Conference Transcript - RYTM 2026-06-08

Speaker 1

All right, good afternoon, everyone. Thanks for joining us at the Goldman Sachs Global Health Care Conference. Thrilled to be joined on stage today with David Meeker, the CEO of Rhythm. And we are thrilled to be hosting you ahead of, I'm going to get this one out of the way early on, ahead of the Indoconference this week where you're going to be sharing data for Prater-Willi. We would love to talk to you about it, but what are you going to be able to say?

David Meeker, CEO

Yeah, thanks, Corinne. I'm excited to be here. Right, we're really looking forward to Saturday. We have our six-month data from the open-label study, an 18-patient study run by Dr. Miller at the University of Florida. We presented some very early results last December. We'll now be presenting the full 17-patient data set at six months with this group. And our goal will be to, our goal, we are presenting four different data points for each patient. We have almost a complete set on the deck. But basically, every patient, you'll have their weight change, the BMI or BMIZ for the kids, the DEXA scan results, which gives you the FAD and the lean changes, and then two patient-reported outcomes, one HQCT, of course, and the second is a PADQ questionnaire, which measures anxiety and distress. And so those will be able to give you, like I said, the data for each patient, and people will have the full picture of that. But we're not in a position to talk more about it at this conference, needless to say, because we're so close to Saturday and there's no real good way to answer even hypothetical questions. So we're going to defer on those.

Speaker 1

All right. And gentle plug that you can join us for dinner post that meeting on Saturday night. And if you'd like to do that, reach out to your salesperson. OK, with that, let's talk about the H.O. launch, because that's also super topical these days. And maybe just given kind of the audience, we could talk first about just HO was approved in March or MCCivory was approved for HO in March. And it was the third approved indication for the drug. But for those not familiar, can you just remind us about the data that supported that approval and what made it on label relative to your expectations and clinical results?

David Meeker, CEO

Yeah, so I'm also excited to get that approval in March, which was a three-month delay on our Purdue for date. I think caught up a little bit in some of the changes in Washington. But the label that we got was a good label. We had been, well, we were trying, as we can do each time, to get a hunger into the indication statement. We were, again, unsuccessful. And I think the biggest reason is when the FDA, as they've explained it, to get something in the indication statement, you really need hunger to, one, be in your primary endpoint. It was, in this case, a key secondary. But also, we study in that trial, as people remember, kids as young as four years of age and individuals as old as 66. And so having one patient-reported outcome measure for that full range, you have different measures. And so we ended up having subsets of populations, and they don't tend to give you an indication based on subsets. So for that reason, hunger didn't get into the indication statement. but it is in the label, and that's really only an issue, and I'll get back to the launch here in a minute, but that's only really an issue for our conversations with Medicare specifically. Medicare by statute does not cover weight loss drugs, and so anything in the indication statement which would help differentiate us from a more general obesity, anti-obesity medication. We've talked to CMS, and they're very receptive, They understand what we are trying to do, and they understand our drug's different, but they felt bound by statute. So from a label standpoint, we got pretty much everything we want. No real restrictions on the label. It's not defined by the requirement for imaging, for example, and the like. It's for, you know, acquired hypothalamic obesity. So we felt really good about where we ended up coming out of the regulatory process.

Speaker 1

And then we talked about it on our first quarter earnings call, the initial six weeks of launch and I don't know if we want to dive into that now I'm happy to offer a few comments or turn it back to you for some more questions yeah let's get there but first I just want to talk about the size of the market opportunity because I think when you started introducing this it was very much five to ten thousand and as we've gotten close to the launch and then since the launch I think you guys have solidified around that ten thousand number so maybe you could talk about what kind of gave what are the kind of puts and takes that gave you confidence in that 10,000 number, and what have you learned now that you're on market in terms of kind of understanding the market opportunity there?

