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Pacific Edge 2018 Annual Meeting of Shareholders

AGM16 August 2018PEBHealthcare

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


Page 3 of 14

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.


Page 10 of 14


• 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.


Page 13 of 14

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.


Page 14 of 14

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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