Good afternoon. Welcome to the Vera Therapeutics Investor Call and Webcast. At this time, all attendees are in a listen-only mode. A question and answer session will follow the formal presentation. Due to time constraints, we kindly ask that our analysts who have joined to ask a live question to limit themselves to one question each. As a reminder, this call is being recorded. A replay will be made available on the Vera website following the conclusion of the event. I'd now like to turn the call over to Sean Grant, Chief Financial Officer at Vera Therapeutics. Please go ahead, Sean. Good afternoon, everyone. Thank you for joining us. Earlier today, Vera Therapeutics announced that the U.S. Food and Drug Administration has granted accelerated approval to TRUTAKNA for adults with IgA nephropathy. A copy of the press release we'll reference today is available in the Investor and Media Relations section of our website. Before we begin, I'd like to remind you all that today's call contains forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements contain comments about TRUTAKNA's clinical profile, our expected commercial launch, our confirmatory trial, expected data in our pipeline. These statements are subject to risks and uncertainties and are not guarantees of future performance and represent only our views as of today. We specifically disclaim any obligation to update them. With that, it's my pleasure to turn the call over to our Founder and Chief Executive Officer, Dr. Marshall Fordyce. Marshall? Thank you, Sean. Good afternoon, everyone. Earlier today, the FDA granted accelerated approval to TRUTAKNA, atacicept-vymj, the first and only BAFF and APRIL inhibitor indicated to reduce proteinuria in adult patients with primary IgA nephropathy at risk for disease progression. For the patients we serve, for the nephrology community, for everyone at Vera, this is a significant milestone. First, we're extremely grateful to the patients and families who trusted us by joining the ORIGIN program, to the investigators and study teams who held the highest standards of clinical science, to the FDA for its rigorous and timely review, to the IgAN Foundation and the broader patient community who have worked alongside us for years. Thank you. This approval is yours as much as it is ours. IgA nephropathy is a B-cell-mediated disorder with kidney pathology. B cells are activated by two cytokines, BAFF and APRIL, that fuel the production of the antigen and autoantibodies that lead to the formation of immune complexes that subsequently damage the kidney. Until now, we have lacked a therapy that can comprehensively address the key upstream drivers of IgAN pathophysiology. TRUTAKNA does exactly that. It targets both BAFF and APRIL. This is why we believe TRUTAKNA is positioned to become a transformational therapy in IgAN. With that, I want you to hear about the clinical experience from our Chief Medical Officer and resident nephrologist, Dr. Robert Brenner. Rob? Thank you, Marshall. It's a pleasure to review the clinical data that supported the FDA approval of TRUTAKNA, a therapy for IgA nephropathy with disease-modifying potential. As Marshall mentioned, IgA nephropathy is a B-cell-mediated disease that leads to progressive and irreversible kidney damage. Two cytokines, BAFF and APRIL, play a central role in activating B cells, which then produce the antigens and antibodies that ultimately form the pathogenic immune complexes responsible for kidney injury. TRUTAKNA was rationally designed as a native human TACI-Fc fusion protein. By comprehensively inhibiting both BAFF and APRIL, TRUTAKNA targets the underlying immune drivers of IgA nephropathy. This approach reduces the formation of pathogenic IgA-containing immune complexes and addresses the disease process at its source with disease-modifying potential. The ORIGIN 3 trial is an ongoing global, multi-center, randomized, double-blind, placebo-controlled Phase III trial in adult patients with IgA nephropathy. Participants were randomized one to one to receive either TRUTAKNA or placebo. The primary endpoint of the pre-specified 36-week interim analysis evaluated the change in 24-hour urine protein-to-creatinine ratio compared with placebo in the first 203 participants who received at least one dose of study drug. At 36 weeks, patients treated with TRUTAKNA achieved a 46% reduction in UPCR from baseline and demonstrated a statistically significant and clinically meaningful 42% reduction compared with placebo. The reduction in proteinuria consistently favored TRUTAKNA across all pre-specified subgroups, including age, sex, race, geographic region, baseline proteinuria, baseline GFR, and baseline use concomitant SGLT2 inhibitors. TRUTAKNA-treated patients also showed meaningful improvements in other key markers of IgA nephropathy disease activity. These included a 68% reduction in galactose-deficient IgA1 and resolution of hematuria in 81% of patients who had hematuria at baseline. TRUTAKNA was generally well-tolerated. The most common adverse events were infections occurring in 32% of TRUTAKNA-treated patients, compared with 28% in the placebo group, and injection site reactions occurring in 30% versus 5%, respectively. Most adverse events in the TRUTAKNA group were mild to moderate in severity and resolved without