KalVista Pharmaceuticals Q1 2026 Earnings Report

KalVista Pharmaceuticals EPS Results

• Actual EPS: -$1.12
• Consensus EPS: -$0.91
• Beat/Miss: Missed by -$0.21
• One Year Ago EPS: N/A

KalVista Pharmaceuticals Revenue Results

• Actual Revenue: $1.43 million
• Expected Revenue: $1.97 million
• Beat/Miss: Missed by -$542.00 thousand
• YoY Revenue Growth: N/A

KalVista Pharmaceuticals Announcement Details

• Quarter: Q1 2026
• Date: 9/11/2025
• Time: Before Market Opens
• Conference Call Date: Thursday, September 11, 2025
• Conference Call Time: 8:30AM ET

KalVista Pharmaceuticals (NASDAQ:KALV) is a clinical‐stage biotechnology company focused on the discovery and development of small‐molecule protease inhibitors for orphan and specialty disease indications. The firm’s scientific platform centers on selective inhibition of plasma kallikrein, a serine protease implicated in disorders characterized by vascular leak, edema and inflammation. KalVista’s approach leverages oral and intravitreal delivery formats to target both systemic and ophthalmic conditions.

The company’s lead programs include an oral plasma kallikrein inhibitor in clinical trials for the acute treatment of hereditary angioedema (HAE) attacks and an intravitreal kallikrein inhibitor being evaluated for diabetic macular edema. These candidates are designed to address unmet needs in rare disease and ophthalmology by improving patient convenience, reducing the burden of disease manifestations and potentially offering long‐lasting therapeutic benefit.

Founded in 2010 and headquartered in Cambridge, England, KalVista also maintains operations in Boston, Massachusetts. The company completed its initial public offering on the Nasdaq exchange in 2015 and has since advanced its pipeline through a combination of in‐house research, strategic collaborations and contract manufacturing partnerships. KalVista’s programs target patient populations in North America, Europe and other markets with significant unmet medical need.

KalVista is led by President and Chief Executive Officer Anna Berkenstock, PhD, who brings extensive experience in drug discovery, development and corporate strategy. The broader leadership team and board of directors draw on deep expertise in rare disease biology, protease chemistry and clinical development to guide the company’s strategic priorities and global growth.

KalVista Pharmaceuticals Q1 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: FDA approval of ECTERLEET on July 7 marks the first oral on-demand therapy for acute HAE and is poised to transform the global treatment paradigm.
• Positive Sentiment: Early U.S. launch metrics have exceeded expectations with 460 patient start forms (nearly 5% of the U.S. HAE population) and activation of 253 prescribers, including 96% of tier one physicians.
• Positive Sentiment: International regulatory progress includes a positive CHMP opinion in Europe, UK MHRA approval, and anticipated decisions in October (EC) and late 2025 (Japan), supporting staged launches in key markets.
• Neutral Sentiment: Q1 results show $1.4 million in net ECTERLEET revenue, operating expenses of $60.4 million, and ~$191 million in cash ($207 million pro forma) funding operations into 2027.
• Neutral Sentiment: The quick start program enables immediate patient access while medical-exception processes secure paid coverage, with parity access to branded therapies anticipated over time.

Presentation

[Operator]

Ladies and gentlemen, thank you for standing by. Welcome to KalVista Pharmaceuticals' operational update and first fiscal quarter financial results. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you would need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. 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.

[Ryan Baker, Head - IR at KalVista Pharmaceuticals]

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 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 Sweeney, Chief Commercial Officer, and Brian Pikos, Chief Financial Officer. Dr. Paul Audia, 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 three months ending July 31, 2025, including FDA approval of ECTERLEET and other regulatory updates.

[Ryan Baker, Head - IR at KalVista Pharmaceuticals]

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.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

Thank you, Ryan, and welcome everyone to our first-ever financial update conference call. It's been a momentous few months for KalVista Pharmaceuticals, highlighted by our announcement on July 7th that the FDA approved ECTERLEET as the first and only oral on-demand therapy for acute hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 and older. This approval has positioned ECTERLEET 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 ECTERLEET, for the first time, people living with HAE have an oral on-demand therapy they can take at the first signs of an attack, achieving symptom relief in the same timeframe as injectable therapies, with a pristine safety profile.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

ECTERLEET 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 ECTERLEET 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 ECTERLEET 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 outstanding fashion on a successful launch.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

The fact that already almost 5% of the entire U.S. HAE population has submitted a prescription for ECTERLEET 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 ECTERLEET 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 it 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.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

Also in July, the UK MHRA granted marketing authorization of ECTERLEET, 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 UK 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 ECTERLEET, but also lays the foundation for meaningful commercial growth and long-term value creation for our shareholders.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

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?

