Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM) Q3 2022 Earnings Call Transcript

So there’s a very tight connection, especially in the first 30 days just to answer any questions. So overall, once again, we just really try to provide a very personalized hands-on experience for both the patient as well as ACP. On to the next question, which was relating to the average time from script to reimbursement approval I’ll just give one example, just to highlight what it is to look like as we move forward. One, we’re in a stage or a launch where there aren’t a lot of policies outlined for IMCIVREE for the BBS indication. As time progresses, we hope that there are policies that are put in place that will make the whole reimbursement process quicker just in terms of approval. So as we’re working within this stage of launch, one example I will outline is, for example, one payer, it took quite a bit of steps, including going to the appeals process to get the first script approved.

However, subsequent scripts that came to that specific payer were approved within days. So even for specific parents, it may take some time for the initial script to get approved, but we hope as we move forward, similarly, the time to script the approval will be up.

Operator: Our next question our next question will come from the line of Dae Gon from Stifel.

Dae Gon : Hope you guys hear me, congrats on the progress from me as well. One on HO and one commercial question from me. With regards to the Phase III HO trial design that you outlined a couple of days ago, you mentioned it’s about 120 patients, randomized placebo to setmelanotide and I guess, 99.5% powering as it stands. Can you maybe walk us through the thought process behind going after 120 patients. The 99.5% is extremely derisking, but just wanted to get your thoughts on why you sort of landed at that 120 number? And then commercial question, of the 120 prescriptions or more than 120 prescriptions, can you talk about how much overlap there is with the 350 that you had talked about previously identified, diagnosed? And maybe as an extension, how does that compare with the Cribs registry?

David Connolly : Yes. Let me take the HO question first, and Jennifer take the second. So the 120 patients going into the FDA meetings, we knew and you all knew that given the efficacy we had seen in the Phase II, the number of patients required to prove efficacy was likely to be relatively small. 120 patients is was more than that, not surprisingly. So that was really a discussion around safety. This is a new indication, and that was just negotiated, if you will, agreed upon a number of patients that would provide a robust evaluation of safety in this new indication, but it was not driven by efficacy. Next, Jennifer.

Jennifer Chien : Relating to the 120 scripts, I will say that one piece is just in terms of the outline that almost 1/4 of the scripts were coming from HCPs that were not known to Rhythm prior to prescription. So that one piece speaks to the progress just in terms of the teams continue to make around diagnosing additional physicians with BBS patients. It speaks to the very collaborative relationship that we have with the BBS Patient Association just in terms of helping to inform patients of the availability of IMCIVREE. It also speaks to the very collaborative relationship that we have with the folks and health care providers over at Marshfield. In terms of the exact overlap of the scripts with folks that are in the cribs registry, we don’t have that information in terms of understanding all the physicians with specific patients that are part of the crib registry itself.

I will say that just in general, though, the teams are just continuing to expand the opportunity around educating the physicians that we have that already have BBS patients and once again, really trying to expand the opportunity just in terms of additional patients that get diagnosed.