Good morning, ladies and gentlemen, and welcome to the Viridian Therapeutics conference call. At this time, participants are in a listen-only mode. Later, we will conduct a question- and- answer session and instructions will be given at that time. As a reminder, this conference call is being recorded. I will now hand the call over to Greg Rossino, Senior Director of Investor Relations at Viridian. Please go ahead. Thank you, operator. Good morning, everyone. Thank you for joining us to discuss the FDA approval of Lumvoa, the newly announced brand name for veligrotug, or VELI, for the treatment of Thyroid Eye Disease. You can access the press release and the slides for today's call on the Investors Page of our corporate website at viridiantherapeutics.com. Before we begin, I would like to remind everyone that today's call and webcast will contain forward-looking statements, including statements about our commercial market opportunity. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecasted. A description of these risks can be found in the forward-looking statement disclaimer in the press release and slides issued today, as well as our SEC filings. On today's call are Steve Mahoney, our President and Chief Executive Officer; Radhika Tripuraneni, our Chief Medical Officer; Tony Casciano, our Chief Commercial Officer; and Shan Wu, our Chief Business Officer. Following prepared remarks, we will open the call for questions. With that, I'm pleased to turn the call over to Steve. Great. Thanks, Greg. Good morning, everyone. Thank you for joining us. Today is a landmark day for patients living with Thyroid Eye Disease. It's also a historic day for us at Viridian. As Greg mentioned, Lumvoa is our newly announced brand name for our IV program, and its approval is our first FDA-approved medicine and first commercial product. Developing Lumvoa would not have been possible without the dedication of the TED community, including patients, caregivers, the trial investigators, and their study teams. For the Viridian team, this approval reflects our relentless focus on execution and our strong teamwork across clinical development, regulatory, medical affairs, commercial, market access, supply chain, and many other departments and functions that we rely on to keep moving forward. This same cross-functional execution has us well-positioned to launch with focus, discipline, and urgency. Turning to slide five, Lumvoa is now FDA-approved. Lumvoa is the first approved treatment for TED with a label that includes data for both active and chronic patients. As a reminder, Lumvoa was approved under priority review, which speaks to the strength of the supporting data and the approved commercial product profile. We are extremely excited to bring TED patients a compelling new treatment option with a differentiated profile, including a short, streamlined course of therapy. On the call today, you'll hear from Radhika, our Chief Medical Officer, about the key data in Lumvoa's label and why we have a lot of confidence in this differentiated profile for patients and physicians. You'll also hear from Tony, our Chief Commercial Officer, about our Lumvoa commercial strategy and priorities for launch. Before we get into the data, let's briefly review TED's impact on patients and what we believe differentiates Lumvoa. Thyroid Eye Disease, or TED, is an autoimmune condition characterized by inflammation, tissue expansion, and damage around the eyes. As a result, patients can experience proptosis, or bulging of the eyes, diplopia, or double vision, and other disease manifestations that include pain, redness, eyelid retraction, and often impacts mental health. The most severe cases can also be sight threatening to patients. These symptoms are disfiguring and debilitating and affect how patients function every day. On slide seven, we believe Lumvoa brings a differentiated treatment option to these patients. Both of Lumvoa's phase III pivotal clinical trials, THRIVE and THRIVE-2, met their primary and all secondary endpoints with a statistically significant improvements across the key signs and symptoms of TED. Proptosis, diplopia, and disease activity such as pain and swelling. Both active and chronic patients experienced rapid onset of treatment benefit, achieving significant improvements in proptosis and diplopia after only one infusion of Lumvoa. Lumvoa is the first approved product for TED to meaningfully impact diplopia in both active and chronic disease, including statistically significant and durable effects on both diplopia response and complete resolution. Again, in both active and chronic TED patients. Lumvoa offers a short 12-week course of therapy that patients complete in just five infusions. This profile is generating real excitement among both physicians and patients, particularly in a market where many patients and physicians are looking for treatments with shorter treatment dosing regimens and/or fewer doses. With that, I'll turn it over to Radhika to walk through Lumvoa's label and key clinical data. Thank you, Steve. We're really excited about the approval of Lumvoa and its broad label. Lumvoa is approved for the treatment of Thyroid Eye Disease regardless of disease activity or duration. It is the first approved treatment for TED to have both active and chronic data in its label. These data show that Lumvoa significantly and durably improved proptosis and diplopia for patients living with both active and chronic TED and has a safety profile consistent with the IGF-1R class. Let's take a closer look at these trials and the key Lumvoa data. Lumvoa's phase III trials, THRIVE in active TED and THRIVE-2 in chronic TED, are the two largest pivotal trials completed to- date in TED. Furthermore, THRIVE-2 included chronic patients with all levels of disease activity as measured by Clinical Activity Score or CAS. In both trials, Lumvoa was administered as an IV infusion every three weeks for five infusions, a 12-week course of therapy. We designed these studies to generate clear label supportive data in both active and chronic disease, so physicians have confidence in treating across the TED spectrum. Turning to slide 11, THRIVE showed robust and statistically significant outcomes across the key signs and symptoms of active TED, with strong results in proptosis, diplopia, and CAS reduction at week 15. These are clinically meaningful results that showcase the strength and consistency of Lumvoa's impact. Let's take a closer look at proptosis in THRIVE. For patients with active TED, Lumvoa showed rapid and durable improvements in proptosis, with reductions observed after just one infusion at three weeks and continuing through week 15. 70% of Lumvoa patients achieved a proptosis response at week 15, which was the primary endpoint of the clinical trial. This treatment response was 14 x that of the placebo response. 