Pacific Edge 2020 Annual Shareholders Meeting
5 August 2020
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PACIFIC EDGE 2020 ANNUAL SHAREHOLDERS’ MEETING
CHAIR AND CEO SPEECHES
CHAIRMAN’S PRESENTATION: CHRIS GALLAHER
OUR COMMERCIAL JOURNEY
Staying the course over a long period of time and in the face of adversity, and continuing to believe that
what you are doing will make a difference, is a testament to the commitment and resilience of Dave
Darling and his team over a 15 year period.
We have been delighted in the last two months to have successfully achieved two of our most significant
commercial milestones – agreement with Kaiser Permanente, one of the USA’s largest and best regarded
healthcare providers, to use our tests; and receiving inclusion in a Local Coverage Determination which
was the final step needed to gain national reimbursement in the USA.
LCD
Coverage under the LCD enables reimbursement from the Centres for Medicare and Medicaid ...the CMS...
for two of our Cxbladder products. CMS patients represent approximately 40% of our Cxbladder
commercial sales in the US and we expect this to increase steadily as we progress over the next 12 months.
In addition, we will be negotiating for payment on the historical 22,000 invoices we have submitted to the
CMS prior to receiving the LCD, for which we have not been paid. Securing a significant proportion of
these funds is important to Pacific Edge and our shareholders as it will provide us with additional capital
to support the execution of our US commercial plans, and develop the next horizons of growth for your
company.
The LCD inclusion is also expected to positively impact on demand and reimbursement decisions from
other healthcare organisations and payers as well.
ANZ Investment
The achievement of the Kaiser Permanente and LCD milestones were the triggers for ANZ Investments to
approach the company and offer to invest $22m at a 14% premium to the prevailing share price.
This is a real financial vote of confidence in the company and its prospects by a substantial and reputable
NZ Institution and has enabled us to broaden our institutional shareholding base and raise growth capital
for the company in a very cost effective manner.
The market’s response to these three recent events has been very encouraging for the Board and
management and will, I hope, have given all shareholders confidence in our future outlook.
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Other Highlights
There were several other successes during the year.
Entering into a commercial agreement with Kaiser Permanente provides the company with a significant
opportunity to develop short, medium and longer term value through multiple products with a single large
institutional customer.
Another important achievement for us was inclusion in the USA’s National Comprehensive Cancer
Network bladder cancer guidelines. These guidelines are widely recognised and used as the standard for
clinical policy and practice in oncology by clinicians and payers in the USA.
In addition, our commercial growth has continued and we have an increasing number of urologists and
customers using our tests, particularly in the USA and in New Zealand.
Achieving these latest milestones is a testament to the hard work and perseverance of our Pacific Edge
team, and the result of years of clinical research, sales and marketing activity, user programmes and
relationship building with key organisations and influencers.
To attain this point in the company’s growth has been both challenging and rewarding. On behalf of the
Board, I would like to acknowledge and thank shareholders who have patiently supported us over this
time.
RESPONDING TO COVID-19
As a Board, our focus is on overseeing the successful implementation of our strategy, ensuring robust
governance processes and supporting management. We are also heavily involved in the capital
management and funding of our company and oversight of our commercial progress.
However, this year was the first time for any of us that we have had to deal with a global pandemic that
closed down medical practices and affected patients around the world.
We felt the impact of COVID-19 in the first two weeks of April with urologists struggling with the
conflicting demands of COVID-19 restrictions and managing bladder cancer patients, all of whom are
deemed at-risk patients. However, our New Zealand business has been quick to return to normal trading
and the USA, whilst still largely under the influence of COVID-19, has been making good progress.
Across this challenging time, we were able to reduce costs to offset expected income reductions and we
also received financial support in the form of COVID-19 relief packages from Governments in New Zealand,
Australia and the US.
OUR GROWTH STRATEGY
Our strategy remains consistent – to attain global reach with our comprehensive suite of Cxbladder
products and to maximise the value of our technology for the benefit of our shareholders.
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We will do this by:
• Commercialising all four of our Cxbladder tests in our targeted markets around the world;
• Sustaining our first mover advantage and positioning Cxbladder as the preferred detection and
management test for urothelial cancer; and
• Growing the adoption of Cxbladder by large scale institutional healthcare customers, for multiple
clinical needs.
Underpinning all this is the commitment to building a profitable business and delivering superior value to
patients, physicians and our shareholders.
OUTLOOK
We now have all the fundamentals in place and, on the back of this, we will be moving to scale up the
adoption of our tests by large healthcare organisations in our targeted markets. This won’t happen
instantly but we do expect to see commercial use and revenues ramping up over the next 12 months and
into the future.
Cash and cashflow management remain very front of mind as you would expect from a growth business.
Including the recent growth capital from ANZ, Pacific Edge had total cash and cash equivalents of $31.3
million as at 4 August 2020. We also expect the increase of commercial test sales to have a positive impact
on our earnings and operating cashflows.
The US market remains our primary focus with an annual addressable market of $1.2 billion US dollars
1
.
