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

Hi, everyone. Thank you for joining us today at the Vera fireside chat. I'm covering analyst, Ritu Baral from TD Cowen at the TD Cowen Healthcare Conference. And joining us from Vera, this is a very incomplete list. We have CEO, Marshall Fordyce. We have our CFO and our new Chief Commercial Officer as well. Welcome, Matt. Welcome, Sean. So ongoing FDA review. Obviously, you guys have submitted the atacicept application. It has been accepted and you have your July 7 PDUFA with priority review. The data package seems awfully straightforward. What's left to discuss as like review issues for your mid-cycle. I mean we've talked about the label and stuff like that, that seems like a labeling thing. So what are points of potential FDA focus?

Great. Great to be here, too. Thanks so much. PDUFA date is July 7. We're in the midst of prior review, which we're very pleased about the progress, and we can just reflect to you from our internal work with FDA that it's straightforward. Everything that you would expect at this stage of FDA review is happening and we expect to meet that PDUFA date and be ready. There aren't any major themes that are coming up. I think it's reasonable to say that label and negotiations happen later in the cycle. And I think there's quite a lot of learning that we can already take from the field to date, but we're very confident that we're going to get to the July 7 PDUFA date, and we're going to be ready commercially beforehand.

So speaking of the label, a lot of investor discussion has been, can you incorporate the 2-year placebo-controlled eGFR data from the Phase II into the clinical data section of the label. And then there were interesting developments within the Otsuka label for VOYXACT, which was recently approved, and this idea that they had no proteinuria restriction for their IgAN indication. Are those review issues to discuss? Or is that a last 6 weeks labeling issue?

Yes. Again, I think when we get into specific label negotiations, that's later in the cycle, I agree with you, the most -- one of the most interesting things from Otsuka sibeprenlimab label is that the indication statement is broader than the first wave of IgAN therapeutics. There was no proteinuria threshold that defined a high-risk patient. And in fact, the indication statement calls for all patients at risk, and it doesn't provide a proteinuria threshold. So that immediately broadens the patient population who could benefit from that drug. We expect something very similar in our label. But of course, that won't be final until we have a label.

Does that mean that the definition or the understanding of what defines an at-risk IgAN patient is evolving past UPCR?

Absolutely. So...

So what would it encompass?

So there are patients with low proteinuria, proteinuria below a gram, below 0.5 gram who, despite having that proteinuria profile are still having rapid GFR loss. Those patients exist. And there is, of course, an important correlation between proteinuria and GFR outcome, but it doesn't define on a patient-per-patient basis what the risk is.

Is that a large proportion of IgAN patients?

It's a significant group. So we're extremely excited that the overall GFR profile is transformative for atacicept having a slope of minus 0.6 at 2 years. is a result that's never been seen before, to your first question, that's what's published in both our Phase II manuscript and referenced in our Phase III New England Journal Medicine manuscript. And that really, in our view, is what's the most important thing. If you are a patient or a family member, and you've got IgAN, what's going to define your future health and whether you have kidney function or not before the age of 50 is your GFR. And that really has certainly shifted in the conversation. I think most nephrologists would reflect that new reality. We've never had medicines that stop GFR decline in this disease. And so of course, you have a historical focus on proteinuria, but GFR is what defines efficacy in this new class of medicines that we're now leading.

So some check NDA check off the box questions. How is the CMC module? How is your supply chain, potential inspections progressing? And are there any sort of CMC risks to the approval time line that could trigger a 3-month delay?

Yes, great question. I could just continue to reflect confidence that we don't expect any delays with respect to CMC inspection, CMC issues, we're very close to July 7 from Vera's perspective.

Have you send whether your manufacturers are already GMP certified or whether there are inspections that need to be done?

Yes. We have shared and we're not giving specific timing on inspections and the results at this stage. But again, we're well into the process. There haven't been issues. Our supply chain, both for drug substance, drug product, the auto-injector that we're expecting to bring to market on July 7, those vendors that are in our supply chain, all have commercial products that have been on the market.

