KALV - NASDAQ

Ladies and gentlemen, thank you for standing by. Welcome to KalVista Pharmaceuticals operational update and First Fiscal Quarter Financial Results. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to turn the conference over to Ryan Baker, Head of Investor Relations. Sir, please go ahead.

Thank you, operator. Good morning, everyone, and thank you for joining us to discuss KalVista Pharmaceuticals fiscal year 2026 first quarter financial update and operating results. Please note we'll be making certain forward-looking statements today. We refer you to KalVista's SEC filings for a discussion of the risks that may cause actual results to differ from the forward-looking statements. On the call with me today from KalVista are Ben Palleiko, Chief Executive Officer; Nicole Sweeny, Chief Commercial Officer; and Brian Piekos, Chief Financial Officer. Dr. Paul Audhya, our Chief Medical Officer, will be joining us for the Q&A portion of the call. Ben will begin with a review of the company's progress during the 3 months ended July 31, 2025, including FDA approval of EKTERLY and other regulatory updates. Nicole will then review the company's commercial progress to date and Brian will cover the company's financial statements for the most recent quarter. We will then open the call for questions. With that, I will now turn the call over to Ben.

Thank you, Ryan, and welcome, everyone, to our first ever financial update conference call. It's been a momentous few months for KalVista, highlighted by our announcement on July 7 that the FDA approved EKTERLY as the first and only oral on-demand therapy for acute HAE attacks in adults and pediatric patients aged 12 and older. This approval has positioned EKTERLY to transform the treatment paradigm globally for people living with HAE. We initiated the U.S. launch immediately following approval and are pleased to report today our initial launch metrics. With EKTERLY, for the first time, people living with HAE had an oral on-demand therapy they can take at the first signs of an attack, achieving symptom relief in the same time frame as injectable therapies with a pristine safety profile. EKTERLY breaks through the barriers imposed by injections, and we believe it is poised to become the foundational HAE treatment globally. It enables people with HAE to adhere to treatment guidelines, which recommend treating attacks early and considering treatment of all attacks with the goal of achieving total disease control and normalizing lives. Since initiating our U.S. launch, the community response to EKTERLY has been overwhelmingly positive and early uptake is even greater than our expectations. People living with HAE, physicians and payers all have engaged rapidly, which speaks to the unmet need that EKTERLY addresses. In a few moments, I'll turn the call over to Nicole to discuss our commercial progress in more detail, but I will say that we are already seeing the results of the investments we made prior to approval in our commercial infrastructure and we are executing an outstanding fashion on a successful launch. The fact that already almost 5% of the entire U.S. HAE population has submitted a prescription for EKTERLY clearly speaks to all these elements, including the quality of the commercial team we have established. Beyond the U.S., we continue to make important regulatory progress in our efforts to bring EKTERLY to people living with HAE around the world. In Europe, sebetralstat received a positive CHMP opinion in July for the treatment of acute HAE attacks with a final European Commission decision expected in October. The Committee for Orphan Medicinal products also confirmed maintenance of orphan designation, underscoring the significant unmet need that sebetralstat addresses in the EU and granting a 10 years of market exclusivity upon approval. We anticipate a staged launch in Europe over the next 12 to 18 months commencing with Germany pending approval. Also in July, the U.K. MHRA granted marketing authorization of EKTERLY as well as adding it to the agency's orphan register. With regulatory approval secured, the process now moves to NICE for a health technology assessment to determine patient access and reimbursement. These discussions are essential to ensure broad availability. Based on the current time line, we anticipate a U.K. commercial launch in the first half of 2026. We continue to progress towards anticipated approval in Japan at the end of this year, and launch through our commercial partner, Kaken Pharmaceutical in early 2026. Our Canadian partnership is also progressing towards a regulatory filing and we are currently in discussions with multiple other potential partners worldwide. We believe this progress not only validates the universal need for EKTERLY, but also lays the foundation for meaningful commercial growth and long-term value creation for our shareholders. With that, I'll now turn the call over to Nicole, who will share more detail on early launch progress and some of the performance indicators we will be building on in the quarters ahead. Nicole?

