KalVista Pharmaceuticals, Inc. (KALV) Earnings Call Transcript & Summary

April 7, 2025

NASDAQ US Health Care Biotechnology conference_presentation 37 min

Earnings Call Speaker Segments

Serge Belanger

analyst
#1

Good afternoon. I'm Serge Belanger, one of the health care analysts at Needham. I want to welcome everybody to Needham's 24th Annual Healthcare Conference. And 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. So I'm sure Ben will talk about it.

Serge Belanger

analyst
#2

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. So 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.

Benjamin Palleiko

executive
#3

Yes. Thanks, Serge. Thank you for inviting us here today. Thank you to Needham for hosting this conference. Again, happy to be here, as always. So 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. So we're in the very late stages here with the FDA at this point, working through that process. We've also -- it's notable that 6 other filings we've made around the world for marketing authorization, including in EU, which is actually where I am today because we're reviewing our potential German launch plans for later on this year. So we've got 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

analyst
#4

Great. So 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?

Benjamin Palleiko

executive
#5

Yes. Well, that's the first part, we actually had our late cycle package come about 1.5 weeks ago, and it was clean. The FDA know there's no review issues that are outstanding. They confirmed again for the third time that there's no expected advisory committee. So as far as we know, they are -- by and large, it seems appears done with their substantive review of the NDA. So we'll be expecting to move into labeling here in the near term, and that's obviously the final stage here before we get to approval. And that's kind of where things stand. I forget the other -- what was the second part of your question?

Serge Belanger

analyst
#6

Whether the FDA changes that...

Benjamin Palleiko

executive
#7

Yes, 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 who we've interacted with the FDA have said the same thing. We've seen no delays in any time lines. We've had no indications whatsoever of any...

Serge Belanger

analyst
#8

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

Benjamin Palleiko

executive
#9

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

Serge Belanger

analyst
#10

Okay. And then in terms of your expectations for the sebetralstat or is it actually 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?

Benjamin Palleiko

executive
#11

Yes. We expect it to be a pretty clean label. I mean, again, the data set is 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 3 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. So 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. And we don't actually think it has any terrible implications for the drug regardless. So we've got a pretty broad band here of outcomes that we think are effectively equal and all of which we'd be happy with.

Serge Belanger

analyst
#12

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

Benjamin Palleiko

executive
#13

Generally, that's -- yes, generally, that's in the label, right? It will be a little further down. You'll have some type of -- obviously, you have the primary endpoint listed in the data sheet. So 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 on laryngeal attacks. Again, we've treated the most laryngeal attacks in the clinical trial program pre-approval of anyone. So 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 they're through the labeling.

Serge Belanger

analyst
#14

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

Benjamin Palleiko

executive
#15

Yes. We're busy. We've 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 our field team in other indications. It's a total of 32 reps. So 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. But as I said many times beforehand, about half of those scripts are written by 200 and 90% of those scripts are written by 1,000 physicians. So 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. So 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 the people we brought in. They've already reached out as the last update I got. They've talked to virtually all of the Tier 1 physicians -- actually, virtually all the Tier 1 and Tier 2 physicians, and they've probably talked to 3/4 of the overall population. So they've really been getting out there and interacting with these folks at a very high rate. So the setup is terrific. I mean, we still have, as you know, 3 months to go, just a little less. So we feel like we're going to be in a really good position here in terms of having awareness at 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. So there's no actual sebetralstat discussions ongoing with physicians. That's not in their purview. But there are a lot of other activities they can do, and they've been executing against them really, really well. So 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 is 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. So we're really up to speed on how they view the thing. We are -- we've actually conducted a mock launch at this point. So 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 to 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. And so while 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 time frame before the launch. And I think the team has really executed in a really superior fashion, and I fully expect it to continue to go that way.

Serge Belanger

analyst
#16

Like you said in terms of access, payer coverage, well, 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 can you give us a guide...

