Pacific Edge FY20 Interim Results and Capital Raising
Company Announcement
21 November 2019
1
PACIFIC EDGE FY20 INTERIM RESULTS AND CAPITAL RAISING
Results Snapshot for the six months to 30 September 2019 (compared to prior comparable period (pcp))
Lift in laboratory throughput, commercial test revenue and cash receipts:
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 to 8,147 tests, a 10% increase.
Total laboratory throughput for the PEDNZ business (New Zealand, Australia and Singapore), grew to
1,896 tests, a 50% increase, 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.
Pacific Edge has today announced a fully underwritten capital raising of approximately $20 million via an
initial placement and subsequent 1 for 4.25 pro-rata renounceable rights offer, to assist the Company to
progress its commercial objectives and become cash flow positive as soon as possible. The capital raise is
fully underwritten by Forsyth Barr Group Limited and Jarden Partners Limited.
Summary of Key Commercial Milestones in the Half Year Period:
Cxbladder inclusion in USA’s National Comprehensive Cancer Network (NCCN)
1
guidelines as an approved
intervention for 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 urology
journal, adding significant additional clinical utility evidence in support of Cxbladder.
Updated dossier of clinical evidence accepted for formal review by the Centers for Medicare and
Medicaid Services (CMS) in the USA, as part of process for inclusion in the Local Coverage Determination
(LCD) for the USA market. A successful inclusion in the LCD, combined with the recently announced
inclusion in the NCCN guidelines, is expected to be transformational to test adoption, revenue growth
and operating cashflow.
1
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.
Company Announcement
21 November 2019
2
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 on pages 4 to 6 of this announcement.
Commercial Progress:
Cancer diagnostics company, Pacific Edge Limited (NZX: PEB) (Pacific Edge or the Company) is reporting increased
cash receipts, revenue and laboratory throughput for the first half of the 2020 financial year (1H20) as its
Cxbladder diagnostic tests are adopted into guidelines in the USA and New Zealand, with further endorsement of
performance in published clinical papers.
The Company is making good progress in its target markets of the USA, New Zealand, Australia and South East
Asia, with a number of important commercial achievements in the six-month period. The focus remains on
gaining inclusion in the LCD for CMS patients in the USA and accelerating the commercial adoption of the suite of
Cxbladder tests in all of the Company’s target markets. A successful LCD inclusion decision, in combination with
the recent inclusion in guidelines in New Zealand and the USA, is expected to result in strong increases in test
adoption, revenue growth and operating cash flow.
The annual addressable market for the suite of Cxbladder products was estimated by EY Parthenon
2
as being
US$1.2 billion. Management is focused on completing agreements for the adoption and commercial use of
Cxbladder and building sales from the large institutional accounts and payers Pacific Edge is 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.
Additional peer reviewed papers 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.
CEO of Pacific Edge, David Darling, commented: “Pacific Edge continues to move ever closer to achieving its
commercial goals, particularly in the USA, and significant 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
2
EY Parthenon review of Cxbladder products and commercial strategy in 2018
Company Announcement
21 November 2019
3
successful execution of this next phase of our global growth plan as we continue to progress our objective of
taking Cxbladder to the world.”
Chairman Chris Gallaher said: “The Board remain committed to the Company’s strategy and to achieving the key
milestone of cash flow breakeven. The management team have achieved a number of important outcomes over
1H20, maintaining our momentum and moving us closer towards attaining our commercial goals. The Board’s
focus remains on cash and cash management and ensuring the resources and capital are in place for Pacific Edge
to realise its potential. As such, today we have announced a capital raise consisting of a placement and
renounceable rights issue to shareholders.”
Capital Raising
Pacific Edge has today announced a capital raising of $20 million via an up-front placement and subsequent 1 for
4.25 pro-rata renounceable rights offer, to assist the Company to progress its commercial objectives and become
cash flow positive as soon as possible. The capital raising is fully underwritten by Forsyth Barr Group Limited and
Jarden Partners Limited.
Pacific Edge intends to undertake a placement of new shares at $0.15 per share to raise up to approximately $7
million. The placement will occur today while Pacific Edge is in trading halt, with participants expected to include
a range of institutional and wholesale investors from New Zealand and internationally.
Following completion of the placement, a rights offer of approximately $13.1 million will allow eligible
shareholders to subscribe for 1 additional share for each 4.25 existing shares held on the record date at $0.10 per
share. This represents a 34.0% discount to the theoretical ex-rights price and placement adjusted price of $0.152,
based off last close of NZ$0.165 as at 20 November 2019.
The full terms and conditions of the rights issue will be contained in an offer document which will be distributed
to all eligible shareholders (as defined in the offer document) after the proposed record date.
Rights Issue Timetable
Shares quoted "ex-rights" and rights trading commence: 28 November 2019
Record date for rights issue: 29 November 2019
Offer document and entitlement and acceptance forms sent to eligible shareholders: 2 December 2019
Rights trading cease: 5 December 2019
Rights offer closes: 11 December 2019
Settlement and allotment of rights offer shares: 18 December 2019
All dates and times are indicative only and subject to change.
Company Announcement
21 November 2019
4
ACHIEVEMENT OF KEY MILESTONES:
Cxbladder included in the USA’s NCCN guidelines as an approved intervention for patients being monitored for
recurrence of urothelial cancer.
Inclusion in guidelines underpins adoption and empowers physicians to use Cxbladder in the management of
patients. It provides validation of the clinical evidence for Cxbladder and enables physicians to use Cxbladder
more extensively, as many healthcare providers are not able to fully use Cxbladder without coverage in
guidelines. Inclusion most commonly occurs after significant adoption by physicians and, therefore, most often
occurs after inclusion in the Local Coverage Determination (LCD), a driver of test adoption. The inclusion of
Cxbladder in the July 2019 NCCN guidelines as an approved clinical intervention for high risk patients being
monitored for recurrence of urothelial cancer, is ahead of the Company’s expectations and is expected to have a
positive impact on test sales growth in the USA.
Continuing adoption and increasing test use by New Zealand public healthcare providers (DHBs).
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. This is expected to increase as the Company
works 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, replacing the gold standard cystoscopy in both the evaluation of haematuria
3
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 are continually looking for ways to deliver better care, more efficiently and cost effectively
and the successful healthcare provider look-back audits are of particular interest to these parties.
Further publications of Cxbladder clinical utility performance in peer-reviewed journals adds significant
additional evidence supporting reimbursement of Cxbladder.
Peer reviewed publications are the trading currency of the med-tech world and underpin adoption of any new
technology. These peer reviewed publications provide the clinical evidence that drives the successful inclusion in
guidelines and positive coverage decisions for reimbursement.
In May 2019, a Cxbladder performance paper published in European Urology, the world’s number one ranked
Urology Journal, provided further compelling evidence validating the performance of Cxbladder in evaluating
patients who have an inconclusive diagnosis for UC following cystoscopy and cytology. This is a significant
milestone as less than 10% of the more than 2,000 annual urology papers submitted to this journal meet peer
3
Haematuria is blood in the urine and is a symptom of bladder cancer requiring patients to be evaluated for the presence of urothelial
cancer
Company Announcement
21 November 2019
5
review and are published. Key conclusions showed that Cxbladder does what existing urological technology
cannot currently do, correctly adjudicating atypical cytologies and equivocal cystoscopies and also accurately
ruling out 35% of patients who do not have cancer and thereby avoiding unnecessary invasive procedures.
In June 2019, public healthcare provider Canterbury District Health Board (CDHB) published a real-world clinical
audit, highlighting a significant increase in clinical utility evidence and cementing the adoption of Cxbladder into
the new clinical pathway for the assessment of haematuria in New Zealand. This independent, real-world
evidence publication highlighted the benefits of using Cxbladder in conjunction with imaging for the initial
assessment of all patients that present to the clinic with haematuria for investigation for bladder cancer, giving
rise to the new clinical guidelines. The results showed that this new clinical guideline would result in
approximately one third of patients avoiding the need for invasive and expensive cystoscopy procedures.
Whereas previously these patients would have received a full clinical work-up, they will now be managed within
primary care and will not be referred through to secondary care, delivering positive outcomes for both the
patient and the healthcare provider.
The cumulative and extensive clinical evidence in the peer reviewed publications on Cxbladder, in conjunction
with successful healthcare provider look-back audits, demonstrates significant increases in clinical utility from the
adoption and deployment of Cxbladder for both the patient and the healthcare provider. This is expected to
result in further positive reimbursement outcomes.
Presentations of this clinical evidence at international conferences and workshops by key opinion leader (KOL)
urologists are an important component in building awareness of Cxbladder. A growing number of these KOL
events have been held with international and New Zealand urologists sharing their positive experience of the
adoption of Cxbladder with their global peers.
Updated dossier of clinical evidence accepted for formal review by the CMS, as part of process for inclusion in
the Local Coverage Determination (LCD) for the USA market.
Gaining inclusion in the LCD, which would enable reimbursement from the CMS in the USA, remains a priority
focus for Pacific Edge. Clinical evidence is the critical component for consideration for inclusion in the LCD, and an
updated dossier of clinical evidence was submitted and accepted for review by the CMS in August 2019.
The CMS currently accounts for approximately 47% of the Company’s total annual laboratory throughput in the
USA. As at 30 September 2019, Pacific Edge had completed and invoiced a total of 19,361 tests for CMS patients,
which are yet to be reimbursed. A successful inclusion in the CMS’s LCD is expected to provide a number of
commercial benefits including a significant acceleration in test adoption and revenue growth, receipt of payment
for future tests performed on CMS patients, improved cash collection time for private insurance payers and the
opportunity to negotiate a retrospective payment for invoiced tests previously carried out on CMS patients that
currently exceed 19,000 tests.
Growing recognition and adoption by large healthcare institutions in the USA.
Pacific Edge is building on the success achieved with large healthcare providers in New Zealand as it continues to
roll out its growth strategy in the USA, with increasing engagement from large institutional healthcare providers
that have the potential to be scale users of Cxbladder.
Company Announcement
21 November 2019
6
The USA remains the primary commercial opportunity for Pacific Edge, with a growing number of very large and
reputable healthcare providers and academic centres such as Johns Hopkins Medicine, Cleveland Clinic and
Mount Sinai Hospital growing their commercial use of Cxbladder. An additional 15 healthcare institutions are also
currently evaluating Cxbladder for commercial use. Many of these organisations individually, are bigger than any
one of New Zealand’s public healthcare providers.
Continuing progress in South East Asia.
