VolitionRx — Something innovative in the state of Denmark

VolitionRx (NYSE: VNRX)

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Research: Healthcare

VolitionRx — Something innovative in the state of Denmark

VolitionRx recently announced the initiation of a two-phase logistical study for its Nu.Q™ Triage test for colorectal cancer (CRC) in Denmark, which may enable the inclusion of the test in the country’s national screening program in conjunction with the standard fecal immunochemical test (FIT). The study is expected to take six months to complete with the potential for a decision by the national screening committee by the end of the year. If included, the Nu.Q™ Triage test would be the first blood-based cancer diagnostic as part of a national screening program for CRC.

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Healthcare

VolitionRx

Something innovative in the state of Denmark

Q4 update

Pharma & biotech

20 March 2017

Price

US$4.42

Market cap

US$116m

Net cash ($m) at end Q416

21.2

Shares in issue

26.1m

Free float

74%

Code

VNRX

Primary exchange

NYSE MKT

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(0.2)

10.5

21.8

Rel (local)

(1.4)

4.9

4.5

52-week high/low

US$5.6

US$3.1

Business description

VolitionRx is a diagnostics company focused on developing blood-based cancer diagnostics using its proprietary Nu.Q™ technology. Its lead program is in colorectal cancer, which recently received a CE Mark, allowing for commercialization in Europe

Next events

8,000 subject data at Digestive Disease Week Annual Meeting

May 2017

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

VolitionRx is a research client of Edison Investment Research Limited

VolitionRx recently announced the initiation of a two-phase logistical study for its Nu.Q™ Triage test for colorectal cancer (CRC) in Denmark, which may enable the inclusion of the test in the country’s national screening program in conjunction with the standard fecal immunochemical test (FIT). The study is expected to take six months to complete with the potential for a decision by the national screening committee by the end of the year. If included, the Nu.Q™ Triage test would be the first blood-based cancer diagnostic as part of a national screening program for CRC.

Year
end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
($)

P/E
(x)

Yield
(%)

12/15

0.0

(9.7)

(0.54)

0.0

N/A

N/A

12/16

0.0

(12.3)

(0.53)

0.0

N/A

N/A

12/17e

1.6

(15.3)

(0.58)

0.0

N/A

N/A

12/18e

4.1

(19.6)

(0.71)

0.0

N/A

N/A

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

Unnecessary colonoscopies mar screening programs

Current screening methodologies, such as the FIT test, lead to a large number of false positives. According to data from national screening programs that use FIT, there are around 20 false positives for every true positive, leading to a large number of unnecessary colonoscopies, which tax the health system.

Recent data illustrates the test’s potential

At the 2017 World Congress of GI Endoscopy, VolitionRx presented data based on 3,868 samples of the Nu.Q™ Triage test combined with FIT, which indicated the potential to reduce colonoscopies by 28.6% by reducing the number of false positives. Updated data from around 8,000 samples will be presented at Digestive Disease Week (May 6-9 in Chicago).

Denmark may be first country to validate approach

Once the two-phase study is completed in Denmark later this year, Nu.Q™ could potentially be included in the national screening program starting in January. Besides the revenue from that 20,000-40,000 test order (we assume €50 per test), it would provide validation to the approach and may make inclusion in other national screening programs more likely.

Valuation: $272m or $10.40 per basic share

We have increased our valuation slightly to $272m or $10.40 per basic share, from $267m or $10.23 per basic share. This is mainly due to rolling our NPVs to 2017 and was mitigated by a lower cash balance. Due to continued expense control we have also lowered our operating expense estimates, so that we now expect the company to be slightly cash flow positive in 2020 (previously 2021). We continue to expect VolitionRx to need $45m in cash prior to profitability.

Starting the process in Denmark

In collaboration with Hvidovre Hospital and the Danish Research Group on Early Detection of Colorectal Cancer, Volition has initiated a two-phase logistical study to study some of the practical aspects of including the Nu.Q™ Triage test in the national screening program as an additional layer of screening on top of the standard FIT test. The first phase started in early March in the Capital Region of Denmark and involves three local screening centers and up to 250 subjects. The objective is to evaluate the logistics of collecting and processing the blood samples at a local screening center and then shipping them to a central laboratory in Denmark. The second phase will involve five centers and up to 500 subjects to assess the time that it will take to collect, analyze and deliver results. The results will be delivered directly to the national screening committee with the hope of inclusion in the full screening program, which is slated to start in January 2018.