To maximise our opportunity will require investment to ensure we are adequately resourced to deal with
anticipated demand and to make sure our growth is executed seamlessly and positively.
Our company is uniquely placed to capitalise on the demand for better, more accurate, less invasive and
more cost-effective diagnostics. As we progress with our key objectives, we expect demand and
commercial use of our tests to gather pace.
Before handing over to Dave Darling, I would like to say a few thank yous.
First to your Board for their contribution and wise counsel over the last year. We are a small Board with a
diverse range of skills and experience and everyone has enthusiastically gotten very involved in both the
Board and Committee work. In a company such as ours, the workload on Directors is substantial and I am
very grateful for the support of my colleagues over the year.
Next, to Dave Darling and his team ... the patience and perseverance to develop and commercialise a
breakthrough medical device in the biggest and most challenging medical market in the world is an
outstanding achievement for a company based out of Dunedin.
1
E Y Parthenon 2018
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The job is not done yet and the challenge now in front of us is to grow the volume of our tests as rapidly
as possible and convert our platform now established into value for our shareholders.
Last but not least, a sincere thank you to you, our owners, who have continued to support the company
over our long journey and also shown great patience and perseverance.
CEO’S PRESENTATION: DAVE DARLING
PROGRESS AGAINST STRATEGIC GOALS
Thank you to everyone for joining us today. I’d like to start today by looking at our progress against our
key strategic goals.
LAUNCH AND COMMERCIALISE OUR TESTS
Urothelial cancer is a major global health problem and creates significant healthcare challenges. This
disease is prevalent, has high recurrence rates, is persistent and is expensive to diagnose, treat and
monitor.
Our proprietary suite of Cxbladder tests has been built to meet the multiple needs of physicians,
healthcare providers, patients and healthcare payors. Our tests can be used across the full clinical
pathway, from evaluation through to ongoing monitoring for recurrence of cancer, to address the many
clinical challenges that physicians have identified for us. We know of no other company which has created
a suite of commercial molecular diagnostic products that positively impact clinical decision making across
the entire pathway.
We are commercialising our suite of tests in four targeted markets. These are markets of scale and
markets that have a clear path to reimbursement with a high propensity to pay strong reimbursement
rates for our tests.
Apart from Cxbladder, there have been no new bladder cancer molecular diagnostic tests commercially
available the market in the last 18 years. In fact, we compete against standard technology and tools that
have been in use in urology for some time.
The market offering us the largest and most accessible opportunity right now is the USA and it remains
our primary commercial focus. The total market size for bladder cancer is estimated to be more than
US$5.0 billion with an estimated annual addressable market opportunity for our Cxbladder products of
approximately US$1.2b
1
.
New Zealand is our home market and is leading the way with the adoption of Cxbladder and inclusion in
guidelines. There have been significant changes in the way most New Zealand urologists practice urology,
with Cxbladder added into the standard of care for the majority of public healthcare providers. This major
transformation in physician behaviour foretells the changes that we are now starting to see in the USA,
with the recent announcement of Kaiser Permanente’s commercial use of Cxbladder.
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Australia and South East Asia also offer exciting opportunities for us, although we are at an earlier stage
in the commercial pathway in these two markets. We are currently running clinical trials in Singapore and
these are nearing completion. The published results will form the basis for a proposed Singapore-wide
Cxbladder commercial programme.
In Australia, we are replicating our New Zealand-proven sales and marketing model, to drive sales and, in
2019, our experienced New Zealand Sales Manager relocated to Australia to implement our sales plan.
SUSTAIN THE GLOBAL FIRST MOVER ADVANTAGE
Our second pathway to achieve commercial success is by sustaining our first mover advantage and
positioning Cxbladder as the preferred detection and management tests for urothelial cancer.
Pacific Edge owns world leading technology and intellectual property and we have a significant time based
competitive advantage. The ability for our tests to be used across the entire clinical pathway, the multiple
tests, the consistent performance and the ease of transfer of urine samples from the patient to the lab,
all enhance our competitive advantage.
GROWING PORTFOLIO OF PEER REVIEWED, PUBLISHED PAPERS
To convince urologists, healthcare organisations and payers to adopt and grow their commercial use of
Cxbladder, we need to have published, peer-reviewed clinical evidence. This is the trading currency for
positive reimbursement decisions and recognition by industry guidelines.
We have generated in excess of 10 years of accumulated evidence on thousands of patients all published
in leading, peer reviewed, urology and clinical journals, showing the outperformance of Cxbladder. This
has been a significant and time consuming investment for the company and we are now seeing the fruits
of this in the reimbursement milestones in the USA, increasing adoption in all our markets, and early stage
inclusion in NZ and USA guidelines.
INCLUSION IN CLINICAL GUIDELINES
Inclusion in guidelines follows significant adoption by healthcare providers, and further empowers
urologists and organisations to adopt and use our products. It’s early days for us in our commercial
leverage of the recent guidelines inclusion and this is a process that will continue over the next few years.
A highlight achievement this year was inclusion in the NCCN guidelines for patients being monitored for
recurrence of urothelial cancer. This is a pivotal commercial outcome as these guidelines are widely
recognised and used as the standard for clinical policy and practice in oncology by clinicians and payers in
the USA.
