KalVista Pharmaceuticals, Inc. (KALV)
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24th Annual Needham Virtual Healthcare Conference

Apr 7, 2025

Serge Belanger
Healthcare Analyst, Needham

Good afternoon. I'm Serge Belanger, one of the healthcare analysts at Needham. I want to welcome everybody to Needham's 24th Annual Healthcare Conference. Our next fireside chat session here is with Ben Palleiko, the CEO of KalVista Pharmaceuticals, a company that has a very near-term PDUFA target action date coming up here. I'm sure Ben will tell us about it. For those listening online, you do have the option to submit questions to us via the portal that you're listening in on. We'll take those as they come in. I'll hand it over to Ben, maybe give us a quick overview of the company for those who aren't familiar with KalVista or sebetralstat.

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah, thanks, Serge. Thank you for inviting us here today. Thank you to Needham for hosting this conference again. Happy to be here as always. KalVista is a pre-commercial, nearing approaching commercial company now with sebetralstat, which, if it's approved, will be the first on-demand therapy ever approved for hereditary angioedema, treatment of HAE attacks. We have a U.S. PDUFA date of June 17, as you said. We're in the very late stages here with the FDA at this point, working through that process. We've also, it's notable, got six other filings we've made around the world for marketing authorization, including in the EU, which is actually where I am today because we're reviewing our potential German launch plans for later on this year.

We have the U.S. launch to come, the German launch ideally later on this year, and then a series of additional launches in 2026, both direct by our internal team as well as some through partnerships.

Serge Belanger
Healthcare Analyst, Needham

Great. Like you said, you're kind of in the home stretch here into the PDUFA date. I'm sure you've had your mid-cycle review at this point. I don't know if there's anything you can, any details you can provide us, but just in terms of recent FDA changes, if you're aware of anything that affects the division that's reviewing your NDA.

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah. As the first part, we actually had our late-cycle package come about a week- and- a- half ago, and it was clean. The FDA noted there's no review issues that are outstanding. They confirmed again for the third time that there's no expected advisory committee. As far as we know, they are, by and large, it seems, it appears done with their substantive review of the NDA. We'll be expecting to move into labeling here in the near term. That's obviously the final stage here before we get to approval. That's kind of where things stand. I forgot the other, what was the second part of your question?

Serge Belanger
Healthcare Analyst, Needham

Oh, whether the FDA changes at the review.

Ben Palleiko
CEO, KalVista Pharmaceuticals

Oh, the FDA. Oh, yeah, the FDA. Actually, as you can tell from what I just said, from our perspective, things are just moving smoothly. We've been in regular contact with our RPM. She's indicated that her and her entire team remain there. The other folks we've interacted with at the FDA have said the same thing. We've seen no delays in any timelines. We've had no indications whatsoever of any.

Serge Belanger
Healthcare Analyst, Needham

Nothing impacting manufacturing site reviews or anything? Okay. Good.

Ben Palleiko
CEO, KalVista Pharmaceuticals

They've given no indication other than they're just moving right along.

Serge Belanger
Healthcare Analyst, Needham

Okay. In terms of your expectations for the sebetralstat, or is it Ekterly? Is that the new brand name or proposed brand name? I guess what you're expecting in the label, what you would like to have, what would be nice to have?

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah, we expect it to be a pretty clean label. I mean, again, the data set's really robust. The safety profile has been absolutely pristine throughout the entire development program. There's really nothing here that we think is going to represent any kind of substantive label challenges. I think the biggest item that will get addressed, but we're not terribly concerned about it, is just some kind of max daily dosing. I mean, Firazyr, as an example, has got a maximum of three doses in 24 hours. We would assume that they'll do the same thing for us. Again, they haven't done one of these in a long time. That's why I'm saying this. We presume there'll be some max daily dosing, but we've got really good safety margins, and so we don't really have a lot of concern about where they'll come out on that.

We do not actually think that it has any terrible implications for the drug regardless. We have a pretty broad band here of outcomes that we think are effectively equal, and all of which we would be happy with.

