Viridian Therapeutics, Inc. (VRDN) Earnings Call Transcript & Summary

Good morning, ladies and gentlemen, and welcome to the Viridian Therapeutics conference call. [Operator Instructions] 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, and 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 Sean 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, and 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 5. 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 would 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. But before we get into the data, let's briefly review TED's impact on patients and what we believe differentiates from [indiscernible]. 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, eye lid retraction and often impacts metal health. The most severe cases can also be site-threatening to patients. These symptoms are disfiguring and debilitating and affect how patients function every day. On Slide 7, 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 all secondary endpoints with the statistically significant improvements across the key signs and symptoms of TED, proptosis, depopia and disease activities such as pain and swelling. Both active and chronic patients experience rapid onset of treatment benefit achieving significant improvements in proptosis and diplopia after only 1 infusion of Lumvoa. Lumvoa is the first approved product for TED to meaningfully impact popia in both active and chronic disease, including statistically significant and durable effects on both dipopiaresponse and complete resolution. Again, in both active and chronic TED patients. And Lumvoa offers a short 12-week course of therapy that patients complete in just 5 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 datat. Lumvoa's Phase III trials, THRIVE and Active TED and THRIVE-2 in chronic TED are the 2 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 3 weeks for 5 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 cast reduction at week 15. These are clinically meaningful results that showcase the strength and consistency of Lumvoa's impact. Now let's take a closer look at proptosis and THRIVE. For patients with active TED, Lumvoa showed rapid and durable improvements in proptosis with reductions observed after just 1 infusion at 3 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 14x that of the placebo response, 71% of 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 2 factors, speed of onset and durability drive our confidence in the real-world use of Lumvoa. TED patients are mostly women aged 40 to 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 and 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 remain 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 3 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. Now turning to look at THRIVE-2 and chronic TED, a historically underserved population. Lumvoa delivered statistically significant results across all of the key endpoints in chronic head. 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. Now 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 1 infusion at 3 weeks and continued through week 15, where 57% of Lumvoa patients achieved a proptosis response. This was 7x 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 and THRIVE-2. Majority of the chronic patients treated with Lumvoa experienced an improvement in their diplopia and nearly 1/3 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 and chronic patients were also durable. Among those who experienced the resolution of the diplopia during treatment, 80% maintained the resolution at week 52. Now turning to look at the summary of Lumvoa's safety and tolerability profile in active and chronic pad patients. Lumvoa is generally well tolerated with a 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-build 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, 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 temptations. Today, we enter a large and established market with the favorable dynamics that allow for a focused footprint and efficient use of capital. The current market is annualizing to $2 billion, with approximately 6,000 to 7,000 patients treated annually and low penetration of the overall tab 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 underpenetrated 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 to write more than 80% of all IGFNR 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 the 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 to the treatment journey and building strong early experiences. We're focused on 3 clear launch priorities: drive awareness of Lumvoa, by rapidly engaging our target core prescribers of IGF1R 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, and we believe delivering on these priorities will demonstrate that Meridian 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 have built an experienced and geographic 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 focused 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 has experienced well prepared and ready to go. I'm happy to announce that thanks to our strong prelaunch 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 [ aplopia ] in both active and chronic TED, rapid symptom relief with proptosis reductions as early as 3 weeks. In a short 12-week course of therapy were just 5 infusions. These attributes give our field team a clear and compelling story for physicians and patients. A broad label across active and chronic head, rapid onset, meaningful proptosis and aplopia benefit and a short course of therapy. Moving to the next slide, making Lumvoa accessible as quickly as possible as another key launch priority. We've built a strong foundation for launch through our prelaunch payer engagements. Over the past several years, we conducted extensive payer market research. And since January of this year, our market access field team has been busy, totally leveraging the preapproval 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 [ tedtatients ]-- process which we estimate will take 6 to 9 months to reach critical mass. And finally, we've launched Meridian cares to support patients through their entire treatment journey from patient enrollment through the last infusion. Iridian Cares is a key part of our efforts to support [indiscernible] timely access to Lumvoa and is designed to help patients start and stay on therapy. Brian Cares is a personalized comprehensive support platform for patients, physicians, offices and infusion centers. Our dedicated patient access liaisons, or PAS, 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. It will offer patient financial assistance through Brilliant Cares to help keep Lumvoa accessible. Green cares 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 Viridian Cares 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 believe Lumvoa provides TED patients with a compelling new treatment option. We're excited about launching into a large and underpenetrated market. As we move through the early phases of launch, we will 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, [indiscernible] or Eli has the potential to be the first subcutaneous auto injector for TED patients anchored by 2 successful Phase III pivotal trials in active and chronic tech. Taken together, we believe Viridian has a tech portfolio that can provide multiple differentiated treatment options for tech 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 underpenetrated 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 disease. 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 time frame. Operator, please open the line for questions.