South East Asia (SEA) has been identified as a significant potential market for Cxbladder. The population of SEA is
more than double the size of the population of the USA and therefore presents a large target addressable market
for Cxbladder going forward. Pacific Edge has its beachhead for SEA in Singapore and clinical trials with the five
largest public hospitals in Singapore are nearing completion. The Company expects to publish the results from
these clinical trials in the coming months and they will form the basis for a proposed Singapore-wide commercial
programme. The focus remains on transitioning these hospitals to commercial customers and growing the
adoption of Cxbladder with other large healthcare organisations in the region. In Australia, Pacific Edge has taken
over the sales and distribution of Cxbladder, building on the successful practices developed in the New Zealand
market.
ENDS
For more information contact:
David Darling
Chief Executive Officer
Pacific Edge Ltd
P: +64 (3) 479 5800
OVERVIEW www.pacificedge.co.nz www.pacificedgedx.com
Pacific Edge Limited (NZX: PEB) is a New Zealand publicly listed, cancer diagnostic company specialising in the discovery and
commercialisation of diagnostic and prognostic tests for better detection and management of cancer. Its Cxbladder suite of
non-invasive, simple to use and accurate diagnostic tests provide actionable results, and better detection and management
of urothelial cancer. The Company is developing and commercialising its range of Cxbladder bladder cancer tests globally
through its wholly owned central laboratories in New Zealand and the USA. The Company’s products have been tested and
validated in international multi-centre clinical studies.
ABOUT Cxbladder Triage www.cxbladder.com
Cxbladder Triage combines the power of the genomic biomarkers with additional phenotypic and clinical risk factors to
accurately identify patients with haematuria who have a low probability of bladder cancer and may not require a more
extensive urological evaluation. Cxbladder Triage is a tool for use by clinicians and physicians in primary evaluation of
patients
with haematuria and is intended to reduce the need for an expensive and invasive work-up in patients who have a low
probability of having urothelial carcinoma.
ABOUT Cxbladder Detect www.cxbladder.com
Cxbladder Detect enables the non-invasive detection of bladder and other urinary tract cancers from a small volume of a
patients’ urine. Cxbladder Detect provides clinicians with a quick, cost effective and accurate measure of the presence of the
cancer as an effective adjunct to cystoscopy.
ABOUT Cxbladder Monitor www.cxbladder.com
Company Announcement
21 November 2019
7
Cxbladder Monitor allows urologists to monitor bladder cancer patients for recurrence of the disease. Bladder cancer has a
recurrence rate of 50-80% and requires life-long surveillance. Cxbladder Monitor accurately identifies patients with a prior
history of urothelial cancer whose Cxbladder Monitor score shows that they have a low probability of recurrent urothelial
carcinoma. Cxbladder Monitor is designed to be used as the preferred adjunct test to cystoscopy in the management of
patients for ongoing evaluation of recurrent bladder cancer.
ABOUT Cxbladder Resolve www.cxbladder.com
Cxbladder Resolve identifies those patients who are likely to have aggressive or more advanced bladder cancer. Cxbladder
Resolve, when used as part of the primary evaluation of haematuria and/or in conjunction with other Cxbladder tests (Triage,
Detect), is designed to assist clinicians by accurately identifying patients with a high probability of having high grade or late
stage bladder cancer, for whom alternative or expedited treatment options may be warranted, or who can be prioritised for
further investigation in high throughput settings.
Refer to www.cxbladder.com for more information.
---
INTERIM
FINANCIAL
STATEMENTS
FOR THE SIX MONTHS
ENDED 30 SEPTEMBER 2019
PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019
Note: These Statements are to be read in conjunction with the Notes to the Financial Statements.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2019
STATEMENT OF COMPREHENSIVE INCOME
NOTES
UNAUDITED
SEPT 2019
6 MONTHS
($000)
UNAUDITED
SEPT 2018
6 MONTHS
($000)
AUDITED
MARCH 2019
12 MONTHS
($000)
REVENUE
Operating Revenue 52,2852,033 3,817
Total Operating Revenue 2,2852,033 3,817
Other Income5282442 990
Interest Income115169 323
Foreign Exchange Gain/(Loss)19(5)(1)
Total Revenue and Other Income 2,7012,639 5,129
OPERATING EXPENSES
Laboratory Operations2,6562,356 4,594
Research1,9741,666 3,532
Sales and Marketing4,1024,434 8,236
General and Administration3,3582,902 6,676
Total Operating Expenses612,09011,358 23,038
NET (LOSS) BEFORE TAX(9,389)(8,719)(17,909)
Income Tax Expense--9
(LOSS) FOR THE YEAR AFTER TAX (9,389) (8,719) (17,918)
Items that may be reclassified to profit or loss:
Translation of Foreign Operations(17)1(3)
TOTAL COMPREHENSIVE (LOSS) atttributable
to equity holders of the Company
(9,406)(8,718)(17,921)
Earnings per share for profit attributable to the
equity holders of the Company during the year
Basic and Diluted Earnings per share(0.018)(0.019)(0.037)
Interim Financial Statements
Statement of Comprehensive Income 3
Statement of Changes in Equity 4
Balance Sheet 6
Statement of Cash Flows 7
Notes to the Financial Statements
1. Summary of Accounting Policies 8
2. Going Concern 10
3. Investment and Advances in Subsidiaries 11
4. Dividends 11
5. Revenue and Other Income 11
6. Operating Expenses 12
7. Segment Information 13
8. Share Capital 17
9. Leases 17
10. Reconciliation of Cash used from Operating
Activities with Operating Net Loss 20
11. Contingent Liabilities 20
12. Capital Commitments 20
13. Subsequent Event 20
3 2
PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019
Note: These Statements are to be read in conjunction with the Notes to the Financial Statements.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2019
STATEMENT OF CHANGES IN EQUITY
NOTES
SHARE
CAPITAL
RETAINED
EARNINGS
SHARE BASED
PAYMENTS
RESERVE
FOREIGN CURRENCY
TRANSLATION
RESERVE
TOTAL
EQUITY
($000)($000)($000)($000)($000)
UNAUDITED 6 MONTHS TO 30 SEPT 2018
Balance as at 31 March 2018 131,824 (120,119) 4,055 880 16,640
(Loss) After Tax- (8,719)- - (8,719)
Other Comprehensive Income- - - 1 1
TOTAL COMPREHENSIVE (LOSS) atttributable to equity holders of the Company- (8,719)- 1 (8,718)
Transations with owners in their capacity as owners:
Issue of Share Capital (net of expenses)82,600 - -- 2,600
Exercising of Employee Share Options888 - -- 88
Share Based Payment - Employee Share Options- - 284 - 284
Balance as at 30 September 2018 134,512 (128,838) 4,339 881 10,894
UNAUDITED 6 MONTHS TO 30 SEPT 2019
Balance as at 31 March 2019 146,403 (137,877) 4,507 877 13,910
(Loss) After Tax- (9,389)- - (9,389)
Other Comprehensive Income- - - (17) (17)
TOTAL COMPREHENSIVE (LOSS) atttributable to equity holders of the Company- (9,389)- (17) (9,406)
Transations with owners in their capacity as owners:
Share Based Payments - Employee Remuneration8112 - -- 112
Share Based Payment - Employee Share Options- 435 (115) - 320
Balance as at 30 September 2019 146,515 (146,831) 4,392 860 4,936
AUDITED 12 MONTHS TO 31 MARCH 2019
Balance as at 31 March 2018131,824 (120,119)4,055 880 16,640
(Loss) After Tax- (17,918)- - (17,918)
Other Comprehensive Income- - - (3)(3)
TOTAL COMPREHENSIVE (LOSS) atttributable to equity holders of the Company- (17,918)- (3)(17,921)
Transations with owners in their capacity as owners:
Issue of Share Capital814,391 - - - 14,391
Share Based Payments - Employee Remuneration8188 188
Share Based Payment - Employee Share Options- -612- 612
Share Based Payment - Employee Share Options Expired- 160 (160)- -
Balance as at 31 March 2019146,403 (137,877)4,507 877 13,910
5 4
PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019
Note: These Statements are to be read in conjunction with the Notes to the Financial Statements.
For and on behalf of the Board of DirectorsDirector Director
Dated 21st day of November 2019
AS AT 30 SEPTEMBER 2019
BALANCE SHEET
NOTES
UNAUDITED
SEPT 2019
6 MONTHS
UNAUDITED
SEPT 2018
6 MONTHS
AUDITED
MARCH 2019
12 MONTHS
($000)($000)($000)
CURRENT ASSETS
Cash and Cash Equivalents 2,737 4,560 4,847
Short Term Deposits 2,000 5,500 8,000
Receivables 952 836 1,265
Inventory 828 846 842
Other Assets 923 912 610
Total Current Assets 7,440 12,654 15,564
NON-CURRENT ASSETS
Property, Plant and Equipment 661 876 769
Right of Use Assets91,500--
Intangible Assets 208 273 233
Total Non-Current Assets 2,369 1,149 1,002
TOTAL ASSETS 9,809 13,803 16,566
CURRENT LIABILITIES
Payables and Accruals 3,372 2,771 2,572
Lease Liabilities9 1,149 90 52
Total Current Liabilities 4,521 2,861 2,624
NON-CURRENT LIABILITIES
Lease Liabilities9 352 48 32
Total Non-Current Liabilities 352 48 32
TOTAL LIABILITIES 4,873 2,909 2,656
NET ASSETS 4,936 10,894 13,910
Represented by:
EQUITY
Share Capital8 146,515 134,512 146,403
Accumulated Losses (146,831) (128,838) (137,877)
Share Based Payments Reserve 4,392 4,339 4,507
Foreign Translation Reserve 860 881 877
TOTAL EQUITY 4,936 10,894 13,910
FURTHER INFORMATION:
Return on Assets (%)(96%)(63%)(108%)
Return on Equity (%)(191%)(80%)(129%)
Debt to Equity Ratio (%)99%27%19%
Net Tangible Assets Per Share ($) 0.009 0.022 0.027
Note: These Statements are to be read in conjunction with the Notes to the Financial Statements.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2019
STATEMENT OF CASH FLOWS
NOTES
UNAUDITED
SEPT 2019
6 MONTHS
UNAUDITED
SEPT 2018
6 MONTHS
AUDITED
MARCH 2019
12 MONTHS
($000)($000)($000)
CASH FLOWS TO OPERATING ACTIVITIES
Cash was provided from:
Receipts from Customers 2,350 2,026 3,734
Receipts from Grant Providers 641 663 755
Interest Received 161 250 376
3,152 2,939 4,865
Cash was disbursed to:
Payments to Suppliers and Employees 10,511 11,610 22,431
Net GST cash outflow (inflow)46 (59) (59)
10,557 11,551 22,372
Net Cash Flows To Operating Activities10 (7,405) (8,612) (17,507)
CASH FLOWS FROM/(TO) INVESTING ACTIVITIES:
Cash was provided from:
Proceeds from Short Term Deposits 8,000 5,500 11,000
8,000 5,500 11,000
Cash was disbursed to:
Purchase of Short Term Deposits2,000 - 8,000
Capital Expenditure on Plant and Equipment 41 19 50
Capital Expenditure on Intangible Assets 30 71 106
2,071 90 8,156
Net Cash Flows From/(To) Investing Activities 5,929 5,410 2,844
CASH FLOWS (TO)/FROM FINANCING ACTIVITIES:
Cash was received from:
Ordinary Shares Issued8- 2,623 14,569
- 2,623 14,569
Cash was disbursed to:
Repayment of Finance Leases9 609 43 97
Issue Expenses8 3 23 178
612 66 275
Net Cash Flows (To)/From Financing Activities(612) 2,557 14,294
Net (Decrease) in Cash Held (2,088) (645) (369)
Add Opening Cash Brought Forward 4,847 5,242 5,242
Effect of Exchange Rate Changes on Net Cash (22) (37) (26)
Ending Cash Carried Forward 2,737 4,560 4,847
7 6
PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2019
NOTES TO THE FINANCIAL STATEMENTS
1 . SUMMARY OF ACCOUNTING POLICIES
The unaudited interim financial statements (“Interim Financial Statements”) presented are
those of Pacific Edge Limited (“Company”) and its subsidiaries (“Group”). The Company is
registered and domiciled in New Zealand for the purpose of developing and commercialising
new diagnostic and prognostic tools for the early detection and management of cancers.
