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

Thank you. Great. Good afternoon, everybody. Thanks for sticking around for our last fireside today. We're really pleased to have Vera with us.

I think we're going to have to go back to the chat box. I'm going to let Marshall make some introductory comments, and then we'll jump into Q&A. Over to you, Marshall. Thanks.

Matthew, thanks for having us and me at your conference. Great to have an interview with you today. Marshall Fordyce, I'm the Founder and CEO of Vera Therapeutics. Great day for us today and for patients. Today, we shared the final efficacy analysis from our pivotal Phase 3 trial showing outstanding efficacy by GFR and by kidney composite endpoint. It was an important update for the field and for Vera as an indication of how launch is going. So we shared that, so far about 10 weeks into our first commercial launch, we have over 350 patient start forms or roughly prescriptions, as an early indication of demand. So, two important updates for the company. Great activity happening now and in the coming time. Here we are in September. The data that we top-lined today are being submitted or have been submitted both for presentation and publication. It would be great if we could get that done at next month's major kidney conference, which is called ASN, where we would hope to have an opportunity to present these data in a more fulsome way to the academic world. In conjunction with that, we, of course, are pursuing an SBLA in Q4 to target full approval with these top-line data and more for mid-2027. So, a fantastic moment for us as a company to dive into details about both the clinical results that we shared today, as well as the commercial progress early on in our first launch in the disease IgA nephropathy with TRUTAKNA.

Wonderful. Yeah, no, I mean, really exciting updates for today. So maybe first, can we put the clinical data into context? What does what you share mean? What does it mean to patients? You know, how should people think about progression of the kinds of patients that you put into the study and, you know, how you've changed that progression?

Yes, sure. I mean, we ran a global, randomized, double-blind, placebo-controlled trial in the typical patient who is at high risk of disease progression. So to put it into context, think about who are these patients and what do they experience on current standard of care. They're 40 years old. Their GFR is on average 60, which means that they've already lost roughly 40% of their kidney function by 40 years old. And if you follow the placebo arm, they're losing up to, you know, 5 to 10 mLs per year in our trial. So these are patients who are 40, on their way to dialysis by the age of 50. So that puts you into the context of what disease situation are we trying to alter? What we've shared is data from the final efficacy analysis, so we've ended the randomized phase, and what we've shared is that the GFR difference, meaning the kidney function difference, between TRUTAKNA and placebo is 5.5 mL per minute per year. So that's significant. That means that over a 2-year period, 104 weeks, which is the extent of the data we looked at, if you're on placebo, you're losing 10% your kidney function. So that's a bad situation. We essentially have normalized the GFR for patients who have a placebo on TRUTAKNA. Now the GFR slope for those patients over that 104-week period was -0.6. So just under 1. People without disease lose about 1 mL per minute per year. So this is on average what a patient or what a person without disease experiences. It's also what international guidelines are trying to target for patients to reverse these bad outcomes for patients. So that was, we shared the primary endpoint, confirmatory endpoint that we agreed with FDA, which is at 1 year at 52 weeks. And we also looked at the totality of the data where lots of patients went out to up to 2 years, and that's the 2-year GFR slope comparison. So at 5.0 as a treatment delta, is the largest number we've seen in the field. Moreover, we shared clinical outcome data. So what happens to these patients on placebo? Well, in our trial, 8 of those patients met hard, tragic clinical outcomes. They required dialysis, transplant, or they died, 8 of them, on placebo. On TRUTAKNA, none met that outcome. If you add another criteria, which is a significant reduction in GFR of greater than 30%. So that, plus the hard clinical outcomes, we call that the composite kidney endpoint. We showed a hazard ratio of 0.24. The inverse of that, we also call the risk reduction, was 76%. That's a massive risk reduction, that really is the best we've seen in any IgAN, and you can look even broader at other kidney trials, that's a very big effect size for a new medicine. On these data, we plan to continue to lead the field and set a new standard of care for patients. Today, TRUTAKNA is now available to patients in the U.S. through accelerated approval. And I think these data will be incredibly important for patients, for providers, and for payers as we advance our effort to change standard of care.

And, you know, obviously you showed some stuff on the commercial side, and I want to get to that, but maybe just a couple other questions on the profile, right? Obviously, there's another therapy with a similar mechanism filed. Otsuka has their drug on the market. Can you talk a little bit about, you know, the breadth of the data of the competitors and how you think you compare?

