Vera Therapeutics, Inc. (VERA) Earnings Call Transcript & Summary

Good afternoon, and welcome to the Vera Therapeutics Investor Call and Webcast. [Operator Instructions] As a reminder, this call is being recorded, and 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, and 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 Act of 1995. These statements contain comments about TRUTAKNA's clinical profile, our expected commercial launch, our confirmatory trial and expected data and 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, and 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, and 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 and 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 and 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 2 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 iga. 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. 2 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 tachy 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 multicenter, 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 prespecified 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 1 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 prespecified 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 at 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, antidrug 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. And now the full prescribing information for TRUTAKNA, including important safety information, is available online at www.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 United States who are diagnosed with IgAN, and that number is likely to grow as awareness and diagnosis improves. 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 and 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 a 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 $0 out-of-pocket through our TRUTAKNA TruSupport co-pay assist program, our support program for patients who are prescribed TRUTAKNA. It is designed to assist health care providers that patients navigate the fulfillment process. TrueSupport 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 4 doses or a 28-day supply is $32,700. This annualizes to $425,000 per year. We've conducted extensive preapproval 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 glomera 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.

[Operator Instructions] So our first question comes from Anupam Rama at JPMorgan.

A big congrats on the approval. Just a quick question for me. When I look at the label for TRUTAKNA relative to, say, semiperlimab, 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?

Thank you for the question. Anupam, I'll have, Matt Skelton, our Chief Commercial Officer, answer that.

Anupam, yes, thanks for the question. 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.

Our next question comes from Gavin Clarke-Gartner at Evercore.

Congrats on the approval. Nice to see. Maybe you could just lay out the launch metrics that you're presenting to -- are planning to report from the getgo.

Yes. Thanks for the question, Gavin. Matt?

Yes, happy to take that, 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, and we're going to work hard to make sure that we have a high percentage of pull-through of those patient start forms, but that's going to be our main metric and what we'll look at in the early days.

And not to get too tactical here, but are you planning to present some of those metrics on the August earnings or maybe wait more towards Q3 and November?

I'm happy to just say Q3, Gavin.

Our next question comes from Ritu Baral at Cowen.

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 sort of Phase III entry criteria, Matt, how should we think about who you're targeting first out of the gates? And then as you think about that 130 -- I'm sorry, 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 help me take that question.

Yes, 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. So we are hoping that's the case. And I've heard that from the key opinion community as well. But 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. So 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.

Our next question comes from Pete Stavropoulos at Cantor Fitzgerald.

Our genuine congrats on the approval. It's great to see you bring this over the goal line. Can you just talk about the commercialization and sales team in place, sort of their background and experience? And what gives you confidence that it's rightsized and that they can enable a successful launch?

Matt?

Yes. Pete, yes, we feel great about the 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. And importantly, this is a lot of times a relationship business. They have the access with key nephrologists across the country. So 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. So 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.

Yes. Great question, Pete, and I'll just add that Vera, at this stage, with this type of leadership in 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. And 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. So we're not interested in adding additional numbers. This is the right number for our approach and also the quality of the individuals and leadership that we put in the field, we're very pleased with. So this is a very good starting place.

Yes. And Peter, as I had said in my remarks, they're out selling today. So the sense of urgency is there, and we're going to take advantage of the opportunity.

Our next question comes from Paul Choi at Goldman Sachs.

Let me add my congratulations as well. Just curious what your latest market survey work suggests on physician preference of targeting both -- or dual APRIL/BAFF targeting versus just APRIL? And 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 sort of 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 would turn the clock back 2 years ago, I think there was a narrative that maybe blocking BAFF and APRIL might not be advantageous, the data may not be supportive. And 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 bet. The profile of atacicept now approved 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. So 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, it represents an unprecedented opportunity for the prescription for patients with this disease.

Our next question comes from Vamil Divan at Guggenheim.

Congratulations as well on the news. So I have 2 follow-up questions, if I could, on questions that were previously asked or comments from before. So 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 sort of how this will be differentiated from products on the market, products coming? Is there 1 or 2 or 3 user metrics that really stand out most in that market research from with the doctors? And then my second question was just more -- again, another question we get from investors a lot is around obviously, great label you have your broad label. Any updates you can provide on extension strategies around the monthly dosing, which you've talked about before? I don't know, is there any update you can provide at this time on that?