Serge Belanger
Healthcare Analyst, Needham

It should include the quick onset of efficacy, the primary endpoint that you saw, that should all be reflected in the label?

Ben Palleiko
CEO, KalVista Pharmaceuticals

Generally, that's yeah, generally that's in the label, right? It'll be a little further down. You'll have some type of obviously, you have the primary endpoint listed in the data sheet. That will be in there. Everything else we've shown pretty cleanly. I mean, laryngeal attacks are the one thing you think about. We have a lot of data now on laryngeal attacks. Again, we've treated the most laryngeal attacks in a clinical trial program pre-approval of anyone. I don't think we feel that's at risk. We're, again, and based upon the interactions we've had, we're unaware of any items that are outstanding with the FDA that could impact the review or through the labeling.

Serge Belanger
Healthcare Analyst, Needham

Yeah. Okay. I imagine you're well advanced in the commercial preparation and anticipating, I guess, a July launch, I guess, would be when it could take place given the late June PDUFA. Maybe just highlight what's been done, what still needs to be done, and how the initial launch could go.

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah. We're busy. We onboarded the field team in February, which was the last big group we had to pull into the company. Having said that, the field team in HAE is not the size of a field team in other indications. It's a total of 32 reps. It's a very controllable number of people, which is one of the reasons we could bring them in early. They cover about a total of 2,000 HCPs. As I've said many times beforehand, about half of those scripts are written by 200, and 90% of those scripts are written by 1,000 physicians. It's a very small call, tight call, I should say. That's why we can do it with the number we have. It's a great group. I mean, the majority of them have worked in HAE.

The rest have all worked in rare disease and generally have been calling on allergists. By and large, they came to our company and go back into territories calling on the same people they were calling on before. They have been extraordinarily productive to date, which I think is sort of expected given the experience level of people we brought in. They've already reached out, as the last update I got, they've talked to virtually all of the tier one physicians, actually virtually all the tier one and tier two physicians, and they've probably talked to three quarters of the overall population. They've really been getting out there and interacting with these folks at a very high rate. The setup is terrific. I mean, we still have, as you know, three months to go, just a little less.

We feel like we're going to be in a really good position here in terms of having awareness that the HCP level will be high and having a lot of the sort of administrative challenges addressed before we get to approval. Obviously, there's a host of things they can't do, the main one of which is talk about the product. There's no actual sebetralstat discussions ongoing with physicians. That's not in their purview. There are a lot of other activities they can do, and they've been executing against them really, really well. I couldn't be happier with how they've done. In addition to that, we've got multiple other groups, right? The market access team is working hard.

The group that's putting together our patient support services network, which is run by a really terrific person who's got a lot of experience in rare diseases, is getting all that formed and ready for launch. We've conducted coming up on 60 pre-approval information exchange meetings with payers. We're really up to speed on how they view the thing. We've actually conducted a mock launch at this point. We've run the system through one time already just to make sure we can find any kind of things that could be hiccups or other challenges that come into a launch. The global supply chain team has done a really outstanding job of getting all that infrastructure set up so we'll be able to get drug out to patients very quickly post-approval. We're not done yet, and there's clearly a lot more work to be done.

I mean, we are in a really good position given where we stand in terms of timeframe before the launch. I think the team has really executed in a really superior fashion, and I feel expected to continue to go that way.

Serge Belanger
Healthcare Analyst, Needham

Like you said, in terms of access, payer coverage, I guess first on pricing, I know we won't get detailed pricing until launch, but maybe just give us an overview of what are the current products on the market and where they're priced and maybe give us a guide.

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah. I mean, as you know, there's a generic icatibant, been generic now for five years. Generic icatibant, there's a lot of players who've gotten approved, and there's a fair number of them in the market. There's probably at least four or five folks in the market now. The numbers are a little—there's a little bit of a range on the numbers, but plus or minus 3,000, low 3,000s per syringe is probably what a generic costs. From our perspective, that actually has no impact on our pricing decisions at all. Payers aren't expecting us to price comparable to generics. They recognize the value proposition here. The branded therapies are much higher than that. Branded Firazyr is in the range of $11,000 a syringe.

