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PEB Investor Update – December 2019

Investor Presentation10 December 2019PEBHealthcare

UPDATE
EXECUTIVE UPDATE

David Darling, Chief Executive Officer

We were pleased to announce our FY20 half year results on

21 November 2019, reporting increased cash receipts, revenue

and laboratory throughput as our Cxbladder diagnostic tests are

adopted into guidelines in the USA and New Zealand and clinical

evidence publications continue to mount in favour of Cxbladder.

At the same time, we announced a fully underwritten capital raise

to assist Pacific Edge to progress its commercial objectives to

become cash flow positive as soon as possible. The $7 million

Placement has been completed and we were delighted with the

support we received from new and existing shareholders, both in

New Zealand and internationally. Many of these are experienced

investors in the global medtech sector and their support reflects

their confidence in our strategy and Pacific Edge’s future

prospects.

All shareholders have the opportunity to participate in the second

component of the capital raise, a fully underwritten, pro rata,

renounceable, 1 for 4.25 Rights Offer at 10 cents per share. The

Offer Document and Entitlement and Acceptance Form have

been sent to shareholders. To aid shareholders in understanding

our capital raising process, we have provided further commentary

on the Placement and Rights Issue on page 6 of this newsletter.

We are making good progress in our target markets of the USA,

New Zealand, Australia and South East Asia and we achieved a

number of important commercial achievements in the six-month

period. A summary of key milestones is on the next page, and

further detail can be read in the half year results announcement

on our website https://www.pacificedgedx.com/news-and-events/

news/2019/.

Our focus in the USA remains on gaining inclusion in the Local

Coverage Determination (LCD) for patients of the Centers for

Medicare and Medicaid Services (CMS) and accelerating the

commercial adoption of our suite of Cxbladder tests in all our

target markets.

A successful LCD decision, in combination with the recent

inclusion in guidelines in the USA and New Zealand, is expected

to result in strong increases in test adoption, revenue growth and

operating cash flow.

Pacific Edge

pro-rata 1 for 4.25

Renounceable Rights

Offer

REMINDER:


YOU HAVE UNTIL

5.00PM ON

WEDNESDAY

11 DECEMBER 2019

TO SUBSCRIBE FOR

NEW SHARES

Further details about

the Rights Issue

and the terms and

conditions of the issue

are set out in the

Offer Document and

associated application

form.

DECEMBER 2019

2
Total Laboratory Throughput Comparison

0

1,0 00

2,0 00

3,0 00

4,0 00

5,0 00

6,0 00

7,0 00

8,0 00

9,0 00

1H151H161H171H181H191H20

Half Year Comparison

Total Lab Thro ug hp utBillable Tests

0

2,0 00

4,0 00

6,0 00

8,0 00

10, 000

12, 000

14, 000

16, 000

FY15FY16FY17FY18FY191H20

Full Year Comparison

Total Lab Thro ug hp utBillable Tests

Total Laboratory Throughput Comparison

0

1,0 00

2,0 00

3,0 00

4,0 00

5,0 00

6,0 00

7,0 00

8,0 00

9,0 00

1H151H161H171H181H191H20

Half Year Comparison

Total Lab Thro ug hp utBillable Tests

0

2,0 00

4,0 00

6,0 00

8,0 00

10, 000

12, 000

14, 000

16, 000

FY15FY16FY17FY18FY191H20

Full Year Comparison

Total Lab Thro ug hp utBillable Tests

3

The annual addressable market for our suite

of Cxbladder products was estimated by EY

Parthenon as being US$1.2 billion

1

. We are

focused on completing agreements for the

adoption and commercial use of Cxbladder and

building sales from the large institutional accounts

and payers we are targeting in the USA, including

Kaiser Permanente, Johns Hopkins Medicine, the

Veterans Administration, Tricare, the CMS and

other blue-chip institutions.

Demand from public healthcare providers in New

Zealand is expected to continue to grow strongly

and positively impact commercial test throughput

volumes in the future, as remaining public

healthcare providers start commercial use at scale,

and those that have commenced, progress on to

using more than one of the Cxbladder suite of

products.

Further peer reviewed clinical papers of

Cxbladder’s performance are expected to be

published in key urology journals over the second

half of FY20, providing additional compelling

evidence supporting the clinical utility of

Cxbladder. The publication of these papers is

also expected to support Pacific Edge’s LCD

application with the CMS.