Thank you, Ben, and good morning, everyone. As Ben mentioned, our launch readiness activities have ensured that we were well positioned to deliver EKTERLY, the first and only oral on-demand therapy to patients as quickly as possible. While we remain in early days of the launch, I am very pleased with the progress we have seen to date. We are observing encouraging signs across several key performance indicators. From the patient perspective, interest in EKTERLY has been strong and continues to grow. Just days after launch, we attended the HAEA Patient Advocacy Summit in Baltimore where over 1,400 people living with HAE were present. It was an important opportunity to share information and introduce EKTERLY to the community. Within the first few weeks of approval, an additional 500 community members joined our database seeking information and updates on EKTERLY. Through the end of August, more than 4,000 individuals have joined our patient database. Additionally, we continue to host local and virtual education events to increase awareness of EKTERLY among patients and family members. Following our announcement of the FDA's approval of EKTERLY on July 7, I'm excited to share that in the 8-week period ending August 29, we received 460 patient start forms. Early demand has largely come from patients previously on Firazyr and icatibant as expected, but also from all other on-demand therapies, and we are seeing patients on all prophylactic therapies adopt EKTERLY at similar rates. On the access front, we know that formal coverage policies typically take up to 6 months to be established. Even so, we are pleased to see some patients gain paid access, consistent with our expectations. The Quickstart program and medical exception processes are proceeding as planned, and we are confident in our ability to secure broad access over time. For prescribers, our field sales organization is focused on engaging the top 1,000 HAE treating physicians who account for roughly 90% of prescriptions written in the U.S. As expected, early prescriptions have come from KOL to manage the highest number of HAE patients. Importantly, however, adoption has not been limited to the KOLs. We are observing strong interest in prescribing from a broad base of providers, even outside that top 1,000, which underscores the strength of our educational efforts and the clear unmet need EKTERLY is addressing. From launch through August 29, we have activated 253 unique prescribers with 38% of those starting multiple patients on EKTERLY. Over this same time period, our field sales team has reached over 72% of the total physician base, including 96% of the Tier 1 physicians. In addition to KPIs, our KalVista Care hub services are fully operational, helping patients navigate access and financial support. Early feedback from both patients and offices is very positive. Taken together, these early signals reinforce our confidence in EKTERLY's potential to become the foundational therapy for people living with HAE. Looking at future quarters as our launch progresses, we expect the launch KPIs will evolve. And so we will adjust our reporting metrics accordingly. I will now turn the call over to Brian for a review of the company's financial statements for the most recent quarter. Brian?

Thanks, Nicole. Good morning. The press release we issued earlier today contains our full financial results, so I'll provide a few highlights for the 3-month period ended July 31. We are pleased to announce the first sale of EKTERLY reporting $1.4 million in net revenue for the launch period, primarily from stocking orders by the specialty pharmacies and our commercial distribution network. Total operating expenses for the period were $60.4 million, consisting of approximately $15 million in R&D expenses and approximately $45 million in SG&A expenses. The quarter-over-quarter increase in SG&A was driven primarily by external spending related to the EKTERLY launch. Looking ahead to the remainder of 2025, we expect operating expenses to remain relatively consistent as we continue to invest in the EKTERLY launch. Turning to the balance sheet. We had approximately $191 million of cash and investments as of July 31, 2025. We expect that balance together with forecasted EKTERLY revenue to fund the company's operations into 2027. Before turning it over to Ben for closing remarks, I'd like to remind everyone that as previously announced in March, we are changing our fiscal year end to December 31. As part of that transition, we will begin reporting on a traditional calendar quarter basis this fall, starting with the quarter ending September 30, which will capture the 3-month period from July through September. Ben?

Thank you, Brian. As Nicole described, we are pleased with the strong response we are seeing in the early days of our U.S. commercial launch. The level of engagement from people living with HAE and physicians underscores both the unmet need in HAE and the transformational potential of EKTERLY. The rapid adoption we are seeing reinforces our belief that EKTERLY can redefine the standard of care for people living with HAE. We remain focused on executing our commercial strategy with discipline, driving global expansion and continuing to deliver on our vision of bringing this meaningful life-changing treatment to people worldwide. And with that, we will now open the call to your questions. Operator?

[Operator Instructions] And the first question comes from Stacy Ku with TD Cowen.