If it is included, VolitionRx would need to be notified in Q4 in order to provide the estimated 20-40,000 tests required. It would also position the Nu.Q™ Triage test as the only blood-based cancer diagnostic for colorectal cancer to be validated through inclusion in a national screening program. Currently, countries have been generally slow to rollout national screening programs partly due to the fear of the wave of colonoscopies that it would create, leading to low coverage across much of the EU (see Exhibit 1). A positive experience in Denmark could pave the way to increased acceptance into other national screening programs.

Exhibit 1: Percent of populations participating in national CRC screening programs

Source: Cancer Screening in the European Union (2017) by the International Agency for Research on Cancer

According to the International Agency for Research on Cancer, the positive predictive value for the fecal FIT test is 4.4%, meaning there are approximately 20 false positives for every true positive in national screening programs that use it (see Exhibit 2). Importantly, at the 2017 World Congress of GI Endoscopy, VolitionRx presented data based on 3,868 samples of the Nu.Q™ Triage test combined with FIT, which indicated the potential to reduce colonoscopies by 28.6% by reducing the number of false positives.

Exhibit 2: Type of tests used for CRC screening

Source: Cancer Screening in the European Union (2017) by the International Agency for Research on Cancer

With regards to the United States, the company has recently founded a US subsidiary, Volition America, to focus on the efforts of obtaining first a 510(k) and then a PMA approval for Nu.Q™. The company is hoping to announce details on the US approval efforts in the next quarter or two.


Valuation

We have increased our valuation slightly to $272m or $10.40 per basic share, from $267m or $10.23 per basic share. This is mainly due to rolling our NPVs to 2017 and was mitigated by a lower cash balance. We expect to revise our valuation following updates on the company’s US strategy, as well as updates on the process for Nu.Q™ Triage inclusion into national screening programs.

Exhibit 3: VolitionRx valuation table

Product

Main indication

Status

Prob. of commercial success

Launch year

Peak sales ($m)

Patent protection

Economics

rNPV ($m)

NuQ

Colorectal

Development

30%

2017

$404

2034

56% peak margin

$180

 

Colorectal triage

Pre-commercialization

30%

2017

$42

2034

50% peak margin

$17

 

Lung

Development

30%

2018

$145

2034

61% peak margin

$43

Pancreatic

Development

30%

2018

$37

2034

58% peak margin

$10

Total

 

 

 

 

 

 

 

$250

Cash and cash equivalents (Q416) ($m)

$21.2

Total firm value ($m)

$272

Total basic shares (m)

26.1

Value per basic share ($)

$10.40

Warrants and options (12/2016, m)

2.2

Weighted average exercise price ($)

$2.40

Cash on exercise ($m)

$5.2

Total firm value ($m)

$277

Non-warrant options (6/2016, m)

2.4

Total number of shares (m)

30.7

Diluted value per share ($)

$9.03

Source: VolitionRx reports, Edison Investment Research

Financials

The company ended Q416 with $21.2m in net cash with an operating loss for the quarter of $3.3m. This loss is a slight decrease over Q3 (loss of $3.5m), reflecting continued expense control. Due to this, we have lowered our expected operational loss for 2017 from $16.7m to $15.4m and now expect the company to become cash flow positive in 2020 (previously 2021). We continue to expect the company to need $45m in cash prior to profitability.

Exhibit 4: Financial summary

$000s

2012

2013

2014

2015

2016e

2017e

2018e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

55

0

15

0

0

1,622

4,086

Cost of Sales

0

0

0

0

0

(229)

(537)

Gross Profit

55

0

15

0

0

1,393

3,549

Research & Development

(2,843)

(2,504)

(4,044)

(6,102)

(6,838)

(8,621)

(9,483)

Sales, General & Administrative

(1,295)

(2,072)

(1,908)

(3,904)

(5,429)

(8,171)

(12,511)

EBITDA

 

 

(4,083)

(4,576)

(5,937)

(10,006)

(12,267)

(15,399)

(18,446)

Operating Profit (before GW and except.)

