Last close As at 05/08/2026
—
— 0.00 (0.00%)
Market capitalisation
—
Research: Healthcare
Carmat announced on 2 May 2017 that it has obtained approval from the French regulatory agency (ANSM) to resume its pivotal trial for the Carmat heart. This follows a favourable review by ANSM of the actions and analyses taken by Carmat following the trial’s suspension after the death in October 2016 of this trial’s first patient six weeks after his implantation. Carmat maintained that the death was not due to a prosthesis malfunction, but due to poor handling of the batteries by the patient. Our valuation (previous rNPV of €747m in our 15 July 2016 update note) is under review.
Carmat |
Carmat obtains clearance to resume pivotal study |
Resumption of clinical trial |
Healthcare equipment |
5 May 2017 |
Share price performance
Business description
Analysts
Carmat is a research client of Edison Investment Research Limited |
||||||||||||||||||||||||||||||
Carmat announced on 2 May 2017 that it has obtained approval from the French regulatory agency (ANSM) to resume its pivotal trial for the Carmat heart. This follows a favourable review by ANSM of the actions and analyses taken by Carmat following the trial’s suspension after the death in October 2016 of this trial’s first patient six weeks after his implantation. Carmat maintained that the death was not due to a prosthesis malfunction, but due to poor handling of the batteries by the patient. Our valuation (previous rNPV of €747m in our 15 July 2016 update note) is under review.
Year |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/14 |
0.0 |
(20.3) |
(4.14) |
0.0 |
N/A |
N/A |
12/15 |
0.0 |
(20.6) |
(3.81) |
0.0 |
N/A |
N/A |
12/16 |
0.3 |
(25.7) |
(3.80) |
0.0 |
N/A |
N/A |
12/17e |
0.0 |
(21.8) |
(3.62) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles and share-based payments.
The ANSM is requesting that Carmat provide an intermediate analysis on the next five patients to take part in the pivotal study. Carmat is now also working to expand access in the 20-25-patient study to other European countries. It is also preparing to open a new production site, with more automated processes for manufacturing, which the firm indicates should be operational by year-end 2017 and should meet the manufacturing requirements for a future commercial launch.
To date, including the previous four-patient feasibility study (2013 through 2015) and the first recruited patient in the pivotal trial, five patients have thus far been implanted with the Carmat device, all with late-stage heart failure, with survival durations between one and nine months following their surgeries.
The company anticipated that the pivotal study, which first began in summer 2016, could potentially be completed in 2018. We believe it is unlikely that such a timeline will be met given the delay. Given the company’s year-end 2016 net cash position of €28.0m (€31.2m gross cash minus €3.2m debt) and its 2016 cash burn rate (operating cash flow plus net capex) of €22.2m, we expect current cash on hand to fund operations into Q218.
|
Disclaimer
|
|
Disclaimer
|
e-Therapeutics offers public market investors a unique opportunity to gain exposure to a proprietary, cutting-edge in silico drug discovery platform that has already attracted significant investment and has been fully operational since 2014. This second-generation platform has generated new chemical entities (NCEs) in several different disease areas and, under a new CEO, is on the cusp of commercial validation. The priority for the company is securing deals to provide external validation of this approach. e-Therapeutics’ strength is its discovery capability, particularly in complex disease; it also has six internal discovery projects with the prospect of more to come. The CEO’s business review will determine the focus of internal investment and business development activities.