Ionis Pharmaceuticals, Inc. (IONS) Earnings Call Transcript & Summary

Good afternoon, everyone. Thank you for joining the 24th Annual Needham Healthcare Conference. My name is Joey Stringer, and I'm one of the biotech analysts at Needham & Company. It's my pleasure to introduce our next presenting company, Ionis Pharmaceuticals. Joining us today from Ionis is Head of Investor Relations, Wade Walke; Eric Swayze, Executive Vice President of Research; and Kyle Jenne, Chief Global Product Strategy Officer. join. With that, we'll get started. Wade, Eric and Kyle, thank you so much for joining us today. We'll start off with olezarsen, your program in -- for FCS and SHTG. I guess let's focus on SHTG for now. Your Phase III program consists of 3 separate trials. CORE, CORE2 are the pivotal ones, and you focus on SHTG, it's the much larger indication relative to SAS. But what have you learned about the FCS launch so far? How has it been playing out? And then how is it helping set the commercial stage for SHTG?

Thanks for the question, Joey. I think if you don't mind, before we start talking about SHTG, I love people talk about SHTG. We think it's a great space for us to be in. But I kind of want to back up just a little bit and set the stage for Ionis as a whole and kind of where we're heading. This is a big deal for us because with both olezarsen and Tryngolza in FCS. That's our first independent commercial launch and represents really the Pinnacle -- the first true Ionis only step into us being a fully integrated commercial biotech. And that's why we're talking about SHTG, and we think it's a great place to be. So we're pretty excited about that. We think it's obviously a big change for Ionis. It's a change in our business model, and we think that it's the right avenue for patients and shareholders as we go forward. And Tryngolza really just the beginning, talk about SHTG and Tryngolza. We also have the day coming up in August for donidalorsen, which is the potential treatment for hereditary angioedema, where we have some upgrade looking Phase III data and really fantastic switch data. We have a late-stage program in Zilganersen for Alexander's disease, which is a rare leukodystrophy. Key for our neurology programs that we envision is wholly owned. Following that is our Angelman syndrome program, which we also intend to commercialize ourselves and bring it forward for, again, a disease that has no therapy. We're hoping to get enrollment for that complete next year. And these kind of really set the stage, and we'll talk about SHTG in a minute for Ionis wholly owned commercial programs, which we think can return some tremendous value to patients and shareholders. So then if you want to talk about SHTG and the commercial phase, that's why we got Kyle on, and he can start to talk about that.

Yes. Thanks, Eric, and thanks, Joey and team for joining the call today. I'll just mention briefly, as you asked about the FCS launch. It's going extremely well. We did a great job of building a commercial infrastructure the efforts of WANNUA first and our co-commercialization effort but then being ready for our first wholly owned launch with Tryngolza and FCS, which we received approval in at the end of last year. And the performance is very impressive from the commercial team and the medical affairs group so far. We have product in channel before the end of the year. We had patients on drug before the end of last year. And we are continuing to identify, get patients diagnosed and get patients on to both commercial and Medicare drug. So we're very pleased with how this is going so far and the execution on the plans. As it relates to the synergies that you brought up around FCS and SHTG, there are a number of those. When you think about the SHTG indication, which is the much larger indications you referenced, we're talking about triglycerides levels of 500 milligrams per deciliter and above. This is due to primary and secondary causes. So this includes things like diet and lifestyle and other medical conditions and potentially certain medications that patients are on that create this issue. These patients are at high risk of acute pancreatitis. And the #1 goal is to reduce that risk of pancreatitis and its most important reason to treat SHTG. A lot of physicians understand this and they understand the risk, but unfortunately, in today's situation, they've got very few options available to them. And many patients even on standard of care today are unable to get their triglycerides down to the goal due to effective products. So in terms of our infrastructure, as I mentioned in the synergies there, things like our market access teams, our operational groups and the basic foundations kind of the back-office staff for commercialization, there are a lot of synergies there. As it relates to the sales organization, we have a great opportunity. We've got about 30 people or so in the field today. And we'll have the ability to scale that probably in the range of about 200 people or so as we get to SHTG in order to capitalize on the common call points that are out there, the main focus is on endocrinology and cardiology and lipidology. They are the ones that are treating this condition and see these patients. But we also have some other synergies as it relates to our Ionis Every Step program, which is our patient support program. I mentioned the co-commercialization of WANNUA, we have the lead in that with AstraZeneca, and we've been able to build a really strong and capable team around our Patient Services group. And these are a group of nurse case managers that are actually Ionis employees they're able to offer a full suite of services, kind of a white glove service for these physicians and patients. For patients, we're able to do disease state diet education, nutrition education and also, obviously, patient support around injection training and also reimbursement support, if needed. On the physician side, we're able to do things like streamline the prescribing process, support insurance authorizations and do coverage assistance and things. So in terms of synergies, I think in terms of the market itself and what we're seeing in the market and also in terms of our capability and commercial infrastructure, there are a lot of commonalities here and a lot of good things happening.

