Rhythm Pharmaceuticals, Inc. ($RYTM)

Good day, and thank you for standing by. Welcome to the Rhythm Pharmaceuticals Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, David Connolly, Investor Relations. Please go ahead.

Thank you, Marvin. This evening, we issued a press release announcing FDA approval of IMCIVREE for patients with acquired hypothalamic obesity. You can access the press release as well as the slides that we will be reviewing tonight by going to the Investors section on our website. Listed on Slide 3 are the speakers for tonight's call. David Meeker, Chair, President and Chief Executive Officer of Rhythm; Jennifer Lee, Executive Vice President, Head of North America; and Hunter Smith, our Chief Financial Officer; and Alicia Fiscus, our Senior Vice President, Head of Global Regulatory Affairs, are also on the line to answer questions. Before we get started, I would like to remind everyone that the statements we make on this conference call will include forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties and other factors, including those set forth in the risk factors in our SEC filings. In addition, any forward-looking statement made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. Except as required by law, we specifically disclaim any obligation to update or revise any forward-looking statements. With that, I'll turn the call over to David.

Thank you, Dave, and thank you all for joining again on short notice, and it's a relatively uncivil hour of 7:00 p.m. for those of you on the East Coast. It's been an eventful week. As you saw from our press release, we are thrilled to announce that the FDA has granted approval for IMCIVREE in acquired hypothalamic obesity. We all know how difficult it is to develop a therapy, which is safe and effective, let alone potentially transformative for an individual patient. Most development programs fail, and we shared our own challenging development story with you earlier this week. However, what I think we've done well at Rhythm is to follow the science. We know impaired signaling through the MC4R pathway leads to hyperphagia, lack of satiety, impaired energy expenditure and consequent obesity. And we know that IMCIVREE and our next-generation molecules are good MC4R agonist. Our challenge has been to identify those patients with impaired signaling who might benefit from an MC4R agonist. In the case of acquired HO, as many of you may remember, the biology was not obvious. By definition, these patients had injury to the hypothalamus, which in theory might compromise signaling through the pathway. But in addition to pathway injury, wouldn't it be likely one would lose the receptor as well. This disease is a classic example of where a precision medicine unlocks the biology. The fact that we have seen a remarkably consistent response to an MC4R agonist in each of our trials, whether it is IMCIVREE or our next-generation small molecule tells us that the MC4R pathway is central to the biology. So here we are. As highlighted on Slide 6, the indication statement is as follows: IMCIVREE is a melanocortin-4 receptor agonist indicated to reduce excess body weight and maintain reduction long term in adults and pediatric patients aged 4 years of age and older with acquired hypothalamic obesity. We are pleased to have received a broad indication, which is not limited to only tumor-related causes of hypothalamic injury. There are no post-marketing commitments associated with this approval. Slide 7 shows additional elements of the label, dosing, warnings and precautions and adverse events. There is nothing surprising here. Slide 8. Approval was supported by our global Phase III TRANSCEND trial, which evaluated setmelanotide in patients with acquired hypothalamic obesity. The label reflects the full 142 patient data set, which includes the initial 120 patients we read out as part of the primary analysis, the 12 patients from the Japanese cohort and 10 supplemental patients. Treatment with setmelanotide resulted in a statistically significant placebo-adjusted difference of 18.4% in BMI reduction after 52 weeks of treatment. In addition to weight reduction, we also observed meaningful improvements in hunger. Among patients aged 12 and older, those treated with setmelanotide experienced an average 2.3 point reduction in weekly average hunger scores as compared with a 1.4 point reduction in the placebo group. While hunger was not included in the indication statement, these data are included in the new label for IMCIVREE within the clinical results section as it is for each of our other indications. The reduction in hunger is consistent with what we understand about the underlying biology of acquired hypothalamic obesity and with what patients and caregivers describe as the most burdensome aspect of the disease. I know we will get questions as to how this will impact our probability of getting coverage through Medicare. Jennifer and team have continued to work this issue. We have made progress differentiating ourselves from the other anti-obesity medications through the different compendia used by the payers. We will make further progress as we now come with this new indication. We are not starting from 0. Slide 9. Today's approval further validates the central role of MC4R pathway impairment across both genetic and acquired forms of rare obesity. IMCIVREE has now demonstrated benefit across multiple diseases driven by this biology, reinforcing the durability of our franchise and supporting our continued investment in international opportunities and our next-generation MC4R agonist. For hypothalamic obesity, we moved with urgency following proof of concept in the summer of 2022. Following this FDA approval, we look forward to updating you on our Japanese filing progress in Q2. Our EMEA submission for HO is under review. We anticipate the CHMP opinion in Q2 and the EU marketing authorization in the second half of 2026. These are all important milestones for patients with acquired hypothalamic obesity and for Rhythm. Now before I turn the call over to Jennifer, I want to take a moment to thank the patients and their families. I've been part of many clinical trials over my career, and I don't think I've ever worked on a more complicated disease. Injury to this part of the brain leads to many problems which require treatment. Their medication list alone may be 1 or 2 pages. Once you add all the additional testing required to be part of a clinical trial, it can become overwhelming and 1/3 of the patients manage all of that as part of the placebo group for a full year. Their contribution and sacrifice is a real gift to their community. Finally, I want to thank the investigators and their clinical teams for their dedication and to all of the Rhythm employees who worked on this trial, and there were many. It is a passionate and dedicated team who believed in the difference this therapy could make in the lives of patients living with hypothalamic obesity. With that, I'll turn the call over to Jennifer.

