Okay. Morning, everyone. My name is Maury Raycroft, and I'm one of the biotech analysts at Jefferies. It's with great pleasure that I'd like to welcome Ben Palleiko, the CEO of KalVista. Thanks so much for joining us, Ben. And for those who are new to the company, maybe give a one-minute intro to KalVista. Absolutely. All right. First off, thanks, Maury, for having us here, and thanks to Jefferies for the continuing support along the way. KalVista Pharmaceuticals is a soon-to-be commercial company. We are developing sebetralstat for the on-demand treatment of hereditary angioedema. We have a PDUFA date at the FDA of June 17, so right around the corner. Although that is the biggest near-term event for us, we also have multiple other filings around the world, and we expect to be in a position to get European approval later this year and launch there, and get approval and launch in Japan early next year. We are on the way to ideally being a global commercial organization here over the course of 2025. Got it. Yeah, it's a great intro, and you're in the home stretch with the approval coming up in less than two weeks. It'd make your drug, sebetralstat, the first oral on-demand drug to enter the market. What can you share about your latest interactions with the FDA? What's been discussed, and what still needs to be addressed? Is everything on track for the PDUFA? As far as we know, everything's on track for the PDUFA. The FDA, despite all the concerns you've kind of heard generally, we've seen no disruptions along the way. Our review team hasn't changed. All the people have always been in the meetings who need to be. All the timelines have been met. There has been no disruption whatsoever with the FDA. As far as we can tell, we're coming down to the wire, obviously. We've said for a while we've been in label discussions. There's always a little bit of back and forth on that. That seems to all be going well from our perspective. We continue to think they're right on time, and they'll meet the date. Got it. What's the latest you can say related to key discussion points and what's going to be included on the label? Oh, at this point, it's really down to some minor details: tables in or out, the way things are formatted. There's not a lot, there's no real existential issues involved here from our perspective. Got it. You have mentioned in the past you expect it is going to be a broad label as far as region, attack severity. Anything you could say on redosing and whether that is going to be called out in the label? Right. We do expect it to be broadly for the treatment of acute HAE attacks. We do expect it to include adolescents and up. Again, adolescents, we do not talk about much, but that is a group with really high unmet need because functionally all they have available nowadays under age 18 is intravenous therapies. A lot of unmet need there. We do not expect to have any restrictions on laryngeal attacks. We think that will be covered. Obviously, all the other severities would be as well. I think we do think the label is going to be very favorable. We are just kind of just sort of settling in on that with them. Got it. Okay. What can you say about how packaging is going to work commercially? It'll be boxed with individual doses in wallets. Each box will contain multiple doses. We haven't really talked about that yet. You asked about the redosing a minute, but it probably a little bit depends on where the FDA comes in on some of those topics. We have it all kind of ready to roll here once we get the final label settled. Got it. Okay. So when you get the approval, we'll learn more of these details, and we'll see the label. Yes. Yes. Our plan is to have a post-PDUFA conference call where we'll talk about all these details. Got it. Okay. That's helpful. Thinking about the launch, can you give us an update on your team's latest efforts in getting ready for the launch in terms of doctor-patient engagement, Salesforce, supply chain, et cetera? Where are you spending the most time, and what else needs to be done? Yeah. Yeah, I had the great pleasure of spending the last two days, actually, at an offsite that our commercial team had this week where they're going through their final training to get their certifications to be actually able to go out and start actually talking to offices about the drug post-approval. It's a terrific group. I mean, I think I've said before, even though this is a company as our first launch, we have a tremendous amount of experience in HAE. All of our senior leadership have actually launched multiple products in HAE previously. Over half of the field team either has been in HAE or was currently HAE when they joined us. This is a space we know really well. The team is really fully prepped and ready to go. Again, this week has been all about getting the final training, going through the final marketing materials and the visual aids and things of that sort. A really granular set of conversations. In terms of what they've done up till now to get ready, I've said before, there's about 2,000 physicians in the space who really ever write a prescription. We tier them out with about 200 physicians writing half the scripts. About 90% are written by 1,000 physicians, and then the other 1,000 are the small numbers. When we got started, we'd have been pretty satisfied