Carmat — First half of CE mark-enabling trial fully enrolled

Carmat (PAR: ALCAR)

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Research: Healthcare

Carmat — First half of CE mark-enabling trial fully enrolled

In July, Carmat announced the enrolment of the 10th and final patient included in the first leg of its EU pivotal study investigating the surgical implantation of the Carmat total artificial heart (TAH) in patients suffering from end-stage biventricular heart failure (HF). Following the successful surgeries, the company expects to enrol an additional 10 patients in the second cohort by the year end. According to Carmat, data from all 20 patients should be sufficient to obtain CE marking for the bioprosthesis in 2019. Most notably, Carmat announced the first successful donor heart transplant of a TAH patient who was initially too sick to receive a donor heart.

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Healthcare

Carmat

First half of CE mark-enabling trial fully enrolled

Financial and clinical update

Healthcare equipment & services

26 October 2018

Price

€21.05

Market cap

€194m

US$1.18/€

Net cash (€m) at 30 June 2018

39.8

Shares in issue

9.2m

Free float

29.8%

Code

ALCAR

Primary exchange

Euronext Paris

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(19.8)

3.2

(10.8)

Rel (local)

(12.7)

11.1

(5.2)

52-week high/low

€28.3

€19.8

Business description

Carmat is a France–based, medical device company developing a biocompatible, artificial heart to satisfy the lack of donor hearts available for terminal biventricular heart failure patients. The company completed a feasibility study in early 2016, and received authorisation to resume a European pivotal study in May 2017.

Next events

Complete pivotal trial surgical implantations

Year-end 2018

CE mark for Carmat TAH

2019

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

Briana Warschun

+1 646 653 7031

Carmat is a research client of Edison Investment Research Limited

In July, Carmat announced the enrolment of the 10th and final patient included in the first leg of its EU pivotal study investigating the surgical implantation of the Carmat total artificial heart (TAH) in patients suffering from end-stage biventricular heart failure (HF). Following the successful surgeries, the company expects to enrol an additional 10 patients in the second cohort by the year end. According to Carmat, data from all 20 patients should be sufficient to obtain CE marking for the bioprosthesis in 2019. Most notably, Carmat announced the first successful donor heart transplant of a TAH patient who was initially too sick to receive a donor heart.

Year end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/16

0.3

(25.7)

(3.80)

0.0

N/A

N/A

12/17

0.03

(31.5)

(3.24)

0.0

N/A

N/A

12/18e

0.7

(39.6)

(4.21)

0.0

N/A

N/A

12/19e

0.0

(28.7)

(3.11)

0.0

N/A

N/A

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

Completes enrolment of first leg of pivotal trial

Carmat announced the completion of enrolment of the first portion of its EU pivotal study investigating the safety and efficacy of the surgical implantation of the Carmat TAH as an alternative therapeutic among those waiting for human transplants and/or suffering from terminal HF and potentially terminal acute myocardial infarctions (MI). The primary endpoint of the trial is overall survival at six months post-implant, or overall survival to human cardiac transplantation.

Sights set on the CE mark in 2019

In light of the successful completion of the first 10 Carmat TAH implantations, the company plans to begin enrolling patients in the second cohort immediately at the three active international medical centres. According to the company, data from all 20 patients should be satisfactory to achieve CE marking for the Carmat TAH device, which is expected in 2019.

Carmat TAH patient receives donor heart transplant

In August, Carmat announced the completion of the first successful donor heart transplant of a patient previously implanted with the Carmat TAH in October 2017. For eight months, the Carmat TAH supported the patient, who was in end stage HF and previously ineligible for a heart transplant due to pulmonary hypertension. The patient successfully received a donor heart in June.

Valuation: €773m or €83.89 per share

We have raised our valuation of Carmat to €773m or €83.89/share from €697.3m or €77.34share. This increase is due mainly to a rise in the probability of success in the EU market from 25% to 30% as enrolment is progressing well. This is offset by an increase in G&A expenditure, net working capital (NWC) and CAPEX.