[Operator Instructions] Your first question comes from the line of Laura Chico with Wedbush Securities.

Congratulations to the Viridian team. I'd like to ask perhaps a basic clarifying question for you. I know you've made statements that your pricing at parity versus TEPEZZA. If I do some math, one course of TEPEZZA treatment requires about 23 vials for a 75-kilogram 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?

Thanks, Laura. I appreciate the question. Yes, I think just to reiterate it off the bat, we -- our plan is pricing at parity with TEPEZZA. But to go through the details, let me just turn it over to Tony.

Happy to speak more about that. So as stated price to parity with TEPEZZA on a course of therapy basis, which I think is the root of your question. So to clarify, Five infusions of Lumvoa, we priced that to be roughly equivalent 8 infusions for TEPEZZA. So more specifically, wholesale acquisition costs for 5 in seasons of Lymvoa and a typical 75-kilogram patient is approximately USD 450,000. So that's roughly equivalent to 8 infusions of TEPEZZA for that same weight patient.

Your next question comes from the line of Gregory Renza with Truist Securities.

Great. Let me add my congratulations on a tremendous accomplishment today, and great way to get this over the goal line. Steve, you mentioned, of course, you'd be holding quarterly calls. I appreciate all the transparency as you and the team kicked 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.

Yes. Great. Thanks, Greg. I appreciate that question as well. Yes, look, there's the broad categories of us tracking demand, payer coverage field execution. But again, let me give it over to Tony to walk through some of the specifics here. Yes, happy to take that one. First and foremost, I just want to reiterate, we are very bullish on the potential of Lumvoa for reasons stated, large, attractive market, underpenetrated, very addressable and accessible with just over 2,000 core prescribers and single-digit penetration with a very compelling profile that we think stacks up extremely well of our approved products. We also believe that our time to peak will be rapid. So we think on the faster side from a years to peak perspective. That said, early quarters, as is typical with the 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. In the meantime, we'll be focused on metrics in the categories that Steve laid out in his kind of 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 not talking about Lumvoa because it wasn't approved yet, but our profiling accounts, establishing relationships, booking appointments say that 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. So we anticipate starting to see those through the system, as noted, Viridian Cares, which is our patient hub in the backbone of the patient services program here at Vidian, was up and live, 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 has done a really nice job establishing the value for IGF-1R. There's broad coverage in over 85 of U.S. plants 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. So we'll be watching those policies and our ability to influence and drive that process over time. So those 3 things: field execution, how quickly we can reach the Tier 1 physicians with this compelling profile that we believe is Levo enabled by the strong label to demand in the form of enrollment forms. And then last, certainly not least, our ability to attain coverage to make sure that patient access is established quickly and maintained.

That's fantastic. Maybe just as a follow-up, as you talk about the attractive and differentiated label for Lumvoa, 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 subcu option, both on the timing and the approach. Any additional details you're thinking about that program as a follow-on would be great.

Yes. Thanks, Greg. So on Eli, we had our 2 positive Phase III readouts in active and chronic tad, really excited about that program, really, as I 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 of 2027. And so 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 and then we saw great responses on Q8 weekly for proptosis. So diplopia is not your main complaint. So what we really like overall is you've got product offerings across the patient spectrum with respect to Lumvoa now. And then as we make progress, you'll have Q4 we expect to have Q4 weekly subcutaneous dosing as well as Q8 weekly subcutaneous doses, so we can cover the entire patient spectrum on the disease. So a really exciting program. We're looking forward to making more progress.

Your next question comes from the line of Mark Li with UBS.

Congratulations on the approval. We had 1 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. So how are you thinking about where the perhaps low-hanging fruitage 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. So that's just thinking about the opportunity in the first year. And 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 a reimbursement of time that's not going to happen in the third quarter?

