Prepared remarks
Ladies and gentlemen, thank you for standing by. Welcome to KalVista Pharmaceuticals operational update and First Fiscal Quarter Financial Results. 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 in an outstanding fashion on a successful launch. The fact that 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 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 timeline, 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 toward 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 the 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 KOLs 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.
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?
Questions and answers
And the first question comes from Stacy Ku with TD Cowen.
Congratulations on a great early update. We have a few questions, mainly for Nicole. Could you provide more details on the Quickstart program? Additionally, could you clarify the process regarding prior authorizations and medical exemptions? What are your expectations for the timing of getting paid for the drug? How should we interpret the impressive patient start forms in relation to ultimately receiving payment for the drug? It would be helpful to understand that aspect. Regarding the Quickstart program, if you're able, could you share more about the prescribing patterns you are observing? Are patients expected to use EKTERLY chronically as needed? That covers the first question about the Quickstart program. Another question pertains to expectations on timing. We receive numerous inquiries from investors about the 4,000 patients and caregivers who have signed up for EKTERLY updates. Can you provide insight into how many are individual patients or caregivers? As a new treatment, do you think most clinicians will prefer to see their patients in the office? What is the frequency of current visits? Please help us understand that schedule in light of the high patient demand and how you plan to manage those numbers.
Sure. Thanks so much, Stacy, for the questions. So I apologize, there seems to be some technical difficulties here. We've been consistent that we look at the first 6 months of access, and those months 4, 5, and 6 will be crucial for us, which is why we're hoping for significant progression by that time. And in terms of Quickstart, the mechanics of it, if you will, the Quickstart program immediately provides access to EKTERLY at no charge. After the physician submits the start form, it allows KalVista to work with the physician office to pursue a medical exception to gain paid access. So the patient has Quickstart while we work with the office to gain paid access. Once the medical exception is approved, the patient's next shipment will be sent without delay to the payer. If medical exceptions require more time, then we contact KalVista to assist in providing the necessary paperwork. So I think in that regard, we want to move as quickly as possible.
I think it's coming in a little garbled, making it tough for me and likely others to hear.
The next question is on the patents and the timing.
Sure. We are pleased to see rapid growth in our patient database following approval. The new registrations include both individuals and caregivers. Notably, the prescriptions are primarily concentrated around Tier 2 physicians. Our sales representatives are successfully engaging with the physicians who treat these patients, and several of our in-person education programs for patients are yielding positive results. This allows us to connect with patients at the local level and assist them in maximizing the use of the therapy. Regarding prescribing patterns, as for visit frequency, some physicians require an office visit and use telehealth, while others may not require a visit to prescribe the 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. In terms of the script, 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 there will be more interest in repeat prescribers as well as refills. We anticipate there will be conversations around utilization of the product or consumption of our product on a per-patient basis. In terms of Quickstart and paid access, when a physician writes a script for EKTERLY, they create that start form, which they send to the KalVista hub. In parallel, they send a request for Quickstart. Quickstart provides immediate access to EKTERLY at no charge, and our team works with the physician office to pursue a medical exception that allows the patient to gain paid access. So while a patient is on Quickstart, once the medical exception is approved, the patient's next shipment will be sent without delay and billed to their commercial or government payer, depending on their coverage. If that exception takes longer, we will as a company send a second shipment to the patient. Typically, patients receive 2 boxes for their initial prescription, and then refills depend on how the physician writes the prescription. If the refill is written as needed, a patient may receive 2 boxes or more, depending 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 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 from your sales force would be helpful.
Sure, absolutely. So, when we share a start form number of 460, it is that 100% of those individuals also received Quickstart. The program is designed so that the forms come in together, allowing patients immediate access to therapy. We have been encouraged that just a few weeks after approval, EKTERLY paid shipments have started going out to patients where the medical exception was processed quickly. That shows positive signs from payers, and it signals that individuals are continuing to utilize EKTERLY as their primary on-demand therapy. In terms of retreatment rates, we are seeing that feedback from the field has been positive, and we haven't heard anything alarming about any second dosing, but we recognize that the redose rate is somewhere in the low 20s, which is below the Firazyr rate.
And regarding treatment, we have received positive anecdotal feedback from the field. We haven't seen any concerns regarding second dosing. Our open-label studies indicate a consistent trend in the low 20s for redose rate, which is favorable when compared to other medications in the market. Overall, we have not received any negative feedback, and we continue to monitor closely.
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 any adverse event reports which have been pretty minimal. Typically in the first 6 months of the launch, that's the period when prescribers are getting used to the therapy. So there's nothing that's come forward to date. In terms of GI-related adverse events, we haven’t heard about any during the course of the launch, and during the open-label extension, we treated almost 1,000 abdominal attacks, showing an extremely low rate of GI adverse events. So 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. 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 August number was provided because we had it available, and I think there have been a lot of questions about how the trajectory is going to go. What I would say is, we are quite pleased with this growth in demand; it doesn't represent simply a one-time bolus from prior studies. The open-label extension isn't massive. Therefore, the patients transitioning from that program are in the dozens, rather than hundreds. What this really reflects is a sustained and continually growing interest from people. Demand started off higher than we anticipated and continues to increase. We've been experiencing this linear growth without surges that would indicate a one-time event, and we're seeing strong breadth of prescriptions, both high and low attack rate patients, since launch and continuing beyond August. Overall, the trends remain positive.
