KalVista Pharmaceuticals, Inc. (KALV) Earnings Call Transcript

Good day, and thank you for standing by. Welcome to the KalVista Pharmaceuticals FDA approval call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to Ryan Baker, Head of Investor Relations. Please go ahead.

Thanks for joining us to discuss the U.S. FDA approval of sebetralstat, now known by the brand name EKTERLY, the first and only oral on-demand treatment for hereditary angioedema. On the call with me today from KalVista are Ben Palleiko, Chief Executive Officer; Dr. Paul Audhya, Chief Medical Officer; and Nicole Sweeny, Chief Commercial Officer. Brian Piekos, Chief Financial Officer, will join us for the Q&A session. Ben will begin with an introduction, followed by Paul, who will provide an overview of the current HAE treatment landscape and highlights from the EKTERLY U.S. package insert. Nicole will then review the company's commercial strategy and launch plans. We will wrap up the call with a Q&A session. Please note that we will review a slide presentation during our webcast today, which will be posted to the KalVista website after the call. Before we discuss today's news, I remind everyone that we will be making certain forward-looking statements that are based on our current expectations and beliefs. We encourage you to review Slide 2 of the accompanying presentation and our SEC filings, which include detailed discussions of the risks and uncertainties that could cause actual results to differ materially from today's forward-looking statements. With that, I will now turn the call over to Ben.

Thank you, Ryan. Today is a monumental day for the HAE community and KalVista. We are pleased that the FDA has approved EKTERLY as the first and only oral on-demand treatment for hereditary angioedema attacks in people ages 12 and older. This approval represents a major milestone, not only as the first commercial product for KalVista, but more importantly, as the first new on-demand HAE therapy in over a decade. EKTERLY delivers a long-awaited treatment that is safe, effective and easy to take anytime and anywhere. I first want to take a moment to thank the patients who participated in our clinical trials, the investigators around the world who conducted those trials, the HAEA and HAEi for their outstanding patient advocacy efforts and my fellow KalVista colleagues for making today possible. The brand name EKTERLY is a call to action for people living with HAE who act early when treating their attacks. From its inception, EKTERLY was designed to enable people with HAE to comply with global guidelines, which strongly recommend treating attacks as early as possible prior to the progression of swelling, thereby avoiding disabling symptoms caused by HAE attacks. EKTERLY represents our deep commitment to the HAE community. It reflects years of collaboration with people living with HAE to understand their experiences and significant need for an oral treatment that can easily be taken at the onset of an attack regardless of severity or wherever the patient is at the time an attack starts. Paul will discuss the label details in a few minutes. But as a headline, I will note that EKTERLY is approved for all HAE attacks with no restrictions either for severity or regarding the anatomic site of an attack, including the larynx, where speed and ease of administration can make a dramatic difference in treating an attack promptly. Given its unique efficacy and pristine safety profile, we believe EKTERLY is poised to become the foundational therapy for HAE management worldwide. With that, I will now turn it over to Paul to discuss the current treatment landscape and then review key elements of the EKTERLY label.

