Pacific Edge 2018 Annual Meeting of Shareholders
Annual Meeting of Shareholders
Thursday 16
th
August 2018
Addresses by Chairman & CEO
Page 2 of 14
CONTENTS
Welcome ................................................................................................................................. 3
Board of Directors ................................................................................................................... 3
Meeting Agenda ..................................................................................................................... 3
Chairman’s Presentation .......................................................................................................... 4
Consistency of Purpose and Strategy ................................................................................. 4
Financial Results .................................................................................................................. 5
Capital ................................................................................................................................ 5
2019 .................................................................................................................................... 6
Management Presentation ...................................................................................................... 6
Cxbladder: Better Solutions Better Care ............................................................................ 6
FY18 Milestones ................................................................................................................. 6
FY18 Results at a Glance .................................................................................................... 7
New Revenue Reporting Model ......................................................................................... 8
Haematuria, Bladder Cancer and Our US Market Size ....................................................... 9
Cxbladder ........................................................................................................................... 9
Patients Seeking Better Options ......................................................................................... 9
Canterbury DHB Commercial Lookback ........................................................................... 10
New Zealand Leading the Way in the Adoption and Use of Cxbladder .......................... 10
Sales Channels .................................................................................................................. 11
US Market and Customers ................................................................................................ 11
Kaiser Permanente .................................................................................................. 12
CMS ......................................................................................................................... 12
Performance in Line with Peers ............................................................................................. 13
Other Markets ....................................................................................................................... 13
Outlook ................................................................................................................................. 13
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WELCOME
Good afternoon and welcome to the Pacific Edge 2018 Annual Meeting.
I am Chris Gallaher, Chairman of the Pacific Edge Board of Directors. And I thank you all for
being with us here in Dunedin today; particularly those who have travelled to get here.
I also welcome those of you who are joining the meeting online.
BOARD OF DIRECTORS
I would like to start by introducing my fellow Directors.
David Band, Bryan Williams, David Levison, Anatole Masfen and David Darling who is also
our Chief Executive Officer.
I do want to make special mention of David Band who is retiring from the Board today after
10 years of service, the last five years as Deputy Chairman.
I wish to formally thank David for his outstanding contribution to the Company and its
development over a long period of time and his support for me as Deputy chair over the last
two years.
We have a Director recruitment process in progress and will announce a replacement for
David in due course.
I am also pleased to announce the appointment of Bryan Williams to the Deputy Chairman
role.
Bryan, who originally hails from Dunedin, has been a Director of Pacific Edge since 2013, is
an internationally recognised cancer researcher and an experienced company Director.
Anatole Masfen, who has been a Director of the Company since 2008, and who also chairs
the audit and risk and the nominations sub-committees of the Board, retires by rotation and
is standing for re-election by shareholders today. Your Board fully supports Anatole’s re-
election.
MEETING AGENDA
We will start with presentations from myself followed by our CEO, Dave Darling.
Following these presentations, we will be happy to take questions from the floor and from
those of you on-line on those presentations.
We will then move to the formal business of the meeting and the resolutions contained in the
notice of meeting.
Page 4 of 14
There will be an opportunity for you to ask questions on each resolution before it is put to
the vote.
Following the voting on resolutions, we will be happy to take any general questions you may
have in relation to our Company and its operations.
Following the close of the meeting, I invite you to stay and share some light refreshments
with the Pacific Edge team and the Board.
I declare that a quorum is present and that the meeting has been duly convened.
The notice of meeting, which includes the explanatory notes, has been circulated to all
shareholders and I intend to take it as read.
The audited financial statements for the year ended 31 March 2018 were released on 29 June
and included in the annual report.
I would now like to take a few minutes to reflect on the past year and to outline the Board’s
priorities for the year ahead of us.
CHAIR’S PRESENTATION
CONSISTENCY OF PURPOSE AND STRATEGY
We have continued to hold firm to our purpose – why we do what we do.
Simply put; we are all about establishing Cxbladder as the world’s leading molecular
diagnostic technology for the detection and management of bladder cancer and to maximise
the value of our technology for the benefit of our shareholders.
The key market to deliver on this purpose is the USA healthcare market, the world’s largest,
and we continue to invest substantial sums in realising this opportunity.
The pace of our progress in this market is not where we would like it to be, we had planned
to be able to bring the two key opportunities in this market, Kaiser Permanente and achieving
our CMS local coverage determination, to conclusion in the last financial year and are working
assiduously to do so.
Shareholders should be assured that we are doing everything within our control to close these
transactions.
We took the opportunity during the year to conduct an external review of our go-to-market
strategy for the USA market, by EY-Parthenon, a leading global consultancy practice.
Pleasingly, this review confirmed both the scale of the opportunity and our market strategy
and relative to our peer group, we continue to make good progress in the USA.
