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Research: Healthcare
Pixium announced on 24 May 2017 that the French Haute Autorité de Santé (HAS) has requested additional clinical data before agreeing to provide exceptional reimbursement under the Forfait Innovation (FI) programme for Pixium’s Iris II implant system. The HAS agreed that the Iris II meets the critical FI eligibility criteria of providing a sufficiently novel and innovative treatment for a significantly unmet medical need (patients severely visually impacted by retinitis pigmentosa). Pixium now plans to provide interim six-month data from its ongoing 10-patient European Iris-II study, which should be available in Q317, to fulfil this requirement. Hence we believe a decision from HAS on potential Iris-II reimbursement under FI is not likely before late Q317 or early Q417.
Written by
Pixium Vision |
Forfait Innovation decision postponed |
Commercial update |
Healthcare equipment & services |
26 May 2017 |
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Analysts
Pixium Vision is a research client of Edison Investment Research Limited |
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Pixium announced on 24 May 2017 that the French Haute Autorité de Santé (HAS) has requested additional clinical data before agreeing to provide exceptional reimbursement under the Forfait Innovation (FI) programme for Pixium’s Iris II implant system. The HAS agreed that the Iris II meets the critical FI eligibility criteria of providing a sufficiently novel and innovative treatment for a significantly unmet medical need (patients severely visually impacted by retinitis pigmentosa). Pixium now plans to provide interim six-month data from its ongoing 10-patient European Iris-II study, which should be available in Q317, to fulfil this requirement. Hence we believe a decision from HAS on potential Iris-II reimbursement under FI is not likely before late Q317 or early Q417.
Year end |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/15 |
3.3 |
(15.6) |
(1.23) |
0.0 |
N/A |
N/A |
12/16 |
2.5 |
(12.4) |
(0.98) |
0.0 |
N/A |
N/A |
12/17e |
4.9 |
(10.8) |
(0.85) |
0.0 |
N/A |
N/A |
12/18e |
14.9 |
(17.3) |
(1.35) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, share-based payments
As part of Pixium’s initiatives to obtain Iris II reimbursement in Europe, it had applied under the FI programme in France to cover potentially up to 40 implantations over a five-year period at up to 10 French hospitals. It expects such coverage would be contingent on the post-implantation monitoring of approximately half of these patients over a two-year period, to build data supporting the efficacy of the implant. This request is similar to a funding structure in place for Second Sight’s Argus II, where up to 36 patients are being covered by this programme.
The HAS also recommended that Pixium amend its proposed post-implantation monitoring protocol for FI-covered patients to also evaluate quality of life. Pixium agrees to enhance this post-implantation protocol and is confident that it will meet the FI eligibility requirements. As the FI decision has been pushed back to late Q317 or Q417, we believe that the initial FI-reimbursed Iris-II implantations will occur in 2018.
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Disclaimer
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Research: Financials
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