The other therapies, principally, I mean, actually all three of them, Kalbitor, Ruconest, and Berinert, they tend to price—they price on a per vial basis. Optically, they're less expensive. When you actually adjust for the fact that they have multiple vials per attack, they're all around the $15,000-$16,000 range. You could call the price range somewhere between $11,000 on the low side and $16,000 on the high side. We'll be comfortably within that range. We're not trying to push this to the limit. I don't know that we feel like we need to price at a premium to the upper end there. I think we can quite comfortably be somewhere in that range I just talked about and make everybody satisfied.

Serge Belanger
Healthcare Analyst, Needham

On the coverage side, typically we see commercial come on board first, and then over time, government programs lag a little bit. Should we expect the same thing here?

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah, it'll be that way. It's largely a commercial pay population. It's 70% or so commercial, so it's really high commercial. Yes, we do expect that to be factually correct in our specific instance. There'll probably be less implications of that.

Serge Belanger
Healthcare Analyst, Needham

Yeah. The market opportunity, I think it's during your presentation last week or a few weeks ago, I think it was impressive that the number of units has remained very stable for the on-demand. Curious what the makeup of those units are and what you will be targeting upon launch.

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah. This gets a little bit complicated, but if you look at the dose, the units in IQVIA, you'd see this right around 125,000 units a year, and that's like clockwork. If you adjust that for the fact that things like Ruconest or Berinert all use multiple vials, right? You make adjustments to what we call sort of one treatment. You're in around 85,000 doses per year, by which I mean a dose would be one syringe of Firazyr or, again, a couple of vials of Ruconest, for example, because you're using more than one vial to treat an attack. If you look at, again, no matter how you slice it, the numbers are very consistent in that range. The majority of that marketplace, probably pushing three quarters of it, is a combination of Firazyr and generic icatibant. It's mostly generic icatibant.

Generic icatibant is probably five-eighths of that, a small amount of Firazyr, and then Ruconest and smaller still, Berinert below that. Obviously the bottom is Kalbitor, which is maybe a $30 million drug, really small. We expect just arithmetically, the largest portion of demand for sebetralstat to come from the Firazyr users initially, simply because they're the majority. Again, we don't really anticipate any challenges from a payer perspective of moving them from generic icatibant over to branded sebetralstat.

Serge Belanger
Healthcare Analyst, Needham

We expect some pent-up demand as this product becomes available. We kind of saw that a little bit with Orladeyo. Does that give us a proxy of how things could unfold for sebetralstat?

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah. Orladeyo is probably instructive. The patient demand, I think, is probably the most instructive part there. There was a very high level of outreach from patients as they became aware of Orladeyo. I expect some similar type of action from patients as they become aware of sebetralstat post-approval. On the physician side, we probably have a little more support from them than perhaps BioCryst at the time. Again, our clinical data has been really strong and really consistent. We've shown efficacy in all subgroups you can think of, regardless of attack location, severity, again, with mild attacks being some of the hardest attacks to treat, actually. We've shown efficacy in laryngeal attacks. We've shown on top of LTP efficacy. Obviously, we've got adolescents included as well.

I think because of that richness of the dataset and the absolutely benign safety profile, that physicians will initially certainly be more supportive here than they might have been at Orladeyo in the early days, at least.

Serge Belanger
Healthcare Analyst, Needham

Okay. Is this typically a physician-driven kind of decision to switch treatment, or it's an equally patient-friendly involved?

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah. It's a really knowledgeable population. I mean, it's familial, obviously. They have a really good advocacy organization that has a really high level of education activity. People are aware of what's going on in the space. I think, unlike in some other diseases, when they go in, they tend to know what they're looking for. They tend to know what's out there. They tend to know the pluses and minuses. It's certainly more of an information exchange of both directions as opposed to a one-way in this space. We do think that having patient awareness be high and having their education be high is valuable to everybody.

