Biotech Values

[DewDiligence]

BMY/JNJ—Milvexian phase-2 data in treatment of acute ischemic stroke…

PR:
https://finance.yahoo.com/news/breaking-results-phase-2-axiomatic-073600645.html

CC slides:
https://s21.q4cdn.com/104148044/files/doc_presentations/2022/Bristol-Myers-Squibb-ESC-IR-2022-Event-Presentation.pdf

Milvexian is an oral inhibitor of Factor XIa being co-developed by BMY and JNJ (#msg-140083631). For BMY specifically, Milvexian is the company’s hope for replacing Eliquis revenue when Eliquis goes off-patent in 2028.

In the trial reported today, Milvexian + Plavix/aspirin was compared to Plavix/aspirin alone at five different Milvexian doses. Despite the lackluster results, which include a flat dose response, BMY/JNJ have committed to a phase-3 program for Milvexian in three indications: secondary stroke prevention; ACS; and primary stroke prevention in patients with AF. The phase-3 trials are slated to start by year-end 2022 (see slide #13). Curiously, the three phase-3 indications do not include either of the indications tested in phase-2, which are treatment of acute ischemic stroke (see above) and VTE prevention (#msg-166773814).

The main competition for Milvexian is Bayer’s Asundexian, another oral FXIa inhibitor that just started phase-3 trials in AF/stroke prevention and treatment of acute ischemic stroke (https://www.businesswire.com/news/home/20220828005030/en ).

BMY has pegged Milvexian is a $5B+ opportunity (not risk adjusted—see slide #20), but this seems optimistic in light of the dataset released today.