if the team had really just profiled all of tier one and most of tier two. We thought that was a fairly ambitious goal. Actually, as I learned this week, they've profiled almost every one of the 2,000 physicians. They've gotten virtually all of the tier ones, literally with the exception of maybe one or two docs. Tier two, 95%-98% of them they've done, and again, almost all of the tier threes even. We have profiled and actually interacted with essentially all physicians who prescribe in the space at this point. We're very comfortable based upon the enthusiasm we have with physicians that they'll be supportive here. From the patient side, obviously, none of that really you can start until post-approval. We've said before that we have been building a database where patients can opt into. As of this week, I learned we have 2,700 people in that list. That is probably a third of the addressable population in its entirety. Assuming the FDA approves it on time, we think we're going to be in a really good position to very quickly get out to those folks and start to get the word spread. From a supply chain perspective, again, we have a really good supply chain team that's very experienced, and everything's been settled. We've got the whole chain set. We've got the drug ready to go. I mean, all we really need literally is the package insert and then box it up and ship it. We'll be able to move very quickly post-approval to get this out into the marketplace. Got it. If you've interacted with most of the 2,000 doctors, you've got 2,700 potential patients signed up. It means there's pretty good awareness overall. Yeah. Yeah, we think the awareness is among physicians, it's obviously extraordinarily high because, again, we've had a medical affairs team that's been out talking to these people in some cases for three years. So the physician community, I think the awareness is very high. Patient awareness obviously lags a little bit because it has to. I will say I was fairly astonished to hear that we had that many people already who'd shown interest, again, without us actually in any way promoting this to them. I think that just really indicates how high the organic interest is in a therapy of this kind and how much people are really searching for an oral option. I think we're quite pleased with where we stand now. It's important to note, though, that we're not just resting on that. We have a very aggressive plan to get out and raise awareness extraordinarily quickly post-approval. Got it. You mentioned the experience on the sales team. You have a Chief Commercial Officer who has pretty strong experience from prior launches. Maybe just talk about her background and what you guys have learned from prior launches and what you want to leverage and avoid. Yeah. So again, tying back to the strength of the team here in place. Right. Our Chief Commercial Officer, Nicole Sweeney, actually has launched both FIRAZYR and TAKHZYRO with Takeda. She ran the HAE franchise at Takeda. She has obviously extraordinary experience in this space. Our head of U.S. sales and marketing also launched both drugs in this space. Our head of Europe has actually launched three drugs. She launched BERINERT as well. Our head of Japan launched FIRAZYR in Japan. Our head of the patient hub ran the rare disease hub at another large Japanese pharmaceuticals company. We have, again, I told you that over half the field team has been in HAE or is currently. For a first-time launch company, we have an extraordinarily high level of awareness, understanding, and just knowledge about this marketplace that I think really positions us well and has put us in a place where even though we're going out with this early drug, we've got field reps who are very well known to the offices they're calling on, have great relationships, and I think that's going to carry through. Got it. What feedback have you received from payers on pricing and potential generic step edits? It's important to note that HAE is a pretty small category for payers generally. Within that category, prophylaxis is the biggest, far and away the biggest expense for payers. On-demand is a fairly small portion of a fairly small category anyway. However, obviously, we don't take anything for granted. We've gone into the payers over time here with, I think, a very strong value proposition, talking about all the things we've talked about with the investor community as well for years, right? The fact that people don't treat enough attacks, that they have all these debilitating symptoms as a result of it, the fact that on occasion they end up in the emergency room as a result of this, which obviously makes the cost of this skyrocket. We've come in with a very strong value proposition. At this point, we've talked to over 60 payers, just to give you a sense of the number of these pre-approval payer interaction meetings we've had. We've not taken for granted the fact that this is a very efficacious drug and it's safe. We've really gone in and talked to them about how this is actually going to benefit patients and be worthwhile within the category, even though there's other options in the category. The reception has been very strong as a result. We've consistently said that the price range that exists on on-demand therapies, if you look at it on a per-dose basis, is somewhere