Benjamin Palleiko

executive
#17

Yes. I mean, as you know, there's a generic, generic Icatibant has been generic now for 5 years. Generic Icatibant, there's a lot of players who have gotten approved, and there's a fair number of them in the market. There's probably at least 4 or 5 folks in the market now. The numbers are a little -- there's a little bit of a range in the numbers, but plus or minus $3,000, low $3,000 per syringe is probably a generic cost. 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. And the other therapies, principally, I mean, well, obviously, all 3 of them, Kalbitor, Ruconest and Berinert, they tend to price -- they're priced on a per vial basis. So optically, they're less expensive. But when you actually adjust for the fact that they have multiple vials per attack, they're all around the $15,000 to $16,000 range. So you could call the price range somewhere between $11,000 on the low side and $16,000 on the high side. And 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

analyst
#18

And then 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?

Benjamin Palleiko

executive
#19

Yes, it'll be the way. It's largely commercial pay population now 70% or so commercial. So it's really high commercial. So yes, we do expect that to be actually correct. In our specific instance, there'll be probably less implications of that.

Serge Belanger

analyst
#20

Yes. And then 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. So curious how -- what the makeup of those units are and what will be -- what you will be targeting upon launch?

Benjamin Palleiko

executive
#21

Well, if you -- this gets a little bit complicated. But if you look at the dose, the units in IQVIA, you'd see it is 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 use multiple vials, right? So you make adjustments to what we call sort of 1 treatment, you're in around 85,000 doses per year, by which I mean a dose would be once 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. So if you look at the -- again, no matter how you slice it, the numbers are very consistent in that range. The majority of that marketplace, probably pushing 3/4 of it is a combination of Firazyr and generic Icatibant and it's mostly generic Icatibant. And generic Icatibant is probably 5/8 of that. A small amount of Firazyr and then Ruconest and smaller still Berinert below that. And then obviously, the bottom is Kalbitor, which is maybe a $30 million a year drug, really small. We expect the -- just arithmetically, the largest portion of demand for sebetralstat have to come from the Firazyr users initially simply because they're the majority. But again, we don't really anticipate any challenges from a payer perspective of moving them from generic Icatibant over to branded sebetralstat.

Serge Belanger

analyst
#22

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

Benjamin Palleiko

executive
#23

Yes. 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 and 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 did at the time. Again, our clinical data has been really strong and really consistent. We've shown efficacy in all subgroups you could 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. And obviously, we've got adolescents included as well. So I think because of that richness of the data set and the absolutely benign safety profile, the physicians will initially certainly be more supportive here than they might have been at Orladeyo in the early days at least.

Serge Belanger

analyst
#24

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

Benjamin Palleiko

executive
#25

Yes. It's a really knowledgeable population. I mean it's familial, obviously, have a really good advocacy organization that has a really high level of education activity. So people are aware of what's going on in the space. And so 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. And so it's certainly more of an information exchange of both directions as opposed to a one way in this space. And so we do think that having patient awareness be high and having their education be high is valuable to everybody.

Serge Belanger

analyst
#26

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?

Benjamin Palleiko

executive
#27

Well, the truth is I don't think we'll have to do much of anything except to 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 2/3 at the upper end. But somewhere in that vicinity is what the treatment rate is. And it's not really necessarily at all because the attacks don't need -- shouldn't be treated. It's not like they're trifling. What it really comes down to is a lot of cases, the challenges of the current therapies just make it really hard to do that. I mean Firazyr is obviously injectable so it hurts when injected, but it's really acidic, it hurts, 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. We had some -- I mean, Dr. Burnett last week had some -- had a good discussion on this and actually showed some really good slides just showing what that's like. And it's definitely not trivial because the form factor is difficult, they don't carry with them, you can't leave in your car. You got -- there's just a host of kind of burns, a lot of friction in treating with Icatibant. And I'm focused on that just because it's the majority of the marketplace. The IV, you can presume most of those things are the same. But the point is people just don't treat enough attacks for a variety of reasons, and that kind of frictions a lot of it. Whereas with sebetralstat, it's a rock-solid shelf-stable tablet. You can carry in your car, you can carry in your pocket book, you can carry in your backpack, whatever. It's got a nice protective kind of case packaging around it. So if people want to take it with them, they're not putting at risk of whatever smashing it or something, whatever people might be worried about. So the point is you'll have it with you. And clearly, the evidence shows very clearly that if you treat attacks early, you're just far better off and so those people who treat earlier, but coming back to where you started the question, they'll also -- 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, 2/3 maximum in the real world. And so that's 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. And I think the open label...

