2019 finishes strongly

Pacific Edge 10 June 2019 Update
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Pacific Edge

2019 finishes strongly

Financial update

Pharma & biotech

10 June 2019

Price

NZ$0.22

Market cap

NZ$112m

NZ$1.54/US$

Net cash (NZ$m) at 31 March 2019

12.8

Shares in issue

510.8m

Free float

96%

Code

PEB

Primary exchange

NZX

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(13.7)

(26.7)

(13.7)

Rel (local)

(13.6)

(30.2)

(20.9)

52-week high/low

NZ$0.44

NZ$0.18

Business description

Pacific Edge develops and sells a portfolio of molecular diagnostic tests based on biomarkers for the early detection and management of cancer. Tests utilising its Cxbladder technology for detecting and monitoring bladder cancer are sold in the US, New Zealand, Australia and Singapore.

Next events

LCD inclusion

2019/20

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

Pacific Edge is a research client of Edison Investment Research Limited

Pacific Edge recently reported FY19 results, including 12.3% growth in Cxbladder sales compared to FY18. These sales exclude tests for patients covered by the US Centers for Medicare and Medicaid Services (CMS), which currently account for approximately 50% of lab throughput. Total lab throughput increased by 8.6% during the year, with Q419 up 26% compared to Q418 and up 12% compared to the prior quarter. Rest of world (ROW) throughput (which represents 20% of the total) increased by 126% in the quarter versus Q418, mainly due to strength in the New Zealand market.

Year end

Revenue (NZ$m)

PBT*
(NZ$m)

EPS*
(c)

DPS
(c)

P/E
(x)

Yield
(%)

03/18

4.6

(19.6)

(4.5)

0.0

N/A

N/A

03/19

4.8

(17.8)

(3.7)

0.0

N/A

N/A

03/20e

5.9

(17.4)

(3.4)

0.0

N/A

N/A

03/21e

24.5

(0.2)

(0.0)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

Working on CMS reimbursement

Pacific Edge is in the process of gaining inclusion in the CMS’s local coverage determination (LCD), which would enable reimbursement and negotiation for payment of more than 17,015 tests previously performed on patients covered by CMS as of the end of FY19. The company has completed two of the three components necessary for national reimbursement in the US, namely CPT codes and a national price of US$760 per test.

12.3% increase in Cxbladder sales

Cxbladder sales were up 12.3% to NZ$3.8m in FY19. Total laboratory throughput increased 8.6% over FY18 to 15,697 tests, while the total number of billable tests increased 7% to 12,744 (81.2% of the total). This is slightly lower than previous guidance from the company of growth between 10.7% and 17.7% growth (16,000 and 17,000 tests) in total laboratory throughput in FY19, exclusive of any major changes from new customers (like Kaiser Permanente) or CMS LCD inclusion.

New Zealand growth especially strong

ROW throughput was especially strong in the year, up 83%, with an especially strong fourth quarter where growth was 126% compared to Q418. This was mainly driven by New Zealand, where approximately 62% of the population have access to Cxbladder through public healthcare contracts.

Valuation: NZ$219m or NZ$0.43 per share

Our DCF-based valuation has been reduced from NZ$255m (NZ$0.52/share) to NZ$219m (NZ$0.43/share). This reflects a more conservative view of the sales ramp for the Cxbladder franchise in the US, a lower level of net cash and a greater number of shares outstanding. We now expect profitability in FY22 versus FY21 previously.

FY19 results

During FY19, operating revenue grew 12.3% to NZ$3.8m compared to the NZ$3.4m in FY18. Total reported revenue was NZ$5.1m in FY19, up from NZ$5.0m in the previous year. Note that in our financial model we subtract out the interest income and foreign exchange gain (or loss) that the company reports as revenue (per New Zealand accounting practices) and place these items below the operating line in order to normalise across international accounting standards (revenues in our model totals NZ$4.8m in FY19 and NZ$4.6m in FY18). Total laboratory throughput increased 8.6% over FY18 to 15,697 tests, while the total number of billable tests increased 7% to 12,744 (81.2% of the total). The final quarter of the fiscal year finished especially strongly with total lab throughput up 26% compared to Q418 and up 12% compared to the prior quarter. Rest of world (ROW) throughput (which represents 20% of the total) increased by 126% in the quarter vs Q418 mainly due to strength in the New Zealand market, where 62% of the population have access to Cxbladder and the Cxbladder Triage product (used to rule out low-risk patients and reduce the numbers of cystoscopies) is especially popular. Importantly, the company expects the New Zealand business to be cash flow positive in FY20.

