In line with what we saw from the topline release earlier this week, today's presentation showed clinical benefit vs. epoetin alfa across primary and secondary endpoints. Hitting the primary endpoint with strong durability, showing 2.5 years median transfusion independence ~1 year longer than epoetin alfa. Some nuances presented today across RS+ and SF3B1+ subgroups. Both groups, 73% and 62% of patients, respectively, showed stronger responses than the overall ITT population. With SF3B1 wt patients also showing improved responses vs. epoetin alfa and RS- patients showing a slightly reduced response. Important to note, however, RS- patients showed more durable responses, starting at ~80 weeks, vs. epoetin alfa. All in, we like the efficacy profile of Reblozyl and anticipate use ahead of epoetin alfa.

Safety was in line with prior studies, well tolerated with an AE profile comparable to standard of care. 43.8% of patients in the Reblozyl and 59.7% of patients in epoetin alfa arm discontinuing treatment. The difference primarily driven by lack of efficacy in the epoetin alfa arm. The most common AEs in the Reblozyl arm being fatigue, diarrhea, and peripheral edema with instances of 15%, 15%, and 13%, respectively, compared to 7%, 12% and 7% in the epoetin alfa arm. Heme related AEs were in line across both arms with grade 3/4 AEs in line across both arms. All in, we are very comfortable with the safety profile.

Thinking through what this means for Bristol shares and opportunity size in 1L MDS, we currently model adjusted WW peak sales of ~$1B in the indication and WW adjusted peaks sales for all Reblozyl indications at $2.9B with the potential for label expansion to drive durable growth as we look to performance past the ongoing launches of Sotyktu, Camzyos and Opdualag.