David Meeker, CEO

Yeah, so I'll back up and speak a little bit generally about how we get to rare disease epidemiology numbers, and I'll use BVS as an example. When we came out with BVS, it was sort of a, I think, 2,500, 3,000 kind of number. I may even be misquoting there, but it was a little lower than where we are now, and a couple things informed our increase to 4,000 to 5,000, which is a prevalent number that we feel really good about for the U.S. only. And so one is we were doing more genetic screening, so that informed us based on what we felt was the prevalence of the background genetics there, actually got us to a significantly larger number. Two, the prevalence of the disease in Europe and the U.S. we felt was highly similar, so much better understanding of the prevalence of the disease in France, for example, so we could take the French number and then correct on a population basis for the US. So that gave us a second data point. And then third, which is, I think, really important and part of the answer to the HO, is I think when people do rare disease epidemiology, almost invariably, it's rare, not a lot of work has been done, so it tends to be poor in the published literature and the like. And I think you tend to fall in one of two buckets, and one is either you're trying to inflate your numbers a bit to make a business case, but when you get out in the field, it's really hard to find those patients. Or alternatively, you're sort of working straight up from, you know, whatever poor epidemiology you have, and then that epidemiology tends to be larger than what you estimate, not smaller, just because inherently these early estimates tend to underestimate it. I think we're in the second bucket there. So when we went out with our 5,000 to 10,000 estimate, that was very much predicated on sort of the literature kind of review and the like. We then did claims analysis, not just in the U.S., but outside the U.S., so we had claims analysis in Germany. We had claims analysis in Japan. We talk about that, but across populations, all of that was very reinforcing that, gee, the numbers on the higher side, you know, 10,000 as opposed to five, and then this very important is once we had people in the field, they were finding patients. They were getting, you know, strong feedback that the patients where they are in the gestalt of that is that no these numbers feel feel good so yeah right now we estimate there's a 10,000 ish yeah and in terms of like where these patients are treated can you remind us like where are these patients who are the the target physicians and how have you guys tiered your commercial strategy relative to the target physician population yeah so one we just knew based on the the problem here which is you know majority of you know individuals having a tumor, benign tumor, that gets resected. And the complications of that surgery are 80% plus of them have pituitary insufficiency. So by definition, that group tends to be taken care of by endocrinology. Even if they're not their primary, they will see an endo every 6 to 12 months as a rule kind of thing. So we expected them to be in the endocrinologist offices. And then when we did claims analysis, and, you know, this is where you've got a very hard starting point, which is the injury, most often the tumor and the surgery and the like. So you can identify that population very reliably. You can figure out what percentage or, you know, who are the patients who have pituitary insufficiency. And then you begin to get into obesity coding and the like, which is a little less reliable because that doesn't necessarily tell you that that obesity is due to HO. But you're really starting to narrow the funnel there. So based on that, Jennifer and her North American team tiered physicians based on and were appropriately focused on those who had more than two patients, basically. So that was our 5,000 as patients, and we built a sales force with the goal of targeting that 5,000 out of the 10,000-plus endos overall. so that's so then as you've gotten out into the market you're talking to these physicians what have you learned in terms of physician feedback about their enthusiasm for the drug the patients that they're willing to put on it and how they're thinking about adoption yeah hi and as i've said you know very reinforcingly many investors and analysts and the like do their own work and i think everybody's pretty much getting the same feedback and what we're hearing in the office is a huge amount of interest, a surprising to me anyway, lack of awareness in many settings. And if you think about acquired HO, it's not one of those things that many or most endocrinologists were trained on during fellowship. It's a clear disease, but it hadn't been given a name. And what will drive that awareness, as is often the case, is the availability of a therapy. So Before there was a treatment, if you think about an individual with a cranial pharyngioma now getting ready to go to surgery, they will be told, A, not a single patient coming out of surgery will be, if they have hypothyroidism, it will not be missed. 100% of those patients will have their hypothyroid status diagnosed. And secondly, almost all of them will have been educated about that possibility going into surgery. A very low percentage of patients today are educated about the possibility of developing acquired HO. So why is that? There's no therapy. So you're creating anxiety. This is one view of what we hear and the like is you're creating anxiety within the family for a problem that there's nothing to do about. You may have this problem, wow, it sounds horrible, but yeah, there's not much we can do. Now there's something to do. So I think all of those things will greatly accelerate. So back to your question, what we're hearing going in is a huge amount of interest. A majority of the patients are probably in the suspected category, not, you know, confirmed diagnosis. They need to come in and get it. Getting into doctor's offices, which is sometimes hard to get into previously, and those are busy. But now, you know, our field team is getting in there much more reliably.

Speaker 1

Okay, so then with all of that kind of background, you disclosed 150 patient start forms in early May. That was about six weeks into the launch. Can you help us bridge from the patient start forms then to revenue, as well as what can you share qualitatively about the trajectory of patient starts since the last update?