We continue to move ever closer to achieving

our commercial goals, particularly in the USA,

and steady progress is being made. Adoption of

Cxbladder is growing and commercial sales are

increasing.

We remain focused on further accelerating

the adoption of Cxbladder by large healthcare

organisations, both in New Zealand and

internationally, and growing our revenue. Gaining

inclusion in the LCD for CMS patients in the USA

remains our priority and we are working hard on

the successful execution of this next phase of our

global growth plan as we continue to progress our

objective of taking Cxbladder to the world.

HALF YEAR SNAPSHOT

For the six months to 30 September 2019

(compared to prior comparable period (pcp))

• Cash receipts from customers grew to $2.4m,

a 16% increase on pcp and a 37% increase on

2H19

• Operating revenue from test sales increased

12% to $2.3m, with total revenue for the

period of $2.7m

• Total laboratory throughput (which includes

commercial sales as well as tests from User

Programmes) grew 10%

• Total laboratory throughput for the

PEDNZ business (New Zealand, Australia

and Singapore), grew by 50%, driven by

continued strong demand from public

healthcare providers in New Zealand and User

Programmes in South East Asia

• Total billable tests grew to 6,573 tests,

an 8% increase

• Total operating expenses were $(12.1m),

a 6% increase

• Net operating cash outflow reduced to

$(7.4m), a 14% decrease

• Overall, the Company reported a net loss of

$9.4m for the half year period, an 8% increase

on pcp

• Pacific Edge had cash, cash equivalents and

short term deposits of $4.7m as at

30 September 2019

Summary of Key Commercial Milestones in the

Half Year Period

• Cxbladder inclusion in USA’s National

Comprehensive Cancer Network (NCCN)

2


guidelines as an approved intervention

for high risk patients being monitored for

recurrence of urothelial cancer (UC), further

validating Cxbladder and enabling increased

use by clinicians

• Continuing adoption and increasing test use

by New Zealand public healthcare providers

(DHBs), with increasing commercial use

expected to continue to positively impact

commercial test throughput growth in 2H20

• Publication of two further papers in peer-

reviewed journals, including the world’s

number one ranked urology journal

3

, adding

significant additional clinical utility evidence in

support of Cxbladder

• Updated dossier of clinical evidence accepted

for formal review by the CMS in the USA, as

part of process for inclusion in the LCD for

the USA market. A successful inclusion in the

LCD, combined with the recently announced

inclusion in the NCCN guidelines, is expected

to result in strong increases in test adoption,

revenue growth and operating cashflow

• Growing recognition and adoption by large

healthcare institutions in the USA, with a

growing number of very large and reputable

healthcare providers and academic centres

growing their commercial use of Cxbladder or

currently evaluating Cxbladder for commercial

use

• Continuing progress in South East Asia

with clinical trials with the five largest public

hospitals in Singapore nearing completion.

Published results from these will form

the basis for a proposed Singapore-wide

commercial programme

Further details on key milestones can be viewed

in the half year results announcement on our

website.

2

National Comprehensive Cancer Network (NCCN) guidelines provide urology guidelines for physicians treating and managing patients

with cancer and are reviewed annually. Cxbladder received inclusion in the July 2019 update to the NCCN guidelines.

3

European Urology is ranked world no. 1 in urology and is read by more than 20,000 physicians. Its Impact Factor is 17.581

1

EY-Parthenon business review of the annual addressable market opportunity for Cxbladder in the U.S. completed February 2018.

Full Year Comparison

Half Year Comparison

Total Laboratory Throughput Comparison

54
Validation from the New Zealand market continues

to grow, with more than 60% of New Zealand’s

population now covered by contracts with national

public healthcare providers (District Health Boards,

DHBs). This is expected to increase as we work closely

with the remaining public healthcare providers to

increase coverage.

The contribution from these providers is expected

to continue to positively impact commercial test

throughput in the second half of FY20.

The majority of the public healthcare providers in

New Zealand have now adopted Cxbladder into their

standard of care and in some instances, replaced the

gold standard cystoscopy in both the evaluation of

haematuria and in the monitoring for recurrence

of UC.

