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Pacific Edge FY20 Interim Results and Capital Raising

Full Year Results20 November 2019PEBHealthcare

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


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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


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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


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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


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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

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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.

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Disclaimer

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•any errors or omissions in this presentation; or

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this presentation or otherwise arising in connection with this presentation or the information contained in, or

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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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