Vera Therapeutics, Inc. (VERA) November 10, 2026 Conference Transcript

Okay, I think we're ready to get started here. Thanks again, everyone, for joining us at this year's Guggenheim Healthcare Innovation Conference. I'm Vommel Devon, one of the biopharm analysts here at Guggenheim. Next up in this room, very pleased to have the VR Therapeutics team join us. Next to me, we have Marshall Fordyce, who's the CEO of the company, Rob Brenner next to him, the CMO, and Matt Skelton, CCO, at the end of the line here. Thanks so much again for joining us. Obviously, a very ventful 12 months you guys have had since our conference last year, getting to talk on the market. Obviously, a lot of great data generation along the way. Maybe, Marshall, I'll just turn to you if you want to share the highlights that you guys reported last Thursday, just the highlights and what you're highlighting from the first or partial quarter on the market for Tutankhamen.

Great. Well, thanks so much, Vamo, for hosting us here. And last night for dinner, we've had a great day with investors and hope to share our enthusiasm for bringing Trutacna to patients and appreciate how many patients out there could benefit from it, how strong the launch looks in these early days. And you said Matt's at the end of the line. He's at the front line. He's not a chief commercial officer. So really eventful year for us, and I want to provide a few highlights and happy to go right into Q&A. We at Vera are now at an inflection point with our first approved drug, and we just reported Q3 earnings last week, giving an indication of the strength of the Trutacna launch in IgE nephropathy in the United States. That's the beginning of our beachhead as a commercial entity. We reported 700 patient start forms, so an indicator of demand. And that stacks up very well in terms of any renal launch and happy to share kind of how that looks. We see Trutacna as a new foundational therapy for patients with IGAN. We think as a class, the B-cell modulator class is likely to become the new standard of care over time. We got to witness that at the ASN meeting just a few weeks ago in Denver. That's the American Society of Nephrology, the major kidney conference every year, and we were able to have a presence at the opening plenary session with the presentation of our final phase three efficacy analysis that was then published in the New England Journal of Medicine. We were accompanied by the cibaprenlimab phase 3 data, which was in a similar ballpark, and I think most nephrologists got the sense that, you know, the B cell modulator class is changing the landscape in the future for these patients. So launch looks strong in the early days. This category looks very large. I think by most estimates, from a financial point of view, the opportunity for the B-cell modulator class in the United States and IGAN alone looks to be closer to $20 billion as opposed to $10 billion. We and Cibaprenlimab are the only current drugs on the market. We expect a third by the end of the year. So three players in a $10 to $20 billion market is a fabulous opportunity for our business. Beyond that, we will be expanding into new geographic areas. We did share that we have aligned with European regulators with our current data set in IGET, and we'll be filing in Europe in the first quarter of next year. We're making similar progress in Japan. And so the first bit of expansion that you'll see from us in the coming time will be geographic. Beyond that, there is indication expansion, and we showed for the first time a tachycept data in patients with membranous nephropathy, which is another autoantibody-driven glomerular disease. And we showed reduction in the autoantibody PLA2R. We showed a reduction in proteinuria. And internally, we're setting ourselves up for the next trial in MN. Again, that's just kind of the beginning. Outside of nephrology, we see opportunity in rheumatology, neurology, and dermatology as well. So we hope this is just the beginning of what we see as an enormous opportunity for us to serve the patients we hope to serve.

Great. That was a great overview. Obviously, a lot going on there. So maybe we'll start with the news from last week and the sort of initial commercial uptake, and I'll turn to Matt for this to kind of get your perspectives. Obviously, 700 new patients starts approximately in the first 17 weeks, a great number. Maybe you can share a little bit more of sort of the sense that on the ground, sort of the dynamics as the salesperson is talking to doctors, the interest in how they're deciding to start this product.

Sure. Happy to provide a little more color there. Yeah. We're really pleased where we are and what we reported last week. Importantly, our reps are getting good access to the key prescribers. We're spending a lot of time with the higher decile physicians in the space. The message is being received very well. We're very confident in the product profile of True Tech now, and that's generating the demand we've seen so far with the 700-patient start forms. Hey, at this point in time, launch is going exceedingly well.

That's great. Maybe you could talk a little bit about sort of the breadth that you're seeing right now in terms of where you get, where the access is coming from, where the scripts are coming from, and then kind of your plans over the next few quarters to get deeper.