Page 5 of 14
Dave Darling will go into more detail on the USA market in his presentation.
Very pleasingly we continue to make good progress in our New Zealand home market and
we have signed our first commercial agreement in Singapore with the Raffles Group.
FINANCIAL RESULTS
We took the opportunity to early adopt the new accounting standard for revenue recognition,
NZ IFRS 15, which greatly simplifies the complex revenue recognition of sales in the USA
market.
In short, sales from the USA, will be recognised on a cash received basis only, until we receive
our LCD coverage and coverage contracts are concluded with commercial insurers.
This gives transparency to our sales numbers, cash flows and debtors in the USA.
Our reported loss for the year was $19.7m, a $3m improvement over last year.
Had we continued to apply the old accounting standard and relative to the forecasts that
were included in the November 2017 rights issue, total laboratory throughput was 91% of
forecast, and revenue was 95 % of forecast.
Dave Darling will go into more detail on the financial results in his presentation.
CAPITAL
We were encouraged by the support of shareholders in the November 2017 capital raising
which generated $21.3m of cash resources into the Company and the placement last month
to Manchester Management Company of the USA which raised $2.6m.
It was pleasing to attract this investment from an international investor in biotech and life
sciences businesses at a price that supported the November rights issue price.
It adds depth to our share register and reflects a growing international investor interest in
Pacific Edge.
The Company had $16.2m cash on hand at 31 March, since then we have raised $2.6 million
from Manchester Management and our cash burn is on plan.
The Board and management have cash and cashflow management very front of mind as you
would expect from a growth business in the cash burn phase.
The Company is focussed on getting to a cashflow break-even point this financial year and
this very much depends on the successful closing out of the two USA transformational
opportunities that I referred to earlier.
Page 6 of 14
2019
The USA opportunity is the key to our success.
While it is the priority, we will also continue to complete our NZ rollout and build off our start
in Singapore.
Our key metrics going forward will be billable tests and cashflow and we will be reporting
against these in our formal reporting cycle.
Our Company is uniquely placed to capitalise on the demand for better, more accurate, less
invasive and more cost-effective diagnostics.
Before handing over to Dave Darling, I want to finish with a sincere thanks to the Board for
their commitment and wise counsel over the last year and to Dave and his team for their
continuing passion and commitment to delivering on the potential of our Company.
While we are in a long game, and it has been a long journey for the team and our loyal
shareholders, I appreciate the patience shown by all as we work to deliver our goals.
I’ll now pass over to Dave to give his Chief Executive’s review.
MANAGEMENT PRESENTATION
CXBLADDER: BETTER SOLUTIONS BETTER CARE
Our goals remain firm. They are to enable better patient care, better clinical decision making
and better use of healthcare resources by providing faster, more accurate and less invasive
diagnosis and management of bladder cancer. This is at the heart of our business and we
judge our success on achieving these goals.
Our aim is to change long standing clinical practices and encourage adoption of Cxbladder.
While it is taking longer than originally anticipated, as the hurdles continue to move in the
USA healthcare and reimbursement market, we are making positive progress and have a well-
considered strategy for realising the potential of your Company.
FY18 MILESTONES
Again this year, we achieved a number of significant commercial milestones.
The US remains our primary focus – it is the world’s biggest healthcare market and we are
well down the commercial pathway and are now focused on building scale and growing test
sales. The regulatory and reimbursement environment in the US has changed significantly
since we first set our sights on this market. However, we have adapted our tactical plans to
meet the needs of the changing environment and we are making good progress towards our
goals.
Page 7 of 14
There are three significant components of the US reimbursement process that diagnostic
companies must attain; First, you need to have a dedicated code for your products; second,
you need a national price; and last but not least you need to get included in the CMS
insurance coverage (LCD).
Earlier this year, we were granted dedicated CPT codes for two of our tests, by the American
Medical Association. This is a big milestone as CPT codes are only issued for tests that have
entered the mainstream and where the volume of tests used by physicians has been shown
to be indicative of significant adoption. It is the ‘coming of age’ for our tests.
The associated pricing for these codes will be publicly notified in November and this price
will carry across to the test sales for patients that are covered by the CMS. So once we’re
included in the Local Coverage Determination, the product codes and pricing will all be in
place. These are two of the key US reimbursement processes for us and will support any plans
to enter into contract coverage with private insurers in the US.
We’ve seen great progress in New Zealand this year, with MidCentral and Canterbury added
to the list of DHBs around New Zealand who have commercially adopted Cxbladder products
and who are now using our tests at a growing volume.
Signing of our first commercial customer in South East Asia was also a real achievement in
FY18. Raffles Medical Group is a fantastic new customer – they are one of the largest
integrated healthcare providers in South East Asia, they operate across 4 countries in 13 cities
and have more than 2 million customers under care. Our agreement is with Raffles Group
Singapore, and it offers a stepping stone for us into the rest of the Raffles group. While this
is a relatively small commercial proposition for Pacific Edge initially, the potential in South
East Asia is huge and it could one day eclipse the USA.
