All right, great. Good morning, everyone. Thanks for joining us here on the first day of the Leerink Partners Global Healthcare Conference. My name is Tom Smith, one of the senior biotech analysts here at Leerink. It's my pleasure to introduce our first company to the stage this morning, Viridian Therapeutics, and their management team, led by President and CEO Steve Mahoney, Chief Medical Officer Radhika Tripuraneni, and Chief Business Officer, Shan Wu. Thank all for joining us. Looking forward to the discussion. Just a little bit of context. This is one of our top picks for 2026. Company's off to a really great start here. It comes on the back of a 2025 that we think was a great year of execution, including BLA submission for their lead IGF-IR antibody, veligrotug, for the treatment of thyroid eye disease. You guys have a June 30th PDUFA date. Really strong clinical execution as well on their subcutaneous program. We're gonna get two phase III readouts here, one in Q1, one in Q2. A lot coming here over the next 12 months. We think it's a great time to be taking a look at Viridian. With that, Steve, why don't you maybe kick us off here with a little bit of an overview for those in the audience who may be a little less familiar with the story? Yeah, sure. Thank you, Tom. Thank you for having us. Glad to be kicking off the meeting for you. As Tom mentioned, our lead program is about to go commercial, or we expect to go commercial. We have a PDUFA date of June thirtieth this year. That's on the back. Breakthrough Therapy designation, Priority Review. That's an IV program for thyroid eye disease, and all systems go. We are on track for all of those dates. Our interactions with the FDA have been quite positive. We do expect to launch that into the thyroid eye disease market, which is currently annualizing at $2 billion with one product on the market. I'm sure we'll get into more details as we go through this discussion, but we're really excited about that program, and we are almost 100% launch-ready. We also have our second program, which is a subcutaneous delivery, also in thyroid eye disease. This is a half-life extended molecule that we think could be quite important for both physicians and patients with respect to treating the disease and getting on a region expanding market. As Tom mentioned, we have two phase III readouts. We have one that's coming in Q1, you can imagine that's coming relatively quickly on the heels of this conference. We have our Q2 readout for the second phase III. The first phase III is in the active form of the disease, we believe this is a de-risk program from the standpoint that this is the same antibody as the IV program, which had fantastic phase III results. What we have is the same antibody, but it's half-life extended, we are testing Q4 weekly and Q8 weekly arms, that data's coming shortly. We think that's gonna be great. Moving on to the second study, which is in the chronic form, which we'll read out in Q2. Those are the thyroid eye disease programs. We've just announced an earlier stage program also, that has potential applicability in thyroid eye disease, TSHR antibody that we announced earlier this year. That's preclinical. We'll file an IND towards the end of this year for that. That'll help solidify our position in TED, we believe. That program also has potential applicability in Graves' disease, which we think is a pretty exciting opportunity. We'll get into more details there. Finally, we have advancing FcRn portfolio, where we're in first in human studies, and we expect to have data available and clinical development plans announced towards the end of this year. As Tom mentioned, very catalyst-rich year for us, and we're looking forward to it. Awesome. Let's start with veligrotug, and you have the PDUFA date coming up June 30th. That puts you roughly like 113 days out. Maybe you could talk about You mentioned the Breakthrough Therapy designation. I guess, how has that helped you in sort of the regulatory process here? Just high-level talk about your interactions with the agency and I guess the consistency around those interactions, as we've all seen perhaps a little bit of volatility out of FDA in the last several months. Yeah. We're fortunate we have not seen the volatility out of our division. Ophthalmology has been intact from the beginning. The Breakthrough Therapy designation, which we received last spring, really was important from the standpoint that that is the only time that FDA does cross-trial comparisons with standard of care. Really important on the coming out of that to see that we submitted the application, it was essentially based on the rapid onset of treatment effect that we saw in our phase 3s, the impact we had on diplopia, which is double vision in a chronic patient population, which had never been seen before, and then finally, the differences in the dosing regimen and the treatment paradigm. For us, we use five infusions, 10 mgs per kg IV. We have a 30 to 40-minute infusion time. Just, just treatment paradigm versus treatment paradigm, this is not a cross-trial comparison, it's just simply how the treatments work. TEPEZZA has a 20 mgs per kg, 8 infusions, 60-90-minute infusion time. Just on that basis alone, you can see the differences. We submitted the Breakthrough Therapy application on, with those three elements. FDA doesn't communicate as to if it was one or all three of those, but they ultimately did grant Breakthrough Therapy designation, which is important