesResearch Rebates and Tax Incentives 461 452 1,370

Total Other IncomeTotal Other Income 761 761 747 747 1,691 1,691

FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2022

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.


Notes

Unaudited

Sept 2022

6 Months

($000)

Unaudited

Sept 2021

6 Months

($000)

Audited

March 2022

12 Months

($000)

Operating ExpensesOperating Expenses

AmortisationAmortisation 123 123 54 54 156 156

Auditors RemunerationAuditors Remuneration

Group year end financial statementsGroup year end financial statements 69 69 80 80 184 184

Half year review of financial statementsHalf year review of financial statements 29 27 28

Foreign statutory financial statements 13 12 12

Total Auditors RemunerationTotal Auditors Remuneration 111 111 119 119 224

Consultant CostsConsultant Costs 858 400 984

DepreciationDepreciation206 127 264

Depreciation on Right of Use AssetsDepreciation on Right of Use Assets 569 526 1,064

Directors FeesDirectors Fees 247 247 186 186 413 413

Employee BenefitsEmployee Benefits10,797 6,770 16,402

Employee Share Scheme ExpensesEmployee Share Scheme Expenses 93 93 172 172 172 172

Employee Share OptionsEmployee Share Options 567 567 397 397 839 839

Interest on Lease LiabilitiesInterest on Lease Liabilities 46 46 69 69 125 125

NZX / ASX / Registry FeesNZX / ASX / Registry Fees 225 806 901

Rental and Lease ExpenseRental and Lease Expense 38 38 28 28 79 79

Site Fees - Clinical StudiesSite Fees - Clinical Studies 636 636 279 279 599 599

Other Operating ExpensesOther Operating Expenses 9,648 5,782 11,444

Total Operating ExpensesTotal Operating Expenses24,16424,164 15,715 15,715 33,66633,666

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 Options

Employee Share Options are a non-cash expense. Refer to Note 8 of the latest Annual

Report for details of the accounting policy for Employee Share Schemes.


FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2022

NOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTSNOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTS

11 10

PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022
Other Operating Expenses

The major categories of expenditure which make up operating expenses, but are not

disclosed separately on the previous page: Laboratory costs, Information Technology

costs, Compliance and Regulatory costs and 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.

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 their net result 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 segment described above, for the six months ended 30

September 2022, is shown on the followng page.

FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2022

Unaudited 6 Months

to 30 September 2022

Commercial

($000)

Research

($000)

Less:

Eliminations

($000)

Total

($000)

Income

Operating Revenue - External8,707 - - 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 Income8,9555,401 (763)13,593

Expenses

Expenses16,280 7,749 (763)23,266

Depreciation & Amortisation594 304 - 898

Total Operating Expenses16,874 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)

Audited 12 Months

to 31 March 2022

Commercial

($000)

Research

($000)

Less:

Eliminations

($000)

Total

($000)

Income

Operating Revenue - External 11,445 - - 11,445

- Internal - - - -

Other Income 437 2,187 (933) 1,691

Interest Income 2 547 - 549

Foreign Exchange Gain - 193 - 193

Total Income 11,884 2,927 (933) 13,878

Expenses

Expenses 20,378 12,737 (933) 32,182

Depreciation & Amortisation 977 507 - 1,484

Total Operating Expenses 21,355 13,244 (933) 33,666

Loss Before Tax (9,471) (10,317) - (19,788)

Income Tax Expense - - - -

Loss After Ta x (9,471) (10,317) - (19,788)

Net Cash Flow to Operating Activities (8,620) (8,932) - (17,552)

FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2022

NOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTSNOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTS

13 12

PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022
Unaudited 6 Months

to 30 September 2021

Commercial

($000)

Research

($000)

Less:

Eliminations

($000)

Total

($000)

Income

Operating Revenue - External 5,378 - - 5,378

- Internal - - - -

Other Income 239 1,034 (526) 747

Interest Income 1 107 - 108

Foreign Exchange Gain - 497 - 497

Total Income 5,618 1,638 (526) 6,730

Expenses

Expenses 9,137 6,396 (526) 15,007

Depreciation & Amortisation 481 227 - 708

Total Operating Expenses 9,618 6,623 (526) 15,715

Loss Before Tax (4,000) (4,985) - (8,985)

Income Tax Expense - - - -

Loss After Ta x (4,000) (4,985) - (8,985)

Net Cash Flow to Operating Activities (3,393) (5,223) - (8,616)

Eliminations

These are the intercompany transactions between the subsidiaries and the Parent. These

are eliminated on consolidation of Group results.