Thank you, David. This is indeed a long-awaited day, and I am excited for all the patients, their families and physicians as they now have a therapy that specifically targets the root cause of their acquired hypothalamic obesity. I am also excited for Rhythm's North America team who have been preparing and planning for this day for well over a year. Beginning on Slide 11, acquired hypothalamic obesity represents a meaningfully larger opportunity than our genetic indications, including POMC [indiscernible] as well as BBS, while remaining very much a rare disease launch. We estimate there are approximately 10,000 patients living with acquired hypothalamic obesity in the United States with roughly 500 incident patients per year. With today's approval, IMCIVREE becomes the first FDA-approved therapy to address the underlying biology of this disease. Historically, there was no approved treatment and therefore, little incentive to diagnose acquired HO. With the availability of IMCIVREE, we expect more drive to get patients to an accurate diagnosis. And understanding that the need for a treatment option is high, this will lead to more and more patients beginning IMCIVREE over time. Next slide. Our expanded teams are in place, and we are ready to go. As we have shared in the past, we expanded our sales team of territory managers to 42, which is an increase from the 16 territory managers we had in place for the BBS commercial effort. Our territory managers have been and continue to focus on engaging with physicians at key medical centers across the country. Our access team as well as our Rhythm Intune patient service team are also in place. Together, these teams support securing reimbursement for patients, educating patients on what to expect when they begin treatment and helping patients stay on therapy to realize the benefits of IMCIVREE. Next slide. With the treatment now available, we expect acquired hypothalamic obesity to become more widely recognized as a potential repercussion of not only brain tumors and their management, but also potentially the results of other hypothalamic injuries. AHO caused by certain tumors and/or related treatment account for the vast majority of AHO cases, and this population is our immediate focus. Within this population, our goal is for all incident AHO patients to be diagnosed quickly so they can begin and stay on treatment with IMCIVREE. We will similarly work with urgency to give the broader prevalent population to a diagnosis and initiation on IMCIVREE. Next slide. We are excited to have IMCIVREE available to ACPs in acquired hypthalamic obesity patients. The feedback consistently suggests a high unmet need. And as seen in this slide that was shared back in September, the IMCIVREE product profile is resonating with strong interest to prescribe in AHO patients. Now on to my final slide. Today's approval represents a significant milestone for patients. Our full team has been in the field for months, and we are well positioned to execute the launch and continue to increase diagnosis rates, expand access and to see more patients benefiting from therapy. We are ready and look forward to updating you on our progress.

Thank you, Jennifer. And I think now we can turn the call -- open the call for questions.

[Operator Instructions] Our first question comes from the line of Derek Archila of Wells Fargo.

This is Simon on for Derek. Congrats on the approval. Before you had indicated that you will use patient start forms to measure the launch in the beginning. How should we think about the initial patient start form cadence in the first 1 to 2 quarters post launch?