Sure. So, first, I think it's really important when you look at a disease area that has a standard of care with a lot of hope that we can raise the bar. It's great that there are multiple players in that space. That increases the share of voice for changing standard of care. So we actually think that's very helpful for patients and for Vera's potential to really penetrate that market. That mechanism is an APRIL-only mechanism, as opposed to dual BAFF APRIL. From an efficacy perspective, we see our delta between active and placebo at slope for 2 years is 5.0. Theirs is 4.5. And we've also seen no data yet on the composite kidney endpoint that I'm describing, so we look forward to seeing that. We're really the first among the B-cell modulators to share that. Safety looks strong for TRUTAKNA. And we also have the first autoinjector on the market. So this is a very simple device that is simple on a weekly basis, I have it here in my hand. No button push needed, it simply is an injection once per week and it takes just a few seconds. That's what's being asked of patients today as we're out in the field and this is something that I think we really see a lot of acceptance from both patients and physicians.

And then I think the last thing, maybe just comment, right? You've obviously, you have a dual mechanism, APRIL and BAFF, there are other, you know, B-cell modulators in this class that have chosen one of the mechanisms. Any differences you think you're seeing from that in the clinical data so far?

Well, I think the clinical data need to mature further, and we just happen to be the first BAFF APRIL on the market today. And I think I would be looking at long-term kidney outcomes that we've shown today and GFR delta as being the most important to patients, providers, and payers. So I think it remains to be seen how that plays out across the field. Look, this is a really important new step for patients for the field in studying a new standard of care.

Great. So... Why don't we talk about commercial? You obviously gave some updates, but maybe before we get there, can we just talk a little bit about market size, how you think about the market size, and what sort of standard of care for patients is now? And what that tells you about patients that are being treated versus how you might expand that market?

Sure. I mean, this is a very serious unmet need, as I characterized by the patients who we enrolled in this trial. We would estimate this to be in the U.S. alone, roughly 160,000 patients are biopsy-confirmed IgAN patients. We think that that's likely an underestimate. By the time they come on to treatment or into a trial, they tend to be pretty advanced with a GFR of 60 and already 40 or more years old. So we hope to see that shift. That's a large number of patients. The market size is likely very large, in the $10 billion to $20 billion range. When you look at the value that's being delivered for that number of patients, not all of them will be considered at risk for rapid progression. But the label that TRUTAKNA has is broad. It's for any patient at risk of disease progression. Today, most nephrologists define that by those on maximally tolerated standard of care, an ACE or an ARB, most often an SGLT2 inhibitor. For us in Phase 3, it was about six. And then with that background, they're still producing over 1 gram of protein in their urine. That is characterizing the patients who have the placebo GFR decline trajectory and the hard clinical outcomes that we've reported in a relatively short amount of time in a low number of patients. So really that is the market. We're seeing from Otsuka, one of the strongest, maybe the strongest, renal drug launch that we've ever seen in history. They've guided to a $380 million sales number in 2026 in their first full year of launch. That's a good indicator that this is likely a very large market. What we shared this morning is that we have over 350 patient start forms in the first 10 weeks. That tracks very nicely and demonstrates early signs of a growing and large market. We think this will continue to grow as others come to market, and this is a great thing for patients and for the field of nephrology. We see already feedback from the field telling us about our data. That means that we've really been out there. We have good relationships with the physicians in this space. And there's a lot of excitement for a new medicine that can actually stop kidney function decline and change hard outcomes for patients. That'll be really important data for our launch.

Can you characterize, I mean you characterized the little forms, but how should people think about that relative to Otsuka's initial trajectory and, you know, anything you can share in terms of, you know, payers or how people should think about what you need to do on the payer side?

Sure. Sure, we have fantastic commercial leadership within Vera. We hit the ground running. Patient start forms were generated immediately. Drug was in channel. It was really important for us to hit the ground running. We have the right-sized sales force. We have 82 reps. We think that is appropriate for the U.S. area. We're targeting about 6,000 practicing nephrologists. We have additional resources to take up the remaining thousands in the U.S. for prescribing IgAN clinicians. But for those 6,000, 82 reps really has the right contact. We already have early telemetry from our launch that feels right-sized in terms of our ability to touch decile 8, 9, 10 physicians, even multiple times within the first 10 weeks of launch, feels great for where we are. There's other resourcing to be done on the marketing side, and we'll see that evolve this year. Last year at ASN, we had the #1 share of voice among the IgAN developers, and that was from third-party data. So we feel really good about how we've been out in the community leading the conversation about B-cell modulation with TRUTAKNA and dual BAFF APRIL. Really field-leading data were recognized as the leaders by the physicians out there. We continue to do that. We did it today and coming up at ASN next month, we continue to, you know, we'll continue to target that.