Rhythm Pharmaceuticals Inc Q3 2024 Earnings Call Transcript

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

Question: Philip Nadeau - TD Cowen - Analyst : Congrats on a strong quarter. Hunter, first question for you. In the prepared remarks, you mentioned there was some pull forward of demand from Q4 into Q3. Would you be able to quantify what the impact was on Q3 from that pull forward? And any other lumpy items included in the IMCIVREE revenue number?

Question: Philip Nadeau - TD Cowen - Analyst : Okay. That is very helpful. And then second question on the DAYBREAK trial, congrats on the data. They continue to look strong. Can you talk about what you need to see to advance one of those populations to a pivotal study? And when do you think you might be in a position to make a go, no-go decision on those populations?

Question: Philip Nadeau - TD Cowen - Analyst : That is very helpful. Congrats again on the progress.

Question: Corinne Johnson - Goldman Sachs - Analyst : Maybe a couple of questions from us. First, how should we think about sort of the contribution from Europe as we look into 2025? And do you anticipate that it will become sort of a larger share of overall revenue as we get further into that launch? And then could you also provide us some updates on what you're seeing with respect to adherence and compliance in the BBS patient population?

Question: Corinne Johnson - Goldman Sachs - Analyst : Yes, exactly.

Question: Seamus Fernandez - Guggenheim Partners - Analyst : So just wanted to talk a little bit about -- a little bit more about HO and the pipeline assets. Just to start with the data coming out of the eight patients in France, obviously, an impressive result in the adult population. I wanted to just get a little bit more color on the opportunity to continue expanding the early access opportunity in Europe with that data. Is that something that you're able to mobilize and then bring more patients onto therapy sooner with that result? And then the second question is really on the pipeline. Obviously, I know there's a strong view that in IMCIVREE or setmelanotide will continue to be very durable. But I think the opportunity to void the MC1 receptor is certainly quite compelling from our conversations with physicians. So just wanted to get a better sense of how those trials are progressing and when you would hope to really share those data? I believe you said midyear in the past, but I didn't know if there are any updates from a recruitment perspective and execution. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 05, 2024 / 10:00PM, RYTM.OQ - Q3 2024 Rhythm Pharmaceuticals Inc Earnings Call

Question: Seamus Fernandez - Guggenheim Partners - Analyst : Great. And then maybe just as one final question. The opportunity for HO in Japan is something that you've talked about in the past. Can you just give us a sense of how the HO opportunity is likely to emerge there? And is this something that you still feel confident that it is something that Rhythm can take on, on its own?

Question: Philip Nadeau - TD Cowen - Analyst : Congrats on the quarter.

Question: Dae Gon Ha - Stifel - Analyst : And congrats on all the data this week. I guess I'll just focus more on the hypothalamic obesity side. Just a couple of questions there. for 718 Part C data, before you go in there, is there any intention from you guys to share the Phase I healthy volunteer, just so we can get a sense for the PK as well as the hyperpigmentation side of the profile? As we think about the bivamelagon. I guess when you think about the trial itself, how much of an overlap is there between the trial participating in -- I guess, sites participating in that bivamelagon SIGNAL trial versus the Phase III hypothalamic obesity? I recall it was overenrolled. And so I would imagine some of that could bleed into, if you will, and perhaps fast track the bivamelagon enrollment? And then I guess, lastly, just thinking about the broader opportunity, going back to Phil's question, DAYBREAK and M&A, just wanted to get your sense on sort of the commercial opportunity here. Are you guys thinking about hypothalamic obesity and maybe going after something like a profitability goal first? Or would you be looking after more expansion opportunities by going after M&A than DAYBREAK subsets that might be promising.

Question: Whitney Ijem - Canaccord Genuity - Analyst : Just one follow-up on the -- can you guys still hear me, okay?

Question: Whitney Ijem - Canaccord Genuity - Analyst : Okay. Sorry. Follow-up on the Japan opportunity. Can you remind us -- I know you said the filing in Japan is based on the analysis of the overall study plus the Japanese cohort. Is it the full Japanese cohort out to a year of follow up? Or is there a potential for an interim cut with less follow-up of the Japanese cohort in particular?

Question: Jeffrey Hung - Morgan Stanley - Analyst : The French real-world study suggests that patients who had a resection over a decade ago could still derive a benefit from setmelanotide. Are you seeing any patterns on BMI or hunger score that correlates with time since resection? And if not, do you think that setmelanotide would be an ideal therapy regardless of time since resection? And then I have a follow-up. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 05, 2024 / 10:00PM, RYTM.OQ - Q3 2024 Rhythm Pharmaceuticals Inc Earnings Call

Question: Jeffrey Hung - Morgan Stanley - Analyst : Great. And then a few weeks ago, you announced the partnership with Axovia in BBS. Can you just talk about what you hope to gain from it? And will that help you gain greater access to the UK registry to reach additional BBS patients?

Question: Tazeen Ahmad - Bank of America Securities - Analyst : In terms of the Phase III data that you're expecting for HO, I think you've given a little bit of a broad guidance for the first half of 2025. Should we be expecting that timeline to be condensed maybe early next year some time? Or is that the guidance that you're going to maintain? And what's going to need to happen in order for that time line to condense? And then secondly, as you think about HO and the use of setmelanotide there, what have doctors told you about the desire to be able to combine GLP-1s with that drug? And I know you're not doing studies on that per se, but commercially speaking, would that be a good size?

Question: Joseph Stringer - Needham & Company - Analyst : Just back on the BBS launch, you're seeing pretty steady growth in new patient adds, another 100 US. TRx were in the quarter. Just wondering if you can describe the BBS patients that are new to drug at this point in the launch. Are the vast majority newly diagnosed? Where and how are they being identified and/or diagnosed? Any color on this would be helpful. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 05, 2024 / 10:00PM, RYTM.OQ - Q3 2024 Rhythm Pharmaceuticals Inc Earnings Call

Question: Joseph Stringer - Needham & Company - Analyst : Great.

Question: Raghuram Selvaraju - H.C. Wainwright & Company - Analyst : Just wanted to see if you could comment at all on activities that are planned in congenital hyperinsulinism. Over the course of 2025, if we should expect any updates on that front? And also, if you could give us some additional color on where you anticipate there might be additional reimbursed early access programs instituted for setmelanotide over the course of 2025?