71% of the patients maintained their proptosis response through the end of the clinical trial at week 52, which was 40 weeks after their final dose. Lumvoa leads to the rapid relief of proptosis for patients, and the effect is durable. These two factors, speed of onset and durability, drive our confidence in the real-world use of Lumvoa. TED patients are mostly women aged 40- 50 years old who have families, jobs, and lives. They need treatments that deliver rapid and durable improvements of their symptoms, which is an important consideration when patients choose their treatment. Lumvoa also demonstrated rapid, strong, and durable effects on diplopia in THRIVE at week 15, where majority of the patients experienced an improvement in diplopia and nearly half achieved complete diplopia resolution. The majority of these patients remained diplopia-free at week 52, 40 weeks after their final dose. Lumvoa's effects on diplopia were also rapid, with significant diplopia complete resolution results as early as three weeks. Diplopia or double vision can be incredibly debilitating, making everyday activities like reading, driving, and working extremely difficult for patients. Lumvoa's robust and sustained benefits on diplopia are even more meaningful in this light. Turning to look at THRIVE-2 in chronic TED, a historically underserved population. Lumvoa delivered statistically significant results across all of the key endpoints in chronic TED. These results were seen in the largest phase III pivotal study completed to- date in chronic TED. These strong proptosis and diplopia data in chronic TED were encouraging to see and incredibly consistent with Lumvoa's effects in active TED. Let's take a look at proptosis on slide 15. Lumvoa led to rapid, robust, and durable improvements in proptosis in patients with chronic TED. These improvements in proptosis were observed after just one infusion at three weeks and continued through week 15, where 57% of Lumvoa patients achieved a proptosis response. This was seven times that of the placebo response. The majority of responding patients maintained their proptosis response at week 52, which is again 40 weeks after their final dose. The chronic TED population can be harder to treat, so we are very pleased to see how incredibly consistent these proptosis results are with Lumvoa's effects in active TED. Early, robust, and sustained benefit. This underscores Lumvoa's meaningful impact across the full spectrum of TED. Moving to diplopia in THRIVE-2. Majority of the chronic patients treated with Lumvoa experienced an improvement in their diplopia, and nearly a third achieved complete resolution at week 15. Lumvoa is the first approved treatment for TED to demonstrate a statistically significant effect in diplopia response and complete resolution of diplopia in chronic TED. Lumvoa's effects on diplopia in chronic patients were also durable. Among those who experienced the resolution of their diplopia during treatment, 80% maintained their resolution at week 52. Now turning to look at the summary of Lumvoa's safety and tolerability profile in active and chronic TED patients. Lumvoa was generally well-tolerated, with very low discontinuation rates in the clinical trials, and the safety profile we observed is in line with that of an IGF-1R. This profile is supportive of broad use across the TED patient spectrum and offers a new treatment option for patients. With that, I'll now turn the call over to Tony to discuss our commercial strategy and priorities for launch. Thank you, Radhika. I'll spend the next few minutes covering the commercial opportunity for Lumvoa, our readiness, and how we plan to execute at launch. We have an experienced commercial team with a track record of success across multiple launches, including buy and bill products. Our team has been preparing for this approval for quite some time now, and we are ready to launch. Our sales, market access, patient services, and medical affairs teams are in place, and our reps are in the field today. Infrastructure, including our supply chain, is built to support immediate launch execution. We're excited to launch Lumvoa as a newly approved option for TED patients. Today, we enter a large and established market with favorable dynamics that allow for a focused footprint and efficient use of capital. The current TED market is annualizing to $2 billion, with approximately 6,000 to 7,000 patients treated annually and low penetration of the overall TED market. There is meaningful unmet need, strong demand for new therapies, room for market share, and market growth over time. Lumvoa is well-positioned in an under-penetrated TED market with a product profile that we believe is aligned to unmet needs and highly motivating to both physicians and patients. Our primary commercial focus at launch is on the roughly 2,000 core prescribers who write more than 80% of all IGF-1R scripts for TED. These are experienced prescribers with existing referral pathways and who know how to coordinate with infusion centers. We're targeting these core prescribers with compelling Lumvoa product profile and a focused field force. Last but not least, this is a new start market, meaning switching patients off existing therapy is not required to access this market. Every time a TED patient seeks treatment, there's an equal opportunity for Lumvoa to be chosen. Turning to our launch priorities for Lumvoa. As is typical with specialty launches, the early quarters are about driving awareness, establishing access, moving patients through the treatment journey, and building strong early experiences. We're focused on three clear launch priorities. Drive awareness of Lumvoa by rapidly engaging our target core prescribers of IGF-1Rs and the infusion centers who administer them to patients. Differentiate Lumvoa through its clinical profile and the speed and simplicity of treatment, and deliver access with broad payer coverage and world-class patient services. We are not just launching Lumvoa, we are also launching Viridian as a commercial company. Early experiences matter both for patients and physicians, we believe delivering on these priorities will demonstrate that Viridian is a trusted long-term partner, building momentum for Lumvoa and beyond with our broader TED portfolio. Now let's take a look at our field team. We've built an experienced and geographically aligned commercial and medical field organization. We are strategically targeting our key audiences, including KOLs and physicians, the roughly 2,000 core prescribers, payers, infusion centers, physician staff, and patients across our world-class field team. We are positioned well to launch Lumvoa with a focus team of just under 100 sales reps. Our sales reps on average, have over 20 years of relevant experience and more than 350 total President's Club awards, which are annual awards reserved for only the very top-performing sales professionals. In short, this team is experienced, well-prepared, and ready to go. I'm happy to announce that thanks to our strong pre-launch planning and preparation, we have activated this team, and they are out promoting Lumvoa today. Turning to product differentiation. Lumvoa's strong label reflects key points of differentiation on attributes that matter. Robust improvements in proptosis and diplopia in both active and chronic TED, rapid symptom relief with proptosis reductions as early as three weeks. In a short 12-week course of therapy