Ahmad forecasts a lower risk story from here, given clarity on risk/benefit for Syfovre from an FDA stance and a strong launch trajectory, seeing "room for upside."

The Syfovre label for geographic atrophy (irreversible vision loss) was updated to include the safety events of vasculitis with or without occlusion and did not include a BBW.

According to Ahmad, the update was encouraging as it reflects confidence from the FDA, with the ORV rates remaining low at ~0.01%.

The analyst highlights that Syfovre has been compared to Beovu, where ORV rates were much larger after closer analysis, but the label update reflects a clear distinction between the two.

This could benefit the launch, which has been remarkable so far and continued to exceed expectations even after the initial reports of ORV cases, the analyst adds.

 Management commented they are seeing some of the strongest demand in November since the launch.

Ahmad did not anticipate the stock would bake in future value for Syfovre sales in such a short amount of time, but this is reflective of increasing confidence in the risk/benefit profile from physicians and investors. 

Key factors that could provide additional upside include - a strong trajectory for the EU launch (decision in 1Q24), increasing uptake outside of high-volume practices, and further recovery in the third of doctors who stopped use after the safety events.

For FY24, the analyst projects an adjusted EPS of $(1.91) loss. 

Price Action: APLS shares are trading higher by 0.63% to $64.27 on the last check Tuesday.

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