Serge Belanger
Healthcare Analyst, Needham

I think you guys have done a lot of work in market research to demonstrate that there's a number of HAE attacks that go untreated. I forgot exactly what the number is. I'm sure you have a better handle of them than I do, but just curious what you're expecting and what can drive patients to increase their treatment rate.

Ben Palleiko
CEO, KalVista Pharmaceuticals

The truth is I don't think we'll have to do much of anything except give them an appropriate therapy that allows them to do that. I mean, everybody, to your point, I mean, it's consensus. It's commonly known that people don't treat enough attacks. And depending on the data source you see, you could see as low as half of attacks are treated. Maybe it's two-thirds or at the upper end. Somewhere in that vicinity is what the treatment rate is. It's not really necessarily at all because the attacks shouldn't be treated. It's not like they're trifling. What it really comes down to is, in a lot of cases, the challenges of the current therapies just make it really hard to do that. I mean, Firazyr, it's obviously injectable, so it hurts when you inject it. It's really acidic. It hurts when it disseminates.

It causes a mast cell reaction response that leads to kind of almost like a welt around the injection site that can last several hours. I mean, Dr. Burnett last week had a good discussion on this and actually showed some really good slides just showing what that's like. It is definitely not trivial because the form factor is difficult. They do not carry with them. You cannot leave in your car. There is just a host of kind of burdens, a lot of friction in treating with the injectables. I am focused on that just because it is the majority of the marketplace. The IVs, you can presume mostly that those things are the same. The point is people just do not treat enough attacks for a variety of reasons, and that kind of friction is a lot of it. Whereas with sebetralstat, it is a rock-solid, shelf-stable tablet.

You can carry it in your car. You can carry it in your pocketbook. You can carry it in your backpack, whatever. It has a nice protective kind of casing or packaging around it. If people want to take it with them, they're not putting it at risk of, whatever, smashing it or something, whatever people might be worried about. The point is you'll have it with you. Clearly, the evidence shows very clearly that if you treat attacks early, you're just far better off. People will treat earlier. Coming back to where you started the question, we think we're also comfortable they'll treat more attacks. In our open-label extension study, which is ongoing right now, people are treating right around 85% of their attacks versus that, whatever you want to call it, two-thirds maximum in the real world.

That is a pretty big jump. Again, we're not trying to suggest that all attacks have to be treated, but we're enabling people to appropriately treat more attacks, which they should do. I think the open-label shows that.

Serge Belanger
Healthcare Analyst, Needham

Also in the treatment guidelines, right?

Ben Palleiko
CEO, KalVista Pharmaceuticals

Huh?

Serge Belanger
Healthcare Analyst, Needham

It's also part of the treatment guidelines to treat.

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah, you're exactly right. I mean, yeah. I mean, I hadn't even gone there, but you're exactly right. I mean, we are the first drug therapy that really enables people to treat according to the key tenets of treatment guidelines, one of which is consider treatment of all attacks, and B, if you're going to treat, treat. Those two things are just simply not done nowadays. Again, our dataset has been intended to support the ability to treat according to those guidelines.

Serge Belanger
Healthcare Analyst, Needham

Yeah. Okay. While we're on that topic, I know there's another oral on-demand treatment that's currently in development. I don't know if you want to comment on their data, but maybe just highlight some of the things that we should be aware of when making comparisons between sebetralstat and the other products.

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah. It's tough in the space in general. I mean, really no trials historically have used all the same endpoints. There is a lot of apples-to-oranges comparisons that people are forced to make. Factually, I think when you talk to physicians who sort of look at all the datasets, and I did a lot of this at [KalVista] in particular, they view them all as having potentially, effectively similar efficacy. I mean, it's very hard to conceive of a dataset that would be so differentiated from the one we've already generated that would cause people to have major clinical implications. As I said, we've shown efficacy in all types of attacks in multiple different situations. It's been very consistent. If anything, the open-label extension data looks even stronger.

