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Currency in EUR
Last close As at 26/05/2023
EUR0.07
▲ 0.01 (16.67%)
Market capitalisation
EUR10m
Research: Healthcare
The US Food and Drug Administration (FDA) has granted Breakthrough Device designation (BDD) to Pixium’s wireless Prima bionic vision system (BVS), which is currently being assessed in the European PRIMAvera pivotal study in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). This achievement suggests that the FDA recognises GA-AMD is an irreversibly debilitating human disease and that Prima BVS has the potential to provide an effective treatment in this area of unmet need. Pixium remains on track to report top-line data from PRIMAvera in or around year-end 2023. If positive, a CE Mark regulatory marketing submission can be filed in 2024, which we estimate could lead to commercialisation of the Prima system in H125.
Pixium Vision |
Breakthrough designation provides validation |
31 March 2023 |
Share price performance
Business description
Analysts
Pixium Vision is a research client of Edison Investment Research Limited |
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The US Food and Drug Administration (FDA) has granted Breakthrough Device designation (BDD) to Pixium’s wireless Prima bionic vision system (BVS), which is currently being assessed in the European PRIMAvera pivotal study in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). This achievement suggests that the FDA recognises GA-AMD is an irreversibly debilitating human disease and that Prima BVS has the potential to provide an effective treatment in this area of unmet need. Pixium remains on track to report top-line data from PRIMAvera in or around year-end 2023. If positive, a CE Mark regulatory marketing submission can be filed in 2024, which we estimate could lead to commercialisation of the Prima system in H125.
FDA update |
Year end |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/20 |
2.1 |
(8.7) |
(0.26) |
0.0 |
N/A |
N/A |
12/21 |
2.7 |
(10.9) |
(0.23) |
0.0 |
N/A |
N/A |
12/22e |
1.8 |
(12.3) |
(0.21) |
0.0 |
N/A |
N/A |
12/23e |
0.8 |
(18.1) |
(0.21) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments. FY23 EPS loss has been revised (from 0.24 previously) to reflect increase in shares outstanding. All other estimates are unchanged.
The BDD is designed to provide patients with timely access to medical devices that may provide more effective treatment than remaining available options by accelerating their development, assessment and review, while maintaining the statutory standards required for market approval. Product candidates are eligible for BDD if the agency determines that the device ‘provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions’ and also meets one of the following: i) ‘represents breakthrough technology’; ii) ‘no approved or cleared alternatives exist’; iii) ‘offers significant advantages over existing approved or cleared alternatives’; or iv) ‘device availability is in the best interest of patient’. Thus we view the attainment of BDD as a meaningful validation of the Prima platform and consistent with the visual function improvements already shown in the European feasibility study.
Through the BDD, Pixium expects to have opportunities to interact with the FDA’s representatives and experts during the premarket review phase, which may facilitate timely determinations of areas of agreement and may also lead to a prioritised review of the regulatory submission once the required clinical studies are completed. While PRIMAvera was designed to support European market approval, we believe the company remains in discussions with the FDA to determine which additional studies, if any, may be needed for a US premarket approval submission.
We note that Pixium has disclosed that it is funded until the end of Q223 and is exploring various mechanisms to secure the cash flow necessary to pursue its strategic and development objectives. The company recently reported a year-end 2022 gross cash position of €7.7m and an FY22 operating cash burn rate of €11.3m (+28% y-o-y). Given the imminent funding need, we believe any successful fundraising initiatives in the coming weeks would be welcomed by investors.
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Research: Financials
As a specialist lender, S&U is sensitive to the economic background, but in its main motor finance business it has a strong track record of managing and growing through bumpy conditions. The newer property bridging business is maturing and shares a focus on customer service and a conservative underwriting approach. This provides the group with a sound basis for sustainable long-term growth.
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