for two reasons. One, it is essentially a statement that the FDA believes that our drug has the potential to be a substantial improvement on current standard of care. That's a great bar to cross. Secondly, it did lend itself, increased our odds, we thought, of the priority review of the BLA. That in fact did happen, which is why we have a PDUFA date of June third. I think all of that with the consistency of the communications, the regulatory designations that we've got, we feel really good about our position with FDA right now. Awesome. You, you've guided to a mid-2026 launch. You just said almost 100% launch-ready. Mm. Maybe just talk about where you are build out. We hired the field force. How are we thinking about, I guess, access, reimbursement? Like, where are we in that process? I think that's another element of the Breakthrough Therapy. As I mentioned, the Breakthrough Therapy came in late last spring. We started to accelerate our plans for being launch-ready because we felt like that would lead to priority review, as I said. We're well ahead of our plans for being launch-ready. You don't wanna hire your field force until you have several months in front of your PDUFA date, so you can get them in in time to train them and start to build some outreach that they can, that they can do on a pre-approval basis. That is all well ahead. We have market access teams, patient service team, field medical affairs is essentially built out now. We're out there, we're able to have some discussions with respect to getting physicians familiar with our data, which is all we can really do at this point. It is, we are very much launch-ready, we think. Awesome. maybe just give us some updated thoughts around how you're thinking about pricing. I know obviously, you won't make a pricing decision until the drug's approved, but how should we think about how you might price the drug relative to Tepezza? uided obviously on pricing. But what we have done is quite a bit of work with the payer community. We've had interactions with them for quite some time now, and the feedback has been quite positive. They have a lot of familiarity, obviously, with IGF-1R inhibition via TEPEZZA. So the education component of that is really kind of been done. And so we get to take advantage of that. There's a number of things that we get to take advantage of being the second to market here. So with the payers, the guidance that they have given us is that we could expect parity coverage for parity pricing. Now, parity means 10%-15% on either side. There is a very healthy WAC price for Tepezza in the market today. That gives us a lot of benefits going in. We would think about that on a per course basis, so it's the totality of our full regimen from how we think about potential parity as it relates to pricing, because it is that full course of regimen that delivers the value to patients, so our 5 infusions versus the current IGF-IR at 8 infusions. That makes sense. When you think about Veli, I guess, potential early adoption, are there certain segments of either the TED patient population or prescribers that you think are, like, primed and ready for Veli, an alternative to Tepezza? Well, I think, when you look at, you look at the sales of Tepezza on a claims analysis, currently it is skewed more towards the active patient population, and there's reasons for that. I think, you know, they ran their chronic study, on a post-approval basis. The chronic study was relatively limited in scope in some, in some respects. What we tried to do was, we've run a really robust chronic study. We ran our first active study, and then our chronic study, and both those phase III results are the ones that we're referring to as we, as we go towards PDUFA. Our chronic study, was what we feel is a more representative, it's a fulsome look at the chronic population. Again, we did have great results with respect to diplopia response and resolution, which is very important to patients. Again, haven't seen that before. We, we think that that population is going to be something that we will have a really fulsome data set to go into and have discussions with physicians about their use of in their chronic patient population. I think that's gonna be something that we're gonna try to be able to do and we feel good about the position of the data for that. What, what we're trying to do is we wanna make sure that these physician experiences are really positive with our drug. We're gonna be really. really be careful about how we approach that. From a physician standpoint, it's important to remember that this is a really concentrated set of prescribers. There are about 2,000 core prescribers who prescribe IGF-1Rs today. That gives us a very solid, robust starting point for the IV launch in terms of our commercial strategy of who we target from a physician standpoint. These physicians, they already understand the value of IGF-1Rs. They know how to integrate infusion logistics into the care of these patients. You know, coming back to our clinical profile, as Steve said, we think we have a really strong clinical profile that if we're approved, right after we're approved, we would be targeting these physicians with the label that we would have for Veli, which we think is a really strong one. Yeah. That makes a lot of sense to me. I wanna come back to Steve. You mentioned ensuring that the clinicians have a positive first experience. I think when investors are trying to, you know, model out trajectory for a