Congratulations on a wonderful early update. We had a few questions, mostly towards Nicole. Can you just further speak to the Quickstart program? And just maybe help us and other investors understand the process on prior authorizations and medical exemptions. Maybe just talk through your expectations for timing to pay drug? And really, how should we think about that translation of the really impressive patient start forms to eventually getting paid drug. So just help us understand that piece. And then on top of Quickstart program, just maybe if you're willing to -- on top of the details you've provided so far, just talk about the type of prescribing patterns you're seeing. Just help us understand are patients going to be able to have chronic use of EKTERLY as needed. So that's kind of the first question on the Quickstart program and dynamics there. And then another is maybe another just expectations on timing. We get a lot of questions from investors on that 4,000, let's say, patient and caregivers that have signed up for EKTERLY updates. So just give us a sense of how many are individual patients or caregivers as a new treatment, would you expect most clinicians would want to see their patients in the office? And maybe what's the frequency of current visits? Just help us understand that cadence as we think about the high patient demand and how you will have to work through that patient number?

Sure. Thanks so much, Stacy, for the questions. So [Technical Difficulty] we've been consistent that we look at the first 6 months [Technical Difficulty] of those months, access may be in the months 4, 5 and 6, which is really why [Technical Difficulty]. And in terms of Quickstart, the mechanics of it, if you will, the Quickstart program immediately provides access to EKTERLY at no charge. [Technical Difficulty], they submit the start form. And so when the start form comes in, it allows KalVista to work with the physician office to pursue a medical exception to gain [Technical Difficulty]. So the patient has Quickstart, again, while we work with the office to gain paid access. [Technical Difficulty] once the medical exception is approved, the patient's next shipment will be sent without [Technical Difficulty] the government payer. If medical exception, that time period, [Technical Difficulty], then they contact KalVista [Technical Difficulty] provided by KalVista. So I think in [Technical Difficulty]. And obviously, when the [Technical Difficulty] quickly as possible.

I think it is coming in a little garbled, by the way, tough for me to -- and I'm guessing others to hear.

[Technical Difficulty] the next question is on the patents and the timing.

Sure. Absolutely. In terms of the patient database, we're encouraged to grow so quickly after approval [Technical Difficulty] caregiver as well [Technical Difficulty]. What's most interesting is that when we look at the geography [Technical Difficulty] Tier 2 physicians. So to us, that's very [Technical Difficulty] representatives that are going in are connecting with the physicians that treat these patients and a number of our in-person education programs for patients that [Technical Difficulty] programs so that we can be [Technical Difficulty] same geographies is [Technical Difficulty] much to engage with those patients at a local level and help them [Technical Difficulty] therapy. [Technical Difficulty] you had is, I believe, on the visited [Technical Difficulty] a prescriber standpoint and so [Technical Difficulty] approach in terms of some physicians requiring a visit using telehealth and some not requiring a visit in order to prescribe therapy.

And our next question comes from Paul Matteis with Stifel.

Really appreciate it. A couple of questions from us. You talked about how the launch metrics may evolve as you move forward with this launch. Just curious what your expectations are moving forward? And I guess, later this year, is it possible that we could be getting actual number of doses prescribed for example, versus just start forms? And also, and again, this may have been answered. It was a little bit difficult with the audio. But just curious, are you able to confirm just sort of what we've heard previously on the insurance process that patients first receive 2 doses initially and then also afterwards received 2 doses of paid drug automatically if their insurance is approved? Just wanted to confirm that. And if so, how does that inform your perspective on the launch kinetics moving forward this year?

Sure. So in terms of the script to address your first question, we recognize that as we get into months 4, 5 and 6 later in the year, that certainly some of the KPIs will be evolving and more interest in repeat prescribers as well as refills and certainly talking more about utilization of the product or consumption of our product on a per patient basis. So certainly recognize that. And as the year unfolds, plan to share more in terms of a view into other KPIs. And then it may be helpful just to -- I know there was an audio glitch. So it may be helpful just to kind of take a step back on Quickstart as well as paid. And so I think it's important to appreciate that when a prescriber -- a physician writes a script for EKTERLY, they write that start form and they send it into the KalVista hub. In parallel, they do send in a request for a Quickstart. And so how this works is that the Quickstart provides immediate access to treatment for EKTERLY at no charge, and then our staff works with the physician office to pursue medical exception and gain paid access. While a patient is on Quickstart, once that medical exception is approved, the patient's next shipment will be sent without delay and paid by the commercial or the government payer depending on who they have. If that exception requires more time, then we as a company will send a second shipment. And in terms of the other question, I believe you asked just in terms of script. Yes, patients are typically receiving 2 boxes for their initial prescription. And then it's really -- the refill is very much dependent on how that physician writes the prescription. And so if the refill is written as needed, a patient may receive 2 boxes or they may receive more depending on their burden of disease. And so that is something that, again, it's up to the physician as to how they write. Typically, they prescribe PRN for refills to allow patients flexibility to adjust the number of boxes in the future based on their burden of disease.

