Pixium Vision develops bionic vision systems for patients with severe vision loss. Lead product Prima is a wireless sub-retinal implant system for dry age-related macular degeneration (GA-AMD). The company started implantations for the European PRIMAvera pivotal study in Q422.
Pixium started the PRIMAvera European pivotal study in Q420 and completed its target of 38 implantations in Q422, which could lead to top-line data being reported in Q423 or H124. GA-AMD is a leading cause of blindness in older adults, affecting over 2.5 million persons in the United States and Europe, and there is no approved treatment. Pixium reported €7.7m gross cash on 31 December 2022 and expects its current cash position to maintain operations to the end of Q223.
Lloyd Diamond
CEO
Offer Nonhoff
CFO
Forecast net debt (€m)
20.2
Forecast gearing ratio (%)
121
% | 1M | 3M | 12M |
---|---|---|---|
Actual | (4.3) | 7.6 | (87.0) |
Relative | (2.0) | 7.1 | (88.6) |
52 week high/low | €0.6/€0.0 |
Having completed the required 38 implantations in late 2022, Pixium Vision’s key upcoming clinical milestone is the primary efficacy data, expected in or around year-end 2023, from the PRIMAvera European pivotal study assessing the safety and clinical benefits of the wireless Prima System in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). The company’s FY22 results showed a milder operating loss than expected, coming in at €11.9m, below our €12.5m estimate. Pixium has since taken further steps to curb its cash burn rate, and it now expects its funds on hand (€4.7m gross cash as of 31 March) to last until approximately the end of July, versus its prior guidance of June 2023. It is working actively to raise additional funds and has hired two investment banks to reach potential investors worldwide. We have rolled forward our estimates and given that we expect the company’s focus in 2023 and 2024 will be on preparing the Prima System for EU market approval and launch (which we continue to model in H125), we have pushed back our US commercialisation forecast by one year, to H227. We now obtain a pipeline rNPV valuation of €140.1m (vs €146.3m previously).
Y/E Dec | Revenue (€m) | EBITDA (€m) | PBT (€m) | EPS (fd) (c) | P/E (x) | P/CF (x) |
---|---|---|---|---|---|---|
2021A | 2.7 | (9.7) | (10.9) | (0.23) | N/A | N/A |
2022A | 2.0 | (11.5) | (10.3) | (0.21) | N/A | N/A |
2023E | 0.8 | (12.4) | (13.8) | (0.10) | N/A | N/A |
2024E | 0.8 | (10.3) | (13.3) | (0.09) | N/A | N/A |