with just five infusions. These attributes give our field team a clear and compelling story for physicians and patients. A broad label across active and chronic TED, rapid onset, meaningful proptosis and diplopia benefit, and a short course of therapy. Moving to the next slide, making Lumvoa accessible as quickly as possible is another key launch priority. We've built a strong foundation for launch through our pre-launch payer engagements. Over the past several years, we've conducted extensive payer market research, and since January of this year, our market access field team has been busy totally leveraging the pre-approval information exchange process, discussing Lumvoa profile with payers and infusion centers, creating a high level of awareness. As a reminder, today, IGF-1R treatment has broad coverage on over 85% of U.S. plans, which we believe is a strong signal of the value payers see in the class. We have priced Lumvoa at parity with the existing approved IGF-1R therapy on a course of therapy basis and expect coverage consistent with the class. We intend to move as quickly as possible to build broad access to Lumvoa for TED patients, a process which we estimate will take six to nine months to reach critical mass. Finally, we've launched ViridianCares to support patients through their entire treatment journey, from patient enrollment through the last infusion. ViridianCares is a key part of our efforts to support TED patients' timely access to Lumvoa and is designed to help patients start and stay on therapy. ViridianCares is a personalized, comprehensive support platform for patients, physicians, offices, and infusion centers. Our dedicated Patient Access Liaisons or PALs will provide holistic support throughout the Lumvoa treatment journey. Our insurance coverage support will provide information and resources to help navigate the insurance process, including prior authorizations, and will offer patient financial assistance through ViridianCares to help keep Lumvoa accessible. ViridianCares reflects our commitment to providing patients with information, resources, and support to help navigate the treatment process from start to finish. I'm happy to announce today that ViridianCares is live and ready to accept patient enrollments. With that, I'll turn it back to Steve for closing remarks. Great. Thanks, Tony. Today is first and foremost about Lumvoa. We b elieve Lumvoa provides TED patients with a compelling new treatment option. We're excited about launching into a large and under-penetrated market. As we move through the early phases of launch, we'll be focused on key metrics of demand, access, and field execution, which are important early indicators of progress and aligned to our launch priorities. Today is also about establishing a foundation for our broader TED franchise. As a reminder, elegrobart or Ellie has the potential to be the first subcutaneous auto-injector for TED patients, anchored by two successful phase III pivotal trials in active and chronic TED. Taken together, we believe Viridian has a TED portfolio that can provide multiple differentiated treatment options for TED patients, starting with Lumvoa today. In closing, today's approval is an important milestone for the company, an important step forward for the TED community, and the beginning of what we believe can become a leading TED franchise. Lumvoa positions us to serve TED patients with a differentiated product in a large under-penetrated market and with a profile that has generated real enthusiasm among physicians and patients. We intend to build on that foundation with additional innovation intent and over time, more broadly act across thyroid and autoimmune diseases. We are incredibly proud of the work that brought us to this moment, and we're excited about the opportunity ahead. Thanks again, everyone for joining us. We look forward to hosting regular quarterly calls, starting with Q3 earnings in the November timeframe. Operator, please open the line for questions. Keypad. If you would like to withdraw your question, press star one again. As a reminder, please limit yourself to one question and one follow-up. Your first question comes from the line of Laura Chico with Wedbush Securities. Please go ahead. Good morning. Thank you for taking the question and congratulations to the Viridian team. I'd like to ask perhaps a basic clarifying question for you. I know you've made statements that you're pricing at parity versus Tepezza. If I do some math, one course of Tepezza treatment requires about 23 vials for a 75-kg patient. For Lumvoa, this would be less than half the vials for a course of treatment, shorter duration, lower doses. Could you just maybe perhaps clarify what is the price per vial for Lumvoa, and then how does that net out on a per course of treatment basis versus Tepezza? Thank you. Congratulations. Thanks, Laura. Appreciate the question. Yeah, I think just to reiterate right off the bat, our plan is pricing at parity with Tepezza. To go through the details, let me just turn it over to Tony. Yeah, happy to speak more about that. As stated, price to parity with Tepezza on a course of therapy basis, which I think is the root of your question. To clarify, five infusions of Lumvoa, we price that to be roughly equivalent to eight infusions for Tepezza. More specifically, wholesale acquisition cost for five infusions of Lumvoa in a typical 75-kg patient is approximately $450,000. That's roughly equivalent to eight infusions of Tepezza for that same weight patient. Thank you, Tony. Your next question comes from the line of Gregory Renza with Truist Securities. Please go ahead. Great. Good morning, Steve and team. Let me add my congratulations on a tremendous accomplishment today and a great way to get this over the goal line. Steve, you mentioned, of course, you'd be holding quarterly calls. Appreciate all the transparency as you and the team kick off the Lumvoa launch. Just wanted to ask you to touch on perhaps what metrics you will be focusing on and the metrics that you may be perhaps sharing with us to gauge the strength of the Lumvoa launch. Anything on top of coverage, the patients, the demands, the processes would be great. Thanks so much. Great. Thanks, Greg. Appreciate that question as well. Look, there's the broad categories of us tracking demand, payer coverage, field execution. Again, let me give it over to Tony to walk through some of the specifics here. Happy to take that one. First and foremost, just want to reiterate, we are very bullish on the peak potential of Lumvoa for reasons stated. Large, attractive market, under-penetrated, very addressable and accessible with just over 2,000 core prescribers and [significant] penetration with a very compelling profile that we think stacks up extremely well versus approved products. We also believe that our time to peak will be rapid. We think on the faster side from a years to peak perspective. That said, early quarters, as is typical with a buy and bill launch, revenue will not be the primary metric that we'll be tracking. That will take some time to build. As we enter 2027, we think we'll hit meaningful revenues. We'll