Thank you, Ben. I'm Paul Audhya, Chief Medical Officer at KalVista. I'm excited to share some context to the EKTERLY label and take you through some of the key details. As a reminder, hereditary angioedema or HAE is a rare genetic condition that affects approximately 1 in 35,000 to 50,000 people, roughly 8,000 people in the U.S. As you can see in the pictures, HAE causes unpredictable swelling attacks in various parts of the body, including the face and extremities. Swelling in the airway can be life-threatening if not treated. Attacks most often start as mild, but severity can increase quickly. They can also migrate to other anatomic locations, including larynx. Depending on the tissues affected, attack symptoms can last 1 or 2 days, but may persist for up to 5 days if left untreated. As noted in the current treatment guidelines, the main goals of treatment in HAE are to achieve total control of the disease and to normalize the lives of patients. To realize those goals, there are 2 main strategies. Number one, ensure that all HAE patients have ready access to effective on-demand treatment, which ideally offers rapid symptom relief, easy self-administration allowing for early treatment and a good safety profile. And number two, consider the addition of long-term prophylaxis or LTP in appropriate patients, which means evaluating the frequency and severity of attacks, the impact of those attacks on the patient's quality of life and whether adequate control has been achieved with an on-demand treatment. Let's spend some more time on that last one. Treatment guidelines recommend that patients consider the treatment of all attacks regardless of severity as early as possible after onset to minimize symptoms and reduce attack duration. In order to achieve this, patients should be well trained and have ready access to adequate on-demand medication to treat at least 2 attacks. This translates to carrying the medication at all times when leaving home and within reach at home even at nighttime. However, all approved on-demand treatments require administration by subcutaneous injection or intravenous infusion, which present clear barriers for people living with HAE. Therefore, while injectable treatments may be efficacious, they may not be effective. Common barriers to early treatment include anxiety associated with pain and injection site reactions, difficulty injecting and especially infusing treatment, the lack of a private and hygienic location to administer medication outside the home and challenges with portability. As a result, patients frequently avoid treatment. And for some, the therapy may be perceived as more painful or challenging than suffering from an attack. Indeed, observational studies revealed that up to half of attacks go untreated. For attacks that are treated, patients often wait until the swelling becomes severe and thus delay therapy for hours. This is most dramatic in adolescents, a population where icatibant is not approved. And perhaps it's not surprising that given the logistical burden, less than 40% of patients carry their on-demand treatment all the time when traveling outside their homes. Underutilization of injectable on-demand treatments in the form of delays and denial leads to inadequate control of HAE attacks. As a result, physicians and patients have turned to LTP as an easier alternative. Despite prior advancements in HAE, the promise of total control of disease and normalization of patient lives hasn't yet been achieved. With the approval of EKTERLY, we believe the treatment paradigm is ready to change. For the first time, people living with HAE can take an oral on-demand treatment at the first sign of an attack and achieve symptom relief in the same time frame as injectable therapies. EKTERLY has the potential to transform the management of HAE, truly empowering patients to comply with the guidelines to help control and normalize their disease. It is reasonable to say that injections will never be normal. By overcoming the barriers imposed by injectables, EKTERLY is poised to become the new foundation of HAE treatment. So with that background, I'm extremely pleased to share the prescribing highlights from the U.S. package insert. EKTERLY, an oral plasma kallikrein inhibitor is indicated for the treatment of acute attacks of hereditary angioedema in adult and pediatric patients aged 12 and older. EKTERLY has been approved with a recommended dose of 600 milligrams taken orally at the earliest recognition of an HAE attack. A second dose of 600 milligrams can be taken 3 hours after the first dose, if needed. The maximum recommended dose is 1,200 milligrams in any 24-hour period. Further along, you'll note that there are no contraindications and actually no warnings or precautions at all. The adverse reactions, at the top on the right, only include headaches, which were noted to be uncommon but marginally higher than placebo. Regarding the potential for drug interactions related to CYP3A4 or in the setting of hepatic impairment, dose reductions were recommended for strong and moderate CYP3A4 inhibitors and in those with moderate hepatic impairment. There are also recommendations to avoid the use of EKTERLY among those taking strong CYP3A4 inhibitors and moderate or strong CYP3A4 inducers as well as those with severe hepatic impairment. Overall, these represent an extremely uncommon group of patients. Moving on, I'd like to walk you through some key takeaways from different sections in the label. First, in Section 1 on indications and usage, both adolescents and adults were included. Adolescents may be the population with the greatest unmet need as they have the longest treatment delays and difficulty managing their HAE attacks today. There is also no restriction on the type of HAE, so the opportunity to bring actually to all HAE patients in the U.S. with persisting unmet need is possible. Additionally, you'll note that there are no restrictions with regard to attack severity or location, including laryngeal attacks and no restriction on LTP breakthrough attacks regardless of LTP mechanism of action. This represents the largest number of treated attacks in the U.S. as the majority of HAE patients are receiving LTP and many continue to have attacks in all locations and severities. In Section 2, dosing and administration, EKTERLY's label is the only one to include at the earliest recognition of an acute HAE attack, which is at the very heart of treatment guidelines and reflects the most significant advance that comes with EKTERLY. We're also pleased that 600 milligrams is the recommended dose as we believe it provides a deeper longer inhibition of plasma kallikrein without any impact on safety. We also believe that 600 milligrams represents optimal dose for HAE attacks based on overall outcomes in the Phase III KONFIDENT trial and the extensive experience to date in the KONFIDENT's open-label extension. The flexibility to use second dose after 3 hours also exemplifies EKTERLY's excellent safety profile. All of this is consistent with Sections 4 and 5, where there are no contraindications, warnings or precautions. Moving on to Section 6. The table says it all, adverse reactions only comprise headache, which occurred in about 3% of patients receiving EKTERLY 600 milligrams and 1% from placebo. Again, this reflects EKTERLY's pristine safety profile, which underlies the opportunity of 600 milligrams as the recommended dose. Section 12.3, pharmacokinetics, you'll note 2 important recommendations. First, with 600 milligrams, there is greater than 90% inhibition of plasma kallikrein maintained through 6 hours, which supports optimal management of HAE attacks and increases the potential for low redose rates. The second is that there are no restrictions regarding food intake. In other words, EKTERLY can be taken with or without food. Lastly, in clinical studies, EKTERLY's label is the only one to include statistically significant faster times to begin symptom relief, reduction in attack severity and attack resolution. Starting in the lower right-hand corner, the prespecified analysis of the primary endpoint of the Phase III KONFIDENT trial was published in the New England Journal of Medicine in May of 2024. There, the median time to beginning of symptom relief for EKTERLY 600 milligrams was 1.79 hours, and 6.72 hours for placebo. However, what you'll note in the clinical study section is that the medians are based on utilization of a more conservative sensoring approach to analyzing the primary endpoint. Basically, for about 5% of total attacks, patients didn't record responses to treatment in their e-diaries. In the prespecified analysis, for those attacks, we censor them to 0, essentially counting them as neutral in the analysis as we don't know whether they improved or didn't improve over 12 hours. In the alternative analysis, these attacks were considered as not having reached the endpoint within 12 hours, i.e. right censored at 12 hours, which assumes the worst possible outcome. To clarify this change in methodology, there is a footnote for each of the endpoints under each efficacy figure in the clinical study section. The result of this change was that the separation between EKTERLY 600 milligrams and placebo starts earlier and is wired, but it also shifted out the median slightly for EKTERLY 2.0 hours or about 12 minutes longer, but much further out for placebo, which no longer reached the median within 12 hours. I'd like to finish this overview with some of the data we've reported this year from KONFIDENT, our ongoing 2-year open-label extension. As a reminder, this trial has many real-world design elements to gain insights on EKTERLY's potential to improve compliance with on-demand treatment guidelines. First, among 1,706 attacks reported through September 14, 2024, we see a median time to treatment of just 10 minutes. We also observed a median time to end of attack progression of 19.8 minutes. This highlights a rapid response to treatment almost immediately after absorption of EKTERLY. Finally, we've seen a consistent rapid response among attacks that have been highlighted as the most concerning to physicians, including laryngeal, abdominal and LTP breakthrough attacks, all of which have demonstrated a median time to begin symptom relief of 1.3 hours. On the right, as of June 2025, we've captured approximately 700 additional attacks since September 2024, which now includes 2,323 total attacks, 48 laryngeal attacks, 974 abdominal attacks and 463 LTP breakthrough attacks. Before KONFIDENT completes next year, it will be among the largest treatment experiences ever collected in a clinical trial for an on-demand product. We look forward to sharing new results from KONFIDENT later this year, including data on the very high level of treatment satisfaction among participants treating attacks with EKTERLY in the trial. I'll now turn the call over to Nicole Sweeny, who will share how we plan to commercialize EKTERLY. Nicole?