We had a strong year on many fronts, however we didn’t get all of our goals completed and
closing the agreement with Kaiser Permanente and obtaining our Local Coverage
Determination for the CMS patients, remain on our list of priorities for this year.
FY18 RESULTS AT A GLANCE
Sales are growing strongly and in FY18, we saw good commercial growth with a 29% increase
in laboratory throughput to 14,400 tests and 82% of those are billable. We also delivered a
26% growth in revenue measured on a like-for-like basis with last year, and 6% growth in our
cash sales – there’s not too many young companies growing at this rate. As we build our
customer base, our sales will continue to scale up.
We are very conscious of the expenditure and investment we are making into our business,
and while it’s important for us to invest to build our business, we were pleased to have
delivered a 10% reduction in our operating costs, with revenue outgrowing expenses by 13%.
The net operating cashflow deficit of $(18.1)m was at a similar level to last year, with the cash
receipts reflecting sales in the US that were completed over a period that may span over two
Page 8 of 14
years earlier. So the revenue you see entering our books has taken some time to be recovered
and booked.
This time taken to collect cash receipts will improve as commercial agreements with insurers,
large institutions and the CMS are achieved. One of the key components for shortening this
time to cash is gaining our product specific codes and the corresponding national price. So
it was another great outcome for us in FY18 to be awarded specific products codes by the
American Medical Association (AMA). We are now working to complete the award of our
national product prices.
At 31 March 2018 cash in hand was $16.2 million.
We are confident that cash sales will continue to grow over FY19. We appreciated the support
of our shareholders for last year’s Rights Issue and we are working hard to build sales across
our target markets to get us to our cashflow breakeven position.
We are also conscious that there are expectations in the market of exponential sales growth.
While these will occur, they will come as we build our customer base and lock in the
repeatable sales, as we are now seeing in NZ.
NEW REVENUE REPORTING MODEL
As Chris mentioned, we have changed our revenue reporting model so that we now only
recognise revenue for our US customers when the cash payment for the sale is received.
The lion’s share of Pacific Edge’s revenue is being generated from sales to individual patients
in the US. Under this Business to Consumer relationship, the patients retain the liability of
paying for the tests. Their insurer may pay some or all of the cost of the test, depending on
their level of cover and then the patient remains responsible for paying any outstanding
amount. As a result, receipt of cash can take anywhere from 1 to 24 months, with the bulk of
cash receipts coming over 7 to 12 months from the time of sales.
Under the new standard, Pacific Edge’s US revenue is only recognised for these customers
when the cash payment is received. What this means is that a smaller revenue number,
representing this cash-only element appeared in our FY18 financial accounts. However to be
clear the remainder of the commercial tests completed in FY18, that would previously have
been accounted for with the accrual revenue accounting, have not gone away and will appear
on our revenue statement when the cash is received.
We believe this new reporting model, defined by the NZ IFRS accounting standard, provides
a better picture of Pacific Edge’s cash revenues, particularly from the US. We are still accruing
some revenue for a small number of tests sold in other markets, where the reimbursement
process is less complex and we have more certainty over payment.
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HAEMATURIA, BLADDER CANCER AND OUR US MARKET SIZE
The potential market for our tests remains enormous. In the US alone, approximately 7 million
people present with blood in the urine, or haematuria, every year.
Haematuria is a key indicator of bladder cancer and the guidelines state that these patients,
approximately 1.6 million of the 7 million, are worked up with expensive and invasive tests
each year for bladder cancer. This gives rise to approximately 79,000 new cases of bladder
cancer diagnosed in the US annually.
While it is a highly treatable disease it also has a 70% recurrence rate, meaning that patients
live with a regime of regular testing for up to five years or more. The guideline driven
requirement for ongoing monitoring sees approximately 800,000 patients, who have been
treated, regularly returning to the clinic for on-going evaluation over a five year span.
Because of this, bladder cancer has the highest cost of any cancer – up to $240,00 US dollars
per patient.
EY-Parthenon completed a review of our addressable markets for Cxbladder in the US in 2017
and concluded that these markets are in excess of USD$1.2 billion. We are progressively
making inroads into this market and capturing key customers.
CXBLADDER
Pacific Edge is the only Company in the world to offer a suite of molecular diagnostic tests in
any one cancer that address different clinical needs of physicians across the detection and
management pathway for urothelial cancer. This gives us a very unique and far reaching
commercial proposition that we are now leveraging through our clinical publications and into
our sales.
Our key advantages are multiple integrated products, ease of use, ability to transport across
international borders and a fast laboratory turn-around time and most importantly the
increase in clinical resolution. We are providing a unique ‘one-stop-shop’ that physicians and
healthcare providers are looking for.