requiring treatment interruption or discontinuation. Notably, there were no serious, severe, or opportunistic infections observed in TRUTAKNA-treated patients, and no cases of hypogammaglobulinemia were reported. In addition, anti-drug antibodies had no clinically meaningful impact on the pharmacokinetics, pharmacodynamics, safety, or efficacy of TRUTAKNA over the 36-week treatment period. Taken together, these results demonstrate the potential of TRUTAKNA to address the underlying biology of IgA nephropathy while delivering clinically meaningful improvements in key disease measures with a favorable tolerability profile. These findings were summarized and published in The New England Journal of Medicine in November of 2025. Now the full prescribing information for TRUTAKNA, including important safety information, is available online at trutaknahcp.com. With that, let me hand over to Matt Skelton, our Chief Commercial Officer, to cover the commercial opportunity. Matt? Thanks, Rob, and good afternoon. We are thrilled to bring TRUTAKNA to the IgAN community. We believe TRUTAKNA is a highly desirable treatment for IgAN patients. In addition to what Rob said about the clinical profile, TRUTAKNA is delivered through a small 1 ml once-weekly auto-injector, self-administered at home. There are approximately 160,000 IgAN patients in the U.S. who are diagnosed with IgAN, and that number is likely to grow as awareness and diagnosis improve. Importantly, because these are young patients, this is roughly a 75% commercially insured population, a favorable payer mix relative to most markets. We are targeting about 6,000 nephrologists, the prescribers who care for the great majority of these patients. Our team has decades of experience commercializing innovative therapies. Our leadership has successfully launched multiple blockbusters and renal therapies. Our field force of 82 representatives is fully hired, trained, and in territory. They've spent the last few months on disease state education and account relationships. They are ready to promote TRUTAKNA today. The demand signal is strong. In independent market research, nephrologists ranked TRUTAKNA as the most desired IgAN agent in the development pipeline. We've also watched the first wave of B-cell modulators validate this category ahead of us. As a fast follower entering with a differentiated profile and the ease of an auto-injector, the momentum works in our favor. We have been thoughtful about access to TRUTAKNA. The value of TRUTAKNA reflects its ability to address the significant unmet need that continues to exist for patients living with IgAN and the innovation demonstrated in the extensive ORIGIN clinical program. To start, we expect most IgAN patients are commercially insured. Eligible commercially insured patients may pay as little as zero dollars out of pocket through our TRUTAKNA TRU SUPPORT copay assist program, our support program for patients who are prescribed TRUTAKNA. It is designed to assist healthcare providers and patients navigate the fulfillment process. TRU SUPPORT offers insurance coverage information, financial assistance options for eligible patients, and educational resources designed to facilitate a seamless treatment experience. Dedicated team members are available to provide ongoing assistance and access support every step of the way. TRUTAKNA's wholesale acquisition cost on a per carton basis, where each carton represents four doses or a 28-day supply, is $32,700. This annualizes to $425,000 per year. We've conducted extensive pre-approval engagements across the major payers to support broad and timely access at launch. Our objective is to ensure that all eligible patients have access to TRUTAKNA and that we have the appropriate programs in place to support that goal. It is a privilege to be able to deliver a breakthrough therapy like TRUTAKNA to patients living with IgAN. With that, let me hand it back to Marshall. Thank you, Matt. We come to this launch from a position of strength. We've assembled a commercial team with a proven track record of successful product launches. Vera is in a strong financial position with approximately $597 million in cash and marketable securities at the end of Q1, with access to an additional $425 million through our Oxford facility. Our commercial organization is built, trained, and ready. We led the way in the clinical development of an IgAN therapy, and today, we build on that leadership position as we launch TRUTAKNA. Our confirmatory ORIGIN 3 endpoint Estimated glomerular filtration rate, or eGFR, is expected in the third quarter of this year, potentially supporting our path to full approval. That is the kidney function data we believe will further distinguish TRUTAKNA. With that, operator, let's open the line for questions. Great. Thank you, Marshall. At this time, we'll be conducting a question and answer session with our speakers. To our analysts that are joining us live, just a friendly reminder that we kindly ask you to limit your questions to one. Our first question comes from Anupam Rama at JPMorgan. Please go ahead, Anupam. Anupam, you might be on mute. Oh, sorry. Hey, guys. Thanks so much for taking the question, and a big congrats on the approval. Just a quick question from me. When I look at the label for TRUTAKNA relative