between roughly sort of $12,000-$16,000. We think it's completely appropriate to price within that range. We don't need to be heroic here about looking for premiums. We think that'll yield us with a very favorable access profile, certainly on par with the other therapies out there. In many cases, I think maybe we might do better. Formulary conversations will roll out over the next six months. That ties into things like step edits. I mean, obviously, if you talk to 60 people, you get some opinions on everything. We do not really think step edits are a significant issue. There is definitely a step through to branded FIRAZYR. Most payers have that. You have to step through to get to branded FIRAZYR. I am not actually aware of any payers that require a step through generic icatibant to current branded therapies. We do not really expect that to be an issue for us as well. Got it. Is that the same, or do you see any trends for that based on the commercial payers versus the Medicare, Medicaid-focused payers? Just to step out of question. Yeah. No, I'm thinking about it. No, actually, today we don't really see any differentiation at all. People get the fact that people have generic—I mean, something like 80% of all HAE people have had or currently have generic icatibant. So the exposure to generic icatibant is extremely broad. The truth is, even if people did want to consider a step, pragmatically, people have already kind of gone through it. That does not matter whether they're commercial or government pay, which, again, is not a huge share for us of the overall universe. This is roughly a 70% commercial space. Almost all the rest is actually Medicare. Right. Okay. Helpful. Is there a scenario where oral convenience works better than expected and patients are, A, running out of drug too quickly, or B, you start getting payer pushback based on the amount of drug used? Yeah. We thought about this. It is true that when you talk to people about why they do not treat attacks, commonly it is because basically I did not have my whatever, my icatibant with me, or I am just reluctant to use it because of the pain, the logistics, the whatever. You are spot on that you do hear when you talk to people that there is an issue sometimes that they are worrying that if they use it up for less severe attacks when they have a really severe attack, a laryngeal attack, that they may not have it available. Ensuring that people have constant access to the therapy has for a long time been one of our primary concerns. As we have set up the patient support services activity, we have talked about that. The way you deal with that is, especially in this on-demand space where people have to, there's a refill that's required to sort of get done. We have worked through a plan where there will be a fairly routine set of outreach to people, especially in the early days when they're trying to settle in and understand how the therapy works, both to make sure they're having a positive experience generally, right? Support them as they need, but also to make sure that they're not in a position where they worry about running out of drug. Our team is prepared to, as part of those conversations, make sure that people always have sufficient amounts on hand. If, to the extent they're running out ahead of schedule or there's some other challenge, to help them sort through that to make sure they always have what they need. That's a great question. In terms of how that works with payers, the truth is we'll see. For the first year or so, realistically, payers are going to sort of roll with it and see how their experience develops. I mean, we expect to start—I mean, like everyone, it always takes six months really to get formulary. We'll work through that process. There's going to have to be some water that goes under the bridge here before they actually come to some conclusions about what the usage rates are like. Those may bounce around a little bit as people are experimenting with the drug and finding out what works for them best. If that becomes an issue for payers, we'll work through it. Realistically, that's a little ways off for us. Yeah. It could be a good problem to have at that point. You commented during your investor commercial day that the plan is to share more insights on launch metrics as the launch advances. What are the metrics that you plan to share early on, and how do you expect these metrics to evolve as the launch advances? Yeah. Yeah. The early data set is largely interaction-based, right? It's physician interactions. There'll be some patient kind of outreach numbers, those kind of things. That'll fairly quickly evolve into things like quick start forms, right? That we'll start to talk about. As you move a little further in the launch, you start getting into multiple prescriptions written by physicians. You'll obviously start to move into refill metrics, right? That's probably toward the tail end of the year by the time you get to refills. We’ll have a steady cadence. I don't think it's a whole lot different than what anybody else puts out there nowadays, honestly. We're cognizant of the fact that we have to provide these metrics for people to understand the launch. What we have said is we'll put out whatever we can that's useful to make sure that people have the adequate information to understand