Several of New Zealand’s public healthcare providers have also integrated Cxbladder into clinical
guidelines, replacing the gold standard cystoscopy in both the evaluation of haematuria and in the
monitoring for recurrence of urothelial cancer.
Most recently, we have seen biomarker technology referenced in the American Urology Association
guidelines for hematuria. In particular, it was satisfying to see the strong recognition of the performance
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of Cxbladder, in the 2020 AUA guideline update, which specifically references a study, targeting Cxbladder
guideline inclusion, that is currently being undertaken by leading US urologists and institutions that are
utilising Cxbladder.
A second recent announcement has also been made by the AUA for Non-Muscle Invasive Bladder Cancer,
which again, specifically refers to Cxbladder and highlighted the outperformance of Cxbladder in
comparison to some of the already approved diagnostic tests in common use today.
For Pacific Edge, this highlights that the strategy and approach we have taken over the last decade is
starting to resonate within the urology community.
We are now actively working with our growing user-base to continue the data capture and evidence
development so that the guideline panels can confidently support stronger inclusion language for
Cxbladder in the near future.
The important thing to remember here is that our efforts have created a mind shift among the urology
decision makers and we now see changes in their clinical behaviour. We have a technology that is on track
to positively disrupt the traditional approach taken in the detection and management of bladder cancer
and we now have the ‘ear’ of the growing number of physicians who use our technology.
INCLUSION IN CMS’S REIMBURSEMENT COVERAGE IN USA
Inclusion in the Local Coverage Determination, or the LCD, is one of our biggest achievements to date and
enables our ability to receive reimbursement for the many CMS patients that utilise Cxbladder. This
completes the USA’s CMS reimbursement milestones and is expected to result in significant commercial
growth.
Inclusion in the LCD also supports our negotiations with the many private insurance payers in the US who
provide insurance coverage for the approximately 60% of our current commercial tests performed in the
US. The impact of these negotiations will be to increase our coverage and therefore reimbursement, as
well as shortening the cycle time for claims payment, our receipt of the cash.
Now that we have inclusion in the LCD, we will also be seeking to negotiate with the CMS for
reimbursement of the more than 22,000 tests, previously completed and invoiced for CMS patients. There
is precedence for this with other companies which have been reimbursed for the products or services
supplied prior to being covered under an LCD, however, the negotiation is product and company specific,
which limits our ability to pre-determine the monetary size of any outcome.
GROW THE ADOPTION OF CXBLADDER BY LARGE SCALE HEALTHCARE ORGANISATIONS
Our third strategic pathway is scale adoption by large healthcare institutions in all our targeted markets,
particularly the US.
While these large scale customers can take longer to bring to completion, once commercial agreement is
reached, they can provide significant volume, require lower sales maintenance and deliver more
sustainable, longer term growth opportunities.
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COMMERCIAL AGREEMENT WITH KAISER PERMANENTE
Most recently, we were very pleased to be approved for commercial use by Kaiser Permanente, one of
the largest healthcare providers in the US. Kaiser has over 12 million members, operates 39 hospitals and
employs approximately 23,000 physicians. This is a fantastic outcome after a long period of consultation
and working closely with Kaiser Permanente, their due diligence and to ascertain the best use of Cxbladder
in their healthcare settings.
The opportunity with Kaiser will see Cxbladder being used to the full extent of its commercial opportunity,
where the Cxbladder sample collection kit will be sent to the home of patients who are scheduled for their
3-monthly clinic evaluation for monitoring for recurrence of bladder cancer. This will allow the patient to
provide a non-invasive urine sample in the safety of their own home, which is of particular relevance and
importance during this global pandemic.
The use of Cxbladder in this home setting breaks up the traditional patient care model which would
previously require patients to visit Kaiser Permanente’s clinics, hospitals or the physician’s surgery for
their evaluation. The eyes of the urology world are on us right now as we challenge traditional norms
through our leading edge technology.
So, in the near term we are underway with our training programme for the many urology professionals at
Kaiser. We must ensure that our supply chain operates effectively and provides accurate and timely results
back to both Kaiser Permanente and their patients, 100% of the time, and retain our gold-standard service
levels even as volumes ramp up. It is our intention to have all of the training requirements completed to
meet their timelines, within a few months of the start of commercial services.
If executed well, the Kaiser Permanente programme will create multiple product use opportunities, with
strong revenue and improved cash flow for our business.
GROWING USE/EVALUATION OF CXBLADDER BY LARGE SCALE HEALTHCARE ORGANISATIONS
Multiple institutions in both the USA and our other markets are currently using or evaluating Cxbladder,
including some of the most highly recognised healthcare organisations in the world, such as Johns Hopkins
Medicine and the Cleveland Clinic, to name a couple on our list.
Momentum is growing and the new contracts that will result from these will have a significant positive
impact on our financial position when concluded.
Being covered by an LCD and having reached agreement with Kaiser Permanente will definitely assist in
our negotiations with other targeted large scale customers and payers.