Sure, yeah, and I shared this on the call last week. We're getting a good mix from the community. We're getting a good mix from academic centers or thought leaders. We're largely drawing from the prevalent pool of patients. Think about it almost as that placebo arm of our trial. Those are the patients that are going on Trutacna, right? They've been diagnosed for a while. They're on the backbone of IgA or IGAN therapies. You know, ACEs, ARBs, SGLT2s. Some of them have maybe been through a round of Tarpeyo. Those are really good Trutacna patients. Their lab values aren't where the doc wants them to be. And, you know, with the strength of the Trutacna profile, that's an attractive patient for a nephrologist to put on Trutacna.

I would add that it's early days, right? So this is a really early time in a large market. When you do an apples-to-apples comparison of Trutacna and Sibaprenlimab at 17 weeks into the launch, we're at 700 patient start forms. They were at roughly 1,000. That's a fantastic kind of neck and neck. Both programs are growing. This really speaks to a large market. We track everything internally. We're watching and learning that market extremely closely. On the other hand, you know, the potential, we're still in the single digits in terms of the number of patients who could benefit from Trutacna. So a pattern we see now is likely to change in a quarter or two. We're just, and I think a really important data point is our sales force is rarely in a competitive sales position with another company. There's just so much opportunity, so many patients. So if you try to quantify that, you know, we are conservative in our estimate of the number of patients who could benefit in the U.S. It's about 160,000 Americans have biopsy-proven IGAN. That's likely to be a gross underestimate because diagnoses are, you know, that rate is relatively low. But with that as a beginning number, which patients are you worried about progressing? If you look at our own trials or the trials of others in the space, the average age is 40 years old, and the average GFR is 60. And if you follow them on placebo, they're on their way to dialysis by 50 years old. So within 10 years, you just have to look at the data. So the urgency to treat is very evident in the data that we've shown. We are actively out there making sure that we communicate about the urgency to treat the profile of True Tacna. That takes work. It's great that we're not alone, by the way. It's great that there's more than one voice creating that market. We see that really every day. And I think that's an important thing to appreciate, the size of the market, and we're just scratching the surface. And even then, you're looking at some trends showing the largest, most successful nephrology drug launches that we've ever seen, even just in the first few quarters. So I think that's the main message we want to convey.

Yeah, I completely agree with you. And I think it is just the beginning of this huge opportunity for you and a couple other companies. We still get the question from investors. I have to ask her, as you think about the competitive landscape here, again, Sibby on the market now, Povetak is maybe being approved later this month. How do you see the, again, In the context of it, you build this market and, you know, there's room for many, many winners. How do you see the differentiation points for True Tech now against the competitors?

Yeah, I would still say that the market is large and will accommodate three or more players. So with that said, we think we have the winning profile. A tachycept is really defined by efficacy, safety, and form factor, and then how we deliver and ensure access. Efficacy, an important thing to recognize is that you can't do better than stopping GFR decline. There won't be a drug that's going to recreate nephrons. So the data we've shown with GFR, which is physiologic, you know, normal GFR on drug versus on a placebo-controlled trial declined to dialysis. And then we actually showed an improvement in kidney endpoints. So no patients on Trutacna reached transplant dialysis or death versus seven on placebo. You don't even need statistics for that. So efficacy can't get better. Safety is really important. We have shown a placebo-like safety profile of atachyceps that's been studied in thousands of patients over many years of exposure. It's a weekly dose, so that dose interval is an advantage in case something happens along the way, which always happens out for patients and physicians. We think that's the winning profile. We don't think that all things are going to be equal across the board. As others come on, they have to match the efficacy profile, which isn't a given just because it's the same mechanism, doesn't mean it has the same characteristics as a molecule. It's really important to get. The therapeutic window, the Goldilocks. You want efficacy and you want safety. If it's overly potent and you create an infectious risk, you're not in the same league as Trutacna and Vera. And I think that's really important to keep in mind as others come to market.

Matt, anything you would add? I think that covers it quite well.

Okay, great. So I do have a few more questions I'd like to get to on the commercial side, but let me save them. I do want to talk about everything else you highlighted that you're working on. So you mentioned, I think another question we can get on is, so the administration is once weekly now, and you've talked about doing some work to potentially extend the dosing interval. Maybe you can talk about what we should expect on that front, and then, Rob, as well, if you want to comment on some of the plans to sort of look at other indications beyond IGAN.