Yes. Maybe I'll lead off here and then Jennifer can amplify. I think as we've been pretty clear as we've had this question multiple times, and it's the right question coming in. Jennifer said, we're incredibly excited about this opportunity. I mean it's meaningfully larger. It's organized in a very different way in these specialties. And so our ability to identify patients is going to be significantly greater than BBS, for example, which is a bit more of a needle in a haystack exercise. However, as Jennifer said, this is -- has many elements of a rare disease. And those elements, which are not everybody has a diagnosis. And so even though a health care provider may say, yes, that patient fits the profile I hadn't thought about that, they will want to bring that patient back in. And so there'll be issues such as getting access to their physician, health care provider. There's not -- these endocrinologists tend to be busy, so there won't necessarily be immediate access in that sense. So that will be a little bit of a delay. And then although we're in a really good position with the payers having launched PPL, our POMC leptin receptor and BBS, and they have good familiarity with the drug, and we have very good coverage across all payer segments there with the exception of Medicare. That will be our starting point, but you still need policies put in place. But having taken the bulk of the answer, Jennifer, other things there that we should add?

I think you've covered the majority. I would say that the expansion of the team also will allow us to expedite the education and outreach to the physicians that we have outlined. David, you already mentioned the access environment, which I think took years to get to, which is an amazing starting point in terms of the next indication. And we've had positive feedback through the research that we've conducted in terms of the payers understanding that this is an extension in terms of a different indication that is an MC4R disease, different than general obesity. I think the other piece is that the data for IMCIVREE is quite strong in the patient population and the unmet need in this patient population who have some of them tried other things is quite high. So all of this leads to positive condition just in terms of us launching in this indication. I would say that even on the caveat side, everything that you outlined in terms of timing is true. The alignment in terms of rare disease, not all patients are suspected, but we are having very good discussions with physicians who are suspecting and wanting to get patients to a diagnosis. And that's amplified now that there's a treatment option available. So very excited overall in terms of our ability to get this product out to the market.

So Simone, the short answer to your question is it will be a steady ramp faster than BBS, we anticipate, but not we've contrasted with up Prader-Willi launch, for example, which is a near-term reference point that a lot of people point to.

Our next question comes from the line of Tazeen Ahmad of Bank of America.

Congratulations on the approval. I maybe wanted to get a sense, David, about what metrics we should be expecting to get. So for similar types of launches, companies at least initially provide things like script data, maybe number of touch points with physicians, how many physicians are writing scripts, et cetera. Can you give us a sense of what to expect here, if anything, on that granularity that I just asked about? And should we expect you to start breaking out your revenues by indication?

Yes. No, thanks, Pristine. You highlighted exactly what I would anticipate. It's very much what we did with BBS. So we will give you start forms. We will give you insight into payer coverage as we get a sense for lives covered and again, we'll do our best to give you a feeling for how that part of the process is going. Physicians writing scripts is also something that we've done at least qualitatively. So those are the 3 categories in which you can expect to get information. We will not be breaking out revenue initially. I think revenue early on in a rare disease launch is not so helpful because of all the points we highlighted in the answer to the prior question. I think the things with all of you and what we'll be looking at is are patients getting in, getting the diagnosis? Are they getting a script written? And then how are we doing in terms of beginning to work them through the process.

Our next question comes from the line of Michael Ulz of Morgan Stanley.

This is Rohit on for Mike. Congratulations on the approval. I think in the past, you've said greater than 75 patients are enrolled in the extension trial. How soon do you expect them to get on paid drug? And then in terms of pricing, will it be the same as BBS?

Do you want to take that, Jennifer?

Sure. Pricing-wise, we are keeping a similar pricing for all indications for IMCIVREE. In terms of the patients that were in the study, our patient service team has been in very close contact with our clinical teams who've also been putting them in contact with the PIs. So that is an ongoing process just in terms of being able to understand the actual prescriber that would be prescribing the drug to transition patients over from a clinical trial over to commercial. So we're going to be working quickly just in terms of getting those Rxs over and then working the process just in terms of reimbursement and gaining access for those patients.

Our next question comes from the line of Corinne Johnson of Goldman Sachs.

Again on the approval. In the past, you spoke -- I think at last fall, you talked about having 2,000 patients or so identified. I'm curious where that number stands today? And if you could speak to the process of getting those patients actually on the drug. And then kind of separately on the reimbursement front, could you remind us what the payer mix is here and how it compares to your other indications with any kind of read-through implications to the coverage piece of this?