to, say, semaglutide, one thing that sticks out for TRUTAKNA is that you guys don't have any neutralizing antibodies noted in the label. Just wondering if and how you might be able to lean into this commercially or not. Thanks so much. Thank you for the question, Anupam. I'll have Matt Skelton, Chief Commercial Officer, answer that. Hi, Anupam. Yeah, thanks for the question. Hey, I think it's a differentiating factor for us. In addition to the clean label we received, we feel really good about the profile we have. We think we're differentiated on an efficacy and a safety standpoint. Our small volume auto-injector, all of these things are going to lead to us being competitive in the marketplace. Thanks so much for taking our question. Great. Thanks for the question, Anupam. Our next question comes from Gavin Clark-Gartner at Evercore. Please go ahead, Gavin. Hey, guys. Congrats on the approval. Nice to see. Maybe you could just lay out the launch metrics that you're presenting to or planning to report from the get-go. Yeah, thanks for the question, Gavin. Matt? Yeah, happy to take that. Hi, Gavin. I think the main one we're going to be looking at in the early days are patient start forms. That I think is going to be the indicator of demand. We're going to work hard to make sure that we have a high percentage of pull-through of those patient start forms. That's going to be our main metric and what we'll look at in the early days. Not to get too tactical here, are you planning to present some of those metrics on the August earnings, or maybe wait more towards Q3 in November? Happy to just say Q3, Gavin. All right. That's really helpful. Thanks, guys. Thanks, Gavin. Our next question comes from Ritu Baral at Cowen. Please go ahead, Ritu. Ritu, you might be on mute. I am on mute. Sorry about that. Good afternoon, guys. Thank you for taking the question, and congratulations. Also looking at your label, which is delightfully broad, how are you going to target the appropriate patient or the most amenable patient, I guess, to TRUTAKNA, as we think about that 160,000 diagnosed versus the 82 reps. Does the commercial messaging, I guess, wrap around a type of patient, a certain proteinuria level? Are you going by phase III entry criteria, Matt? How should we think about who you're targeting first out of the gates? As you think about that 160,000 diagnosis rate in the U.S., one of our KOLs recently said, at least in the U.K., the diagnosis rate for IgAN was like 10% or 15%. Do you anticipate that this number is already growing? Have you seen that? Matt, happy to have you take that question. Yeah, happy to take that. As far as the number growing, I think, usually you see in markets when better treatments become available, markets tend to grow. We are hoping that's the case, and I've heard that from the key opinion community as well. As far as a type of patient we're looking for, we look at the broader market, there's tens of thousands of patients on supportive care therapy that can use a disease-modifying agent like TRUTAKNA. We want to meet nephrologists where they are. As you indicated, we're really pleased with the broad indication, and I think this gives us a lot of addressable patients to target right out of the gates. Great. Thanks for the question, Ritu. Our next question comes from Pete Stavropoulos at Cantor Fitzgerald. Please go ahead, Pete. Hi, guys. Our genuine congrats on the approval. It's great to see you bring this over the goal line. Thanks for taking our question. Can you just talk about the commercialization and sales team in place, their background and experience, and what gives you confidence that it's right-sized, and that they can enable a successful launch? Great, Matt? Hi, Pete. We feel great about the sales force that we were able to attract. Over 80% have nephrology experience, 90% have rare disease experience. This is a seasoned group of pros that we feel really good about and their ability to compete in the marketplace. Importantly, this is a lot of times a relationship business. They have the access with key nephrologists across the country. We've got the right people out there. As far as the number, we did a lot of work early on to figure out what the optimal number was for the opportunity, and we think we've landed on that. That was reflected in the recruiting process with the sales reps. These folks like large territories and opportunity, and we were able to attract them based on the number of reps we had. Did a lot of claims work for the opportunity. Again, I'm super confident in that number that we're starting out with it. We're not starting out with a toe in the water, Pete, and thinking that we're going to see how it goes and then add to it. This is the number we feel really good about. Great question, Pete, and I'll just add that Vera, at this stage, with this type of leadership and commercial preparation, has been built on years of preparation, from clinical to medical engagement, now to commercialization. The launch meeting that we've recently held was the most cohesive that many of us have ever seen in our career. It's not just the number that we're confident, and that's based on a very quantitative view of what the market looks like to us. We're not interested in adding additional numbers. This is the right number for