First patient enrolled in pivotal RESMAIN study

4SC 19 December 2016 Update

4SC

First patient enrolled in pivotal RESMAIN study

Pivotal study initiated

Pharma & biotech

19 December 2016

Price

€2.32

Market cap

€44m

Net cash (€m) at 30 September 2016

12.3

Shares in issue

19.0m

Free float

38.1%

Code

VSC

Primary exchange

Frankfurt

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(4.1)

7.6

(33.2)

Rel (local)

(10.4)

(3.0)

(38.7)

52-week high/low

€4.2

€2.1

Business description

4SC is a Munich-based cancer R&D company. Epigenetic compound resminostat (HDAC inhibitor) is the lead candidate for Cutaneous T-Cell Lymphoma (pivotal study started in Q416), partnered with Yakult Honsha (Japan) and Menarini (Asia ex-Japan). 4SC is partnered with Link Health for a Phase I oncology asset.

Next events

Further Phase II data analysis in HCC and Phase II NSCLC data Japan (Yakult)

Early 2017

Further patient recruitment into the pivotal resminostat EU trial

2017

FY16 results

March 2017

Analysts

Dr Linda Pomeroy

+44 (0)20 3077 5738

Lala Gregorek

+44 (0)20 3681 2527

4SC is a research client of Edison Investment Research Limited

4SC has announced the enrolment of the first patient in its RESMAIN study. This is a pivotal study to evaluate resminostat (RES), an epigenetic cancer drug for maintenance treatment (MAIN) in patients with advanced-stage cutaneous T-cell lymphoma (CTCL). We expect early data to be reported in 2019. We increase our rNPV to €120m from €117m as we have raised the probability of the CTCL programme in Europe to 30% (from 20%) following the initiation of the trial.

Year
end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/14

7.1

(8.8)

(0.88)

0.0

N/A

N/A

12/15

3.3

(8.4)

(0.59)

0.0

N/A

N/A

12/16e

3.8

(12.9)

(0.68)

0.0

N/A

N/A

12/17e

4.0

(6.0)

(0.31)

0.0

N/A

N/A

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

Pivotal RESMAIN study initiated

The pivotal trial of resminostat in advanced-stage CTCL has been initiated with an announcement that the first patient has been enrolled. The study is a 150-patient, double-blind, randomised placebo-controlled study being conducted in 50 centres, across 10 European countries. Patients who are eligible to be part of the study will have achieved disease control with systemic therapy. The patients will be randomised 1:1 to receive either resminostat or a placebo. The primary endpoint will be progression-free survival and the secondary endpoint time to symptom worsening (itching). We forecast cash reach into 2018, at which time 4SC will need to raise further funding to complete the trial.

Pipeline progression overview

Alongside the CTCL trial, 4SC has a number of other developing parts to its pipeline. It announced potentially positive Phase II results from a more detailed analysis of the HCC Yakult Phase II trial data and has reported that there was a substantial improvement in overall survival in a large subgroup. As a result, 4SC is discussing plans for continued clinical development of resminostat in Japan with its partner Yakult. We expect further data analysis in early 2017. Alongside this, developments during 2016 in its earlier-stage pipeline include a partnership with Link Health in China for its oncology Eg5 inhibitor (4SC-205) and promising preclinical data for its epigenetic HDAC/LSD1 inhibitor (4SC-202), demonstrating preclinical evidence that it could be an effective combination partner for checkpoint inhibitor therapies.

Valuation: Increased to €120m

We have increased our rNPV-based valuation to €120m or €6.3 per share (vs €6.2), as we have raised our probability of resminostat in the CTCL programme in Europe to 30% (vs 20%) following the initiation of the trial. We now use Q316 reported cash of €12.3m. We have also tweaked R&D and SG&A spend down slightly for FY16 and increased R&D in FY17 following updated guidance at the Q3 results. We have not altered our cash reach, which we continue to forecast to 2018.

Exhibit 1: Financial summary

€'000s

2013

2014

2015

2016e

2017e

2018e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

4,904

7,055

3,266

3,800

4,000

5,000

Cost of sales

(1,474)

(4,080)

(1,763)

(1,710)

(1,600)

(1,750)

Gross profit

3,430

2,975

1,503

2,090

2,400

3,250

R&D expenditure

(10,243)

(8,504)

(7,255)

(12,000)

(7,000)

(5,250)

Administrative, distribution and other

(3,779)

(3,908)

(3,163)

(3,957)

(2,369)

(2,440)

Operating profit

(10,592)

(9,437)

(8,915)

(13,867)

(6,969)

(4,440)

Intangible amortisation

(1,593)

(819)

(827)

(827)

(827)

(827)

Exceptionals (impairment / restructuring costs)

(862)

0

0

0

0

0

Share-based payments

(53)

(3)

2

(20)

(20)

(20)

EBITDA

 

 

(7,804)

(8,339)

(7,914)

(12,795)

(5,897)

(3,368)

Operating profit (before GW and except.)

