Vera Therapeutics (NASDAQ:VERA) Q3 2026 Earnings Call

0:00 Good day and welcome to the Vera Therapeutics Business Update and Financial Results webcast for the quarter ended September 30th, 2026. At this time, all participants are in listen-only mode. A question and answer session will follow the prepared remarks. As a reminder, this webcast is being recorded. If you have any objections, please disconnect at this time. I would now like to turn the call over to Josh Chin, Vice President of Corporate Finance and Investor Relations at Vera.

0:25 Please go ahead. Thank you, Operator, and thank you, everyone, for joining us. Earlier today, we issued a press release announcing our business highlights and financial results for the quarter ended September 30, 2026. A copy of the press release is available in the Investors and Media section of our website at ir.veratx.com. Before we begin, I would like to remind everyone that we will be making various remarks about future expectations, plans, and prospects, which constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. The company cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated.

1:17 Thank you for watching. In addition, today's discussion includes results from ongoing clinical trials of Atacicept in investigational uses that have not been approved by the FDA or any other regulatory authority. The full prescribing information for Trutacna, including important safety information, is available on our website. Furthermore, the content of this webcast contains time-sensitive information that is accurate only as of the date of the live broadcast, November 5, 2026.

2:08 VERA undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this broadcast. This webcast is being recorded and an archive will be available on our website for 30 days. With that, I will turn the call over to Dr. Marshall Fordyce, Founder and Chief Executive Officer. Marshall?

2:31 Thank you, Josh, and welcome, everyone. Joining me today are Dr. Robert Brenner, our Chief Medical Officer, Matt Skelton, our Chief Commercial Officer, and Sean Grant, our Chief Financial Officer. The third quarter marked a major turning point for Vera. Following accelerated approval from the FDA in July, we launched Trutacna, the first therapy approved in the U.S. that targets both Bath and April to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. Since the accelerated approval of Trutacna on July 7th, We have received approximately 700 patient start forms to date.

3:22 This early momentum exemplifies our long-standing confidence in Trutacna's potential to become a foundational therapy for IgA nephropathy, and it represents an important first step in delivering on our commitment to people living with this disease. Thank you for watching. The Origin 3 Final Efficacy Results, presented at ASN Kidney Week in October, strengthens the clinical foundation for this next phase of growth.

4:13 As Rob will discuss, in the Origin 3 final efficacy analysis, Trutacna held the rate of kidney function decline to a physiologic level and reduced the risk of kidney disease progression by 76% compared with placebo through 104 weeks. We are pleased with the overall product profile and believe that we have one of the most robust data packages in the B-cell modulator class. These findings build on the proteinuria reduction at 36 weeks that supported accelerated approval. This week, we submitted a supplemental biologics licensing application to the FDA seeking full approval of Trutacna in adults with primary IgA nephropathy based on the Origin 3 final efficacy analysis.

5:13 In addition, following a meeting with the Committee for Medicinal Products for Human Use at the European Medicines Agency, we plan to submit a marketing authorization application in the first quarter of 2027 for standard marketing authorization. Importantly, this application will leverage the same results presented at Kidney Week. These are important regulatory milestones as we advance toward potential full FDA approval in mid-2027, with potential approvals in other regions to follow. Alongside the U.S. launch and our pursuit of full approval in the U.S.

6:00 and other regions, we are advancing the ongoing development program to expand the opportunity for ATACiCEPT, This includes the Phase II Pioneer Basket Trial in broader IgA nephropathy populations and other antibody-mediated kidney diseases, including encouraging interim results presented at ASN, as well as the once-monthly dose range finding study. This integrated program reflects our ambition to build on our progress in adult IgA nephropathy and bring new treatment options to more patients over time. With the early launch progress and expanding clinical evidence, Vera is now viewed as a leading kidney disease company.

6:53 We are entering this next phase with enthusiasm and a clear focus on execution, bringing Trutacna to more eligible patients today while developing opportunities to improve care for more patients in the future. With that, I'll turn the call over to Dr. Robert Brenner for a recap of ASN and an update on our development activities.

