Last close As at 05/08/2026
—
— 0.00 (0.00%)
Market capitalisation
—
Research: Healthcare
Carmat
Written by
Carmat |
Cleared to start pivotal study in France |
Update – clinical trial |
Healthcare equipment & services |
15 July 2016 |
Share price performance
Business description
Next events
Analysts
Carmat is a research client of Edison Investment Research Limited |
|||||||||||||||||||||||||||||||||||||||||||||||||
Carmat has received approval from the health regulatory authorities in France to start a CE mark enabling a pivotal trial for the Carmat bioprosthetic heart. We expect recruitment to start in the coming weeks, which could lead to commercialisation in Europe by H218. Following this clearance, we have raised our Carmat heart probability of success estimate for the EU market to 35% (from 30% previously). This raises our rNPV valuation to €747m (up from €651m), or €133.00 per share after including an estimated mid-2016 net cash position of €41.3m.
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 |
12/16e |
0.0 |
(21.9) |
(3.35) |
0.0 |
N/A |
N/A |
12/17e |
0.0 |
(21.8) |
(3.68) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Pivotal trial expected to start in H216
In addition to patients with end-stage biventricular heart failure, patients who are eligible for a heart transplant but who have a very low likelihood of receiving a donor heart will be allowed to participate in the trial. This inclusion criteria is more relaxed than that of the prior four-patient feasibility study (completed in early 2016), which was limited to terminal-stage biventricular heart failure patients and/or those in an immediate life-threatening situations. Carmat is also working on obtaining clearances to enrol patients in other European countries.
Carmat intends to complete study in 2018
Carmat intends to recruit between 20 and 25 patients across multiple sites, who would be followed for up to 180 days. The firm anticipates that it would be able to recruit patients into the pivotal study in parallel rather than sequentially (as was done in the feasibility trial). This could significantly improve the recruitment rate, as the feasibility study took about two years to recruit four patients. A much more rapid level of recruitment is needed to satisfy the firm’s belief that CE mark clearance and EU commercialisation could occur in 2018.
Valuation: Risked NPV rises to €747m
Regulatory clearance for Carmat to start a CE mark enabling pivotal study is a key development step, and patient recruitment should begin shortly. We have raised our probability of success estimate for the Carmat heart in the EU market to 35% (from 30% previously). This leads to an increased rNPV valuation of €747m (up from €651m and excluding cash), or €133.00 per share after including the H116 €50m financing and assuming a €41.3m net cash position in mid-2016. We assume CE mark clearance and EU launch in H218 and a US market entry under a humanitarian use device (HUD) approach in 2020. We continue to expect current cash on hand to fund operations into H118, and that the firm will raise €40m in both 2018 and 2019 to prepare for launch activities; we expect Carmat to break even in 2020.
Financial summary
Exhibit 1: Financial summary
€000s |
2013 |
2014 |
2015 |
2016e |
2017e |
2018e |
||
Year end 31 December |
IFRS |
IFRS |
IFRS |
IFRS |
IFRS |
IFRS |
||
PROFIT & LOSS |
||||||||
Revenue |
|
|
2,874 |
49 |
14 |
0 |
0 |
13,320 |
Cost of Sales |
0 |
