Rhythm Pharmaceuticals Inc Conference Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Philip Nadeau - Cowen and Company LLC - Analyst : Thanks for taking our questions, and thanks for the transparency. Very helpful. Two from us. I guess first, so you had this information request. It seems like it doesn't change the conclusions. Are there any other outstanding information requests from the FDA, or was this the last one? And then second, if memory serves me, back in 2022 when you got the label extension for BBS, there was also a request for, I think, a sensitivity analysis that resulted in a three-month push to the PDUFA. But ultimately, the application was approved. Can you remind us what happened back in 2022 and how similar the situation is to that?

Question: Derek Archila - Wells Fargo Securities LLC - Analyst : Just a quick question from us in terms of just the reviewers. Any changes there in terms of like who's been reviewing the application that might have driven this change or this additional request or just question there? And then in terms of -- again I guess piggybacking off Phil's question. I mean, is there still a possibility that we could get something on the earlier side of approval before the new PDUFA date, just given that -- is it like such a voluminous data request, as you said with BDS? Is this kind of less volume in terms of data that you're submitting? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Derek Archila - Wells Fargo Securities LLC - Analyst : Yeah. Just any changes in the personnel reviewing the file.

Question: Avi Novick - Morgan Stanley - Analyst : It's Avi Novick on line for Mike. Thank you for taking our questions, and also appreciate all the transparency here. Yeah, so I guess just thinking ahead to the eventual launch, does this three-month extension still enable you to, say, identify more patients? Or how does that impact your launch plans and your launch readiness targets?

Question: Corinne Johnson - Goldman Sachs - Analyst : Maybe you could just talk a little bit about that comment you made regarding including the Japanese data in the filing, how big of an addition is that and any chance that could cause any further delays.

Question: Tazeen Ahmad - Bofa Merrill Lynch Asset Holdings Inc - Analyst : I just wanted to ask you, is there any read through to interactions that you're having with the agency on clinical trials that are currently underway? Are people -- some of the people involved, some of the same people that you're going to have to negotiate with on this PDUFA, I just want to get a sense. You do continue to have important data catalysts upcoming next year and beyond. I just want to get a sense of if anything needs to be changed in terms of timelines, expectations, and/or strategy in your discussions with the agency on pipeline.