Financial Results for the Half Year to 30 September 2022
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
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to notify certain material information to NZX Limited (NZX) and ASX
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Financial data
All dollar values are in New Zealand dollars unless otherwise stated. This
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and activities given in the announcements relating to the results, and
interimreport, for the six months ended 30 September 2022.
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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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Investment risk
An investment in securities of PEL is subject to investment risk and other
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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
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To the maximum extent permitted by law, none of PEL and its advisers,
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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
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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.