7:20 Rob? Thank you, Marshall. Having spent the past few years working to advance Atacicept through clinical development and U.S. regulatory approval, it is deeply rewarding to now see TruTacna reaching patients. I want to recognize our colleagues across the organization for the strong start to the product launch and their commitment to helping patients access treatment. Vera is advancing the ongoing clinical development program with the objective to bring Atacicep to more patients and broaden its potential across autoimmune kidney diseases. That work begins with pursuing full approval in adults with primary IgA nephropathy at risk for disease progression. supported by the Origin 3 Final Efficacy Results.

8:08 Two weeks ago, Dr. Jonathan Barrett presented the Origin 3 Final Efficacy Analysis as a late breaking oral presentation in the opening plenary session of ASN Kidney Week with simultaneous publication in the New England Journal of Medicine. Origin 3 randomized and dosed 428 adults with IgA nephropathy, and the final efficacy analysis met all pre-specified endpoints. On the key secondary endpoint, the placebo-adjusted EGFR change from baseline at 52 weeks was 5.6 mLs per minute. EGFR was minus 0.1 mLs per minute with Trutacna compared with minus 5.7 with placebo on top of background therapy.

8:57 Through 104 weeks, the placebo-adjusted annualized EGFR slope was 5.0 mL per minute per year, with minus 0.6 with Trutacna versus minus 5.6 with placebo. The EGFR benefit observed with Trutacna was preserved across all pre-specified subgroups. These data demonstrate that patients treated with Trutacta lose kidney function at a physiologic rate of approximately minus one mil per minute per year, while patients on placebo and background therapy continue to lose EGFR at a pathologic rate and a high probability of developing kidney failure during their lifetime.

9:43 Trutacta also reduced the risk of the composite kidney disease progression endpoint by 76% compared with placebo through 104 weeks with a hazard ratio of 0.24. 11 patients on TruTacna, or 5%, had a sustained decline in EGFR of 30% or more, compared with 38 patients, or 18%, on placebo. Zero patients on TruTacna progressed to dialysis, kidney transplantation, or death, compared with 7 patients on placebo. At 52 weeks, the placebo-adjusted reduction in UPCR was 51%, and in galactose-deficient IgA1 was 67%, and hematuria resolved in 81% of trutactin-treated patients who had hematuria at baseline.

10:38 And at 104 weeks, the placebo-adjusted reduction in UPCR was 60%, and hematuria resolved in 97% of trutacnic-treated patients who had hematuria at baseline. In the Origin 3 final efficacy analysis, trutacnic was well-tolerated with a safety profile generally comparable to placebo. Overall adverse events occurred in 75% of patients on Zutacna versus 78% on placebo. Serious adverse events occurred in 7% of patients on Drutacta versus 15% on placebo. And adverse events leading to discontinuation occurred in 2% versus 10%, respectively. The most common adverse events associated with Drutacta and placebo, respectively, were infections, 51% versus 52%, and local administration reactions, 30% versus 8%.

11:36 Infection rates were similar between the two arms. There were no opportunistic infections or clinically relevant hypogammaglobulinemia, and no deaths occurred in the Trutacna group. In the final efficacy analysis, 93% of Trutacna-treated patients remained on therapy, compared with 79% on placebo. These results form the basis of the recently submitted SBLA seeking full approval of TruTacna in adults with primary IgA nephropathy, which is anticipated in mid-2027. Origin 3 placebo participants are transitioning to open-label TruTacna for the remainder of the trial, and we reiterate our gratitude to the patients, investigators, employees, and collaborators who helped make this trial possible.

12:27 Next, I'll turn to Pioneer, a phase two basket trial evaluating a tachycept in broader IgA nephropathy populations and in other antibody-mediated kidney diseases. At ASN Kidney Week, Dr. Richard Lafayette presented interim results from the adult IgA nephropathy and primary membranous nephropathy cohorts as a late-breaking oral presentation. At the time of this interim analysis, the IgA nephropathy cohorts enrolled 101 adults with baseline characteristics distinct from what is studied in Phase III IgA nephropathy trials, including patients with EGFR as low as 20 mls per minute, patients with proteinuria below 1 gram, patients with IgA vasculitis with nephritis, and patients with recurrent IgA nephropathy after kidney transplantation.