Half-way there

In July 2018, Carmat announced the successful surgical implantation of the Carmat TAH device into the 10th and final patient, marking the completion of the first half of the CE mark-enabling pivotal trial. Following this update, the company plans to enrol an additional 10 patients to participate in the second leg of the trial at the three presently active medical centres in France, the Czech Republic, and Kazakhstan. However, the company has stated that to keep up with the current implantation rate and meet its guidance to complete enrolment by year-end, it will expand on the network of investigating centres to four new European countries. This expansion includes the Heart Center of the Rigshospitalet hospital in Copenhagen, Denmark, which was recently approved to perform the surgery earlier this year. Nonetheless, we continue to expect completion in mid-2019.

As of 29 September 2018, 11 patients have been surgically implanted with the Carmat TAH. Thus far, the Carmat TAH recipients have demonstrated a one-month survival rate of 91% compared to a one-month survival of 75% demonstrated in the previous feasibility study. Surgery time has also been reduced from seven hours to five hours. Patients spend about six days in intensive therapy and can typically return home from the hospital in 35 days. According to the company, the device has provided cumulative support time of three years and five months.

On 1 August 2018, the company announced the first successful human cardiac transplant of a Carmat TAH recipient at the National Research Center for Cardiac Surgery in Kazakhstan. This end-stage HF patient (male) was initially ineligible to receive a donor heart due to pulmonary hypertension, which is high blood pressure that affects the arteries of the lungs and right side of the heart. Carmat’s device supported the patient for eight months and facilitated recovery from the condition. In June, the patient underwent explanation of the bioprosthetic and implantation of a donor heart. This is the first demonstration of the Carmat TAH effectively serving as a therapeutic bridge to transplant. Later in August, Carmat announced the certification of its new manufacturing site located in Bois-d’Archy, France. According to the company, the automated manufacturing site will enable the production of up to 800 Carmat TAH units per year at full capacity, which should support the recent enrolment ramp-up for the pivotal trial and meet the demands of industrial manufacturing.

To review, the Carmat device is the first biocompatible, biventricular mechanical heart and is designed to replicate the functionality and morphology of the human heart as closely as possible, by applying technology involving self-regulatory mechanisms and biocompatible materials. The device aims to provide a long-term (or potentially permanent) solution to patients suffering from advanced biventricular HF and potentially terminal acute MI (commonly referred to as heart attack), for whom no human transplant is available and who have exhausted all remaining treatment possibilities.

The primary endpoint of the ongoing single arm trial is overall survival on the Carmat TAH at 180-days post-implant, or survival to human cardiac transplantation (provided this occurs prior to the 180-days post-implant mark). The secondary endpoints of the trial include the New York Heart Association (NYHA) HF classification (Exhibit 1), a six-minute walk test, and quality of life measurements that will be assessed at baseline and one, three and six months post-transplant. Adverse events will also be collected throughout the course of the study (ie frequency and incidence of all adverse events as well as frequency, incidence, and type of device malfunction).

Exhibit 1: NYHA heart failure grading system

Class I

Class II

Class III

Class IV

Symptoms

No symptoms

Tiredness, palpitations, shortness of breath after sustained effort

Symptoms or discomfort on the least effort

Symptomatic even at rest

Activity

No limitations

Modest limitations

Marked reduction

Inability to perform nearly all activities; permanently confined to bed

Source: Company reports. Notes: NYHA= New York Heart Association.

This trial follows previous encouraging data from a four-patient feasibility study completed in January 2016. Overall, while the sample size was low, the first three patients (75%) met the company’s targeted success of a survival duration of at least 30-days post-implantation (Exhibit 2). The Agence de Biomédecine, a French organisation overseeing transplant procedures and organ donations, reported in 2013 that the 30-day survival rate in heart transplants (the ‘gold standard’ comparator for an artificial heart) is approximately 80% for patients above age 60.

As a reminder, the current trial, which was first initiated mid-2016, was suspended promptly after the death of the first patient, implanted with the device in August 2016. The study was resumed in May 2017 following analyses that elucidated the cause of death was related to poor battery handling by the patient and not due to device malfunction.

According to the company, data from all 20 patients should be sufficient to achieve a CE mark for the Carmat TAH, which is expected in 2019. The company has also stated that initial commercialisation efforts in the EU will be focused specifically in Germany and France. Moreover, conversations with the FDA and potential US participating medical centres remain ongoing.