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

Thank you, Ben, and good morning, everyone. As Ben mentioned, our launch readiness activities have ensured that we were well positioned to deliver ECTERLEET, 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 ECTERLEET 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 ECTERLEET to the community. Within the first few weeks of approval, an additional 500 community members joined our database seeking information and updates on ECTERLEET.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

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 ECTERLEET among patients and family members. Following our announcement of the FDA's approval of ECTERLEET on July 7, I'm excited to share that in the eight-week period ending August 29, we received 460 patient start forms. Early demand has largely come from patients previously on Fioricet and Acadavant as expected, but also from all other on-demand therapies. We are seeing patients on all prophylactic therapies adopt ECTERLEET at similar rates. On the access front, we know that formal coverage policies typically take up to six months to be established. Even so, we are pleased to see some patients gain paid access, consistent with our expectations.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

The quick start 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 who 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 ECTERLEET is addressing. From launch through August 29, we have activated 253 unique prescribers, with 38% of those starting multiple patients on ECTERLEET.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

Over this same time period, our field sales team has reached over 72% of the total physician base, including 96% of the tier one 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 ECTERLEET'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 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?

[Brian Piekos, CFO at KalVista Pharmaceuticals]

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 three-month period ending July 31st. We are pleased to announce the first sales of ECTERLEET, reporting $1.4 million in net revenue for the launch period, primarily from stocking orders by the specialty pharmacies in 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 ECTERLEET launch. Looking ahead to the remainder of 2025, we expect operating expenses to remain relatively consistent as we continue to invest in the ECTERLEET launch. Turning to the balance sheet, we had approximately $191 million of cash in investments as of July 31st, 2025.

[Brian Piekos, CFO at KalVista Pharmaceuticals]

We expect that balance, together with forecasted ECTERLEET 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 31st. As part of that transition, we will begin reporting on a traditional calendar quarter basis this fall, starting with the quarter ending September 30th, which will capture the three-month period from July through September. Ben?

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

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 ECTERLEET. The rapid adoption we are seeing reinforces our belief that ECTERLEET 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. We will now open the call to your questions. Operator?

[Operator]

Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. The first question comes from Stacy Koo with TV Co, and your line is now open.

[Stacy Ku, Biotechnology Equity Research Analyst at Cowen]

Good morning. Thanks so much for taking our questions and congratulations on a wonderful early update. We had a few questions, mostly towards Nicole. Can you further speak to the quick start program and maybe help us and other investors understand the process on prior authorizations and medical exemptions? Maybe talk through your expectations for timing to paid drug and how we should think about that translation of the really impressive patient start forms to eventually getting paid drugs. Help us understand that piece. On top of the quick start program, if you're willing to, on top of the details you've provided so far, talk about the type of prescribing patterns you're seeing. Help us understand, are patients going to be able to have chronic use of ECTERLEET as needed? That's the first question on the quick start program and dynamics there. Another is maybe just expectations on timing.

[Stacy Ku, Biotechnology Equity Research Analyst at Cowen]

We get a lot of questions from investors on that 4,000, let's say, patients and caregivers that have signed up for ECTERLEET updates. 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? With the frequency of current patient visits, help us understand that cadence as we think about the high patient demand and how you all have to work through that patient number. Thank you so much.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

Sure. Thanks so much, Stacy, for the question. First of all, just to give an answer to that, I think for ECTERLEET, we've been consistent that we look at the first six months and patients continue to develop their policies. You know, first week of every one of those months, access may be limited in months four, five, and six, which is really why we started this program. In terms of quick start, the mechanics of it, if you will, the quick start program immediately provides access to ECTERLEET at no charge. The caregivers submit the quick start form. They submit the start form. When the start form comes in, it allows KalVista to work with the physician office to pursue a medical exception to gain paid access. The patient has quick start again while we work with the office to gain paid access.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

Once the medical exception is approved, the patient's next shipment will be sent without the bill from the government payer. If medical exception is not approved in that time period, you know, the patient needs a refill, then they contact KalVista. The second shipment is provided by KalVista. I think it's important that this team maintains the data that medical exception is applicable to ensure that the patient's next shipment is being paid and obviously when they're in a physician's paid as quickly as possible. I think just to finish, I think.

