Good morning, and welcome to KalVista Pharmaceuticals 8-month Fiscal Year 2025 Financial Results and Corporate Update Conference Call. [Operator Instructions] I would now like to turn the call over to Ryan Baker, Head of Investor Relations for introductory comments.

Thank you, operator, and good morning. As previously announced, the company changed its fiscal year from ending April 30 of each year to ending December 31 of each year. There was an 8-month transition period from May 1, 2025, to December 31, 2025. With that in mind, earlier today, KalVista issued a press release reporting financial results for the 8 months ended December 31, 2025, and provided a corporate update. A copy of the release is available on the Investors section of our website. Before we begin, I'd like to remind listeners that today's discussion will include forward-looking statements. These statements are subject to risks and uncertainties that may cause actual results to differ materially. Please refer to our SEC filings for a discussion of these risks. KalVista undertakes no obligation to update forward-looking statements, except as required by law. I will now turn the call over to our Chief Executive Officer, Ben Palleiko.

Good morning, and thank you for joining us. 2025 was a pivotal year for KalVista, highlighted by the successful multinational launch of EKTERLY, the first and only oral on-demand treatment for hereditary angioedema. Since launching in the U.S. last July, we've seen high rates of early adoption, increasing physician engagement and positive patient feedback. Together, these signals reinforce our belief that EKTERLY has the potential to transform the treatment of HAE. As we build on this foundation, we remain focused on launch execution in the U.S. and Germany, expanding access globally and continuing to generate clinical and real-world evidence to support the long-term growth of EKTERLY. The momentum we are seeing in the launch translated into $35 million in global net product revenue in the fourth quarter, bringing revenue from launch through December 31, 2025, to $49 million and reflecting steady and consistent growth during the first 6 months of launch. Turning to the U.S. launch. As of February 28, we've received 1,702 patient start forms and activated 724 unique prescribers across the United States since the launch last July. These metrics reflect broad engagement across the HAE community and strong awareness among both physicians and people living with HAE. One of the most encouraging signals we are seeing reflects what we believe to be favorable utilization trends. Refills now represent the majority of prescriptions and revenue, indicating that individuals who have tried EKTERLY are continuing to use it to treat attacks. This pattern suggests sustained usage and growing confidence as people living with HAE incorporate EKTERLY into their ongoing management of attacks. We are also expanding the global footprint of EKTERLY. In Germany, the launch is off to a strong start with early adoption trends tracking similarly to those we see in the United States. In Japan, our partner,…

Thank you, Ben. The recent Western and AAAAI scientific meetings, we presented several new analyses from the sebetralstat clinical trial program, including updated findings from the KONFIDENT-S open-label extension study. These data further expand our understanding of the clinical performance of EKTERLY and the evolution of treatment patterns with an oral on-demand therapy. First, looking at the longitudinal data presented at Western, we observed that sebetralstat performed consistently and effectively in nearly 2,500 attacks treated through September of 2025. What was particularly encouraging was that the use of the second dose occurred in only 19.3% of attacks and EKTERLY showed a decreasing trend over repeated attacks to about 12%. The use of conventional injectable treatments occurred in only 5.1% of attacks, which also trended downward toward 2%. While there have been no head-to-head trials, these data are favorable in the context of what has been published in the literature for other on-demand treatments. These findings are also evidence of growing confidence with sebetralstat as patients gained experience. This sustained clinical performance was mirrored by high and durable patient satisfaction, with 91.1% of attacks rated as neutral to extremely satisfied and a median overall score of very satisfied. This leads to AAAAI, where we reported a clear preference for sebetralstat over conventional injectable treatments in the KONFIDENT-S study. A unique part of the open-label, real-world study design was that patients were allowed to choose either sebetralstat or their historic injectable treatment for each attack depending on their preference. Under these conditions, participants chose to treat over 84% of their attacks with sebetralstat. Further, as the study progressed, the preference for sebetralstat grew as patients treated more attacks. Collectively, these findings from confidence reinforce a powerful narrative. EKTERLY is a preferred on-demand therapy, enabling patients to treat the vast majority of attacks, treat them early, and achieve high levels of sustained satisfaction after switching from injectables. Importantly, these results also reflect the trends we are seeing commercially, including growing physician confidence and increasing adoption by people living with HAE. Finally, I am pleased to highlight that these clinical insights are already being translated into global standard-of-care recommendations. The newly released international pediatric HAE guideline recommends EKTERLY as a first-line therapy for adolescents aged 12 and older. The guideline committee issued a strong recommendation based on our robust clinical data published in high-tier, peer-reviewed journals. Importantly, the guidelines emphasize that early intervention and ready access to on-demand treatment are the keys to better outcomes. This directly supports our findings that oral therapy has the potential to remove the barriers that have historically caused adolescents to wait nearly 8 hours before treating an attack with injectable therapy. With that, I'll turn the call over to Nicole to provide an update on the commercial launch.