David Meeker, CEO

Yeah, I mean, as you know, and we've gotten feedback on this, there's aspects of this opportunity which are very specialty-like, and that's a huge advantage. For an ultra-rare disease, and this is at 10,000, that's still ultra-rare by any definition, but the specialty-like aspect of this is if they're not diagnosed, they have a presentation slash phenotype, which is very diagnosable. I mean, it's not hard to recognize once you know what they're looking for, and they are concentrated in the specialty. So they are extremely approachable. Our ability to penetrate into that should be high. On the other side of the equation, which is, yeah, we have many of the challenges of a classic ultra-rare, which is day one, awareness is still relatively low, a lot of work to do. Two, access to the physicians will be writing the script, still challenging. It's not like endos have big open spaces in their clinic day where patients can just come in and get their script written. Three, it's an ultra-rare, so there's no difference necessarily from anything else where it's a prior off, you have to go through, you have to get policies in place, And so for BBS, the average time out of the gates to getting a patient from a script to approval was about three months. Now, average, so some patients went through much more quickly, some took longer, and the longer ones were the multiple appeals that took you out into the, you know, farther than that. I'd say our very early start here has been very much what we expected, which is a little easier than BBS, not surprisingly. They know the drug, most of these payers, and the disease itself is clearly, you know, more severe at one level than what the BBS patients are experiencing. So all of that, I think, bodes well for what we expect to have as broad coverage, similar to what we had for BBS.

Speaker 1

Okay. So I guess with that in mind, maybe be a little bit more specific. When do you anticipate having most of the coverage plans in place? And in the interim, what should we anticipate with respect to reimbursement?

David Meeker, CEO

Yeah, so, you know, 6 to 12 months, using BBS as an example. When a new drug gets approved, they don't call a committee meeting. You just get reviewed whenever their, you know, formulary committees come up to do their reviews. So, you know, think 6 to 12 months.

Speaker 1

And what do you anticipate in terms of, like, gross to net over time once these coverage plans are in place and any other kind of free drug aspects we should keep in mind?

David Meeker, CEO

Yeah, so we don't discount, and haven't, and don't anticipate doing that going forward. Our gross net is driven very much off the Medicaid population, which has a mandatory discount, as you know. So that'll be the same here. We don't have a good feeling for the size of the Medicaid population. It was large in BBS, a significant part of our overall population. I think there's reasons to believe it might be a little smaller. Conversely, the Medicare population may be a little bit larger, given the fact that you have a relatively normal survival. And we have almost very few, if any, over 65 Medicare-eligible patients. Maybe yes, we will have some here.

Speaker 1

How should we think about compliance and adherence, like maybe relative to your other launches or, you know, based on any color you can provide NHL? And maybe talk specifically about that hyperpigmentation piece or any other things that you think are big drivers of compliance and adherence over time?

David Meeker, CEO

Yeah. I mean, this is a group where, if anything, I think the adherence will be higher than it was with BBS, although I think it was quite good in BBS overall. The difference here is you've got a population who had a quote-unquote before state when they were normal. Now they've experienced the abnormal and desperately want to get back to the normal state, and so they start feeling better. And so all of those things, I think, are strong contributors toward what we would anticipate would be high levels of adherence. The hyperpigmentation in BBS, which is our major experience, about five to six percent of patients discontinue because of hyperpigmentation. Not a huge number out of the total, of course, I think there's likely to be some maybe meaningful part of the population which is on the sidelines. And so we look forward to the next generation therapies, you know, bringing in on the BBS world. And BBS is a complicated disease. In HO, and talking to some of the KOLs, I mean, some of the feedback is, yeah, they just don't care. I mean, they're just happy to be. So I'm guessing it'll be less here. It won't be zero.

Speaker 1

Okay. What about the kind of motivation to get on drug between pediatric and adult populations, and any other kind of differences between those two groups of people, whether it's the physician or the patient?

David Meeker, CEO

Yeah, I don't know yet. I mean, you can hypothesize reasonably that, you know, kids, there may be a greater motivation. They've got their parents there, you know, helping to, you know, get them in. On the other hand, peds endo, there's fewer of them. Maybe the availability, you know office slots and like may dictate that i think if you're living with this problem and you know you have it it's going to be pretty high um whether you're an adult i think the group that may be more challenged is if you're out 20 years from your insult and you don't have a diagnosis you may just not know and so um one of the things that we see sometimes when rare disease launches is this concept of, like, a bolus, et cetera.