[Stacy Ku, Biotechnology Equity Research Analyst at Cowen]

I think you're coming in a little garbled, by the way. Tough for me to, and I guess you know this, to hear.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

You're alone. I'll go a little further at the beginning. The next question was on the patterns and the timing.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

Sure. Absolutely. In terms of the patient database, we were very encouraged to grow so quickly after approval. As the majority of patients become members of caregivers as well, to ensure that what's most interesting is that when we look at the demography, it's just that we'll see a clustered around the office of our onboarding and our tier two physicians. To us, that's very encouraging. The representatives that are going in are connecting with the physicians that treat these patients. A number of our in-person education programs for patients have their pet programs so that we can engage in person in those same geographies. It's going to be much to engage with those patients at a local level and help them from advanced to therapy. The third input that you had is, I believe, on the visiting for a prescriber standpoint.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

What we observed is that physicians are approached in terms of some physicians requiring a visit using telehealth and some not requiring a visit in order to prescribe therapy. Stacy, did I address your question?

[Operator]

Our next question comes from Paul Matthias with Steve Fool. Your line is open.

[Paul Matteis, MD & Head - Therapeutics Research at Stifel Financial Corp]

Hey there. Thank you so much for taking our questions. 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. Later this year, is it possible that we could be getting, you know, actual number of doses prescribed, for example, versus just start forms? Also, and again, this may have been answered, was a little bit difficult with the audio. Just curious, are you able to confirm just sort of what we've heard previously on the insurance process that, you know, patients first receive, you know, two doses initially and then also, afterwards receive two doses of paid drug automatically if their insurance is approved? Just wanted to confirm that.

[Paul Matteis, MD & Head - Therapeutics Research at Stifel Financial Corp]

If so, you know, how does that inform, you know, your perspective on the launch kinetics, moving forward this year? Thanks so much.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

Sure. In terms of the script to address your first question, we recognize that as we get into months four, five, and six later in the year, certainly some of the KPIs will be evolving and more interest in repeat prescribers as well as refills and talking more about utilization of the product or consumption of a product on a per-patient basis. We certainly recognize that, and as the year unfolds, plan to share more in terms of a view into other KPIs. It may be helpful, I know there was an audio glitch, so it may be helpful to take a step back on quick start as well as paid. I think it's important to appreciate that when a prescriber, a physician, writes a script for ECTERLEET, they write that start form and send it into the KalVista Care Hub.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

In parallel, they send in a request for quick start. How this works is that the quick start provides immediate access to treatment for ECTERLEET 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 quick start, 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. In terms of the other question I believe you asked, just in terms of script, yes, patients are typically receiving two boxes for their initial prescription. The refill is very much dependent on how that physician writes the prescription.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

If the refill is written as needed, a patient may receive two boxes or they may receive more depending on their burden of disease. That is something that, again, it's up to the physician as to how they write. Typically, they prescribe p.r.n. for refills to allow patients flexibility to adjust the number of boxes in the future based on their burden of disease.

[Paul Matteis, MD & Head - Therapeutics Research at Stifel Financial Corp]

Thank you for the color.

[Operator]

The next question will come from Tizine Ahmed with Bank of America. Your line is open.

[Tazeen Ahmad, MD - US Equity Research at Bank of America]

Hi guys, good morning and congrats from me as well and 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 % were through a quick start, what % are reimbursed, and what % may be coming from, you know, another source? I just want to get a sense of where you are in the early stages of reimbursement. Are we still going to be able to track these numbers quarter to quarter? The second question is, is it too early to know what the re-treatment rates are? You're just still a few weeks into the launch, but any kind of anecdotes you can share from feedback from your sales boards would be helpful. Thank you.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

Sure, absolutely. When we share a start form number of 460, it is that 100% of those individuals also received quick start. As the programs are designed so that the forms come in together, 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, actually paid shipments starting to go out to patients where the medical exception process went through rather quickly. That is something that we continue to watch and it does grow week to week. Also, even more recently, seeing our first refills for on the paid side of things was also very encouraging because to us that just signals not only a 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.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

With regard to re-treatment, Tizine, 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 continue to think that's not really an issue. The open label, we've talked about this probably multiple times, the re-dose rate, you know, somewhere in the vicinity of the low 20s, 22, 23%, which is actually even below the zero rate. We don't think that represents any issues with anyone, whether it's patients or payers. It just absolutely falls at the lower end of what's seen in the world nowadays.

[Tazeen Ahmad, MD - US Equity Research at Bank of America]

Okay. Last question for me, any feedback on side effects observed so far, any laryngeal attacks or any kind of GI discomfort? Thanks.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

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 six months of a launch, that's the period in which it's most intense when the prescribers are getting used to the therapy. 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. Over the open label extension, we treated almost 1,000 abdominal attacks. Even in that setting, we're seeing extremely low GI adverse event rates. I think really this is a drug that's not associated with GI adverse events.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

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 they'd had a laryngeal attack and were very pleased with the outcome. They said it had worked quite well for them. Limited stories and tough to extrapolate, but everything so far has been favorable.