Pacific Edge Diagnostics New Zealand Limited and Pacific Edge Diagnostics USA Limited
manage and operate the laboratories used for processing Cxbladder tests. Pacific Edge Pty
Limited’s purpose is to research and develop the Cxbladder product and other prognostic
tools. Pacific Edge Diagnostics Singapore Pte Limited sells and markets bladder cancer
products and assists with research and development and Pacific Edge Analytical Services
Limited is a service entity.
The Company is a for profit entity, registered in New Zealand under the Companies Act
1993 and is a reporting entity for the purposes of the Financial Markets Conduct Act 2013.
The Company is listed with NZX Limited with its ordinary shares quoted on the NZX Main
Board.
Basis of Preparation
The Interim Financial Statements for the six months ended 30 September 2019 have been
prepared in accordance with the requirements of the NZX Listing Rules.
The Interim Financial Statements have been prepared in accordance with New Zealand
Generally Accepted Accounting Practice (NZ GAAP) and comply with NZ IAS 34 - Interim
Financial Reporting. In complying with NZ IAS 34, these consolidated Interim Financial
Statements also comply with IAS 34 - Interim Financial Reporting and should be read in
conjunction with the Company’s 2019 Annual Report. The Interim Financial Statements
for the six months ended 30 September 2019 are unaudited. Comparative balances for 30
September 2018 are unaudited, whilst the comparative balances for 31 March 2019 are
audited.
The Interim Financial Statements are prepared on the basis of historical cost, except where
otherwise identified. The presentational currency used in the preparation of the financial
statements is New Zealand dollars and all values are rounded to the nearest thousand dollars
($000).
Accounting Policies
All significant accounting policies have been applied on a basis consistent with those used in
the audited financial statements of Pacific Edge Limited for the year ended 31 March 2019
except for the adoption of NZ IFRS 16 which has impacted the accounting for leases. Pacific
Edge Limited adopted NZ IFRS 16 on its effective date 1 April 2019. In accordance with the
modified restrospective adoption of this standard, the prior period comparative has not been
restated. Further details of the impact of this accounting standard are detailed in Note 9.
Authorisation
The Interim Financial Statements were authorised by the Board of Directors on 21 November
2019. The annual financial statements for the year ended 31 March 2019 were authorised by
the Board of Directors on 29 May 2019.
Audit
The Interim Financial Statements have not been audited. The comparative full year financial
results for the year ended 31 March 2019 have been audited.
Basis of Consolidation
The following entities and the basis of their inclusion for consolidation in these Interim
Financial Statements are as follows:
Ownership Interests
& Voting Rights
Name of Subsidiary
Place of
Incorporation
(or registration)
and Operation
Principal Activity
30 Sept
2019
(%)
30 Sept
2018
(%)
Pacific Edge Diagnostics
New Zealand Limited
New Zealand
Commercial Laboratory
Operation
100100
Pacific Edge Pty LimitedAustralia
Biotechnology Research
& Development
100100
Pacific Edge Diagnostics
USA Limited
USA
Commercial Laboratory
Operation
100100
Pacific Edge Diagnostics
Singapore Pte Limited
Singapore
Biotechnology Research
& Development
100100
Pacific Edge Analytical
Services Limited
New Zealand
Diagnostic
Biocomputational
Services
100100
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2019
NOTES TO THE FINANCIAL STATEMENTS
9 8
PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019
2. GOING CONCERN
The Interim Financial Statements have been prepared on the going concern basis which
assumes that the Company and Group will have sufficient cash to pay its debts as they fall
due for a minimum of 12 months from the signing of the Interim Financial Statements.
As at 30 September 2019, the Company and Group had $4.737m of cash, cash
equivalents and short term deposits on hand (2018: $10.060m). The Company and
Group expects to raise approximately $20m, either through its capital raise, or in
reliance on the associated underwrite, through the capital raise activity outlined
in Note 13. The Company and Group had net assets of $4.936m (2018: $10.894m) at
30 September 2019 and cash receipts totalling $3.152m were received in the six month
period to 30 September 2019 (2018: $2.939m). Net cash out flows from operating activities
for the six month period to 30 September 2019 were $7.405m (2018: $8.612m).
While the Company and Group continues to incur operating losses, the Company and Group
remains solvent and continues to pay its debts as they fall due. The Company and Group
continues to progress commercial negotiations with targeted large scale health organisations
in the USA and whilst these negotiations are taking longer than expected to complete,
the Company and Group continues to make good progress with these negotiations. The
new contracts that will result from these commercial negotiations are expected to have a
significant positive impact on the Company’s and Group’s financial position once they are
concluded.
The Company and Group has prepared cash flow forecasts which indicate that if these
commercial negotiations continue to be delayed and the Company and Group is not able to
raise the capital discussed in Note 13, the Company and Group may not have sufficient cash
to meet its minimum expenditure commitments and support its current levels of activity.
The Company and Group may therefore need to raise additional funds to continue as a
going concern. This indicates that there is a material uncertainty as at 30 September 2019
that may cast significant doubt on the Company’s and Group’s ability to continue as a going
concern and, therefore, that it may be unable to realise its assets and discharge its liabilities
in the normal course of business.
To address the future additional funding requirements of the Company and Group, the
Directors have:
- Entered into discussions to secure additional equity funding from current or new
shareholders,
- Continued to monitor the Company’s and Group’s ongoing working capital
requirements and minimum expenditure commitments, and
- Continued to focus on maintaining an appropriate level of expenditure to support
business growth in line with the Company’s and Group’s available cash resources.
The Directors are confident that they will be able to obtain additional equity funding to
enable the Company and Group to meet its minimum expenditure requirements and support
its planned level of expenditure.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2019
NOTES TO THE FINANCIAL STATEMENTS
3. INVESTMENT AND ADVANCES IN SUBSIDIARIES
The consolidated Interim Financial Statements incorporate the assets and liabilities and
results of Pacific Edge Diagnostics New Zealand Limited, Pacific Edge Diagnostics USA
Limited, Pacific Edge Diagnostics Singapore Pte Limited, Pacific Edge Analytical Services
Limited and Pacific Edge Pty Limited, all of which are 100% owned by the Company.
Subsidiaries have a 31 March balance date. The investments in and advances to subsidiaries
are eliminated on consolidation in the Group financial statements.
4. DIVIDENDS
The Company does not propose to pay dividends to shareholders similar to previous years.
This policy continues.
5. REVENUE AND OTHER INCOME
Unaudited
Sept 2019
6 Months
($000)
Unaudited
Sept 2018
6 Months
($000)
Audited
March 2019
12 Months
($000)
Cxbladder Sales
- US 1,984 1,837 3,296
- Rest of World 301 196 521
Total Operating Revenue 2,285 2,033 3,817
Other Income
Grant Income49 352 773
Research Rebate Received 233 90 217
Total Other Income 282 442 990
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2019
NOTES TO THE FINANCIAL STATEMENTS
11 10
PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019
6. OPERATING EXPENSES
The note below highlights total expenses shown within total operating expenses. These
items are then split across functions; laboratory operations, research, sales and marketing
and general and administration as reported in the Annual Report.
Notes
Unaudited
Sept 2019
6 Months
($000)
Unaudited
Sept 2018
6 Months
($000)
Audited
March 2019
12 Months
($000)
Operating Expenses
Amortisation58 79 154
Auditors Remuneration
- Group year end financial statements73 118 167
- Half year financial statements review
report to Directors
21 - 21
- R&D review of Callaghan Innovation4 3 3
- Foreign statutory financial statements-- 9
Depreciation79 116 237
Depreciation on Right of Use Assets9571 - -
Directors Fees169 136 279
Employee Benefits5,558 5,184 10,708
Employee Share Scheme Expenses115 88 188
Employee Share Options318 284 612
Interest on Lease Liabilities948 - 7
Rental and Lease Expense*20 594 1,128
Other Operating Expenses5,056 4,756 9,525
Total Operating Expenses12,090 11,358 23,038
*Due to the adoption of NZ IFRS 16, this now only includes short term, low value and variable lease
payments. The remaining payments are now represented by depreciation on right of use assets
and interest on lease liabilities.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2019
NOTES TO THE FINANCIAL STATEMENTS
Employee Share Options
Employee Share Options are a non-cash expense. Refer to Note 10 of the 2019 Annual
Report for details of the accounting policy for Employee Share Schemes.
Employee Share Scheme Expenses
Employee Share Scheme Expenses are a non-cash expense. These relate to shares issued to
employees in lieu of cash bonuses.
Other Operating Expenses
The major categories of expenditure which make up operating expenses, but are not
disclosed separately above, are Laboratory costs, Information Technology costs, Compliance
and Regulatory costs, NZX and Registry fees, Investor Relations costs, Consultants and
Contractors.
7. SEGMENT INFORMATION
Operating segments are reported in a manner consistent with the internal reporting
provided to the chief operating decision-maker. The chief operating decision-maker, who is
responsible for allocating resources and assessing performance of the operating segments,
has been identified as the Chief Executive Officer who makes strategic decisions.
There are two operating segments at balance date:
1. Commercial: The sales, marketing, laboratory and support operations to run the
commercial businesses worldwide
2. Research: The research and development of diagnostic and prognostic products for
human cancer.
The reportable operating segment Commercial derives its revenue primarily from sales
of Cxbladder tests and the reportable operating segment Research derives its revenue
primarily from grant income. The Chief Executive Officer assesses the performance of the
operating segments based on net (loss) for the period.