Yes, happy to answer both those questions. So on the patient population active chronic -- our strategy at launch with Lumvoa is conversion of existing TEPEZZA prescribers. So we're targeting, as mentioned, roughly 2,000 core prescribers that make up over 80% of current TEPEZZA use. Most of TEPEZZA used today is inactive. 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 the data coming from the THRIVE-2 data set, where we saw really nice responses in both proptosis in [indiscernible] but in particular, an unmet 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. So to answer it quick shortly, we would assume most of the penetration will be into active as is similar with the class in the market today. But 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 to start. Yes, look, so as mentioned, Viridian Cares is open. We're accepting patient enrollment forms. And every patient that comes in, we'll get a poll assign the patient access liaison to try to navigate through that system. So 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. So one, we don't expect much stocking in this market is just in time inventory. We'll have some modest stocking with the distributors, but really not much to speak of at the infusion centers to order that on a kind of 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. And the last PC and coverage where we don't anticipate 85% coverage at launch. We'll have some coverage at launch. We'll start to pick up some of those plans, but that will play out over time. So 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 -- but certainly, as we end the year, we would expect that run rate to increase and result in meaningful revenue as we turn into '27.

Your next question comes from the line of Joseph Thome of TD Cowen.

Congratulations on the approval. Maybe the first one, when you think about those 2,000 core prescribers based on your field work 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 -- and then second, do you expect that Amgen would do any sort of increased discounting with TEPEZZA now that there is another entrant in the market, maybe why or why not? And how best can the company manage that.

Yes. Great question. So 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. But 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. So -- 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. So introducing new economics to physicians to incent prescribing behavior is not in play either. So we're fairly confident that there will not be a pricing response by Amgen. We're ready for any scenario then. I'll just throw that out there. We planned this all out with multiple different scenarios. -- and potential actions by Amgen. If that were to happen, of course, would 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. I mean, this is, as we said, a very tight 20-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. Really, it has more to do with patients density. So 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 keep patients on a more frequent basis.

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

Congrats on the early approval here, and -- now that you have both active and tonic had 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? And then I have a follow-up.

Yes. Great question. So just to restate, payer coverage today for the idea upon our classes, it's pretty broad. Over 85% of plans have policies in place for both active and chronic, certainly won't hurt those conversations. 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. And that's around more than just the chronic data. We think there's 3 primary attributes that makes Lumvoa a very compelling and competitive profile. Dosing is an obvious one, 5 infusions over 12 weeks, lasting just 30 to 45 minutes each infusion. As a reminder, TEPEZZA, a full course of therapy is 8 infusions lasting 21 weeks in each infusion lasting 60 to 90 minutes. So clearly, differences there in both the duration frequency and total time on therapy, and we think that's important. It's actually 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. So we do think that those timing differences matter. Second, is the speed of Lumvoa. So we saw statistically significant responses in proptosis and as well as 3 weeks after just 1 dose of Lumvoa. And third, as you point out, very strong chronic data, namely in diplopia, which is a little bit -- was a little bit unexpected to be quite honest with you, where we thought aplopia resolution and response in those chronic patients regardless of CAS 037. So those 3 things, dosing, speed of onset chronic data, diplopia particular chronic data, which is in the label that launch, we think those 3 things are what make Lumvoa, a very compelling option for patients. And we believe, again, because of the dynamics of this market being a new start, every time a patient goes in and start therapy with a physician, there's a fair shot, whether that's going to be TEPEZZA, and we believe that Lumvoa has a very good shot of being selective there. Also mentioning that those 3 attributes that we are very confident in and very excited about. We're 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. So yes, everything is 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. And 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 [indiscernible] do you think are particularly comparable across those metrics?

Yes. So we want to reach those core prescribers as fast as many possible. I know it's going to quantify a 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 6 to 9 month mark. That's more a reflection of payer process. We'll push Tempo on that. We're off to a really good kind of fast start based on the preapproval information exchange conversations that the team was really busy executing against in the spring time frame. So no specifics on quantifiable measures other than the 6 to 9 months to hit critical mass. The rest of these things we're trying to do as fast as even be possible.

Your next question comes from the line of Alex Thompson with Stiefel.

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? And then maybe as a follow-up as well, could you talk about how revenue recognition will work to Viridian in this context.

Yes, yes, of course. So maybe I'll take the last one first. So revenue recognition. So revenue will be recognized as it is received by the distributors. So again, as mentioned before, we don't anticipate much of any stocking, maybe some modest stocking early days, but revenue we recognized once it's received. Early days, so I think there was a question there about medical exception. So as you mentioned, medical exception will be something that will be leveraged in the early days as payer coverage is building. Again, we estimate 6 to 9 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 Viridian Cares really helps us in the early days of launch, regardless of the policy in place or not, will be assigned to every patient that's enrolled in the Viridian Cares program. and work with insurance companies through that medical exception process. For those not familiar, if there is any policy in place, a lot of times, payers will push the approval to a medical exception process. What that means is an extra call of the office, potentially some extra paperwork -- and 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. So we would expect that to be taking place in the next -- 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 -- we have until July 1, 11:59 PM, I believe. So it's again 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.