[Operator]

The next question is going to come from Maury Raycroft with Jefferies. Your line is open.

[Maury Raycroft, Equity Research Analyst at Jefferies]

Hi, good morning. Congrats on the progress and the update today, and thanks for taking my question. 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 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.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

Yeah, hey, thanks, Maury. Nice to hear from you. We chose to put out the August number because we had it, and I think there have been a lot of questions about how the trajectory is going to go. What I would say is, and we were quite pleased with this, this doesn't just simply represent a sort of a one-time bolus of rollover people or something. First of all, the open label extension, even though it's big for HAE, isn't super big. The people coming off who could plausibly move on are measured in dozens, not hundreds. What this really represents is a sustained, continually growing level of interest from people. Demand certainly started off, I think, higher than we anticipated, and it's continued to go from there.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

The curve has been a fairly linear growth from here with really no surges along the way that would represent to us this was any sort of one-time event. We've been very, and this a little bit goes to the fact, and we talked about this 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. Again, through ever since the launch and even continuing now past August, we've continued to see the same trends.

[Maury Raycroft, Equity Research Analyst at Jefferies]

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

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

That's probably a good question for Brian Pikos.

[Brian Piekos, CFO at KalVista Pharmaceuticals]

In terms of inventory at the specialty pharmacies, like most rare disease launches, we expect long-term averages for specialty pharmacies to hold two to four weeks of inventory. In the early part of the launch, that can move around a bit, but we don't expect anything different as compared to other rare disease launches, especially medicines.

[Maury Raycroft, Equity Research Analyst at Jefferies]

Got it. Okay. Thanks for taking my questions.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

Thanks, Maury.

[Operator]

The next question will come from Joseph Schwartz with Leerink. Your line is open.

[Will Soghikian, Equity Analyst at Leerink Partners]

Hey guys, this is Willan for Joe today. Congrats on the great quarter and strong start to the launch. One question for us, just want to drill down a bit more on the patient profile. Could you share anything beyond what their prior therapy might have been? Are you seeing any meaningful patterns on attack rate severity, attack frequency, and what their typical attack rate might have been before initiating treatment? Thank you.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

Sure. I'm glad to take that question. 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 would be some of our earliest adopters. We see adoption across a wide array of patient types in terms of the burden of disease. We have seen and are very pleased with the adoption with those high-burden patients. The profile of the product was attractive to them. We have seen that population be some of our earliest adopters. We absolutely have seen adoption across the burden of disease base, if you will.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

Across all prophylactic therapies.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

Yeah, just something else to add is that, you know, 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 prophylaxis overall. We actually see the brand share for prophylaxis line up as well with the patient base we have launched to date. It is very encouraging to just see this use by a very broad population, whether it's based on burden of disease or previous on-demand or current prophylactic treatment.

[Will Soghikian, Equity Analyst at Leerink Partners]

Great. Thank you so much, guys.

[Operator]

Our next question will come from Pete Stavropoulos with Cantor Fitzgerald. Your line is open.

[Pete Stavropoulos, Director - Biotech Equity Research at Cantor Fitzgerald]

Yeah, hi, Ben and team. Congratulations on the quarter. Can you just remind us how many patients are in the OLE or are actually U.S.-based? I know you said it's somewhere in the dozens. What is the expected cadence or timeline to shift the majority of these patients to commercially reimbursed scripts? Also, from a non-access perspective, outreach to patients, perhaps educational or informational programs, what's been the outcome to date for those efforts to sort of raise awareness about ECTERLEET's profile? Do you have a sense of the proportion of patients from the 460 start forms that were directed from these efforts?

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

I can do the first one, Nicole, and you can do the second. Pete, in terms of the OLE rollover, 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. Some of whom had already gone on to the early access program and finished, and some of whom are still actually continuing on the OLE for a while longer. There is no dramatic sort of burst of people that would immediately switch on to commercial. I think 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.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

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. Over to you on the second one.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

Yeah, so in terms of your second question, certainly we see the earliest patient adopters, as I mentioned earlier, are, when we mapped them from a geography standpoint, obviously clustered around our tier one and tier two physicians, which connects back to our marketing list. 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. That was also a chance for us to engage with full family members. 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 ECTERLEET to the family.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

That's certainly something that we've been doing since launch at the in-person conference and the dinner program since, and we'll carry that approach certainly into the fall, in addition to other non-personal marketing efforts, emails, and things like that.

[Pete Stavropoulos, Director - Biotech Equity Research at Cantor Fitzgerald]

Thank you very much for taking our questions.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

Thanks, Pete.