On the clinical side of things, CORE and CORE 2 primary endpoint is percent change in fasting trades. But can you talk about the importance from both a clinical and commercial perspective, the key secondary endpoints in particular, the acute pancreatitis. How big of a deal is AP for patients and payers?

Yes, Eric, I'll take this one as well and talk through this a little bit. But first, we're really looking forward to learning more about the benefit that olezarsen can bring to patients with SHTG as we report on both core and CORE 2 data in the second half of this year. So it's coming up here fairly quickly. The CORE and CORE 2 studies are powered for the primary endpoint, which is present triglyceride reduction from baseline compared to placebo at 6 months. However, the positive thing that we've got going right now is we've got the results that we saw in the FCS balance study. This gives us great confidence in terms of the potential to see a benefit in AP and CORE, be it in trends and/or statistical significance. So it's important to note as well in this category that there are already established guidelines in both endocrinology and cardiology in place for SHTG and treating physicians firmly believe that reducing triglycerides as much as possible, you need to reduce triglycerides as much as possible because of the severely elevated triglycerides and the risk again of pancreatitis. So in CORE and CORE 2, we've enrolled over 1,000 patients in these two studies. Baseline triglycerides were 836 milligrams per deciliter in CORE and 749 in CORE 2. And in the combined study, we've got about 40% to 50% of the patients -- or excuse me, the study participants at greater than 880 milligrams per deciliter. So the study is designed and really the baseline demographics from these Phase III studies, it really increases our confidence in terms of the potential to generate robust data in these patient populations. Unlike FCS patients that have SHTG, they've got functional levels of LPL, which means they've actually got greater ability to metabolize triglycerides than people with who don't have LPL activity. So what we believe that we can reasonably expect are higher levels of triglyceride reductions in SHTG. And we also expect a little bit of a lower rate of AP just because of the greater impact of triglyceride lowering that the much larger size of the study represents. So we've got a study size that's about 10x the size of study size that was in FCS. So that gives us some confidence that we can actually see benefit on in SHTG patients. But we'll wait and see how the data reads out, obviously. But these patients are at risk of AP. We know that the need is to bring these patients down and get them to goal to prevent the initial AP attack from ever happening if patients haven't had one before or reduce the risk of a second or third attack, which actually increases exponentially after you've had your first attack. So we believe the AP trends can be beneficial to payers in the U.S. specifically. But we don't think we need that to achieve statistical significance in order to get reimbursement and access to the drug based on our market research and the time that we spent with payers thus far.

Do you have to hit the primary endpoint in both CORE and CORE 2 for regulatory approval? How do you think regulators will view a successful outcome?

Yes. So as I mentioned a minute ago, we're really well powered in each of these studies to hit the primary endpoint, which is triglyceride lowering. Both studies enrolled considerably more patients than we needed for our powering assumptions. So TG lowering is important because the medical guidelines that I was referencing just a few seconds ago. But things are in place right now, and we've been able to demonstrate an that patients with TG lowering results and reductions in AP events as well. So we've got that already. But from a regulatory standpoint, we'll just need to hit the primary endpoint and demonstrate triglyceride lowering in order to potentially get the product approved.

Got it. And from a statistical analysis plan for the two CORE Phase III trials. What's the -- can you walk us through that on the primary trade endpoint and the AP secondary point, you touch on it a little bit before.

I can take that, if you want. So on Core and Core 2, we've published fairly recently in the American Heart Journal. So the study design, the powering assumptions and the baseline characteristics of the patient population. So you can look online at the American Heart Journal website, that paper. But basically, we've got the parent assumptions of the study to show with fewer patients than we actually enrolled, but they were able to get 90% powering to hit a 60% reduction in triglycerides or greater in the patient population in both CORE and CORE 2, which -- and since we overenrolled both those studies, we're well powered to do that in both studies. And so we're pretty confident that studies are designed appropriately. And we've already mentioned that the baseline characteristics indicate that we have a pretty severe patient population with 40% to 50% of the patients in each study having triglycerides above 880. So they're pretty severe. They have pretty high triglycerides. And once you get above 880, your chance for keep pancreatitis increase that risk increases in an exponential manner. So we think it's a good population that have enrolled. And I think we've got the right study design.