Many of the healthcare providers in Pacific Edge’s

other target markets of Australia, Singapore and

the USA have similar challenges to New Zealand’s

public healthcare providers, with increasing demand

for services, capacity limitations and constraints on

servicing time, all of which may impact negatively on

the patient.

Accordingly, healthcare providers in New Zealand

and internationally are continually looking for ways

to deliver better care, more efficiently and cost

effectively. The successful look-back audits that have

been published on Cxbladder by public healthcare

providers in New Zealand have been of particular

interest to other potential customers in our target

markets.

In May 2019, a paper published in the world number

one ranked urology journal, European Urology,

validated the use of Cxbladder to remove the global

diagnostic dilemma faced by physicians in treating

and managing patients with urothelial cancer.

This dilemma occurs on a surprisingly high number

of patients, when the existing gold standard tests

and procedures are not able to determine a clear

diagnostic outcome for the assessment of urothelial

cancer. This diagnostic dilemma leads to many

patients having to have further tests and procedures

many of which are invasive. Cxbladder solves this

dilemma.

In a video released on UroToday, two of the authors

of the paper, Dr Badrinath Konety and Dr Neal Shore,

provide an overview of the compelling evidence

and findings of this study and their conclusions and

recommendations.

or view on the UroToday website

www.urotoday.com under Bladder Cancer videos

Dr. Badrinath Konety MD, MBA serves as CEO of the

University of Minnesota Physicians as well as Vice Dean

for Clinical Affairs at the University of Minnesota Medical

School. He is also a professor in the Department of

Urology and Director of the Institute for Prostate and

Urologic Cancers.

Dr Neal Shore, MD, is the Medical Director of the

Carolina Urologic Research Center. He practices with

Atlantic Urology Clinics in Myrtle Beach, South Carolina.

Both Dr Konety and Dr Shore regularly use Cxbladder in

their medical practices.

Concluding statements from Dr Badrinath Konety:

• “Cxbladder is a, I would say, a next generation of

bladder markers, and we’ve been trying to develop

bladder markers to better identify bladder cancer

using urine specimens for the better part of three

or four decades now and each decade or two we

come up with the next generation.”

• [Cxbladder] has “been a brilliant technology that

we are going to be able to use, I use it quite a bit

in my practice based on specific indications.”

• “So the idea is, can we somehow figure out a

way to reduce all these unnecessary workup in

patients who are going to turn out to be negative

on that kind of a workup anyways. So this marker

Cxbladder in a nutshell, we think can really help...”

• “So in conclusion, Cxbladder clearly appears to

outperform urine cytology for identifying patients

with Urothelial Carcinoma overall, it missed fewer

cancers, only about 8% of cancers as opposed

to a much larger percentage with urine cytology.

It clearly adjudicated all the atypical cytology

patients and helps in patients with atypical

cytology, and equivocal cystoscopy.”

• “This really provides a strong argument for

using Cxbladder instead of cytology as the

accompanying test to a cystoscopy. This will

avoid the atypical cytology results and potentially

minimize the unnecessary workup in some of these

patients, particularly those undergoing hematuria

workup.”

• “I think there’s significant utility in using Cxbladder

in evaluation of patients both in the context of

hematuria, but also for surveillance of those who

have a prior history of urothelial carcinoma. This

would allow us to avoid unnecessary cystoscopies

potentially in about 35% of patients.”

• “The AUA guidelines on non-muscle invasive

bladder cancer do indicate that urinary markers

could potentially be of value in interpreting the

likelihood of cancer in patients with atypical

urine cytology, or in those who are undergoing

intravascular BCG therapy to assess response.

So that may be one potential setting in which

something like Cxbladder could be used in

adjudicating atypical reads on cytology or it could

also be used in place of cytology as a companion

to cystoscopy, to really help identify more of the

tumors and also decrease the false-negative rate.”

GROWING MOMENTUM IN NEW ZEALAND

CXBLADDER ADOPTED BY NEW ZEALAND’S PUBLIC HEALTHCARE PROVIDERS

COMPELLING EVIDENCE SUPPORTS CXBLADDER

UROTODAY VIDEO PRESENTATION

62% of New Zealand – that’s over

3 million people have access

to Cxbladder


CLICK HERE TO WATCH THE VIDEO NOW

Contract Cover of New Zealand’s

Population Using Cxbladder

76
By undertaking the capital raising in two

components - a Placement of new shares

and a Rights Issue for existing shareholders -

Pacific Edge has been able to raise significant

new capital to enable the company to achieve

its core objective to break-even as soon as

possible.