Thank you, Paul. I'm Nicole Sweeny, Chief Commercial Officer of KalVista. I'm excited to talk about how we are working to put EKTERLY into patients' hands as soon as possible. I want to reinforce a point that Ben shared earlier. EKTERLY is based on a call to action for people living with HAE to act early when it comes to treating their attacks. And for the first time ever with EKTERLY, they are able to do so. EKTERLY is the first and only oral on-demand HAE treatment. This allows patients to discreetly carry treatment with them at all times so they are prepared for their next attack. Each dose offers injection-like efficacy. It's proven to halt progression quickly and safely without any needles or pain. EKTERLY has been demonstrated to be safe and effective in treating all attacks, all attack locations and all attack severity. Additionally, as Paul mentioned, EKTERLY has been FDA approved for use in adults and children 12 years of age and older. This is particularly meaningful for the adolescent population as Firazyr and icatibant are not approved for use. Our commercial team will be selling EKTERLY in physician offices this morning. Our team is poised to drive swift demand. Our payer team has been educating national and regional payers for the past year. Our field sales team is competitively sized, which provides complete national coverage of HAE prescribers. Our commercial team has decades of combined experience in HAE, rare disease and high-performing product launches. Leadership and field teams include professionals who have successfully launched both prophylactic and on-demand HAE therapies. As most sales reps have worked in the HAE space, they have strong relationships with target prescribers and knowledge of how these accounts adopt a new HAE therapy. Our field team is focused on driving early EKTERLY adoption with the top 1,000 health care professionals that account for 90% of HAE claims today as this is where the highest patient concentration and unmet need exists. They will reach the remaining 10% of prescribers as the summer progresses. Our field team has been active in these target accounts since February, providing disease state education and will now pivot to product education. The team has appointments in place for the months following approval with virtual speaker education launches to reach the entire care team within key accounts. Shifting gears to the patient community, our goal is to introduce EKTERLY and ensure people living with HAE can have informed discussions with their physicians about making a treatment change. Within a few weeks of launch, we will host patient education programs where patients who utilized EKTERLY in the Phase III clinical trial will share personal experience with the HAE community around the country. In addition, we will participate in the HAEA Patient Summit meeting, which kicks off July 10. This meeting happens every few years and brings together people living with HAE and their families to connect and learn more about developments in HAE. For KalVista, this creates an opportunity to introduce EKTERLY to over 1,200 members of the community. It's a tremendous event and the HAEA is a deeply valued partner to KalVista. On the access side, both our KalVista patient hub, KalVista Cares and QuickStart programs are live. QuickStart provides patients immediate access to EKTERLY at no charge during the time period their claim for paid access is in process. Each EKTERLY pack includes 2 doses or 4 tablets. Tablets are provided within wallet-sized blister cards, which provide discrete access to therapy. We anticipate product availability in mid-July. EKTERLY is the first new on-demand treatment approved in over a decade and the first oral option ever. We continue to hear from health care professionals and patients that EKTERLY fills a clear unmet need in HAE treatment. We price EKTERLY competitive to existing branded therapies in the HAE market. We believe this pricing reflects the innovation we're bringing to the community and will support broad utilization. Lastly, we've taken a comprehensive approach to ensure access support, which includes KalVista Cares, our patient hub. From reimbursement support to QuickStart Access, our infrastructure is built to minimize delays and help people start therapy quickly. As a company, we understand the importance of delivering accurate and timely visibility into launch progress. Based on historical rare disease launches, we know that third-party data sources can often lag or present an incomplete picture, especially in the early weeks of commercialization. We recognize that we will need to share regular updates externally. In the early days of launch, KPIs will focus on awareness and engagement efforts in the field as well as QuickStart demand. As launch progresses, we will share greater insights that reflect broad adoption by key stakeholders. We're incredibly proud to introduce EKTERLY, the first oral on-demand HAE treatment, and believe there's a clear path for EKTERLY to become the foundational treatment in HAE. Our launch strategy is focused and intentional. Today, we will start by driving early demand with patients who have communicated the highest dissatisfaction with current therapies, particularly patients on Firazyr and icatibant. From there, we'll accelerate adoption by converting patients on all on-demand therapies. As utilization expands and patients experience the benefits of EKTERLY, we expect treatment rates to rise and the on-demand market to grow. The opportunity is significant, and we are ready. The infrastructure is in place. Our field team is deployed, the KalVista Patient Support Hub is live. This is an immediate launch backed by years of preparation and deep expertise in HAE product launches. I'll close by extending a heartfelt thank you to members of the HAE community who supported our trials and helped us reach this moment. We are excited to bring this life-changing treatment forward to the HAE community. I'll now pass it back to Ben.