Veli launch, like the obvious analog here is TEPEZZA, which is like one of the best rare disease launches of all time. Maybe you could just talk a little bit about that comparison and sort of, you know, your expectations for the Veli revenue launch trajectory. What are some of the considerations, kinda puts and takes in making that comparison to the TEPEZZA launch? Well, I think one of the, I think the TEPEZZA launch, when that occurred, the only options for patients at that time, was surgery, which is a really rough surgery, and steroids, which don't necessarily work. It was the first time that patients had been offered a treatment of that kind. I think that was a little bit of a different launch. I think From our perspective, again, Patients are educated on IGF-1R, physicians are educated on IGF-1R now, and payers are educated on IGF-1R. We do get to plug into that system that's already essentially been built. I think that's gonna be really helpful to us. We also ran our clinical trials globally, but we had a lot of success in the United States. We've enrolled 1,200 patients in these studies since January of 2024. That's an enormous number of patients with a lot of participation out of the US. We think that the lot of the high prescribers at TEPEZZA were some of our principal investigators, so there is that level of experience with our drug. We expect that that will be beneficial to us as well. That makes sense. You submitted an application for approval in Europe in January. Mm-hmm. Maybe just talk about the strategy in Europe, how are you thinking about building out sales infrastructure there versus partnering? Yeah. I guess in this world of MFN considerations, like, how are we thinking about that particular aspect? We did we did file in Europe. We like the optionality that comes from that. We will have decisions to make as to the form of the infrastructure, if we build any infrastructure at all, whether we use a distributor network versus actually building infrastructure. The nice part is, this is another example of Tepezza filed last year, and they are going through the pricing component on a country-by-country basis, as you have to. We get to benefit from those discussions as well, and we have to see how that plays out. Essentially can do a lot of that work and so we can understand it. Then price will determine what type of approach we take there. Again, we have the benefit of being able to watch and learn from that. Yep. Great. I wanna shift gears and talk about the SubQ program, and I think we've alluded to this a couple of different times, but maybe just come back and help us understand the differences and similarities between elegrobart and veligrotug, and I guess the way that you've designed the REVEAL studies, how that differs from THRIVE for the IV. Sure. When you look at Elenbe and Veli, they're fundamentally the same compound with a couple key distinctions. They do have the same binding domain, but in particular, Elenbe or elegrobart has a half-life extension on it. Because of it, ultimately, the studies are constructed a little bit differently. The Veli studies with regards to THRIVE and THRIVE 2 had a data endpoint at roughly 15 weeks, which is after the three weeks after the fifth infusion. Here in this case, we're also studying in the REVEAL and REVEAL 2 studies, we're studying two dose arms, so Q4 and Q8. Because of that, the dosing time period to maintain the placebo-blinded portion is a little bit longer, so the data readout is roughly at week 24, four weeks after the last injection of the Q8 arm. That's kind of the nature of those two compounds, we're very excited and feel like there'll be a fair amount of ability to read through and excitement from the Veli to the Elenbe, given the nature of the compounds. The inclusion/exclusion criteria Yeah ...are very similarly designed to THRIVE and THRIVE-2, and of course, with a large overlap in principal investigators as well. Got it. We're gonna see these top-line results shortly from REVEAL-1. Just help us understand how you're framing expectations, like how do you view the bar for success with REVEAL? Is it kind of like carbon copy of what you saw out of the IV experience, keeping in mind all of the similarities and differences we just talked about? I think when you look about, or when you think about the study with regards to REVEAL, it's really about what do physicians expect with IGF-1Rs, and their experience right now is really driven by what's currently available. If you look at that data set, the registrational data set suggests a range in terms of what the proptosis responder rate would be anywhere between 50%-70%. We believe that if Elenbe performs, you know, in a similar fashion, you could really provide a compelling profile of a drug that ultimately you're able to deliver, you know, at home by a patient in the convenience of an autoinjector. A really differentiated option, which is, you know, quite compelling when you think about the patient population and the amount of time and energy it takes to ultimately come in for an infusion. I think that's really important, right? Because TEPEZZA's kind of set that range of 50%-70% on the placebo-adjusted basis for proptosis response. To Radhika's point, if we simply have, if a physician can look at that and say, "I feel comfortable sending a subcutaneous autoinjector to your house because I think you're going to get IGF-1R-like efficacy," then that's a, that's a win for us, we think. Yep. Okay. 