Total Laboratory Throughput

Unaudited

Commercial

(#tests)

Research

(#tests)

Total

(#tests)

6 months ended 30 September 2022 12,422 2,495 14,917

12 months ended 31 March 2022 19,196 3,890 23,086

6 months ended 30 September 2021 9,192 1,944 11,136

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.


FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2022

Segment Assets and Liabilities Information

Unaudited as at

30 September 2022

Commercial

($000)

Research

($000)

Total

($000)

Total Assets8,906 97,851 106,757

Total Liabilities5,990 1,924 7,914

Audited as at

31 March 2022

Commercial

($000)

Research

($000)

Total

($000)

Total Assets 6,031 109,251 115,282

Total Liabilities 4,571 2,335 6,906

Unaudited as at

30 September 2021

Commercial

($000)

Research

($000)

Total

($000)

Total Assets 5,529 94,441 99,970

Total Liabilities 4,073 2,502 6,575

Additions to non-current assets for the period include:

Commercial

($000)

Research

($000)

Total

($000)

Property, Plant & Equipment487 17 504

Right of Use Assets - - -

Intangible Assets 441 30 471

Total Additions to Non Current Assets 928 47 975

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 2022

NOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTSNOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTS

15 14

PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022
Geographic Split of Revenue and Non-Current Assets

The Group generates most of the operating revenue from Commercial tests from the US

and New Zealand, and also receives Grant revenue from Australia and New Zealand. Rest

of World consists of Revenue from Australia and Singapore.

Unaudited

Sept 2022

6 Months

($000)

Unaudited

Sept 2021

6 Months

($000)

Audited

March 2022

12 Months

($000)

Operating and Other RevenueOperating and Other Revenue

USUS8,2998,299 4,982 4,982 10,640 10,640

New ZealandNew Zealand 638 915 1,729

Rest of WorldRest of World 531 531 228 228 767 767

Total Operating and Grant RevenueTotal Operating and Grant Revenue9,4689,468 6,125 6,125 13,136 13,136

Unaudited

Sept 2022

6 Months

($000)

Unaudited

Sept 2021

6 Months

($000)

Audited

March 2022

12 Months

($000)

Non-Current AssetsNon-Current Assets

USUS 1,500 1,500 1,866 1,866 1,611 1,611

New ZealandNew Zealand2,544 1,649 2,057

Rest of WorldRest of World - - 5 5 - -

Total Non-Current AssetsTotal Non-Current Assets4,0444,044 3,520 3,520 3,668 3,668

7. SHARE CAPITAL

Sept 2022

Shares

6 Months

Shares (000)

Unaudited

Sept 2022

6 Months

($000)

Unaudited

Sept 2021

6 Months

($000)

Audited

March 2022

12 Months

($000)

Opening Balance 810,087 294,139 190,305 190,305

Issue of Ordinary Shares - Placement 80,000 103,487

Issue of Ordinary Shares - Exercise of

Share Options

1,175 4,040

Issue of Ordinary Shares - Employee

Remuneration

1

93 93 172 172

Less: Issue Expenses (2) (3,955) (3,865)

Movement 93 91 77,392 103,834

Closing Balance 810,180 294,230 267,697 294,139

1

During the period 92,985 shares were issued as part of employees remuneration in lieu of cash payments at an

average price of $1.00 per share. (Six months to September 2021 and Twelve months to March 2022: 123,086 at

$1.40).

There are 810,180,218 (September 2021: 788,469,244 and March 2022: 810,087,233)

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.


FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2022FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2022

NOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTSNOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTS

17 16

PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022
8. RECONCILIATION OF CASH USED IN OPERATING ACTIVITIES WITH

OPERATING NET LOSS

Unaudited

Sept 2022

6 Months

($000)

Unaudited

Sept 2021

6 Months

($000)

Audited

March 2022

12 Months

($000)

Net Loss for the Period(10,571) (8,985) (19,788)

Add Non Cash Items:

Depreciation206 127 263

Loss on disposal of Property, Plant and Equipment 16 - 11

Amortisation 123 54 156

Employee Share Options 567 397 839

Employee bonuses paid in shares in lieu of cash 93 172 172

Depreciation on right of use assets 569 526 1,064

Interest on finance leases shown in lease repayments 46 69 126

Total Non Cash Items1,620 1,345 2,631

Add Movements in Other Working Capital items:

(Increase) in Receivables and Other Assets(2,493) (484) (1,772)

(Increase) in Inventory (500) (166) (217)

Increase in Payables and Accruals998 172 1,786

Effect of exchange rates on net cash (3,026) (498) (192)

Total Movement in Other Working Capital(5,021) (976) (395)

Net Cash Flows to Operating Activities(13,972) (8,616) (17,552)

9. CONTINGENT LIABILITIES

There were no known contingent liabilities at 30 September 2022 (September 2021: Nil

and March 2022: 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 2022 (September 2021: Nil and March

2022: Nil).