Sure. Rob, you want to start with the monthly program? Yeah. So, um... As Marshall shared, we really We celebrate the dosing profile that we provide today. Weekly, small-volume, auto-injectors, self-administered at home, used throughout the development program. We think it's a great solution for patients with a chronic disease. These are otherwise young, healthy people. And, you know, Saturday morning, taking a little time to give themselves the injection works really well. Feedback from the community. I've been out in the field a lot. I hear over and over again from physicians. They like the flexibility that's represented by a weekly administration paradigm. It's, one, not burdensome for patients, and, two, if there would be an issue, it gives them an ability to withhold the drug for a little while. But we are now coming to the close of the data readout for an ongoing monthly dose range-finding study. We are looking at three different monthly doses compared to weekly. This is de novo monthly dosing off the bat in patients with IJ nephropathy. We're going through the final stages to be able to look at the data this quarter. We haven't seen it yet, but our expectation is we'll be able to look at these different dose cohorts. We're going to look at pharmacokinetics, pharmacodynamics, efficacy, and safety, determine which dose we like the best, and then next step would be to go and make a proposal to the agency of what it will take to secure label claims. We also have a cohort that is extending from weekly dosing out to monthly, and that will read out after the end of the first quarter next year.

A couple of follow-ups, just in terms of the monthly, any of the sort of things, as you think about the profile which you have right now, which is very attractive. Are there things you wouldn't want to sacrifice, whether it's an auto-injector or

the size of the… We want to retain the phenomenal efficacy that we've now shared with the community. We want to retain the terrific safety profile that we've now shared. We like a single injection delivered through an auto-injector device. So those are the foundations for what we're looking for as we select a dose.

Okay. All right, great. So then maybe we can look to other indications.

So one of the things that we have been excited about for some time is our Phase II basket trial called PIONEER. PIONEER is unique in the IgA nephropathy development landscape, and that is the only trial that has basically opened the door to enroll all comers with IgA-mediated disease. That includes patients with very high or very low proteinuria, patients with far advanced loss in GFR, patients with vasculitis along with their kidney involvement, pediatric patients, and patients who've already had a kidney transplant because they developed kidney failure as a consequence of their IgE nephropathy, and now there's recurrence in the transplanted All of these patients are being studied, and we shared some of the initial results at ASN a couple weeks ago. In addition, under the same trial umbrella, we're looking at other autoimmune kidney diseases led by primary membranous nephropathy, and it also includes FSGS, a minimal change disease. These are forms of autoimmune kidney disease where B-cell-produced autoantibodies react against glomerular antigens and drive disease. So the data that we showed at ASN showed that by week four, we are declining the concentration of anti-PLA-2R antibodies in the membranous population. And the majority of patients who have membranous nephropathy have this specific autoantibody that we can measure in the clinic. And we're also showing that we're reducing proteinuria. So these data, coupled with broader experience in this disease, give us a lot of confidence that the profile of Trutacna really syncs well with the pathophysiology of membranous nephropathy. And we think there's an opportunity to come forward with an exciting program when we're ready to move on that.

And I think that speaks to the larger idea when the Vera team in-licensed Atachycept close to eight years ago. And that is a fundamental dissatisfaction with how we as physicians treat patients with autoimmune disease. Currently, patients are treated with steroids or immunosuppressive therapies. To have a profile where you can treat an autoimmune disease that's primarily driven by B cells or autoantibodies and do that in a way that doesn't induce an infectious liability, that's a total unlock for a much broader set of opportunities. And we begin in nephrology. That's where we've built our credibility and experience. I love that Rob and the team have developed the Pioneer Program. It's our job serving nephrologists to give them more data, clinical safety and efficacy data, and be transparent about that. That's how we build our credibility and brand within the nephrology space. But we clearly have opportunity to go into rheumatology, neurology, dermatology, where there are B-cell-driven diseases that do not have a treatment option with this kind of profile. And that's an important piece to keep in mind as we build the opportunity in the future.

And maybe specifically on the membranous, what should be the next steps here? When should we expect to hear more about your plans going forward?

Yeah, we have been looking at this disease with fresh eyes. We paid attention to the trials that have been conducted, both to secure label claims and just that have been done by the community. There are a lot of learnings there. And I think, as we've done in other in other areas with our development program, we're thinking about something novel.