be focused on metrics in the categories that Steve laid out in his initial response there, which are around field execution, demand, and payer coverage. What we'll be looking at in each of those different categories specifically, we want to make sure that the field team is out reaching those 2,000 core prescribers as quickly as humanly possible. We had a nice head start. As discussed on prior calls, we've had this team in place for quite some time. They've been out not talking about Lumvoa because it wasn't approved yet, but out profiling accounts, establishing relationships, booking appointments. They are in the field today off and running. Actually had some calls happening over the weekend, believe it or not, thanks to the preparation prior to approval. We'll also be tracking very closely, obviously, demand via enrollment forms. We anticipate starting to see those through the system. As noted, ViridianCares, which is our patient hub and the backbone of the patient services program here at Viridian, was up and live, is accepting enrollments today, was open actually at the end of the day on Friday, shortly after approval and the press release went out. Payer coverage will absolutely be critical early days. As mentioned, Amgen and Horizon have done a really nice job establishing the value for IGF-1Rs. There's broad coverage in over 85% of U.S. plans today. We believe based on our pricing, again, at parity, that we would experience the same type of broad coverage in due time. We will push tempo on that and try to get speed to coverage as quickly as humanly possible. We'll be watching those policies and our ability to influence and drive that process over time. Those three things, field execution, how quickly we can reach the Tier 1 physicians with this compelling profile that we believe is Lumvoa enabled by the strong label Two, demand in the form of enrollment forms. Last, certainly not least, our ability to attain coverage to make sure that patient access is established quickly and maintained. That's fantastic. Thanks, Tony. Thanks, Steve. Maybe just as a follow-up, as you talk about the attractive and differentiated label for Lumvoa, I'm just curious, with this now all in hand, how, Steve, does this maybe impact or shape or reshape how you're looking at taking your plan with Ellie and the subQ option, both on the timing and the approach? Any additional details you're thinking about that program as a follow-on would be great. Congrats again. Thanks, guys. Thanks, Greg. On Ellie, we had our two positive phase III readouts in active and chronic TED. Really excited about that program. Really, as we mentioned, the first auto-injector for subcutaneous delivery of an IGF-1R could be really exciting and market expanding. That program is underway. We have to finish up those trials. We had our top-line readouts in March and April, but we have to finish up those trials in the follow-up period. We are on track for BLA submission in Q1 2027. We are looking to advance through that process, through the BLA submission. We are looking to advance both Q4 weekly and Q8 weekly. We saw great responses in Q4 weekly with respect to proptosis and diplopia. We saw great responses on Q8 weekly for proptosis, so if diplopia is not your main complaint. What we really like overall is you've got product offerings across the patient spectrum with respect to Lumvoa now. As we make progress, we expect to have Q4 weekly subcutaneous dosing as well as Q8 weekly subcutaneous dosing so we can cover the entire patient spectrum on the disease. Really exciting program. We're looking forward to making more progress. Your next question comes from the line of Michael Yee with UBS. Please go ahead. Great. Thanks. Congratulations on the approval. We had one question and a follow-up. First question was just in thinking about the opportunity for your launch, do you think that the opportunity would be particularly strong in chronic, where I think that Tepezza has not much use, and that's probably due to the label. How are you thinking about where the perhaps low-hanging fruit is or where there's a particular opportunity that we could see you have a good penetration into or differentiation from in the first few quarters or first year? That's just thinking about the opportunity in the first year. Then a follow-up is around just the early metrics. I know you want to get metrics, and you said there won't be much revenue. I think consensus has revenues, a little bit of revenues in Q3 and in Q4. Is it possible to have patients treated in Q3, or is it just due to reimbursement time that it's not going to happen in the third quarter? Thank you. Yeah, happy to answer both those questions. On the patient population, active chronic, our strategy at launch with Lumvoa is conversion of existing Tepezza prescribers. We're targeting, as mentioned, the roughly 2,000 core prescribers that make up over 80% of current Tepezza use. Most of Tepezza use today is in active. We estimate roughly 80% of those 6,000 to 7,000 patients annually that receive Tepezza, annualizing out to roughly $2 billion, is in the active. We would expect most of the early use with Lumvoa to follow suit and to be in the active population. However, I think we would not be surprised at all to see some movement in the chronic population based on the strength of the label and the strength of data coming from the THRIVE-2 data set where we saw really nice responses in both proptosis and diplopia. In particular, on that need in this market, in the chronic population, with the strength of the diplopia data showing both resolution and response with a favorable safety profile. To answer it quick, shortly, we would assume most of the penetration would be into active, as is similar with the class in the market today. We think we have a shot over time to access some of those chronic patients as well. Second question was around revenue and when we would anticipate patients start. As mentioned, Viridian Cares is open. We're accepting patient enrollment forms. Every patient that comes in will get a PAL assigned, a patient access liaison, to try to navigate through that system. It is entirely possible for patients to start on therapy in the first couple of quarters. We just believe critical mass will happen around 2027 as we turn the corner, and that's due to a number of different things. One, we don't expect much stocking in this market. It's just-in-time inventory. We'll have some modest stocking with the distributors, but really not much to speak of at the infusion centers. They'll order that on a dose-by-dose perspective. Two, we know in this market, even at peak, it takes some time to work your way through a PA process, which is not too dissimilar from other specialty biologic markets. We know it can take 60 to 90 days today with Tepezza, and we would expect for it to take about that long for us. A little bit longer in the early days, and we'll look to tighten that up over time as coverage comes online. The last piece being coverage where we don't anticipate 85% coverage at launch. We'll have some coverage at launch. We'll start to tick off some of those plans, but that