Segment income, expenses and profitability are presented on a gross basis excluding inter-
segment eliminations to best represent the performance of each segment operating as
independent business units.
The segment information provided to the Chief Executive Officer for the reportable segment
described above, for the six months ended 30 September 2019, is shown on the following
page.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2019
NOTES TO THE FINANCIAL STATEMENTS
13 12
PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019
Unaudited 6 Months
to 30 September 2019
Commercial
($000)
Research
($000)
Less:
Eliminations
($000)
Total
External
Income
($000)
Income
Operating Revenue - External 2,280 5 - 2,285
- Internal - - - -
Other Income 180 522 (420) 282
Interest Income1 116 (2) 115
Foreign Exchange Gain2 16119
Total Income 2,463 659 (421) 2,701
Expenses
Expenses 7,194 4,609 (421) 11,382
Depreciation & Amortisation 513 195 - 708
Total Operating Expenses 7,707 4,804 (421) 12,090
Loss Before Tax (5,244) (4,145) - (9,389)
Income Tax Expense----
Loss After Tax (5,244) (4,145)- (9,389)
Net Cash Flow to Operating Activities (4,349) (3,056) - (7,405)
Audited 12 Months
to 31 March 2019
Commercial
($000)
Research
($000)
Less:
Eliminations
($000)
Total
External
Income
($000)
Income
Operating Revenue - External3,817 - - 3,817
- Internal199 - (199)-
Other Income 213 1,669 (892)990
Interest Income4 368 (49)323
Foreign Exchange Gain(1)1 (1)(1)
Total Income4,232 2,038 (1,141)5,129
Expenses
Expenses15,625 8,163 (1,141)22,647
Depreciation & Amortisation135 256 - 391
Total Operating Expenses15,760 8,419 (1,141)23,038
Loss Before Tax(11,528)(6,381)- (17,909)
Income Tax Expense9 - - 9
Loss After Tax(11,537)(6,381)- (17,918)
Net Cash Flow to Operating Activities(11,709)(5,798)- (17,507)
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2019
NOTES TO THE FINANCIAL STATEMENTS
Unaudited 6 Months
to 30 September 2018
Commercial
($000)
Research
($000)
Less:
Eliminations
($000)
Total
External
Income
($000)
Income
Operating Revenue - External2,033 - - 2,033
- Internal76 - (76)-
Other Income 41 577(176)442
Interest Income2 167- 169
Foreign Exchange (Loss)- (4)(1)(5)
Total Income2,152 740 (253)2,639
Expenses
Expenses7,348 4,068 (253)11,163
Depreciation & Amortisation66 129 - 195
Total Operating Expenses7,414 4,197 (253)11,358
Loss Before Tax(5,262)(3,457)- (8,719)
Net Cash Flow to Operating Activities(5,506)(3,106)- (8,612)
Eliminations
These are the intercompany transactions between the subsidiaries and the Parent. These
are eliminated on consolidation of Group results.
Segment Assets and Liabilities Information:
As at 30 September 2019
Commercial
($000)
Research
($000)
Total
($000)
Total Assets 3,151 6,658 9,809
Total Liabilities 3,421 1,452 4,873
As at 31 March 2019
Commercial
($000)
Research
($000)
Total
($000)
Total Assets2,02814,53816,566
Total Liabilities1,7688882,656
As at 30 September 2018
Commercial
($000)
Research
($000)
Total
($000)
Total Assets 2,493 11,310 13,803
Total Liabilities 2,100 809 2,909
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2019
NOTES TO THE FINANCIAL STATEMENTS
15 14
PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019
Total Laboratory Throughput:
Commercial
(#tests)
Research
(#tests)
Total
(#tests)
Six months ended 30 September 2019 6,573 1,574 8,147
Twelve months ended 31 March 2019 12,744 2,953 15,697
Six months ended 30 September 2018 6,078 1,319 7,397
Laboratory Throughput is a key metric for the Group: Laboratory Throughput provides
evidence of the increasing usage of Cxbladder products globally and the rates of adoption
between different customer segments. Total laboratory throughput includes billable/
commercial tests, which are invoiced to customers (including CMS tests), and tests which
are not considered to be billable as these tests relate to user programs or other non-
chargeable activities.
Billable/commercial test numbers are also a key metric for the Group: the tests are those
for which the Company is actively seeking reimbursement and cash receipts. Given the
time lag in the US between processing a Cxbladder test and receiving the associated cash
receipts, reported revenue based on the application of our accounting policy and billable
tests do not correlate in the same time period with one another. Billable test numbers also
include tests for CMS patients, which are all invoiced to CMS but for which revenue is not
being recognised.
Additions to non-current assets for the period include:
Commercial
($000)
Research
($000)
Total
($000)
Property, Plant & Equipment24 17 41
Right of Use Assets1,715 442 2,157
Intangible Assets- 30 30
Total Additions to Non-Current Assets1,739 489 2,228
Sales between segments are carried out at arm’s length. Post adoption of NZ IFRS 15,
the revenue from external parties reported to the Chief Executive Officer is measured in a
manner consistent with that in the Statement of Comprehensive Income.
The amounts provided to the Chief Executive Officer with respect to total assets and total
liabilities are measured in a manner consistent with that of the financial statements. These
assets and liabilities are allocated based on the operation of the segment and the physical
location of the asset.
There are no unallocated assets or liabilities.
8. SHARE CAPITAL
Sept 2019
6 Months
Shares (000)
Unaudited
Sept 2019
6 Months
($000)
Unaudited
Sept 2018
6 Months
($000)
Audited
March 2019
12 Months
($000)
Opening Balance 510,871 146,403 131,824 131,824
Issue of Ordinary Shares - Rights Issue
and Direct Offers
- - 2,623 15,044
Issue of Ordinary Shares - Exercise of
Share Options
- - - -
Issue of Ordinary Shares - Employee
Remuneration
510 115 88 188
Less: Issue Expenses - (3)(23)(653)
Movement510 112 2,688 14,579
Closing Balance 511,382 146,515 134,512 146,403
There are 511,381,538 (March 2019: 510,871,464 and September 2018: 474,792,378) Ordinary
Shares on issue.
All fully paid shares in the Company have equal voting rights and equal rights to dividends.
All Ordinary Shares are fully paid and have no par value.
9. LEASES
The Company adopted NZ IFRS 16 on its effective date 1 April 2019. Prior to 31 March 2019,
leases of property, plant and equipment were classified as either finance or operating leases
under NZ IAS 17. Payments made under operating leases were included in the profit or loss
on a straight-line basis over the period of the lease. Items leased under a finance lease were
capitalised with a corresponding liability. The asset was depreciated in accordance with
the property, plant and equipment policy and the lease liability was amortised in line with
finance lease payments.
From 1 April 2019, leases are recognised as a right of use asset and a corresponding liability
at the date at which the leased asset is available for use. Each lease payment is allocated
between the liability and finance cost. The finance cost is charged to profit or loss over the
lease period. The lease asset is depreciated over the shorter of the asset’s useful life and the
lease term on a straight-line basis.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2019
NOTES TO THE FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2019
NOTES TO THE FINANCIAL STATEMENTS
17 16
PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019
Assets and liabilities arising from a lease are initially measured on a present value basis.
Lease liabilities include the net present value of the following lease payments:
• fixed payments (including in-substance fixed payments), less any lease incentives
receivable
• variable lease payments that are based on an index or a rate
• amounts expected to be payable by the lessee under residual value guarantees
• the exercise price of a purchase option if the lessee is reasonably certain to exercise
that option, and
• payments of penalties for terminating the lease, if the lease term reflects the lessee
exercising that option.
The lease payments are discounted using the lessee’s incremental borrowing rate, being the
rate that the lessee would have to pay to borrow the funds necessary to obtain an asset
of similar value in a similar economic environment with similar terms and conditions. Lease
assets are measured at cost comprising the following:
• the amount of the initial measurement of lease liability
• any lease payments made at or before the commencement date less any lease
incentives received
• any initial direct cost
The Company mainly leases property and laboratory equipment.
The Company has used the modified retrospective transition resulting in no changes being
made to comparative periods.
The Company used the following practical expedients permitted by the standard in applying
NZ IFRS 16 for the first time:
• use of a single discount rate to leases with reasonably similar characteristics;
• use of hindsight in determining a lease term;
• reliance on previous assessments on whether leases are onerous; and
• exclusion of initial direct costs for the measurement of the lease asset at the date of
initial application.
The key impacts for the company in the 6 months ended 30 September 2019 were:
• Increased the net loss by $52,000 as the interest and depreciation calculated under
NZ IFRS 16 is greater than the lease payments under NZ IAS 16.
• Additional right of use assets recognised on transition and subsequent to totalling
$1,863,000 and $70,000.
• Additional lease liabilities recognised on transition and subsequent to totalling of
$1,863,000 and $70,000.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2019
NOTES TO THE FINANCIAL STATEMENTS
Unaudited
Sept 2019
6 Months
($000)
Right of Use Asset
Cost
Assets recognised on initial transition - previously operating assets1,863
Assets recognised on initial transition - previously under a finance lease223
Additions70
Transfers to plant, property and equipment(155)
Foreign currency translation64
2,065
Accumulated Depreciation
Depreciation571
Transfers to plant, property and equipment on transition(24)
Foreign currency translation18
565
Net Right of Use Asset Balance1,500
Lease Liability
Liabilities recognised on initial transition1,863
Lease liabilities previously recognised as finance leases83
Additions70
Lease repayments(609)
Interest charged48
Foreign currency translation46
1,501
Split by:
Current liability1,149
Non-current liability352
1,501
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2019
NOTES TO THE FINANCIAL STATEMENTS
19 18
PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019PACIFIC EDGE LIMITED INTERIM FINANCIAL STATEMENTS 2019
10. RECONCILIATION OF CASH USED FROM OPERATING ACTIVITIES WITH
OPERATING NET LOSS
Sept 2019
6 Months
($000)
Sept 2018
6 Months
($000)
March 2019
12 Months
($000)
Net Loss for the Period(9,389)(8,719)(17,918)
Add Non Cash Items:
Depreciation79 116 237
Amortisation58 79 154
Employee Share Options318 284 612
Employee Bonuses Paid in Shares in Lieu of Cash115 88 188
Depreciation on right of use assets571 - -
Interest on finance leases shown in lease repayments48 - -
Total Non Cash Items1,189 567 1,191
Add Movements in Other Working Capital items:
Decrease/(Increase) in Receivables and Other Assets- (80)(341)
Decrease /(Increase) in Inventory14 (94)(90)
Increase/(Decrease) in Payables and Accruals799 (292)(353)
Effect of exchange rates on net cash(18)6 4
Total Movement in Other Working Capital795 (460)(780)
Net Cash Flows to Operating Activities(7,405)(8,612)(17,507)
11. CONTINGENT LIABILITIES
There were no known contingent liabilities at 30 September 2019 (March 2019: Nil and
September 2018: Nil). The Company and Group have not granted any securities in respect
of liabilities payable by any other party whatsoever.