Exhibit 1: Cxbladder contract coverage in New Zealand

Source: Pacific Edge

Note that the sales figures exclude the approximately 50% of tests for patients covered by CMS and that cumulatively 17,015 tests have yet to be booked (as of the end of FY19) as the company awaits an LCD. As a reminder, the company has completed two of the three components necessary for national reimbursement in the US, namely CPT codes and a national price of US$760 per test. The final step will be to gain inclusion in an LCD. An LCD is a document that includes the coverage decisions of the Medicare Administrative Contractor (MAC). An LCD would provide the conditions of the coverage as well as the price, guidance on reimbursement and coding information. Unfortunately there is no set process for achieving an LCD and in many ways it is the epitome of arbitrary bureaucracy.

Once an LCD inclusion is attained, reimbursement from CMS should become consistent and timely. Besides this immediate benefit of new tests being covered by CMS, the company may finally receive payment on the more than 17,000 tests previously conducted for CMS patients. Pacific Edge has not received payment for tests provided to patients covered by CMS until LCD inclusion so there could be a multi-year backlog of test revenue that would be recognised in a single reporting period post-inclusion. Based on a price of US$760 per test these payments could total US$12.9m. In addition, private payers often base their own coverage decisions and reimbursement levels on the coverage listed in an LCD, so a success here is expected to lead to faster growth for the company.

Valuation

Our DCF-based valuation has been reduced from NZ$255m (NZ$0.52/share) to NZ$219m (NZ$0.43/share). This reflects a more conservative view of the sales ramp for the Cxbladder franchise in the US, a lower level of net cash and a greater number of shares outstanding. We will revisit these estimates once CMS reimbursement is in place, as once LCD inclusion occurs revenue recognition would normalise and the backlog of unpaid tests from previous years would provide a boost to revenue as they are paid.

Exhibit 2: Valuation based on DCF

Discounted cash flow (NZ$000)

219,393

Net cash at 31 March 2019 (NZ$000)

12,847

Valuation (NZ$000)

219,393

Number of shares (m) at 31 March 2019

510.82

Value per share (NZ$)

0.43

Source: Edison Investment Research

Financials

We have lowered our FY20 revenues estimate to NZ$5.9m from NZ$10.2m as a lack of CMS reimbursement appears to be continuing to restrain sales in the US, and have also increased our estimates for operating expenses by NZ$0.3m as they came in slightly higher than expected. We are introducing FY21 estimates, which include NZ$24.5m in product sales, which assumes LCD inclusion and CMS reimbursement, and we expect profitability in FY22 (previously FY21).

Exhibit 3: Financial forecast changes

FY20e

FY21e

Old

New

Old

New

Revenue (NZ$m)

10.2

5.9

N/A

24.5

PBT (normalised) (NZ$m)

(13.2)

(17.4)

N/A

(0.2)

EPS (NZ$)

(0.03)

(0.03)

N/A

(0.00)

Source: Edison Investment Research

The company had net cash of NZ$12.8m at 31 March 2019 thanks to capital raises that brought in NZ$14.6m to the company. These include a NZ$2.6m share raise with Manchester Management Company, a US-based fund specialising in life sciences, an additional private placement of shares to raise proceeds of around NZ$7m through the issuance of around 20m shares at NZ$0.35 each, and a share purchase plan for New Zealand resident shareholders. We currently estimate the future financing needs of the company to be NZ$10m, unchanged from our previous estimate despite these recent additional sources of capital, as our sales estimates are now reduced.

Exhibit 4: Financial summary

NZ$000s

2018

2019

2020e

2021e

Year end 31 March

NZ GAAP

NZ GAAP

NZ GAAP

NZ GAAP

PROFIT & LOSS

Revenue

 

 

4,642

4,807

5,942

24,494

Cost of Sales

(4,619)

(4,594)

(5,053)

(5,559)

Gross Profit

23

213

889

18,935

EBITDA

 

 

(19,500)

(17,840)

(17,525)

(31)

Operating Profit (before amort. and except.)