Jonathan?

Sure. So we had outlined the 200 number back in September. Since that point, our teams have been continuing to reach out to physicians -- and so that number is growing. We are not updating that number at this point of time. But just in terms of process-wise, I think that there are going to be physicians with diagnosed patients that are ready to go just in terms of ready to prescribe IMCIVREE. The timing element is the timing element of when that next -- that physician will actually be seeing that patient in the next visit. So there's a bit of a lag from approval to actually getting the Rx as the physician has a discussion with that patient. From a payer mix perspective, our data outlined as we went through the process, more patients that had backgrounds that were very similar to AHO patients starting with the brain tumor, the management, the evidence of endocrinopathies, evidence of obesity and was seeing an endocrinologist on an ongoing basis. So while we have that information, we don't have validation that they're all diagnosed AHO patients. So the payer mix is still TBD at this point of time. I think with that said, from BBS versus AHO, these tumors are bimodal just in terms of age distribution. So I would expect that there would be a skew towards older patient population in general, which may impact the payer mix. But similarly to BBS, we're going to have to see what the age distribution and payer mix ultimately looks like. In the initial stages of the BBS launch, we saw younger patients in general that were scripted initially. So we're going to have to see how that goes as we move forward with the launch.

Our next question comes from the line of Samantha Semenkow with Citi.

I'm wondering, just based on the payer interactions that you've had to date prior to the approval, what are payers looking for in terms of a patient disposition? Is there a certain amount of BMI change that they're looking for? Is it the rapid weight gain? I'm just curious what they are going to be scoring on in order to approve treatment with IMCIVREE.

Yes. So what was interesting, even looking at the BBS launch is that they were definitely looking similar just in terms of does this drug actually work? I think that was like the main thing, and that will be similar for the HO patient population. The standard is a change just in terms of BMI from baseline to the first evaluation point. But there were other things even that indicated that there was clinical benefit, especially if it was expressed by the physician in terms of impact on hunger and those types of parameters. So I think it's like holistic just in general, and they are really looking to see that the patients are benefiting on this drug.

Our next question comes from the line of Jonathan Wolleben.

I'm wondering if you could talk a little bit about your expectations for prior authorization, what payers are going to want to see to get patients on drug and remind us of what's necessary for an actual diagnosis of HO.

Right. So in terms of the market research that we did, we did ask general questions in terms of what would be required for documentation of the diagnosis, and we also probe specifically on different points. So in terms of documentation by the physician, it was a clinical diagnosis similar to our study. There was no specific requirements for imaging in terms of MRI or CT scans to prove this point. but more like looking back in terms of the fact that, that patient had, for example, the brain tumor patients, an injury that happened with confirmation that there was obesity that also -- a weight gain that happened shortly after. So more of a clinical diagnosis versus a requirement for imaging that was expressed in the market in sights.

Our next question comes from the line of Thomas Smith of Leerink Partners.

This is Brian Kony on for Tom Smith. Congrats again on the approval. Just curious here if you can elaborate on your launch readiness in terms of the size of the sales team. And maybe if you can comment on your strategy in focusing on patients that had previous tumor treatments versus patients that are currently being treated or seen by an endocrinologist.

Sure. So our sales team was hired last year, and we have a rightsized team that is 42 on ground that have been working through the tiered list in terms of targeted ACPs to educate. Holistically, our data leads us to the physicians that have the highest volume of potential AHO patients just in terms of prioritization. It just also naturally led us to key centers that treat pituitary brain tumor patients. And these centers are outlined across the nation. And this is where the patients go when they're diagnosed with a brain tumor. That's where they get their management. It's where they are linked also with an endocrinologist that is there to treat their resulting endocrinopathies. So I would say that, that is a high area of focus and it allows us to potentially get patients to a really quick diagnosis once the symptoms of AHO actually initiate. However, like I said, like our list leads us to the physicians and not all the physicians that we've identified are dislocated just in these centers themselves. So we're going physician by physician in terms of that education, and we'll continue to do that throughout the launch.

Our next question comes from the line of Ellen Horste of TD Cowen.

Congratulations on the approval. I'm on for Phil. One question from us. Previously, you mentioned that you're in the process of getting an ICD-10 code for HO. Do you have an update on the estimated time line for that? And do you see that as a growth lever in the early launch?