where things stand. Got it. Okay. Makes sense. Any thoughts on just how you're setting expectations for launch? Consensus numbers, I was looking at those the other day. They're higher than where we're at currently. I don't know what your thoughts are for the first couple of quarters, if you can comment on that. Yeah. There's probably a little bit more than an average dispersion of views on the launch, right? Because it's a little bit—I mean, there hasn't been a launch like this in a long time. I do think one of the challenges people have is trying to model it. That's one of the reasons we tell people we'll provide this kind of fulsome set of data because it is definitely trickier than average because, again, people have to get refills. We haven't guided to any of the numbers. We don't really comment on where the street stands. I think all we tell people is that we think the fundamentals are good here. I mean, again, it's an efficacious drug. It's utterly been shown to be safe in multiple clinical trials. We think physicians have high awareness and high enthusiasm. We think patients will as well. We're optimistic. We do not take anything for granted. The plan is to get out there and work hard to make sure that we make this go as well as we would like it to. Got it. Okay. Where do you expect first adopters to come from? You mentioned the database already where you've got 2,700 people signed up. Can you also talk about the use of free drug initially and maybe early launch incentives to get patients to try the drug out? Yeah. Yeah. If you talk to physicians about who they think is going to be the appropriate patient for this, almost uniformly, this almost makes it harder. They say everybody. There is really no subset they will point you to. The question becomes who is going to be more motivated to sort of call their physician and get out there to get it early. There is clearly a subset of patients that have very high on-demand usage rates. A priori, I think our expectation would be they are most likely to be the ones who are enthusiastic about getting in. Certainly, as part of the practice profiling effort, when our team goes in and sits down with physicians to the extent that everyone is willing, we will talk about in general terms what the patient panel looks like, what the need is, right? Physicians will, at some level, create their own list of—in fact, some of them explicitly have created their own list of, "Here's my first contacts," right, of people I'll go to. I do think that's generally going to be more likely to be the high-burden patients. Although the truth is, it's almost anybody's guess. That is one of the reasons we have said that in the early days, the uptake curve could be a little jagged because you can certainly see the case, especially when you have small numbers of patients on therapy where, one, we could get a bunch of high-use patients, and the next week you get a bunch of lower-use patients. The numbers kind of may move a little bit. We will, I guess, at some level, just like everybody else, we'll see. We have put a lot of effort into working with the physician offices to help them understand their patient panel, talk about where those people's needs stand, and make sure that to the extent possible that they are being contacted, the highest-need people are being contacted early. Got it. For prescribers, you mentioned the tier one, tier two. Are the tier one prescribers going to be the ones that are prescribing the most initially, or do you think, I guess, how do you see that playing out? Are they going to be more reluctant to change all their patients over? Yeah. Frankly, tier ones probably have the highest level of enthusiasm because they're the ones that have known this drug for the longest, right? That is the group we have been talking to for three years. Certainly, the tier threes, if anything, are the people who we haven't spent as much time with to date and who may be a little slower on the uptake. The tier ones, again, they're half the prescription volume just by themselves. We think that there's a very high level of enthusiasm. We know of a fair number of those people that are proactively planning to call effectively all their patients very quickly and sort of introduce them as an option. We will have some different support mechanisms for them to do that outreach as well. I think it is very likely that rather than being reluctant, actually, they are probably the most eager prescribers. In terms of adoption, to your point, like the risk of it, people tend to have some amount of icatibant or whatever else they use on hand. In terms of the transition over, to the extent, and I think it is not unlikely that there is some concern among patients that they are trying a new therapy and they want to make sure it works for them. They are all going to have probably to a great extent this kind of safety net of whatever they were using previously. They will still have some on hand. Definitely, that is something we are aware of. I mean, when you take icatibant, it hurts. It hurts to inject yourself, obviously. The drug is really acidic, right? It hurts as it disseminates. People get a little bit of a pop from it, they say. There is an absolute physical sensation here. No one's going to get that with sebetralstat. You take the tablet. Obviously, everything, the