11. SUBSEQUENT EVENTS

There are no subsequent events.

FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2022

12. RELATED PARTIES

Details of all related party relationships have been disclosed in the annual report for

the year ended 31 March 2022. No new transactions with directors or key mangement

personnel occurred that would be considered a related party.

13. PROPOSED LOCAL COVERAGE DETERMINATION (LCD) CHANGES -

POTENTIAL IMPACT ON REVENUE

On 29 July 2022 Pacific Edge Limited became aware of proposed changes by Novitas,

the Medicare Administrative Contractor (MAC) with jurisdiction for Pacific Edge’s US

laboratory to the LCD that governs the reimbursement of Cxbladder in the US by the

US Centres for Medicare & Medicaid Services (CMS).

If the proposed LCD was approved unchanged, Cxbladder would not qualify for coverage

from Novitas for tests reimbursed by the CMS. These tests represent a significant portion

of current Cxbladder testing revenue. Multiple companies with dozens of diagnostic tests

that have existing coverage or are seeking coverage, would similarly be impacted by this

proposal.

Having consulted with US-based advisers and industry experts, Pacific Edge believes

the proposed changes are unlikely to survive the ongoing review process in their current

form. The consensus view Pacific Edge received was that the proposed changes to the

LCD are contrary to US legal requirements and precedent. The proposed changes also

fundamentally change the process for determining coverage for specific tests and could

deprive US clinicians and Medicare patients access to diagnostic tools with proven, peer-

reviewed clinical utility.

Novitas closed the period for public comments on the proposals on 6 September 2022.

Novitas has not provided a specific date for a decision, however Pacific Edge understands

the proposed LCD expires if it is not notified within 12 months from the date of proposal of

July 28 2022. Regardless of a positive or negative determination, Pacific Edge understands

CMS is required to give Pacific Edge at least 45 days’ notice of the effective determination

date. Pacific Edge continues to receive payment in line with the existing LCD.

Full details of the market update relating to the proposed LCD can be found by following

the link below.

https://www.nzx.com/announcements/396175

FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2022

NOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTSNOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTS

19 18

PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2022
14. NET TANGIBLE ASSETS

Accounting Policy

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 2022

6 Months

($000)

Unaudited

Sept 2021

6 Months

($000)

Audited

March 2022

12 Months

($000)

Total Assets106,757 99,970 115,282

Less Intangible Assets 784 231 434

Less Total Liabilities7,914 6,575 6,906

Net Tangible Assets98,059 93,164 107,942

Number of Shares Issued (000’s)810,180 788,469 810,087

Net Tangible Assets per share$0.121 $0.118 $0.133

FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2022

NOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTS

20

87 St David Street, PO Box 56, Dunedin, New Zealand
P +64 3 479 5800 F +64 3 479 5801

www.pacificedgedx.com

---

Template
Results announcement

(for Equity Security issuer/Equity and Debt Security issuer)

Updated as at 17 October 2019



Results for announcement to the market

Name of issuer Pacific Edge Limited

Reporting Period 6 months to 30 September 2022

Previous Reporting Period 6 months to 30 September 2021

Currency NZD (New Zealand Dollar)

Amount (000s) Percentage change

Revenue from continuing

operations

Operating revenue $8,707

Other income $4,886

Operating revenue 62% increase

Other income 261% increase

Total Revenue $13,593 102% increase

Net profit/(loss) from

continuing operations

($10,571) 18% increase in loss

Total net profit/(loss) ($10,571) 18% 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

$0.121 $0.118

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 released NZX release. Further information is also set out

in the unaudited financial statements of the Company for the 6

months to 30 September 2022 which accompany this

information.

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 +64 (3) 479 5800

Contact email address grant.gibson@pelnz.com

Date of release through MAP 24/11/2022


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.