Sure. Our efforts just in terms of getting the ICD-10 code specific for HO are ongoing. And the timing will be TBD as we continue those discussions. And we hope very much to have something in place similar to our success in terms of getting one in place for BBS. I think that because, of course, having the ICD-10 code in place would be a true -- would be great just in terms of having another crumb that's quite strong to lead us to the right physician to educate. With that said, as I've outlined, I think that the data that we have to triangulate to that right physician in HO is so much stronger than our ability to do the same for an indication like BBS. So I feel very confident just in terms of the list that we have in terms of physicians even without that code at this point in time.

Our next question comes from the line of Seamus Fernandez of Guggenheim Securities.

This is Evan Wang on for Seamus. Adding our congrats on the approval. Understanding that there's no update on the patients identified, but can you talk more about the reception from the physician outreach thus far, I guess, both in terms of if the number of patients they're managing is in line with your estimates and also how they're planning to initially prescribe IMCIVREE among their patients?

Sorry, can I just ask you to repeat the last part of the question?

Curious if any learnings from the physician outreach in terms of how they plan to initially prescribe IMCIVREE among their patients.

Okay. Sure. I think overall, just as we have gone through the list, one, the data limitation is that our purview of look back is limited to patients who had brain tumor management within the past 10 years. So that's one limitation. But it's also potentially one reason why some of the patients or some of the physicians actually have more patients than what our claims analysis has shown. On the flip side, we have come across some physicians who were identified as having a patient that has indicated that they do not. So it's a bit of a mix, but I would say holistically, just in terms of even taking a look at that number that we outlined in September, we feel very good just in terms of being able to identify the right physician that ultimately may have one of these patients. And I would say that a lot of those discussions are leading to those moments where the physician may not even know that they have that patient, but in reflection in terms of the background, they're thinking twice in terms of whether or not they actually do have these patients within their practice. And that's the evaluation that they're doing following our education. In terms of Rxs, like I said, it's -- as in any disease, any -- I would say that there are physicians who are -- have and quite aware just in terms of AHO and been diagnosing those patients and treating those patients and understands the need for another therapy and are ready to prescribe. And on the other end of the spectrum, like I said, there are certain physicians who -- well, they didn't even realize that they may have a patient and our education is getting them to that point where they need to do further evaluation. So I think the education is what will lead to the Rxs with some ready to go and some needing a bit more time.

Our next question comes from the line of Dennis -- then of...

This is Anthea on for Dennis. Congrats on the approval. Could you provide a little bit more information on kind of the CMS' receptivity to rare obesity indications and what the gating factors are for coverage, not only for HO, but also whether that could come online for BBS and POMC as well?

Maybe... Go ahead, Jo.

So we -- when we got approval for BBS, we engaged with all payers, including CMS, knowing that there was the restriction that was specifically outlined in terms of Medicare for weight loss medications. At that time, it was a different group that we spoke with that there was clarity just in terms of wanting just something more than weight loss in terms of the indication and the PI itself. We reengaged in discussions but decided more recently in terms of AO to hold off until we actually saw what our ultimate label would look like. That doesn't mean though we weren't continuing our efforts. We continued our efforts across the board to support access, which included what David outlined in terms of our work compendia by compendia. These are clinical compendias and pricing compendias. And throughout all that work, we were able to convert the classification of IMCIVREE from an anti-obesity medication to something different in each of those categories, whether it's genetic protein replacements or endocrine and metabolic agents. And through that process, we've gone back to payers, and we've had success just in terms of being able to once again gain access through that differentiation. So now that we have our indication, we do plan to go back to CMS and outline the progress that we've made and continue those discussions. David, I don't know if you want to add anything there.

Our next question comes from the line of Lisa Walter of...

On the approval. Just curious, does your market research with payers suggest that they would be open to covering a combo treatment with IMCIVREE and a GLP-1? Any color here would be helpful.

So our market research was focused on covering IMCIVREE. So we did not ask the specific question in terms of combo therapy. I think holistically, our real sort of positioning of the drug is the initiation and the foundation treatment for these patients to address what's missing in their -- and the cause of their specific obesity. So that was the discussions that we had. So I don't have color just. In terms of combination.

