Cohort 2 starts in ONCOS-102 melanoma trial

Targovax 12 March 2019 Update
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Targovax

Cohort 2 starts in ONCOS-102 melanoma trial

Q418 results

Pharma & biotech

12 March 2019

Price

NOK8.12

Market cap

NOK427m

Cash (NOKm) end-Q418 (excludes government long-term debt)

151

Shares in issue

52.6m

Free float

55%

Code

TRVX

Primary exchange

Oslo Stock Exchange

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(1.0)

(0.3)

(49.4)

Rel (local)

(3.4)

(2.8)

(50.5)

52-week high/low

NOK18.0

NOK7.0

Business description

Targovax is an immunoncology company headquartered in Oslo, Norway, with two technology platforms that are being developed in oncological indications. ONCOS-102 is an oncolytic virus technology. TG is a therapeutic cancer vaccine platform comprising peptides mimicking the most common RAS oncogenic mutations.

Next events

ONCOS-102 mesothelioma
Phase I data

H120

ONCOS-102 melanoma
Phase I interim data

H119

TG02 colorectal cancer
Phase I interim data readout

H119

TG01 pancreatic cancer three-year survival data

H119

Analysts

Jonas Peciulis

+44 (0)20 3077 5728

Alice Nettleton

+44 (0)20 3077 5700

Targovax is a research client of Edison Investment Research Limited

Targovax’s Q418 presentation discussed highlights from the past year, focusing on the data readouts from the TG01 study in pancreatic cancer (PC) and the ONCOS-102 melanoma Phase I data. Management’s plan for 2019 is largely unchanged: data from the first cohort of the ONCOS-102 melanoma study will be published in H119, treatment of the second cohort is ongoing and early interim data from TG02 colorectal cancer study will be published in H119. Management will also present three-year survival data from the TG01 PC study in H119 and is confident in finding a partner for continued development of TG01 in PC. Cash reaches into 2020, while our valuation is marginally higher at NOK1.46bn or NOK27.7/share.

Year end

Revenue (NOKm)

PBT*
(NOKm)

EPS*
(NOK)

DPS
(NOK)

P/E
(x)

Yield
(%)

12/17

0.0

(122.3)

(2.6)

0.0

N/A

N/A

12/18

0.0

(147.3)

(2.8)

0.0

N/A

N/A

12/19e

0.0

(140.2)

(2.7)

0.0

N/A

N/A

12/20e

0.0

(137.2)

(2.6)

0.0

N/A

N/A

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

ONCOS-102 Phase I melanoma study progressing

The focus for the next 12 months will be the ONCOS-102 Phase I melanoma study in combination with Keytruda in CPI refractory patients (discussed in our November 2018 update). ORR and immune data from the first cohort (n=9) will be published in H119, and the first patient from the second cohort (up to 12 patients, increased dosing) was treated on 11 February 2019. Meanwhile, management made progress on its TG platform development strategy and is confident of securing a collaboration agreement for TG01 in pancreatic cancer, potentially as soon as this year. This is now the main development path for the TG01 project, which was modified in response to changing standard of care in pancreatic cancer management (discussed in our June 2018 update).

Financials: Cash reach to 2020

Targovax reported immaterial revenues and an operating loss of NOK42.2m in Q418, compared to NOK32.5m in Q417, largely in line with our expectations. External Q418 R&D expenses were NOK21.0m versus NOK12.2m a year ago indicating a more intensive clinical R&D. Targovax had cash and cash equivalents of NOK151m at the end of Q418 and guided this should be sufficient to reach 2020, which is in line with our model.

Valuation: NOK1.46bn or NOK27.7/share

Our Targovax valuation is modestly higher at NOK1.46bn or NOK27.7/share compared to NOK1.41bn or NOK26.8/share due to rolling our model forward, which was partially offset by lower net cash position. All other assumptions for our rNPV model are unchanged except for a small modification in the colorectal cancer project (see below). ONCOS-102 melanoma Phase I interim data expected in H119 are the nearest major catalyst for the share price, while there will be several other data readouts over the next 12–18 months (Exhibit 4).