12. CAPITAL COMMITMENTS
There are no capital commitments at 30 September 2019 (March 2019: Nil and September
2018: Nil).
13. SUBSEQUENT EVENTS
On the 21st of November 2019, the Company announced a capital raise of approximately
$20m by way of a private placement and a 1 for 4.25 rights issue for ordinary shares which
is intended to close on the 11th of December 2019. The capital raise is fully underwritten by
Jarden Partners Limited and Forsyth Barr Group Limited.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2019
NOTES TO THE FINANCIAL STATEMENTS
20
87 St David Street, PO Box 56, Dunedin, New Zealand
P +64 3 479 5800 F +64 3 479 5801
www.pacificedgedx.com
---
Pacific Edge Limited
Results announcement
(for Equity Security issuer/Equity and Debt Security issuer)
Results for announcement to the market
Name of issuer Pacific Edge Limited
Reporting Period 6 months to 30 September 2019
Previous Reporting Period 6 months to 30 September 2018
Currency NZD
Amount (000s) Percentage change
Revenue from continuing
operations
- Operating revenue $2,285
- Other income $416
- Operating revenue: 12%
increase
- Other income: 32% decrease
Total Revenue $2,701 2% increase
Net profit/(loss) from
continuing operations
($9,389) 8% increase
Total net profit/(loss) ($9,406) 8% increase
Interim/Final Dividend
Amount per Quoted Equity
Security
The Company does not propose to pay dividends to
shareholders
Imputed amount per Quoted
Equity Security
Not Applicable
Record Date Not Applicable
Dividend Payment Date Not Applicable
Current period Prior comparable period
Net tangible assets per
Quoted Equity Security
$0.009 $0.022
A brief explanation of any of
the figures above necessary
to enable the figures to be
understood
For commentary on the results, please refer to the commentary
in the related NZX release. Further information is also set out in
the unaudited financial statements of the Company for the 6
months to 30 September 2019 which accompany this
information.
Authority for this announcement
Name of person authorised
to make this announcement
Kate Rankin, Chief Financial Officer
Contact person for this
announcement
Kate Rankin
Contact phone number 03 479 8510
Contact email address kate.rankin@pelnz.com
Date of release through MAP 21 November 2019
Unaudited financial statements accompany this announcement.
---
FY20 Interim Result and Capital Raising Presentation
21 November 2019
Disclaimer
Important Notice
This presentation has been prepared by Pacific Edge Limited (PEL) solely to provide interested parties with further
information about PEL and its activities at the date of this presentation.
Information of a general nature
The information in this presentation is of a general nature and does not purport to be complete nor does it contain all
the information which a prospective investor may require in evaluating a possible investment in PEL or that would be
required in a product disclosure statement for the purposes of the New Zealand Financial Markets Conduct Act 2013
(FMCA). PEL is subject to a disclosure obligation that requires it to notify certain material information to NZX Limited
(NZX) for the purpose of that information being made available to participants in the market and that information can
be found by visiting www.nzx.com/companies/PEB. This presentation should be read in conjunction with PEL’s other
periodic and continuous disclosure announcements released to NZX.
Not an offer
This presentation is for information purposes only and is not an invitation or offer of securities for subscription,
purchase or sale in any jurisdiction.
Not financial product advice
This presentation does not constitute legal, financial, tax, financial product advice or investment advice or a
recommendation to acquire PEL securities, and has been prepared without taking into account the objectives, financial
situation or needs of investors. Before making an investment decision, prospective investors should consider the
appropriateness of the information having regard to their own objectives, financial situation and needs and consult an
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Forward-looking statements
This presentation contains forward-looking statements that reflect PEL’s current views with respect to future events.
Forward-looking statements, by their very nature, involve inherent risks and uncertainties. Many of those risks and
uncertainties are matters which are beyond PEL’s control and could cause actual results to differ from those predicted.
Variations could either be materially positive or materially negative. The information is stated only as at the date of this
presentation. Except as required by law or regulation (including the NZX Listing Rules), PEL undertakes no obligation to
update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
To the maximum extent permitted by law, the directors of PEL, PEL and any of its related bodies corporate and affiliates,
and their respective officers, partners, employees, agents, associates and advisers do not make any representation or
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limitation, liability for negligence).
Financial data
All dollar values are in New Zealand dollars unless otherwise stated.
This presentation should be read in conjunction with, and subject to, the explanations and views of future outlook on
market conditions, earnings and activities given in the announcements relating to the results, and annual report, for the
year ended 31 March 2019.
Effect of rounding
A number of figures, amounts, percentages, estimates, calculations of value and fractions in this presentation are subject to
the effect of rounding. Accordingly, the actual calculation of these figures may differ from the figures set out in this
presentation.
Past performance
Investors should note that past performance, including past share price performance, cannot be relied upon as an indicator of
(and provides no guidance as to) future PEL performance, including future financial position or share price performance.
Investment risk
An investment in securities of PEL is subject to investment risk and other known and unknown risks, some of which are beyond
the control of PEL. PEL does not guarantee any particular return or the performance of PEL.
Distribution of presentation
This presentation must not be distributed in any jurisdiction outside New Zealand in circumstances in which the distribution of
this presentation would be unlawful . The distribution of this presentation in jurisdictions outside New Zealand, Australia or
Singapore may be restricted by law, and persons into whose possession this presentation comes should observe any such
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No offer in the United States
This presentation is not for distribution or release in the United States. This presentation does not constitute an offer to sell, or
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and will not be, registered under the US Securities Act of 1933, as amended, or the securities laws of any state or other
jurisdiction of the United States, and may not be offered or sold in the United States except in transactions exempt from, or
not subject to, registration under the US Securities Act of 1933, as amended, and applicable US state securities laws.
Disclaimer
None of PEL or PEL’s advisers (including the lead manager(s) or underwriter(s) for any offer of PEL securities) or any of their
respective affiliates, related bodies corporate, directors, officers, partners, employees and agents, have authorised, permitted
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To the maximum extent permitted by law, none of PEL and its advisers (including the lead manager(s) or underwriter(s) for any
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•any errors or omissions in this presentation; or
•any failure to correct or update this presentation, or any other written or oral communications provided in relation
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By receiving this presentation, you agree to the above terms and conditions.
2
About Pacific Edge
and Cxbladder
Global first mover advantage
Four class leading, proprietary, non-invasive, urine-based diagnostic
tests (Cxbladder) for the detection and management of urothelial
cancer (UC)
1
- the first new commercial tests for UC globally in 17
years
2
.
Large global addressable market
Addressing a large, under-served global market opportunity; Annual
Addressable Market (AAM) for Cxbladder in the U.S. of up to US$1.2
billion.
3
Unique commercial proposition
First-to-market products targeting multiple clinician defined needs.
Cxbladder provides enhanced diagnostic outcomes not currently
available from existing technology, resulting in lower healthcare costs
for payers and better health outcomes for patients.
Proven model with compelling performance
Track record of successfully launching high-impact, high-value
diagnostic products used by urologists and medical practitioners.
Large portfolio of published clinical evidence
Products are underpinned by extensive clinical validation and clinical
utility evidence published in top-tier international journals; facilitating
test adoption, reimbursement and NZ and U.S. guideline inclusion.
Established lab and sales infrastructure
Commercial sales in New Zealand, Australia, Singapore and the U.S.
underpinned by:
•Two proprietary CAP
4
-accredited, CLIA
5
certified laboratories (one
in Dunedin, New Zealand and one in Pennsylvania, U.S.) with
combined design capacity for 295,000 tests per annum;
•Dedicated sales force calling on urologists.
Increasing commercial momentum
Test adoption and revenue are growing; continued reimbursement
progress in the U.S. with both public and private payers; NZ and U.S.
guideline inclusion; over 60% of New Zealand’s population currently
under coverage (up from 35% FY18).
Future pipeline in other cancer biomarkers
Identified biomarkers and IP supporting new product development
and long-term growth; IP portfolio across 4 different cancers.
4
1. Urothelial cancer includes bladder cancer (which accounts for ~95% of all urothelial cancers).
2. The UroVysion FISH assay was the last diagnostic test to be made commercially available in 2002
3. EY-Parthenon review of the U.S market opportunity for Cxbladder completed in February 2018
4. CAP: College of American Pathologists
5. CLIA: Clinical Laboratory Improvement Amendments of 1988
Pacific Edge
Overview
Pacific Edge
1
Investment Opportunity
Proximity to significant cash reimbursement event and consequential strong cash uplift
•Significant advances have been made in the last 12 months in clinical evidence for
reimbursement approvals - including the CMS for consideration for inclusion in a Local Coverage
Determination (LCD).
•Post a successful inclusion in a LCD, and in combination with the recent inclusion in guidelines,
Pacific Edge expects a significant increase in test adoption, revenue growth and operating cash-
flow.
Competitive advantage continues to grow
•Cxbladder has recently been included in the NCCN guidelines in the U.S. and clinical guidelines
in New Zealand providing a compelling opportunity for medical practitioners and urologists to use
Cxbladder more extensively.
•Cxbladder’s intellectual property and published evidence portfolio continues to grow globally
supporting Pacific Edge’s competitive advantage.
5
Significant progress underpins reduction in risk profile and proximity to full reimbursement coverage
1. Pacific Edge is listed on the New Zealand Stock Exchange (PEB.NZX)
6
•March 2018: Notification of Product Specific CPT
1
codes from the American Medical Association for Cxbladder Detect and Cxbladder Monitor.
•August 2018: Public Healthcare Provider, Counties Manukau District Health Board (New Zealand) commercially adopts Cxbladder.
•August 2018: Public Healthcare Provider, Hauora Tairawhiti District Health Board (New Zealand) commercially adopts Cxbladder.
•October 2018: Commencement of commercial evaluation of Cxbladder by Johns Hopkins Medicine (U.S.).
•October 2018: Notification of a National Price for all Cxbladder tests of US$760 per test in the U.S. (effective 1 January 2019).
•November 2018: Public Healthcare Provider, Capital & Coast District Health Board (New Zealand) commercially adopts Cxbladder.
•March 2019: Public Healthcare Provider Hawkes Bay District Health Board (New Zealand) commercially adopts Cxbladder.
•May 2019 and June 2019: Publication of two more papers in peer-reviewed journals (including the world’s number 1 ranked Urology Journal
2
)
adding significant additional clinical utility evidence in support of Cxbladder.
•July 2019: Cxbladder referenced as a recommended clinical path for Urologists in the National Comprehensive Cancer Network (NCCN)
Guidelines in the U.S.