efficacy is great, but you do not get the same physical sensation. We are definitely cognizant of the fact that there is going to be a little bit of a process of getting used to. This sounds a little backwards almost, but getting used to having a therapy that works without being painful. Yeah. Yeah. Interesting. As far as what your team can do, I think you mentioned they can work with the doctors to help with outreach to the patients. Can they also help with just the paperwork for facilitating switching from acai to? Yeah. Yeah. You actually asked about free drug ImmunoGen. This ties into that. We actually have a quick start program that we've put in place. The mechanics here are that there will be a form. It will be available either online or printed out. Following the physician visit, whether it is live or it could even be telehealth, that form gets completed by the physician, in addition to the prescription. That goes to our patient support services, the patient hub. They process to confirm insurance. Immediately, for everybody, they will ship the first box of sebetralstat to that person. People will, ideally, fairly quickly after they get the prescription written, get their first box to be able to use. The idea here is that the expectation is this, as an average, that this first box probably lasts people plus or minus a month. During that time is when the payer assistance team is working on getting commercial coverage put into place. Ideally, in most cases, when they have the next shipment, that's under commercial coverage. Essentially, everybody will be getting free drug on the first go. Got it. For getting onto formularies, you're thinking like six months- nine months? Absolutely average. I mean, I guess if volume really took off, some people might move earlier. That is kind of what the norm is, and we fully expect to be within that range. Got it. Okay. We talked about metrics. Do you have a general sense of when you'd want to provide initial revenue guidance? Not for a while. The numbers are going to be pretty small for the first quarter or two, right, to the point of free drug and kind of getting up to speed. Realistically, it takes a little bit of time to build. Plus, we're currently on an April 30 fiscal year. We're in the process of changing that to a calendar year, which is something people have asked us to do for almost a decade, right? There is going to be a little bit of an offset in how our reporting goes nowadays. The first quarter we'll report will be a quarter ending July 31. Obviously, that'll come out in early September. That will be as good an update as we can give on the first month or two after launch. After that, we'll have another update in December. Again, just to set expectations properly, the first quarter or two are not huge numbers, but then they ideally grow meaningfully after that. Got it. Okay. Maybe talk about XUS. You mentioned Germany, U.K., Japan, and you've got the partnership in Japan. Would you do similar deals like the deal with Kaken in Japan? Yeah. The Japan deal made a lot of sense for us because we have an excellent team in Japan, a really good group. In terms of the investment, especially in today's world, the investment required to sort of build a commercial effort and the risk attached to that, Japan's a little bit of a complicated market. Getting an established player in the market that already has the physician call point, that has the team that can sort of do it efficiently made a lot of sense for us. That was the basis of the Kaken deal. The financial terms were quite favorable compared to where the market sits. Outside of that, we've always said we plan to launch in Europe on our own. That continues to be the case. Europe, you can do really efficiently. Again, we've got a lot of experience launching HAE products in Europe. I talked about that a few minutes ago. Europe is primarily, to be frank, Germany. Germany plus the U.K. together is probably two-thirds of your total European revenues. Germany, you can obviously launch extraordinarily quickly at post-approval with this kind of free pricing dynamic they have. Germany makes a lot of sense to go to immediately, which is why we will. The U.K. also makes a lot of sense to go to. Plus, the company has a meaningful presence in the U.K. Beyond that, Europe will kind of roll out over time. The point is, we like Europe. We can cover Europe on our own. We think the economics make sense the way we've conceived it. We've got a very lean team in Europe. Our plan is to continue to move that forward there on our own. Outside of that, by and large, we'll do commercial agreements around the world. We've got a number of those already in process. I think you'll start to see those roll out over the course of this year to cover some of the other territories. Got it. Okay. I wanted to talk more about the market opportunity as well. What are your latest thoughts on just the on-demand market size based on your market research? What are the key drivers of sebetralstat and what you're going to do that will expand the on-demand market? Yeah. We've put these numbers out a fair bit. If you look at the on-demand doses, if you will, in the U.S., I'm only going to talk about the U.S. right now today. There's right around 84,000 plus or minus doses per year that are prescribed and used. That