Okay. All right, so maybe now coming back to the sort of lead opportunity here in IGAN in the U.S., maybe Matt, I'll bring you back in here. So a lot of questions around sort of payer access in this space, again, especially with competition, a pretty price point that I think people were a little surprised by when Asuka set the pricing here. How do you see this payer landscape playing out here over the next one to three years as, again, there'll be three players in the space in what looks like maybe a bigger population of patients than we initially thought?

Sure. Yeah. I think the bigger population that we initially thought will play out over the next few years, I don't think that's going to happen in the next year. So overall budget impact is not huge with payers. When you look at this and look at other therapeutic areas that they spend a lot more time managing. You know, I've said this many times. Our strategy with payers is we want to maintain parity access. We're not going to actively try to seek out preferred status. I can't predict how the rest of the market is going to act, but that's certainly our strategy going into next year, when there will be three players, is we'd like to compete. In the physician office? And that'll be our strategy.

Okay. And there's a couple of important potential advantages you guys have. So you have the EGFR data now presented, published in the New England Journal next year, middle of the year. So you should get a full approval as opposed to accelerated approval. How does that change the dynamics both with payers and also with physicians?

So I have a very active access team with great relationships with the payers. Policies are being developed as we speak. Most policies to label. That we feel really good about, but the, yeah, you think about the totality of our data package is pretty hard to beat and is very compelling to payers. Efficacy, safety, and the very convenient auto injector all plays very nicely when we talk to payers.

Okay. And there are other, you know, obviously options or treatments that these patients are on outside the B-cell modulators, especially the ERAs, another branded class that's, you know, newer to the market. Are you seeing any pushback or questions from payers around the use of combination approaches with the B-cells on top?

No, what we're seeing there is some branded step-throughs, step-throughs with Filspari, step-throughs with Van Raffia. That affects the entire B-cell class. I think those are in place now. As the data from ASN gets more digested in the payer world, I think those will be hard to defend, those step-throughs. That'll take a little time, but I think the strength of what was shown at ASN from us. From cibiprilamab will be hard to deny from a payer perspective.

Okay. And you touched on this a lot last week in the call a little bit as well, but just the discussion around the weekly versus monthly with cibiprilamab being available now. Can you share a little bit more kind of what that conversation is like with physicians, kind of how are patients reacting to the two different options, and what's driving them to change?

Yeah, you know, I know it's a point of emphasis at places like this. Where it's not a point of emphasis is in the nephrologist's office. Nephrologists don't object to a weekly. In fact, it's much more in line with what they're used to using. Nephrologists use a fair amount of GLP-1s. It's a comfortable interval for them. They're very familiar with the auto-injector. The 82 reps for Vera do not run into the objection of, yeah, your efficacy sounds great, I really like your safety profile, but I don't like weekly. That's just not a conversation that happens. So, we're... We think we have a really patient-friendly solution in small-volume weekly auto-injector, and we're quite confident, and I think the 700 patient start forms that we reported last week speak to that.

Okay, great. So we have a couple more minutes left here, so maybe, Roger, I'll turn back to you. You've alluded to this a couple times in terms of other opportunities outside of kidney, and maybe someone questioned what I asked Rob before. What's the plan here? When should we expect to hear more from Vera on moving into those areas?

Yeah, well, again, thanks for having us. Fantastic conference. And just want to say that this has been a phenomenal year for Vera. We really were formed to change medicine and to build a business that's growing and has the opportunity to grow fast. And I think we've shown that we can do that. We now have Trutacna out on the market as of July 7th. Our early signs of launch look strong. Building that vertical and having the number one name and credibility within the nephrology space is incredibly important to us. Coming out of ASN, we achieved the number one share of voice for the second year in a row. These are incredibly important accomplishments for us. Geographic expansion for Trutac and IGAN is the first step. And then really important that we start to set up a broader view of where Trutac could be used with this profile. So I don't want to give a lot of specifics now, but you can imagine that like we've done for geography, we take the existing data and the profile. We form a clinical plan. We align with regulators, and then we can be shovel-ready to go on multiple new programs in the future, and that's within nephrology but also outside. So a lot of growth ahead for us, Vamil. It's been a great year so far.

You know, congrats on all the progress. Obviously great to see, and we'll keep watching going forward, but a really great setup for going into 2027. Thanks so much. Thank you.