...progressing towards a transformational commercial inflexion point
1. Current Procedural Terminology (CPT) is a medical code set that is used to report medical, surgical, and diagnostic procedures and services to entities such as physicians, health insurance companies and accreditation organizations.
2. European Urology has an Impact Factor Rating of 17.58 and is read by more than 20,000 Urologists across the globe.
Recent Achievements Highlight Accelerating Momentum and Adoption of Cxbladder
Urothelial Cancer is a Significant Global Healthcare Challenge
•~ 550,000 new cases in 2018
1
•~ 200,000 deaths annually
1
•Globally 10
th
most common cancer but
6
th
most common in men
1
•High recurrence rates (70% recurrence
following treatment)
•Requires regular monitoring
•High detection and management costs
with invasive tests and procedures
•Patient compliance low ~40% leading to
an increase in disease progression
5%
are upper tract (not
including kidney)
95%
are bladder cancer
Ureter
Bladder
Kidney
7
Urothelial cancer
UROTHELIAL CANCER
1. Bray et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 3 cancers in 185 countries. Ca Cancer J Clin. 2018;68:394-424.
~7 million patients
present with haematuria
annually and 3.4 million are
worked up to look for
bladder cancer
1
~4 million cystoscopies were
performed in 2018
1
(many of which are
unnecessary and are
replaceable with a non-
invasive, accurate
diagnostic test)
More than 81,000
new bladder cancers are
diagnosed every year in the
U.S.
2
4
th
most common cancer in
men in the U.S.
3
1 in 42 people
will be diagnosed with
bladder cancer in their
lifetime
4
More than 800,000 people
living with bladder cancer will
present annually up to 4
times a year for up to 5 years
for evaluation for the
recurrence of urothelial
cancer
Average lifetime costs of
US$220,000
per patient (recurrence rate
of 70% with expensive
surveillance)
1
Direct costs associated
with bladder cancer
predicted to
reach US$4.9 billion in
2020
1
Based on direct costs alone,
bladder cancer has the
highest per patient treatment
costs of any cancer over the
patient lifetime
1
Urothelial Cancer is a Significant Healthcare Challenge in the U.S.
8
1. Presentation from Dr Sia Daneshmand (Director of Urologic Oncology and Clinical Research, USC) July 2019 2. NIH National Cancer Institute, 2016
3. American Cancer Society, 2019 4. Bladder Cancer Advocacy Network, 2017
Existing Tests and Procedures have Significant Shortcomings...
CYSTOSCOPY CYTOLOGY FISH
USE
Detection of bladder cancer Identifying urothelial carcinoma
Conducted as a result of atypical
cytology
SOURCE MATERIAL
Endoscopic procedure of the bladder
Whole cells that have sloughed off
tumor and are caught in voided urine
Whole cells that have sloughed off tumor
and are caught in voided urine
RESULTS
Performance does not meet the
expectations of physicians; invasive
and expensive
Subjective. High rate of atypical or
suspicious findings
Quantitative (# of cells with aneuploidy.)
Moderate rates of non-diagnostic results
SENSITIVITY
Sensitivity 71% and Specificity 65%
2
Very low (32%-62%)
1,2
Poor (39%) with high variability
1
1. BMC Urol. 2016.
2. Konety et al, European Urology, May 2019
Cancer
Normal
9
...they are expensive, invasive and have poor relative performance...providing significant opportunities
for new diagnostic tests that are cheaper, non-invasive and more accurate...Cxbladder
•Four class leading, accurate, non-invasive, urine based diagnostic tests for UC
addressing multiple unmet needs across the clinical pathway.
•Cxbladder Triage (CxbT): Front line test for use in the primary evaluation of
haematuria to rule out patients who do not have cancer
•Cxbladder Detect (CxbD): For use by urologists for patients who have been
referred for a full urothelial cancer workup to detect cancers
•Cxbladder Resolve
1
(CxbR): Segregates low grade tumours from high grade and
late stage tumours
•Cxbladder Monitor (CxbM): Provides front line identification for patients returning
to the clinic who do not have UC
•Globally Cxbladder are the first new diagnostic tests for UC to be made commercially
available in 17 years.
•Non-invasive, accurate, clinically validated, high clinical utility.
•Integrated into standards of care and guidelines for a number of providers in New
Zealand and the U.S.
10
Cxbladder Revolutionises How Urologists Detect and Manage Urothelial Cancer
World Class Diagnostic Tests Validated by International Urologists - Now in Guidelines
Cxbladder provides better care for patients, better utility for urologists and savings for the payers
1. Cxbladder Resolve has not yet launched in the USA
FULL EVALUATION TESTING
DIAGNOSED WITH UC
MONITORING FOR
RECURRENCE
Year One: up to six times
Years Two to Five: up to four times/year
REFERRAL TO A UROLOGIST
Historically, the diagnosis and
monitoring of urothelial cancer
has involved an arduous
regime of invasive and
expensive tests over the
lifetime of the patient.
In the U.S. alone, more than 4
million cystoscopies were
performed in 2018
1
.
A cystoscopy is a painful,
invasive and expensive
procedure that requires a tube
with a scope to be inserted in to
the urethra.
CANCER MANAGEMENT
EVALUATION BY PRIMARY
PHYSICIAN
STANDARD OF CARE
Due to the high recurrence rates of UC,
patients undergo regular, highly invasive
testing
HISTORICAL TESTING
Cxbladder Triage
Primary evaluation of haematuria to
rule out patients who do not have
cancer
Cxbladder Detect
For use by urologists to detect cancer
Cxbladder Resolve
Segregation of low grade tumours
from high grade and late stage
tumours
Cxbladder Monitor
Monitoring for recurrence of the
disease
CXBLADDER
1. Presentation from Dr Sia Daneshmand (Director of Urologic Oncology and Clinical Research, USC), July 2019
11
Cxbladder is Used at Multiple Decision Points across the Clinical Pathway
The Evaluation of Haematuria: Large Global Market Opportunity for Cxbladder
Approximately 80% of macrohaematuria patients and 98% of microhaematuria patients who have a workup for UC do not have
cancer – the new guidelines in New Zealand now enable all of these patients to be tested by Cxbladder
Microscopic
≥3 RBCs
1
per high powered field
Macroscopic (gross)
Visible to the naked eye
Represents up to 20%
of all urologic visits
2
Up to 20% of Medicare
beneficiaries present with
haematuria annually
3
Cxbladder accurately rules-out patients who do not have UC
Stones
Infection
Benign Prostatic Hyperplasia (BPH)
Idiopathic (benign)
Urologic Cancers
(UC, Renal Cell and Prostate)
12
HAEMATURIA
DEMOGRAPHICS
CAUSES
1. RBC: Red Blood Cells
2. American Urological Association, 2016.
3. Haematuria is the most common symptom of bladder cancer
Cxbladder Provides Actionable Results for Multiple, Physician-Defined, Clinical Needs
Clinical Gaps
1.Patients unable to undergo standard work-up:
•Renal insufficiency
•Dye allergies
•Pregnancy
2.Current AUA Haematuria Guidelines over prescribe
1
:
•High marginal costs > US$1 million to find an additional cancer
•Extensive radiation creates more cancers than it finds
3.Chronic unresolved haematuria:
•
Need to confirm no presence of UC after initial work-up
•
Inconclusive results (i.e. atypical cytology and equivocal
cystoscopy) create diagnostic dilemmas for Urologists
4.Performance of existing tests and procedures falls short of
physicians expectations:
•
Current guidelines require multiple expensive and invasive
tests
1
•
Gold standard cystoscopy has relatively poor sensitivity (73%)
and specificity (67%-81%)
2
Clinical Utility of Cxbladder
Confirms
The absence of UC with high sensitivity AND high NPV
3
–
“Power of the Negative”
Replaces
The old regime of expensive and invasive tests
Triages
Patients who have a low risk of disease removing them from
having a full clinical work-up, lowering healthcare costs and
patient fatigue
Clarifies
Provides accurate adjudication of atypical or equivocal results
from existing gold standard tests and procedures, thereby
lowering the need for patients to have further invasive tests
and procedures
1. Georgiera et al JAMA Internal Medicine 2019.
2. Mowatt et al 2011 Jocham et al 2007.
3. Negative Predictive Value (NPV); used in conjuction with high sensitivity, provides rule-out capability for the high proportion of patients who do not have disease
13
Cxbladder has Multiple Layers of Intellectual Property
1 Unique proprietary buffer in the
sample system
Midstream urine is collected in a Cxbladder
urine collection cup. RNA in the cells is
preserved in a proprietary buffer enabling
global transport to Pacific Edge’s CAP
accredited, CLIA-approved laboratories in
New Zealand and the U.S.
Sample
Collection
Biomarker
Measurement
RT-qPCR
1
2 Specific proprietary genomic
biomarkers for urothelial cancer
Genomic biomarkers, specific to
urothelial cancer, identified by
Pacific Edge’s intellectual property
are amplified from RNA and
quantified in Pacific Edge’s high-
throughput laboratories
3 Proprietary trade secret
algorithms in central repository
Cxbladder score is calculated from
the quantity of each genomic
biomarker in relation to each other
and additional data from phenotypic
biomarkers and clinical variables
using a proprietary algorithm
14
1. RT-qPCR: Reverse Transcription Quantitative Polymerase Chain Reaction: Industry recognised standards, well validated molecular process used to estimate the concentrations of specific oligonucleotides
Patient Compliance with Current Surveillance Guidelines is Poor
A 2011 study of patients with bladder cancer
between 1992 and 2002 found only 1/4545 received
all the recommended measures; much of the
variation is unexplained but the authors noted that
“Due to the invasive nature of the surveillance and
treatment strategies, non-adherence with clinical-
practice guidelines may be attributed to patient
factors such as advanced age or the pre-existing
comorbid conditions”
1
Onerous, invasive and expensive tests and procedures drive a low level of patient compliance with
urologists recommendations – resulting in poorer patient outcomes
1. Chamie K, Saigal CS, Lai J et al. Cancer. 2011;117(23):5392-5401.
2. Han et al. Patient, Provider, and Facility Factors Associated with Underuse of Guideline Recommended Surveillance for High-Risk Non-Muscle Invasive Bladder Cancer – A National Study. Veteran Affairs Urological Forum. AUA Poster
Presentation May 2018.
3. Schrag D, Hsieh LJ, Rabbani F et al. J Natl Cancer Inst. 2003;95(8):588-597.
Of 2017 patients included, 651 (32%) received
cystoscopy less frequently than every 4 months.
One third of veterans with high-risk non-muscle
invasive bladder cancer (NMIBC) do not receive the
recommended high intensity surveillance
2
“Only 40% of patients adhere to the recommended
schedule of bladder cancer surveillance”
3
15
Patients Dislike Invasive Tests
PATIENT COMMENTS:
•“I recommend being put to sleep. Dealing with these while awake was horrible.”
