VolitionRx — New platform format; more proof-of-concept data

VolitionRx (NYSE: VNRX)

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Research: Healthcare

VolitionRx — New platform format; more proof-of-concept data

The last several months were eventful for VolitionRx. The publication of the first ever proof-of-concept data in haematological cancers was the R&D highlight in Q419. On the corporate front, the company has acquired Octamer, now an in-house manufacturer of a key assay component, and is rapidly developing its veterinary subsidiary in the US. From a platform perspective, VolitionRx is moving away from traditional ELISA plates to a new format immunoassay based on magnetic particles. This is expected to improve the analytical performance of VolitionRx’s Nu.Q assays in the clinical studies. Our valuation stays at $223m or $5.42/share.

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Healthcare

VolitionRx

New platform format; more proof-of-concept data

Q419 company results

Healthcare equipment & services

28 February 2020

Price

US$3.33

Market cap

US$137m

Net cash ($m) at end Q419

14.1

Shares in issue

41.2m

Free float

55%

Code

VNRX

Primary exchange

NYSE

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(28.4)

(37.6)

15.2

Rel (local)

(22.0)

(34.0)

8.0

52-week high/low

US$6.42

US$2.90

Business description

VolitionRx is a life sciences company developing novel, simple-to-use, blood-based tests to diagnose a range of cancers and conditions by identifying and measuring nucleosomes in the blood stream. The primary focus is to develop the Nu.Q family of blood-based diagnostics tests for cancer.

Next events

Proof-of-concept data with product-grade assays

2020

Updates on the studies run with the National Taiwan University

2020

Update on the collaboration with the Texas A&M University in animal health

2020

Updates on the studies run with Fosun Long March

2020

Analyst

Jonas Peciulis

+44 (0)20 3077 5728

VolitionRx is a research client of Edison Investment Research Limited

The last several months were eventful for VolitionRx. The publication of the first ever proof-of-concept data in haematological cancers was the R&D highlight in Q419. On the corporate front, the company has acquired Octamer, now an in-house manufacturer of a key assay component, and is rapidly developing its veterinary subsidiary in the US. From a platform perspective, VolitionRx is moving away from traditional ELISA plates to a new format immunoassay based on magnetic particles. This is expected to improve the analytical performance of VolitionRx’s Nu.Q assays in the clinical studies. Our valuation stays at $223m or $5.42/share.

Year end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
($)

P/E
(x)

Yield
(%)

12/18

0.0

(18.0)

(0.57)

0.0

N/A

N/A

12/19

0.0

(16.1)

(0.41)

0.0

N/A

N/A

12/20e

0.0

(17.4)

(0.43)

0.0

N/A

N/A

12/21e

0.1

(18.8)

(0.44)

0.0

N/A

N/A

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

Moving to magnetic particle-based assays

Historically, VolitionRx developed its Nu.Q assays using the classic ELISA plate-based technique. Although it had the advantage of being a very cost-effective method, VolitionRx recognised the need for a high-throughput solution. Therefore, the company has decided to move away from ELISA solid-surface plates and instead use magnetic particles to precipitate nucleosomes from blood plasma (magnetic immunoassay). When compared to ELISA, the new format provides a 10–20x improvement in sensitivity, a significant increase in the reproducibility of results and a test turnaround time improvement to around one hour 20 minutes from six hours before. VolitionRx plans to use the new format in its all clinical trials.

Financials: Well-controlled costs

VolitionRx reported an operating loss of $16.1m in FY19, compared to $17.9m a year ago, largely in line with our expectations. Its cash position at the end of 2019 was $17.0m ($2.8m in debt). VolitionRx has received in total $16.5m in cash from warrant exercises by existing shareholders ($3.3m were received in non-dilutive funding). Cash burn remained stable at around $1.2m per month in 2019. Assuming a similar level of cash burn (approximately $3.6m per quarter), our model suggests a runway to 2021.

Valuation: $223m or $5.42/share

Our valuation of VolitionRx is virtually unchanged at $223m or $5.42/share as rolling our model forward was offset by a lower net cash position. Our other R&D assumptions, detailed in our previous notes, remain unchanged, but we note that VolitionRx has multiple ongoing projects, which could result in new product ranges beyond those included in our model at this point, such as new cancer indications (blood cancer), Nu.Q Vet for animal health and Nu.Q Capture for liquid biopsy.

First ever proof-of-concept data in haematological malignancies

In December 2019, VolitionRx released results from a proof-of-concept study testing its Nu.Q assays in lymphoma and leukaemia. A single Nu.Q assay correctly detected 80% of newly diagnosed cases (at 95% of specificity) of non-Hodgkin’s lymphoma (NHL), acute lymphocytic leukaemia (ALL) and acute myeloid leukaemia (AML). The area under the curve (AUC) was 91%. These results were achieved with only one assay. There is also potential for a multi assay panel in blood cancers as well, as VolitionRx reported that a number of its other Nu.Q assays reported individual performance results within the range of 79–91%.

