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Research: Healthcare
Pixium Vision
Pixium Vision |
Iris II receives CE mark clearance |
Update – CE mark |
Healthcare equipment |
27 July 2016 |
Share price performance
Business description
Next events
Analysts
Pixium Vision is a research client of Edison Investment Research Limited |
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Pixium announced on 25 July that its Iris II epi-retinal implant has received CE mark clearance from European regulatory authorities. This pivotal step helps validate the device’s safety and can enable the first stage of a commercial roll-out of this device in certain European markets. Our rNPV, inclusive of net cash, is €11.62 per share (vs €10.28 previously).
Year |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/14 |
2.4 |
(11.6) |
(1.18) |
0.0 |
N/A |
N/A |
12/15 |
3.3 |
(15.6) |
(1.23) |
0.0 |
N/A |
N/A |
12/16e |
2.9 |
(14.2) |
(1.11) |
0.0 |
N/A |
N/A |
12/17e |
5.5 |
(24.1) |
(1.89) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Clinical trial and reimbursement activities underway
We expect Pixium to implement the first phase of an EU commercial roll-out and seek reimbursement in Germany, France, the UK, Spain and Austria. Emphasis will be placed on selected ophthalmic surgery centres of excellence, particularly those sites that have participated in earlier trials of the earlier-generation Iris I implant. We believe that Second Sight’s Argus II implant is reimbursed at €96,000 in France (Pixium’s home market). We believe this can bode well for Pixium, as the Iris II has significantly more electrodes than the Argus II (150 vs 60), which may improve the level of visual resolution perceived by the user.
Iris II study underway, discussions with FDA in H216
A multi-centre 10-patient European study of Iris II in visually blind patients with retinal disease started in January 2016 and will assess the effectiveness of the device for at least 18 months. Interim data from the trial should further assist reimbursement applications in EU territories. Pixium plans to discuss the US clinical development strategy for both Iris II and its next-generation Prima sub-retinal implant with the FDA in H216. We continue to model US Iris II commercialisation in 2018 and Prima launches in 2019 for the EU and in 2021 for the US.
Valuation: Raising rNPV to $132m
Following CE mark clearance, we have raised our Iris II commercial probability of success estimate to 55% (from 40%, previously), with US regulatory risk and commercialisation risks (market acceptance, reimbursement) remaining as risk-adjustment factors. Our pipeline rNPV is €132.3m (vs €113.5m, previously). After including H116 net cash of €16.1m (€16.2m gross cash minus €0.2m in short-term advances), we obtain an equity valuation of €148.3m, or €11.62 per share (vs €10.28 previously). We model a 2016 operating cash burn rate of €15.1m, and continue to assume Pixium will raise €20m in financing in 2016 and €30m in both 2017 and 2018. For illustrative purposes only, we added these requirements to long-term debt, and our model does not include the potential dilutive impacts of future equity offerings.