There is no longer any discussion about the clinical validity of our products. Cxbladder is
progressively being added to the standard of care, is starting to replace the gold standard in
treatment and management guidelines for large public healthcare in New Zealand and is
being adopted strongly and widely offshore.
PATIENTS SEEKING BETTER OPTIONS
There is growing recognition of Cxbladder’s performance by clinicians and patients are
becoming more aware of Cxbladder’s non-invasive nature. Recently, in partnership with the
Bladder Cancer Advocacy Network in the USA, we surveyed over 1,000 bladder cancer
patients and caregivers in the USA. The results were astounding.
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• 66% of patients say they suffer discomfort, pain, embarrassment or anxiety when
having a cystoscopy,
• Of those, 71% say they would choose Cxbladder as part of their bladder cancer
management plan.
• In addition, 68% would use Cxbladder to reduce the frequency of cystoscopies as part
of their ongoing surveillance.
Patients and clinicians are clearly seeking a better option and Pacific Edge is providing it with
Cxbladder.
CANTERBURY DHB COMMERCIAL LOOKBACK
Medical products by their very nature have a high threshold for proof of performance before
mainstream adoption. This burden of proof is extensive, time consuming and expensive. It
provides a hurdle for strong adoption and drives reimbursement.
The commercial lookback by the Canterbury DHB on their use of Cxbladder for the evaluation
of all haematuria patients, demonstrated the commercial benefits of our product and is a
great endorsement for adoption by other large healthcare providers.
Canterbury had been using our tests with increasing volumes over the last 24 months and
they completed an evaluation of this against their clinical and budgetary needs. What it
found was that the use of Cxbladder delivers expected and published performance. As a
result, Canterbury have rewritten their guidelines, removing the gold standard and replacing
it with Cxbladder, so Cxbladder and imaging are now the new standard of care in the initial
work-up of all haematuria patients.
The results, in abstract format, have been published in the British Journal of Urology
International and a follow-up clinical paper is being drafted for submission for peer review
and publication.
This clinical outcome saw Cxbladder added to the South Island wide, electronic Health
Pathways guidelines. This means that primary care physicians get to use Cxbladder for the
frontline management of all patients who present with blood in their urine. This outcome was
more than we had expected and has led to a nationwide move by other DHBs to follow suit.
NEW ZEALAND LEADING THE WAY IN THE ADOPTION AND USE OF CXBLADDER
As we expect to happen in other countries, New Zealand is now at tipping point with the
majority of the large District Health Boards adopting Cxbladder and adding it into their
standard of care. We have recently announced the addition of the Counties Manukau DHB
to the growing list of New Zealand DHB’s signing up and adding Cxbladder into their
standard of care. Counties Manukau DHB provide healthcare services to approximately 12 %
of New Zealand’s population and they have a long queue of patients waiting for up to a year
for a cystoscopy. Cxbladder will now fix that problem for them.
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In New Zealand, there is no longer a question of clinical validity or utility – the outperformance
of Cxbladder is accepted. It’s now about the fit within the specific healthcare organisation,
how they can best use our tests and allocating funds to pay for them.
• Mid-Central DHB led the world with the signing into commercial use of all four
Cxbladder products.
• Bay of Plenty and Lakes DHBs continue to grow their use of Cxbladder.
• Canterbury DHB has integrated Cxbladder Triage into the Health Pathways – the
recommended pathway of care for patients with haematuria
• Waitemata DHB has also added Cxbladder to their standard of care for all patients
being managed for the recurrence of the disease.
• And most recently, Counties Manukau has joined the growing list of DHBs using our
tests.
SALES CHANNELS
New Zealand is a great example of what our tests can achieve in terms of better patient care,
better outcomes and better use of limited healthcare resources.
Following the success we have seen in our home market, we are growing our focus
internationally on the large healthcare institutions, which have similar characteristics to the
DHBs in New Zealand. We have seen the impact our technology makes on these large
healthcare providers who have burgeoning patient needs, few resources and need to show
value changes for their clinical services.
The sales cycle may be longer, however once an agreement is in place, these larger
customers provide significant volume with lower sales maintenance and more sustainable,
longer term growth opportunities for our business.
In line with this, we have re-focussed our US sales team, added more resource for these
institutions, while continuing to maintain relationships with existing large practice urologists.
User Programmes remain an essential part of our adoption strategy and a growing number
of clinicians across the US, New Zealand, Australia and Singapore are engaged in User
Programmes as part of their adoption cycle for Cxbladder. User Programmes enable the
physicians to gain a first-hand experience in their specific clinical settings. This then leads to
the selection of the Cxbladder product most suitable to their needs.