ADAPTING TO COVID-19: THE GLOBAL TELEHEALTH REVOLUTION
The COVID-19 pandemic has had a transformational effect on traditional healthcare.
The number of physicians using telehealth has grown significantly, with some organisations reporting up
to 90% of their consultations being tele-consultations, up from around 30%.
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Cxbladder now plays an important, enabling role in this new telehealth environment, allowing patient
evaluation and assessment to be managed remotely. Our Cxbladder in-home urine sample process
incorporates the delivery and of sample kits direct to patient’s homes, oversight of the sample collection
with one of our customer liaison managers, then collection and delivery to Pacific Edge laboratories for
analysis, encryption and return of the result.
Given that many urology patients are in the +65 years age bracket and therefore at higher risk from COVID-
19, it also helps to maintain social distancing, removing the need to visit busy medical centres or collection
points.
The clinical utility provided by the Cxbladder in-home sampling programme has been recognised in both
the USA and New Zealand. In New Zealand during the COVID lock-down, three large public healthcare
providers have been actively using Cxbladder for in-home sample collection and two public healthcare
providers have moved to mainstream commercial use from one and now on to two Cxbladder products.
This has obvious benefits for patients and frees up essential healthcare capacity.
QUOTE FROM DR NANCY GIN, KAISER PERMANENTE
In a MEDPAGE TODAY article, published in July, Dr Nancy Gin, the Executive Vice-President of Quality and,
Chief Clinical Quality Officer for the Kaiser Federation, said...”that they [KP] had seen dramatic shifts in
telemedicine, with remote healthcare visits increasing from about one in five visits before the pandemic
to more than four in five. The speed with which this shift took place -- days and weeks rather than months
and years -- stands as a collective accomplishment in the rapid evolution of care.
She also specifically mentioned Cxbladder, saying: “...similarly, patients can self-administer diagnostic
tests to detect and monitor other conditions from home. For example, a simple urine test can be mailed
directly to the homes of bladder cancer patients to monitor for the presence of cancer biomarker genes.”
The global precedent has now been locked in place by the COVID pandemic, and we expect that tele-
consultations will become more common practise going forward. In line with this, in-home sampling is
also expected to become an accepted option for patients and physicians, even once the COVID-19
restrictions are eased. This provides yet another strong point of difference for our Cxbladder tests that is
now being utlised by customers, such as Kaiser Permanente in the US and our NZ based public healthcare
providers.
FY20 PERFORMANCE
We have already provided a lot of detail on our FY20 performance, in our results announcement and
presentation and our annual report. I’ll provide a short summary today.
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FY20 FINANCIAL SUMMARY
Our stated goal for the FY20 financial year was to continue the progression to achieving our pivotal
commercial outcomes of Pacific Edge.... albeit with a similar net investment to the prior year...... We
achieved this goal.
The key metrics we use to measure our progress are operating revenue, laboratory throughput and
commercial test volumes. These all increased year on year.
Our financial results for the year ended 31 March 2020 include:
A 7% increase in Laboratory Throughput to more than 16,000 tests; a 14% increase in Operating revenue
from test sales which was $4.4m and we reported a Net Loss After Tax of $(18.9)m.
NEAR TERM GOALS AND GROWTH CATALYSTS
Many of the foundations for commercial success have now been completed and adoption of Cxbladder
and commercial sales are increasing.
We have identified opportunities for growth in all our targeted markets and are progressing in a number
of key areas which will help us achieve our goals of growing our global reach, building and strengthening
our customer base and increasing sales and adoption. All of which will drive greater cash revenue.
USA - CATALYSTS
The USA remains our primary commercial focus and there are a number of catalysts which will drive our
commercial growth:
The agreement with Kaiser and the coverage under the LCD will not only drive direct sales with those
organisations but will also help us capture other large healthcare institutions and convert them to
commercial customers.
We increased the number of US sales reps over the last quarter of FY20 to help drive growth in this market,
and despite the impact of COVID-19, we are seeing an increasing number of healthcare organisations and
urologists evaluating or commercially using Cxbladder. However, all-in-all we have seen a tougher than
usual time in the USA over this COVID window, where many of the states are still in some form of lockdown
and so access by our sales executives is limited.
We have a targeted list of institutions that have large scale commercial urology programmes in the US,
that are currently using or evaluating Cxbladder and we will focus on getting these to emulate the Kaiser
commercial outcome. We will also be working to add further large institutions to the list and to grow their
commercial use. Concurrent with all of this, we will be putting a team of skilled negotiators to work on
gaining in-contract status with the many private payers that are currently reimbursing us for Cxbladder.
We are planning to expand our specialist sales and customer service teams to take full advantage of the
expected increase in adoption that comes from attainment of the LCD, the great endorsement from our
agreement with Kaiser Permanente and to maximise the growth opportunity in the USA.
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We will continue to invest in clinical evidence to support our adoption and are planning to launch our
fourth product, Cxbladder Resolve, into the USA market following publication of the validation study late
in the 2021 calendar year.
