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Research: Healthcare
Pixium Vision
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Pixium Vision |
First patient implanted with Iris II retinal prosthesis |
First Iris II implant |
Medical technology |
25 February 2016 |
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Business description
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Pixium Vision is a research client of Edison Investment Research Limited |
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Pixium has announced it has successfully implanted the first patient with its second-generation epi-retinal implant, Iris II. This is the first patient enrolled in a study of up to 10 patients with retinitis pigmentosa or other retinal dystrophies. Pixium filed for CE mark approval in December 2015 for Iris II.
Year end |
Revenue (€m) |
PBT* (€m) |
EPS* (€) |
DPS (€) |
P/E (x) |
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 |
4.4 |
(16.5) |
(1.29) |
0.0 |
N/A |
N/A |
12/17e |
6.6 |
(19.9) |
(1.56) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
First perception of light
The pivotal trial for Iris II recently enrolled and successfully implanted its first patient. Iris II is an epi-retinal implant that uses signals from a video camera to stimulate the nerves in the retina to simulate the image captured by the camera. The implant was made into a 58-year-old retinitis pigmentosa patient, who reported first perception of light after many years in the darkness; the patient will now receive training to learn how to interpret the light signals.
Upgraded technology
Iris II is expected to provide greater acuity and more realistic synthetic vision by providing more electrodes (150 vs 50) than the Iris I and incorporating a biomimetic camera, which captures continuous video of the changes in the surrounding environment. Prior cameras captured traditional video frames. Pixium plans to enrol up to 10 patients with retinitis pigmentosa or other retinal dystrophies in its current trial. Iris II was submitted for CE mark in December 2015, and the company expects approval in mid-2016.
Prima on track
Pixium is also advancing its sub-retinal implant (Prima) in preclinical studies. The recently completed chronic thermal safety study was conducted by Pixium’s partners at Stanford University, and revealed positive chronic thermal safety. The first-in-man implant is expected in Q316.
Valuation: Adjusted to €10.50 per share
Pixium is well capitalised with €24.4m in cash at FY15, which should be sufficient to progress the Iris programme to CE mark approval and conduct human studies with the Prima implant. We expect additional capital to be required for commercialisation in FY17. We have updated our risk-adjusted NPV model to reflect latest cash (€24m) and rolled it forward to 2016, resulting in a new valuation of €10.50/share (vs €10.27/share). Our model has been updated for FY15 results, with the key change to forecasts being a reduced R&D spend in FY16, to €18m (vs €22m previously), to reflect the current run-rate. R&D in FY17 is forecast at €20m.
Exhibit 1: Financial summary
€000s |
2013 |
2014 |
2015 |
2016e |
2017e |
2018e |
||
Year end 31 December |
IFRS |
IFRS |
IFRS |
IFRS |
IFRS |
IFRS |
||
PROFIT & LOSS |
||||||||
Revenue |
|
|
1,478 |
2,427 |
3,296 |
4,440 |
6,628 |
22,846 |
Cost of Sales |
0 |
0 |
0 |
0 |
(765) |
(2,636) |
||
Gross Profit |
1,478 |
2,427 |
3,296 |
4,440 |
5,863 |
20,210 |
||
R&D expenses |
(6,590) |
(10,963) |
(15,169) |
(17,761) |