US MARKET AND CUSTOMERS
The USA is the world’s largest healthcare market, and with 5 million potential test
opportunities for Cxbladder each year, it remains our primary focus.
We have been marketing our tests to urologists for the past three years and we are now
seeing an increasing number transitioning from User Programmes to commercial customers.
Page 12 of 14
The award of CPT codes and the associated pricing will allow us to start negotiating with
insurers and funders and will carry across to the CMS. So once we’re included in the Local
Coverage Determination, the product codes and pricing will all be in place for reimbursement
to commence.
We are now in contract with the VA and TRICARE which gives us access to a combined 20
million-plus military personnel in the US and their families. The VA has a large network of
clinics across the US and each of these is autonomous, similar to the DHB network of large
public health care providers in New Zealand.
Our Federal Supply Schedule agreement means we can sell our tests to VA physicians, at an
agreed ceiling price, but each individual VA centre can still negotiate their own pricing.
Gaining adoption in each centre is taking longer than we anticipated, however we are starting
to see early sales from the initial centres we targeted. We are putting in place User
Programmes for several of the larger sites and their success is expected to carry adoption
across a large number of the VA sites.
Kaiser Permanente
is one of the largest integrated healthcare organisations in the US, with
its own network of clinics, hospitals and patient centres. It serves more than 11.8 million
members and offers a significant opportunity for our Company.
To have a new healthcare product or service adopted into Kaiser requires a huge amount of
clinical validation and sign off from a large team of clinical, budgeting and management
personnel. The clinical validation requirements have been met by Pacific Edge, and
demonstrate outstanding performance of our tests, but we have little control over the internal
decision making process.
We are doing all that we can to conclude our process with Kaiser and move to a commercial
relationship.
CMS
– Good progress is also being made with the regulatory process to obtain a Local
Coverage Determination, which will enable reimbursement for patients covered under the
CMS. This is an iterative, unstructured and lengthy process that can take companies 3-5 years
to complete and which everyone must follow.
Approximately 50% of our US patients are covered under the CMS and whilst we are
obligated to carry out these tests and invoice the CMS, currently we are not yet able to
receive payment. Once we receive our inclusion in the LCD, we will be able to receive
reimbursement and we will seek payment for the many patients done to date.
The commercial process in these large organisations has been unchartered ground, and we
have little control over their decision processes. However, our progress is in line with other
similar companies operating in the US in the molecular diagnostic space with similar cancer
focussed products.
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PERFORMANCE IN LINE WITH PEERS
If we look at our performance in comparison to other molecular diagnostic companies in the
US, as outlined in our annual report and on the slide in front of you, you can see that we have
a very similar sales trajectory from time of launch to that of our US Based, molecular
diagnostic company, peers. Coverage and reimbursement decisions are key to driving
volume We expect to see an uplift in sales as we continue to sign commercial contracts and
gain inclusion in the LCD.
OTHER MARKETS
It has been satisfying to see the global firsts occurring with our large public healthcare
providers in NZ. Test sales are growing and in FY18, NZ accounted for 14% of total laboratory
through-put.
The uptake in Australia has been disappointing and we are taking over the sales process and
will shift the focus to large healthcare institutions to replicate the success we are having in
New Zealand.
Meanwhile, Singapore is turning into another early success story. We are only in the initial
stages of entry into this market, but already we have multiple User Programmes underway
with the large hospitals and have signed a commercial agreement with Raffles Medical Group
who are represented in four countries and 13 cities across South East Asia.
OUTLOOK
The commercial opportunity for our Company is becoming a reality and the market
opportunity remains significant. There is growing awareness, support and adoption of our
tests being reflected in sales in our key markets and also in the adoption to standards of care
and inclusion in local guidelines. We expect to see continuing sales growth over the next year
from new and existing customers.
The US remains our primary focus for growth and will be our main area of investment again
in FY19 as we position Cxbladder as the preferred detection and management tests of choice
for physicians, in a market that offers more than 5 million potential test opportunities each
year.
Our priority remains to conclude the commercial process, as rapidly as possible, with Kaiser
Permanente; and attain inclusion in the CMS Local Coverage Determination for
reimbursement for the large and growing numbers of tests processed for patients covered
under the CMS.
We have a growing list of large institutions in User Programmes in our key markets, many of
which we expect will start their process of transition to a commercial dependence on
Cxbladder products.
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We will also be working closely with VA centres and TRICARE to build on initial sales and
grow the penetration into the more than 300 VA clinics across the country.
With the adoption of the new accounting standard and the longer time than anticipated to
finalise commercial agreements with Kaiser and attain inclusion in the Local Coverage
Determination (LCD) for CMS patients, we expect to provide updated guidance in a cash
revenue format for FY19 later in this calendar year.