13:19 In these populations, Atacicept reduced proteinuria by 52% from baseline at week 24, similar to the results from origin 3. Reductions were consistent across cohorts with low baseline EGFR, low baseline proteinuria, and IgA vasculitis with nephritis. At the time of this interim analysis, the primary membranous nephropathy cohort enrolled 16 adults with anti-PLA2R positive disease, most of whom had nephrotic range proteinuria. Reductions in anti-PLA2R antibody levels were detectable as early as week four, and proteinuria declined over the first 12 weeks of treatment. These early data are consistent with what we would expect from a mechanism that acts upstream of autoantibody production.

14:12 In this interim analysis of Pioneer, the safety profile was consistent with a broader Attachycept experience, with no adverse events leading to discontinuation and no opportunistic infections. We believe these results support continued investigation of Attachycept and antibody-mediated glomerular diseases. Finally, in a separate poster, we outline the pioneer investigation of pediatric patients with IgA nephropathy. The trial is currently enrolling children aged 10 and older, and we expect to open enrollment to children aged 2 to 10 in the future. We will also be reviewing data from the ongoing monthly dose range finding study of Atacusept later this quarter. Our goal is to build on the evidence in adult IgA nephropathy while pursuing the most promising opportunities to bring this important therapy to additional patient populations.

15:07 I'll now turn the call over to Matt Skelton to discuss our commercial progress. Matt?

15:15 Thank you, Rob. The Trutacna launch is off to a strong start. As Marshall mentioned, we have received approximately 700 start forms since launch to date. We are encouraged by this early demand, which reflects both the significant unmet need in IgA nephropathy and the receptivity to the Trutacna product profile. At the same time, we are just scratching the surface of the large potential for Trutacna. As we have said from the outset, adoption will build over time as nephrologists identify appropriate patients, work through access requirements, and gain experience with Trutacna. Our sales, market access, and patient support teams are working together to help eligible patients move from a treatment decision to starting therapy.

16:12 Beyond the safety and efficacy data, we believe that the experience of once-weekly self-administration at home with a small-volume auto-injector adds to Trutacna's appeal for patients and physicians. Based on field feedback and over 29,000 sales calls to date, many patients like the ease of weekly at-home administration, while many physicians like the flexibility of weekly dosing should an adjustment be needed based on clinical judgment. Helping eligible patients access treatment is a key launch priority. We are encouraged by the payer coverage policies taking shape Our focus is on securing coverage that allows eligible patients to begin treatment without unnecessary delay.

17:07 Through TrueTacna TrueSupport, our patient support program, we are helping TrueTacna patients navigate insurance coverage, including benefit verification, prior authorization and appeals, and are working to connect them with financial assistance options. Eligible commercially insured patients may pay as little as $0 out of pocket through our copay assistance program. And finally, our patient assistance program may provide Trutacna at no cost to eligible uninsured or underinsured patients. We are building a strong foundation for sustained growth by broadening adoption and expanding access for eligible patients.

17:55 We are encouraged by the progress so far and confident in the opportunity ahead for TruTacna. I'll now turn the call over to Sean to review our financial results. Sean?

18:10 Thank you, Matt. I'll provide an overview of our financial results for the third quarter ended September 30, 2026. Additional details are available in today's press release in our Form 10-Q. Net product revenue from sales of Shrutakna was $10.3 million for the third quarter of 2026, our first partial quarter of commercial sales. Cost of sales was $3.3 million. Research and development expenses were $41.3 million for the third quarter of 2026, compared with $56.5 million for the same period in 2025. The decrease was primarily due to a reduction in contract manufacturing expenses recorded in research and development.

18:59 Following accelerated approval on July 7, 2026, manufacturing costs for TruTacna Commercial Supply are now capitalized as inventory, whereas they were previously expensed as research and development. Selling, general, and administrative expenses were $61.4 million, compared with $27.5 million for the prior year period. The increase was primarily reflected investment in the commercial launch of TruTacna. Net loss for the quarter was $93.7 million, or $1.30 per share, compared with a net loss of $80.3 million, or $1.26 per share, for the prior year period. For the nine months ended September 30, 2026, net cash used in operating activities was $305.9 million, compared with $171.1 million for the prior year period, primarily reflecting increased investment in the commercial launch of Tritacna.