Exhibit 1: Financial summary
€000s |
2014 |
2015 |
2016e |
2017e |
2018e |
||
Year end 31 December |
IFRS |
IFRS |
IFRS |
IFRS |
IFRS |
||
PROFIT & LOSS |
|||||||
Revenue |
|
|
2,427 |
3,296 |
2,866 |
5,525 |
25,875 |
Cost of Sales |
0 |
0 |
0 |
(1,894) |
(12,154) |
||
General & Administrative |
(2,299) |
(2,680) |
(3,893) |
(6,495) |
(9,600) |
||
Research & Development |
(10,963) |
(15,169) |
(12,301) |
(20,000) |
(22,000) |
||
EBITDA |
|
|
(10,835) |
(14,552) |
(13,328) |
(22,864) |
(17,878) |
Depreciation |
(813) |
(1,144) |
(1,086) |
(1,265) |
(1,430) |
||
Amortization |
0 |
0 |
0 |
0 |
0 |
||
Operating Profit (before exceptionals) |
|
(11,648) |
(15,697) |
(14,414) |
(24,129) |
(19,308) |
|
Exceptionals |
0 |
0 |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
0 |
0 |
||
Operating Profit |
(11,648) |
(15,697) |
(14,414) |
(24,129) |
(19,308) |
||
Net Interest |
37 |
52 |
240 |
16 |
(401) |
||
Profit Before Tax (norm) |
|
|
(11,611) |
(15,644) |
(14,174) |
(24,113) |
(19,710) |
Profit Before Tax (FRS 3) |
|
|
(11,611) |
(15,644) |
(14,174) |
(24,113) |
(19,710) |
Tax |
0 |
0 |
0 |
0 |
0 |
||
Profit After Tax and minority interests (norm) |
(11,611) |
(15,644) |
(14,174) |
(24,113) |
(19,710) |
||
Profit After Tax and minority interests (FRS 3) |
(11,611) |
(15,644) |
(14,174) |
(24,113) |
(19,710) |
||
Average Number of Shares Outstanding (m) |
9.8 |
12.7 |
12.8 |
12.8 |
12.8 |
||
EPS - normalised (€) |
|
|
(1.18) |
(1.23) |
(1.11) |
(1.89) |
(1.54) |
EPS - normalised and fully diluted (€) |
|
|
(1.18) |
(1.23) |
(1.11) |
(1.89) |
(1.54) |
EPS - (IFRS) (€) |
|
|
(1.18) |
(1.23) |
(1.11) |
(1.89) |
(1.54) |
Dividend per share (€) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
||
BALANCE SHEET |
|||||||
Fixed Assets |
|
|
9,932 |
11,087 |
11,106 |
12,341 |
14,911 |
Intangible Assets |
9,259 |
8,822 |
8,494 |
8,494 |
8,494 |
||
Tangible Assets |
673 |
2,265 |
2,613 |
3,848 |
6,417 |
||
Current Assets |
|
|
44,866 |
27,682 |
33,279 |
37,735 |
47,298 |
Short-term investments |
0 |
0 |
0 |
0 |
0 |
||
Cash |
42,132 |
24,354 |
28,501 |
30,780 |
34,044 |
||
Other |
2,735 |
3,328 |
4,778 |
6,955 |
13,254 |
||
Current Liabilities |
|
|
(4,051) |
(3,498) |
(2,325) |
(1,231) |
(2,156) |
Creditors |
(4,051) |
(3,498) |
(2,325) |
(1,231) |
(2,156) |
||
Short term borrowings |
0 |
0 |
0 |
0 |
0 |
||
Long Term Liabilities |
|
|
(245) |
(315) |
(20,337) |
(50,337) |
(80,337) |
Long term borrowings |
(167) |
(164) |
(20,165) |
(50,165) |
(80,165) |
||
Other long term liabilities |
(78) |
(151) |
(172) |
(172) |
(172) |
||
Net Assets |
|
|
50,503 |
34,956 |
21,723 |
(1,491) |
(20,284) |
CASH FLOW |
|||||||
Operating Cash Flow |
|
|
(8,426) |
(15,584) |
(15,060) |
(25,236) |
(22,335) |
Net Interest |
37 |
52 |
240 |
16 |
(401) |
||
Tax |
0 |
0 |
0 |
0 |
0 |
||
Capex |
(1,772) |
(2,106) |
(1,097) |
(2,500) |
(4,000) |
||
Acquisitions/disposals |
0 |
0 |
0 |
0 |
0 |
||
Financing |
42,705 |
56 |
63 |
0 |
0 |
||
Net Cash Flow |
32,543 |
(17,582) |
(15,854) |
(27,720) |
(26,737) |
||
Opening net debt/(cash) |
|
|
(9,420) |
(41,965) |
(24,190) |
(8,335) |
19,385 |
HP finance leases initiated |
0 |
0 |
0 |
0 |
0 |
||
Other |
1 |
(193) |
0 |
0 |
(0) |
||
Closing net debt/(cash) |
|
|
(41,965) |
(24,190) |
(8,335) |
19,385 |
46,122 |
Source: Edison Investment Research, Pixium Vision accounts. Note: 2014 and 2015 revenues include tax credits and subsidies, which are forecast at approximately $3m per year through 2018.
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