Just wanted to clarify, we were reviewing the label for TEPEZZA. It looks like the Section 14 clinical trial section doesn't actually include the chronic TED data just wanted to confirm, is that your guys has rated the label difference as well? And do you think there will be a meaningful advantage in the eyes of physicians?

Yes. This is Radhika. Thanks for the question. Yes, the deposit label doesn't include the chronic 4 study. It includes a Phase II study and in their Phase III study. We do believe that is definitely a point of cation, as we pointed out earlier on the call, because being able to provide that information ultimately to physicians give them a really good clarity across the full broader TED spectrum basically from the moment that we're out in the field.

Next question comes from the line of Rami Katkhuda with LifeSci Capital.

I wanted to share my congrats on the approval as well. I mean, 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 teb population? And then maybe secondly, given the label and more convenient profile, do you see an opportunity to expand the TED market with Valley? Or is the focus primarily on converting the current opportunity?

Yes. Great questions. I'll take -- again, take the second 1 first. So I 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. And as discussed, most of the use today is occurring inactive. So we estimate over 80% of current as used to be enacted. So again, we believe that most of the use for Lumvoa early days will be enacted as well. However, we know from market research that roughly 30% of patients decline therapy when offered. And 1 of the top reasons that we hear them say in research is just the burden of therapy. And for a 40- to 50-year-old working age female, signing up for 8 infusions lasting 60 to 90 minutes each time and total course of therapy over 21 weeks is a lot and too much for some patients. We believe that some of those patients that know to that may say, yes, to Lymboa with 5 infusions lasting 30 to 45 minutes each and completion of therapy at 12 weeks. That's why we're so bullish on that difference and 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. So I 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. So Endo is that right, we will target, right? We're targeting anybody that writes the TEPEZZA because we're looking to convert them. And 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 Eli 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 and as we lose 3 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.

Your next question comes from the line of Lisa Walter with RBC Capital Markets.

Congratulations on the approval. Just maybe throughout your preapproval information meetings, just curious what aspects of Lumvoa payers find meaningful differentiator versus [indiscernible] -- and were there any discussions of becoming the preferred option on formulary? Any color here would be helpful.

Great questions. So 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 are working with. There's a lot of product spending 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. So preferring one versus the other, while that's not a strategy of ours anyway, it was not something that we discussed. But 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 6 to 9 months to critical mass.

The next question comes from the line of Rich Law with Goldman Sachs.

Congrats on the early approval. How many chronic patients who have higher degree of symptom severity do you believe could benefit from treatment are not picking TEPEZZA?And is there anything you can do to promote Lumvoa in those patients that Amgen is not doing or able to do since chronic data is not in that label? And then I have a follow-up.

Yes, great question. I think the nature of this market is -- those 2,000 core prescribers, while most of their prescribing is happening and roughly over 80%, we believe, in the active population, they are seeing chronic patients. And 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. So 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. So no -- 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 -- we like their advertisements to help kind of grow this market and develop it. But now, we'll be crystal -- 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.

And then just a follow-up. So looking at the label, IPD was licit in the warning and precautions although we haven't you guys or heard you guys talk about it. Was that just a class effect from TEPEZZA since it was mentioned in the trial -- in this trial and the post-approval use. Is there any way to differentiate here as well?

Yes. Thanks for the question. That's correct. The IBD section in the warnings precaution is basically a class morning given the experience that it's been seen with regards to TEPEZZA. So 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 follow the label to a T.

The next question comes from the line of Douglas Tsao with HC Wainwright.

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 sort of not having a J code for the first few months will impact the launch? And I'm just curious also as a follow-up in terms of sort of ramping up while you're getting coverage put in place. It does sound like your preapproval 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 that since your process might take a few more weeks?

Yes, both great questions. So 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 Markets Day and how it's constructed, most of these patients -- the vast majority are receiving their treatment, not in the physician office, but in infusion centers. And infuse centers are -- they're used to dealing with temporary J codes. That said, yes, 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. So we'll work through that in the first couple of quarters, but this is nothing different from any other launch in any other [indiscernible] 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. So we have a full -- yes, sorry, we have a full complement of patient services. We're doing white lump with Viridian cares. There are multiple programs in place for coinsurance for co-pay assistance and for urgent starts. So for those patients that are site threatened, there's a mechanism for them to get rapid access rather than wait.