Speaker 1

I guess, how do you think about whether that's something that could play out in the HO launch versus I think what you've characterized in prior launches as slow and steady growth?

David Meeker, CEO

Yeah, so I think I'll characterize HO as steady. We can take out the slow part. But it's every launch, you know, there'll be a segment of the population that can see it coming and, you know, a bit of pent-up demand. And we can't tell you if that first six weeks experience reflected an element of that. I'm sure it did to a small extent. But the ingredients that are here and the opportunity says, no, we didn't get a big bolus, and now it's going to taper off. I mean, this was a really good start. We feel good about it. But we're looking for steady growth here going forward. And the other thing, we'll consciously endlessly say this, right? It's a rare disease launch.

Speaker 1

Don't beat us up in the quarters. it's um you know you will be up and down around you know whatever the expectations may be that's a rare disease launch but the overall opportunity here over time and absolutely you know we're more and more bullish about that opportunity the more we learn about it okay um so recognizing you can't talk about the prater willy data coming this year but maybe we can talk about the opportunity set that you see in prater willy why was this an indication that you thought worth kind of pursuing from a development perspective, and how do you envision the role semelanotide could play in that population?

David Meeker, CEO

Yeah, I mean, like every company, and certainly the way I've thought about being in this industry, is, you know, you want to be addressing unmet needs. We, I've never been a sort of me-too kind of strategy in terms of, you know, that's not really what we do or certainly probably don't do well. So, pray to willy, huge unmet medical need, incredibly complicated disease. the biology that got us interested as people remember we ran that trial in the late teens and our initial read on that was negative but when you went back and looked at it and looked at the patients on the highest dose for the longest period the famous 8 weeks, 4 patients 3 out of those 4 patients did have a response and so it gave us some encouragement and we know that But, you know, MEGLE2, for example, one of the genes that is affected in a Prader-Willi patient is a gene that's part of the signaling through this MC4R pathway. We studied MEGLE2 in our daybreak, and in the three patients who we had confirmed evidence that they had true loss of function, that was encouraging. They had a reasonable response. And so, yeah, so I think the biology is likely to be embedded. The challenge with Prader-Willi is it's so complex, and you have multiple genes that are affected. There's a lot of other stuff going on, and most specifically the behaviors. And one of the most challenging aspects of the behavior is, for example, the obsessive-compulsive part of it, which is, and I use the example, as you know, around if you're hardwired to have a snack at 10 a.m., even if you're not hungry, you remove that part of the drive. I still that's part of my structured day I want that snack and so you know there's a lot a lot of reasons why you know studying the drug has been been challenging here for everybody going into it but but biologically that's why being on my need I think there's a chance we can make a difference so one of the questions we've fielded in the past has been kind of the clinical relevance of weight loss as an endpoint versus hyperphagia how do you think about weight loss as a primary endpoint in Prater-Willi trials and the relevance that that would then translate for a commercial product? Yeah, I mean, we were clear, I was clear when we went into this, that we have a drug which has the ability to impact weight, and we, you know, and that's a, no drug is approved for that, and, you know, clearly a big part of their unmet medical need, and so that for sure would be part of a development program going forward. But, no, I think the Solano experience, you know, and what the majority of the companies that have been working to develop a drug for have pursued, one, it's hyperphagia is a big part of the challenge just for the families and the patient, you know, how to manage that given all their behavioral challenges. Two is the fact that with the Solano, now Nurocarin, diazoxide approval that set a precedent. And so there's a paradigm out there now where you can run a hyperphasia trial that's shorter, so four to six months as opposed to weight loss trials, which are 52 weeks. So I think if we do something, we would certainly look at both approaches.

Speaker 1

Okay. In terms of how you're sizing the commercial opportunity in Prater-Willi, how should we think about it relative to maybe like AHO or other indications you currently have in development? And what have you learned with now approved products on that market in terms of the size of market, enthusiasm to treat, et cetera?

David Meeker, CEO

Well, I'll take the line. I mean, I think, you know, the experience of the diazoxide choline out of the gate was pretty remarkable but not surprising in that, you know, this is a community that is very strong. I mean, they've been together for a long time. They're very well organized. They provide tremendous support to any company that's trying to develop a drug. So they're following all programs. They're hopeful for any treatment. So to get the approval, that was just a huge win for the community, very well known within the community, pent-up demand for sure. That was one part of the dynamic. And the second is it's a very distinct disease, So they tend to be taken care of by expert centers. They tend to have clinics that they come into. So their ability as patients' families to access the system when the new drunk comes out and get a script written is much greater than HO, for example, where it doesn't have that same kind of organized community and access to the health care system in the form of clinics.

