Hi, everyone. Thank you for joining us today, at the Vera Therapeutics Fireside Chat . I'm covering analyst Ritu Baral from TD Cowen, at the TD Cowen Healthcare Conference. 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. Ongoing FDA review, obviously you guys have submitted the atacicept application. It has been accepted and, you have your July 7th 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, but that seems like a labeling thing, so, you know, what are points of potential FDA focus?
Great. Great to be here, Ritu. Thanks so much. PDUFA date is July seventh. We're in the midst of prior to review, which we're very pleased about the progress. 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. 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 the negotiations happen later in the cycle. I think there's quite a lot of learning that we can already take from the field to date.
We're very confident that we're gonna get to the July seventh PDUFA date, and we're gonna be ready commercially beforehand.
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? You know, there were some 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?
Yeah. Again, I think when we get into specific label and negotiations, that's later in the cycle.
I agree with you. One of the most interesting things from Otsuka's 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. That immediately broadens the patient population who could benefit from that drug. We expect something very similar in our label. 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.
What would it encompass?
There are patients with low proteinuria below a gram, below half a gram, who, despite having that proteinuria profile, are still having rapid GFR loss. Those patients exist. There is, of course, an important correlation between proteinuria and GFR outcome.
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.
You know, we're extremely excited that the overall GFR profile is transformative for atacicept. Having a slope of minus 0.6 at two 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 The New England Journal of Medicine manuscript, 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 gonna define your future health and whether you have kidney function or not before the age of 50 is your GFR. 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. 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.
Some NDA check-off-the-box questions. How's the CMC module? How is your supply chain, potential inspections progressing, and are there any sort of CMC risks to the approval timeline that could trigger a three-month delay?
Yeah, great question. We 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 seventh from Vera's perspective, and those are not issues.
Have you said whether your manufacturers are already CGMP certified or whether there are inspections that need to be done?
Yeah. 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 7th, those vendors that are in our supply chain all have commercial products that have been on the market.
Understood.
Yeah.
The review team, leveling up a little bit, has that stayed intact since the pre-NDA meeting?
Yes.
Okay. All right, those are the check off the box items. Good. Now we get to the interesting stuff. Pricing and commercial strategy. How do you plan on positioning atacicept to the market, especially against sibeprenlimab, especially against potential. Well, Voyxact now approved from Otsuka and potential competition from povetacicept?
Sure. I'll start with a few comments.
Sure.
I'd love to introduce Matt Skelton .
Chief Commercial Officer to the street here. Look, this is a large unmet need. We've been sharing that for some time, lots of patients. I think the majority of the opportunity is in the United States. The majority of the opportunity is young people, commercial pay. We estimate over 70% commercial pay. That's a pretty interesting perspective on what the opportunity looks like. Of course, there is now a track record of premium pricing, including Voyxact's most recent price.
It's not hard to get to a very significant market opportunity when you look overall at the IgAN market. Today, we even see early signs of demand. 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 and FILSPARI. Then what does the Voyxact launch look like in the first.
A few months? Matt, maybe you could highlight, you know.
How fast that was.
some of what we've seen.
Yeah.
Yeah.
About that demand.
Yeah. Hi, everybody. We're super encouraged with the early days of the launch. 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 gonna be good for us, right? I think being a fast follower, having the PDUFA in July and getting out there is the market's gonna be ready, that much more ready for us to come out. You know, 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 gonna 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, you know, what patient response has been to that?
Not much.
Just anecdotal. You know, the, the prefilled syringe is quite big.
It kind of fits in your hand, but not quite.
It's big. It's a high volume. It's 2 ml. We think we have a more elegant solution in an auto-injector.
You know, you mentioned, you know, 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.
A once weekly low volume auto-injector.
Are you currently laying an inventory ahead of the PDUFA?
Yeah, inventory is not gonna be an issue.
Okay.
For us.
It's not gonna show up on... Okay.
No.
No. Yeah.
How are you gonna approach patient identification, assuming approval July seventh? It is gonna be sort of the middle of the summer, which can be weird for a launch.
Yeah.
How are you approaching patient identification, prescriber education, given, you know, the complexity of IgAN diagnosis and management, but also the unmet need?
Yep. A few things. Our sales force is fully hired. They will be trained and in territory 3 months before the launch.
This is the 82 person.
Correct.
Yeah.
Correct. They're all on board, ready to go. They will be out there having those disease state education discussions with physicians, making appointments, doing all the things you can do pre-launch. Everything short of you can't talk about the drug, right? I think those are all really important things to get ready.
As far as patient identification, again.
Yeah.
Back to something I said earlier, is that's why I'm glad that Otsuka's out there talking about IgAN.
Cause you can target Like, you can see who's writing those scripts and target those patients.
Oh, yeah. Yeah.
Quickly writers.
As far as targeting of physicians.
Yeah.
Yeah. It's not 100% straightforward, but we're gonna target about half of the nephrologists in the U.S.