will play out over time. What that equates to is as we fill the funnel with enrollment forms and start to help those patients and physicians get through the PA process We would expect maybe a few to start in the third quarter. Certainly as we end the year, we would expect that run- rate to increase and result in meaningful revenue as we turn into 2027. Thank you. Your next question comes from the line of Joseph Thome of TD Cowen. Please go ahead. Hi there. Good morning. Congratulations on the approval, and thank you for taking my questions. Maybe the first one, when you think about those 2,000 core prescribers, based on your fieldwork so far, have you identified a group that you think might be sort of the earliest to adopt the therapy? Do they have a specific profile? They're maybe not happy with Tepezza or have low infusion availability in terms of sites, I guess anything that you can point to there. Second, do you expect that Amgen would do any sort of increased discounting with Tepezza now that there is another entrant in the market? If so, why or why not, and how best can the company manage that? Thank you very much. Yeah, great question. Maybe I'll start with the second question. We don't anticipate any pricing actions from Amgen. Obviously, we don't control the price of Tepezza. Based on market dynamics, this is a buy-and-bill space. You typically don't want to be the first mover to apply a discount in the commercial setting just because of the ASP plus reimbursement at stake. There are other reasons why we think Amgen would not want to impact pricing in response to the launch of Lumvoa. I believe the value has been clearly established with payers. This is not a market where physicians are doing the infusing. Introducing new economics to physicians to incent prescribing behavior is not in play either. We're fairly confident that there will not be a pricing response by Amgen. We're ready for any scenario, though. I'll just throw that out there. We've planned this all out with multiple different scenarios and potential actions by Amgen. If that were to happen, of course, we'd be ready, but we don't anticipate that to be the case. The first question was around, are there physician types that are more likely to adopt versus others? This is, as we said, a very tight 2,000-ish core prescriber market, which is great for us. You can hit that easily with just under 100 sales reps. Certainly, as is typical in other markets, they decile out. There are high-volume prescribers and lower volume prescribers that make up that 2,000 core prescribers. It has more to do with patient density. We see some centers having more patients come through on a more frequent basis. We would anticipate those would be the places that we would see the most use early days, versus some of the lower decile core prescribers that may not see patients on a more frequent basis. Great. Thank you very much. Your next question comes from the line of Thomas Smith with Leerink Partners. Please go ahead. Hey, guys. Good morning. Congrats on the early approval here, and thanks for taking our questions. Now that you have both active and chronic TED data on label, where do you think this is going to benefit you the most? Is it the conversations with payers and sort of the breadth of coverage, or is it with prescribers and trying to drive broader prescribing into the chronic population? I have a follow-up. Great question. Just to restate, payer coverage today for the IGF-1R classes is pretty broad. Over 85% of plans have policies in place for both active and chronic. Certainly won't hurt those conversations, but we're aiming for parity, which is based on our parity pricing strategy. From a physician perspective, I think this is where the strength of the label and the strength of the data in that label benefits us and benefits Viridian and patients with TED. That's around more than just the chronic data. We think there are three primary attributes that make Lumvoa a very compelling and competitive profile. Dosing is an obvious one. Five infusions over 12 weeks, lasting just 30 to 45 minutes each infusion. As a reminder, Tepezza, a full course of therapy is eight infusions lasting 21 weeks, and each infusion lasting 60 to 90 minutes. Clearly differences there in both the duration, frequency, and total time on therapy. We think that's important, especially when you consider this patient population is typically a 40- to 50-year-old active female living an active life, holding an active job, managing an active family. We do think that those timing differences matter. Second is the speed of Lumvoa. We saw statistically significant responses in proptosis in as little as three weeks after just one dose of Lumvoa. Third, as you point out, very strong chronic data, namely in diplopia, which was a little bit unexpected, to be quite honest with you, where we saw diplopia resolution and response in those chronic patients, regardless of CAS zero through seven. Those three things, dosing, speed of onset, chronic data, diplopia in particular, chronic data, which is in the label at launch. We think those three things are what make Lumvoa a very compelling option for patients. We believe, again, because of the dynamics of this market being a new start, every time a patient goes in and starts therapy with a physician, there's a fair shot whether that's going to be Tepezza or Lumvoa, and we believe that Lumvoa has a very good shot of being selected there. Also worth mentioning that those three attributes that we are very confident in and very excited about were also the basis of our breakthrough designation submission, which again was, as we all know at this point, granted by the FDA, which led to our priority review, which gave us our PDUFA of the 30th and approval on Friday. Yes, everything's coming together for us. We believe we've got a very compelling profile and excited to have that out there today in front of physicians. Got it. That's super helpful. Then, just a quick follow-up if I could. With respect to the key metrics of demand you highlighted, the new patient start forms, the field execution and the payer coverage, any additional color you could provide quantitatively with respect to how you're gauging success here over the first 12 months? Any targets around percentage of covered lives or detailing of the 2,000 core prescribers? Any benchmarks or analogs you think are particularly comparable across those metrics? Thanks so much. We'll want to re-expose core prescribers as fast as humanly possible. I know it's not a quantifiable metric, but that's how we're operating at Viridian, as fast as humanly possible. One metric that we have stated is we expect critical mass on payer coverage to happen around the six- to nine-month mark. That's more a reflection of payer process. We'll push tempo on that. We're off to a really good fast start based on the pre-approval information exchange conversations that the team was really busy executing against in the spring timeframe. No specifics on quantifiable metrics other than the six to nine months to hit critical mass. The rest of these things we're trying to do as fast as humanly