Hi, everyone. My name is Maury Raycroft. I'm one of the biotech analysts at Jefferies. I'm happy to introduce Ben Palleiko, the CEO of KalVista. It's a fireside chat format. Thanks so much for joining us today, Ben. Maury, thanks as always for the invite, and grateful to Jefferies for all they've done with us over the years. Happy to be here. Maybe starting off, if you can give one minute intro to the company for people who may not be familiar with the company. Sure. KalVista Pharmaceuticals is a commercial pharmaceuticals company nowadays. In July, we got FDA approval and then promptly launched our first product, which is called EKTERLY. EKTERLY is approved in the U.S. and actually multiple other countries now for the on-demand treatment of acute attacks of HAE. HAE, for those of you who don't know, it is a genetically driven disease where people have these episodic bouts of potentially severe swelling. There's a number of therapies available for it. They all work reasonably well, but the critical difference of EKTERLY is that it allows people to treat it using an oral therapy for the first time ever. That's a fairly substantial advance in the space that I suspect we'll talk about more. Yeah, yeah. Launch has been going for about four and a half months. Understanding it's only been about a week since your third quarter update. Maybe can you give some more, maybe we'll try to get some more clarity on some of the metrics. So far, you've got 937 star forms. How are you setting expectations for penetration and cadence of new patients through 2026 as adoption broadens? Sure. Yeah. As of today, we're actually over 1,000 patients on therapy. You know, comfortably over 10% of the marketplace at this point, making our way to whatever that would be, 12% or 13%. The uptake, you know, just given from that statistic alone, you can presume has been extraordinarily fast. There's, again, coming back to what I said in my opening remarks, that this is a meaningful therapeutic advance for the category. A lot of people have known over time they should treat their attacks more frequently, and they should treat them earlier in the cycle. For a lot of reasons, having to do with the fact that all these other therapies existed until EKTERLY were injected or even IV infused, they just didn't do it enough. The reason for the swift uptake is the fact that for the first time, we've given people something that actually enables them to treat their attacks in the way they're supposed to, the treatment guidelines call for. Again, EKTERLY, the name was carefully picked because it ties to the concept of act early, which is exactly what people with HAE are supposed to do. Treatment guidelines call for patients to, first of all, make their own decisions about the treatment of attacks. Second of all, to consider treating all attacks. Even mild attacks can become very significant. They can escalate over time. If you're going to treat, you should always treat early. EKTERLY is, among other things, a call to action to remind these folks that they should be treating their attacks early. Based on the evidence we've seen in both the clinical trial program and to date in the marketplace, you know, that's exactly what they're doing, which is one of the reasons patient satisfaction so far has been so high. Got it. Yeah, it's helpful. Maybe clarify, so when patients get their patient start form, they get a free drug sample, and then they go on to pay drug. How does that work? Maybe just talk about the expected time to pay drug as payer policies mature in early 2026. Absolutely. Right. The first part, the mechanics can be a little confusing. We do try to explain this a little carefully. When a person goes in and talks to their physician about EKTERLY and decides it's the right approach for them to take and wants to switch, the physician effectively writes them two prescriptions. One's called on what's called a start form, where they get a lot of data, insurance information. You can find it online. It has a lot of information. The second thing is the physician writes them a prescription for EKTERLY. They actually will get a standard prescription, right? They're usually written with an initial fill quantity. Could be one carton, could be more cartons. Typically they're written as refill as needed after that. They are usually valid for a year. The key point here is this is not a sampling program. People do not just get EKTERLY and take it home and try it. People actually agree to switch to EKTERLY to do this. Both those start forms go to our patient services hub. The hub then confirms the person has insurance coverage. Once that has been done, we will actually ship them, what you said, the free drug, this initial carton of EKTERLY. The idea here is let them start getting experience. Let them get it in their house. They are probably still going to have—they are almost certainly still going to have their prior on-demand therapy available to them. Let them get experience using Ekterly in a low-risk environment. At the same time as they are doing that, the team works through to get the commercial coverage. As soon as commercial coverage is reached, whether or not they have used their free drug that we sent them earlier, we will then give them the initial commercial fill called for in the prescription. They are on Ekterly, and they will go from there and refill as needed. The mechanics are, it sounds a little complex sometimes. People, I think, have wondered sometimes, do you have to use all the free drug before you can get commercial? There are a lot of questions. That is how it works. It is very seamless, would be, I guess, the right word for the thing. The second part of your question, I