For further information please contact:
David Darling
Chief Executive Officer
Pacific Edge Ltd
P: +64 (3) 479 5800
Jackie Ellis
Investor Relations
Pacific Edge Ltd
P: +64 (27) 246 2505
---
2018 Annual Shareholders’ Meeting
16 August 2018
Pacific Edge 2018 ASM Presentation
BOARD OF DIRECTORS
Chris Gallaher
Independent Director, Chairman
David Band
Independent Director (retiring at ASM)
Bryan Williams
Independent Director
David Levison
Independent Director (US-based)
Anatole Masfen
Independent Director
David Darling
Executive Director and Chief Executive Officer
Slide 2
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; and scientific
progress and clinical opportunities.
MEETING AGENDA
ØPresentations:
Address from the Chair, Chris Gallaher
Address from the Chief Executive Officer, David Darling
ØShareholder Discussion
ØResolutions as per Notice of Meeting:
Re-election of Anatole Masfenas a Director
Authorise the Directors to fix the auditor’s remuneration
Increase in Directors’ remuneration by 9.8% to $302,000
ØGeneral Business
ØClose of Annual Meeting
Slide 3
CHAIRMAN’S PRESENTATION
Chris Gallaher
MANAGEMENT PRESENTATION
David Darling, CEO
Pacific Edge 2018 ASM Presentation
CXBLADDER:
BETTER
SOLUTIONS,
BETTER CARE
Our goals are to enable better patient
care, better clinical decision making and
better use of healthcare resources by
providing faster, more accurate and less
invasive diagnosis and management of
bladder cancer
Pacific Edge 2018 ASM Presentation
FY18 MILESTONES
We are changing long standing clinical practices with adoption of Cxbladderinto clinical guidelines
Received approval for CPT Codes from
American Medical Association
Signed contract with MediNcrease
Health Plans in USA
External Growth Accolades:
•TIN100 Top Ten Hot Emerging Companies
•20th in Deloitte Fast50
•5
th
in FT 1000 High Growth Companies Asia
•Inclusion in Deloitte Asia Pacific Technology Fast 500
Signed first commercial agreement in
Singapore, with Raffles Group
Completion of successful
$21.3m capital raising
APRILMAYJUNEJULYAUGSEPTOCTNOVDECJANFEBMAR
Slide 7
Suite of Cxbladder tests
adopted by MidCentralDHB
Pacific Edge 2018 ASM Presentation
FY18 RESULTS AT A GLANCE
Slide 8
1
3
5
7
9
11
13
15
FY14FY15FY16FY17FY18
Thousands
Laboratory Throughput
(Includes commercial tests and
User Programmes)
29% increase in lab throughput
82% billable
0
2
4
6
8
10
12
14
FY17FY18
$Millions
FY17: FY18 Revenue
Increase
Accrued revenue under old standard
Cash recognised under new standard
6% increase in cash
revenue
Commercial tests processed up 29%
Test sales up 6%
14,440
$3.4m
Total revenue up 6%
$5.0m
Operating expenses reduced by 10%
$24.6m
Revenue outgrowing expenses
(FY18 on FY17)
13%
Operating cashflow in line with
expectations and the previous year
$(18.1)m
Net Loss improved 13% on FY17
$(19.7)m
Cash and cash equivalents as at 31 Mar 18
$16.2m
Pacific Edge 2018 ASM Presentation
NEW REVENUE REPORTING MODEL
FY18 Adoption of IFRS 15: US cash based revenue recognition
ØCurrently, approx. 60% of Pacific Edge US sales are directly to the
patient (B2C relationship) –patient has liability
ØMajority of B2C payments are from private or public insurance.
ØPayment can take anywhere from 1 to 24 months to be received,
with the bulk of cash receipts coming within 7 to 12 month
period
Ø
Pacific Edge now only recognises the revenue for its US
customers when the cash payment is received
ØUS revenue that was previously reported as accrued revenue is
now not recogniseduntil the cash for those sales is received
ØAll tests sold and billed will continue on in the Pacific Edge billing
and reimbursement process and actively chased for collection
and only booked as the cash is received
ØThe Board believes this new reporting model provides a more
representative view of Pacific Edge’s cash revenues, particularly
from the US.
Slide 9
Commercial agreements with large institutions and private
insurance companies will increase collectability of revenue
Pacific Edge 2018 ASM Presentation
HAEMATURIA AND BLADDER CANCER
The US opportunity dominates our commercial focus
Pacific Edge’s
addressable market in
the USA alone:
5 million tests per year
worth up to US$1.2
billion
Validated by EY-Parthenon review*
Slide 10
Approx. 7 million
people present with
haematuria annually
in the US
79,000+ new bladder
cancer cases in USA
every year
9
th
most common
cancer in the world
4
th
most common in
men
70% recurrence rate
leads to many clinical
procedures
Highest medical cost
of any cancer up to
US$240k per patient
Pacific Edge:
Suite of four
Cxbladder tests
16 years of R&D and
validation
Primary focus is the
USA, the world’s
largest healthcare
market
Commercial
partnerships in USA,
NZ, Australia and
Singapore
*EY Parthenon, a leading international consulting firm, has endorsed Pacific Edge’s USA market strategy and confirmed the addressable market for Cxbladderin the USA to be
more than US$1.2 billion
Pacific Edge 2018 ASM Presentation
CXBLADDER
Validated by world leading physicians
The first new diagnostic test for bladder cancer to be made
commercially available in the US market in 16 years.