REST OF WORLD
In New Zealand, we are looking to bring the remaining public healthcare providers into contract and
expand the use of Cxbladder tests by existing customers.
The focus for Australia and South East Asia is to transition the public health care providers from their
clinical studies to a commercial customer model, as well as progress discussions with potential strategic
partners in South East Asia. Right now these countries are still struggling with the COVID-19 pandemic and
may take some time to return to normality.
NEAR-TERM OUTLOOK IS TO GROW OUR BUSINESS REVENUE
So in summary, our short to medium term focus is all about generating more revenue and improving
cashflow.
Primarily it involves executing on the two recent commercial catalysts, the LCD for CMS patients and the
commercial agreement with Kaiser Permanente. Both will require investment into additional resources to
ensure we are able to leverage the opportunity and the anticipated increase in demand in a seamless and
positive manner.
As well as future CMS tests, we will also be negotiating with Novitas for reimbursement for the 22,000+
tests done to date.
Inclusion in the LCD by the CMS also opens the doors for us to start contract negotiations with the more
than 300 private payers who provide insurance to the 60% of our current commercial customer-base, to-
date.
For Kaiser Permanente, our immediate next steps are further training for their healthcare professionals,
and ensuring that our supply chain is in place and working at 100% effectiveness to provide Kaiser’s
urologists and their patients with our gold-standard of service and care.
The opportunity is then for further products to be adopted into use by Kaiser Permanente with the
resulting revenue and cashflow benefits for our business.
Thank you.
ENDS
---
PACIFIC EDGE
ANNUAL
MEETING
5 August 2020
BOARD OF DIRECTORS
Chris Gallaher
2
Bryan Williams
David Darling
David Levison
Sarah Park
Anatole Masfen
GOVERNANCE
Board of Directors
Experience in governance, finance, sales
management, cancer research,
biotechnology and life sciences,
investment and business advisory.
Subsidiary Board Directors
In-country commercial experience and
scientific and/or clinical expertise.
Scientific and Clinical Advisory Boards
Expert advice on global clinical needs
and product applications, scientific
progress and clinical opportunities.
MEETING AGENDA
•Presentations:
•Address from the Chair, Chris Gallaher
•Address from the Chief Executive Officer,
Dave Darling
•Shareholder Discussion
•Resolutions as per Notice of Meeting:
•Re-election of Bryan Williams and Dave
Darling
•Authorise the Directors to fix the auditor’s
remuneration
•General Business
•Close of Annual Meeting
3
CHAIRMAN’S
ADDRESS
Chris Gallaher
4
MILESTONES ON OUR COMMERCIAL JOURNEY
5
•Evolution of Pacific Edge from a research organisation to a commercial entity.
•Development of commercial strategy for New Zealand, Australia and USA, world’s largest
healthcare market.
•Development and launch of world class CLIA and CAP accredited laboratories in the USA and
NZ.
•Extension of strategy to include “One-Stop-Shop” of Cxbladder products. Launch of multiple
Cxbladder products.
•Adapted strategy to focus on large scale healthcare organisations in all targeted markets.
•Progression of the opportunity in South East Asia.
•Increasing coverage by private payers (insurers).
•Reached commercial agreement with Kaiser Permanente for Cxbladder.
•Achievement of the major US reimbursement milestones, including inclusion in LCD for CMS
reimbursement.
•Growing adoption and use of Cxbladder by urologists and healthcare providers.
RESPONDING TO COVID-19
6
•Operated as an essential business during COVID-19 restrictions in NZ and the USA.
•Reduction in Total Laboratory Throughput during April 2020. Recovery from May 2020 following
the easing of restrictions and growing demand for our in-home sample collection service.
•Took steps to preserve cash and provide flexibility to employees. All discretionary spend was
reviewed and either cut or deferred over this period.
•Global pandemic has highlighted the need for novel ways to detect cancer early and guide patient
treatment.
•Cxbladder in-home sampling enables physicians to maintain timely evaluation and diagnosis of
bladder cancer and manage at-risk patients.
•Growing recognition of the benefits of Cxbladder in-home sampling solution as evidenced by
three public healthcare providers (DHB’s) in New Zealand commencing use of Cxbladder’ssample
collection kit, for in-home sample collection, in April 2020 and the recent commercial agreement
with Kaiser Permanente.
•Expect demand for in-home sample collection to continue as an additional option for urologists to
better manage patients beyond Covid-19 as demand for telehealth services continues to grow.
7
WE ARE POISED TO GROW
WE HAVE A STRONG OUTLOOK
•Test use and revenue expected to ramp up in FY21.
•Cash and cashflow management remain front of mind;
escalation of commercial test sales expected to have a
positive impact on our operating cashflows.
•Identified opportunities for growth in all our targeted
markets.
•US market remains primary focus.
•Additional growth capital from ANZ will support the
company to scale-up the business to meet the
expected increase in demand for Cxbladder.
•Resources will be directed towards achieving
commercial contracts with large institutional
healthcare customers and growing sales to existing
customers.
8
“We are now on the cusp of
realising our full commercial
potential. Our company is uniquely
placed to capitalise on the demand
for better, more accurate, less
invasive and more cost-effective
diagnostics.