Your next question comes from the line of Derek Archila with Wells Fargo.

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 kind of give us some thoughts or analogues there on how you think about that? And also for IV, some of the feedback that we got is preference for treating active patients with IV versus subcu in the future? Maybe any comments that you could provide.

Yes, good question. So first question on time to peak. So we believe it will 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. So 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 buying bills. So we do anticipate that we'll be able to get to the 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, it 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. So a patient starts tomorrow and get an infusion every 3 weeks, that infusion center would typically be ordering the product prior to each of those infusions, right? So not all at once. So just a clarifying statement there. There was also a question of active versus chronic with I think 1 of the things that we're most excited about is the strength of the Lemvoa label, and we believe that, that's going to be a compelling choice for physicians and patients today as you fast forward to adding Eli, 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 in Eli, which is safely and simply delivering IDF-1R to a patient's home and as little as 3 doses. -- in an easy-to-use auto-injector that can be self-administered in under 10 seconds. You have those 2 compelling profiles to offer a physician and a patient with TED it's tough to see a patient that Brian doesn't have an answer for. So 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.

Congrats on the approval. I guess for Tony, can you just talk about maybe the 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? And then I have a follow-up.

Can you -- sorry, can you repeat that question? I wasn't sure what you were saying at the midst front of that question?

Yes, no problem. The first one was kind of the level of awareness among the initial prescriber base that you'll be targeting? And then 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? So 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, full team has been out there for a number of years, sharing the data, talking to KOLs, but also high prescribers in the space investigators, which we have several of the larger, more prominent KOLs in the TED marketplace were also investigators for the Viridian trial. So again, it's a small group. They talk a lot, roughly 2,000 of them. They talk a lot to each other as well. And we've engaged with a high number of them to date and awareness is really high. So 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. And we think that what that looks like when we talk to physicians, they tell us, -- if the 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 to conclude that Lumvoa profile, it makes a whole lot of sense given the alternatives.

And then -- how should we think about retreatments beyond the initial 5 injection or 8 injection treatment courses? I know it's not on label for either Lumvoa or TEPEZZA, but how common is it? And is it covered by insurance provider.

Yes, it's a great question. So how common is it we estimate from claims that roughly 5% to 6% annually of patients that are on TEPEZZA. It's their second course of therapy. So it is happening out there. How it happens, it was related to a question that was asked earlier around the medical exception process. So almost every plant, I think there's a couple out there that may have a policy in place. Their policy for IGF-1R is 1 per lifetime. That's from a policy perspective. However, if the patient responded well the first time in a position is motivated to try to go through that exception process. There are avenues to get second multiple courses approved. Not on label for Dement 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.

Next question comes from the line of Lachlan Hanbury Brown with William Blair.

I'll add my congratulations. Maybe Tony, following up on that one. Just -- so is it fair to assume that you've the sales team at this point has basically made 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 have it 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 is it -- should we be assuming that's not really the dynamics as they have TEPEZZA available.

Yes. Great questions. So over 90% of them, we've already had conversations with Reach visited in the profiling portion of this. So again, we're hitting the ground running with some costs 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, which depends on widely available and widely approved. It doesn't mean it won't happen, but it's not something that I would expect to be of any significance.

And we will take the final question from Andy Chan with Wolf Research.

This is Brendan on for Andy. And -- we're curious to know, how would you benchmark yourselves against the first few quarters of the TEPEZZA? assuming obviously no bolus, do you think you would do 1/4 of TEPEZZA enrollment, half of it? What do you think is reasonable from your end?

It's a great question. And Horizon did a fantastic job launching TEPEZZA. A little bit different of a circumstance, right? You go back in time to when TEPEZZA was launching, when Horizon launched that product and basically, these patients had surgery or steroids. So no real -- obviously, no approved IGF-1R, certainly not a lot of options. So I would not draw any conclusions on our projected first couple of 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 prescribing most of the dates today. But the receptivity to trying something new. And we think Lumvoa is a nice really good new choice for them that we know from market research, they're excited to try. So we're very excited about the next few quarters.

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. And 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. and we're excited about the position we're in and the opportunity ahead of us. So we're looking forward to getting out there and helping as many tad patients as we can. So 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.