This was the first time VolitionRx released Nu.Q performance results in haematological malignancies. Furthermore, the results demonstrated in these indications was the best single Nu.Q assay performance in any cancer tested by VolitionRx. Therefore, we believe that the company will explore this direction further even though the primary indications of interest remain colorectal, lung and prostate cancer. VolitionRx mentioned that the next step in haematological malignancies is to conduct a larger clinical trial using patient blood samples.

It is too early to consider how Nu.Q could fit in the current diagnostic protocols in these cancers, but definitive tools to diagnose blood malignancies are tissue sample analysis obtained by lymph node biopsy or bone marrow aspiration, so highly invasive. An accurate, non-invasive, blood-based test would have an advantage in this setting, but more Nu.Q performance data are needed.

In our last outlook report we described the proof-of-concept data with product grade assays in lung and colorectal cancers released last year.

Octamer acquisition ensures supply of key component

From a corporate development perspective, the acquisition of Octamer was the highlight of Q419. In December 2019, VolitionRx announced that its Belgian subsidiary had reached an agreement to acquire epigenetics company Octamer for approximately €650k ($725k) in cash and restricted common stock of VolitionRx (€350k cash plus 73,000 shares). In addition, the parties entered into a five-year royalty agreement, based on which previous owners of Octamer would receive single-digit royalties from sales of recombinant nucleosomes to pharma companies. This was a strategic acquisition, which ensured that VolitionRx now has a full control of the supply of the key component for its product grade assays, the recombinant nucleosome used as the calibrant. In our last outlook report we described in detail how transformative the development of the recombinant nucleosome was for VolitionRx’s Nu.Q technology.

In addition to recombinant nucleosomes, Octamer also manufactures and sells histones, octamers and DNA templates, which are used in epigenetic research and drug discovery. VolitionRx indicated that it will explore the opportunity to commercialise Octamer’s remaining product portfolio as well, although no specific details have been given yet.

Financials and valuation

VolitionRx reported an operating loss of $16.1m in FY19, compared to $17.9m a year ago, largely in line with our expectations. The company had cash of $17.0m at end-Q419 ($2.8m in debt) vs $13.4m a year ago. Throughout 2019 VolitionRx received in total $16.5m in cash from warrant exercises by existing shareholders, demonstrating strong support. An additional $3.3m was received in non-dilutive funding. Cash burn remained stable at around $1.2m per month in 2019. Assuming a similar level of cash burn (approximately $3.6m per quarter), our model suggests a runway to 2021. We include $10m in the form of long-term debt (as per our principles) to fund the operations until the end of 2021.

Our valuation of VolitionRx is unchanged at $223m or $5.42/share, as rolling our model forward was offset by a lower net cash position (vs our last update issued in November 2019). Our other R&D assumptions, detailed in our previous notes, remain unchanged. VolitionRx, however, has multiple ongoing projects, which could result in product ranges beyond those included in our model at this point, such as new cancer indications (blood cancer), Nu.Q Vet and Nu.Q Capture. These projects are still relatively early, and we therefore do not include them in our valuation.

Newsflow that VolitionRx expects to report in 2020 includes:

more clinical data with the upgraded magnetic particle-based assays in a range of cancers;

updates on the large-scale trials in Asia, Europe and the US (more details in our last report);

progress within its Nu.Q Vet program; the company expects to complete pre-analytical and clinical studies and launch the first product potentially even this year;

2019 was a breakthrough year for VolitionRx’s so called Nu.Q Capture project, which is exploring the use of Nu.Q technology to enrich cancer nucleosomes for liquid biopsy; in coming months VolitionRx expects to report more updates; and

publications of abstracts and peer-reviewed articles with clinical results.

Exhibit 1: Valuation of VolitionRx

Product

Main indication

Status

Prob. of commercial success

Launch year

Peak sales ($m)

Patent protection

Economics

rNPV ($m)

Nu.Q

Colorectal

Development

30%

2021

$404

2034

56% peak margin

$161

 

Colorectal triage

Development

40%

2021

$42

2034

50% peak margin

$11

 

Lung

Development

20%

2022

$132

2034

61% peak margin

$30

Pancreatic

Development

20%

2022

$42

2034

58% peak margin

$7

Total

 

 

 

 

$209

Net cash and cash equivalents (last reported, $m)

$14.1

Total firm value ($m)

$223

Total number of basic shares (m)

41.2

Value per basic share ($)

$5.42

Warrants and options (m)

4.4

Weighted average exercise price ($)

$3.84

Cash on exercise ($m)

$16.7

Total firm value (fully diluted) ($m)

$239

Total number of shares (fully diluted) (m)

45.4

Value per share (fully diluted) ($)

$5.27

Source: Edison Investment Research, VolitionRx reports

Exhibit 2: Financial summary

$000s

2017

2018

2019

2020e

2021e

Year end 31 December

US GAAP

US GAAP

US GAAP

US GAAP

US GAAP

PROFIT & LOSS

Revenue

 

 

0

0

17

30

100

Cost of Sales

0

0

0

0

(183)

Gross Profit

0

0

17

30

(83)

Research & Development

(8,906)

(10,907)

(10,363)

(10,985)

(11,644)

Sales, General & Administrative

(6,140)

(6,991)

(5,697)

(6,266)

(6,893)

EBITDA

 

 

(15,046)

(17,898)

(16,085)

(17,221)

(18,620)

Operating profit (before amort. and except.)