“As we progress with our key
objectives, we expect demand and
commercial use of our tests to
gather pace and for revenue to
ramp up.”
CHIEF
EXECUTIVE
OFFICER’S
ADDRESS
Dave Darling
9
PROGRESS AGAINST STRATEGIC
GOALS
10
LAUNCH AND COMMERCIALISE ALL
FOUR CXBLADDER PRODUCTS IN OUR
TARGETED MARKETS AROUND THE
WORLD TO DRIVE A PROFITABLE
BUSINESS.
11
Cxbladderin a class of its own;
•Suite of four, class leading, accurate, non-invasive, urine
based diagnostic tests for urothelial cancer (UC).
•Addressing multiple unmet needs across the full clinical
pathway for UC.
•Cxbladder, only new test commercially available for UC
detection and management globally in the last 18+ years.
•Revolutionises how urologists detect and manage UC.
SUSTAIN THE GLOBAL FIRST MOVER
ADVANTAGE WITH CXBLADDER
BECOMING THE PREFERRED GO-TO
DETECTION AND MANAGEMENT
TESTS FOR UROTHELIAL CANCER.
•Increasing validation by international urologists and
in per reviewed published literature.
•Inclusion in clinical guidelines in New Zealand and
USA’s NCCN guidelines.
•Growing adoption and use by urologists.
•LCD inclusion for Cxbladder Detect and Cxbladder
Monitor.
•Validation from internationally recognised Kaiser
Permanente.
12
GROWING PORTFOLIO OF
PEER REVIEWED,
PUBLISHED PAPERS
•Publication of peer-reviewed papers is key
to gaining adoption, recognition in
guidelines and positive reimbursement
decisions for coverage.
•Generated in excess of 10 years of
accumulated evidence and multiple, major
peer reviewed publications.
•Cxbladder has class leading performance
metrics: Sensitivity, Specificity and Negative
Predictive Value.
•Publication of three additional peer-
reviewed papers during the year,
highlighting Cxbladder’s outperformance
and adding significant additional clinical
utility evidence to drive positive
reimbursement decisions for Cxbladder.
13
INCLUSION IN CLINICAL GUIDELINES
14
Inclusion in guidelines follows significant adoption, and further
empowers urologists and organisations to adopt and use our products.
•Majority of New Zealand’s public healthcare providers have adopted
Cxbladder into their standard of care, and in some cases, into clinical
guidelines, replacing the gold standard cystoscopy in both the
evaluation of haematuria and in the monitoring for recurrence of
urothelial cancer.
•Inclusion in the USA’s National Comprehensive Cancer Network
bladder cancer guidelines for patients being monitored for
recurrence of urothelial cancer in FY20.
•Biomarker technology and Cxbladder referenced in the American
Urological Association (AUA) clinical practice guidelines.
INCLUSION IN LCD FULLY ENABLES CMS REIMBURSEMENT
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USA Reimbursement Milestones Achieved:
✓Receipt of Product Specific CPT codes
for Cxbladder Detect and Cxbladder
Monitor (January 2019)
✓Notification of a National Price for all
Cxbladder tests of $760 per test in
(October 2018)
✓Inclusion of Cxbladder Detect and
Cxbladder Monitor in a Local Coverage
Determination (LCD) from 1 July 2020
Successful inclusion in the LCD is expected to
result in significant commercial growth:
•Enables reimbursement by CMS
*
for all
future tests conducted on CMS patients
•Supports PEB’s negotiations with other
private insurance payers in the US
•PEB will negotiate with CMS for
reimbursement of previous tests done for
CMS patients (22,000+ tests)
•Timing for cash receipts expected to
improve significantly.
*Centers for Medicare and Medicaid Services.
GROW THE ADOPTION OF CXBLADDER BY
LARGE SCALE INSTITUTIONAL
HEALTHCARE CUSTOMERS, FOR MULTIPLE
TARGETED CLINICAL NEEDS
•Building on success achieved with large public
healthcare providers in New Zealand and most recently,
Kaiser Permanente in the USA to conclude commercial
agreements with other scale institutional customers.
•While these customers can take longer to bring to
completion, once commercial agreement is reached
they can provide significant volume, require lower sales
maintenance and deliver more sustainable, longer term
growth opportunities.
•Ongoing commercial negotiations and start up
processes underway with multiple targeted institutional
customers in the USA.
16
COMMERCIAL AGREEMENT REACHED WITH KAISER PERMANENTE
17
“Cxbladder’sability to provide for the
collection of the urine sample in-home will
allow Kaiser Permanente patients to be
regularly tested for bladder cancer at home
and will also enable their physicians to do
more patient management using tele-
consultation.
“Based on the test results, many patients will
also be able to avoid having any further
invasive procedures. This has obvious benefits
for patients and also frees up essential
healthcare capacity for Kaiser Permanente.”