$6,000, right?
Right around $6,000.
Yeah.
Right. You know, for IgAN, there's only been an ICD-10 code since October of 2023. As in the world of coding, that's still fairly new.
We certainly have that data to say, "Hey, let's look at the claims data to see who is using the code." Then through other ways, we triangulate around, it kinda looks and seems like it's an IgAN patient under the care of this doctor, and that was included in our targeting.
Is there a ideal patient subpopulation you think that's a low-hanging fruit? How would you define them?
Yeah, a really good question, and usually when you launch a drug in this, you wanna paint a picture of, "This is the patient to start using this drug." We haven't got to that point yet where I wanna be that prescriptive.
It's changed a little, 'cause I think what you had with the earlier IgAN drugs, you had a proteinuria threshold to which they treated.
Yeah.
Right? Where they had to be over a level to start the drug. That's not the case in the Voyxact label.
I don't think it's gonna be the case in ours.
Yeah.
It's kind of where the physician head is. We wanna meet the nephrologist where they are today, and that will probably tend to be a little higher risk patient as they view it. We'll start there. The key is we want physicians to start using the drug.
Are you given the fact that you may not have proteinuria restrictions on the indication label, are you prioritizing the 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 either on launch as possible?
Yeah. I'm glad we're doing that study. We're the only ones that are studying that.
Yeah.
I think when physicians have those questions, we'll be able to provide answers.
Right
that we're actually doing the work.
Right.
Yeah. I would highlight, you know, this is a large prevalent pool.
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. If you're thinking about 80,000 patients on average 35 years old who are gonna 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, you know, 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.
Right.
That's a lot of patients who need a profile that we think we're gonna have at launch.
Remind me when we're gonna get the PIONEER data that expanded IgAN.
We've guided to the first half.
Okay
You know, roughly the cadence.
The nephrology community is the American Society of Nephrology is a fall meeting in October, November.
Yep.
The other meeting is the European meeting.
Which is in June. We do expect to share some data. We've guided for PIONEER to the first half of the year.
You would have that upon launch?
It would be out there at least in a presentation form.
Got it. What launch metrics do you plan on providing post-approval?
Yeah. I think we're gonna be conservative about that initially. We're not gonna give specific guidance, but we'll certainly give a sense of demand as we come out of the gate. We'll be as transparent as we can and set reasonable expectations, around, you know, how quickly we're gonna change standard of care here.
Yeah. We'll track patient start forms.
I think that's traditionally been, if you look at others in the IgAN space have reported those-
Start forms
... and still report those.
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 atacicept 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, eight months ago.
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, Pre-Approval Information Exchanges, with large payers, educating them on the space, what's coming. We've been doing all of that type of homework and 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 to label. We feel really good about those and think that will probably.
When we hit the market.
Are you seeing any step edits within that?
The only step throughs we're seeing are ACE/ARB.
Okay.
Which I don't even see as a, as an issue.
Yeah.
Again, what you're hearing, is there, acceptance or pushback of combination therapy for IgAN patients, to layer on IgAN, not just ACE and ARBs, but.
Couple like branded therapies?
Yeah. Yeah.
Great question. Haven't heard anything specific to that yet.
I think it's still early days.
Positive or negative?
Yeah.
Okay. How should we think about the mechanics of gross to net? Are you planning like a specialty distributor who's gonna take like a little off the top and then the Medicare/Medicaid discount contributing to that?
Sure.
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 23 1, the automatic 23 1.
Exactly. Yeah. Well, it's a smaller percentage of the business.
Yeah. Our distribution model is through specialty pharmacy, so as you said, there's a little admin fee there. That's something that we are going to keep our eye on is gross to net.
And control what we can control. We'll see how the market reacts as far as any rebating or discounting.
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?
Yep. Our specialists in distribution and building out the hub have been with us now almost six 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 that will do the hub for us.
Oh, okay.
Right? One that they're that physicians are very familiar with, CoverMyMeds.
Okay.
Right? High level of familiarity.
Hey, we realize going into this space that it needs to be white glove treatment, and we need to make sure that every patient in office intends to get on drug.
Gets on drug. 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?
Yeah. I think it depends. You know, 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 solo modulator although we're still interested to see what the two-year GFR data show.
We haven't seen that yet. That's gonna be an important data point. Then there's our data.
Anyone else who comes along. We'll wait to see randomized control trial data, and two-year GFR data is gonna be really important. In our view, efficacy by GFR is really a major driver. We 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 povetacicept. It's been a topic of the posters with zigakibart. How do you see that shaking up, and what do doctors seem to care about?
I think ultimately doctors and FDA and what makes it into the label.
