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DewDiligence

02/28/22 10:00 AM

#241592 RE: DewDiligence #240290

VTRS sells JV stake in Humira/Enbrel/Eylea-biosimilars portfolio_to Biocon for $3B plus contingencies…

4Q21 results:
https://investor.viatris.com/news-releases/news-release-details/viatris-reports-strong-fourth-quarter-and-full-year-2021

CC slides:
https://investor.viatris.com/static-files/6a055dc2-4cd2-4d6c-91c9-c426ec1dcbce

Note: VTRS is retaining its participation in the Botox-biosimilar program with RVNC.

DewDiligence

05/10/22 7:06 PM

#242447 RE: DewDiligence #240290

Re: RVNC / VTRS Botox biosimilar

On today's 1Q22 CC, VTRS President, Rajiv Malik said that FDA approval of the Botox biosimilar (via the 351(k) biosimilar pathway) is now targeted for 2026. Previously, VTRS had said that the 351(k) submission was expected in 2024, suggesting that FDA approval was expected in 2025. The later expected approval is due to a delay stemming from RVNC's change to its working cell bank, which provides the bulk drug substance for both Daxi and the Botox biosimilar.