Understood. And the review team leveling up a little bit, has that stayed intact since the preNDA meeting?

Yes.

Okay. All right. Those are the check off the box. Now we get to the interesting stuff. Pricing and commercial strategy. How do you plan on positioning atacicept to the market, especially against sibe, especially against potential, look, VOYXACT now approved from Otsuka and potential competition from pove.

Sure. I'll start with a few comments then I'd love to introduce Matt Skelton, our Chief Commercial Officer, to TheStreet here. Look, this is a large unmet need. We've been sharing that for some time. So lots of patients. I think the majority of the opportunity is in the United States. The majority of the opportunity is young people. So commercial pay, we estimate over 70% commercial pay. That's a pretty interesting perspective on what the opportunity looks like. And then, of course, there is now a track record of premium pricing, including VOYXACT's most recent price. So it's not hard to get to a very significant market opportunity when you look overall at the IgAN market. And today, we even see early signs of demand. So you can look at what demand has looked like in the IgAN population for what we might call the first wave of IgAN products, TARPEYO, FILSPARI. And then what does the VOYXACT launch look like in the first few months? And Matt, maybe you could highlight some of what we've seen about that demand.

How does that look?

Yes. Hi, everybody. We're super encouraged with the early days of the launch. So Otsuka reported 500 patient start forms in the first 11 weeks of launch, which I think is a really encouraging sign of adoption by nephrologists of B cell modulators. What's good for B cell modulators is going to be good for us, right? And so I think being a fast follower having the PDUFA in July and getting out there is the market is going to be ready, that much more ready for us to come out. So really good early signs. I think you also saw that they guided to $163 million in sales for this year, which if they meet that, which I think based on 500 patient start forms in the first 11 weeks, is a pretty conservative estimate. That's going to exceed all the other earlier IgAN launches, FILSPARI, TARPEYO.

Have you been hearing anything on the real-world patient experience with the prefilled syringe and what patient response has been to that?

Not much, just anecdotal, but the prefilled syringes is quite big. It kind of fits in your hand but not quite big. And it's a high volume, it's 2 ml. We think we have a more elegant solution in an auto-injector. And you mentioned from a competitive standpoint, what are we going out with, I think it's the whole package and the whole profile. But an important part of that offering is, I think, we have a much more patient-friendly offering and a once-weekly low-volume auto-injector.

Are you currently laying an inventory ahead of the PDUFA?

Yes, inventory is not going to be an issue.

Okay. And it's not going to show up on -- okay. How are you going to approach patient identification, assuming approval, July 7. It is going to be sort of the middle of the summer, which can be weird for a launch, but how are you approaching patient identification, prescriber education, given the complexity of IgAN diagnosis and management but also the unmet need.

Yes. A few things. So our sales force is fully hired. They will be trained and in territory 3 months before the launch.

This is the 82%.

Correct. correct. They're all on board, ready to go, and they will be out there, having those disease state education discussions with physicians, making appointments, doing all the things you can do prelaunch, everything short of -- you can't talk about the drug, right? But I think those are all really important things to get ready. And as far as patient identification, again, back to something I said earlier, is that's why I'm glad that Otsuka is out there talking about IgAN.

Cause you can target, like you can see where the -- who's writing those scripts and target those patients...

Oh, yes. So as far as targeting a physician, yes. So it's not 100% straightforward, but we're going to target about half of the nephrologists in the U.S.

6,000, right?

Right around 6,000, right? And for IgAN, there's only been an ICD-10 code since October of '23. So in the world of cutting, that's still fairly new. So we certainly have that data to say, hey, let's look at the claims data to see who was using the code. And then through other ways we triangulate around, it kind of looks and seems like it's an IgAN patient under the care of this doctor and that was included in our targeting.

Is there an ideal patient subpopulation you think you can -- that's a low-hanging fruit, how would you define them?