•“Asked doc for valium to relax, as anxiety is rampant and pain is terrible.”
•“Avoid office cystoscopy and insist on procedure being done in the operating
room under general anesthesia.”
•“Cystoscopy has to be done under general anesthesia because it is so painful.
Urination is extremely painful for two to three days afterwards.”
•“How clean is the tool? I get a lot of infections post cystoscopy and TURBT.”
•“Usually ends with an infection.”
•“Barbaric. Needs to be a better and more comfortable process.”
•“There has to be a better, non-invasive procedure. My urothelial passage has
been destroyed, now have a suprapubic catheter.”
PATIENTS REPORTED MODERATE TO SEVERE:
65%
DISCOMFORT
(n = 905)
56%
1. Bladder Cancer Advocacy Network patient survey, 2018, Urology Times.
Patient Feedback Regarding Cystoscopy: A BCAN
1
Survey in > 900 U.S. Patients with UC
65%
ANXIETY
(n = 906)
38%
PAIN
(n = 890)
16
Clinical
Evidence
Major Peer-Reviewed Publications Highlight the Clinical Validation of Cxbladder
18
Publication
N Cxbladder Results
Patients Samples Sensitivity Specificity NPV
Outperformed All
Comparator Covered Tests
O’Sullivan P, Sharples K, Dalphin M et al.
Journal of Urology, 2012.
485 81.8% 85.1% ✓
Breen V, Kasabov N, Kamat AM et al.
BMC Medical Research Methodology, 2015.
939 81.8% 85.1%
✓
(including FISH)
Kavalieris L, O’Sullivan PJ, Suttie JM et al.
BMC Urology, 2015.
587 95.1% 98.5%
Kavalieris L, O’Sullivan P, Frampton C et al.
Journal of Urology, 2017.
763 1036 93% 97%
Lotan Y, O’Sullivan P, Raman JD et al.
Urologic Oncology, 2017.
803 1016 91% 96%
✓
(including FISH)
Cxbladder has class leading performance metrics: Sensitivity, Specificity and Negative Predictive Value
Major Peer-Reviewed Publications Highlight the Clinical Utility of Cxbladder
19
Publication Setting
N
Impact of Cxbladder Results
Patients Samples On Diagnostic Tests On Invasive Tests
Darling D, Luxmanan C, O’Sullivan P et al.
Advances in Therapy, 2017.
Haematuria
Evaluation
33 396
Decrease
(5%; 25%)
Decrease
(11%; 31%)
Lough T, Luo Q, Luxmanan C et al.
BMC Urology, 2018.
Haematuria
Evaluation
33 396
Decrease
(41% per patient)
Decrease
(51% per patient)
Lough T, Luo Q, O’Sullivan P et al.
Oncology and Therapy, 2018.
UC
Surveillance
30 828
Decrease
(38.7%)
Decrease
(37.2%)
Davidson P, McGeogh G, Shand B
NZ Medical Journal, 2019
Haematuria
Evaluation
570 570
Decrease
(32.7%)
Decrease
(32.7%)
Konety et al, European Urology 2019
Atypical
cytology and
equivocal
cystoscopy
852 852
Correctly adjudicated
100% of Atypical
cytology
Correctly adjudicated
100% of equivocal
cystoscopy
Cxbladder significantly reduces the need for expensive, invasive tests
Diagnostic Out-Performance Published in the World’s #1 Urology Journal
•Diagnostic outperformance published in global number one
1
ranked urology
journal, European Urology, in May 2019.
•Cxbladder providing enhanced diagnostic outcomes not currently
available from existing technology.
•Enables physicians to remove the diagnostic dilemma faced when existing
gold standard tests and procedures are not able to determine a clear
diagnostic outcome.
•“Significant utility is gained from the inclusion of Cxbladder in the
evaluation of patients for UC in both haematuria and monitoring
settings, with 35% of patients avoiding cystoscopies”
•“Cxbladder correctly adjudicated 100% of atypical cytologies and
equivocal cystoscopies”
20
This real world outcome positions Cxbladder for further
inclusion in other international guidelines
Demonstrates the significant clinical utility of Cxbladder
1. European Urology has an Impact Factor Rating of 17.58 and is read by more than 20,000 urologists across the globe.
Commercial
Progress
Growing Commercial Adoption in New Zealand Leads the World
22
•New Zealand’s public healthcare providers are leading
the global adoption of Cxbladder.
•Majority have now adopted Cxbladder into their standard
of care and, in some cases, their clinical guidelines,
replacing cystoscopy.
•Demand exceeding expectations with strong growth from
new and existing customers.
•Demand expected to continue to grow in FY20.
Total contract coverage of more than 60% of New Zealand’s
population through public healthcare providers
Our Primary Focus: The U.S. Market
A scale opportunity in both the evaluation of haematuria and monitoring for UC recurrence
1. EY-Parthenon business review of the annual addressable market opportunity for Cxbladder in the U.S. completed February 2018
23
One More Milestone Needed to Obtain National Public Reimbursement in the U.S.
2 of the 3 milestones required for national public reimbursement
in the U.S were successfully achieved in FY19
Clinical evidence milestones required for Cxbladder’s inclusion
in a LCD
1 Receipt of Product Specific CPT codes for Cxbladder Detect and
Cxbladder Monitor (March 2018) – which improves cash conversion.
2 Notification of a National Price for all Cxbladder tests of US$760 per
test for the CMS (announced October 2018, effective 1 January 2019) –
which facilitates private payer negotiations.
3 Progress is being made with the third and final milestone, to have
Cxbladder included in a Local Coverage Determination (LCD) - which
would allow for reimbursement from the CMS for approximately 47% of Pacific
Edge’s total U.S. laboratory throughput.
CMS - The Centers for Medicare & Medicaid Services (CMS) is the U.S. federal agency that administers the Medicare program and works in partnership with state governments to administer Medicaid
and other health programmes. Medicare is the federal health insurance program for (1) people who are 65 or older, (2) certain younger people with disabilities and (3) people with End-Stage Renal
Disease. This is the scheme that covers most of the CMS patients for whom Pacific Edge provides tests.
These patients account for approximately 47% of Pacific Edge’s total U.S. laboratory throughput. As at 30 September 2019, PEB had completed and invoiced a total of 19,361 tests for CMS
patients in the U.S., for which they are yet to be reimbursed. PEB will seek reimbursement for these tests when they receive a Local Coverage Determination (LCD) for Cxbladder.
Local Coverage Determination (LCD) - A Local Coverage Determination is a decision by a Medicare Administrative Contractor (MAC) which determines whether a particular service offered by a
healthcare provider in their geographic jurisdiction is ‘reasonable and necessary’ and therefore covered for reimbursement by the CMS. These coverage decisions are issued in a document called a
Local Coverage Determination (LCD). An LCD provides specific conditions of the coverage, including price, and guidance on reimbursement including coverage guidance and coding information. This
information is useful to the many other private payers (insurance companies) for their contracting of the same product or service. PEB, which has a centralised laboratory service business with a
Laboratory Developed Test, need a LCD from their local MAC to gain U.S.-wide reimbursement coverage.
1 Analytical Validity
2 Clinical Validity
3 Clinical Utility – Pacific Edge will continue its submission of clinical
evidence in support of Cxbladder’s inclusion in a LCD. An updated dossier
of evidence focused on clinical utility was submitted for review in August
2019.
24
Estimated Timeframes for Completion of LCD Review
25
New CMS review process estimated to take
~6 months from evidence submission
PEB reasonably expects to know the outcome
of the LCD review process in Q1 2020
•Inclusion in a LCD for reimbursement for CMS patients
requires iterative review and sign-off of the clinical
evidence for Cxbladder by our MAC (Novitas)
•Legislation changed in early 2019 targeted to provide
applicants with greater transparency to the LCD process
•In the expert opinion of PEB’s LCD consultant, the
process between valid submission of Cxbladder’s new
evidence and the conclusion of the formal review
process is expected to take ~6 months
•The LCD process requires submission of new
Cxbladder clinical utility evidence
•Cxbladder’s evidence dossier has recently been
updated with new evidence
1
from two additional
publications, and Cxbladder’s recent inclusion in the
NCCN guidelines. This additional new evidence is
expected to meet Novitas’s requirements for clinical
utility
2
•An updated dossier of evidence was submitted to PEB’s
MAC for formal review in August 2019
•Expert opinion estimates the completion of the LCD
review and outcome could reasonably be expected in
the Q1 of FY21
2
1
Evidence must be peer reviewed published scientific and clinical evidence
2
Expert opinion from PEB’s LCD consultant
Successful Inclusion in a LCD is Expected to Result in Significant Commercial Growth
Test adoption and revenue growth:
U.S. adoption and demand for Cxbladder is expected to be positively impacted on inclusion in a LCD – which is expected to result in accelerated
revenue growth (as evidenced by the growth profiles of other listed peer group diagnostic companies in the U.S.).
An LCD provides insurance coverage for all U.S. patients who are covered by the CMS in the urologist’s clinical pathway for the detection and
management of urothelial cancer. An LCD will also support Pacific Edge’s commercial negotiations with private insurance payers in the U.S.
Recent inclusion in the NCCN guidelines combined with a successful LCD inclusion would be transformational to test adoption and revenue
growth.
Balance Sheet:
Following inclusion, Pacific Edge will enter into negotiations with the CMS for reimbursement of the large number of Cxbladder tests that have
been invoiced to the CMS:
•As at 30 September 2019, PEB had completed and invoiced a total of 19,361 tests for CMS patients in the U.S., which are yet to be
reimbursed.
•This negotiation with the CMS is expected to result in a one-off backlog payment to Pacific Edge.
Cashflow:
On inclusion in a LCD, Pacific Edge will receive regular payment for all future covered tests conducted on CMS patients. At forecast test volumes,
this is expected to improve operating cashflow by approximately NZ$800k per month.
Payments for tests conducted on CMS patients (who currently account for approximately 47% of total U.S. laboratory throughput) are expected to
be paid within 45 days of receipt (versus a current cash conversion period of 7 to 12 months), resulting in a significant positive impact on the
operating cashflow of the company.
Timing for cash receipts will improve significantly with the award of a LCD as PEB will also be in a better position to enter into more contracts with
other individual payers (such as insurance companies). Once in contract with private payers, their normal payment terms apply.