Thanks, Nicole. I'm picking up from where Nicole left off on this slide. We anticipate that the on-demand segment of the HAE market will grow by 70% to $1.2 billion by 2030, a significant portion of which will be fueled by the introduction of EKTERLY. For the first time, patients have access to an oral on-demand treatment that provides the opportunity to change how and when attacks are treated. As a result, in addition to the general transition to EKTERLY that we expect, we also expect to see an increase in the overall attack treatment rate as people with HAE are more willing and able to treat attacks that currently may go untreated for many reasons. With FDA approval of EKTERLY now secured in the U.S., we're also preparing for global expansion, beginning with a potential EMA decision and a targeted launch in Germany later this year. In the first half of 2026, we expect to launch in Japan in collaboration with our partner Kaken Pharmaceutical as well as in the U.K., pending local approvals. Additional market launches are planned in 2026 and beyond, including Canada, where we recently entered into a licensing agreement to support approval and commercialization. As we finish this part of the call, a quick anecdote to highlight how we think EKTERLY can change HAE management. At a recent conference, I met with a physician who relayed to me a real-world story about one of his patients who's been using EKTERLY. She was driving her car to work one day recently when she felt an oncoming abdominal attack. Historically, she was due to the cat event, which would have made treatment of the impending attack impossible without major changes to her day and abdominal attacks are among the most painful to endure. However, in this case, at the next stoplight, she pulled out her EKTERLY wallet, took her dose and continued to work. She reported to the physician at her next visit that her attack didn't progress further and within about an hour, she felt fine. This is exactly how people with HAE should be able to manage their disease and reflect the results we have seen to date in the data set that is closing in on 2,500 treated attacks. This is also why we believe EKTERLY is poised to fundamentally transform the HAE treatment landscape. It has the potential to replace injectable, painful and cumbersome on-demand options with an oral therapy that directly addresses treatment burden while providing the necessary efficacy and safety that people living with HAE expect. We believe EKTERLY could become the treatment of choice among adolescents, adults and if approved in the future, pediatrics. In closing, we're incredibly proud to bring EKTERLY to people living with HAE as an innovative oral therapy that redefines what's possible in HAE management, and we are fully committed to delivering its impact on day 1 and every day after. Our infrastructure, team and strategy are fully in place to deliver a successful launch and sustained performance, and we look forward to providing further updates in the near future. With that, we'll now open the call for your questions.