Four high performance Cxbladder products in use by clinicians and
now being integrated into standards of care and guidelines.
ØNon-invasive
ØSimple to use
ØAbilityto transport samples across international borders
ØFast laboratory turnaround
ØIncrease in clinical resolution
ØCan reduce healthcare spend
Ongoing clinical validation continues to demonstrates the
outperformance of Cxbladder compared to other commonly used
diagnostics. Third party clinical outcomes now being published
support the transition into commercial reality.
PATIENTS SEEKING
BETTER OPTIONS
The use of Cxbladder can replace or reduce the use
of cystoscopies –an invasive, painful and costly
procedure
Survey of over 1,000 US bladder cancer patients:
Ø66% of patients say they suffer discomfort, pain,
embarrassment or anxiety when having a
cystoscopy
ØOf those, 71% say they would choose Cxbladder
as part of their bladder cancer management
plan
Ø68% would use Cxbladder to reduce the
frequency of cystoscopies as part of their
ongoing surveillance.
“Cystoscopy was very painful. I hope to never go
through that again.”
“Cystoscopy is an experience I would love to
discontinue. I hope that some form of technology
soon takes its place. There is nothing pleasant about
the procedure.”
Slide 12
“I wish there was a better, less invasive way to determine if
tumoursand cancers have returned.”
Slide 13
WORLD FIRST: CANTERBURY DHB ‘COMMERCIAL
LOOKBACK’ ON SUCCESSFUL COMMERCIAL USE
ØThe use of Cxbladder delivers greater accuracy and significant patient
and cost advantages than the existing pathway guidelines
ØThe risk of missing a significant bladder cancer is negligible when
Cxbladder Triage is added into the algorithm for the assessment of
haematuria
Ø32% of patients were able to avoid secondary care, and to have their
assessment in the community through their primary care GPs
ØCanterbury DHB has extended its inclusion of Cxbladder in its
HealthPathwayto include the use of Cxbladder Triage as the primary
tool for the evaluation of haematuria, replacing cytology and up to a
third of all of the cystoscopies
ØThe commercial lookback provides strong clinical and econometric
evidence to support positive adoption by other large healthcare
providers and acceptance
ØAbstract published in BJU International –a leading urology journal -and
full paper in review for publication into their Standard of Care
Pacific Edge 2018 ASM Presentation
Slide 14
NEW ZEALAND LEADING THE
WAY WITH ADOPTION AND USE
OF CXBLADDER
ØMid Central District Health Board (DHB) led
the world with commercial use of all four
Cxbladder tests
ØBay Of Plenty and Lakes DHBs continue to
grow their use of Cxbladder
ØCanterbury led the world with the signing
of Cxbladder Triage and the integration into
the electronic guidelines for Cxbladder
Triage; and their comprehensive
commercial look-back over 12 months of
use that is currently in peer review for
publication
ØWaitemata DHB has added Cxbladder
Monitor to standard of care
ØRecently started service provision of
Cxbladder to Counties Manukau
Pacific Edge 2018 ASM Presentation
SALES CHANNELS
Shifted focus to large healthcare institutions
ØSales focus on targeted large healthcare institutions has increased
in all target markets following the success achieved in NZ
ØDedicated US sales team -additional resource focused on
institutions
ØUser Programmes remain the primary driver for encouraging trial
and adoption
ØFocus on digital marketing with specific campaigns around key
period –Bladder Cancer Awareness Month, Men’s Health
ØWorking with academic centres and hospitals to gain acceptance of
Cxbladder into their care pathways
ØRecognition in a number of high profile business reports –TIN Top
Ten Hot Emerging Companies, Deloitte Fast50 New Zealand,
Deloitte Asia Pacific Technology Fast500, FT 1000 High Growth
Companies Asia Pacific
Slide 15
Pacific Edge 2018 ASM Presentation
MARKETS
USA remains the primary focus
Slide 16
•Growing number of urologists
transitioning from User Programmes to
commercial customers
•Leverage CPT Codes and pricing set by
American Medical Association to negotiate
commercial agreements with insurers and
funders
•Continuing to seek the regulatory and
commercial agreements required to
operate effectively in the USA and ensure
timely reimbursement, particularly from
the Centersfor Medicare & Medicaid
Services and other large insurance
providers such as Kaiser Permanente.