Thank you, Paul. We launched EKTERLY in the U.S. on July 7, 2025, and now approximately 9 months into the launch, we continue to see steady growth driven by increasing prescriber engagement and positive patient experience. As Paul outlined earlier, data presented at the AAAAI showed the high confidence health care providers have in prescribing EKTERLY and the high satisfaction their patients are having with the drug. Momentum to adopt EKTERLY continues to build. For January and February 2026, we recorded 384 new start forms, which brings the launch to date start form total to over 1,700. The U.S. HAE population is estimated to include approximately 9,000 patients. And based on our current start forms, almost 20% of individuals with HAE have initiated EKTERLY. We have now received start forms from 49 states and have recently expanded into Puerto Rico, further broadening access to therapy. On the prescriber side, during the first 2 months of 2026, we added 144 prescribers, bringing the launch-to-date total of unique prescribers to 724. The breadth and depth of EKTERLY use across all prescriber tiers continues to grow in a linear fashion. 29 of the top 30 HAE prescribers in the country have prescribed EKTERLY for multiple patients. As is typical in the early stages of a launch, we expect some quarter-to-quarter variability in certain metrics. The severe winter weather this quarter affected physician office activity and processing of start forms. We believe this is a temporary dynamic and does not reflect any fundamental change in the underlying demand for EKTERLY. Prescriber engagement also continues to expand. On average, we are adding approximately 3 new prescribers each day, and we recently recorded a milestone where 10 new prescribers activated in a single day. These trends reflect increasing awareness and growing physician confidence as experience with…

Thanks, Nicole. As a result of changing our fiscal year-end from April 30 to December 31, the results we are reporting today reflect the 8-month transition period from May 1, 2025, through December 31, 2025. For comparability, we are presenting the 2025 results against unaudited financial information for the same period in 2024. As previously announced, net product revenue for the 8-month transition period ended December 31, 2025, was $49.1 million, including $35.4 million generated in the 3 months ended December 31. Fourth quarter revenue benefited from our specialty pharmacy customers adding inventory ahead of the holiday shutdowns, which they were able to work through in January. Total operating expenses were $160.2 million compared with $117 million in the prior year period. Cost of revenue was $3.1 million and reflects expenses directly associated with product sales. Inventory sold in 2025 is not reflected in cost of revenue because it was manufactured prior to FDA approval and expensed to the R&D line at the time produced. Research and development expenses were $33.4 million compared with $52.2 million in the prior year period. The decrease primarily reflects lower clinical trial costs as the KONFIDENT trials wind down, reduced discovery activities, the reclassification of certain medical affairs expenses from R&D to SG&A beginning in the fall of 2024 and the capitalization of manufacturing costs following FDA approval in July 2025. SG&A expenses were $124.7 million compared with $64.9 million in the prior year period, driven primarily by commercial launch activities and the continued build-out of infrastructure to support the commercialization of EKTERLY. Operating loss for the period was $112 million compared with $117 million in the prior year period. As of December 31, 2025, we had $300 million in cash and investments, which we believe is sufficient to fund the company to profitability under our current operating plan. Overall, this period reflects our transition to a global commercial organization with the direct launch of EKTERLY in the United States and Germany. The investments made in 2025 position us to support continued commercial execution. Looking ahead, we expect operating expenses to remain relatively consistent when adjusted for a 12-month period, with the exception that cost of revenue will increase meaningfully as we sell through the remaining zero-cost inventory. With respect to the non-financial KPIs, starting with the first quarter 2026 earnings call, we will report patient start forms and unique prescribers for the 3-month period ended that corresponds to the financial results of that reporting period. With that, I'll turn the call over to Ben for closing remarks. Ben?

Thank you, Brian. We are very encouraged by the early launch trajectory of EKTERLY and the strong response from people living with HAE and physicians. With continued U.S. growth, expanding international launches, and a pediatric filing ahead, we believe we are well positioned for 2026 and beyond. Our focus remains on disciplined execution, expanding access globally, and delivering on the full potential of EKTERLY for the HAE community. Operator, we'll now open the call for questions.

[Operator Instructions] Our first question comes from Tazeen Ahmad with Bank of America.