our approach. Yeah. Also the quality of the individuals and leadership that we put in the field we're very pleased with. Yeah. This is a very good starting place. Yeah. Pete, as I had said in my remarks, they're out selling today, the sense of urgency is there, we're going to take advantage of the opportunity. All right. Great. Thanks for taking our questions, congrats once again. Thanks for the questions, Pete. Our next question comes from Paul Choi at Goldman Sachs. Please go ahead, Paul. Hi. Good afternoon, everyone. Let me add my congratulations as well, and thanks for taking our question. Just curious what your latest market survey work suggests on physician preference of targeting both or dual APRIL-BAFF targeting versus just APRIL. In terms of physicians prescribing TRUTAKNA or other B-cell modulators here, what is your sense as to how many physicians are just sort of waiting for final eGFR results before starting to write a script which could really unlock the opportunity here? Great. Good question, Paul. I'm going to have Rob Brenner, our CMO, answer that. Thanks, Marshall. I think if we were to turn the clock back two years ago, I think there was a narrative that maybe blocking BAFF and APRIL might not be advantageous, the data may not be supportive. Now, as we look through with care at the accelerated approval label for atacicept, I think we can put that narrative into kind of historical bed. The profile of atacicept, now approved of TRUTAKNA, is precisely what I think the medical community has been looking for as a treatment option for patients with IgA nephropathy at risk for disease progression. As we see it, the feedback we've received has been consistently favorable for an inhibitor that is designed to reduce both BAFF and APRIL, and in many ways, this represents an unprecedented opportunity for the prescription for patients with this disease. Great. Thank you. Great. Thank you for the questions, Paul Choi. Our next question comes from Vamil Divan at Guggenheim. Please go ahead. Great. Thanks for taking my questions. Congratulations as well on the news. I have two follow-up questions I could on questions that were previously asked, or comments from before. You mentioned, I think, in your market research that the physicians you've spoken to see atacicept as the most desired product. I'm curious if maybe you can share a little bit more on what specifically it is about that we get a lot of questions from investors on how this will be differentiated from products on the market, products coming. Is there one or two or three sort of metrics that really stand out most in that market research with the doctors? My second question was just more, again, another question we get from investors a lot is around, obviously, a great label you have here, nice broad label. Any updates you can provide on extension strategies around the monthly dosing, which you've talked about before? I don't know if there's any updates you can provide at this time on that. Thank you. Matt, you want to answer. I'm happy to take that. Regarding the market research, what I had referred to in my comments up front was from a third-party source, Spherix data. That was not our own market research that had said that. Details of that I don't have, but that, again, I think adds to the validity of it, that it was from a third party. I've also spoken to, I think, the profile and the differentiation. We think we have robust efficacy and safety profile, a very patient-friendly offered in a once-weekly auto-injector and small volume. All of that packages into a real nice opportunity and something that we think is differentiated in the marketplace. Vamil, good question. We do have additional studies ongoing. There haven't been significant updates that we're sharing today. There's good progress that we're excited about across the full program. Today, we'll focus on the TRUTAKNA launch. Thank you very much. Thanks. Congrats. Thanks for the questions, Vamil. Our next question comes from Rami Katkhuda at LifeSci Capital. Please go ahead, Rami. Hey, guys. Wanted to pass along my congratulations as well. Thank you for taking my questions. I guess, how long do you expect it will take to get TRUTAKNA broadly available in channel? Are there any remaining gating factors? More broadly, do you expect there to be a bolus of patients ready for treatment, or how should we be thinking about the sales ramp for your new product here? Yeah. Matt? Yeah. Hi, Rami. We expect to have drug in channel in three to four weeks. As a company and getting its first product on the market, there are some things we had to wait for the approval. That was a little limiting factor but three to four weeks we are confident in. Hey, as far as a bolus of patients ready to go, that's not our expectation. We don't think we saw that with the first B-cell modulator on the market. I would hope for a nice, steady demand curve. Great. Thanks for the questions, Rami. Our next question comes from Farzin Haque at Jefferies. Please go ahead, Farzin. Congrats on the approval, and thank you for taking my question as well. What are some of the learnings from Otsuka's launch that you can leverage for payer discussions and market uptake? Also interested in what will be your messaging to the payers for formulary positioning with the higher