CO.DON — Green light for Spherox from the EMA

CO.DON — Green light for Spherox from the EMA

CO.DON is a leading manufacturer of autologous cell therapies for the treatment of cartilage defects. The company’s main product, Spherox, is based on the core spheroid technology and can repair cartilage defects of the knee of up to 10cm2 in a minimally invasive procedure. The Phase III clinical trial allowed CO.DON to obtain marketing authorisation from the European Medicine Agency (EMA) in July 2017, which opened access to all European markets. The company is preparing for the roll-out of Spherox and has already received a green light from the UK’s National Institute for Health and Care Excellence (NICE).

CO.DON

Green light for Spherox from the EMA

Pharma & biotech

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15 November 2017

Price

€10.43

Market cap

€203m

Share price graph

Share details

Code

CNWK

Listing

Xetra

Shares in issue

19.5m

Business description

CO.DON is a biopharmaceutical company, focused on commercialising regenerative treatments for cartilage repair. Spherox, has received EMA marketing authorisation for knee cartilage repair and is on track to be launched in multiple European countries.

Bull

Established market base and successful distribution in Germany.

Substantial expansion possible after the EU-wide marketing authorisation.

Positive interim findings from clinical trials support efficacy and safety.

Bear

Visibility increased after EMA authorisation, which could invite competition (although clinical trials are lengthy).

Although well financed now, any unexpected operational setbacks could lead to need for additional capital.

Dependent on positive reimbursement decisions in other EU countries.

Analysts

Jonas Peciulis

+44 (0) 20 3077 5728

CO.DON is a leading manufacturer of autologous cell therapies for the treatment of cartilage defects. The company’s main product, Spherox, is based on the core spheroid technology and can repair cartilage defects of the knee of up to 10cm2 in a minimally invasive procedure. The Phase III clinical trial allowed CO.DON to obtain marketing authorisation from the European Medicine Agency (EMA) in July 2017, which opened access to all European markets. The company is preparing for the roll-out of Spherox and has already received a green light from the UK’s National Institute for Health and Care Excellence (NICE).

Autologous cell-based transplants for cartilage repair

CO.DON specialises in the regenerative treatment of articular cartilage defects. During a biopsy procedure healthy cartilage cells are taken from the patient’s own cartilage as well as a blood sample. This is cultivated in a laboratory outside the body using CO.DON’s innovative biological techniques to create cartilage, which is then transplanted back into the defect area. Following the EMA approval, Spherox is currently the only authorised advanced therapy medicinal product (ATMP).

EMA’s approval opens multiple European markets

Although CO.DON’s products have been sold in Germany since 1997, the EMA authorisation was required for EU-wide distribution. The efficacy and safety of Spherox from a Phase III trial (n=102) are expected later this year. Meanwhile, three-year follow-up interim data from the Phase II trial (n=75) have shown significant improvements across two outcomes (patient-reported and imaging-based). Accumulated data from the trials supported the EMA’s approval in July 2017.

Valuation: EV of €183m

H117 revenues of €3.0m were flat y-o-y, while operating loss was €2.4m vs -€1.2m a year ago due to product roll-out and regulatory expenditure. Consensus estimates are for positive EBIT of €2.1m on sales of €20.7m in 2020. In October, CO.DON raised €15.5m gross and will invest in the expansion. Current estimated net cash is €20.1m, resulting in an EV of €183m; this appears undemanding given the opportunity to expand into multiple European markets. Especially encouraging is the recommendation of the method by the UK’s NICE and a wholesale licence granted by the UK Medicines & Healthcare products Regulatory Agency (MHRA).

Consensus estimates

Year
end

Revenue
(€m)

PBT
(€m)

EPS
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/15

5.1

(2.9)

(0.18)

0.0

N/A

N/A

12/16

5.6

(3.7)

(0.23)

0.0

N/A

N/A

12/17e

6.2

(5.8)

(0.29)

0.0

N/A

N/A

12/18e

8.6

(5.8)

(0.29)

0.0

N/A

N/A

Source: Company data, Thomson Reuters

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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

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Disclaimer

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 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") (c) FTSE [2014]. "FTSE(r)" 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

295 Madison Avenue, 18th Floor

10017, 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

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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Mensch und Maschine Software provides CAD/CAM software to the industrial and construction sectors to support the digitisation of their design, manufacture and build processes. The company has enjoyed strong growth over recent years, with revenues and EBITDA growing at CAGR 8.8% and 101% in 2012-2016. The ongoing transition to accommodate Autodesk’s shift to a subscription-based model is nearing completion, which should see VAR return to growth in FY18. This is coupled with continued strength in the high margin proprietary software division, which grew 8% y-o-y in 9M17. The shares trade in line with peers on a consensus FY18e P/E basis.

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