Yes. Really good question. And usually, when you launch a drug in this -- you want to paint a picture of this is the patient to start using this drug. We haven't got to that point yet where I want to be that prescriptive because it's changed a little because I think what you had with the earlier IgAN drugs, you had a proteinuria threshold to which they treated, right, when they had to be over a level to start the drug. That's not the case in the VOYXACT label that I don't think it's going to be the case in ours. But it's kind of where the physician head is. So we want to meet the nephrologist where they are today, and that will probably tend to be a little higher risk patient as they view it, and we'll start there. The key is we want physicians to start using the drug.

So are you -- given the fact that you may not have proteinuria restrictions on the indication label. Are you prioritizing that expanded IgAN population in the PIONEER study so that you can sort of generate that data in the expanded population so that you can use it as close to launch or on launch as possible?

Yes. I think it's -- I'm glad we're doing that study, and we're the only ones that are studying that. So I think when physicians have those questions, we'll be able to provide answers that we're actually doing the work.

I would highlight this is a large prevalent pool. And if you look at the patient starts that we're hearing from those that are out there in the market, that's still just scratching the surface. There are 160,000 prevalent patients more or less in the United States alone. We estimate roughly half of those patients are in this rapid progression pool. So if you're thinking about 80,000 patients on average, 35 years old who are going to be on dialysis by 50, that's a highly motivated group and physicians who are caring for them want a solution for that. To have a solution atacicept that stops GFR decline in those patients. I think you can even be conservative on your penetration into that pool of roughly 80,000 and say you don't need to be overly specific on your targeting. That's a lot of patients who need a profile that we think we're going to have a launch.

But remind me when we're going to get the PIONEER data that expanded IgAN?

We've guided to the first half. So roughly the cadence in the nephrology community is the American Society of Nephrology is a fall meeting in October, November. And the other meeting is the European meeting, which is in June. So we do expect to share some data we've guided for PIONEER to the first half.

And then you would have that upon launch?

It would be out there at least in the presentation for.

Got it. What launch metrics do you plan on providing post approval?

Yes. I think we're going to be conservative about that initially. We're not going to give specific guidance, but we'll certainly give us a sense of demand as we come out of the gate. And I will be as transparent as we can and set reasonable expectations around how quickly we're going to change standard of care here.

Yes. We'll track patient start forms. And I think that's traditionally been if you look at others in the IgAN space have reported those and still report those. So I think we'll -- that's something we'll keep a close eye on and probably report.

How are you approaching market access and reimbursement, especially in light of the high pricing of competition and the value that ataci brings to the table.

Sure. I'll take that. We have had a very experienced value and access team out in the field since -- gosh, 8 months ago. So they've been out great relationships in the space, know all the payers. That's the first step, right? They've been out there. We have conducted now over 20 -- what are called PIE presentations, preapproval information exchanges with large payers, educating them on the space, what's coming. So we've been doing all of that type of homework and end market preparation as you should. We've seen now 9 policies on VOYXACT that have come out, payer policies. They are not restrictive. They're 2 label. And we feel really good about those and think that will probably follow when we hit the market.

Are you seeing any step edits within that?

The only step through as we're seeing our ACEi/ARB which I don't even see as an issue.

And again, what you're hearing is there acceptance or pushback of combination therapy for IgAN patients to layer on IgAN, not just ACEi and ARBs.

A couple of like branded therapies?

Yes.

Great question. I haven't heard anything specific to that yet. I think it's still early days.

Positive or negative, okay.

Yes

Okay. How should we think about the mechanics of gross to net. Are you planning like a specialty distributor, who's going to take like a little off the top and then the Medicare Medicaid discount contributing to that. What should we be modeling going forward?

Sure. Marshall said this earlier, a good thing about the space from a commercial perspective is it's almost 75% commercial pay. That helps gross to net, right?

You don't have that 231, the automatic 231.