0 |
0 |
0 |
0 |
(15,984) |
||
General & Administrative |
(4,694) |
(5,408) |
(6,012) |
(6,000) |
(6,000) |
(9,150) |
||
Research & Development |
(13,376) |
(14,031) |
(13,392) |
(16,000) |
(16,000) |
(6,000) |
||
EBITDA |
|
|
(15,197) |
(19,390) |
(19,390) |
(22,000) |
(22,000) |
(17,814) |
Depreciation |
(920) |
(479) |
(377) |
(236) |
(226) |
(1,216) |
||
Amortisation |
0 |
0 |
0 |
0 |
0 |
0 |
||
Operating Profit (before exceptionals) |
|
(16,117) |
(19,869) |
(19,767) |
(22,236) |
(22,226) |
(19,030) |
|
Exceptionals |
25 |
(127) |
(89) |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
0 |
0 |
0 |
||
Operating Profit |
(16,091) |
(19,996) |
(19,857) |
(22,236) |
(22,226) |
(19,030) |
||
Net Interest |
(324) |
(476) |
(838) |
316 |
401 |
12 |
||
Profit Before Tax (norm) |
|
|
(16,440) |
(20,345) |
(20,605) |
(21,920) |
(21,826) |
(19,018) |
Profit Before Tax (FRS 3) |
|
|
(16,415) |
(20,472) |
(20,694) |
(21,920) |
(21,826) |
(19,018) |
Tax |
1,770 |
2,209 |
3,149 |
3,200 |
0 |
0 |
||
Profit After Tax and minority interests (norm) |
(14,670) |
(18,136) |
(17,456) |
(18,720) |
(21,826) |
(19,018) |
||
Profit After Tax and minority interests (FRS 3) |
(14,645) |
(18,263) |
(17,546) |
(18,720) |
(21,826) |
(19,018) |
||
Average Number of Shares Outstanding (m) |
4.3 |
4.4 |
4.6 |
5.6 |
5.9 |
5.9 |
||
EPS - normalised (€) |
|
|
(3.42) |
(4.14) |
(3.81) |
(3.35) |
(3.68) |
(3.21) |
EPS - normalised and fully diluted (€) |
|
|
(3.42) |
(4.14) |
(3.81) |
(3.35) |
(3.68) |
(3.21) |
EPS - (IFRS) (€) |
|
|
(3.42) |
(4.17) |
(3.83) |
(3.35) |
(3.68) |
(3.21) |
Dividend per share (€) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
||
BALANCE SHEET |
||||||||
Fixed Assets |
|
|
1,633 |
1,377 |
1,215 |
1,163 |
1,139 |
19,922 |
Intangible Assets |
125 |
254 |
218 |
218 |
218 |
218 |
||
Tangible Assets |
1,508 |
1,123 |
998 |
945 |
921 |
19,705 |
||
Current Assets |
|
|
20,351 |
12,665 |
7,435 |
38,767 |
16,965 |
19,164 |
Short-term investments |
0 |
0 |
0 |
0 |
0 |
0 |
||
Cash |
16,884 |
9,219 |
3,012 |
34,344 |
12,543 |
14,613 |
||
Other |
3,467 |
3,447 |
4,422 |
4,422 |
4,422 |
4,550 |
||
Current Liabilities |
|
|
(6,254) |
(4,750) |
(4,722) |
(4,722) |
(4,722) |
(4,722) |
Creditors |
(6,254) |
(4,750) |
(4,722) |
(4,722) |
(4,722) |
(4,722) |
||
Short term borrowings |
0 |
0 |
0 |
0 |
0 |
0 |
||
Long Term Liabilities |
|
|
(844) |
(1,349) |
(2,246) |
(2,246) |
(2,246) |
(42,246) |
Long term borrowings |
(822) |
(1,349) |
(2,224) |
(2,224) |
(2,224) |
(42,224) |
||
Other long term liabilities |
(22) |
0 |
(22) |
(22) |
(22) |
(22) |
||
Net Assets |
|
|
14,886 |
7,944 |
1,681 |
32,961 |
11,136 |
(7,882) |
CASH FLOW |
||||||||
Operating Cash Flow |
|
|
(9,314) |
(18,270) |
(16,349) |
(18,800) |
(22,000) |
(17,942) |
Net Interest |
(324) |
(476) |
(838) |
316 |
401 |
12 |
||
Tax |
0 |
0 |
0 |
0 |
0 |
0 |
||
Capex |
(266) |
(331) |
(292) |
(184) |
(202) |
(20,000) |
||
Acquisitions/disposals |
0 |
0 |
0 |
0 |
0 |
0 |
||
Financing |
11,932 |
6,033 |
11,185 |
50,000 |
0 |
0 |
||
Net Cash Flow |
2,029 |
(13,044) |
(6,295) |
31,332 |
(21,801) |
(37,930) |
||
Opening net debt/(cash) |
|
|
(215) |
(16,062) |
(7,870) |
(788) |
(32,121) |
(10,319) |
HP finance leases initiated |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
13,818 |
4,852 |
(787) |
(0) |
0 |
0 |
||
Closing net debt/(cash) |
|
|
(16,062) |
(7,870) |
(788) |
(32,121) |
(10,319) |
27,610 |
Source: Carmat accounts, Edison Investment Research
|