Medigene — Funded to execute clinical development strategy

Medigene — Funded to execute clinical development strategy

Medigene recently announced a placing of €20.7m gross (issuing 1.96m new shares at €10.55) to intensify its R&D through the expansion of its planned T-cell receptor (TCR) modified T-cells clinical programme. This leaves it well funded (pro forma cash €67.7m) to advance both its DC vaccine programmes and TCR programme. We expect 2017 to be a year of important progress for Medigene, in particular the start of its first company-initiated TCR clinical study. We have increased our rNPV-based valuation to €315m (vs €293m), as we now include the cash from the fund-raising and have rolled the model forward.

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Written by

Medigene

Funded to execute clinical development strategy

Q1 results and fund-raising

Pharma & biotech

12 May 2017

Price

€10.84

Market cap

€240m

Net cash (£m) 31 March 2017
(pro forma adjusted for net equity raise)

67.7

Shares in issue

22.1m

Free float

70.7%

Code

MDG1

Primary exchange

XETRA

Secondary exchange

Frankfurt

Share price performance

%

1m

3m

12m

Abs

(10.6)

(18.1)

27.6

Rel (local)

(14.7)

(24.8)

0.1

52-week high/low

€14.83

€6.25

Business description

Medigene is a German biotech company with complementary technology platforms in cancer immunotherapy. Dendritic cell vaccines are in Phase I/II clinical studies, while a T-cell receptor candidate should enter the clinic in 2017.

Next events

Interim results

3 August 2017

TCR (IIT) clinical trial initiation

H217

First TCR (CIT) clinical trial initiation

H217

Analyst

Dr Linda Pomeroy

+44 (0)20 3077 5738

Medigene is a research client of Edison Investment Research Limited

Medigene recently announced a placing of €20.7m gross (issuing 1.96m new shares at €10.55) to intensify its R&D through the expansion of its planned T-cell receptor (TCR) modified T-cells clinical programme. This leaves it well funded (pro forma cash €67.7m) to advance both its DC vaccine programmes and TCR programme. We expect 2017 to be a year of important progress for Medigene, in particular the start of its first company-initiated TCR clinical study. We have increased our rNPV-based valuation to €315m (vs €293m), as we now include the cash from the fund-raising and have rolled the model forward.

Year
end

Revenue
(€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/15

6.8

(12.8)

(0.74)

0.0

N/A

N/A

12/16

9.7

(11.3)

(0.56)

0.0

N/A

N/A

12/17e

9.0

(18.6)

(0.89)

0.0

N/A

N/A

12/18e

9.3

(20.2)

(0.91)

0.0

N/A

N/A

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

Fund-raising provides option to expand TCR CIT

Medigene recently announced a €20.7m gross fund-raising through a placing of 1.96m shares at a price of €10.55 each. It was achieved via an accelerated book build and has strengthened the company’s institutional shareholder base. According to the company, the funds will provide the option to expand and/or accelerate its TCR clinical programme into additional indications and geographic regions, such as the US. For further details regarding the TCR trials planned and for an overview of preclinical data on its selected TCR trial candidate (HLA-A2:01-restricted TCR) targeting PRAME (tumour antigen) see our recent outlook note.

Strong outlook in 2017 and beyond

We believe Medigene will take significant steps in 2017. For example, we expect it to initiate its own TCR clinical study as well as an investigator-initiated TCR study. Alongside progressing its TCR programme into the clinic, we also expect it to generate further TCR leads, particularly through its TCR development deal with bluebird bio, a prominent T-cell immunology company. It is worth noting that Medigene operates in an area of significant interest, particularly around CAR-T candidates and technologies and its TCRs could offer efficacy/safety advantages.

Valuation: Increased to €315m

We have increased our rNPV-based valuation to €315m (vs €293m) or €14.2 per share (vs €14.7 per share), as we now use Medigene’s Q1 cash position of €48m and include the net pro forma cash (€19.7m) recently raised. We have also rolled the model forward three months. All other assumptions remain the same, although we now forecast cash reach into FY20. Medigene is well funded, which we believe will enable it to execute its clinical development strategy and should take it to reported data from the ongoing DC trial and 2017 initiated TCR trials. We also note that there is potential for newsflow relating to the progression of TCR leads resulting from its bluebird bio deal and for further TCR R&D collaborations to be made.

Exhibit 1: Financial summary

€'000s

2014

2015

2016

2017e

2018e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

13,784

6,808

9,749

8,959

9,263

of which: Veregen revenues (royalties/milestones/supply)

5,195

3,101

3,048

3,128

3,433

R&D partnering (SynCore/Falk Pharma/grants)

6,096

1,214

3,155

0

0

Non-cash income (Eligard)

2,493

2,493

2,493

2,493

2,493

Bluebird bio partnership

1,053

3,338

3,338

Cost of sales

(2,086)

(1,103)

(1,402)

(1,231)

(1,353)

Gross profit

11,698

5,705

8,347

7,728

7,910

Selling, general & administrative spending

(7,081)

(7,615)

(7,942)

(8,286)

(8,524)

R&D expenditure

(7,498)

(8,529)

(11,538)

(17,884)

(19,672)

Other operating spending

0

.