And sorry, if I missed this before, but are the patients ratified between CORE and CORE 2 on trade levels?

They are. So we stratified them above 880 or above and below 880, and we have a secondary analysis that looks at triglyceride lowering in those two different subpopulations.

Okay. Got it. What are your updated thoughts on pricing strategy for the larger SHTG indication, what are reasonable comps to think about on price?

Yes. So we priced FCS as an ultra-orphan or ultra-rare disease. So we're close to $600,000 annually on the FCS population, which has about 3,000 patients in the U.S. For the SHTG population, we're talking about potentially addressing 1 million to 3 million plus patients. So we'll need to bring the price down, obviously, to probably specialty pricing. So the $10,000 to $20,000 range is kind of directionally where we're headed. We've got a lot more work to do. We also need to see how the Core and Core 2 studies readout to see what data we have to substantiate the profile of the drug and work with payers on that. But to that range of $10,000 to $20,000 is kind of directionally hopefully helpful for you guys.

Yes. The SHTG market, do you think that's a winner-take-all market? Or what product profile will ultimately win majority market share?

Yes, that's a great question. First, we are super excited that we've got first-mover advantage in this market. right? The currently available products, unfortunately, just aren't significant enough in terms of triglyceride lowering to help physicians and patients get to goal and to get them out of harm's way of having acute pancreatitis or other events potentially. So first-mover advantage here. We've got about an 11-month advantage in FCS that we're capitalizing on now. We've got about a 2-year advantage in SHTG. So I think first-mover advantage is a key part to this. The other thing I'll just mention is the product profile for olezarsen and our Tryngolza is very, very strong. We've got substantial and sustained reductions in APOCIII. We've got substantial and sustained reductions in triglycerides. We've got the acute pancreatitis data in the label for FCS today, which is a supportive evidence as to why these patients need to be treated. We've got a strong safety profile. We've got the ability to self-administer with an auto-injector, similar to what we have with WANNUA but very strong data and evidence, and we're anticipating the same from CORE and CORE 2 as those studies read out. And then the final thing I'll mention is we've got a really strong commercial team and medical affairs group. We have very strong talent that's joined the organization with numerous years of experience and they know how to build a commercial team and launch execution, and they really know how to make a difference for these patients and physicians. So I'm really encouraged by the commercialization efforts as well.

Got it. And speaking of when you obviously approved in December of 2023, had posted solid $42 million in fourth quarter '24 sales. Can you talk about some of the launch metrics and how these are trending in the drug's first full year launch?

Yes. We have been so pleased really with the launch in polyneuropathy. And we're really excited that we're on track also as well for the data in cardiomyopathy in the second half of 2026, which is obviously a much larger indication and the ability to serve two indications. AstraZeneca has already provided peak sales potential in the multibillion dollar range for WANNUA. We've got very attractive royalties on this program up to the mid-20% range in the U.S. in the mid-teens, ex U.S. So it's going to translate into substantial royalty revenue for Ionis. As it relates to WANNUA you were asking about, we've gained a lot of momentum last year throughout the year. to serve the polyneuropathy indication specifically. We captured just over 50% of the total U.S. growth in polyneuropathy product sales from Q3 to Q4. And new-to-brand share is over 40% now. So we are competing very, very effectively in this space. So it's great to see sequential growth throughout the year. We've got strong demand, as you mentioned, in the fourth quarter, with sales nearly doubling compared to the third quarter uptake continues to be strong, not only in the centers of excellence, but we are now starting to see the broadening use in the community setting for this patient population. And the main focus on this launch is newly diagnosed patients. We really are looking at naive patients to get newly diagnosed patients started on WANNUA. That's where AstraZeneca's focus is. we are seeing some switches. We are seeing some patients that are used in combination with some of the stabilizers that are out there. But really, the focus is on growing this untapped market right now and getting WANNUA to be the product of choice. The reason that they were seeing physicians use this product as a first-line treatment of polyneuropathy is a couple of things. First, quality of life improvements. They're seeing the polyneuropathy be controlled well controlled month-over-month. The second thing is the profile with the ability to self-administer with the auto-injector. This, again, allows a lot of flexibility for patients to manage and control their own disease. And then the third thing is around access, both in the commercial and the Medicare setting the majority of patients have a $0 out-of-pocket expense for WANNUA. So it's very affordable for these patients to have access to. So we're really encouraged that the profile is playing out very positively. We're seeing the growth that I just explained and the profile overall of the drug is competing very effectively in the market.