Additional immune data from ONCOS-102 first cohort

Targovax presented some additional observations from the first cohort in Phase I melanoma trial where patients were treated with the lead asset oncolytic virus ONCOS-102. Analyses were carried out on tumour biopsies from these patients and the findings suggest ONCOS-102 could effect T-cell activation. We see the results as encouraging, especially because there is a continuing correlation with patient 5 in terms of immune response, who was the only patient with a complete response. A more detailed review of the released data is in our November 2018 note, while the additional details presented during the Q418 results call include:

IFN-γ ELISPOT analyses of week three biopsies from two patients showed there were increases in tumour-specific T-cells in the tumours (an apparent infiltration of T-cells) measured by the number of T-cells that recognise tumour-specific antigens MAGE-A1 or NY-ESO-1. This suggests that treatment with ONCOS-102 may have elicited a T-cell response in these patients.

Exhibit 1: Data from two patients showing potential T-cell response

Granzyme B, a protease released by cytotoxic T-cells, was measured and data were presented from four patients showing a general increase in granzyme B from baseline to day 22, which had reduced again by day 64. The initial increase also suggests that treatment with ONCOS-102 may have elicited a T-cell response against the tumour. In patient 4 there was an apparent response in both the primary and non-injected tumours, a so-called ‘abscopal effect’.

Exhibit 2: Granzyme B-expressing CD8+ T-cells, showing change from baseline

Financials and valuation

As Targovax’s Q418 results were in line with our expectations, we made no major changes to our estimates. Full-year operating loss was NOK146m with external R&D expenses accounting for NOK64m. We expect the company will maintain similar or slightly less intensive clinical R&D activities (because a partner is being sought for the TG01 project) and our total operating loss estimate for 2019 is NOK140m (unchanged). Therefore, the cash position of NOK151m at the end of Q418 should reach 2020. As Targovax’s R&D pipeline matures, several projects should reach mid-stage around 2021, which is when we expect another substantial increase in R&D spend. The required additional funding for 2020 is reflected in our model (Exhibit 5) as a long-term debt of NOK118m, as per our research principles.

Our updated valuation is NOK1.46bn or NOK27.7/share compared to NOK1.41bn or NOK26.8/share previously, which is based on a risk-adjusted NPV analysis using a 12.5% discount rate, including NOK151m gross cash at end-Q418 (Targovax booked total gross debt of NOK53.1m in Finnish government grants, but repayment is needed only if the products are sold or launched). We increased the required time to market for the colorectal cancer project by one year, which is mainly a result of fine-tuning our NPV model. We keep other assumptions relating to the clinical trials in our rNPV model unchanged (described in our initiation report). Upcoming near-term catalysts are (Exhibit 4):

ONCOS-102 mesothelioma Phase I interim data expected in H120.

ONCOS-102 melanoma Phase I interim data readout data expected in H119.

TG02 colorectal cancer Phase I interim data readout data expected in H119.

TG01 pancreatic cancer three-year survival data H119.

TG02 + PD-1 combination pre-clinical data expected in H219.

Exhibit 3: Sum-of-the-parts Targovax valuation

Product

Launch

Peak sales
($m)

Unrisked NPV (NOKm)

Unrisked NPV/share (NOK)

Probability (%)

rNPV
(NOKm)

rNPV/share (NOK)

ONCOS-102 - advanced melanoma

2025

590

2,475.5

47.0

10%

466.7

8.9

ONCOS-102 - mesothelioma

2026

424

1,967.5

37.4

10%

352.2

6.7

TG02 - CRC

2027

1,714

3,377.4

64.2

10%

484.9

9.2

Net cash at end-Q418

151.2

2.9

100%

151.2

2.9

Valuation

7,971.6

151.5

1,455.0

27.7

Source: Edison Investment Research. Note: WACC = 12.5% for product valuations. Note: Excludes conditional government long-term debt of NOK48.8m.

Exhibit 4: Targovax R&D pipeline

Source: Targovax Q418 presentation 14 February 2019. Note: Trials sponsored by collaborators highlighted in grey.

Exhibit 5: Financial summary

NOK'000s

2016

2017

2018

2019e

2020e

December

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

37

37

27

0

0

Cost of Sales

0

0

0

0

0

Gross Profit

37

37

27

0

0

Research and development

(45,001)

(45,571)

(64,006)

(55,567)

(50,103)

EBITDA

 

 

(119,226)

(119,630)

(145,804)

(139,856)

(136,929)

Operating Profit (before amort. and except.)