GROWING EVALUATION AND USE OF CXBLADDER BY
LARGE HEALTHCARE INSTITUTIONS
USAUSASOUTH EAST ASIA
•Kaiser Permanente
•Carolina Urologic Research
Center
•City of Hope
•Cleveland Clinic
•Cornell
•Fox Chase CC
•Johns Hopkins CC
•MD Anderson
•Moffitt CC
•Ohio State University CC
•Penn State Milton S. Hershey
Medical Center
•Rush University
•Thomas Jefferson University
•TriStar Medical Center
•UCLA
•University of California-San
Diego
•University of California-San
Francisco
•University of Chicago
•University of Colorado
•University of Michigan
•University of Minnesota
•University of Oklahoma
•University of Pennsylvania
•University of Southern
California
•UT Southwestern
•VA Accounts
•Wellstar
•Singapore General Hospital
•Tan Tock Seng
•Khoo Tech PuatHospital
•KK Women’s and Children’s
Hospital
•National University Hospital
•Raffles Medical Group
•Gleneagles Private Hospital
NEW ZEALAND
•Majority of public healthcare
providers
18
ADAPTING TO COVID-19: TELEHEALTH
19
•COVID-19pandemichascatalysedadramaticincreaseintheuseof
telehealthastheprimarymodeofconsultationforpatients
1
.
•Cxbladderis now being used to enable tele-health. The Cxbladder
in-home urine sample collection process incorporates the delivery of
Cxbladder’ssample collection kits direct to patient’s homes, and
then collection and delivery to Pacific Edge laboratories for analysis.
•Allows patient evaluation and assessment to be managed remotely.
•Benefits for older and ’COVID-at-risk’ patients, removing the need to
visit busy medical centres or collection points.
•Provides another strong point of difference for Cxbladder.
1. “The COVID19 pandemic has drive perhaps the greatest transformation in healthcare delivery in modern times”. MEDPAGE TODAY July
2020, Dr Nancy Gin, Executive Vice-President of Quality and, Chief Clinical Quality Officer for the Kaiser Federation
Dr Nancy Gin, Chief of Clinical Quality at Kaiser Permanente:
July 2020
“... we have seen dramatic shifts in telemedicine in just the past few months. At
Kaiser Permanente healthcare visits delivered remotely have increased from about
one in five visits before the pandemic to more than four in five today. The speed
with which this shift took place --days and weeks rather than months and years --
stands as a collective accomplishment in the rapid evolution of care. And these
changes are here to stay...
“...similarly, patients can self-administer diagnostic tests to detect and monitor
other conditions from home. For example, a simple urine test can be mailed directly
to the homes of bladder cancer patients to monitor for the presence of cancer
biomarker genes...”
https://www.medpagetoday.com/practicemanagement/telehealth/87744
20
FY20 PERFORMANCE
21
FY20 FINANCIAL SUMMARY
$MillionsFY20FY19% change
Operating Revenue
1
4.43.814%
Total Revenue
5.25.11%
Operating Expenses
24.123.0(5)%
2
Net Loss After Tax
(18.9)(17.9)(5)%
Cash Receipts from Customers
4.43.719%
Net Operating Cashflow
(15.4)(17.5)12%
Cash, cash equivalents and
short term deposits
14.812.815%
Share Capital
165.4146.413%
22
1: Revenue excludes tests sold in the US for which cash payment has yet to be received, as well as tests completed for patients covered by the CMS. As at 31 March 2020,
Pacific Edge has completed and invoiced a total of 21,789 tests for CMS patients in the USA, for which it is yet to be reimbursed.
2: Year on year Operating Expenses increased by 2% after adjustment for foreign exchange rates
✓Increase in Operating Revenue
✓Increase in cash receipts from customers
✓Improvement in Net Operating Cashflow
✓Small increase in Operating Expenses –
impacted by forex rates
✓Small increase in Net Loss After Tax
✓Net operating cash outflow reduced to
$15.4m, in line with expectations
✓Increase in net cash, cash equivalents and
short term deposits
NEAR TERM GOALS AND
CATALYSTS FOR GROWTH
23
CATALYSTS TO DRIVE GROWTH
THROUGH FY21: USA
Primary focus for all markets is achieving commercial contracts with
large institutional healthcare customers and growing sales to
existing customers
•Leverage the recent inclusion in the LCD to gain coverage with
private insurers.
•Ramp up in demand from Kaiser Permanente.
•Leverage our agreement with Kaiser Permanente to complete new
commercial agreements with other healthcare institutions of scale.
•Increase reimbursement coverage with private payers (insurance
companies).
•Publication of additional clinical evidence supporting the
outperformance of Cxbladder, to enable recognition of Cxbladder
in guidelines.
•Commercial launch of the fourth Cxbladder test (Cxbladder
Resolve) planned for late FY21.
Slide 24
REST OF WORLD
CATALYSTS TO DRIVE GROWTH
•Further adoption of Cxbladder
by public healthcare providers
in NZ and Australia.
•Publication of additional clinical
evidence supporting the clinical
utility of Cxbladder to drive
further reimbursement,
coverage and guideline
inclusion.
•Publication of a white paper
summarisingthe results from
the completed user programs
from five public hospitals in
Singapore.