And the next question will come from Tazeen Ahmad with Bank of America.

Congrats from me as well on a good start to the launch. I'm sorry if you already said this before, but maybe you can clarify, have you broken down of the 460 start forms? What percent were to a Quickstart, what percent are reimbursed and what percent may be coming from another source? I just want to get a sense of where you are in the early stages of reimbursement. And are we still going to be able to track these numbers quarter-to-quarter? And then the second question is, is it too early to know what the retreatment rates are? You're just still a few weeks into the launch, but any kind of anecdotes you can share some feedback from your sales force, it would be helpful.

Sure, absolutely. So the -- when we share a start form number of 460, it is that 100% of those individuals also received Quickstart. And so again, as the programs are designed so that the forms come in together, so patients have immediate access to therapy. We certainly were very encouraged and have been encouraged to see that we have started just a few weeks after approval, EKTERLY paid shipments starting to go out to patients where the medical exception process went through rather quickly. Certainly, that's something that we continue to watch, and it does grow week to week. And also even more recently seeing our first refills for -- on the paid side of things was also very encouraging because to us, that's just signals not only positive sign from the payer side of things, but also that, that individual is really continuing to utilize the product and adopt it as their primary on-demand therapy.

And with regard to treatment, Tazeen, I mean, we've certainly heard some anecdotal feedback from the field already. It's all been, I think, very positive. We haven't really heard anything about any kind of second dosing. We -- but again, we continue to think that's not really an issue. The open label, we've talked about this publicly multiple times, the redose rate somewhere in the vicinity of the low 20s, 22%, 23%, which is actually even below the Firazyr rate. So we don't think that represents any issues with anyone, whether it's patients or payers. And again, because it just absolutely falls quite the lower end of what's seen in the world nowadays.

Okay. And then last question for me. Any feedback on side effects observed thus far, any laryngeal attacks or any kind of GI discomfort?

This is Paul Audhya. No, actually, we've been hearing overall consistency between what we observed in the open-label extension and what we're seeing in terms of just any adverse event reports which have been pretty minimal. Typically in the first 6 months of the launch, that's the period in which it is most intense when the prescribers are getting used to the therapy. And so there's nothing that's come forward to date. Certainly, in terms of GI-related adverse events, we haven't heard about any during the course of the launch and actually over the open-label extension, we treated almost 1,000 abdominal attacks. And even in that setting, we're seeing extremely low GI adverse event rate. So I think really, this is a drug that's not associated with GI adverse events.

I really think the only anecdote we've heard so far has actually been favorable, which was we did have one person call our patient hub to let people know that it had a laryngeal attack and we're very pleased with the outcome. They said it worked quite well for them. So limited stories and tough to extrapolate, but everything so far has been favorable.

And the next question is going to come from Maury Raycroft with Jefferies.

Congrats on the progress and the update today. I'll ask one about the 460 start forms as well. Just wondering if you can provide a July versus August breakdown just in trying to get a perspective into how much was from rollover from clinical studies or a bolus waiting for the launch. And whether you think this early demand could suggest a linear trajectory?

Thanks, Maury. Nice to hear from you. The -- we chose to put out the August number because we had it, and I think there've been a lot of questions about whether -- how the trajectory is going to go. What I would say is, and we're quite pleased with this. This is -- this doesn't just simply represent a sort of a onetime bolus of rollover people or something. First of all, the open-label extension, even though it's big for HAE, isn't super big. So the people coming off who could plausibly move on are measured dozens, not hundreds. What this really represents is a sustained -- continually growing level of interest from people. And so demand certainly started off, I think, higher than we anticipated and it's continued to go from there. So the curve has been a fairly linear growth from here with really no surges along the way that would represent to us, this was a sort of onetime event. We've been very -- and this a little bit goes to the fact, and we talked about a little bit in the comments, the fact that patient interest has been very broad, certainly even broader than we thought it would be in terms of just people on prophylaxis as well as people with high or low attack rates. We've seen a really terrific breadth of prescriptions. And again, through -- ever since the launch and even continuing now past August, we've continued to see the same trends.