 

 

(119,510)

(119,926)

(146,100)

(140,152)

(137,225)

Intangible Amortisation

0

0

0

0

0

Exceptionals

0

0

0

0

0

Other

0

0

0

0

0

Operating Profit

(119,510)

(119,926)

(146,100)

(140,152)

(137,225)

Net Interest

(3,203)

(2,347)

(1,249)

0

0

Profit Before Tax (norm)

 

 

(122,713)

(122,273)

(147,349)

(140,152)

(137,225)

Profit Before Tax (reported)

 

 

(122,713)

(122,273)

(147,349)

(140,152)

(137,225)

Tax

260

328

334

0

0

Profit After Tax (norm)

(122,453)

(121,945)

(147,015)

(140,152)

(137,225)

Profit After Tax (reported)

(122,453)

(121,945)

(147,015)

(140,152)

(137,225)

Average Number of Shares Outstanding (m)

34.5

47.3

52.6

52.6

52.6

EPS - normalised (NOK)

 

 

(3.55)

(2.58)

(2.79)

(2.66)

(2.61)

EPS - normalised fully diluted (NOK)

 

 

(3.55)

(2.58)

(2.79)

(2.66)

(2.61)

EPS - reported (NOK)

 

 

(3.55)

(2.58)

(2.79)

(2.66)

(2.61)

Dividend per share (NOK)

0.0

0.0

0.0

0.0

0.0

Gross Margin (%)

100.0

100.0

100.0

N/A

N/A

EBITDA Margin (%)

N/A

N/A

N/A

N/A

N/A

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

N/A

N/A

N/A

N/A

N/A

BALANCE SHEET

Fixed Assets

 

 

339,512

367,415

371,129

370,844

370,577

Intangible Assets

338,213

366,250

370,240

370,240

370,240

Tangible Assets

1,299

1,165

889

604

337

Investments

0

0

0

0

0

Current Assets

 

 

185,832

276,193

166,509

21,517

15,320

Stocks

0

0

0

0

0

Debtors

0

0

0

0

0

Cash

171,629

261,573

151,189

6,197

0

Other

14,203

14,620

15,320

15,320

15,320

Current Liabilities

 

 

(29,184)

(28,295)

(59,377)

(42,308)

(43,256)

Creditors

(29,184)

(28,295)

(50,250)

(33,181)

(34,129)

Short term borrowings

0

0

(9,127)

(9,127)

(9,127)

Long Term Liabilities

 

 

(94,992)

(108,156)

(103,565)

(103,565)

(221,415)

Long term borrowings

(39,714)

(48,806)

(43,933)

(43,933)

(161,783)

Other long term liabilities

(55,278)

(59,350)

(59,632)

(59,632)

(59,632)

Net Assets

 

 

401,168

507,157

374,696

246,488

121,226

CASH FLOW

Operating Cash Flow

 

 

(112,892)

(111,093)

(112,816)

(144,962)

(124,018)

Net Interest

3,203

2,347

1,249

0

0

Tax

0

0

0

0

0

Capex

(37)

(56)

0

(31)

(29)

Acquisitions/disposals

0

0

0

0

0

Financing

114,593

194,407

(30)

0

0

Other

(8,738)

(4,753)

(3,041)

1

0

Dividends

0

0

0

0

0

Net Cash Flow

(3,871)

80,852

(114,638)

(144,992)

(124,047)

Opening net debt/(cash)

 

 

(135,786)

(131,915)

(212,767)

(98,129)

46,863

HP finance leases initiated

0

0

0

0

0

Other

(0)

0

0

0

0

Closing net debt/(cash)

 

 

(131,915)

(212,767)

(98,129)

46,863

170,910

Source: Targovax accounts, Edison Investment Research

General disclaimer and copyright

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

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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

Neither this document and associated email (together, the "Communication") constitutes or form part of any offer for sale or subscription of, or solicitation of any offer to buy or subscribe for, any securities, nor shall it or any part of it form the basis of, or be relied on in connection with, any contract or commitment whatsoever. Any decision to purchase shares in the Company in the proposed placing should be made solely on the basis of the information to be contained in the admission document to be published in connection therewith.

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 (nor will such persons be able to purchase shares in the placing).

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 Targovax and prepared and issued by Edison, in consideration of a fee payable by Targovax. 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 Edison analyst 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.

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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

Neither this document and associated email (together, the "Communication") constitutes or form part of any offer for sale or subscription of, or solicitation of any offer to buy or subscribe for, any securities, nor shall it or any part of it form the basis of, or be relied on in connection with, any contract or commitment whatsoever. Any decision to purchase shares in the Company in the proposed placing should be made solely on the basis of the information to be contained in the admission document to be published in connection therewith.

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 (nor will such persons be able to purchase shares in the placing).

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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