The Placement of new shares was structured

so as to introduce new investors to the register

and was at a price that was close to the market

price of the day. Despite the strong demand,

the Placement was limited to $7 million,

ensuring capacity for existing shareholders

wanting to participate in the Rights Issue

and minimising dilution. The Placement

was successfully completed and strongly

supported, with a number of new NZ and

international investors joining the company’s

share register.

The issue of a ‘Right’, is a right to buy a

share at a certain price at a future date. It

grants shareholders the right, but not the

obligation, to buy new shares. With the Rights,

a shareholder can purchase new shares at a

discount to the market price. Shareholders

may also trade their Rights on the market

the same way that they would trade ordinary

shares, enabling them to gain some value if

they decide not to take up their Rights and

participate in the capital raise.

Pacific Edge is offering existing shareholders

the ‘right’ to acquire new Pacific Edge shares

at 10 cents per share. This is a discount to the

Placement (which was at 15 cents per share).

If you decide to trade your rights, their value

is dependent on what another party (buyer)

is willing to pay for them. Assuming a market

share price of 15 cents per Pacific Edge share,

and a Rights price of 10 cents, it suggests that

trading of the Right could be expected to be

in the range up to 5 cents per Right.

In any capital raising where there is an

increase in the total number of the shares in

the market, then there could be a dilution

on existing shareholders. By taking up their

Rights, existing shareholders are able to

avoid unnecessary dilution. The Rights on

offer to each shareholder are proportional

to each shareholder’s current shareholding.

If you do not wish to participate in the

capital raising and take up your Rights, your

shareholding will be diluted due to the new

shares being issued to existing and new

shareholders. Pacific Edge has arranged

for a broker to sell the rights for ineligible

shareholders on a best efforts basis and

return any proceeds to those investors.

In conclusion, this capital raising process

gives existing shareholders the opportunity

to participate in the capital raising on more

favourable terms than those purchasing

new shares in the Placement. With the

Rights issue being ‘fully-underwritten’, it

guarantees that the company will achieve

the full $20 million in funds to enable it to

achieve its core objective to break-even as

soon as possible.

WHY A PLACEMENT AND A

RIGHTS ISSUE TO RAISE

$20 MILLION IN NEW CAPITAL?

WELCOME TO GRANT GIBSON,

CHIEF FINANCIAL OFFICER

Grant Gibson has been appointed as Pacific Edge’s

new Chief Financial Officer. Grant is an experienced

financial executive and chartered accountant, who

brings significant financial experience to the role.

Grant was most recently Chief Financial and Operating

Officer for Dunedin-based company, TracMap,

where he was responsible for leading the financial

management and operations across the company with

commercial subsidiaries in three international markets.

Prior to that, he worked in executive finance roles at

Westpac, including as Head of Finance for Westpac

New Zealand. He was the head of the finance team for

New Zealand’s largest financial transaction, the local

incorporation of Westpac New Zealand, a complex

and heavily regulated transaction involving billions of

dollars.

Grant replaces Kate Rankin who has been Chief

Financial Officer over the past five years and has made

a significant contribution to our company.

INTRODUCING OUR TEAM

STAY IN TOUCH

ENEWS

We encourage our shareholders to sign up

to receive email notification of news and

announcements from Pacific Edge.

Sign up here or visit the Investor Centre on our

website www.pacificedgedx.com.

UPCOMING KEY DATES

FY20 Financial Year End: 31 March 2020

FY20 Results Announcement: By end-May 2020

FOLLOW US

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twitter.com/Cxbladder

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bladdercancer.me

CONTACT US

87 St David Street

PO Box 56, Dunedin, New Zealand

T +64 3 479 5800

enquiries@pelnz.com | pacificedgedx.com

PACIFIC EDGE IS HONOURED
TO HAVE BEEN ANNOUNCED

AS THE WINNER OF THE

EXCELLENCE IN INNOVATION

AWARD 2019

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.