Got it. That's helpful. And maybe just going forward, as we focus more on revenue numbers going forward, how should we think about just stockpiling as a dynamic there?

That's probably a good question for Brian Piekos.

In terms of inventory at the SPs, like most rare disease launches, we expect long-term averages to SPs to hold 2 to 4 weeks of inventory. I think in the earlier part of the launch, that can move around a bit, but we don't expect anything different as compared to other rare disease launches, specialty medicines.

And the next question will come from Joseph Schwartz with Leerink.

This is Will on for Joe today. Congrats on the great quarter and strong start to the launch. So one question for us. Just want to drill down a bit more on the patient profile. So could you share anything beyond what their prior therapy might have been? And are you seeing any meaningful patterns on attack rate severity, attack frequency and what their typical attack rate might have been before initiating treatment?

Sure. I'm glad to take that question. And heading into the launch, I think we had conducted a great deal of market research that indicated those patients with more severe burden of disease that those would be some of our earliest adopters. And certainly, we see adoption across a wide, I would say, array of patient types in terms of the burden of disease. But we have seen and are very pleased with the adoption with those high burden patients. And the profile certainly of the product was attractive to them, and we have certainly seen that population be some of our earliest adopters, but we absolutely have seen adoption across the burden of the disease base, if you will.

And across all prophylaxis therapies.

Yes. Just something else to add is that we've seen -- when we look at the current use of prophylaxis with our patients, we do see that the utilization really lines up with the market share in terms of use of prophy overall. And then we actually see the brand share for prophylaxis lineup as well with the patient base we have launched to date. So again, it's very encouraging to just see this used by a very broad population, whether it's based on burden of disease or previous on-demand or current prophylactic treatment.

And our next question will come from Pete Stavropoulos with Cantor Fitzgerald.

Congratulations on the quarter. Can you just remind us how many patients are in the OLE are actually U.S.-based? I know you said somewhere in the dozens. And what is the expected cadence or time lines to shift the majority of these patients to reimbursed -- commercially reimbursed scripts? And also from a non-access perspective, I've reached to patient, perhaps educational or informational programs. What's been the outcome to date for those efforts to sort of raise awareness of EKTERLY's profile? And do you have a sense of the proportion of patients from the 460 start forms that were directed from these efforts?

I guess I'll do the first one, Nicole, and you can do the second. So Pete, in terms of the OLE rollover, I mean it's important to note that the OLE at least from a U.S. patient perspective, was several dozen patients, not several hundred patients, for example, and some of whom had already gone on to the early access program when they finished and some of them are still actually continuing on the OLE for a while longer. So there is no dramatic sort of burst of people that would immediately switch on the commercial. I think -- and that's why I was saying earlier, our view is that these folks are coming on as part of this generalized demand uptake. And then effectively, their numbers are kind of subsumed by the larger demand we're seeing. So they're certainly out there, and I think we're comfortable they're moving over, but it's very hard for us to track just based upon the fact that, like I said, they're not an enormous immediate transition group. And over to you on the second one.

Yes. So in terms of your second question, certainly, we see the earliest patient adopters. As I mentioned earlier, our -- when we've mapped them from a geography standpoint, obviously cluster around our Tier 1 and Tier 2 physicians, which connects back to our marketing list. But also we had a tremendous opportunity with the HAEA Patient Summit. We announced our approval on Monday. We went to that summit on Friday. There were 1,400 members of the community there. So that was also a chance for us to engage with full family members. And so since that time, our education efforts have been very much driven to do local education programs, trying to invite family members to come out certainly with the intent to provide more education and adoption for that individual, but also to help introduce EKTERLY to the family. And so that's certainly something that we've been doing since launch at the in-person conference in the dinner program sense, and we'll carry that approach certainly into the fall in addition to other nonpersonal marketing efforts, e-mails and things like that.

And the next question will come from Serge Belanger with Needham.