Exhibit 2: Summary of feasibility study outcomes for Carmat bioprosthetic heart

Patient

Centre

Date of implantation

Primary outcomes

1

Hôpital Européen Georges-Pompidou

18 December 2013

Patient survived until March 2014 (75 days). An electrical component fault caused the bioprosthesis to malfunction. Approval to resume study from the French National Agency for Medicines and Health Products Safety (ANSM).

2

Nantes University Hospital

5 August 2014

Patient survived nine months, of which four months were at home. Malfunction caused by fault with steering motors led to circulatory insufficiency and hospitalisation on 1 May 2014. Patient re-implanted the next day but died later that same day due to multiple organ failure.

3

Hôpital Européen Georges-Pompidou

8 April 2015

Patient discharged in September 2015, but was hospitalised in November 2015 and died due to respiratory failure following a chronic renal failure

4

Hôpital Universitaire de La Pitié Salpêtrière

22 December 2015

Patient died on 11 January 2016, but the severity of their underlying condition (patient had biventricular heart failure and required continuous life support) was deemed responsible for their death. The Carmat heart was believed to have functioned optimally during implantation.

Source: Company reports

Valuation

We have increased our valuation of Carmat to €773m or €83.89 per share from €697.3m or €77.34 per share. This increase is due mainly to an increase in the probability of success in the EU market from 25% to 30% as the trial continues to progress well without additional issues (as a reminder we had previously lowered the probability of success in the EU market from 35% to 25% following the trial stoppage). This was offset by an increase in G&A expenditure, net working capital (NWC) and capex (see financial section below). As we believe the company places a higher priority on obtaining CE mark clearance for the EU market than on developing the Carmat heart for the US market, we continue to apply a lower (20%) probability for commercialisation in the US. We expect to update our valuation with interim data from the pivotal trial and with feedback from the FDA regarding potential trial initiation in the US.

Exhibit 3: Valuation of Carmat

Product contributions (net of R&D and Marketing costs)

Indication

Prob. of success

Launch year

Launch pricing

Peak sales (€m)

rNPV (€m)

Carmat artificial heart in EU market

Terminal heart failure and myocardial infarctions

30%

2020

€160,000

2,169 in 2024

1021.8

Carmat artificial heart in US market (under HUD)

Terminal heart failure and myocardial infarctions

20%

2021

$200,000

620 in 2025

160.4

Corporate costs & expenses

G&A expenses

-73.7

Net capex, NWC & taxes

-375.0

Total rNPV

733.5

Net cash (at 30 June 2018)

39.8

Total firm value

773.3

Total shares (m)

9.2

Value per basic share (€)

83.89

Source: Edison Investment Research

Financials

Carmat’s H118 post-tax loss was €18.9m, up 34% from the same period for the year prior (H117: loss of €14.1m), which is attributable to increases in both R&D expenditure and SG&A. This includes costs associated with the continuation of the CE marking process including finalisation of technical models, preliminary work for the opening of the Bois-d’Archy manufacturing site, which is now operational, and the internationalisation of the pivotal study, which includes training teams at new investigation centres.

Carmat finished H118 with €39.8m in net cash (€44.0m gross cash at 30 June 2018 minus €4.2m in long-term debt). We continue to expect that Carmat’s burn rate in 2018 will be significantly higher than in 2017, due to our expectations of an increased recruitment rate for the ongoing EU pivotal trial and reflecting CAPEX investments incurred to expand production capacity.

We estimate that Carmat’s funds on hand will support its operating runway into Q219. We continue to assume that Carmat will need an additional €100m to complete the regulatory, manufacturing and commercial activities needed for the Carmat device to reach Carmat sustainable profitability. We assume Carmat will raise €50m in each of 2019 and 2020, which we illustrate as long-term debt (Exhibit 4). We do not expect Carmat to start generating sustainable, positive, recurring operating cash flows until 2021, once its sales and manufacturing efficiencies start to exceed all projected overhead costs.