I mean, we've showed a bunch of data recently where people are having symptom relief in closer to 1.3 hours, which is terrific. The phase three data from the other folks, it will come out sometime next year. It'll be what it'll be. I don't think we view it as having any real competitive impact on us whatsoever. I think from a safety standpoint, mechanistically, plasma kallikrein inhibition has been shown to be utterly safe. Again, we've shown the use of sebetralstat on top of other plasma kallikrein inhibitors or an antibody. There are no downside risks at all to inhibiting plasma kallikrein chronically to any level. I think there is definitely still out there a potential risk or consideration associated with bradykinin antagonism. I think what's never been done is actually chronic what's never been tested yet.

What I think would be an interesting thing to do would be to look at an acute bradykinin antagonist on top of a chronic bradykinin antagonist and see if that has any risk profile implications.

Serge Belanger
Healthcare Analyst, Needham

Yeah. Okay. Just thinking of the ex-US opportunity here. I think in the U.S. market, the patients on prophylactics represent about 70% of the patient population. What is it in Europe, and how does that impact the on-demand segment?

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah. ex-US is a whole different ball game. Again, because we were talking about Germany today, Germany's probably got the second highest level of prophylaxis usage in the world, modern prophylaxis. That's actually a key consideration. Germany's maybe a third, 35% or so, what I would call modern prophylaxis. The rest is on-demand. Outside Germany, actually, when you're talking about modern prophylaxis, the rates are even much lower. The U.K., notionally, it looks like it maybe is maybe 40% prophylaxis. If you actually look at what those folks are using in the U.K., the vast majority of people using prophylaxis are on androgens, which are effective but have obviously terrible long-term side effects. The modern prophylaxis usage in the U.K., just as one example, is probably closer to 15%, maybe make its way to 20%.

As we look at the rest of the world, really, not just Europe, we see that those are the kind of rates you're talking about for prophylaxis. Because you're dealing with government payer systems and all the complexities of that, those rates aren't really likely to go up a whole lot, especially as sebetralstat comes on the scene and offers a much more viable alternative for an on-demand therapy. I guess the summary is the rest of the world is very, very heavily weighted toward on-demand and likely to stay that way for multiple reasons. That's one of the reasons we feel like we have a really good ex-US opportunity.

I mean, again, the U.S. is still the largest market for us, but we think even though the pricing ex-US tends to be more challenged, that just the structure of the marketplace globally really lends itself towards a therapy like sebetralstat.

Serge Belanger
Healthcare Analyst, Needham

I'm not asking for guidance here, but as we think about the split between US, ex-US, once you get to a more steady state in sales, is it kind of 80/20 or how do you think?

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah. That's as good an estimate as any. I mean, I think most therapies, most drugs kind of end up that way. Kind of a Pareto rule. I think we'll be somewhere in that ballpark as well.

Serge Belanger
Healthcare Analyst, Needham

Okay. You discussed an ODT formulation of sebetralstat. I think it's initially part of a pediatric label expansion, but maybe it becomes a lifecycle strategy for the product just because where we are and what additional data you'll need to get that onto the market.

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah. Yeah. Just to touch on that, I mean, to your point, the initial reason for developing an orally disintegrating tablet was for use in a pediatric indication. The initial label we expect for sebetralstat will be ages 12 and up, which is great because actually under 18 does not have anything except for really IV therapies available nowadays, peds included. As you saw a few weeks ago, we announced that we have completed enrollment in our ongoing pediatrics trial, which will take sebetralstat down to age two. For that, we use a weight-based dosage, which uses these ODT tablets. To get that sNDA filed, we just need to wrap up the trial. We are looking for a targeted number of attacks and we expect we will be filing the sNDA in the first half of next year. That trial is moving right along.

I mean, in that enrolled search, I mean, literally a full year faster than we thought it would. It was really impressive, the outpouring of support globally. I mean, because we did do this in a number of territories. It was just remarkable how much interest there was in this. That trial is going terrific, far ahead of schedule. Coming back to your question on ODT, at the same time, we decided that there might be certain adults or adolescents who might prefer an ODT formula as well. We've created one. We don't actually, for that, have to generate any more efficacy data. It's just about building the safety database. We've actually taken some of the people from the 302, the open-label extension study, converted them over to the ODT to build out the safety database, just get enough exposures.