Really depends on controlled trial data. We wouldn't, you know, 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, you know, conducted its Phase II and Phase III program. We did dose findings. We have a clear understanding of dose and safety. I think we'll wait to see data from others. You know, the bar is these are young patients. They want the efficacy of GFR stability, and they don't wanna 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 auto-injector, small volume, and that's the offering we've got. I just think it's too early. Of course, everyone's gonna wanna predict the future. I get it. You know, we don't think that, you know, assuming our data is gonna be replicated by other drugs, other mechanisms, other doses, is a very, you know, clear way to predict the future.
What about ex U.S. regulatory? How are you thinking about Europe? How are you thinking about MFN?
Yep
And population sizes?
Yeah. I'll say what we're acting on and what we're thinking about. I think thinking goes with MFN. Clinical regulatory-wise, Vera has conducted its atacicept program in a global fashion. In both Phase II and Phase III, we have clinical regulatory presence in Europe, in Japan, and other ex US countries. We've made full progress in 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.
GFR is more important ex U.S., is kind of a general comment I would make.
You might wait for that.
GFR data.
There's no waiting at Vera.
Yeah
But we don't have to wait.
Okay.
The timing is working out that we continue to make clinical regulatory progress, you know, we continue to have full optionality. With MFN, I think we're watching to see how that continues to settle in. Being at a point of optionality at this point is a strong place for us to be.
Is IgAN one of those kidney diseases that's like has a curiously outsized prevalence in Japan?
Yeah. There is a higher prevalence of IgAN in Japan and other Asian countries. China, for example...
Like East Asian countries.
Yep
On average, I think, you know, there's an estimate of, you know, 3 million-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 healthcare system and more frequent screening? For example, in South Korea, there are aggressive screening programs by proteinuria in schools, and they pick it up more. I think if you look at.
In schools?
Yeah, in schools. Young people looking at proteinuria. There are healthcare system differences that could account for that. There's, you know, speculation as to overall, you know, other immunogenic differences.
The fact is it's higher per capita.
Another major focus of investor conversation is your monthly dose, or the development of the monthly dosing. Can you talk us through the status of that study and the timelines and what you hope PD efficacy will look like?
Yeah.
What's acceptable and essentially means equivalence.
Yeah. I think we can't be overly specific. I can say that we started our monthly dosing study at three different doses last year versus placebo. It's not in healthy volunteers. This is in IgAN patients.
This is about a year ago, right?
Yeah.
To you started this? Yeah.
That trial is, has enrolled.
And we are looking at a variety of endpoints and what's important is that we're looking at PK/PD and align with FDA and what endpoints are gonna be important to bring that forward all the way to the market. So we haven't been specific. We wanna look at the data. We wanna align with FDA. And I think the most meaningful, you know, data point for the street is that, you know, what does that offering look like for patients as a new component of Vera's IgAN strategy. At the same time, the lion's share of our focus is, of course, on our go-to-market product this year.
Have you commented on the formulation and concentration of that monthly? 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'm gonna ask about. Or could it be, if the formulation was the same, an sNDA with a quick path to the market?
Yeah, 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 biologic space. All of those are under consideration and, internally.
When do you-
Yeah
sit with FDA to map this out?
Yeah, haven't been specific, but we're looking at data this year.
When we look at data, we're gonna be carrying that to FDA when we have a view.
Got it.
Yeah.
In our last few minutes, could you review for us the IP portfolio around atacicept and IgAN? Also FSGS, I don't think we're gonna get time to go into FSGS component of PIONEER, but we're expecting that soon too. IP around those uses and ongoing strategy IP portfolio strategy.
Sure. Sure. Those paying close attention have seen that we've played a pretty standard playbook with IP.
Yep.
This is a biologic. There is the regulatory exclusivity of +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 date is 2047. If you think about what it takes to make TACI-
These are use patents?
Yeah.
This is gonna be IP based on process, based on formulations improvements, methods of use. 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.
Patented that are really important in actually producing the product. This is really standard, and we've seen this play out before in biologics, and that's the approach Vera's taken. I think, when we consider a 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.
I think that leaves us 90 seconds for VT109.
Yes.
Your newest pipeline candidate.
Yeah. Yeah. Another part of the extended franchise is the molecule we licensed.
From Stanford about a year and a half ago, making good progress. It's still pre-commercial... pre-clinical. An interesting molecule that's another BAFF/APRIL inhibitor.
Yeah
With a different mechanism BCMA.
Where would that fit?
It would potentially enable longer dosing intervals.
Than even monthly. Going to quarterly or a few times a year, and that's the promise of another program in the future. You know, our strategy is to bring a very strong data package efficacy, safety, patient experience with the first auto-injector BAFF/APRIL inhibitor to market, and then build on additional extensions so that we have additional offerings. Monthly and even less frequent dosing. I come from, you know, from originally from the Gilead world, where, you know, one pill once a day was a really big deal in HIV.
Yeah
2 injections a year. That's an incredible development for patients and for really public health and how we treat people. It's amazing to be in this position now, creating a new category.
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.
Okay.
Thank you for the insights.
Appreciate it. Yep.
Thanks, Ritu.