50%-70% placebo-adjusted proptosis responder rate. I guess, what are we looking for on the other measures? One of the things I think is most compelling about veligrotug is you mentioned the diplopia resolution. Any reason for thinking we would see something different with the subQ? No, not necessarily. I mean, I think we'll have to wait and see the data, but the study's powered and intended to look at proptosis responder rate, so that's our primary efficacy endpoint for the study. Yep. Okay. Let's turn to safety tolerability and investors within the class focused on sort of the on-target toxicities, hearing impairment, hyperglycemia. Maybe walk us through sort of your puts and takes here with the subQ and your expectations for the on-target toxicity rates in REVEAL. Similar to the efficacy dynamic, I mean, elegrobart is ultimately also within the IGF-1R class, you know, we do believe that there will be a clinical profile or safety profile that's consistent with that. I think there are some opportunities when you look at how we've designed the study, and have some potential with regards to upside. You know, safety is often thought to be driven by Cmax, one of the things which you'd think about through this study and the way this study was designed is there's an ability to perhaps have a lower Cmax in this study compared to what we saw in the Veli experience. While we think the profile will be consistent, we'll have to wait for the final data to feel comfortable. Got it. We're looking for basically consistency with the IV. Okay. The reason for that, Tom, is, we think that if we hit that efficacy bar and have consistent safety, which is something that physicians today know how to manage, it's expected, it's known, then it will look like an IGF-1R and a physician can prescribe that for a patient to take in a autoinjector at home. It'll be that convenience of the at-home self-administration with the autoinjector that will really drive the adoption of this drug, not just in the currently treated population, but be able to expand the number of patients who elect to come on to IGF-1R therapy. That's a perfect segue. Let's talk about, I guess, potential market expansion with the subQ and I guess what your sense is from some of the clinician feedback. Is this the case where, you know, you may be capturing patients earlier in the disease course? Is it the case where, you know, like subQ over IV is just gonna be a more preferred option, so you're gonna be treating essentially the same segment of patients? Are there more chronic patients that you could potentially tap into and kind of activate that market? Like how should we be thinking about expansion? It's a great question. We definitely think that the subQ will have the ability to expand the market. We have a couple of analogs, and we point out a couple in our corporate deck as well that really show a subQ coming on after a IV incumbent, massively expanding the market. There are a few ways that we think this will happen. One, not everyone lives next to an infusion center, that sheer access to drug is much more improved with a self-administered drug that patients can take at home. We imagine this to be something that would be mailed to a patient's home for them to, again, self-administer in a autoinjector. The types of physicians who are willing to prescribe also expands with the subQ. The rigamaroles of an infusion logistics while you know, we plan to do a really robust job with that of walking patients and physicians through that, there are just some physicians who are not used to infusion dynamics that would be now willing to prescribe a subQ that doesn't have those logistics and hurdles for them to run through. There are the patients, the kinds of patients who will come onto therapy. It's not necessarily patients who are earlier in their diagnosis. It's patients who are who have who are more on the moderate side of that moderate to severe. They have a little bit less severe of disease, still have moderate to severe TED, but in the current setting of asking them to go to an infusion center, they're weighing in their minds that perhaps the burden of that treatment option doesn't outweigh the potential benefits that they will receive. We would hope to capture some of those patients as well. Through all of that, the types of physicians, the types of patients, and then just the low-hanging fruit of we now can access every patient around the country versus just those who live close to infusion centers. Yeah. That makes sense. What's the current thinking on sort of long-term split between IV and subQ in this market? In a mature market where the subQ is on the market and has expanded that overall denominator, we do expect about a 70% of that market to be subQ and about 30% to be IV. It's a really nice setup for us that, we do think there will be a good portion, that 30% who stay with an IV, and the Veli profile is as strong as it is. We'll have a really, fantastic IV option to provide patients, and of course, we'll have the subQ, which, when, elegrobart launches, we believe that will be the only autoinjector that's available for patients, for TED. Got it. I wanna ask about sort of the competitive dynamics. Seen a number of competitors run into some issues here over the last 12 months. argenx terminated their TED program based on futility. We saw the top line data from Roche's satralizumab, where you have one positive phase III study, one that missed stats. It sounds like they're gonna file that. I