possible. Makes sense. Thanks, guys. Congrats again on the approval. Your next question comes from the line of Alex Thompson with Stifel. Please go ahead. Hey, great. Congrats on the approval and the great label. I guess sort of digging in on early launch connects a little bit more. Maybe could you talk a little bit about sort of the early launch dynamics here around medical exception and the importance of getting a permanent J-code in this process? Then maybe as a follow-up as well, could you talk about how revenue recognition will work to Viridian in this context? Thanks. Yeah. Of course. Maybe I'll take the last one first. Revenue recognition. Revenue will be recognized as it is received by the distributors. Again, as mentioned before, we don't anticipate much of any stocking, maybe some modest stocking early days. Revenue will be recognized once it's received. Early days, I think there was a question in there about medical exception. As you mentioned, medical exception will be something that will be leveraged in the early days as payer coverage is building. Again, we estimate six to nine months to hit critical mass there. In the meantime, it doesn't mean that a patient can't get access to the product. In fact, they can, and this is where the strength of ViridianCares really helps us in the early days of launch. Regardless of the policy in place or not, a PAL will be assigned to every patient that's enrolled in the ViridianCares program and work with insurance companies through that medical exception process. For those not familiar, if there isn't a policy in place, a lot of times payers will push the approval to a medical exception process. What that means is an extra call to the office, potentially some extra paperwork. That is a process that's put in place to give patients access to products prior to the plan having a chance to review and establish a policy. We would expect that to be taking place over the several months as we're building that critical mass. Last question was on J-code. Again, really convenient timing for us on the approval being the 26th. We have until July 1st, 11:59 P.M., I believe, to get in a J-code submission. We will hit that mark, and we anticipate having a permanent J-code in the first quarter of 2027. Your next question comes from the line of Faisal Khurshid with Jefferies. Please go ahead. Hey, guys. Thank you for taking the question. Just wanted to clarify, we were reviewing the label for Tepezza, and it looks like the Section 14 Clinical Trials Section doesn't actually include the chronic TED data. Just wanted to confirm, is that you guys' read of the label difference as well, and do you think that'll be a meaningful advantage in the eyes of physicians? Yeah, this is Radhika. Thanks for the question. Yes, the Tepezza label doesn't include the chronic four study. It includes a phase II study and then their phase III study. We do believe that is definitely a point of distinction, as we pointed out earlier on the call, because being able to provide that information ultimately to physicians gives them a really good clarity across the full, broader TED spectrum, basically from the moment that we're out in the field. Excellent. Thank you. Next question comes from the line of Rami Katkhuda with LifeSci Capital. Please go ahead. Hi, guys. Wanted to share my congrats on the approval as well. Thank you for taking my questions. As you mentioned, the inclusion of chronic data is differentiated versus Tepezza. Do you expect you need broader outreach to endos to more meaningfully penetrate the chronic TED population? Maybe secondly, given the label and more convenient profile, do you see an opportunity to expand the TED market with Veli, or is the focus primarily on converting the current opportunity? Yeah, great questions. I'll, again, take the second one first. Would not at all be surprised to see this market expand with the introduction of Lumvoa based on the strength of the profile and the mere fact that we'll be introducing just under 100 sales representatives to the existing promotional effort by Amgen. Now, the strategy is conversion at launch. As discussed, most of the use today is occurring in active. We estimate over 80% of current Tepezza use to be in active. Again, we believe that most of the use for Lumvoa early days will be in active as well. However, we know from market research that roughly 30% of patients decline therapy when offered. One of the top reasons that we hear them say in research is just the burden of therapy. For a 40-to 50-year-old working age female, signing up for eight infusions lasting 60 to 90 minutes each time and a total course of therapy over 21 weeks is a lot, and too much for some patients. We believe that some of those patients said no to that may say yes to Lumvoa with five infusions lasting 30 or 45 minutes each and completion of therapy at 12 weeks. That's why we're so bullish on that difference. Normally in markets, people maybe not get too excited about a convenience benefit, but this particular patient type, this particular disease state, this particular situation, we do think that that's a winning attribute. Would not be surprised at all to see the market expand due to those factors. But again, our specific strategy at launch is on conversion of existing prescribers. Endos that write, we will target. We're targeting anybody that writes Tepezza because we're looking to convert them. Endos that don't write, that's not going to be a target of us, of our sales force at launch. That may change with the introduction of Ellie, if and when approved, as we believe that profile, safely and simply delivering an IGF-1R to a patient's home in a pen that they can self-administer in as little as three doses in under 10 seconds. We believe that changes the math for the willingness of endos to prescribe potentially, and we'll assess that as we get closer to that launch. Again, if and when approved. Makes a lot of sense. Thanks, and congrats again. Your next question comes from the line of Lisa Walter with RBC Capital Markets. Please go ahead. Good morning. Thanks for taking our question, and congratulations on the approval. Throughout your pre-approval information meetings, what aspects of Lumvoa did payers find meaningful or differentiated versus Tepezza? Were there any discussions of becoming the preferred option on formulary? Any color here would be helpful. Great questions. We were really excited to be able to participate in those meetings and really impressed by the receptivity. These payers have a lot of companies they're working with. There's a lot of products pending approval, and sometimes it's difficult to get appointments. That was not the case with Lumvoa, partly due to the breakthrough designation that we received generated a really high level of enthusiasm and excitement. Nothing in particular, honestly. I think the profile in totality was exciting. Payers are excited to have a second option for patients to access. The nature of these discussions is more sharing the data. We don't get into pricing discussions. We don't get into contracting discussions. Preferring one versus the other, while that's not