Yes. And the only thing I'd add to that, I think we, over the past few years, learned a lot about GLP-1s and their potential use in patients with MC4R deficiency. For the most part, POMC, leptin receptor biallelic BBS, they're not used, not to say that there isn't some use. And we had additional data as part of this current study, where we had about 30 patients in the trial who would -- either about half of those patients had previously used a GLP-1 and not had the response they wanted or they were on the drug when they started in the trial, which was allowed as long as they weren't actively losing weight. And we were able to have the weight curves or BMI curves, if you will, for each of those patients, and you could see the accelerated weight gain when they had their injury, you could see when they started their GLP-1s and almost always, in each of these patients' cases, in those where there was some weight loss, it tended not to be sustained for the most part, and then it would start to regain and then they had a good response to setmelanotide. But I think the conclusion here is if you have a deficit in your MC4R signaling, one of the other anti-obesity medicines is going to have a hard time working. It's not that it can't have any effect, but it will have a hard time working. So back to Jennifer's point that we do think that you want to restore the normal physiology first, replace what's missing in this case, the alphimelanocyte stimulating hormone with an analog such as IMCIVREE. And then once you've done that, if you need additional, then, of course, you can add something on. And I don't know if Jennifer mentioned, I mean, we have not basically had a requirement to step through GLP-1s. They have not been researched in this indication. They're not specifically indicated for that, although they're indicated for weight reduction. So we'll see. But I think the biggest issue is they're not the biologic answer here.

Our next question comes from the line of Paul Matteis of Stifel.

This is Julian on for Paul. Congrats on the update and positive news. Just wanted to clarify whether you all were expecting for the treatment of hyperphagia to be included in the indication statement? Or does it read exactly as you anticipated with its inclusion in the clinical data section? And then one other quick question as well is on the warning slide for the monitoring patients for adrenal insufficiency, do you have a sense on what that exactly entails? And is that surprising to you given the population here?

Yes. I'll take the adrenal first. And then Alicia, maybe you want to make a comment on how the whole hyperphagia piece evolved. The adrenal insufficiency caution there and the warning is something we favored being put in. 80%-ish of these patients -- well, 80-plus percent have some degree of hormonal insufficiency, pituitary insufficiency, often which includes the presence of either vasopressin insufficiency, formerly known as diabetes insipidus, and/or adrenal insufficiency. And so if they have an acute injury or some severe event, then they need coverage of their steroids, stress dose steroid dose, if you will. And for the diabetes and sipitus, the vasopressin insufficiency part of their disease, their challenge there is that they can't manage their salt and water. So they have to be very closely monitored. And that's their baseline state before they enter the trial or went on IMCIVREE. The point of that warning was just that as you -- if you are losing weight and you're eating changes and the like, you want to pay attention to both the doses of the medications you're on, and they are on many because particularly if there's a weight-related part of that. And in this case of the vasopressin insufficiency, your water balance and so your sodium. So it's to make sure that doctors are vigilant. They don't just start a medication like this and realize that these complicated patients may not have other things which need to be monitored. Alicia, do you want to just comment a little bit on. the hyperphagia?

Yes, sure. Thanks, David. So giving hyperphagia or reduction in hunger in the indication statement, we were limited because the FDA will not accept a subgroup analysis for labeling claims. Our hunger instrument assesses self-reported in age 12 and over, which is the self-reported is what they place the most value on and caregiver reported under 12.

And just to finish on that, the question was, was it what we expected? Yes, this is what we expected. Was it what we had hoped for? No. We had hoped for potentially that this time we would be able to break through. But as Alicia said, they've been just remarkably consistent on their general response to how they see the hyperphagia piece of it.

I'm showing no further questions at this time. I'd now like to turn it back to David Meeker for closing remarks.

Great. Well, thanks, everybody, for tuning in, as I said, on short notice. Obviously, an important moment for Rhythm, but a really important moment for patients with hypothalamic obesity. I mean the role this part of their disease plays on their overall quality of life is immense. And I think as all of us have heard these stories and got to know some of these patients and their families, they were really -- they are desperate for help. And setmelanotide is not a cure, but I think it has an opportunity to make a real difference for these patients. So we're really excited to get going, and I think we're well positioned to do that, and we look forward to updating you all. Thank you.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.