Got it. That's helpful. And maybe just going forward, as we focus more on revenue numbers, how should we think about just stockpiling as a dynamic there?
In terms of inventory at the specialty pharmacies, similar to most rare disease launches, we expect long-term averages to hold at 2 to 4 weeks of inventory. In the earlier part of the launch, inventory levels can fluctuate, but we don't anticipate anything different when compared to other rare disease launches and specialty medications.
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. Heading into the launch, we conducted extensive market research indicating that patients with a higher burden of disease would be early adopters. We have seen strong adoption from high-burden patients, which aligns with our expectations. The product profile has been particularly attractive to them. Adoption has been observed across a wide range of patient types, indicating good penetration, showing interest from both high and low burden patients.
And our next question will come from Pete Stavropoulos with Cantor Fitzgerald.
Congratulations on the quarter. Can you remind us how many patients in the OLE are actually based in the U.S.? I understand you mentioned it's in the dozens. What is the expected timeline for shifting the majority of these patients to commercially reimbursed prescriptions? Additionally, from a non-access perspective, what have been the outcomes so far for the educational or informational programs intended to raise awareness of EKTERLY's profile? Do you have an estimate of the proportion of patients from the 460 start forms that resulted 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, it's important to note that at least from a U.S. patient perspective, we are looking at several dozen patients rather than several hundred. Some had already entered the early access program when they finished the OLE, while others are still continuing there. It’s challenging to track their transition to commercial as it’s not a large immediate switch. We're comfortable that they’re transitioning but it's integrated into the overall demand uptake. As for the second part, I'll hand it over to you, Nicole.
In terms of outcomes from our educational informational efforts, the earliest adopters have been influenced significantly by their education. Mapping patients from different geographic regions connects with our Tier 1 and Tier 2 physicians, correlating with our marketing efforts. We had a tremendous opportunity with the HAEA Patient Summit, where we announced our approval just days prior and engaged with over 1,400 members of the community. We continue to host local education programs, which aim to educate both patients and their families about EKTERLY and its benefits. This personalized approach will be key to our outreach moving forward.
And the next question will come from Serge Belanger with Needham.
First question regarding securing formulary coverage. Could you provide an update on where you are and where you expect to be? And are you expecting to be at parity versus other products in terms of step-throughs, prior authorizations, and quantity limits? And just a quick one, I noticed on Slide 14 of your updated slide deck, you increased the size of the projected market growth by about 25%. What are the assumptions behind that increase in growth expectation?
In terms of access, I would say that things are progressing as we anticipated utilizing medical exception and that we would see access to paid happen on a limited basis, growing over time. From a steady state perspective, yes, we do anticipate parity access to branded therapies in the market. While we were aware of the potential requirement for a step-through generic icatibant, we have seen one instance to date. Even in that scenario, patients have been able to move forward with EKTERLY quickly due to their prior experience with generic icatibant. Therefore, we're hopeful that parity access to branded therapies will be achieved as we progress.
On the market number, Serge, thank you for your keen observation. This increase reflects our expectation of a larger market size, based on reevaluating market doses and projected pricing. The expectation of a higher branded price, based on our weighted average cost of capital, drove an upward revision from our previous estimates. Overall, this is a straightforward update reflecting a solid growth expectation.
And the next question will 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.
Well, one, as I just mentioned, the vast majority of patients have experience on the generic icatibant, allowing for other potential avenues of approval. The feedback from physicians indicates that describing a fail or failure of icatibant to payers is reasonably straightforward, citing examples such as injection site reactions or difficulties with administering subcutaneous injections based on a patient's history of abdominal attacks. This outlines the small percentage of cases that may encounter this issue, but we feel that there's a clear path to transition how patients can appropriate EKTERLY. In terms of providing further clarity on percentage lives covered, it's something we recognize that a lot of stakeholders are interested in. As we continue with the launch, we will share progress from the payer side of things concerning ongoing paid access and establishing those policies.
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 about revenues. EKTERLY was available roughly 10 days following approval, and I'll clarify that we had start forms coming in the day of approval. In fact, our first start form came in before lunchtime on the day we announced it, so start forms did precede actual shipments by 10 days.
Regarding revenue recognition, we follow ASC 606, as all pharmaceutical companies do. Our customer base is the specialty pharmacies, and revenue is recognized once the product is received by the specialty pharmacies. There is typically a lag between this recognition and the product being dispensed to patients.
I am showing no further questions at this time. This does conclude today's conference call, and thank you for your participation, and you may now disconnect.