[Operator]

The next question will come from Serge Bellinger with Needham. Your line is open.

[Serge Belanger, Senior Analyst at Needham & Company]

Hi, good morning. First question regarding securing formulary coverage. Maybe just give us an update on where you are and where you expect to be. Our expectations are that you'll still be at parity versus other products in terms of step-throughs, prior auths, and quantity limits. 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. Thanks.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

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 anticipated utilizing medical exception and that we would see access to paid happen on a more limited basis rather quickly. That would grow over 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. Certainly going into launch, we were aware that there may be some exceptions where a payer might choose to require a step-through generic Acadevant. There's been one instance that we've seen to date. It's really important to note that even where that instance has come up, patients actually have ECTERLEET and are getting it paid.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

The reason for that is because 80% of patients have either been on generic Acadevant or are on generic Acadevant previous to ECTERLEET. Even in that instance where we have faced that one step in a policy, the patients have been able to move forward and already have their ECTERLEET in hand paid for. For us, we're continuing to advance our efforts. At this point, we maintain the view that parity access to the other branded therapies will be expected.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

On the market numbers, 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'd 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've talked about a lot, and also a branded price, which was down closer to the standard fair zero 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 WAC and where the market sits nowadays. 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. That's really what it reflects.

[Serge Belanger, Senior Analyst at Needham & Company]

Got it. Thanks.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

Yep.

[Operator]

The next question is going to come from Devanjana Chatterjee with Jones. Your line is now open.

[Debanjana Chatterjee, Vice President at Jones Trading]

Hi, thanks for taking my question and congrats on the quarter. As 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 a catavant to approve ECTERLEET? I have a quick follow-up.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

Sure. As I just mentioned, it's important that the vast majority of patients have experience on generic Acadavant so they can move through that step rather quickly. For that minority, which would be 20% of patients, the feedback that we hear from physicians is that actually describing a fail or a failure of Acadavant to a payer is quite simple. 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 sub-Q in the abdomen is difficult and challenging. They could have difficulties with hand swelling, so therefore administering a sub-Q is really quite difficult.

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

Again, we see that being an absolute minority of cases where an individual would face it, but there is experience in the market with those examples I gave you for overcoming and establishing that a patient has failed generic Acadavant and can quickly move on to ECTERLEET in this instance.

[Debanjana Chatterjee, Vice President at Jones Trading]

That's helpful. Thank you. At some point, in terms of the KPI, will you be sharing % like covered?

[Nicole Sweeny, CCO at KalVista Pharmaceuticals]

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. I would just say stay tuned for further updates from the company, but certainly we appreciate that there's a need to do so.

[Debanjana Chatterjee, Vice President at Jones Trading]

Thank you.

[Operator]

Our next question will come from John Wilbon with Citizens. Your line is open.

[Catherine Okoukoni, Analyst at Citizens JMP]

Hi, this is Catherine on for John. I have a quick question about the number of scripts and patients that essentially account for the revenues reported in July. I know there's about $1.4 million reported. Also, when did ECTERLEET become available in July? Was it immediately post-approval? Thank you.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

Brian can answer the second question on that with regard to revenues. ECTERLEET was available roughly 10 days following approval. We had it on the 1st of the start.

[Brian Piekos, CFO at KalVista Pharmaceuticals]

Yeah, in respect to revenues, we're getting the same... Oh, sorry, go ahead.

[Benjamin Palleiko, Director & CEO at KalVista Pharmaceuticals]

Just to tie that to start forms, 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 of the announcement. Start forms did predate actual shipments by 10 days.

[Brian Piekos, CFO at KalVista Pharmaceuticals]

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

[Catherine Okoukoni, Analyst at Citizens JMP]

Thank you so much.

[Operator]

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.

Participants

Executives

• Ryan Baker, Head - IR
• Benjamin Palleiko, Director & CEO
• Nicole Sweeny, CCO
• Brian Piekos, CFO

Analysts

• Stacy Ku, Biotechnology Equity Research Analyst at Cowen
• Paul Matteis, MD & Head - Therapeutics Research at Stifel Financial Corp
• Tazeen Ahmad, MD - US Equity Research at Bank of America
• Maury Raycroft, Equity Research Analyst at Jefferies
• Will Soghikian, Equity Analyst at Leerink Partners
• Pete Stavropoulos, Director - Biotech Equity Research at Cantor Fitzgerald
• Serge Belanger, Senior Analyst at Needham & Company
• Debanjana Chatterjee, Vice President at Jones Trading
• Catherine Okoukoni, Analyst at Citizens JMP