[Operator Instructions] Our first question comes from Paul Matteis with Stifel.

Congrats on the approval. I was wondering if you could share more color on the metrics you plan on sharing early in the launch and how those metrics might evolve over time as you get more information? And then I have one follow-up.

Paul, thank you for the question. I'll actually ask Nicole to give the details there.

Sure. Paul, as shared earlier on our call, looking at the early days and weeks of launch, certainly, we plan to share forward information just about engagement with our key accounts in terms of the frequency and engagement with our Tier 1, 2 and 3 accounts as well as engagement with the patient community. In addition to that, we will provide updates on demand in a general sense in terms of QuickStart requests and start forms that are being processed. And certainly, as the launch takes hold, what will be of keen interest to us as well as I'm sure you and others will be repeat use. So in the weeks and months following that we will share updates as we see repeat prescriptions coming through those key accounts as well as refills on a per patient basis. In addition to that, during the course of the upcoming months, we will also provide a view into payer engagement and a view into how the formulary process is unfolding.

Okay. Great. And just two quick things to clarify here Nicole. One, in the open-label extension, what did you see in terms of the frequency of use? And do you think that's a good benchmark for real-world use? And then two, on your point on getting on formulary, I guess, as I understand it right, everything in this category is reimbursed via special -- via medical exemption. So how much is actual formulary access going to matter here? And how much is payer access is really going to change over time?

Sure. And why don't I address your second question first, and then I'll turn it over to Paul. As with other HAE products, we do anticipate in the early months of launch that medical exception will be the primary means for an individual to gain paid access to EKTERLY. Certainly, the payers have indicated that they typically take about 6 months to see how demand comes in for a new product, and then they'll set their formularies at the close of that 6-month time period. So again, as with other HAE products, we anticipate heavy medical exception for the first 6 months of post approval.

And then on the first question earlier around frequency of use in our open-label extension, we are seeing upwards of 80%, 85% of attacks being treated. So it's exactly what we expected that the rate would be much higher than we see in observational studies with the injectable drugs, which are basically have -- really to a maximum about 2/3. So this is really much higher.

Our next question comes from Maury Raycroft with Jefferies.

Congrats on the approval milestone. Just based on the patient interest you're seeing from your awareness website and doctor interest, how are you setting expectations for the early launch? And then as a follow-up to Paul's question, can you talk more about how you'll customize drug supply for patients with different monthly attack rates? And what you think the typical prescription and supply will look like for patients?

So Maury, so we -- on the second part at least, going to the last part first, we have the KalVista Cares, as we talked about, set up as an organization that will be in close contact with patients as we go forward. And so the idea here is that patients will get their initial box of EKTERLY, but we'll be checking with them routinely to make sure that their supplies aren't running low and making sure they always have sufficient on hand to be comfortable treating attacks. We do know that one of the reasons people don't treat attacks is the fact that they worry about not having available when needed. So the idea is to make sure that they're never in that position. And then on the first part of the question, Nicole can you please take that?