Congrats on another strong quarter. Can you talk to us about how do we think about the uptake for the ex-U.S. launches? You guys have made it to 20% of U.S. patients in a short amount of time. So can you maybe talk about the nuancing in the country specifically, let's say, Germany and Japan, to help us with how to think about uptake in general? And then for peak sales, what do you expect the split to be for revenue between U.S. and ex-U.S.

Sure. Thanks for the question, Tazeen. I'll start off and then I think Nicole can give some more detail. So at a high level, the German trends we've seen are tracking more or less the U.S. trends. It's obviously a much smaller marketplace, but the patient uptake has been quite strong. And I think we're comfortable that, that growth is going to look a lot like it looks in the U.S., again, just from a smaller base point. Japan, we did launch, but just factually, it's too early to tell. We did our -- we had our first sale in Japan last week. So it's probably a little early to extrapolate from that trend at this point, but more to come here as that launch progresses. And then with regard to peak sales splits, in general, the U.S. obviously represents the vast majority of sales for effectively any pharmaceuticals product. And so it will be somewhere in the 85/15, plus or minus a few points in either direction, U.S. sales over time. As we've said consistently, ex-U.S., the vast majority of the world is overwhelmingly on-demand only. You don't see a lot of modern prophylaxis use outside the U.S. But again, just because the pricing dynamics tend to be so much different from a unit standpoint, it may be pretty sizable. But from a dollar standpoint, it will always be a relatively small proportion.

Next question comes from Paul Matteis with Stifel. This is Julian on for Paul. Congrats on the strong progress. Can you just tell us a little bit about the types of patients that have started on therapy over the last couple of months in terms of phenotype and how they may compare to the end of last year? And further, you also talked about how the end of the year may have been impacted by the holidays and you still showed some linear growth in start forms. Just curious over the next couple of months, if you expect to continue to see increased linear growth? And anything that we should think about going into 1Q with respect to inventory or GTN would be helpful.

Sure. So thanks for your question. In terms of patients adopting EKTERLY we're very pleased to continue to see that the high-burden segment, we continue to increase our share with that segment in particular, as we look at the past few months of 2026. We're also very encouraged to see the broadening though of our patient base of growing both those patients with both mild and moderate burden of disease. And to us, that just really signals the broad appeal of EKTERLY to the entire population. And then in terms of the holidays, certainly, we do believe that demand is very strong in the fundamentals in terms of just the attractiveness of the profile for both patients and physicians. But we did certainly see earlier this year as many companies that the severe weather that impacted several states with multiple storms certainly did have a negative impact on demand in terms of the ability for patients to get into the offices to see their physician as well as for staff to complete administrative steps to complete paperwork for start forms.

Brian, do you want to talk about Q1?

Sure. We, like other high-priced specialty medicines will have a small impact to Q1 gross-to-net associated with co-pay assistance. It's kind of small in magnitude of order and temporary in terms of just getting through the deductible reset process.

Our next question comes from Stacy Ku with TD Cowen.

We have a couple. So first, maybe could you comment on how refill trends are progressing in 2026 and where you think things could settle just given really the high demand you're seeing for EKTERLY. So that's the first question. And then a couple of quick follow-ups. Are you able to comment on the high-burden patients where you are in the penetration of that patient bolus? So that's the second question. And then the third, we appreciate you providing forms through February. Are you able to comment high level if the rate of patient start form adds is similar in March? Are you seeing kind of the same dynamic that we've seen in Q4? I appreciate you following up on that. And Nicole, aligned with the processing of start forms, could you just further discuss your comment there? Is it just the normal seasonality around deductible resets, payer changes, et cetera?

Sure. Sure, absolutely. And I appreciate the question. So in terms of refills, we're very pleased to see that we're really maintaining the trends that we've discussed on previous calls and that refills, we're seeing patients anywhere between 1 to 3 cartons per refill as well as the high-burden patients continue to refill more frequently than when we look at those with more mild and moderate burden. And we've seen -- again, we've discussed that looking at claims data for some of the other on-demand therapies, those more mild-to-moderate burden patients are refilling just a few times a year, and we see that the high-burden patients refilling certainly more frequently. In terms of the share of the high-burden patients, we continue to grow. We're roughly around 1/3 at this point in time. And so we're pleased to see that continue to grow quarter-over-quarter. And really just the attractiveness of the profile continue to draw that particular segment of the market. And then just looking -- could you just remind me of your questions with regards to seasonality, just to make sure that we're answering it appropriately.

Yes. I just want to make sure we can maybe further just dissect your comment of processing of start forms, just the processing aspect of it. Is it around the normal seasonality from high deductible resets, payer changes, et cetera, as we think about kind of the short-term Q1 dynamics?