Slide 25
NEAR TERM GOALS:
NEW ZEALAND
•Bring the NZ business to a cash-flow positive position.
•Extend the commercial coverage by public healthcare
providers in NZ from 65% toward 100%.
•Grow out the number of Cxbladder products in use
with each of the existing public healthcare customers.
AUSTRALIA AND SOUTH EAST ASIA (SEA)
•Transition the Australia and Singapore public health
care providers from their clinical studies to a
commercial customer model.
•Facilitate commercial discussions with large scale SEA
healthcare provider partners to grow Pacific Edge’s
SEA business.
NEAR TERM ACTIONS AND OUTLOOK
•Near term objective is to grow revenue and improve cashflow.
•Primary focus is on executing on two recent commercial catalysts –the LCD for CMS patients and
reaching a commercial agreement with Kaiser Permanente.
•LCD:
•In FY20 we processed 4,691 (43%) commercial tests for CMS patients and expect this to increase
•Negotiation with Novitasfor reimbursement of the 22,000+ tests done to date
•Contract negotiations with the 300+ private payers who provide insurance to patients in the US
•Kaiser:
•Finalising supply chain logistics and training. Expected to be completed within three months.
•Future opportunity to extend commercial use to cover multiple Cxbladder products.
26
SHAREHOLDER DISCUSSION
27
BUSINESS OF THE MEETING
28
RESOLUTIONS
•Resolution 1: That Bryan Williams, who retires by rotation and is
eligible for re-election, be re-elected as a Director of the Company.
•Resolution 2: That Dave Darling, who retires by rotation and is eligible
for re-election, be re-elected as a Director of the Company.
•Resolution 3: To record the re-appointment of
PricewaterhouseCoopers as auditor of the Company and to authorise
the Directors to fix the auditors’ remuneration for the ensuing year.
29
PROXIES AND VOTING
We have received the following valid votes and proxies:
PROXIES AND POSTAL VOTES
FORAGAINSTDISCRETIONARYVALID
VOTES/PROXIES
RECEIVED
% OF TOTAL
ISSUED CAPITAL
1Re-election of Bryan Williams265,069,764
95.16%
5,085,559
1.83%
8,838,728
3.01%
278,539,05138.46%
2Re-election of Dave Darling305,852,656
97.23%
326,825
0.10%
8,383,728
2.67%
314,563,20943.44%
3Authorisationto fix the auditors’
remuneration
306,017,809
97.30%
108,596
0.03%
8,375,647
2.66%
314,502,05243.43%
Voting instructions for voting online are available at: http://www.linkissuers.co.nz/VirtualAnnualMeeting/OnlinePortalGuide.pdf
30
OTHER BUSINESS
31
Close of the
Meeting
Presentations are available at
www.pacificedgedx.com
www.pacificedge.co.nz
www.cxbladder.com
www.pacificedgedx.com
DISCLAIMER
Information
The information in this presentation is an overview and does not contain all information necessary to make an investment decision. It is intended to constitute a
summary of certain information relating to the performance of Pacific Edge Limited. The information in this presentation is of ageneral nature and does not purport to
be complete. This presentation should be read in conjunction with Pacific Edge's other periodic and continuous disclosure announcements, which are available at
nzx.com.
Not financial product advice
This presentation is for information purposes only and is not financial or investment advice or a recommendation to acquire financial products of Pacific Edge, and has
been prepared without taking into account the objectives, financial situation or needs of individuals. Pacific Edge, its directors and employees do not give or make any
recommendation or opinion in relation to acquiring or disposing of shares. In making an investment decision, investors must relyon their own examination of Pacific
Edge, including the merits and risks involved. Investors should consult with their own legal, tax, business and/or financial advisors in connection with any acquisition of
financial products.
Future performance
This presentation contains certain 'forward-looking statements', for example statements concerning the development and commercialisation of new products,
regulatory approvals, customer adoption and results of future clinical studies. Forward-looking statements can generally be identified by the use of forward-looking
words such as, 'expect', 'anticipate', 'likely', 'intend', 'could', 'may', 'predict', 'plan', 'propose', 'will', 'believe', 'forecast', 'estimate', 'target', 'outlook', 'guidance' and
other similar expressions. The forward-looking statements contained in this presentation are not guarantees or predictions of future performance and involve known
and unknown risks and uncertainties and other factors, many of which are beyond the control of Pacific Edge and may involve significant elements of subjective
judgement and assumptions as to future events which may or may not be correct. There can be no assurance that actual outcomes will not materially differ from
these forward-looking statements. A number of important factors could cause actual results or performance to differ materially from the forward-looking statements.
The forward-looking statements are based on information available to Pacific Edge as at the date of this presentation. Except as required by law or regulation
(including the NZX Main Board Listing Rules), Pacific Edge undertakes no obligation to provide any additional or updated information whether as a result of new
information, future events or results or otherwise.
No representation
To the maximum extent permitted by law, Pacific Edge and its advisers, affiliates, related bodies corporate, directors, officers, partners, employees and agents make no
representation or warranty, express or implied, as to the currency, accuracy, reliability or completeness of information in thispresentation.
33
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.