forgot, I guess. Just the expected amount of time to pay drug as payer policy. Oh, yeah. You know, in initial start, it does take a little bit of while. These are effectively, it's 100% medical exception coverage to get going. You know, that's sort of a six-eight, maybe a little longer week process on average. That does disguise a wide distribution of time frames. We've had people come in with a prescription and immediately go to commercial. We've had people take meaningfully longer than that as they go through, you know, because there can be multiple rounds of appeals processes. These all have to be done by the physician offices, which can be onerous, right? We're not allowed to help them along the way. It can take longer. As it matures, what we'd expect is that time frame will compress down. Payers get more experience with EKTERLY w e get more experience of what they require to help make some decisions. As you get to formularies, which is really a 2026 event, that's when the time frames start to become more efficient. Because now, typically, we've gotten some payer coverages already. They've generally been favorable. Generally, they're what's called PA to label, prior authorization to label. Once you have that, that's a pretty straightforward process because you know what the payer is going to require. You just have to get through it. The timing gets more efficient. In the early innings, it takes a while. Even in the future, over time, routinely in this space, companies will always end up with 20%-25% of folks who are always medical exception. That's just how it works. Okay. Can you provide any perspective into refills so far and how the new starts to refill mixture can evolve over time? Yeah. Refills to date are still evolving. We have seen, among all prescriptions, refills. One of the questions people had was, will people just get one box, one carton, and then just never use it, never refill again? I think we've fairly conclusively disproven that. We're definitely seeing people of all disease severity levels getting refills. Of course, factually, the people that have the most refill requirements are the people with the most severe form disease. They can be quite high-frequency users. We define in our criteria, people with two or more attacks a month, we consider to be people with severe disease. Right now, they're probably 15%-20% of the total patient population. At the moment, because they're the highest users of on-demand generally, they're an outsized proportion of the people that have switched to EKTERLY so far. At the end of the September quarter, about half of our prescriptions were with people in the severe disease category. They refill at much faster rates. Their average refill to date has been something like three to four weeks. They are typically refilling with multiple cartons. That is a very high frequency. Those people will probably continue to go at that rate. Certainly, as we get into the broader population, the average refill rate will certainly come down because, again, those folks are 20% or so of the population. In the long run, when you look at how refill rates work in the space, with Firazyr, based on claims data, we think people refill about three or four times a year, so every three or four months. Given the fact that we expect them to use more EKTERLY than they use Firazyr, that could be a slightly higher frequency for us. We'll be making our way to something less than three or four weeks, or I guess longer than three or four weeks as an average refill time. Got it. Okay. Base case is refills could look similar to Firazyr, but because you've got an oral drug, it could be more convenient, could be higher than that. I think the base is probably higher than that. It is going to take us a while to get to the long term. We do continue to expect that for the foreseeable future, a disproportionate share of the new patient additions will be these severe disease folks. That number will not shift dramatically, probably in the near term. Over time, it will trend downward. Yeah. How long did it take for Firazyr to get to like a steady state? In terms of just the overall? I mean, I think that, well, that drug grew all the way until it went generic. I mean, you know, at a pretty substantive rate. I mean, because again, that was a step change. Because until Firazyr, all you ever had was IV therapy. So that grew very consistently, basically until genericization. We think EKTERLY is the next step change in the space. Got it. Trajectory could look similar to that. In the long run, this whole market should convert to orals. I mean, just to put it out there, right? I mean, there's no reason to stay on an injectable therapy in the presence of EKTERLY, which requires you to make no trade-offs for the benefit of it. Coming back to this kind of consistent growth, this entire on-demand space should, over time, switch to oral. Right. Yeah. Okay. Maybe going back to your earnings update. You had $13.7 million in revenue last quarter. Are you putting any additional granularity behind the number in respect to inventory versus patient use? How should we think about getting to an inventory steady state? Yeah. Most of that's going to be, I mean, most of that's going to be usage, to be flat out. Now, we haven't talked about it as a split between new patients and refills. It is mostly usage. Certainly, there's some inventory build in there. This isn't a space where you have massive inventories. I mean, our CFO consistently talks about you maybe get three, four weeks of inventory. The dollar amount, of course, of that will grow over time. As a percentage, it should stay somewhat consistent. This does reflect actual, primarily end user demand for