Speaker 1

With regard to the epidemiology, you know, the whole world, I think the published literature is pretty good.

David Meeker, CEO

We've done our own work just to try to understand if there's some nuances we're missing. You know, 10,000 to 20,000, I think the addressable population, you know, as a starting point, you know, might look at it, you know, more around the 10,000 piece of it, 10,000 person part, but it's clearly in the 10,000 to 20,000 range.

Speaker 1

So with Vicat on market, I guess, where do you see the residual unmet need for patients in Prader-Willi, and how does that map to what Sambalanatide could offer? You've kind of answered some of this, but just put a finer point on that.

David Meeker, CEO

Yeah, I mean, so I'm absolutely convinced that drug works, and it's just a very challenging population, number one. And what they showed and got approval on was the hyperphagia piece of this. I think the unmet need, again, is something. It may be that you can have greater effects on hyperphagia, so it's not that they've fully addressed it, one. Maybe no single drug will address it. I mean, that's another potential outcome. We talked about the BMI, the weight-related issues, not there. They're not, because of the side effects of a diazoxide, they're not indicated.

Speaker 1

The ability to use in diabetes is more challenging, not that you can.

David Meeker, CEO

So there's parts of the population where, as with any drug, the profile of the drug may not match up and give you access to the full population. So there remains, and there will remain, I think, a huge unmet need.

Speaker 1

And how do you think about potential combination use with VICAT and how will that kind of inform potential future studies in terms of inclusion criteria, et cetera?

David Meeker, CEO

Meaning learning off what they did?

Speaker 1

Well, yeah. And also, like, will you allow for combinations?

David Meeker, CEO

Oh, that's how I allow. So in the data set we have with Dr. Miller, there's about nine patients who are out of the 17 who are on VICAT. So, you know, people can look at that. It's a small data set, of course. But I don't know. Going forward, we'll have to see. We'll get through them. We'll talk about it after.

Speaker 1

On the Next Generation program, 718 and BIVA-Malagon, I guess first we'll see some updated data from the BIVA one-year study this weekend as well, or that will be highlighted at the conference. Could you talk a little bit about that program, what you've seen, and the path from here to registrational trial?

David Meeker, CEO

Yeah, I mean, it's all highly confirmatory. I mean, the one-year data is highly confirmatory. I think the mean values are driven, again, by, you know, they're basically about the same as setmelanotide. And we had some patients in there who were, you know, a small number of the teenage, younger teenage kids who were still struggling a little bit, taking the drug, weren't fully compliant. So drug works. I think we've got a good read to the dose. I think there's personally low risk to a phase 3 trial. We will run that trial largely outside the U.S. So depending on which countries you're in, it always introduces some variables in terms of getting the trial up and going. But our goal is to get first adult patients treated by the end of the year. And the pediatric formulation, I think, will be available in the first quarter. So what we would do there is the peds part of the trial would come in once that formulation. This is a chewable tablet, so we've significantly improved the size of the tablets with our current approach formulation, and as I said, we'll get down to the H4 with this chewable tablet.

Speaker 1

And how will the registrational program compare to the semelanotide program in terms of any sort of features there?

David Meeker, CEO

Very similar. Again, we'll look at this whole issue of hyperphagia and, you know, between it will be the key secondary probably and or, but, you know, BMI will be a primary endpoint. So it will be very similar. You and I, as you go forward, I think we're going to work harder to get DEXA scans more formally on all patients. There's more and more interest in the quality of weight loss. I think the way our mechanism works, we've done really well on the quality of weight loss, which is, you know, we're restoring more normal physiology, which, again, if you're a teenage boy, you know, you should put on lean mass. And you see teenage boys, you know, going through puberty, putting on, you know, lean mass. And so, you know, all of that, I think, is a real positive that we'd like to help the world understand.

Speaker 1

Okay. You are also planning to share 718 data in AHL this year. Maybe you could remind us what exactly will be shared, maybe when you think we could kind of have that data, and how it'll inform next steps.

David Meeker, CEO

Yeah, so we'll target the next quarter earning call. There's about 10-ish patients that we'll have data on. And, yeah, I mean, people ask, well, what should we look for? I mean, you know, what we're looking to see is how this compares to setmelanotide, very similar to what we did for bivum elegan. So we'll show you that data.