Yes. And switching to cardiomyopathy, big picture question on the market. How big do you think the total market is in cardiomyopathy, just given what we know about tafamidis sales and some Pfizer commentary that the drug only has 20% market penetration.

Yes. The market is definitely underserved across the globe. I think when Pfizer originally was launching tafamidis in this space, they said it was about 100,000 potential patients, I think. The estimates that we're hearing now are probably 300,000 to 500,000 patients potentially in the cardiomyopathy. And I think as you see more drugs come to market and more companies enter this space, I think you're going to continue to see the growth of this market. But I think ultimately, this is north of $15 billion. We're hearing somewhere between $15 billion to $20 billion in terms of the size of the market. Again, what we're trying to do is use Ionis' deep knowledge in the ATTR space, combined with AstraZeneca's significant commercial reach globally where they can get to markets very fast and be able to get to these untapped markets over time and see a new be accepted and ultimately become the treatment of choice for these patients all over the globe.

The cardiomyopathy space, it's competitive. Obviously, there are two approved oral drugs, stabilizers. [ SILENCE ] are recently approved. So I guess big picture, how do you view this market or how do you see this market playing out given the competitive dynamics around those three competitors. Also thinking about the potential for tafamidis LOE in 2028 and any other factors that we should consider that plays into your long-term outlook?

Yes. I think you're already seeing this with the new drug approved in the fourth quarter of last year, for example, that there is definitely an additional need for different therapies and different treatments in this space. not only from the stabilizer class but obviously from the silencer class as well. We are really looking forward to seeing the data from our landmark study in the second half of 2026. Just as a reminder, we've got the cardio transform study, which is the largest and the most comprehensive study in the ATTR-CM space to date. It's designed to deliver just a robust data set in a very broad population of patients, including those that are on or naive to stabilizers that represents the dynamic in the evolving space that you were just referencing. But we expect, again, as I was talking about the profile of eplontersen earlier, the efficacy and safety, the monthly self-administration the expertise that we have, combined with AstraZeneca's reach and obviously, cardiovascular leadership all over the globe that we believe that this can be a treatment of choice for ATTR patients. Again, I mentioned the market size at $15 billion plus, you're going to see multiple treatments that we believe do very well in this category. And we believe that planters is going to be one of those that performs very, very well with estimates north of $5 billion globally according to AstraZeneca.

Yes. And you guys mentioned that eplontersen. The Phase III cardiomyopathy trial. Can you just briefly outline trial design there and highlight some of the key design elements that you think gives you confidence that you're going to -- that you have the right approach here, #1 and the results set you up for long-term success in this space.

Yes. I mean, as Kyle alluded to, it's the largest study by far in the space. So it's more than twice as big as other studies. We made that decision a while ago to increased the size of the study when it became apparent from the epi that was out there that patients were doing a little better with cardiomyopathy and more severely is affected as for example, with the tafamidis trial. So as Kyle alluded to as a result, we think we have the ability to deliver a really robust data set in a lot of patients and it with patients both on monotherapy and also patients that are already on a stabilizer such as tafamidis. We've got a lot of patients in the trial in both situations. Primary endpoint is a composite outcome of cardiovascular mortality and frequency of their current events at week 140. So we think it's a pretty good trial that can generate a lot of data including on subgroups with those on stabilizers are naive to stabilizers and which will kind of represent how patients get treated in the real world, we think. And we also built in some nice in my view, nice cardiac imaging substudies. There's an MRI sub-study and a cyntography substudy, which we think will get additional value of data generated about the potential benefits of eplontersen in patients with cardiomyopathy. And we think it's a very nice program. We'll give us a great data set, and we'll -- if it's successful, will set us up and AstraZeneca to run a drug to patients.

Got it. Great. Well, a helpful discussion on WANNUA and the TTR space. So I want to switch to donidalorsen for HAE. Obviously, PDUFA coming up in August of this year. start off with the market size question. There are multiple prophylactic therapies that are approved, TAKHZYRO and ORLADEYO. Can you outline what the current prophylactic market size is in terms of number of patients and sales?