0

0

0

Operating profit

(2,881)

(10,439)

(6,891)

(18,443)

(20,286)

Goodwill & intangible amortisation

(527)

(526)

(525)

(524)

(523)

Exceptionals

0

0

4,242

0

0

Share-based payment

(66)

(111)

(50)

(50)

(50)

EBITDA

 

 

(2,005)

(9,384)

(10,238)

(17,644)

(19,488)

Operating profit (before GW and except.)

 

 

(2,288)

(9,802)

(10,558)

(17,869)

(19,713)

Net interest

(1,774)

(2,914)

(1,009)

(1,495)

(1,928)

Other (forex gains/losses; associate profit/loss)

(1,257)

(46)

263

720

1,489

Profit before tax (norm)

 

 

(5,319)

(12,762)

(11,304)

(18,644)

(20,152)

Profit before tax (FRS 3)

 

 

(5,912)

(13,399)

(7,637)

(19,218)

(20,725)

Tax

155

400

228

0

0

Profit/(loss) from discontinued operations

0

0

0

0

0

Profit after tax (norm)

(5,164)

(12,362)

(11,076)

(18,644)

(20,152)

Profit after tax (FRS 3)

(5,757)

(12,999)

(7,409)

(19,218)

(20,725)

Average number of shares outstanding (m)

12.2

16.8

20.0

21.0

22.1

EPS - normalised (€)

 

 

(0.42)

(0.74)

(0.56)

(0.89)

(0.91)

EPS - FRS 3 (€)

 

 

(0.47)

(0.77)

(0.37)

(0.91)

(0.94)

Dividend per share (€)

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed assets

 

 

46,617

51,552

47,742

50,012

52,282

Intangible assets & goodwill

38,377

35,713

35,767

35,243

34,720

Tangible assets

951

2,502

3,323

6,117

8,910

Other non-current assets

7,289

13,337

8,652

8,652

8,652

Current assets

 

 

24,666

59,900

63,973

61,190

36,767

Stocks

4,406

6,654

7,866

7,866

7,866

Debtors

1,733

763

1,175

1,175

1,175

Cash

14,976

46,759

52,630

49,847

25,424

Other

3,551

5,724

2,302

2,302

2,302

Current liabilities

 

 

(7,755)

(9,664)

(11,966)

(11,966)

(11,966)

Trade accounts payable

(1,785)

(1,354)

(973)

(973)

(973)

Short-term borrowings

0

0

0

0

0

Deferred income

(57)

(226)

(3,575)

(3,575)

(3,575)

Other

(5,913)

(8,084)

(7,418)

(7,418)

(7,418)

Long-term liabilities

 

 

(14,457)

(13,879)

(21,157)

(17,820)

(14,482)

Pension provisions

(413)

(359)

(408)

(408)

(408)

Long-term borrowings

0

0

0

0

0

Other liabilities (Deferred taxes; Trianta milestones)

(3,221)

(2,915)

(2,395)

(2,395)

(2,395)

Deferred revenues (Eligard non-cash income & bluebird bio)

(10,823)

(10,605)

(18,354)

(15,017)

(11,679)

Net assets

 

 

49,071

87,909

78,592

81,416

62,601

CASH FLOW

Operating cash flow

 

 

(8,765)

(10,585)

(3,611)

(19,469)

(20,977)

Net interest

9

(20)

(45)

5

(428)

Tax

0

0

(102)

0

0

Capex

(873)

(1,328)

(1,677)

(3,019)

(3,019)

Expenditure on intangibles

0

0

0

0

0

Acquisitions/disposals

0

0

10,537

0

0

Equity financing

14,502

43,695

(77)

19,700

0

Other

(62)

21

846

0

0

Net cash flow

4,811

31,783

5,871

(2,783)

(24,424)

Opening net debt/(cash)

 

 

(10,166)

(14,976)

(46,759)

(52,630)

(49,847)

HP finance leases initiated

0

0

0

0

0

Other (foreign exchanges differences)

(1)

0

0

0

0

Closing net debt/(cash)

 

 

(14,976)

(46,759)

(52,630)

(49,847)

(25,424)

Source: Medigene accounts, 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 Medigene 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.
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Frankfurt +49 (0)69 78 8076 960

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Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

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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 Medigene 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.
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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

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

Research: Healthcare

Paion — On track for two filings by mid-2018

Paion has completed patient recruitment in its pivotal bronchoscopy study of its ultra-fast-acting sedative remimazolam. Results are likely by mid-2017 and, if positive, would put it on track to file for US approval for procedural sedation in mid-2018. Paion is also preparing a dossier for a filing for general anaesthesia (GA) in Japan in a similar time frame. It has also outlined a programme that could see it restart Phase III studies in GA in Europe (estimated cost €20-25m). Paion has sufficient cash to fund operations beyond end 2018, but would need additional funds to complete the Europe development programme. We leave our valuation unchanged at €214m ahead of the key bronchoscopy trial results.

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