 

(8,084)

(8,615)

(8,090)

(13,020)

(6,122)

(3,593)

Net interest

48

(228)

(331)

75

150

100

Other (profit/loss from associates)

19

39

58

75

75

75

Profit before tax (norm)

 

 

(8,036)

(8,843)

(8,421)

(12,946)

(5,972)

(3,493)

Profit before tax (FRS 3)

 

 

(10,525)

(9,626)

(9,188)

(13,718)

(6,744)

(4,265)

Tax

0

(70)

(40)

0

0

0

Profit after tax (norm)

(8,017)

(8,874)

(8,403)

(12,871)

(5,897)

(3,418)

Profit after tax (FRS 3)

(10,525)

(9,696)

(9,228)

(13,718)

(6,744)

(4,265)

Average number of shares outstanding (m)

10.1

10.1

14.3

19.0

19.0

19.0

EPS - normalised (€)

 

 

(0.80)

(0.88)

(0.59)

(0.68)

(0.31)

(0.18)

EPS - FRS 3 (€)

 

 

(1.04)

(0.96)

(0.64)

(0.72)

(0.36)

(0.22)

Dividend per share (€)

0.0

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed assets

 

 

11,591

10,639

11,077

10,043

9,280

8,542

Intangible assets

10,651

9,836

9,123

8,164

7,451

6,738

Tangible assets

602

425

357

282

232

207

Investments and other

338

378

1,597

1,597

1,597

1,597

Current assets

 

 

6,114

4,295

22,415

9,156

12,873

8,693

Stocks

23

25

20

20

20

20

Debtors

346

652

94

94

94

94

Cash

4,899

3,202

21,476

8,419

12,136

7,956

Other current assets

846

393

817

623

623

623

Current liabilities

 

 

(3,587)

(4,842)

(5,593)

(3,187)

(3,437)

(3,937)

Creditors

(675)

(993)

(688)

(688)

(688)

(688)

Short-term borrowings

0

(317)

(1,962)

0

0

0

Deferred revenue (short term)

(1,589)

(2,638)

(1,779)

(1,750)

(2,000)

(2,500)

Other current liabilities

(1,323)

(894)

(1,164)

(749)

(749)

(749)

Long-term liabilities

 

 

(2,836)

(8,042)

(1,471)

(188)

(10,038)

(10,038)

Long-term borrowings

0

(6,131)

0

0

(10,000)

(10,000)

Deferred revenue (long term)

(2,682)

(1,788)

(1,433)

(150)

0

0

Other long-term liabilities

(154)

(123)

(38)

(38)

(38)

(38)

Net assets

 

 

11,282

2,050

26,428

15,824

8,678

3,260

CASH FLOW

Operating cash flow

 

 

(7,052)

(8,302)

(8,916)

(11,483)

(5,997)

(3,868)

Net interest

66

0

(2)

2

4

3

Tax

0

(70)

(40)

0

0

0

Capex

(99)

(100)

(109)

(150)

(175)

(200)

Expenditure on intangibles

(21)

(3)

(114)

(114)

(114)

(114)

Acquisitions/disposals

10

0

0

650

0

0

Financing

0

477

27,608

0

0

0

Other

0

0

4,333

0

0

0

Net cash flow

(7,096)

(7,998)

22,760

(11,095)

(6,282)

(4,180)

Opening net debt/(cash)

 

 

(12,064)

(4,899)

3,246

(19,514)

(8,419)

(2,136)

HP finance leases initiated

0

0

0

0

0

0

Other

(69)

(147)

0

0

0

0

Closing net debt/(cash)

 

 

(4,899)

3,246

(19,514)

(8,419)

(2,136)

2,044

Source: 4SC and Edison Investment Research

Edison, the investment intelligence firm, is the future of investor interaction with corporates. Our team of over 100 analysts and investment professionals work with leading companies, fund managers and investment banks worldwide to support their capital markets activity. We provide services to more than 400 retained corporate and investor clients from our offices in London, New York, Frankfurt, Sydney and Wellington. 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 2016 Edison Investment Research Limited. All rights reserved. This report has been commissioned by 4SC 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 2016. “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 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

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 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

Edison, the investment intelligence firm, is the future of investor interaction with corporates. Our team of over 100 analysts and investment professionals work with leading companies, fund managers and investment banks worldwide to support their capital markets activity. We provide services to more than 400 retained corporate and investor clients from our offices in London, New York, Frankfurt, Sydney and Wellington. 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 2016 Edison Investment Research Limited. All rights reserved. This report has been commissioned by 4SC 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 2016. “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 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

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 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

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