Outlook Therapeutics Inc (OTLK)

[H2R]

Hi Thermo,

I'm trying to reconcile two elements that seem contradictory on the surface. I was wondering if you would enlighten me. I did send IR a question about the legal enforcement around compound pharmacies continuing post approval but I did not get any reply.

The two elements:

1. It seems that legally, compound pharmacies would not be able to continue providing doctors with repackaged beva:

https://ir.outlooktherapeutics.com/static-files/b4e4a969-af03-4f17-9680-882c1c84239d
Feb 2022 presentation:

Slide 11 : " Once a drug or biologic is FDA approved and commercially available compounding is no longer authorized.2,3,4,5" (more on that slide)

Slide 31: " Initial U.S. target segment worth potentially billions in yearly revenue are served by compounding pharmacies which by law should give way to Outlook Therapeutics’ ONS 5010, if FDA approved"

2. However, the 12/29/2022 filing competitive landscape includes compound pharmacies

https://www.annualreports.com/HostedData/AnnualReports/PDF/NASDAQ_OTLK_2022.pdf

Competitive Landscape

Off-label use of bevacizumab (Avastin) is estimated to be approximately 50% of the overall market in the United States. The current FDA approved market leaders for the treatment of wet AMD are VEGF inhibitors, including EYLEA, BEOVU, LUCENTIS, SUSVIMO and VABYSMO.

Would you have any insight in terms of the ability of compound pharmacies to continue providing repackage bevacisumab post FDA approval of ONS-5010 (which will hopefully happen)? And what would be the ability of OTLK to enforce a legal decision if that is the case?

Thanks Termo!

Best of luck with your investments!