guess we'll see what the path forward is for that compound shortly. Amgen is obviously also developing a sub Q version of TEPEZZA. Can you just give us some thoughts on how you see the competitive landscape over the next like 12-36 months, and specifically maybe some thoughts around the Amgen offering as that looks like potentially most likely to get to market perhaps, but with maybe a sub-optimal commercial profile? Yeah, I mean, I certainly, as you referenced, a number of programs have fallen away. I think, you know, for us, what we know that IGFR is the relevant target. When you see the FcRn programs and IL-6 and IL-11, and you see those programs fall off, it's not wholly unexpected, I guess I would say, particularly for moderate to severe, where you really need, to Shan's point, you really need to hit, those certain endpoints of proptosis, diplopia, overall inflammation and redness and pain. We always felt that IGFR was the right target. There were other attempts at IGFR inhibition. Those programs have also gone away. I think the thing to think about is that at Viridian, the trials that we've run, both in the IV program and in the subQ program, we've enrolled those on time, if not earlier than expected. We've over-enrolled those studies, not necessarily because we wanted to over-enroll, but just 'cause of patient demand. As I mentioned earlier, you know, even in the REVEAL studies for the subQ program, 67% of REVEAL-1 enrolled in the United States and 56 in REVEAL-2. So these are folks that are choosing to go into a placebo-controlled study even in spite of the fact that there's a commercially available IGF-1R. So we think that speaks volumes to the remaining patient demand that's out there. I think the other studies that you referred to, they did have trouble enrolling. The TEPEZZA subQ that you're referring to, as far as we know, and I think this is widely understood now, it's more of a subQ infusion pump. It's an on-body wearable. You attach it to your abdomen, and it has an infusion time over 30 minutes or so. and that's dosed. It's not half-life extended, so it's every two weeks for 24 weeks. you can just imagine we've tested that profile in market research, and obviously we feel that we have a good position. If a year ago, 18 months ago, the competitive landscape was of something that people paid a lot attention to. I think that's cleared up quite nicely in our favor now. Awesome. We have a couple of minutes left. I wanna talk about FcRn, and like, when I think about your FcRn portfolio, I think it gives you tremendous optionality, right? This is potentially, if Immunovant perhaps shows you that FcRn may work in TED, you have some inherent, you know, exposure to that mechanism and could choose to advance in TED. It also gives you optionality to advance in a whole ton of different areas. You have two different compounds. Maybe just help us think about, like, how you're thinking about this strategically, and I guess, like, when we might learn more about where you intend to take the FcRn franchise? We're excited about both the compounds that we have. The 006 compound is an Fc fragment, which we believe there may be something special about an Fc fragment in terms of efficacy and safety. We'll say more this year about development plans for that program. The second program, 008, is a half-life extended FcRn with the currently marketed and also those in development drugs being for the vast majority, weekly dosing for FcRns. We think an extended half-life FcRn molecule that extends that dosing regimen for patients can be a potential game changer in the FcRn space. That cleared IND that we announced with our earnings a couple of weeks ago, and we're in healthy volunteer studies. We'll have healthy volunteer data second half of this year. In terms of how we think about it, we think we, again, like the optionality of having both of these compounds and having especially a VRDN-008 with the potential to be best in class. We'll say more as the year goes on in terms of indications, how we plan to be competitive and potential differentiation for both of these. Super helpful. You mentioned the TSHR-targeted program. I think there's certainly a lot of growing excitement around that target. Maybe just a quick 30-second soundbite. Where did this program come from? Internally derived? Mm-hmm. You know, how are you thinking about potentially deploying that strategically? I know this is gonna be in the clinic later this year. Yeah. We did develop it internally. We've been working on it for quite a while. And obviously monitoring, other companies are working on it. I think it's still early days on TSHR in terms of we wanna see what the clinical profile looks like, not only from ours, but from the others. And we think this got applicability in both TED and Graves'. The Graves' opportunity, as people know or may or may not know, is more the refractory Graves' population, because 85%-ish of the Graves' population is currently under control under a generic antithyroid. We're really talking about that other, that subset of the population, but that is a sizable population. That is a sizable opportunity, so we're interested in it, but we gotta see the clinical profile progress. Yep. IND filing Q3. Yep. Awesome. Q4. Q4. Sorry. Q4. Got it. Okay. Unfortunately, we're up against time. Thank you, Steve, Radhika, and Shan for joining us. Huge year ahead for Viridian. Looking forward to staying in touch. Absolutely. Thank you. Thank you, Tom. Thank you.