KalVista Pharmaceuticals, Inc.

Good day and thank you for standing by. Welcome to CalVista Pharmaceuticals 2025 Third Quarter Financial Update and Operating Results Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. Please note that today's conference is being recorded. I will now hand the conference over to your first speaker, Ryan Baker, Head of Investillations. Please go ahead.

Thank you, Operator. Good morning, everyone, and thank you for joining us to discuss CalVista Pharmaceuticals' 2025 third quarter financial update and operating results. Please note we'll be making certain forward-looking statements today. We refer you to CalVista'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 CalVista are Ben Palayko, Chief Executive Officer, Nicole Sweeney, Chief Commercial Officer, Ryan Picos, Chief Financial Officer, and Dr. Paul Audia, our Chief Medical Officer. Ben will begin with a review of the company's progress during the three months ended September 30th, including an overview of Ectorly's early launch, both in the US and abroad, as well as other regulatory updates. Paul will give an update on recently presented data from our Confident Kid trial in HAE for children ages two to 11, as well as new patient satisfaction data. Nicole will review the company's commercial progress to date, and Ryan 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 thank you, everyone, for joining us today. And I want to wish a happy Veterans Day to all my fellow veterans listening in. We are highly encouraged by Ectoly's first three months on the U.S. market. Adoption has been steady and linear with real world utilization tracking as we expected. The takeaways are clear. Demand for Ecterly is strong. It is being used to treat a significant number of HAE attacks, and it is meeting the expectations of people living with HAE for a highly efficacious and safe therapeutic alternative. We continue to believe that Ecterly will evolve to become the foundational treatment for HAE. In addition, We are executing on our mission to bring Ectoly to people living with HAE globally. The German launch is now underway, with initial uptake validating the ex-US interest in Ectoly. The approval footprint continues to grow, with a recent approval in Australia adding to the existing authorizations in the US, UK, EU, and Switzerland. In parallel, we continue to evaluate optimal strategies to expand access in geographies where we won't launch on our own. In addition to the collaborations we've previously announced, we anticipate that we will be completing more agreements later this year and in early 2026. We also continue to generate important new data to help educate the HAE community generally, as well as to demonstrate the real-world benefit of ECRLE to people living with HAE. Last week, during the American College of Allergy, Asthma, and Immunology meeting, we provided a report on the high satisfaction rates for patients in CONFIDENT-S who'd switched to Sevitralstat from injectable on-demand therapies. Additionally, interim results from our CONFIDENT-KID trial show that Sevitralstat enables early, effective, and safe treatment of HAE attacks in children ages 2 to 11. Paul will provide more detail on all of that in a minute. We've also continued to grow the key capabilities of the company demonstrated by the recent hires of Bilal Arif as our Chief Operating Officer and Linnea Esfizi as Chief People Officer. Both bring decades of experience that will make them important contributors as we work to evolve CalVista into a leading rare disease company. Finally, with our recent convertible node offering, we are fully financed through profitability, allowing us to remain sharply focused on executing the actively launch while evaluating additional growth opportunities. I will now turn the call over to Paul, who will update you on the latest data from Confident S and Confident KID.