First question regarding securing formulary coverage. Maybe just give us an update on where you are and where you expect to be. And then our expectations that you'll still be at parity versus other products in terms of step-throughs, prior auths and quantity limits? And then just another quick one. I noticed on Slide 14 of your updated slide deck, you increased the size of the projected market growth by about 25%. Maybe just talk about the assumptions behind that increased growth expectation.

Sure, absolutely. I think in terms of the access side of things, I would say, at this point in time, things are certainly progressing how we would -- how we anticipated utilizing medical exception and that we would see access to paid happen on a more limited basis rather quickly, but certainly that, that would grow over the time. And we certainly anticipate that. If we think about steady state from the access side of things, yes, we do still anticipate parity access to branded therapies in the market. And certainly going into launch, we were certainly aware that there may be some exceptions where a payer might choose to require a step-through generic icatibant. There's been one instance that we've seen to date. But it's really important to note that even where that instance has come up, patients actually have EKTERLY and are getting it paid. And the reason for that is because 80% of patients have either been on generic icatibant or are on generic icatibant previous to EKTERLY. So even in that instance where we have faced that one step at a policy, the patients have been able to move forward and already have their EKTERLY in hand paid for. So certainly, for us, we're continuing to advance our efforts. But again, at this point, we maintain the view that parity access to the other branded therapies will be expected.

And on the market number, Serge, first of all, kudos to you for reading the deck in detail before the call. Thank you for that. The second thing would be, it's pretty straightforward. When we've done those numbers, which was a while ago, we had obviously done it based on an estimate of the market size, total market doses, which we talked about a lot and also a branded price, which was down closer to the standard Firazyr price. As part of the update, we revised all that to reflect the fact that the branded prices in our expectation is meaningfully higher based upon our WACC and where the market sits nowadays. And so it's just a fairly straightforward exercise to market back to an updated expectation on the pricing and then you grow it a little bit from there. So that's really what it reflects.

And the next question is going to come from Debanjana Chatterjee with Jones.

Congrats on the quarter. So you mentioned about the generic step-through that might be required by certain insurers. What do you think these payers would like to see in terms of either safety or efficacy failure on icatibant to approve EKTERLY? And I have a quick follow-up.

Sure. Well, one, as I just mentioned, it's important that the vast majority of patients have experience on generic icatibant, so they can move through that step rather quickly. So for the minority, which would be 20% of patients. The feedback that we hear from physicians is that actually describing a fail or a failure of icatibant to a payer is quite simple, and it could come down to injection site reactions. It could also be, for instance, that someone has a history of abdominal attacks and administering a subcu and the abdomen is difficult and challenging. They could have difficulties with hand swelling, so therefore, administering a subcu is really quite difficult. So again, we see that being an absolute minority of cases where we -- an individual would face it, but there is experience in the market with, again, those examples I gave you for overcoming and establishing that a patient has failed generic icatibant and can quickly move on to EKTERLY in this instance.

That's helpful. And at some point, in terms of the KPI, would you be sharing percentage lives covered?

I think that's something that as we continue through launch, we'll certainly share more progress in terms of our efforts from the payer side of things. The exact details and KPIs, I think that's probably to be determined at this point in time. But certainly, we recognize there's interest in providing more clarity on our efforts to ensure that there's ongoing paid access and establishing those policies. So I would just say stay tuned for further updates from the company, but certainly, we appreciate that there's a need to do so.

And our next question will come from Jon Wolleben with Citizens.

This is Catherine on for Jon. A quick question about the number of scripts and patients that potentially account for the revenues reported in July. I know there's about 1.4 million reported. And also, when did EKTERLY become available in July? Is it immediately post approval?

Brian can answer the second question on the -- with regard to revenues. EKTERLY was available roughly 10 days following approval. We had [Technical Difficulty].

In respect to revenue...sorry, go ahead.

Just to tie that out. But just to tie that to start forms, though, just to be clear, we were getting start forms actually the day of approval. Our first start form came in before lunchtime on the day we announced. So start forms did predate actual shipments by 10 days.

And just on the revenue recognition side, we have followed 606 as every other pharmaceutical company does. You'll see that our customer base is the specialty pharmacy. So we recognize revenue when a product is received by the specialty pharmacies. And then there is a lag from there when they go out and reach the patients.