a strategy of ours anyway, was not something that we discussed. We are, again, just to restate, I think the level of enthusiasm by these payers gives us a lot of confidence post-approval that we'll be able to access and have these meetings to review policies in a timely basis, which we estimate will take roughly six to nine months to hit critical mass. Got it. Thanks so much. The next question comes from the line of Rich Law with Goldman Sachs. Please go ahead. Hey, guys. Congrats on the early approval. How many chronic patients who have higher degree of symptom severity do you believe could benefit from IGF-1R treatment are not taking Tepezza? Is there anything you can do to promote Lumvoa in those patients that Amgen's not doing or able to do since chronic data is not in that label? I have a follow-up. Yeah. Great question. I think that the nature of this market is those 2,000 core prescribers, while most of their prescribing is happening in roughly over 80%, we believe, in the active population, they are seeing chronic patients. We believe based on the strength of the THRIVE-2 data set that these patients that fall within that study criteria have a clear benefit with Lumvoa. Again, I just want to restate, we're not looking to actively add prescribers to this market. We are, however, looking to bring the full data set to these 2,000 core prescribers because we think Lumvoa is a really good option for patients and will create a compelling choice for both patients and physicians. I don't think there's anything special or incremental that we'll do to go find these patients. We're certainly not going to go direct to patient with advertising, try to motivate them. We know that Amgen continues to do so. We hope they continue to do so. We like their advertisements to help grow this market and develop it. No, we'll have a crystal clear focus on conversion of existing prescribers and the patients that those physicians treat. We think, again, Lumvoa is a very compelling choice. Thanks. Just a follow-up. Looking at the label, IBD was listed in the warning and precautions. Although we haven't seen you guys or heard you guys talk about it. Was that just a class effect from Tepezza since it was mentioned in this trial and the post-approval use? Is there any way to differentiate here as well? Yeah. Thanks for the question. That's correct. The IBD section in the warnings and precaution is basically a class warning given the experience that it's been seen with regards to Tepezza. There's no concern that we were able to see and identify in the course of our studies with regards to it. It's not necessarily an area we're looking to differentiate on because obviously we'd follow the label to a T. Great. Thank you. The next question comes from the line of Douglas Tsao with H.C. Wainwright. Please go ahead. Hi, good morning. Thanks for taking the questions. Congrats on the approval. I guess, Tony, if you could maybe just provide a little more color in terms of, you indicated you expect to get a J-code in January. How do you think not having a J-code for these first few months will impact the launch? I'm just curious also as a follow-up in terms of ramping up while you're getting coverage put in place. It does sound like your pre-approval process or prior auth process will be a little longer than what it will be with Tepezza. Do you anticipate having any kind of quick start program to get patients started on therapy so you don't lose them to patients who are just anxious to get treatment, but since your process might take a few more weeks? Thank you. Yeah, both great questions. As you state, we do expect J-code in the early part of 2027 as we'll hit this next quarterly intake window. In the meantime, because of the nature of the TED market today and how it's constructed, most of these patients, the vast majority are receiving their treatment not in a physician office, but in infusion centers. Infusion centers, they're used to dealing with temporary J-codes. That said, it will create a little more work and uncertainty from a reimbursement perspective for some of the smaller infusion centers as we're working through a temporary J-code. Some will be okay with it. Some might be uncomfortable with it. We'll work through that first couple quarters, but this is nothing different from any other launch in any other buy- and- bill space. This is not something that's special to us. What is special to us is the favorable dynamic that we're not asking many physicians to take on the risk of a temporary J-code. We're asking infusion centers who are used to dealing with temporary J-codes. Can you repeat your second question? Quick start program. Sorry. We have a full complement of patient services. We're going white glove with ViridianCares. There are multiple programs in place for coinsurance, for co-pay assistance, and for urgent starts. For those patients that are site-threatened, there's a mechanism for them to get rapid access rather than wait. Great. Thank you very much. Your next question comes from the line of Derek Archila with Wells Fargo. Please ask a question. Hey, good morning, and congrats on the update here on the approval. Maybe a question for Tony. I know you had mentioned your view that you'll see a quicker ramp- to- peak. Maybe you could just give us some thoughts or analogs there on how you think about that. Also for IV, some of the feedback that we got is preference for treating active patients with IV versus subQ in the future. Maybe any comments that you could provide. Thanks. Yeah, good question. First question on time to peak. We believe it'll be rapid for a couple of different reasons. One being that this is a new start market, and we don't require any switching of patients off of therapy. This is almost exclusively an incident market, which lends itself to a faster ramp. We anticipate this to be on the faster side in terms of years to peak as is might be typical with other buy and bill. We do anticipate that we'll be able to get to peak revenue quickly. Again, just to restate, the first couple of quarters, however, will be more about patient enrollment, speed to coverage, and then engaging with those Tier 1 physicians as we build patients in the funnel and those convert in 2027 into meaningful revenue. One thing I would just like to point out as that revenue materializes. There was a question about recognition, which I gave kind of an accounting answer to. Just to clarify, infusion centers will be ordering the product, whether it's Tepezza or Lumvoa, on a dose-by-dose basis in most cases. If a patient starts tomorrow and gets an infusion every three weeks, that infusion center would typically be ordering the product prior to each of those infusions. All right, not all at once. Just a clarifying statement there. There was also a question of active versus chronic with Ellie. I think one of the things that we're most excited about is the strength of the Lumvoa label. We believe that that's going to be a compelling choice for physicians and patients today. As you fast-forward to adding Ellie, if and when approved, and just look at the profile and suite of offerings that Viridian can