EKTERLY, and then to a lesser extent, just because of the time we've been out there, refills. To your point, Maury, over time, refills will become a more substantial percentage of the overall revenues. We're still a ways off from that for a time period to come here that just the gross new patient adds are going to be the primary driver. Got it. Okay. For refills, do you think some patients could try to stockpile some of the drug? Is that a possibility? Do you think there could be some payer quantity limit issues as well that you're in? For sure. Okay. Factually, we don't know. Certainly, we expect, it seems almost certain that people will stockpile this to some level. I mean, we've talked about the fact that people don't treat enough attacks. One of the reasons they don't treat enough attacks, probably the primary reason, is they don't like the current injectables. The other reason is they don't have it with them. They don't carry it. EKTERLY is absolutely, I mean, the way that it's designed, it's in a—they come two doses in a carton. The doses are in these really convenient wallets. It's the kind of thing we intentionally made it so you can keep it in your backpack. You can leave it in your office drawer, right? You can have it sort of in the places in your life where you have attacks. Up until now, you didn't have the opportunity to treat them. We have a terrific anecdote of one woman who, very quickly after approval, actually had EKTERLY with her and was driving to work and felt an attack come on. She actually treated herself at a red light. Popped it out, took the tablets, went about her business, and said she felt great in a very short period of time afterwards. That is a poster example of the benefits of this therapy. If she'd had her—I think she was a icatibant user beforehand, right? In that case, you're not going to treat with icatibant at a red light. She'd have had to take a whole different path to treatment. Yes, there will be some level of patient stocking. Do we think it to be dramatic? Probably not, right? We think a lot of this is going to continue to be kind of recurring usage. Got it. Quantity limits you asked about as well. Payers do typically manage all the branded therapies by quantity limits. Most commonly, they're letting people get around two whatever cartons. A month is probably an average quantity limit. We don't think that's going to infringe on the vast majority of users. To the extent you have these high volume users, in particular, they're already well known to the physicians and to the payers. They're the kind of people that you can get exceptions for. Yes to quantity limits as a probable event. Certainly no worse than existing branded therapies. Certainly not in a way that we think is going to infringe upon people's reasonable access to the drug. Got it. Makes sense. Based on what you've said so far, it sounds like patients should be pretty sticky to EKTERLY, too, where you're not going to have any reason for patients to switch back to injectable or drop-off treatment. Is that fair? Yeah, absolutely. Again, there are no downsides to EKTERLY compared to the other therapies out there. All it does is make your life better because you have it with you and it's easier to take. You will treat more attacks and you will treat them earlier. Stickiness also involves other things, including, for example, patient services. We have a patient services is sort of a mandated element of this space. Everybody has to have a really robust operation. We have a terrific one. We actually did an initial survey a few weeks ago just to get initial kind of feedback from patients. We are rated right up there on par with all the other ones in the space, despite the fact that they have been there for 10 years and we have been there for not much more than 10 weeks. Got it. Maybe just comment on how safety or adverse events looks post-launch compared to your clinical study so far. Yeah. In the real world, you have these Firazyr updates that come routinely. Our Chief Medical Officer gets Firazyr updates every day. They've transitioned the program so every single thing goes into Firazyr, basically. Nothing is showing up of any significance at all. We've seen nothing that looks different or has at all altered the safety profile of drug, which through the entire clinical development program has been absolutely pristine. Got it. Okay. Of the 423 unique prescribers, how many are Tier 1? How should we think about the cadence of new prescribers in 2026? The majority of the early prescribers will be Tier 1. We've activated those folks at a very high level. Certainly, we've started to move into the Tier 2 and even to a greater extent than we expected into the Tier 3 physicians. Just so everyone understands, Tier 1s write about half the scripts. Tier 2 write another 40% of the scripts. And Tier 3, which is 1,000 physicians, write about 10% of the scripts. It is a really concentrated call point. We've done extremely well with those tier ones and tier twos to date, far better than we thought we would. What's important is they're not only prescribing, but they're repeat prescribing. About three quarters of the prescriptions in the quarter came from repeat prescribers. That goes to both the breadth is great. The depth is almost even better because what that means is these folks are just at a fairly steady pace converting their panel over to EKTERLY. Got it. Okay. I want to shift gears briefly. In our view, an overhang for your stock is related to Pharvaris' phase three data, which is also an on-demand HAE setting that could read out any day by the end of this year. We also think that even if Pharvaris' data appears better numerically than your data, just