The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Tazeen Ahmad - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Congrats on a good quarter. I wanted to maybe ask a question on what I think is your next upcoming pipeline catalyst, that's the Prader-Willi data.
David, can you just frame for us what the study is? Is it an exploratory study? Or is this a high conviction study because there is a history of
setmelanotide being looked at in this indication before. And I think people would just appreciate getting a sense about how you're feeling about
what data would be good data and what the next step would be if it is good data?
Question: Tazeen Ahmad - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: And how many patients worth of data would that be?
Question: Michael Ulz - Morgan Stanley - Analyst
: Congratulations on all the progress. Maybe just a quick follow-up on the Prader-Willi question. I appreciate the color on the number of patients,
but can you give us a sense on what sort of level of follow-up you're expecting?
Question: Michael Ulz - Morgan Stanley - Analyst
: Got it. That's helpful. Maybe I could just ask a quick follow-up. Assuming if the data is positive, how do you think about some of your next-generation
MC4Rs like bivamelagon? Is that something you consider taking forward in this indication as well?
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: Congrats on the productive quarter. A follow-up from us on Prader-Willi too, just circling back on what is good data. It seems like there's a few
elements to the data we'll be looking at BMI decreases, reductions in hunger as well as the consistency across the patient population. David, could
you give us some sense as to how you -- what you want to see to move forward? What would be good data in terms of weight loss effects on hunger
and consistency?
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AUGUST 05, 2025 / 12:00PM, RYTM.OQ - Q2 2025 Rhythm Pharmaceuticals Inc Earnings Call
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: Great. And one quick housekeeping question for Hunter, if I might. In terms of OpEx, your guidance for the non-GAAP operating expenses is very
clear. But in terms of stock comp, there's $15.9 million in Q2. I think you had like $30 million in stock comp of all of 2024. So how should we think
about stock comp going forward in the second half of 2025?
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: Got it. So this is a good baseline to use as we think.
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Just had one question for David here and then one for Hunter. So David, just will you be providing updated estimates for HO prevalence during
the Commercial Day of September? And I guess what gets you confident that they're at the higher end of the range, as you said in the prepared
remarks?
And then just a quick one for Hunter. Again just in terms of the growth that you've been reporting ex-US for the past two quarters, how should we
be thinking about that moving forward?
Question: Corinne Johnson - Goldman Sachs Group Inc - Analyst
: Maybe on the other clinical update expected later this year, you now have the first patient enrolled in Part C. Could you provide any clarity on the
nature of the data you could possibly share later this year, recognizing that enrollment is going to continue into next year? And then on the HO
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AUGUST 05, 2025 / 12:00PM, RYTM.OQ - Q2 2025 Rhythm Pharmaceuticals Inc Earnings Call
use, I think you said that there is meaningful ex-US utilization. But do you have any visibility on whether there are HO patients getting IMCIVREE
off label here in the US?
Question: Dennis Ding - Jefferies LLC - Analyst
: I had one on Prader-Willi. So just given the availability of VYKAT and the fact that your Phase II is being done at a single center, what sort of guidance
are you giving Dr. Miller in terms of who to enroll in the study versus maybe who she uses VYKAT? Specifically, like what types of patients would
go on to the study? And do you think that would make it more difficult potentially for setmelanotide to show an efficacy signal there?
Question: Raghuram Selvaraju - H C Wainwright & Co LLC - Analyst
: This pertains to CMC. I was just wondering if you could comment on the status of the development of the smaller pill for bivamelagon and also
the key objectives in your auto-injector development work for RM-718, including, but not limited to, the possibility of developing a formulation
that might be dosable less frequently than once weekly.
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AUGUST 05, 2025 / 12:00PM, RYTM.OQ - Q2 2025 Rhythm Pharmaceuticals Inc Earnings Call
Question: Heidi Jacobson - Leerink Partners LLC - Analyst
: This is Heidi Jacobson on for Faisal Khurshid. Can you share any updated thoughts on the Phase III study design for bivamelagon in acquired HO,
including dose, study size and what is left to get done before that study can get rolling?
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