(20,426) |
(21,958) |
||
SG&A expenses |
(1,035) |
(3,111) |
(3,824) |
(4,015) |
(6,023) |
(9,034) |
||
EBITDA |
|
|
(6,147) |
(10,834) |
(14,553) |
(16,203) |
(19,392) |
(9,485) |
Operating Profit (before GW and except) |
|
(6,147) |
(11,647) |
(15,697) |
(16,470) |
(19,775) |
(10,037) |
|
Intangible Amortisation |
0 |
0 |
0 |
(866) |
(810) |
(744) |
||
Exceptionals |
0 |
0 |
0 |
0 |
0 |
0 |
||
Operating Profit |
(6,147) |
(11,647) |
(15,697) |
(17,336) |
(20,585) |
(10,782) |
||
Other |
0 |
0 |
0 |
0 |
0 |
0 |
||
Net Interest |
1 |
36 |
52 |
0 |
(139) |
(139) |
||
Profit Before Tax (norm) |
|
|
(6,146) |
(11,611) |
(15,645) |
(16,470) |
(19,914) |
(10,177) |
Profit Before Tax (FRS 3) |
|
|
(6,146) |
(11,611) |
(15,645) |
(17,336) |
(20,725) |
(10,921) |
Tax |
0 |
0 |
0 |
0 |
0 |
0 |
||
Profit After Tax (norm) |
(6,146) |
(11,611) |
(15,645) |
(16,470) |
(19,914) |
(10,177) |
||
Profit After Tax (FRS 3) |
(6,146) |
(11,611) |
(15,645) |
(17,336) |
(20,725) |
(10,921) |
||
Average Number of Shares Outstanding (m) |
27.3 |
9.8 |
12.7 |
12.7 |
12.7 |
12.7 |
||
EPS - normalised (€) |
|
|
(0.23) |
(1.18) |
(1.23) |
(1.29) |
(1.56) |
(0.80) |
EPS - FRS 3 (€) |
|
|
(0.23) |
(1.18) |
(1.23) |
(1.36) |
(1.63) |
(0.86) |
Dividend per share (€) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
||
BALANCE SHEET |
||||||||
Fixed Assets |
|
|
8,965 |
9,932 |
11,087 |
12,122 |
13,160 |
14,160 |
Intangible Assets |
8,277 |
9,259 |
8,822 |
8,104 |
7,445 |
6,854 |
||
Tangible Assets |
641 |
627 |
2,072 |
3,825 |
5,523 |
7,113 |
||
Other |
47 |
46 |
193 |
193 |
193 |
193 |
||
Current Assets |
|
|
11,327 |
44,867 |
27,682 |
9,388 |
12,704 |
15,863 |
Stocks |
0 |
0 |
0 |
500 |
1,000 |
1,500 |
||
Debtors |
0 |
0 |
0 |
0 |
0 |
0 |
||
Cash |
9,420 |
42,132 |
24,354 |
5,560 |
8,376 |
11,035 |
||
Other |
1,907 |
2,735 |
3,328 |
3,328 |
3,328 |
3,328 |
||
Current Liabilities |
|
|
(2,038) |
(4,050) |
(3,498) |
(3,498) |
(3,498) |
(3,498) |
Creditors |
(1,379) |
(1,729) |
(2,159) |
(2,159) |
(2,159) |
(2,159) |
||
Short term borrowings |
0 |
0 |
0 |
0 |
0 |
0 |
||
Short term leases |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
(659) |
(2,321) |
(1,339) |
(1,339) |
(1,339) |
(1,339) |
||
Long Term Liabilities |
|
|
(30) |
(245) |
(315) |
(315) |
(25,315) |
(40,315) |
Long term borrowings |
0 |
0 |
0 |
0 |
(25,000) |
(40,000) |
||
Long term leases |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other long term liabilities |
(30) |
(245) |
(315) |
(315) |
(315) |
(315) |
||
Net Assets |
|
|
18,224 |
50,504 |
34,956 |
17,696 |
(2,949) |
(13,790) |
CASH FLOW |
||||||||
Operating Cash Flow |
|
|
(5,188) |
(8,389) |
(15,532) |
(16,822) |
(20,010) |
(10,102) |
Net Interest |
0 |
0 |
0 |
0 |
0 |
0 |
||
Tax |
0 |
0 |
0 |
0 |
0 |
0 |
||
Capex |
(303) |
(1,773) |
(2,299) |
(2,168) |
(2,231) |
(2,297) |
||
Acquisitions/disposals |
0 |
0 |
0 |
0 |
0 |
0 |
||
Financing |
11,822 |
42,705 |
56 |
0 |
0 |
0 |
||
Dividends |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
1 |
169 |
(3) |
197 |
58 |
58 |
||
Net Cash Flow |
6,332 |
32,712 |
(17,778) |
(18,793) |
(22,184) |
(12,340) |
||
Opening net debt/(cash) |
|
|
(3,088) |
(9,420) |
(42,132) |
(24,354) |
(5,560) |
16,624 |
HP finance leases initiated |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
(1) |
0 |
0 |
||
Closing net debt/(cash) |
|
|
(9,420) |
(42,132) |
(24,354) |
(5,560) |
16,624 |
28,965 |
Source: Edison Investment Research, Pixium Vision accounts
|
Research: Financials
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