After that, we'll be able to file an sNDA on that as well. That'll happen after the pediatrics in all likelihood. There's really nothing more except building out the exposure database.

Serge Belanger
Healthcare Analyst, Needham

Is there a potential to even improve on the onset with the ODT formulation? I know that's not being evaluated, but.

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah. Actually, it's really hard to do anything better than you can with sebetralstat. It hits the stomach and just dissolves. It's absorbed in the upper GI tract. It gets to efficacious blood levels in 15 minutes or less. It's incredibly rapidly absorbed. I mean, again, we don't really talk about time to progression because we don't think it's a terribly useful endpoint. Just to give a sense, right, when you're getting to blood levels that fast, our time to progression's in that vicinity as well, something sub-20 minutes. An ODT, just believe it or not, because of the way the film-coated tablet works so well, an ODT actually probably wouldn't materially enhance the release profile at all. I mean, maybe it would on the margin. Maybe it's a few minutes here or there. That's really not what we're trying to solve for.

Like sebetralstat, it really gets into the bloodstream quickly.

Serge Belanger
Healthcare Analyst, Needham

Okay. And the IP implication of an ODT formulation that extends what you have or I mean, you're already pretty far out, so I don't know if it makes that much of a difference.

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah. We're the late 2030s anyway, and then you'll some other things, pediatrics and such. Yes, it does. Obviously, it gives you another it gives you a formulation patent. I'm not trying to downplay that. Factually, the real driver here was just to give people another alternative and primarily to give pediatrics a viable method of dosing.

Serge Belanger
Healthcare Analyst, Needham

Yeah. I think we only have five or so minutes. Maybe we can cover the financials, cash balance, especially given where we are in this market right now and kind of what kind of runway that gives you.

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah. Our fiscal year wraps up here in 23 days. We filed our most recent year, which was the January quarter, a month or so ago. We have guided to the fact that we were very comfortable with our funding situation. We're funded into at least the second half of 2027. That is not an aggressive calculation by any means. We tend to be very careful about these things. We run a tight operation. I mean, we're focused in the spending on sebetralstat. We've cut all the other expenses back appropriately to really allow us to focus on that and give sebetralstat the launch it deserves. That is our jobs, one, two, and three. The spend is really tightly focused right now. The runway is very long. I think we're very comfortable.

About a year ago now, we said that we'd expected that we could be cash flow positive within the first few years of launch. We are really focused on using this as an opportunity to get the company to an even stronger financial position.

Serge Belanger
Healthcare Analyst, Needham

Okay. You mentioned you have filed in six ex-U.S. territories. Those are all territories where you plan to have a list of people in place to market the products?

Ben Palleiko
CEO, KalVista Pharmaceuticals

No. No. Obviously, we're launching in the U.S., and I told you we're launching ourselves in the EU behind that. Germany, then the U.K., probably late next year. We have a really good team in Japan. We like Japan as a market. That is a place where we might consider having a partner pick up some of the work on the sales and marketing side. Again, our team is really strong, and we like what they do. There is probably leverage in Japan with regard to other organizations that are already kind of well established on the commercial front. That is a place where we could do it ourselves, and our baseline plan has always been to do it ourselves. I think if a partner offered us appropriate value, we'd seriously consider that.

Outside of that, this will be done through partnership arrangements and a lot of distributor-type agreements going forward. I mean, we've had a tremendous amount of interest. I mean, we've got interest on every continent, but Antarctica. I think you'll start to see a series of those agreements come together over the course of the year.

Serge Belanger
Healthcare Analyst, Needham

Maybe just to wrap up, if there's anything you feel is misunderstood or underappreciated about the Ekterly market opportunity or just the KalVista story in general.

Ben Palleiko
CEO, KalVista Pharmaceuticals

I think the KalVista story is pretty straightforward. It's an execution play. We know how to execute. We've got a really experienced team here. We've got a commercial team that I put up against anyone in the space. I mean, we have a lot. We have multiple people who've launched multiple HAE drugs. All the senior leadership of the company has launched multiple drugs in the HAE market before. This is a space we know well. We know the people. We know the docs really well. We know the advocacy group. I'll put us up against anybody in the space from a commercial standpoint.