In terms of the prescriptions and how we anticipate the physician writing a prescription for EKTERLY, we anticipate that the initial fill will be for one box of EKTERLY and then they will write similar as they do to other on-demand treatments, PRN, refill as needed. And that is an approach physicians take today, recognizing that the burden of disease and the number of attacks really varies from one of their patients to the next. So therefore, we anticipate, again, they would take that similar PRN approach for EKTERLY.

Our next question comes from Debanjana Chatterjee with Jones.

Congrats on the approval. Could you expand a little bit more on the drug interactions labels and how it might have any influence on the uptake?

So in terms of drug-drug interactions, we did some studies. We see that with moderate CYP3A4 inhibitors or those that have stronger inhibition or induction that it can increase or decrease the concentration. It's overall a relatively small population that have these other drugs on board. So we don't actually think that it's going to have very much impact at all. In terms of the exposure or experience that we've had with this in doing our open-label extension in our clinical trials, there are very, very few patients who were not eligible due to use of these other therapies. So we don't think it's going to really have any material impact. And again, just as a reminder, HAE patients are patients who don't have a significant number of other comorbidities. And because of that, they're not really using these drugs in a meaningful way. So we don't think it will have any impairment on uptake.

And I have a quick follow-up. How should we think about the gross to net as the launch progresses?

We're going to bring Brian Piekos in here to pick up those questions.

So the gross to net will be on a long-term basis, typical for what you see in rare disease in the upper teens to low 20s. As we're getting to the launch and there are some fixed fees, the gross to net may be slightly higher. But again, it will quickly normalize to that rate we've talked about.

Our next question comes from Joe Schwartz with Leerink Partners.

Congrats on the great achievement. Do you see different phases to EKTERLY launch? For example, are there early, mid and later adopters? And how would you characterize different subgroups as you look at the HAE patient population? And then I have a follow-up.

Yes. So Joe, I'll start, and I think Nicole can [indiscernible] in here. When we talk to physicians, we do hear that effectively, they believe EKTERLY is appropriate for everybody. So we don't actually see them making distinctions between different populations that might have a greater or lesser need for it. They seems to be very confident that there's a uniform desire among the patient population to have access to this. And I think the data set we've generated, which shows efficacy in all these important subgroups, right? I mean, abdominal attacks and people on LTP and certainly laryngeal attacks, that has really become the basis of this physician enthusiasm, which is there's effectively no subgroup where we've shown that this doesn't have a substantial improvement in terms of their time to symptom relief and sort of control of their attacks. So as a general comment, which may be a little bit simple, the physician community, we think is going to want to talk to effectively everybody about this. Now in terms of -- from the patient side, where the greatest [indiscernible] will be, certainly, Nicole, you've got some thoughts on that, and we can talk a little more detail about who we think will be the first calls to the offices?

Yes, absolutely. With research that we've conducted with patients that are utilizing various on-demand as well as prophylactic plus on-demand treatment, we see that the patients that have experienced and are currently on icatibant and Firazyr see the -- express the greatest interest in adopting EKTERLY swiftly. And that was about 80% of the Firazyr and icatibant patients communicating a high interest in adopting EKTERLY. And just one other thought going back to the physician side of things. As our sales team has been in the field profiling all of the physicians, all 2,000 physicians, the Tier 1s, 2s and 3s, we see interest -- and high interest to utilize EKTERLY throughout those tiers. But to answer your question, we certainly anticipate the earliest adoption, those earliest prescriptions to come in from the Tier 1 physicians as they manage those patients that have the highest unmet need and really signal that the highest urgency to try something new with EKTERLY.

That's very helpful color. And then as a follow-up, I'm just wondering, it's actually a question we get from investors pretty frequently. What will a patient or their physician need to demonstrate in order for a patient who's on generic icatibant to be eligible for EKTERLY prescription?

Yes. Today, that is -- today, there are patients that -- to move off icatibant. I think that's what you're referring to, to demonstrate that failure on icatibant. It's actually a fairly low bar in terms of what is utilized today. And so really it can be feedback from the physician and the patient, recognizing that the patient doesn't tolerate that product. That can be injection site reactions as well as specific reactions that happen in the abdomen area as that is where the product is administered and oftentimes, individuals have abdominal attacks. But we most commonly hear that it's just injection site reaction of any kind, which, as you know, being familiar with the Firazyr Phase III study, nearly all patients in the Phase III studies experienced those reactions. So again, fairly common and something that can be moved forward fairly quickly in terms of demonstrating a failure on icatibant.

Our next question comes from the line of Serge Belanger with Needham.