pricing in place? Yeah, Matt? Yeah. We have our own plans and strategy in place that we're going to go after the market. I think what is encouraging from us from the Otsuka experience is that there's been good uptake, and I think, they have set the table well for another B-cell modulator, and one that I think is differentiated. That's helpful for us and I think creates a nice opportunity for us to hit the market running. I know you had a second part of that question. Yeah, basically formulary positioning with the higher pricing. We've done a lot of homework with the payers, a lot of pre-approval information exchanges. We feel good about the price we're entering the market in, and, yeah, I wouldn't necessarily call that a premium. Got it. Thank you so much. Thank you, Farzin. Our next question comes from Ryan Deschner at Raymond James. Please go ahead, Ryan. Thanks. A big congratulations on the approval here. My question is, do you have any additional resolution on the timeline for submission of full approval later this quarter, or on the initial PIONEER readout in IgAN patients? Thanks. Ryan, thanks for the question. I'll have Rob answer that one. Yeah, I don't think any change. We've shared that we have pulled forward the time of the final analysis of ORIGIN3 to Q3 of this year. We are on track to read out, still in accordance with that timeline, and that sets us up for potential filing for full approval in Q4. People are hard at work at those activities, in parallel with us celebrating this launch and making success. PIONEER, we had initial disclosure of data at the past European Renal Association meeting. I think you'd expect that we'll have more to say in terms of data release at ASN this year. Okay, thank you. Thanks for the question, Ryan. Our next question comes from Sadia Rahman at Wells Fargo. Please go ahead, Sadia. Hi. Thanks for taking the question, and congrats on the approval. I wanted to get your expectations for the cadence of PSFs here. Should we expect something similar to what Otsuka has been reporting with its launch in IgAN? Do you think, with Otsuka already having an established nephrology presence in the U.S., marketing another drug, did that help their launch and could it take more time to see that kind of traction with TRUTAKNA? Thanks. Okay. Matt? I said earlier, I think that they've set the table for us, and we have seen that B-cell modulators are being accepted in the nephrology community, but at this time, we're not really giving guidance on how we think those PSFs will ramp up. I think it'd be premature to do that. Okay. Got it. Thank you. Thank you, Sadia. Our next question comes from Arthur He at H.C. Wainwright. Please go ahead, Arthur. Hey, good afternoon, guys. I just want to congratulations again. Two question, one for Rob's. Do you guys have any follow-up data on the ADA incidents after 36 weeks? For Matt, what's a reasonable gross net we could assuming for the early launch trajectory? Thank you. Great. Rob? Yeah. The information that's included in the prescribing information on ADAs reflects all of the data points that were available at the time of the interim look. It reflects more than just a 36-week exposure. I think it's important that this is the first B-cell modulator that has no evidence of any drug antibodies having an impact on pharmacokinetics, pharmacodynamics, efficacy, or safety. That I think is great for patients, and certainly when we do the final analysis for safety and efficacy and file for full approval, that will have additional information that we'll be able to share in the updated prescribing information. Great. Matt? Yeah. On gross to net, that's something we haven't given guidance on. It's something we are certainly going to keep our eyes on and try to protect as high a percentage as possible. We haven't really put that out there yet as far as expectations. Awesome. Thanks for taking my question. Yeah. Great. Thank you, Arthur. We have time for one more question. Dina Ramadane at Bank of America, please go ahead. Hi, good afternoon, and congrats on the approval. Thank you so much for taking our question. I just wanted to ask if you had any general thoughts on Voyxact's final eGFR results. I believe we saw them last week. Do you view it as kind of just a net positive tailwind for the class? Does it impact maybe how your sales reps will present TRUTAKNA's data package to physicians and ability to kind of highlight the long-term Phase II eGFR data? Thank you. Thanks for the question. Rob? Thanks, Dina. I do think our focus is to tell the comprehensive story about atacicept now aligned with the prescribing information. We did see that Otsuka put out written comments about their final results. We don't have any numbers, so I'm not really confident that I'm in a position to talk about what may or may not be those results until we see them, my guess is that won't happen until we get to ASN. In the meantime, we've got a great story to tell about TRUTAKNA, that's what we're going to do. I don't think any news that comes from Otsuka is going to change our focus and our confidence in how this launch is going to go. Got it. Thank you. Thank you for the question, Dina. This concludes today's question and answer session and investor webcast. We thank you for joining us, and you may now disconnect