Stacy, it's Ben. Just -- I think there's a couple of seasonality things we've tried to highlight here and maybe we're mixing a little bit together. The first is the fact that in Q4, we've said fairly consistently the wholesalers, the PBMs -- the wholesalers ended up with higher-than-average stock towards the end of the year. And also, we do think that patients took on more drug in Q4, whether that was for increased need or just in anticipation of the kind of standard Q1 deductible resets, we'll never really know. But we fairly consistently said the volumes were probably higher in Q4, driven by some of these seasonal factors. And that -- some of that resets in Q1. And so we've just been trying to tell people that that's kind of a normal course activity. With regard to the start forms, we've consistently said, and we believe this trend will continue that we expect the launch to be consistent and linear. That does not mean, I think when Nicole was trying to highlight those, it will be consistent and linear, but there will be fluctuations quarter-to-quarter, and we don't attach any fundamental significance to them. It's just driven by a number of factors. What she was, I think, trying to highlight was the fact in January and February, you had several bouts of extreme weather in the U.S. and that absolutely impacted physicians' offices. There were certainly days in January and February when we had zero start forms simply because all the offices were closed. And so that does have a little bit of impact on some of the numbers we've talked about so far. But again, it's not a fundamental thing. It's just a weather thing. And also, she was trying to highlight the fact that when physicians' offices are closed, the start forms, which the physicians' offices have to process just don't get processed and so -- and to convert them to commercial. And so there's just some factors like that. We're just trying to make sure everyone is aware of as we roll through Q1. But the high-level message is we believe in the linearity of the launch to a greater or lesser degree. And I think we're very comfortable with the way things are progressing and nothing about this we're trying to suggest any shift in our anticipation of the future growth.

Our next question comes from Maury Raycroft with Jefferies.

This is Amy on for Maury. Congratulations on the strong quarter. We have 2 questions. One is a follow-up. Can you talk more about EKTERLY currently the refill rate and the dynamics? And how do you think the refill pattern will evolve in 2026 as the patient base broadens? The second question is, can you talk more about how you see the sales shaping up for the rest of the year? And would you be possible to share guidance at some point? And if not, what are the possible gating factors to do that?

Yes, I'll start with the second question, and then Nicole will pick up on the refill rates. Again, I think as is the norm with companies of our stage in the launch and activity level, we're just not in a position to provide guidance at this point. Again, for us, every quarter is the first quarter we've done this. And so for us to make any long-term projections right now, I think we're -- would probably not be helpful and may be defeating to everybody's activities. So what we do try to do is just convey what we do -- what we are seeing that's been consistent, and that just ties back to what I said to Stacy a minute or 2 ago just about how the launch continues to be to be quite consistent in terms of patient demand metrics. And all the other metrics that flow from that, patient commercial starts, refill rates, all that stuff also continues to trend in a favorable direction with really no dramatic shifts noted or expected. With that, I'll turn it over to Nicole to talk about the refill question.

Sure, absolutely. So as mentioned earlier, with refills, we typically see 1 to 3 cartons per refill. And so when we discuss our high-burden patients, those individuals are typically receiving more on the 2 to 3 cartons on a regular basis and that regular basis being every 1 to 2 months. And then when we take a look at those that have more mild to moderate burden of disease, they're really averaging more in the lower end of that 1 to 3, so typically 1 to 2 cartons and the frequency of which we would expect would really line up more with what we see with some of the other on-demand therapies in terms of them refilling approximately 3 to 4 times a year.

Our next question comes from Joseph Schwartz with Leerink.

This is Will on for Joe. Congrats on the progress this quarter. So it's great to see the penetration into the U.S. market continue to grow at such a strong rate at this very early stage in the launch. And as we think about it moving forward, where do you expect things to eventually settle out? And what kind of peak penetration are you targeting? And how does that inform the growth of the on-demand market from $650 million to $1.5 billion?