Serge Belanger

analyst
#28

The treatment guidelines, right? It's also part of the treatment guidelines to treat...

Benjamin Palleiko

executive
#29

Well, yes, exactly. I mean, yes, I mean, I hadn't even gotten there, but you're exactly right. I mean we are the first drug therapy that really enables people to treat according to the key tones of treatment guidelines, one of which is consider treatment of all attacks and b, if you're going to treat, treat -- and those 2 things are just simply not done nowadays. And again, our data set has been intended to support the ability to treat according to those guidelines.

Serge Belanger

analyst
#30

Yes. Okay. And 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 the data, but maybe just highlight some of the things that we should be aware of when making comparisons between sebetralstat and the other products.

Benjamin Palleiko

executive
#31

Yes. It's tough in the space in general. I mean really no trials historically have used all the same endpoints. And so there's 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 data sets, and I did a lot of this at quarter end in particular, they view them all as having potentially effectively similar efficacy. I mean it's very hard to conceive of a data set 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're -- we've got -- we've showed a bunch of data recently where people are having symptom relief in closer to 1.3 hours, which is terrific. But the Phase III data from the other folks that will come out sometime next year, it will be what it will be. I don't think we view it as having any real competitive impact on us whatsoever. And I think from a safety standpoint, I think 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 at any level. I think there is definitely still out there a potential risk or consideration associated with bradykinin antagonism. And I think that's -- what's never been done is actually chronic -- what's never been tested yet and 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

analyst
#32

Yes. Okay. Just thinking of the ex U.S. 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?

Benjamin Palleiko

executive
#33

Yes. Ex U.S. is a whole different ball game. Again, because we're talking about Germany today, Germany has probably got the second highest level of prophylaxis usage in the world, modern prophylaxis, and that's actually a key consideration. Germany is maybe 1/3, 35% or so, what I would call modern prophylaxis and the rest is on demand. And outside Germany, actually, again, 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. But if you actually look at what those folks who 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. And so the modern prophylaxis usage in the U.K., just as one example, is probably closer to 15%, maybe make its way to 20%. And so 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. And 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. So 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 of reasons. And so that's one of the reasons we feel like we have a really good ex U.S. opportunity. I mean, again, the U.S. is still the largest market for us, but we think even though the pricing ex U.S. tends to be more challenged that just the structure of the marketplace globally really lends itself towards a therapy like sebetralstat.

Serge Belanger

analyst
#34

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

Benjamin Palleiko

executive
#35

That's as good an estimate as any. I mean I think most people -- most therapies, most drugs kind of end up that way, kind of a pareto rule. I think we're pretty somewhere in that ballpark as well.

Serge Belanger

analyst
#36

Okay. And you discussed a no DT formulation of sebetralstat. I think it's initially part of a pediatric label expansion, but maybe it becomes a life cycle strategy for the product. Discuss where we are and what additional data you'll need to get that on to the market?

Benjamin Palleiko

executive
#37

Yes. Yes. So just to touch on that. I mean, to your point, the initial reason for developing oral 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 doesn't have anything except for really IV therapies available nowadays, peds included. But as you saw a few weeks ago, we announced that we've completed enrollment in our ongoing pediatrics trial, which will take sebetralstat down to age 2. And for that, we use a weight-based dosage, which uses these ODT tablets. And to get that sNDA filed, we just need to wrap up the trial. We're looking for a targeted number of attacks. We expect we'll be filing the sNDA in the first half of next year. So that trial is moving right along. I mean in that enrolled I mean, literally a full year faster than we thought it would. It was really impressive, the outpouring support globally. I mean, because we did do this in a number of territories. And it was just remarkable how much interest there was in this. So that trial is going terrific, far ahead of schedule. But coming back to your question on ODT. At the same time, we decided that there might be certain adults -- adolescents who might prefer an ODT formula as well. So 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. So 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 to get enough exposures. And then after that, we'll be able to file an sNDA on that as well. That will happen after the pediatrics in all likelihood. But there's really nothing more except building out the exposure database.

