Rhythm Pharmaceuticals Inc Q3 2025 Earnings Call Transcript

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

Question: Mike Oles - Morgan Stanley - Analyst : Yep, good morning. Thanks for taking the question, and congratulations on all the progress. Maybe just one quick one on Bivomegalon, if you can share your latest thinking on the trial design for your Phase 3 HO study. And just curious if you received any initial feedback yet from the FDA there. Thanks.

Question: Mike Oles - Morgan Stanley - Analyst : Great. Thank you.

Question: Philip Nadeau - Cowen and Company LLC - Analyst : Good morning, and congrats on the progress. Thanks for taking our question. Our question is to dive into the PWS and efficacy endpoints a bit further to understand what you need to see to advance MCV forward in PWS. So in terms of weight, you suggested something that suggests 5% weight loss at one year. Can you give us more of a sense of what that is? Is that 2.5% at 26 weeks, or is there a different way to think about it? And then in terms of hyperphagia, a similar question, you said it's gonna be hard Interpret, but nonetheless, hyperphagia is a major determinant of quality of life in Prader-Willi, so is there any level of hyperphagia change that would be proof of concept and warrant further development? Thanks. Yeah.

Question: Philip Nadeau - Cowen and Company LLC - Analyst : That's helpful. Thank you.

Question: Derek Archila - Wells Fargo Securities LLC - Analyst : Hey, good morning, and thanks for taking the questions here. So, first question, just can you discuss some of the drivers behind the changes to the ongoing variability trial for MCVRI? It looks like you extended it out to 52 weeks from '26, and what looks like the potential to explore adding sites to the trial? And then the second question, just briefly, can you discuss if you've had any FDA, you know, agreements or discussions around the indication statement for HO and whether it could or could not, you know, include hyperphagia. Thanks. 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 04, 2025 / 1:00PM, RYTM.OQ - Q3 2025 Rhythm Pharmaceuticals Inc Earnings Call

Question: Derek Archila - Wells Fargo Securities LLC - Analyst : So nothing to read through.

Question: Whitney Lam - CG - Analyst : Thank you for taking our questions. This is Angela for Whitney. Maybe switching gears a little bit, a question on the HO launch. Any updates you can provide around conversations you're having with payers? Should we assume that most or all patients will be on the free drug program until payers start to finalize their policy updates in three to six months after approval or any color to provide around the gross to net round knowledge?

Question: Corinne Johnson - Goldman Sachs Group Inc - Analyst : Good morning. This is Eric on for Corinne Johnson here. The question we have is, just to double-click a little more on the HO launch that we were just discussing here, how should we think about the process for and the cadence of reimbursement and the anticipated gross-to-net in HO, specifically relative to VBS? Can you just give us a little more color on that? 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 04, 2025 / 1:00PM, RYTM.OQ - Q3 2025 Rhythm Pharmaceuticals Inc Earnings Call Unidentified Company Representative You want me to speak to gross-to-net to start? I think what we anticipate in terms of differences gross-to-net is It's a little hard to say. We've had around a 50-50 Medicare commercial mix for BBS. We don't know how different the HO population will be, but that is the primary driver of our growth to that because we don't rebate in any meaningful way. So it really is just a question of what's the Medicaid share. That, of course, assumes that we still do not have Medicare access. If we are able to get Medicare access, then that GTN mix will shift favorably.

Question: Dennis Ding - Jefferies LLC - Analyst : Hi. This is for Dennis Ding. Thank you for taking our questions. We had one on the PWS. When you disclose the initial data in December potentially, should we also be expecting a go versus no-go decision in terms of moving into Phase 3? Or is there a scenario where you would wait for a longer follow-up before making that decision? Thank you.

Question: Dennis Ding - Jefferies LLC - Analyst : Got it. Thank you. Unidentified Participant Thanks.

Question: Raghuram Selvaruri - HC Wainwright - Analyst : Thanks so much for taking our questions. I just wanted to ask about the German observational study findings and how you expect that to potentially percolate into other indications beyond Bardett-Beetle syndrome and what impact you anticipate this might have on prescribing decisions in those areas. Thank you.

Question: John Wolban - Citizens - Analyst : Hey. Thanks for taking the question and squeezing me in. Just wondering, and sorry if I missed this earlier, of the 2,000 potential patients, have you been able to identify any more information on them, on who may or may not be good candidates for one reason or the other? Or is it simply that you have kind of an identifier through the claims analysis you've done?

Question: John Wolban - Citizens - Analyst : Got it. Thanks, John.

Question: John Wolban - Citizens - Analyst : in 2026. So look forward to the next update. Thanks all.