Speaker 1

Maybe you could talk a little bit about why these drugs matter from a, like, broader corporate strategy perspective. of why does it matter to have an oral and a weekly injectable in terms of the overall franchise?

David Meeker, CEO

Yeah, from a patient standpoint, I mean, it's just, I think there's clear advantages to the oral over a daily injectable and a weekly is a weekly. I think from a side effect profile, the biggest difference for these drugs will be the hyperpigmentation. And as I said, I do think it's just not a good way to estimate this, but we will be very interested to see if it unlocks. And I think it will, some percentage of the population that's sitting on the sideline. And then, of course, from a patent standpoint, this was really important, I mean, to continue to move.

Speaker 1

Okay.

David Meeker, CEO

And as you think about kind of allocating investment dollars behind each of these programs and with multiple indications that you could kind of go into, how are you thinking about prioritizing and selecting which drug for which indication? yeah probably the tbd to be determined category i think um you know we can all have our opinions about you know which might be better i think in general for a big opportunity like ho our goal will be to approve both get both approved but there's no urgency to get both approved i think we'll move as we are with billa and ho we don't have to rush out and do 718 for example and ho So we can get there, but not tomorrow kind of thing. So we would not prioritize that as the next piece. So we'd probably do some other things with HO. For the smaller opportunities, like going back to some of the daybreak genes and the like, we will develop one or the other, because it's unlikely we'd run the two trials, and that just seems like a bit excessive maybe for a small opportunity. And I don't know. We'll debate it internally why we pick one approach for one of the diseases and another for the other.

Speaker 1

And with respect to Prater-Willi, can you share at this stage how you would think about 718 versus that melanotide, or what data do you need to have in hand before making that decision is maybe an easier question to answer.

David Meeker, CEO

Yeah, I'm going to infer that one until Saturday.

Speaker 1

No problem. How should we think about the funding picture from here in terms of path to profitability or any additional kind of capital needs you might have as you look at a relatively broad now portfolio across MC4R?

David Meeker, CEO

So as Hunter likes to say, you can shout out from the audience here, we have more than 24 months of cash, which at one level I think the analyst population would interpret as enough to get us into profitability, obviously. It depends on what assumptions you make around revenue and the like because that's part of that. But that guidance does include a good amount of our developmental work and the like. So increase gets back to liquidity and how low do you want to go. And so whether we'd want to top up at some point is a reasonable question. If we did that, as Gunnar would say, we wouldn't do it with equity. There's lots of other instruments and ways to do that, that certainly being one given where we are as a company.

Speaker 1

Okay. So a lot of things to invest behind, but you have done a little bit of BD in the past. I guess what role should we think about BD playing in your forward strategy for the company on maybe like one, three, five year sort of timeline? Yeah.

David Meeker, CEO

So one year, we would remain in our current posture, which is completely opportunistic. If somebody came to us with something that they felt rhythm could provide a unique contribution and or one of us on the leadership team had insight into an opportunity, then of course we would look at that, but we're not actively looking. We have more to do internally than we can process, arguably. Three- to five-year timeline, absolutely. I think, you know, building a more specific external facing effort, looking for things that might complement. And it's all a function of, you know, size of the company and increases your ability to do those kind of things and do them well, I think.

Speaker 1

As you think about that, like, three to five year view, how do you think about the core competencies that Rhythm has in-house that would inform what kind of assets you might be open to bringing in?

David Meeker, CEO

Yeah, I mean, we've been clear we're not an obesity company. That's certainly not our goal here. What are we good at? I think we are good at rare. And so it's not, and there's no rare, it doesn't have to be an endocrine rare. It doesn't, I mean, rare is rare. I think that, you know, if you have a good solution to an unmet medical need, you can build an effort around it, and we would do that. And we're a global organization. We're going direct, I think, which speaks, again, in almost every place, which speaks to the way we think about it and also the capabilities, particularly of our international team. So think rare first, but, you know, rare is also a blurry line. So I think depending on how strong we are, we'd be pretty open to some different scenarios.

Speaker 1

I think with that, we did it. It was lovely chatting with you. Much appreciated to everyone who joined us here and online.

David Meeker, CEO

Thank you, Karen.

Speaker 1

Thanks, David.

David Meeker, CEO

Very much appreciate it.