Serge Belanger

analyst
#38

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

Benjamin Palleiko

executive
#39

Actually, it's really hard to do anything better than you can with sebetralstat like 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 only talk about time to progression because we don't think it's a terribly useful endpoint. But if you -- just to give a sense, right, when you're getting blood levels that fast, our time to progressions in that vicinity as well, something sub-20 minutes. So it's -- 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 and there. But that's really not what we're trying to solve for. Like sebetralstat, it really gets into the blood stream quickly.

Serge Belanger

analyst
#40

Okay. And the -- I guess the IP implication of an ODT formulation that extend what you have or I mean you're already -- so I don't know if it makes that much of a difference.

Benjamin Palleiko

executive
#41

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

Serge Belanger

analyst
#42

Speaking of the last 5 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?

Benjamin Palleiko

executive
#43

Yes. Well, our fiscal year wraps up here in 23 days. So we'll -- so we filed our most recent Q, which was the January quarter, a month or so ago. We have guided to the fact that we're 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. 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 1, 2 and 3. And so the spend is really tightly focused right now. And so the runway is very long. I think we're very comfortable. And we've said about a year ago now that we said that we'd expect that we could be cash flow positive within the first few years of launch. So we're really focused on using this as an opportunity to get the company to an even stronger financial position.

Serge Belanger

analyst
#44

And I think you mentioned you have filed in 6 ex U.S. territories. Those are all territories where you plan to have a listed people in place to market the products?

Benjamin Palleiko

executive
#45

No, no. We will -- obviously, we're launching in the U.S., and I told you we're launching ourselves in the EU behind that and then U.K. probably early next year. We have a really good team in Japan. We like Japan as a market. But 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. But there's probably leverage in Japan with regard to other organizations that are already kind of well established on the commercial front. So that's a place where we could do it ourselves, and our baseline plan has always been to do it ourselves. But 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. And we've had a tremendous amount of interest. I mean we've got interest on every continent but Antarctica. And I think you'll start to see a series of those agreements come together over the course of the year.

Serge Belanger

analyst
#46

And maybe just to wrap up, if there's anything you feel is misunderstood or underappreciated about the actually market opportunity or just the KalVista story in general?

Benjamin Palleiko

executive
#47

Well, I think to do the second part first, 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. So this is a space we know well. We know the people. We know the docs really well. We know the advocacy group. We're -- 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, a lot of things in development for prophylaxis and how is it going to affect the market? And is the market going to continue to exist. Data for the past 5 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 5 years. Going forward, there's -- let me think about this. There's 4 therapies approved. There's at least 6, and I think there are actually maybe 7 therapies in development. There's 2 more prophylaxis therapies launching this year. There's a lot of prophylaxis. It's going to be a busy, busy space. I mean, it's going to look hypercompetitive. But that doesn't really have a lot of implications for us. We don't 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 don't think that these prophylaxis therapies meaningfully are differentiated in terms of efficacy. They all have really good efficacy. I mean, I'm not saying anything bad about any of them, but they're more or less equivalent and people still have breakthrough attacks. And we've seen in our open-label extension study. This has been noted in many, many places, breakthrough attacks happen. So the truth of the matter is those are -- to a large extent, all the prophylaxis options are different dosing schedules more than anything. And we're completely happy to be Switzerland, conveniently sit in Switzerland and be a neutral party that provides an on-demand option for all of those therapies. And 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

analyst
#48

Yes. 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 be the -- play the same role on the on-demand side?

Benjamin Palleiko

executive
#49

Yes. 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 and talk to talk about prophylaxis and -- I mean, to talk about HAE treatment. And 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 in the future that can fundamentally change in a very insignificant way, which is you get HAE, you're going to talk to your physician. And the first thought is going to be, why don't we try sebetralstat. Your attack rates are -- assuming 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. It's -- 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. And 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. But that is a very different conversation than what happens nowadays. And in our opinion, that everybody is 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. And so that's great for them. Physicians are happy because physicians have well-controlled patients who and that makes physicians happy because that's what they're trying to solve for. And I think from a system-wide perspective, all these prophylaxis therapies are $500,000 at least each. And 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 the world of sebetralstat as your primary therapy, those costs are a lot more. I mean, it would take a lot of sebetralstat to get to that kind of a number. So we think this can literally be a situation where everybody is better off.

Serge Belanger

analyst
#50

Yes. 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.

Benjamin Palleiko

executive
#51

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

Serge Belanger

analyst
#52

Thank you.

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