20:05 As of September 30, 2026, we had $384 million in cash, cash equivalents, and marketable securities. In late October, we drew $75 million in our debt facility. On a pro forma basis, adjusting solely to reflect the October borrowing as if it had occurred on September 30, our balance of cash, cash equivalents, and marketable securities would have been $459 million. As of today, up to $350 million remain available under our debt facility, subject to the satisfaction of certain conditions. Together, our cash resources and borrowing capacity provide the financial flexibility to support the Trutecno launch and our ongoing trials.

20:53 This concludes our prepared remarks. Operator, we are ready to open the call for questions. We will now begin the question and answer session. If you would like to ask a question, please use the raise hand icon, which can be found in the black bar at the bottom of the webinar application screen. When you hear your name called, you'll be prompted to unmute your line and ask your question. We will now take a moment to allow the queue to form. Our first question comes from Anupram Rama with JP Morgan. Anupram, please unmute your line and ask your question. Anupam, please unmute your line.

21:45 Oh, can you hear me now? Sorry. Yes, indeed. Sorry about that. Thank you. Great. Hey, guys, this is Joyce on for Anupam. Thanks for taking our question. I know it's only been two weeks since ASN, but we were just wondering if there's been any early sort of signs of pull through in terms of demand or patient start forms after the final origin three presentation. Thanks.

22:11 Yeah, Matt, maybe you could answer that question for us.

22:16 Yeah. Hey, the demand continues at a nice pace since ASN. It would be probably too early to see an inflection at this point, but we were super pleased with the VERA showing at ASN and think that that's going to be a catalyst for us in Q4. Thank you. Our next question comes from Gavin Clark Gardner with Evercore ISI.

22:52 Hey guys, thanks for taking the question. On the monthly data, so Rob, you noted in your prepared remarks that you will be seeing monthly data later this quarter. Are you expecting to present that data publicly, or are you waiting for some additional data next year, or are you waiting to have some more regulatory clarity before giving an update here? Really just overall, what is your level of confidence on the monthly program at this point?

23:25 Yeah, thanks for the question. The Atacusep dose range finding study is ongoing. The study includes three different de novo monthly dose cohorts, a cohort switching from weekly to monthly dosing, and a control weekly cohort. We're going to be looking at all the data, PK, PD, efficacy measures, and safety from the de novo cohorts with the analysis forthcoming with this quarter. and we'll be looking at the results from the SWITCH cohort in Q2 of 2027. We're not very far away from having those data in hand. I think we'll stare into them internally and then we'll have more to say after we've looked at the results. Our next question comes from Ritu Bra with TD County.

24:13 Please unmute and ask your question.

24:20 Good afternoon, guys. Can you hear me okay? Yes, indeed. Thank you.

24:27 I wanted to ask about questions for Matt specifically. What are you seeing now and maybe retrospectively in the last three months or so on trends of diagnosis in IGAN now that there's two players in the market and disease awareness by at least one more. Are you seeing rising trends, increased diagnostic codes being utilized? And then my second question has to do about the current prescriber characteristics and call points. Can you walk us through how you're prioritizing call points and prescribers? Like, do you have tiering based on whether they're at like centers of excellence versus community.

25:19 Just that sequencing. Thanks.

25:24 Sure. Hi, Ritu. Yeah, I think it would be too early for us to comment on if we're seeing increased diagnosis rates or coding. I think right now what we're seeing is we know that there's a large prevalent pool of patients that are already diagnosed with IGAN, that are already receiving kind of backbone treatments of IGAN. Those are the patients that we're seeing that are being moved True2Chakna, and those are the ones we're discussing with nephrologists. As far as what the prescribers look like, what our call points are, is in these early months, we're spending our time where the business is with the high decile physicians, 8, 9, 10 deciles. Also, we're in the academic centers as well.