having the event out of the way should remove an overhang for your stock. How do you see the upcoming Pharvaris' data update and how should investors contextualize this update versus EKTERLY? Yeah. No surprise. We get these questions a lot. I think this serves as our occasional reminder that events that matter to investors do not always matter to companies. By which I mean, the Pharvaris data is a data event. It is going to be what it is going to be. The stocks are going to react in some way. That is sort of what a lot of people now are focused on. To us, though, as a commercial company selling product right now, it has actually no influence on our trajectory. Why is that? Kind of three reasons. The first is investors do not really focus on this, but we do and practitioners will as well. Despite the fact that that study is represented as being comparable to our study, it is actually very, very much different in very important ways. Our study was, well, the largest clinical trial program ever conducted in HAE, but also a very straightforward test of the efficacy of EKTERLY now against placebo. We basically told people, if you feel an attack coming on, treat it early. Treat it even if it's mild. If you think your symptoms warrant, take another dose. Then report these results as you see fit. Factually, RAPID is none of those things. It's a highly engineered study. It requires an extraordinary amount of physician interaction by patients. They're not allowed to treat attacks without calling their physician. They're not allowed to treat mild attacks. They're not allowed to take a second dose without checking with their physician. They're trained on how to report the outcomes measures. They have another interaction with their physician that is sort of intended to support their decision about whether or not they've reached complete symptom resolution. The study could not be more different in practice from ours. It is engineered to create a clinical outcome where they can claim comparative efficacy. I am not trying to say that that should not matter to investors. I am not an investor. I am not trying to tell people how they should analyze this. What that means, though, is for us, from a competitive standpoint, whenever that drug reaches the market, all of that criteria means these results will be viewed in a very different lens, which is going to be very hard to actually claim in a commercial setting that you have actually got any kind of differential. Because everyone knows you designed it to create this differential, right? That raises questions. The first part is the data set. I'm not denying it. It's potential importance to investors. That data set has no importance to us. The second thing is we are in the market since July 7. We are signing up hundreds of new people per month. The patient satisfaction measures on EKTERLY to date have been tremendous. The feedback we've received from the physician community has been outstanding. That's going to continue apace. Nothing's going to change that trajectory. We're just adding people. In 2027, we'll have a lot of people on EKTERLY. We'll have a lot of people who are using a lot of EKTERLY. There's going to be no compelling, coming back to the first point, there's going to be really no compelling reason for them to switch. If you're sitting there and you like EKTERLY and it's working well for you and you have your patient services hub that's really treating you well and you have your payer situation all resolved, you're not going to switch to EKTERLY. We will be the market leader in 2027. I'm confident, as I sit here, we will remain the market leader post their entry as well. The third thing I say kind of ties back to something I said a few minutes ago. In the presence of oral therapies, this entire market should switch over to orals. There's no reason to stay in injectables, which does mean there's plenty of space for two entrants in the market overall. That's kind of my three parts answer to what do we think about the data. Okay. Yeah, it's helpful. I guess for the two phase threes, I think it makes sense. Two very different phase three studies. It doesn't matter to your commercial opportunity as it stands. Will investors compare this phase three data set to your phase two data set? I think there could be some similarities just with having the doctor confirmation in there. Are they still very different comparison? Our phase three, we did have them confirmed. But just to be clear, we had 100% confirmation. And we also allowed them to treat mild attacks in the phase three. Even there, the distinction, the only thing that's comparable between our phase two and their phase three is we did ask patients to confirm an attack with the physician in the phase two study. That was because no one had ever done a study of this type before and no one actually knew what to expect. We removed that requirement in our phase three. We literally had no requirements for physician interaction at all in the phase three study. You could say that's one distinction. All the other things I delineated, though, remain the same for the phase two. Okay. Got it. Maybe talk about the XUS launch. You had the first shipment to Germany in October. You expect to launch in the U.K. in the first half of 2026 and Japan in the first quarter of 2026 with your partner, Kaken. Maybe talk about the opportunity XUS and also EU pricing there. We saw a Germany price listing. Wanted to know if that's finalized. Yeah. The good news about the rest of the world is it's almost entirely an on-demand marketplace. There's very little prophylaxis usage outside the U.S. Even in countries where there appears to be a substantial amount of prophylaxis usage, like the U.K., for example, what you actually find is that's not modern prophylaxis. That's things like attenuated androgens, tranexamic acid. There's a lot of these older therapies those folks mostly use. You see very little prophylaxis usage, by which I mean modern ones, outside the U.S. The less good news is those markets priced at a fraction of the U.S. pricing. 