Yes, I'll just -- I'll start with the global market. This is north of $3 billion for HAE treatments globally. There are about 20,000 patients in the U.S. and Europe today that are diagnosed with HAE. The prophylactic market obviously continues to grow in the United States. Which is -- it's primarily a switch market, right, because the majority of these patients, upwards of probably 70% of these HAE patients in the U.S. are on a prophylactic treatment today. Outside the U.S., it looks a little bit different. The prophylactic treatment is gaining ground, but it's more of a growth story. It's a marketplace to be developed. Our estimates for donidalorsen will be with peak sales north of $500 million. As I mentioned, it's going to be a switch market. So it's going to take a little bit of time to transition these patients from their current therapies that they're on today and for physicians and patients to gain experience with donidalorsen. But we will go after newly diagnosed or naive patients as well as switch patients. But the bolus of these patients in the U.S., obviously, will be switch patients. I think what we know about these patients in the U.S. is that many of them are unsatisfied with their current treatments. They're unsatisfied for really three different reasons, either it's not effective enough and they're having breakthrough attacks and they're not well controlled. They are not tolerating their treatment very well because some of these treatments have very large bolus injections. You have to take them very frequently, which is the third thing, the convenience factor of having to administer this on an every 2-week basis or if you're on an oral, having to do this every single day. But donidalorsen, I think, has an opportunity to bring something different for these patients, not only really strong efficacy and control as we've published. But also tolerability in terms of the ability to self-administer with the auto-injector. And then also the convenience. We're shifting out the dosing regimen from every 2 weeks, which is a standard today on the injectables to every 4 weeks or potentially every 8 weeks with this treatment. So we believe we're going to be able to compete effectively, and we've got some unique data sets and reasons why in terms of the product profile itself.

No, HAE is a rare disease that kind of sits outside of Ionis' current commercial focus on CV metabolic and CNS program. So what gives you the confidence that you can execute commercially in this indication?

Yes. So I'll start with the fact that the performance in the clinical trials were so strong, right, to carry this program forward and for us to pursue the marketplace, we had to have a convincing product that we believed in, and we have exactly that, as I just mentioned. The data around the efficacy and the tolerability and convenience, the switch data that we've generated demonstrating that patients move from one1 of the existing prophylactic treatments over to donidalorsen that they do better when they do switch and that they prefer donidalorsen once they're on it. When we started to see that data thinking about our synergies that we do have, we talked about the synergies between FCS and SHTG earlier. When you think about the synergies in the back office, we think about our patient support program and also things like market access, et cetera. This is a program that we can layer into our commercial portfolio and do really well with north of $500 million, as I referenced, but also be able to have those other synergies where we'll have to build is on the field force size, right? So we will have a stand-alone field force dedicated to HAE. But being in this class of medication and how profitable this segment is we believe we can compete effectively and that it will be a valuable return for Ionis to be able to stay in this market, take this program forward.

Great. The pelacarsen program, partnered with Novartis, can you briefly walk us through the economics to Ionis?

I'll take that one. So we're really excited about pelacarsen. It's a medicine we discovered target risk factor, cardiovascular risk factor or called Lp(a) and that's one that Novartis has currently in a Phase III study that's on track to read out in the first half of next year. So this is one where we got with Novartis. Novartis has estimated that there's going to be peak sales in the multibillion-dollar range from the estimates that gives us a royalty that is in the mid-teen to low 20% range. And we're also eligible to receive more than $1.2 billion in payments for pelacarsen under our agreements with Novartis and also with Royalty Pharma on this program. So our next milestone payment for this would be a $50 million milestone payment on NDA acceptance.

Great. That's very helpful, Wayde. Novartis, they announced in late January that the top line data for the Phase III CV outcomes trial for pelacarsen. It was shifted from second half of 2025 in the first half based on blinded event rate. So I guess, how should we view the potential impact to that shift on the trial outcome?

Yes, you bet. So it is an event-based study. So the only thing that's changed is the estimate when we achieved the events needed for the power assumptions and there was a paper published last week on the study design and baseline characteristics of the study that indicated that it was powered 90% power to achieve about 80% or risk reduction or hazard ratio, so about a 20% risk reduction in the overall patient population. And so the extension of the readout timing doesn't affect the parent assumptions or the probability of success just meant that the initial estimate for the timing for that, reaching those events was off a little bit. So we're still in a very confident that the study design is appropriate for the powering. And if you look at the baseline characteristics, I give also comments because the median Lp(a) is [ 18 mg per deciliter, well above the rest threshold of 50 million and even above the higher risk threshold of 90 mg per deciliter which is one of the subgroup analysis that we're looking at in the study. So about 80% or so of the patients are above 90 milligrams per deciliter. So in the higher risk subpopulation. So looking at the baseline characteristics, the study population and the state of design gives us confidence that the study can give us robust data on whether or not lowering -- having substantial lowering of Lp(a) can reduce the risk of cardiovascular events.