(19,816)

(18,077)

(17,833)

(400)

Intangible Amortisation

(188)

(154)

(58)

(70)

Exceptionals

46

(4)

0

0

Operating Profit

(19,958)

(18,235)

(17,891)

(470)

Other

0

0

0

0

Net Interest

231

323

385

191

Profit Before Tax (norm)

 

 

(19,585)

(17,754)

(17,447)

(210)

Profit Before Tax (FRS 3)

 

 

(19,727)

(17,912)

(17,506)

(279)

Tax

0

(9)

0

0

Profit After Tax (norm)

(19,585)

(17,763)

(17,447)

(210)

Profit After Tax (FRS 3)

(19,727)

(17,921)

(17,506)

(279)

Average Number of Shares Outstanding (m)

438.4

481.2

510.9

510.9

EPS - normalised (c)

 

 

(4.5)

(3.7)

(3.4)

(0.0)

EPS - FRS 3 (c)

 

 

(4.5)

(3.7)

(3.4)

(0.1)

Dividend per share (c)

0.0

0.0

0.0

0.0

Gross Margin (%)

N/A

N/A

N/A

N/A

EBITDA Margin (%)

N/A

N/A

N/A

N/A

Operating Margin (before GW and except.) (%)

N/A

N/A

N/A

N/A

BALANCE SHEET

Fixed Assets

 

 

1,135

1,002

798

526

Intangible Assets

281

233

284

326

Tangible Assets

854

769

514

200

Other

0

0

0

0

Current Assets

 

 

18,530

15,564

9,079

9,903

Stocks

752

842

842

842

Debtors

1,064

1,265

1,265

1,265

Cash

16,242

12,847

6,362

7,186

Other

472

610

610

610

Current Liabilities

 

 

(2,999)

(2,624)

(12,624)

(12,624)

Creditors

(2,926)

(2,572)

(2,572)

(2,572)

Short term borrowings

0

0

(10,000)

(10,000)

Short term leases

(73)

(52)

(52)

(52)

Other

0

0

0

0

Long Term Liabilities

 

 

(26)

(32)

(32)

(32)

Long term borrowings

0

0

0

0

Long term leases

(26)

(32)

(32)

(32)

Other long term liabilities

0

0

0

0

Net Assets

 

 

16,640

13,910

(2,779)

(2,226)

CASH FLOW

Operating Cash Flow

 

 

(18,331)

(17,830)

(16,709)

801

Net Interest

231

323

385

191

Tax

0

0

0

0

Capex

(335)

(156)

(162)

(168)

Acquisitions/disposals

0

0

0

0

Financing

21,318

14,569

0

0

Dividends

0

0

0

0

Other

(1,261)

(275)

0

0

Net Cash Flow

1,622

(3,369)

(16,485)

824

Opening net debt/(cash)

 

 

(14,564)

(16,143)

(12,763)

3,722

HP finance leases initiated

(99)

15

0

0

Other

56

(26)

0

(0)

Closing net debt/(cash)

 

 

(16,143)

(12,763)

3,722

2,898

Source: Company accounts, Edison Investment Research


General disclaimer and copyright

This report has been commissioned by Pacific Edge and prepared and issued by Edison, in consideration of a fee payable by Pacific Edge. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2019 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2019. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd who holds an Australian Financial Services Licence (Number: 427484). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

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The Investment Research is a publication distributed in the United States by Edison Investment Research, Inc. Edison Investment Research, Inc. is registered as an investment adviser with the Securities and Exchange Commission. Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

Frankfurt +49 (0)69 78 8076 960

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Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

General disclaimer and copyright

This report has been commissioned by Pacific Edge and prepared and issued by Edison, in consideration of a fee payable by Pacific Edge. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2019 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2019. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd who holds an Australian Financial Services Licence (Number: 427484). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

The Investment Research is a publication distributed in the United States by Edison Investment Research, Inc. Edison Investment Research, Inc. is registered as an investment adviser with the Securities and Exchange Commission. Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1,185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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