Exactly. Yes. Well, it's a smaller percentage of the business, yes. Our distribution model is through specialty pharmacy. So as you said, there's a little admin fee there. But that's something that we are going to keep our eye on is gross to net and control what we can control. And so we'll see how the market reacts as far as any rebating or discounting but that would not be our intention out of the gates.

What are your current plans for like a patient hub and wraparound services, support services, whether insurance, whether it's compliance, et cetera?

Yes. So our specialists and distribution in building out the hub have been with us now almost 6 months. The hub is in full development.

Is it your hub? Or is it the specialty pharmacist hub, specialty pharmacies hub?

That's part of it, but we're working with someone else and we'll do the hub for us. Right, one that they're very -- the physicians are very familiar with CoverMyMeds right? So high level of familiarity. So we realize going into this space that it needs to be white glove treatment, and we need to make sure that every patient in an office intends to get on drug, gets on drug. So that's something we've paid a lot of attention to and dedicated significant resources to.

What are your expectations for peak share in the U.S. and the key drivers that you anticipate will aid in achieving that?

I think it's too early to give a number there, Ritu. Again, I think...

What's reasonable do you think?

Yes. I think it depends. We've been pretty consistent, we think the B-cell modulator class is a step into the future from what has existed so far. We would consider Otsuka's product to be so modulator, although we're still interested to see what the 2-year GFR data show. So we haven't seen that yet. That's going to be an important data point. And then there's our data. And then anyone else who comes along, we'll wait to see randomized controlled trial data and 2-year GFR data is going to be really important. So in our view, efficacy by GFR is really a major driver. We've set a high bar for safety, which is placebo-like safety without a significant imbalance which...

Do you expect that to be a differentiator with some of the other mechanisms? I know it's a topic of discussion with pove. It's been a topic of the posters with [ GFR high bar ], how do you see that shaking up? And what do doctors seem to care about?

Yes. I think ultimately, doctors and FDA, what makes it into the label really depends on controlled trial data. So we wouldn't spend a lot of time on safety signals in an open-label trial until seeing whether that's balanced by placebo or not in a meaningful population. That's how Vera has conducted its Phase II and Phase III program. We did dose findings, we have a clear understanding of dose and safety. And I think we'll wait to see data from others. But the bar is these are young patients. They want the efficacy of GFR stability, and they don't want to lose their kidney function and end up on dialysis. And they'd like that without a safety liability. That's a really strong way to have an offering and a self-administered autoinjector, small volume. And that's the offering we've got. And I just think it's too early. Of course, everyone is going to want to predict the future, I get it. But we don't think that assuming our data is going to be replicated by other drugs, other mechanisms, other doses, is a very clear way to predict the future.

What about ex U.S. regulatory? How are you thinking about Europe? How are you thinking about MFN and population sizes.

Yes. I'll say what we're acting on and what we're thinking about, and I think thinking goes with MFN. Clinical regulatory-wise, Vera has conducted its atacicept program in a global fashion. So in both Phase II and Phase III, we have clinical regulatory presence in Europe, in Japan and other ex U.S. countries. And we've made full progress and regulatory discussions across the board. There are differences between regions in terms of how much experience or buy in there is with proteinuria as an accelerated approval endpoint. And so GFR is more important ex U.S. as kind of a general comment I would make.

So you might wait for that, eGFR data?

There's no waiting at Vera, but we don't have to wait. The timing is working out that we continue to make clinical regulatory progress. And we continue to have full optionality. And with MFN, I think we're watching to see how that continues to settle in and being at a point of optionality at this point is a strong place for us to be.

As IgAN one of those kidney diseases that's like has a curiously outsized prevalence in Japan?

Yes, there is a higher prevalence of IgAN in Japan and other Asian countries, China for example.

Like East Asian countries.

On average, I think there's an estimate of 3 million to 5 million patients with IgAN in China for example. And there's a debate is that more disease detection, is it higher diagnosis because of a different health care system and more frequent screening. So for example, in South Korea, there are aggressive screening programs by proteinuria in schools, and they pick it up more. So I think if you look at in schools -- yes, and schools and young people looking at proteinuria. So there are health care system differences that could account for that. And there's speculation as to overall other immunogenic differences, but the fact is it's higher per capita.