In terms of the opportunity, I guess the biggest part, and I think this has sort of become less of a concern, but certainly the question always becomes, there's a lot of things in development for prophylaxis, and how is it going to affect the market? Is the market going to continue to exist? Data for the past five years shows the market exists and does just fine. You touched on this earlier, the fact that scripts really haven't moved in the last five years. Going forward, let me think about this. There's four therapies approved. There's at least six, and I think there are actually maybe seven therapies in development. There's two more prophylaxis therapies launching this year. It's a lot of prophylaxis. It's going to be a busy, busy space. I mean, it's starting to look hyper-competitive.

That does not really have a lot of implications for us. We do not see a wholesale transition of people from on-demand to prophylaxis currently. We think in the presence of sebetralstat, those currently satisfied people will be even more satisfied. We do not think that these prophylaxis therapies meaningfully are differentiated in terms of efficacy. They all have really good efficacy. I mean, I am not saying anything bad about any of them, but they are more or less equivalent. People still have breakthrough attacks. We have seen an open-label extension study. This has been noted many, many places. Breakthrough attacks happen. The truth of the matter is those are, to a large extent, all the prophylaxis options are different dosing schedules more than anything.

We're completely happy to be Switzerland, conveniently since I'm in Switzerland, and be a neutral party that provides an on-demand option for all of those therapies. I will predict that no matter which of those you pick, they're all going to have people who are still going to be using on-demand, whatever the prophylaxis is.

Serge Belanger
Healthcare Analyst, Needham

Yeah. I think Orladeyo on the prophy side has kind of become the de facto first treatment for any new HAE patients. Is there any reason to believe that sebetralstat wouldn't play the same role on the on-demand side?

Ben Palleiko
CEO, KalVista Pharmaceuticals

Yeah. I mean, again, we put this chart up on the commercial day. Right now, you go in to talk, you're newly diagnosed with HAE. You go in to talk to your doc about prophylaxis and, I mean, to talk about HAE treatment. Basically, the only option is, which prophylaxis do you want? Takhzyro or Orladeyo? Needles or no needles? High efficacy or a little bit of a high efficacy, but you got a little bit of a path to get there. We do think that in the future, that can fundamentally change in a very significant way, which is you get HAE, you go in to talk to your physician, and the first thought is going to be, why don't we try sebetralstat? Your attack rates are, assuming your attack rates are within a relevant range, and you don't have other burdens you're dealing with. Try sebetralstat.

See if you can use it to deal with your attacks as they come on. Obviously, it's super convenient, right? Again, side effect profile is terrific. Safety has been really clean. Efficacy shows certainly comparable to injectables. See how it works. If you're still having attacks or if you have some other burdens that come along or however, whatever you need to treat your disease with, then we talk about adding prophylaxis on top of it. That is a very different conversation than what happens nowadays. In our opinion, everybody's better off in those circumstances. In the second world I talked about, people with HAE are better off because their treatment burden is lowered, right, concomitant with their disease burden. That is great for them. Physicians are happy because physicians have well-controlled patients who that makes physicians happy because that's what they're trying to solve for.

I think from a system-wide perspective, all these prophylaxis therapies are $500,000 at least each. Then coming back to the fact that people are still using on-demand, your patients pay $600,000 or $700,000 a year from an all-in cost perspective. In a world of sebetralstat as your primary therapy, those costs are a lot lower. I mean, it would take a lot of sebetralstat to get to that kind of a number. We think this can literally be a situation where everybody's better off.

Serge Belanger
Healthcare Analyst, Needham

Yep. Okay. We're running out of time, so maybe we'll end here. I want to thank you, Ben, for spending time with us this afternoon, giving us an overview of KalVista. And obviously, we'll wish you good luck for June.

Ben Palleiko
CEO, KalVista Pharmaceuticals

Always nice to talk to you, and thanks again for having us in today.

Serge Belanger
Healthcare Analyst, Needham

All right. Thank you.

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