(4,083)

(4,576)

(5,937)

(10,006)

(12,267)

(15,399)

(18,446)

Intangible Amortisation

0

0

0

0

0

0

0

Other

0

0

0

0

0

0

0

Exceptionals

0

0

0

0

0

0

0

Operating Profit

(4,083)

(4,576)

(5,937)

(10,006)

(12,267)

(15,399)

(18,446)

Net Interest

0

0

0

0

0

71

(1,121)

Other

(39)

840

(2,320)

471

252

0

0

Profit Before Tax (norm)

 

 

(4,083)

(4,576)

(8,358)

(9,666)

(12,267)

(15,327)

(19,567)

Profit Before Tax (FRS 3)

 

 

(4,122)

(3,736)

(8,258)

(9,535)

(12,014)

(15,327)

(19,567)

Tax

0

0

(0)

5

0

0

0

Deferred tax

0

0

(0)

(0)

(0)

(0)

(0)

Profit After Tax (norm)

(4,083)

(4,576)

(8,358)

(9,661)

(12,267)

(15,327)

(19,567)

Profit After Tax (FRS 3)

(4,122)

(3,736)

(8,258)

(9,530)

(12,014)

(15,328)

(19,567)

Average number of shares outstanding (m)

9.4

10.8

13.5

17.7

23.0

26.7

27.7

EPS - normalised (c)

 

 

(43.62)

(42.24)

(62.08)

(54.49)

(53.22)

(57.51)

(70.60)

EPS - FRS 3 ($)

 

 

(0.44)

(0.34)

(0.61)

(0.54)

(0.52)

(0.58)

(0.71)

Dividend per share ($)

0.0

0.0

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

1,522

1,065

1,097

1,489

2,721

2,243

1,890

Intangible Assets

1,430

1,002

809

705

602

602

602

Tangible Assets

91

63

289

784

2,119

1,640

1,288

Other

0

0

(0)

(0)

(0)

(0)

(0)

Current Assets

 

 

416

941

2,192

6,070

21,846

23,120

20,954

Stocks

0

0

0

0

0

11

26

Debtors

0

0

0

0

0

289

728

Cash

376

889

2,139

5,916

21,679

22,652

20,033

Other

39

53

53

154

167

167

167

Current Liabilities

 

 

(695)

(957)

(2,713)

(1,120)

(2,033)

(1,478)

(1,848)

Creditors

(695)

(957)

(2,713)

(1,120)

(2,003)

(1,478)

(1,848)

Short term borrowings

0

0

0

0

(31)

0

0

Long Term Liabilities

 

 

(635)

(433)

(352)

(548)

(1,524)

(16,524)

(31,524)

Long term borrowings

0

0

0

0

(432)

(15,432)

(30,432)

Other long term liabilities

(635)

(433)

(352)

(548)

(1,092)

(1,092)

(1,092)

Net Assets

 

 

607

617

224

5,891

21,009

7,360

(10,528)

CASH FLOW

Operating Cash Flow

 

 

(2,315)

(3,084)

(4,141)

(8,766)

(9,056)

(13,966)

(17,578)

Net Interest

0

0

0

0

0

0

0

Tax

0

0

0

0

0

0

0

Capex

(91)

(1)

(303)

(352)

(415)

(30)

(41)

Acquisitions/disposals

0

0

0

0

0

0

0

Financing

2,576

2,828

5,627

12,498

25,302

0

0

Dividends

0

0

0

0

0

0

0

Other

0

0

0

0

(553)

0

0

Net Cash Flow

171

(257)

1,183

3,379

15,279

(13,996)

(17,619)

Opening net debt/(cash)

 

 

(348)

(376)

(889)

(2,139)

(5,916)

(21,216)

(7,220)

HP finance leases initiated

0

0

0

0

0

0

0

Exchange rate movements

(40)

4

(44)

13

146

0

0

Other

(103)

765

111

385

(125)

0

0

Closing net debt/(cash)

 

 

(376)

(889)

(2,139)

(5,916)

(21,216)

(7,220)

10,399

Source: VolitionRx reports, Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world-renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisers and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2017 Edison Investment Research Limited. All rights reserved. This report has been commissioned by VolitionRx and prepared and issued by Edison for publication globally. 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. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US 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. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and 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 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. This document is provided 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.
Edison has a restrictive policy relating to personal dealing. 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. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. 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. 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 (ie 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. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2017. “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.

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

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 8249 8342

Level 12, 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

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world-renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisers and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2017 Edison Investment Research Limited. All rights reserved. This report has been commissioned by VolitionRx and prepared and issued by Edison for publication globally. 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. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US 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. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and 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 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. This document is provided 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.
Edison has a restrictive policy relating to personal dealing. 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. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. 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. 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 (ie 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. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2017. “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.

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

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 8249 8342

Level 12, 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

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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