Exhibit 4: Financial summary

€(000)

2016

2017

2018e

2019e

31-December

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

263

28

708

0

Cost of Sales

0

0

0

0

General & Administrative

(6,426)

(8,421)

(11,473)

(14,248)

Research & Development

(17,912)

(21,890)

(27,442)

(10,000)

EBITDA

 

 

(24,075)

(30,283)

(38,207)

(24,248)

Depreciation

(504)

(752)

(1,237)

(4,389)

Amortization

0

0

0

0

Operating Profit (before exceptionals)

 

(24,579)

(31,035)

(39,444)

(28,636)

Exceptionals

(75)

(56)

(3)

0

Other

0

0

0

0

Operating Profit

(24,655)

(31,090)

(39,447)

(28,636)

Net Interest

(1,143)

(472)

(157)

(43)

Profit Before Tax (norm)

 

 

(25,722)

(31,507)

(39,601)

(28,679)

Profit Before Tax (FRS 3)

 

 

(25,797)

(31,563)

(39,604)

(28,679)

Tax

2,817

2,335

987

0

Profit After Tax and minority interests (norm)

(22,905)

(29,172)

(38,615)

(28,679)

Profit After Tax and minority interests (FRS 3)

(22,980)

(29,228)

(38,617)

(28,679)

Average Number of Shares Outstanding (m)

6.0

9.0

9.2

9.2

EPS - normalised (€)

 

 

(3.80)

(3.24)

(4.21)

(3.11)

EPS - normalised and fully diluted (€)

 

(3.80)

(3.24)

(4.21)

(3.11)

EPS - (IFRS) (€)

 

 

(3.81)

(3.24)

(4.21)

(3.11)

Dividend per share (€)

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

1,751

4,752

15,204

35,815

Intangible Assets

196

72

91

91

Tangible Assets

1,555

4,680

15,113

35,724

Current Assets

 

 

35,738

65,098

19,747

20,456

Short-term investments

0

0

0

0

Cash

31,163

60,723

14,809

15,519

Other

4,575

4,375

4,937

4,937

Current Liabilities

 

 

(5,195)

(7,944)

(7,609)

(7,609)

Creditors

(5,195)

(7,944)

(7,609)

(7,609)

Short term borrowings

0

0

0

0

Long Term Liabilities

 

 

(3,213)

(3,714)

(4,240)

(54,240)

Long term borrowings

(3,213)

(3,714)

(4,240)

(54,240)

Other long term liabilities

0

0

0

0

Net Assets

 

 

29,082

58,191

23,101

(5,578)

CASH FLOW

Operating Cash Flow

 

 

(20,111)

(23,806)

(38,079)

(24,248)

Net Interest

(1,143)

(472)

(157)

(43)

Tax

0

0

0

0

Capex

(1,096)

(3,559)

(11,689)

(25,000)

Acquisitions/disposals

0

0

0

0

Financing

50,175

57,537

4,012

0

Net Cash Flow

27,825

29,700

(45,913)

(49,291)

Opening net debt/(cash)

 

 

(788)

(27,951)

(57,009)

(10,569)

HP finance leases initiated

0

0

0

0

Other

(662)

(642)

(527)

0

Closing net debt/(cash)

 

 

(27,951)

(57,009)

(10,569)

38,721

Source: Company reports, 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 PTy Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2018 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Carmat 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 Investment Research Pty Ltd (Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd (AFSL: 427484)) and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. 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 2018. “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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London +44 (0)20 3077 5700

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US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205

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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

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 PTy Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2018 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Carmat 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 Investment Research Pty Ltd (Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd (AFSL: 427484)) and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. 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 2018. “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

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

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Sydney +61 (0)2 8249 8342

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Fidelity European Values — Outperforming in an uncertain market

Fidelity European Values (FEV) is a relatively defensively positioned trust investing primarily in continental European equities. Recent performance has been strong relative to its FTSE World Europe ex-UK index benchmark and peers, helped by its exposure to defensive technology stocks, less interest rate-sensitive banks, and energy stocks, as well as holding no automotive stocks. The portfolio remains well-balanced, but is now more concentrated in a smaller number of stocks (currently 47), as the manager has taken profits where prospects for sustained dividend growth have weakened, and few new ideas have met his investment criteria. FEV’s consistent longer-term track record and tendency to outperform in periods of market weakness may find appeal in an uncertain market environment.

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