Another major focus of investor conversations is your monthly dose or your monthly development of the monthly dosing. Can you talk us through the status of that study and the time lines? And what you hope PD efficacy will look like? What's acceptable and essentially means equivalents?

Yes. I think we can't be overly specific. I can say that we started our monthly dosing study at 3 different doses last year versus placebo. It's not unhealthy volunteers, it was in IgAN patients...

It was started a year ago, right? A year ago...

So that trial has enrolled, and we are looking at a variety of endpoints. And what's important is that we're looking at PK/PD and aligned with FDA and what endpoints are going to be important to bring that forward all the way to the market. So we haven't been specific. We want to look at the data. We want to align with FDA. And I think the most meaningful data point for TheStreet is that, what does that offering look like for patients as a new component of Vera's IgAn strategy? And at the same time, the lion's share of our focus is, of course, on our go-to-market product.

Have you commented on the formulation and concentration of that monthly because I think what we're focused on is like would this have to be an entirely new NDA because the formulation differences would be so different. Obviously, that would be like another patent thing, which I want to ask about. But -- or could it be if the formulation was the same an sNDA with a quick path to the market.

Yes. All those are good questions. We haven't given specificity on dose volume concentration. There certainly are formulations that allow you to concentrate greater than the 150 mg per ml rough standard that we see in the biologics space. And so all of those are under consideration and internally.

When do you sit with FDA to map the cell?

Yes, haven't been specific, but we're looking at data this year. When we look at data, we're going to be carrying that to FDA when we have a view.

Got it. And in our last few minutes, could you review for us the IP portfolio around ataci and IgAN. Also FSGS, I don't think we're going to get time to go into FSGS component of PIONEER, but we're expecting that, too. But IP around those uses and ongoing strategy, IP portfolio strategy.

Sure. So those paying close attention have seen that we've played a pretty standard playbook with IP. This is a biologic, there is the regulatory exclusivity of plus 12 years in the U.S. and 10 years in Europe. That said, we've taken all of the steps required to protect this franchise. Right now, that data is 2047. And so if you think about what it takes to make atacicept as a...

And these are -- use patents.

Yes, this is going to be IP based on process based on formulations improvements, methods of use. So there's a suite of patents that are important in protecting us through 2047, and that's been a development only in the last couple of years within the Vera team. And beyond that, of course, there are -- there's know-how and trade secrets that aren't patented that are really important and actually producing the product. This is really standard. We've seen this play out before in biologics, and that's the approach there has taken. So I think when we consider biosimilar entry to the market, that's further into the future, and I think we've taken all the steps you would expect for a company like ours to protect a very valuable product.

And I think that leaves us 90 seconds for your VT-109, your newest...

Yes. So another part of the extended franchise is the molecule we licensed from Stanford about 1.5 years ago, making good progress. It's still pre-commercial -- preclinical, an interesting molecule that's another BAFF/APRIL inhibitor with a different mechanism, BCMA.

Where would that fit?

It would potentially enable longer dosing intervals than even monthly. So going to quarterly or a few times a year, and that's the promise of another program in the future. So our strategy is to bring a very strong data package efficacy, safety, patient experience with the first autoinjector BAFF/APRIL inhibitor to market and then build on additional extension so that we have additional offerings. So monthly and even less frequent dosing. I come from -- originally from the Gilead world where one pill once a day was a really big deal in HIV, and now it's 2 injections a year. That's an incredible development for patients, for really public health and how we treat people. So it's amazing to be in this position now creating a new category and being the leader in that category, the recognized leader coming out of 2025 and having really the first BAFF/APRIL on the market within a few months. We're ready to launch, and it's a really exciting time.

Great. Well, thank you, guys. We are at time. Thank you for the insights.

Thanks, Ritu.