introduce to the market and bring to the market with Lumvoa profile, which we talked about, and Ellie which is safely and simply delivering IGF-1R to a patient's home in as little as three doses in an easy-to-use auto-injector that can be self-administered in under 10 seconds. You have those two compelling profiles to offer a physician and a patient with TED. It's tough to see a patient that Viridian doesn't have an answer for. I think, yes. So active and chronic in a future state with both of those products. It's very, very exciting for us to look at the opportunity in both of those patient types. Your next question comes from the line of Serge Belanger with Needham & Company. Please go ahead. Hi, good morning, and congrats on the approval. I guess for Tony, can you just talk about maybe the level of awareness among the initial prescriber base that you'll be targeting and what their evaluation process will be, now that they can get their hands on Lumvoa. I have a follow-up. Hey, sorry, can you repeat that question? Wasn't sure what you were saying up in the front of that question. Yeah, no problem. The first one was the level of awareness among the initial prescriber base that you'll be targeting. Secondly was what you think the evaluation process will be for those physicians now that they can get their hands on Lumvoa. I see. That's clear. First question, awareness is high, right? The reps have been in-market profiling accounts, not talking about Lumvoa, but talking about Viridian for a few months now. Before that though, the MSL team, the full MSL team, has been out there for a number of years, sharing the data, talking to KOLs, but also high prescribers in the space and investigators. Which we have several of the larger, more prominent KOLs in the TED marketplace who are also investigators for the Viridian trial. Again, it's a small group. They talk a lot. Roughly 2,000 of them. They talk a lot to each other as well. We've engaged with a high number of them to- date. Awareness is really high. We feel very fortunate to be entering this market from a position of strength with good awareness of the product, good awareness of the company, and again, a really tight call set to go out now with the approved label and educate physicians to make that evaluation. We think that what that looks like when we talk to physicians, they tell us as a patient comes in, they present with TED, they discuss their treatment options, and this will be a conversation between a physician and their patient on what choice makes the most sense to them. I'm biased, but I think a reasonable person will conclude that Lumvoa profile makes a whole lot of sense given the alternatives. How should we think about retreatments beyond the initial five-injection or eight-injection treatment courses? I know it's not on label for either Lumvoa or Tepezza, but how common is it? Yeah. Is it covered by insurance providers? Yeah. It's a great question. How common is it? We estimate from claims that roughly 5%-6% annually of patients that are on Tepezza, it's their second course of therapy. It is happening out there. How it happens is related to a question that was asked earlier around the medical exception process. Almost every plan, I think there's a couple out there that may have a policy in place, their policy for IGF-1R is one per lifetime. That's from a policy perspective. However, if a patient responded well the first time and a physician is motivated to try to go through that exception process, there are avenues to get second multiple courses approved. Not on label for Tepezza, not on label for Lumvoa. I think we said publicly prior to today that we are assessing ways to generate data to try to enable that to be a bit of a smoother process. Got it. Thank you. Next question comes from the line of Lachlan Hanbury-Brown with William Blair. Please go ahead. Yeah. Thanks for the question, I'll add my congratulations. Is it fair to assume that the sales team at this point has basically made or established relationships with all of the core prescribers if they've been out there for a few months, or is there still some that you sort of haven't met? And maybe following on from that, do you have a sense if there's any kind of bolus of patients out there that docs are maybe waiting to start on this? Or should we be assuming that's not really the dynamic since they have Tepezza available? Yeah, great questions. Over 90% of them we've already had conversation with, reached, visited in the profiling portion of this. Again, we're hitting the ground running with some calls happening over the weekend and the sales force out in full force today within 24 business hours of approval by the way, based on the strength of the preparation of the team. On the bolus of patients, we don't anticipate a bolus of patients. I think the nature of TED, the disfiguring and disabling aspects of it, we don't anticipate that physicians and patients are waiting for another product with Tepezza widely available and widely approved. Doesn't mean it won't happen, but it's not something that I would expect to be of any significance. Thanks. We will take the final question from Andy Chen with Wolfe Research. Please go ahead. Hey. This is Brandon for Andy, thanks for taking the question. We're curious to know, how would you benchmark yourselves against the first few quarters of the Tepezza launch? Assuming obviously no bolus, do you think you would do a quarter of Tepezza enrollment, half of it? What do you think is reasonable from your end? It's a great question. Horizon did a fantastic job launching Tepezza. Little bit different of a circumstance. You go back in time to when Tepezza was launching, when Horizon launched that product, basically these patients had surgery or steroids. Obviously no approved IGF-1R. Certainly not a lot of options. I would not draw any conclusions on our projected first couple quarters with theirs because it's a drastically different situation. However, what we learned from that is this is a physician group that when they see a product that makes sense for their patients, they will adopt it quickly. It's part of what has us so excited about the accessibility of this market, not just the size of the physician group that's prescribing most of the Tepezza today, but the receptivity to trying something new. We think Lumvoa is a nice really good new choice for them that we know from market research they're excited to try. We're very excited about the next few quarters. All right. Thank you. There are no further questions at this time. I will now turn the call back over to Steve Mahoney for any closing remarks. Thank you. Thanks everybody for all your questions and joining us today. Look, we're really excited about the approval of Lumvoa. It was a great milestone for patients, a great milestone for the company. We're excited about the position we're in and the opportunity ahead of us. We're looking forward to getting out there and helping as many TED patients as we can. Thank you very much for joining us today, and I'm sure we'll be talking to many of you soon. Thank you. Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.