Yes, sure. Will. We believe this market over time should overwhelmingly convert to oral therapies. The injectables, obviously, everyone knows this, they're quite efficacious. They've served patients well for the past decade. But I think it's fairly obvious from just how EKTERLY has done to date, we've entered a new era here of therapeutics in HAE and orals that offer all the benefits of the injectables with none of the burdens of the injectables just are a better option for patients, just the classic sort of dominant choice. And so we do believe that over the next several years to a very high rate, the market should transition to orals. So that's a key underlying expectation here. And as part of the transition to orals, what you should also see is treatment rates go higher. Right now, again, it's kind of commonly accepted, and this has been talked about many times in many different venues that something between 50% and 65%, call it, 60% plus or minus of attacks are treated at all nowadays. So setting aside the fact that late treatment is right, you've only got slightly more than half of attacks under any circumstance that are treated, period. And so the point there is that as that attack rate goes up, obviously, the usage of therapeutics to treat these attacks will obviously be substantially increased as well. And so the point there is that the market overwhelm overall just gets larger. And that's really, again, just driven by the fact that when you have a better option to treat your attacks with, you'll treat more of your attacks. So we think the story of the on-demand market coming back to your dollar size is driven largely by just that central fact of the fact that you have now…

Our next question comes from Serge Belanger with Needham.

Nice 1Q preview. I guess, first, regarding payer reimbursement and access, any updates there? And I think in the past, you had mentioned that most of the patient starts or prescriptions were being almost universally covered under medical exception. Just curious if there's been any change on that front. Secondly, I think in the past, you've talked about potential use of EKTERLY as a short-term prophylactic. What does that market opportunity look like? And do you need to conduct clinical trials to capture that opportunity?

Serge, it's good to hear from you, and thanks for all the questions. I think maybe Nicole can talk a bit about the reimbursement metrics. And then I think we'd like to bring Paul into the conversation here and have him talk about the short-term prophylaxis, the work we're doing in that space and why we think it's important.

Sure. I'm glad to speak to you about the access side of things. We continue to convert paid patients across all the payers. Right now, we are leveraging a mix of medical exception as well as the EKTERLY policies where we have them in place. Those policies commonly are PA to label. There are some instances where we give a step through icatibant, but given the experience that people have with that product, we're able to move those patients through without delay. Right now, our payer team is very much focused on really those remaining large PBMs who we expect to formalize policies in the coming months. So from our view, we're very much on track and looking to have really that steady-state access realized later this year in 2026.

Serge, in terms of the STP opportunity, we currently still thinking about this from a research perspective. And so there are ongoing studies. We've currently seen use in about 50 procedures that are fairly invasive. And so far, the medication seems to work quite well. We're going to share the data at upcoming clinical conference. And we are initiating an additional trial to look at use in short-term prophylaxis. The reality is today, similar to the more general framework that injectable therapies are challenging to use in the setting of short-term prophylaxis where the recommendation remains strong that for patients undergoing procedures that they have an STP, that is typically recommended as an IV C1 inhibitor. This gives patients an additional option to consider using their oral on-demand therapy instead. And so we're still evaluating what the opportunity there is. But the data to date are pretty encouraging and it's a space to watch. Ben, I don't know if you want to add anything to that?

Yes. Serge, it's really just to tie. I mean, STP, pediatrics, at a high level, what we're really looking to do is continue to provide EKTERLY in places where we think it can address a meaningful unmet need. We haven't talked much about pediatrics today, but clearly, that's a space where it's not a lot of patients, but the current options are very much undesirable. And so we think that EKTERLY, even though it's not going to come for another year or so, still will offer an opportunity for folks to really address the unmet need in this young population in a much better way than they can currently. And so it may not be a huge economic pickup for us. But in terms of just expanding the availability of EKTERLY to populations that really could get benefit from it, we think it's substantial. And STP is exactly the same thing. I don't think we're presenting this as an enormous step-shift in terms of revenue opportunities. But there's a high need nowadays for better ways for patients to treat themselves prior to their procedures. Based upon the data we've seen so far, we think EKTERLY holds a lot of promise in there. And so this really all this comes under the tent of EKTERLY, really, we do expect to become the foundational therapy for HAE management. And this is just 2 more ways that we expect to accomplish that.

Our next question comes from Jon Wolleben with Citizens.

It's Catherine on for Jon. I have kind of a quick follow-up question to the kind of thought of patients switching from icatibant. Are you seeing any like -- is it too early to be seeing any dent in the amount of prescriptions for generic icatibant? And is any of that data going to be kind of captured by you guys have shown just kind of track how the launch of EKTERLY is impacting that generic market?

So a couple of things here. First of all, the vast majority, as you would expect at this point in the launch -- of people who are transitioning EKTERLY still are in the process of switching over to EKTERLY. And so it's largely -- when we talk about the 1,700 start forms, it's start forms. Not all of those people have moved to commercial. And so you would -- the number is still small enough that I think you probably wouldn't see a tremendous impact to date in that data, if you were to look at it. But I do think that as you play through the year, that will start to become more apparent. But factually, we're still relatively early in the launch from a commercial shipments perspective. And so it's going to take a little bit longer for what you talk about to play through.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.