PEB Investor Update – December 2019
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
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Total Laboratory Throughput Comparison
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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
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Sign up here or visit the Investor Centre on our
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UPCOMING KEY DATES
FY20 Financial Year End: 31 March 2020
FY20 Results Announcement: By end-May 2020
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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.