20% of the U.S. price is probably not a bad estimate. In some countries, factually, it could be lower than that over time. Specifically, the German pricing, Germany has a little bit of a unique system. There's free pricing when the drug is first approved, but then you negotiate. Then there's kind of a reimbursement. You have to make it down the cycle depending on what price you end up with. We haven't published the German pricing yet. It won't be published for a long time. It won't be finalized for a year. We are commercial in Germany, to your point. We have established a price. That price may or may not be close to what the final price is going to be. We won't know for a long time. In the rest of the countries in the world, to your point, we're still working through the pricing mechanisms, whether it's NICE in the U.K. or in Japan. There's a pricing regimen you have to work through as well. None of those other countries are even close to having pricing set. Okay. Yeah. Okay. Yeah. Overall, long-term, XUS is maybe 20% of your global revenue, just to give a sense of the directionality. Got it. Okay. That's helpful. Yeah, we've heard from some KOLs that some Prophy patients are willing to switch to an on-demand-only management if an oral on-demand drug is available. Have you seen Prophy patients switch to on-demand-only since launch? What does their profile look like? Right. So factually, if they drop their prophylaxis after switching to EKTERLY in the commercial setting, we wouldn't know. We don't have any indication. I guess maybe they'd use more, but that would take a while to figure out. They weren't supposed to do it in the open label, but we have had a few patients who stopped their prophylaxis. That's not against—we did not recommend it, right? We have not recommended anyone do this, but we have seen it happen. Certainly, over the long run, there is an interesting question of, again, we think EKTERLY is a very good drug. We think it can meet the needs of a lot of people. Prophylaxis, whether it's injectable prophylaxis or oral prophylaxis, does bring its own set of burdens. It's either a tablet every day or it's injections every couple of weeks or whatever. If you believe that there is a subset of the prophylaxis patients who maybe do not have such severe form disease and who maybe had a low baseline attack rate anyway, I think a very interesting question is, as they get used to EKTERLY in their on-demand setting, would that make them think about whether they need to continue their prophylaxis? We think that is not an unlikely outcome. The evidence for that will take a long time to figure out. Got it. Have you had some patients switch from Ruconest o r are they using Ruconest and EKTERLY at the same time? I guess any. Again, coming back to when people switch, they will generally have some leftover on-demand of their prior therapy anyway. We have seen switches from all the on-demand therapies, including Ruconest. We've seen them roughly in proportion to their current market shares. We expect those transitions to continue at a fairly consistent rate. Got it. Okay. Maybe just briefly talk about the pediatric setting there. You reported some data at ACAI recently. How big could that market be in the United States? The NF people are small. There's probably 500 peds in America with the disease. So it's not a huge revenue opportunity, if you will. But it is an important unmet need because the only approved therapy under the age of 12 is actually IV delivered, which is an enormous problem. In very brief summary, the data we presented at the college a couple of weeks ago was really important for two reasons. First of all, we showed some initial efficacy data. And what we showed is that the peds results are great. Kids have roughly the same time to symptom relief. Again, the safety profile remains outstanding. It's all the similar data shown in pediatrics. Almost more importantly, though, what we showed is the level of unmet need in the pediatric setting has been utterly unrecognized. When we designed this trial, we actually made the criteria for enrollment be that kids had to have one attack in the last year to be eligible because they were believed to have attacks at very, very low rates. What we've discovered in this trial was actually these kids are attacking on average 0.8 attacks per month, 10 attacks a year, basically 10x what people thought they had. What was happening we've discovered is that not that these kids weren't having attacks, it's that in the presence of the only therapy being IV, a lot of these attacks just weren't being treated. Kids didn't want it. Parents didn't want to give it to them, right? You had this dramatic undertreatment. What I think is really important about EKTERLY is, again, coming back to this change in the whole way this disease is treated, is now in the presence of EKTERLY, you're starting to unmask all that. You're seeing these attack rates be much higher. You're seeing these treatment rates go up. Again, we think the same thing is true in the adult population that'll play out over time. Certainly in pediatrics, it was a very stark example of the fact that it's not that there's unmet need. It was just unrecognized because when you don't have a therapy, you don't do anything. You don't talk about it. Makes sense. Okay. We're out of time.