26:09 So that's been a real emphasis in these early months of launch. Our next question comes from Pete Steropoulos with Cantor Fitzgerald. Please unmute and ask your question. Hi Marshall, Sean, Rob, and Matt.

26:30 This is Samantha on the line for Pete. Congrats on the early commercialization updates. Could you give us some more granularity on the types of patients represented in the patient start forms received to date? Are physicians initiating Trutacna in a broad population or sticking to higher risk patients? Trying to understand how broad of a population you are seeing adoption with, including patients closer to the KDGO threshold of 0.5 grams per day.

27:01 Thanks for the question, Samantha. We're thrilled with the early momentum. And Matt, maybe I'd have you reiterate the indication statement breadth and maybe some color on what we're seeing early here.

27:14 I think we are seeing the benefits of the broad indication statement, Samantha. We're seeing patients with more than a gram of protein and we're seeing patients prescribed that have less than a gram of protein. So we're pleased. I think it's a pretty broad swath we're seeing. And I think that that mix will continue. And, you know, hopefully we're tapping into what is currently viewed as less severe patients. So, yeah, but right now a good mix. Our next question comes from Rami Kalkouda with LifeSci Capital. If you could unmute your line and ask your question.

28:01 Hey guys, congrats on the progress and thanks for taking my questions as well. I know it's still early, but what are you guys seeing in terms of prescriber breadth and depth? Are early tritacna prescriptions concentrated among a smaller number of high volume nephrologists or are you seeing broader adoption with fewer prescriptions per physician?

28:21 Matt? Yeah, happy to take that. You know, I'd like to get another quarter on my belt before we really start diving into depth and breadth, but we are pleased so far. The 700 patient star forms are not being driven by a small cohort of physicians. We feel good about the breadth to date. Our next question comes from Mohit Bansal with Wells Fargo. Please unmute and ask your question.

28:56 Thank you for taking my questions. A couple of questions, if I may. One is, have you disclosed out of the 10 million, how much was stocking versus the demand sales? That's number one. And number two, you mentioned that there were no cases of clinically relevant hypogamma in Phase 3 trial. Would you be able to explain how it was defined? and if there were cases falling below 300 during this trial. Thank you very much and congrats on the quarter.

29:29 Thanks so much, Mahit. Maybe Matt first on the stocking question and then Rob on the hypogamma handling.

29:36 Yeah, I can start. Hi, Mohit. Yeah, about half of that is demand, about half is inventory. And we fully expect that ratio to go much higher for demand in the next quarters.

29:55 Yeah, in terms of hypogammaglobulinemia, we haven't seen clinically relevant hypogammaglobulinemia in the program. In Origin 3, patients received their drug assignment without interruption and were not withheld due to their IgG levels. In the Phase 3 protocol, we used an IgG threshold below 200, and if there were two values below 200, there would be discontinuation of treatment. No patient reached that threshold. There's been no imbalance of infections across the program and no opportunistic infections. Our next question comes from Vamil Devan with Guggenheim Securities. Please unmute and ask your question.

30:44 Great, thanks for taking the question. Maybe just following up on that last question around immunoglobulin levels, can you just share what you're seeing in terms of doctors as they start patients on this or maybe broadly on these new B-cell modulators? Are they monitoring their patients' immunoglobulin levels? I know it's not required or mandated by GFTA, but I'm just curious if in the real world if you're seeing any changes. and doctors doing that just as they get used to using these new products. And then, Marge, I just have a quick clarification question I'm getting from a couple of people. It sounds like going forward on the earnings updates, we should expect you'll give PSFs through the end of the prior quarter, not the date of the call. Can you just clarify that? That's what you meant.

31:29 And would you be providing any updates sort of into a quarter? Just getting a couple of people asking me that question. So if you can clarify, thanks.

31:37 Yeah, happy to clarify that. Going forward, we'll use the quarter definitively moving forward. We think in this early stage, it's important to give an up-to-date view of demand in the early stage of launch. I would clarify that there is no monitoring required for the use of TruTacna, and that's been true both in clinical as well as our experience out in the field with commercial utilization. Our next question comes from Farzee and Huck. Please unmute and ask your question.