 

 

(15,046)

(17,898)

(16,085)

(17,221)

(18,620)

Intangible Amortisation

0

0

0

0

0

Other

0

0

(42)

0

0

Exceptionals

0

0

0

0

0

Operating Profit

(15,046)

(17,898)

(16,085)

(17,221)

(18,620)

Net Interest

(73)

(111)

(14)

(143)

(221)

Other

414

0

0

0

0

Profit Before Tax (norm)

 

 

(15,119)

(18,009)

(16,099)

(17,364)

(18,842)

Profit Before Tax (FRS 3)

 

 

(14,705)

(18,009)

(16,099)

(17,364)

(18,842)

Tax

0

0

0

0

0

Deferred tax

(0)

(0)

(0)

(0)

(0)

Profit After Tax (norm)

(15,119)

(18,009)

(16,099)

(17,364)

(18,842)

Profit After Tax (FRS 3)

(14,705)

(18,009)

(16,099)

(17,364)

(18,842)

Average Number of Shares Outstanding (m)

26.4

31.4

39.2

40.7

42.4

EPS - normalised ($)

 

 

(0.57)

(0.57)

(0.41)

(0.43)

(0.44)

EPS - FRS 3 ($)

 

 

(0.56)

(0.57)

(0.41)

(0.43)

(0.44)

Dividend per share ($)

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

4,057

3,587

3,735

3,020

2,477

Intangible Assets

576

467

372

372

372

Tangible Assets

3,481

3,120

2,981

2,266

1,723

Other

(0)

0

381

381

381

Current Assets

 

 

10,319

13,657

17,289

1,566

644

Stocks

0

0

0

0

9

Debtors

0

0

0

5

18

Cash

10,116

13,427

16,966

1,238

295

Other

202

230

323

323

323

Current Liabilities

 

 

(2,290)

(2,333)

(3,860)

(3,327)

(3,593)

Creditors

(1,847)

(1,917)

(3,212)

(2,679)

(2,946)

Short term borrowings

(444)

(417)

(648)

(648)

(648)

Long Term Liabilities

 

 

(2,376)

(3,015)

(3,233)

(3,233)

(13,233)

Long term borrowings

(1,313)

(1,984)

(2,195)

(2,195)

(12,195)

Other long term liabilities

(1,063)

(1,031)

(1,038)

(1,038)

(1,038)

Net Assets

 

 

9,709

11,895

13,931

(1,975)

(13,705)

CASH FLOW

Operating Cash Flow

 

 

(12,193)

(14,733)

(12,739)

(15,728)

(10,942)

Net Interest

0

0

0

0

0

Tax

0

0

0

0

0

Capex

(1,425)

(302)

(511)

0

(1)

Acquisitions/disposals

0

0

0

0

0

Financing

998

17,245

16,591

0

0

Dividends

0

0

0

0

0

Other

(136)

(138)

(142)

0

0

Net Cash Flow

(12,756)

2,073

3,198

(15,728)

(10,943)

Opening net debt/(cash)

 

 

(21,216)

(8,360)

(11,026)

(14,123)

1,605

HP finance leases initiated

0

0

0

0

0

Exchange rate movements

(89)

(379)

140

0

0

Other

(12)

973

(241)

0

0

Closing net debt/(cash)

 

 

(8,360)

(11,026)

(14,123)

1,605

12,548

Source: Company data, Edison Investment Research


General disclaimer and copyright

This report has been commissioned by VolitionRx and prepared and issued by Edison, in consideration of a fee payable by VolitionRx. 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.

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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.

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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 VolitionRx and prepared and issued by Edison, in consideration of a fee payable by VolitionRx. 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 2020 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2020. “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 Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). 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

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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Research: Healthcare

Telix Pharmaceuticals — Progress on clinical, regulatory and BD fronts

Telix has had a raft of announcements, marking its steady progress in a range of areas. Notably, the company received feedback from the FDA regarding the clinical briefing package to support an NDA for illumet, which it says should be ready in March or April 2020. Additionally, Telix will be expanding its pivotal ZIRCON study of TLX250-CDx to the US with the recent IND filing for the program. The company also provided a first look at its Phase I/II study of TLX101 for glioblastoma multiforme (GBM). Finally, it announced two separate deals for preclinical programs.

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