accounts for the fact that some things like RUCONEST use multiple vials to treat an attack. If you looked at units, it would give you a bigger number. The units obviously do not account for the fact that some of these drugs use multiple units to treat one attack. It is basically one attack treatment. If you put a branded price on that, if you just took that 84,000, you put the FIRAZYR WAC, which is right around $12,000 on that, you're obviously meaningfully north of a billion dollars already. The actual dollar size of the market nowadays is much less than that, largely because you've got generic icatibant, which is majority share and is very low priced. If you branded the market as a whole, you'd be comfortably north of a billion dollars. We think that icatibant users in particular will switch at a very high rate to sebetralstat. We think the offering is particularly appealing to them, and so there's some market share expectation on that. Importantly, though, we also think that the market can grow because it's well known that people only treat about half or maybe two-thirds of their attacks nowadays, and so undertreatment is rife. What we expect is that people will treat meaningfully more attacks in the presence of sebetralstat. That is not to suggest that they treat attacks unnecessarily, but they have attacks now they should treat that they just do not. To give a comparator, in our open label extension right now, people are treating right around 83% of their attacks. It is, what is that, 25% higher than you see in the real world nowadays. In addition to the whatever portion of the market we can capture from switches, we do think usage will go up meaningfully, and that will be beneficial. Over time, I think you start to think about how the market might evolve a little differently. Everyone assumes that people kind of inexorably come in and go on to prophylaxis and stay on prophylaxis. That is because there is really no better option nowadays. I mean, the truth is, if you're thinking about the trade-offs between treatment benefit and treatment burden, prophylaxis is absolutely your best choice nowadays for many people, which is why two-thirds of the market or more is prophylaxis. In the future, though, in the presence of sebetralstat, we think there's a lot of people who may reconsider that, whether it's actually still the best benefit for them. No matter how efficacious your prophylaxis is, 30 tablets a month is a lot of tablets. Two injections a month or even one injection a month is a lot of injections. Certainly, there are people who have very severe disease who really need that. Clearly, there's a place for prophylaxis for a meaningful portion of this marketplace. In the world today, because of the fact that treatment burden is so high in many cases, there's probably a fairly significant percentage of people who currently use prophylaxis who may start to reconsider that as sebetralstat becomes available. They get some use from it, get some experience treating breakthrough attacks with it. They may well decide that actually this works just fine for their purposes. There's probably some incremental growth there in a different way than I think people think about nowadays, which is to assume that prophy kind of grows to the sky. Yeah. Yeah. Great overview of the market dynamics and how this could play out for on-demand. Quick question, just whether you're having conversations with prophy companies about potentially collaborating in some way to maybe bundle products commercially, or how do you think about that? We like sebetralstat. We think it's going to do really well. We don't think we need to tie up with anybody. We're completely happy to be Switzerland here in this case. Prophy is a complicated market. It's probably on the cusp of becoming hyper-competitive, right? You've got four therapies approved, two more coming this year, and five more behind that. The prophy dynamics are probably a little bit tricky nowadays, and I think going to get vastly more tricky in the next few years. We think the on-demand dynamics are much more straightforward. We think we have the dominant therapy in the space. The nearest potential competitor is a long way behind us. We think we can bring a really high-value offering that people are going to enjoy and appreciate. We can let the prophylaxis market play out however it does without any regard to us. Got it. All makes sense. Maybe just in closing, if you want to mention just key financials with cash and where that gets you. Yeah. Again, we're in April 30 fiscal year. At this point, the last quarter reported ended in January. We had right around $250 million in the balance sheet at that point. We've guided that we're funded into at least the second half of 2027. We've also said multiple times that we expect that, again, we run a lean operation. We do think we could become cash flow break-even on the sales of sebetralstat within a few years after launch. We feel like we're in a financially really strong position. We've got all the resources we need to do the launch very well. We don't really foresee any cash limitations here on getting this drug out to people or for the foreseeable future. I think we're really content with where we stand. Great. Thank you very much for joining us today, Ben. Thanks again. Nice talking to you Maury.