32:16 Hi, thank you for taking my question. I wanted to get some more color on the PSFs. Like, what is the split between the treatment naive patients versus, like, switches of an existing agent? And within the switches, like, how much is coming off filspary, tarpeo, and even foxyte, for that matter?

32:35 Yeah, Matt, I'll have you take that and, you know, just clarify what we mean by switch versus standard of care out there. Yeah, sure. Yeah.

32:46 This 700 PSFs are almost all from the prevalent patient pool. So these patients are on the backbone of therapy, be that steroids, ASAR, SGLT2s. Many have been on Filspari and R-Tarpeo. So that really is the patient that physicians are choosing to move on to Tritacna. at this point. I wouldn't, and Marshall said, I wouldn't call it switching. I think it's just almost a graduation and a move to a truly disease-modifying agent like Trutacna. Our next question comes from Dina Ramadane with Bank of America.

33:35 Please unmute and ask your question.

33:41 Good evening, guys. Thanks for taking my question and congrats on all the progress this quarter and the updates. Just two quick ones from us. Among physicians who have submitted one patient start form, what determines whether they progress to a second, third, and so forth patient? Are repeat prescribers responding primarily to ease of access, patient experience with the autoinjector, early proteinuria measurements, or confidence created by the final origin3data. And second one, you guys previously described your access objective as kind of parity with other products in the market. What does that mean in operational terms today, specifically across covered commercial lives? Like what proportion of policies are permitting Trutecna without a branded product step edit and do those requirements differ from voice acts?

34:34 Thank you so much.

34:37 Matt, could you take that? Yeah, I'm happy to take that. I'll handle it. On the covered lives, we're progressing well there. We're on track to meet a goal of 50% of covered lives by the end of the year. Any branded step-throughs that are out there with payers impact the B-cell class in the same way. And some of the branded step-throughs that are out there usually involve Filspari or Ventrafia. But on the payer front, as each week goes by, we're seeing improvements and we feel good about our progress there. Regarding the physicians that have written or submitted a PSF, keep in mind, Dina, that a busy nephrologist for us in the community has Thank you for joining us.

35:46 But there's nothing stopping them from writing that second. I think it's just the opportunity to use the product again. What is a really rewarding part of we've been out there long enough now where many patients have come back in for a second visit once they've been on Trutacna and are seeing fantastic results from the lab values, that is certainly a validation to the nephrologist and the patient of what TrueTacNet can provide and certainly is a great stimulus for that second, third, and fourth patient start form.

36:23 Yeah, I'll just add that this is a transformative product profile and just presented at ASN and published in the New England Journal looking at renal endpoints. These are data that we expect will be very impactful in terms of the launch going forward. So I'm very encouraged by these early signs of a successful launch. Our final question comes from Ryan Deschner with Raymond James. Please unmute your line and ask your question.

36:59 Hey, thanks for the question. Congrats on the SBLA submission and strong early launch data. I'm curious on Label expectations now that you've submitted your SBLA for full approval. How you're thinking about what data might make it onto the label and what differences on the first page of the label you're expecting versus your accelerated approval label and how that thinking has evolved over time.

37:23 Yeah, Rob, I'll have you take that. Yeah, so the accelerated approval is based on a proteinuria reduction endpoint, and the label calls out that the impact of Trutacta on GFR and kidney function has not yet been established. Expectation is that with full approval now based on the GFR results, that that language will be removed, and so the indication will be based on Thank you. This concludes our Q&A session. I will now turn the call back to Dr.

38:11 Fordyce for closing remarks.

38:36 Thank you, operator. Just to close, we are proud of the progress we've made to date as a commercial stage company. As we look ahead, our focus is on continuing to build out the TrueTacna launch to advance toward potential full approval and developing a Tachycept for additional patients who need new treatment options. With that, I want to thank the patients, investigators, physicians, and the Vera employees who have made this progress possible. We're excited about the opportunity ahead and are committed to executing with urgency and with discipline. Thank you for your time and have a good day.

39:23 We'll close the call now.