26
Institutional Users and Payers in the U.S. Validate Cxbladder
•Johns Hopkins Medicine
•Carolina Urologic Research Center
•Cleveland Clinic
•Fox Chase Cancer Center
•Penn State Milton S. Hershey
Medical Center
•UCLA
•University of Minnesota
•Mount Sinai Hospital (NY)
•University of Pennsylvania
•University of Southern California
•University of Rochester
•University of Oklahoma
•City of Hope
•Thomas Jefferson University
•University of California-San Diego
•University of California-San
Francisco
•Aetna
•Blue Cross Blue Shield
•Cigna
•Humana
•Medicare Advantage
•United Healthcare
•Veterans Health Association
•MediNcrease Health Plans
27
Healthcare Institutions Commercially Using
Cxbladder
Major Insurance Companies Paying for Cxbladder
•An additional 15 Healthcare Institutions in the U.S. are currently evaluating Cxbladder for commercial use
•Academic centres are healthcare centres of excellence that have high volume healthcare businesses
1H20 Financial Result Summary
(NZ$’000) 1H20
1
1H19
1
% Change
Operating Revenue
2
(test sales) 2,285 2,033 12%
Total Revenue 2,701 2,639 2%
Operating Expenses 12,090 11,358 6%
Total Comprehensive Loss 9,406 8,718 8%
Cash Receipts from Customers 2,350 2,026 16%
Net Operating Cash Outflow 7,405 8,612 (14%)
Cash on hand as at 30 September 4,737 10,060 (53%)
1. Half year ended 30 September
2. Operating revenue excludes tests sold in the U.S. for which cash payment has yet to be received, as well as tests covered by the CMS. CMS tests account for approximately 47% of total U.S. laboratory throughput and PEB will seek reimbursement
for these invoiced tests on a successful inclusion in the CMS’s LCD. As at 30 September 2019, Pacific Edge has completed and invoiced a total of 19,361 tests for CMS patients in the U.S, which are yet to be reimbursed.
28
1H20 Financial Result Highlights and Commercial Milestones
•Cash receipts from customers increased 16% on pcp and 37% on 2H19.
•Operating revenue
from Cxbladder test sales increased 12% on pcp.
•Total laboratory throughput increased 10% on pcp to 8,147 tests.
•Total laboratory throughput for New Zealand, Australia and Singapore increased 50% on
pcp to 1,896 tests
•Total billable tests increased 8% on pcp to 6,573 tests.
•Net operating cash outflow reduced 14% on pcp.
•Cxbladder included in the NCCN guidelines as an approved intervention for patients
being monitored for the recurrence of UC.
•Publication of a further two peer reviewed papers highlighting Cxbladder’s
outperformance adding significant additional clinical utility evidence in support of
Cxbladder.
29
Total Laboratory Throughput Comparison
30
0
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
1H151H161H171H181H191H20
Half Year Comparison
Total Lab ThroughputBillable Tests
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
FY15FY16FY17FY18FY191H20
Full Year Comparison
Total Lab ThroughputBillable Tests
Detect
57%
[CATEGOR
Y NAME]
[PERCENT
AGE]
Total Laboratory
Throughput
by Test Type
(as at 30 Sept 2019)
Unique Multi-Market and Multi-Product Opportunity for Cxbladder
31
Triage
22%
Total Laboratory
Throughput
by Region
(as at 30 Sept 2019)
Rest of World
23%
U.S.
77%
Detect
57%
Monitor
21%
Progressive adoption of the suite of tests provides a unique, global competitive advantage
Successful Execution of Key Objectives is Driving Growth
U.S.:
•Achieve the third and final milestone (LCD) for national reimbursement.
•Increase the focus on closing institutional customers.
•Launch 4
th
Cxbladder product (Cxbladder Resolve) and upsell additional Cxbladder tests.
•Build on initial sales to the Veterans Administration and other Federal, Military and institutional scale customers.
New Zealand:
•Further accelerate the roll out of Cxbladder with public health care providers (DHBs).
•Bring New Zealand subsidiary to a cashflow positive position.
Australia:
•Replicate the successful New Zealand sales and marketing model to drive sales growth.
South East Asia:
•Transition our User Programmes in Singapore into commercial customers.
•Progress discussions with potential strategic partners.
Clinical Evidence:
•Continue to expand the evidence portfolio to drive further reimbursement, coverage and guideline inclusion.
32
Execution of commercial objectives over the short to medium term is expected to result in a step change in growth
Positive Growth Outlook
33
Continued growth in commercial
sales is expected from new and
existing customers.
Demand from public healthcare
providers in New Zealand is
expected to grow strongly and
positively impact laboratory
throughput volumes.
U.S. demand is expected to be
positively impacted from having
national product specific CPT
codes and a national CMS
reimbursement price in place.
Inclusion in the NCCN guidelines
recommendations for surveillance
of high risk patients is expected to
positively impact commercial
growth in the U.S.
Compelling clinical validation and
clinical utility evidence is expected
to facilitate significantly stronger
test adoption, reimbursement and
further guideline inclusion.
Total operating expenses in FY20
are expected to remain in line
with FY19.
Capital Raising
Pacific Edge is seeking to raise NZ$20m through a fully underwritten placement
and rights issue
The offer is
to provide capital
resources to assist
the company to
progress
commercial
objectives in the
targeted markets
and become cash
flow positive as
soon as
possible. In the
absence of LCD
inclusion or other
material
commercial
development, this
capital is expected
to provide funding
until January 2021.
Purpose:
Summary of Offer Terms:
Placement
Offer Size $7.0m (46,666,667m shares) fully underwritten
Offer Price $0.15 per new share, representing a 11.8% discount to five day VWAP prior to announcement of $0.170 per share
Ranking
New Shares issued on completion of the Placement will rank equally with existing shares and will be quoted on NZX and
be eligible to participate in the Rights Offer
Eligibility Institutional Investors and New Zealand resident clients of retail brokers
1 for 4.25 Rights Offer
Offer Size $13.1m (131,362,852m shares) fully underwritten
Offer Price
$0.10 per new share, representing a 41.2% discount to five day VWAP prior to announcement of $0.170 per share and a
34.0% discount to the Theoretical-Ex-Rights and Placement Adjusted Price of $0.152 per share
Ranking New Shares issued on completion of the Rights Offer will rank equally with Pacific Edge’s existing quoted ordinary shares
Eligibility
Any person who is recorded in Pacific Edge’s share register as a Shareholder at 5.00pm (NZ time) on the Record Date:
(a) whose address is shown in Pacific Edge’s share register as being in New Zealand, Australia or Singapore; or (b)
whose address is shown in Pacific Edge’s share register as being in Hong Kong who Pacific Edge considers is a
professional investor as defined in the Securities and Futures Ordinance (Cap.571) of the Laws of Hong Kong; and, in
each case, to whom Pacific Edge, in its sole discretion, is satisfied that the Offer may lawfully be made under all
applicable laws without the need for any registration, lodgment or other formality and who is not in the United States and
is not acting for the account or benefit of a person in the United States
Rights
Trading
PEB intends that the Rights will be quoted on the NZX Main Board
35
Capital Raising Timetable
Offer announced 21 November 2019
Placement
Placement conducted under trading halt 21 November 2019
Trading expected to resume 22 November 2019
Settlement and allotment of placement shares 26 November 2019
Rights Offer
Shares quoted "ex-rights" and Rights trading commence 28 November 2019
Record date for rights issue Offer Document 29 November 2019
Offer Document and Acceptance Forms sent to Eligible Shareholders 2 December 2019
Rights Trading cease 5 December 2019
Rights Offer closes 11 December 2019
Settlement and allotment of rights issue shares 18 December 2019
36
FY20 Interim Result and Capital Raising Presentation
21 November 2019
---
Pacific Edge Limited
Corporate Action Notice
(Other than for a Distribution)
Page 1 of 2
Section 1: issuer information (mandatory)
Name of issuer Pacific Edge Limited
Class of Financial Product Ordinary shares
NZX ticker code PEB
ISIN (If unknown, check on NZX
website)
NZPEBE0002S1
Name of Registry Link Market Services Limited
Type of corporate action
(Please mark with an X in the relevant
box/es)
Share purchase
plan
Renounceable
Rights issue
X
Capital
reconstruction
Non
Renounceable
Rights issue
Call Bonus issue
Record date 29/11/2019
Ex-Date (one business day before the
Record Date)
28/11/2019
Currency NZ$
Section 2: Rights issue)
Number of Rights to be issued 131,362,852
Number of Financial Products to be
issued under the Rights issue
131,362,852
ISIN of Rights Security (if applicable) Not yet assigned
Minimum entitlement N/A
Entitlement ratio (for example 1 for 2) New 1 Existing 4.25
Treatment of fractions Rounded down
Subscription price $0.10
Letters of entitlement mailed 2/12/2019
Offer close 5pm, 11/12/2019
Quotation Date (if applicable) Market open on:
28/11/2019
Allotment Date Market open on:
18/12/2019
Section 7: Authority for this announcement (mandatory)
Name of person authorised to make this Kate Rankin (CFO, Pacific Edge)
2 of 2
announcement
Contact person for this announcement Kate Rankin (CFO, Pacific Edge)
Contact phone number +64 3 479 8510
Contact email address kate.rankin@pelnz.com
Date of release through MAP 21/11/2019
---
4706210v02
21 November 2019
NZX Limited
Level 1, NZX Centre
11 Cable Street
Wellington
PACIFIC EDGE LIMITED (NZX: PEB): RIGHTS ISSUE
NOTICE PURSUANT TO CLAUSE 20(1)(a) OF SCHEDULE 8 TO THE FINANCIAL MARKETS
CONDUCT REGULATIONS 2014
1. Pacific Edge Limited (Pacific Edge) has announced that it intends to raise approximately
$20.1 million (Offer). The Offer will consist of:
a. a fully underwritten placement of $7.0 million; and
b. a fully underwritten renounceable rights issue to raise approximately $13.1 million.
2. The Offer is for new fully paid ordinary shares of the same class as already quoted on the
NZX Main Board operated by NZX Limited. The Offer is fully underwritten by Forsyth Barr
Group Limited and Jarden Partners Limited.
3. Pursuant to clause 19 of Schedule 1 of the Financial Markets Conduct Act 2013 (FMCA) and
clause 20 of Schedule 8 of the Financial Markets Conduct Regulations 2014 (FMC
Regulations), Pacific Edge advises that:
a. The Offer is being made in reliance upon the exclusion in clause 19 of Schedule 1 of
the FMCA and Pacific Edge is giving this notice under clause 20(1)(a) of Schedule 8
of the FMC Regulations.
b. As at the date of this notice, Pacific Edge is in compliance with the continuous
disclosure obligations that apply to it in relation to Pacific Edge's ordinary shares.
There is no information that is "excluded information" as defined in clause 20(5) of
Schedule 8 of the FMC Regulations.
c. As at the date of this notice, Pacific Edge is in compliance with its financial reporting
obligations.
4. The Offer is not expected to have any material effect or consequence on the control of Pacific
Edge.
On behalf of
Pacific Edge Limited
Chris Gallaher
Chairman
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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