Anything else wait on the stats plan for the Phase III? You touched on it a little bit, but my understanding, if I was looking at CD risk reduction on the primary endpoint for both plus and then the 90-plus mg per deciliter. Can you explain the significance of each of these analysis? And I guess how will these be -- how do you think these will be viewed by regulators? And what would this mean from a commercial opportunity perspective?

Sure. So the first endpoint is in the total population, which is patients who have a greater than 70 mg per deciliter. And that's, again, a 90% powered to see a 20% risk reduction in the subgroup that's greater than 90% from that -- from the study. We also have a primary endpoint there that looks at the CD risk reduction that's powered to get a 25% risk reduction at a 90% powering. So pretty good opportunity to hit that one as well. So if we hit either one, it's a positive study, basically, I would say, if we only hit it in the greater than 90 mg per deciliter, that would probably limit the label to see to patients greater than although you never know with -- given that there's no treatment for high Lp(a), exactly where that will end up in labeling, that's part of discussions. But that could be a potential outcome if we only hit it in the greater than 90.

Got it. Last, I want to briefly touch on Angelman Syndrome by AA2 program there. Can you briefly outline the unmet need here? And what is the commercial opportunity in Angelman syndrome?

Sure. I'll start, and Kyle can jump on the commercial opportunity if I mangle it. But it's Angelman syndrome is a rare disease, but it's a pretty big rare disease. We -- in research kind of thought of it as a SPINRAZA-like type of opportunity. and it has a huge unmet medical need. It's a debilitating neurodevelopmental disease where the patients really never developed beyond a very young cognitive age. It's a tremendous burden on families and caregivers. And they're desperately in need of disease-modifying treatments and that's what we set out to develop and what we think we have. So our drug raises the levels of UBE3A protein, which is what's deficient in the disease. We show met preclinically, and we showed that in our Phase I/II HALO study, where we demonstrated consistent and meaningful improvements relative to natural history on a whole bunch of functional areas, more than 90% of the patients showed clinically meaningful improvements relative to natural history and overall agent symptoms on a measure of SaaS called SaaS, we also looked at specific measures in terms of communication, cognition and motor function on things like the Vineland and the Bailey 4, which will be used for the primary or Phase III study, which we plan to get started the first half of this year and hopefully complete enrollment next year. There we have a cognitive an expressive communication endpoint for the primary on the Bailey 4 scale. We think it's a great opportunity with patients who really need immunotherapy.

What we think differentiates Ionis' approach and program in Angelman relative to some of the competitors out there?

Well, I'll start with the drugs. We've been use a, what I'll call a validated chemical class. It's the same type of molecule that led to SPINRAZA and QALSODY, the same type of molecule that is currently Phase IIb study run by Biogen with the MAPT till lowering drug BB-8, which we have nice data on that has lowered its target broadly in the CNS. You can see it with pet imaging. The class has a proven safety record, consistent and validated dosing ranges. So we kind of know how to dose. We know the safety and we know the durability, which I really think helps us design our trials. We benchmark our drugs against everything out there in a model that predicts human performance, human gene in a mouse, and we think it's the best way to do this. So we're very, very happy with the activity and duration and profile of our drug. As far as the Phase III trial, we have a placebo-controlled approach for our study, which we think is the gold standard to evaluate safety and efficacy in clinical trials also helped simplify the burden on the sites a bit because you just need one team to minister the drug. And rack to the molecule, we don't have to do things like use a top table. We haven't been administered corticosteroids. We have no load. So we like the profile of our drug in the way it's administered. We think it is -- it's consistent with the way we've done all of our intrathecal drugs based on our vast experience in the space and we think the molecule class is right for this patient population. And we're clearly running out of time because of our license.

No, we are up on time. So it was good timing, but -- thank you, Wayde, Kyle and Eric for participating. It was a very helpful discussion.

Thanks for having us.

Thank you, everyone, for joining on the webcast. Everyone, have a good day and a good rest of the conference.