VETERANS ADMINISTRATION AND TRICARE
Currently targeting 14 larger VA centres, early sales from two of
the initial five centres targeted. Gaining traction at a slower pace
than anticipated. User Programmes will be necessary to grow
adoption.
KAISER PERMANENTE
Continuing commercial discussions. Working with Kaiser’s staff on
necessary business elements to ensure that the start-up of
commercial tests can occur shortly after an agreement is reached.
CENTERS FOR MEDICARE AND MEDICAID (CMS)
Continuing to work through the process required to gain the LCD,
which will enable timely and consistent payments patients covered
by Medicare.
Pacific Edge 2018 ASM Presentation
PERFORMANCE IN LINE WITH PEERS
Cxbladder sales tracking well; in line with other leading molecular diagnostic companies in the US
Gaining coverage and reimbursement decisions
will be key to driving volume
ØSales of Cxbladder are currently in line with those of
Genomic Health’s Oncotype Dx and MDxHealth’s
ConfirmMDxat the time of their launch
ØContinuing to gain coverage and positive
reimbursement decisions will be crucial to help
accelerate test volume
ØGuideline inclusion has also served as a key catalyst
for sales volume and physician adoption for other
diagnostic peers
Te st Vo l u m e o f M o l e c u l a r D i a g n o st i c s C o m p a n i e s p o st l a u n c h
Genomic
Health
*Cxbladder Pacific Edge Year 3 estimate from October 2017 Forecast
Cxbladder is tracking
in line with other US
Mol Dx companies
Pacific Edge 2018 ASM Presentation
OTHER MARKETS
Slide 18
NEW ZEALAND
•Majority of NZ’s large DHBs now actively using Cxbladder
•Complete New Zealand rollout with aim to have all DHBs using
Cxbladder
AUSTRALIA
•Disappointing uptake to date. Working with distribution partner to
drive trial and adoption
SINGAPORE
•Four key hospitals underway with User Programmes -complete
User Programmes and transition to commercial customers
•Work with Raffles Medical Group Singapore to encourage use and
build sales
Pacific Edge 2018 ASM Presentation
OUTLOOK
FY19 Revenue Uplift Expected In Line With Annual Trends
ØCommercial growth in USA remains paramount
ØFocus on growing the number of large institutional healthcare accounts including Kaiser
Permanente
ØAttain inclusion in LCD for CMS patients, which make up 60% of current commercial
sales. This will ensure cash uplift and timely reimbursement from CMS
ØContinuing uplift in commercial sales expected from existing and new customers
ØBuild on initial sales from targeted VA centres and expand number of centres being
targeted
ØContinue to build on the library of papers in peer reviewed clinical journals, that
demonstrate the clinical utility and validity of our products
ØGiven the adoption of the new reporting standard and the longer time than anticipated
to finalise commercial agreements with Kaiser and attain inclusion in the LCD for CMS
patients, the company expects to provide updated guidance for FY19 later in the
calendar year.
Slide 19
SHAREHOLDER DISCUSSION
BUSINESS OF THE MEETING
Pacific Edge 2018 ASM Presentation
RESOLUTIONS
RESOLUTION 1: That Anatole Masfen, who retires by rotation and is eligible for re-election, be re-elected as a
Director of the Company
RESOLUTION 2: 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
RESOLUTION 3: That pursuant to clause 25 of the Company’s Constitution and NZX Main Board Listing Rule
3.5.1, the maximum aggregate amount payable to non-executive Directors be increased to $302,000 per
annum (9.8% increase).
Slide 22
Pacific Edge 2018 ASM Presentation
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 Anatole Masfen96.85%1.93%1.22%202,181,22742.61%
2Authorisationto fix the auditors’
remuneration
98.64%0.16%1.20%202,299,55542.63%
3Increase in aggregate directors’ fees to
$302,000 per annum (9.8% increase)
89.60%9.44%0.96%191,060,71340.26%
Voting instructions for those voting online are available at:
http://www.linkissuers.co.nz/VirtualAnnualMeeting/OnlinePortalGuide.pdf
Slide 23
OTHER BUSINESS
Pacific Edge 2018 ASM Presentation
www.pacificedge.co.nz
www.cxbladder.com
www.pacificedgedx.com
David Darling
Chief Executive Officer
Pacific Edge Limited
Tel: +64 3 479 5802 Mobile: +64 21 797981
Email: david.darling@pelnz.com
CLOSE OF THE MEETING
Presentations are available at www.pacificedgedx.com
Pacific Edge 2018 ASM Presentation
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 a general 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 Pacific Edge securities, and has been
prepared without taking into account the objectives, financial situation or needs of individuals. Pacific Edge, its directorsand 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
securities.
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.
Slide 26
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.
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