Thanks, Ben. I'm pleased to highlight that we continue to generate and publish important insights from our ongoing clinical trials, further building the case for actually across various patient segments. Starting with our late record ACAAI, we provided a significant update on our registrational Confident KID trial for sebatrol-setting children with HAE age 2 to 11. With 36 children enrolled, this is the largest trial ever conducted in the pediatric HAE population, and we are incredibly proud to have fully recruited it almost a year ahead of schedule. This speaks to the high level of unmet need for these children and their caregivers. A remarkable finding from the interim analysis is the extent to which this group of children is experiencing attacks. As of June 6, 2025, 65 attacks were treated by 26 children translating to an attack rate of 0.8 attacks per patient per month. This far exceeds the historical understanding of attack frequency in this population. We believe that the high attack rate in company kids reflects an accurate unmasking of the true disease burden that was previously hidden by the difficulties associated with administering and receiving injectable treatments. The invasive and burdensome nature of intravenous and subcutaneous on-demand treatments creates a powerful disincentive for children and their parents to seek treatment for anything but the most severe attacks. We believe that this has led to significant underreporting of attacks. The availability of an oral on-demand treatment fundamentally lowers the barrier to treatment. This allows for a high attack rate to be documented because children and their caregivers are no longer faced with the choice of enduring the trauma of an injection versus riding out a potentially worsening attack. Returning to the results, treatment was rapid, with caregivers, or the children themselves, administering Sevatrolza ODT in a median of 30 minutes. This option, where children can actually treat themselves, is a totally unique feature of Compton and Kidd, and increases the importance of the results, as the inability to self-treat attacks by children is such a major issue with injectables. The median time to symptom relief was a rapid 1.5 hours, in the dosing group who experienced the vast majority of attacks. Crucially, there were no treatment-related adverse events or reports of difficulty swallowing the orally disintegrating tablets formulated for kids. These results further highlight Eckerle's potential to expand to people of all ages living with HAE. We expect to submit the NDA for pediatrics in Q3 of 2026. Turning now to our long-term open-label extension, Competence, we continue to amass a large volume of data collected under conditions that mimic real-world utilization. For October 31st, the trial has accumulated over 2,700 attacks treated with Ectoly. Notably, this includes 59 laryngeal attacks, 560 attacks in patients receiving long-term prophylaxis, and 584 attacks treated by adolescents. The highest number of attacks treated by an individual participant is 118 over 23 months. As our patient experience has grown, we have observed key changes in dosing behavior. We focused on patients who reached 30 treated attacks, representing about one quarter of confidence participants. We noted a clear trend. The proportion of patients using a second dose of actually within 12 hours fell from 22.5% during the first attack to just 13.5% by the 30th attack. In the same group, these are conventional injectable therapy dropped from 8% at the beginning of the trial to 0% by ASPAC-30. We believe these marked reductions in the use of a second dose or conventional therapy reflect patients' growing assurance and ex-release reliability. We plan to present this important data in more detail in an upcoming scientific congress. Coming back to ACAAI, we presented new treatment satisfaction data from confidence in participants who had switched from injectable on-demand treatments to cebatrol sets. The median satisfaction score for attacks treated with sebatrolsat was 2, or very satisfied, on a 7-point scale, ranging from minus 3, which was extremely dissatisfied, to 3, which was extremely satisfied. Overall, 84% of attacks treated with sebatrolsat were rated by participants as ranging from satisfied to extremely satisfied, with the vast majority being either very or extremely satisfied. The high satisfaction scores reported by patients who have successfully transitioned from injectable therapies to sebatrol stat speak to the impact of having a simple, effective, and reliable oral on-demand treatment readily available. So what are the implications? We know that a patient's decision to switch medication is often a direct measure of their unmet need or dissatisfaction with their current regimen. Therefore, as patients achieve a high level of satisfaction with Exolate, the probability of them seeking to switch therapies in the future is expected to decrease. This supports Acterly's role as a foundational therapy for HAE for the long term. To conclude, the breadth and depth of our clinical data, coupled with a high-level patient satisfaction, is translating into early commercial momentum. We're seeing strong uptake and growing confidence among prescribers as awareness of Acterly continues to build. To discuss how the launch is unfolding, I'll now pass the call to Nicole.

Thanks, Paul. I'm pleased to share that the U.S. launch of EFTRLi continues to accelerate with sustained demand and growing enthusiasm among prescribers and patients. In less than four months since launch, we have received 937 start forms, representing more than 10% of the HAE community. This level of early engagement is strong by any launch standard and reflects an extraordinary level of community adoption. Importantly, this demand is broad-based. We are seeing rapid uptake across all AJE patient segments, including prophylaxis users as well as adolescents. People are switching from all on-demand therapies, but the greatest number have been from Firzir and Acatabant, as expected, given their market share. Also, as we expected, the earliest and greatest number of those switching to Ectorly have been high-burden patients who experience frequent attacks, whether or not they're on prophylactic therapy. Provider activation is also expanding rapidly. We have 423 unique prescribers and continue to add three to four new prescribers each day. Awareness levels are exceptionally high, with 100% of Tier 1 HCPs and 95% of all target HCPs reporting awareness of ecterlies. These metrics reflect both the strength of our field execution and the enthusiasm of the medical community for Ectorly. As prescribers gain more experience with Ectorly and hear from their patients who have switched, their confidence continues to rise. Launched to date, repeat prescribers account for 75% of all Ectorly start forms, a strong indicator of familiarity and trust in Ectorly's profile. This provider enthusiasm is matched by a strong depth of utilization in patients. Though the data is early, patients that are refilling their prescriptions, including those on quick start and paid therapy, are doing so every three to four weeks. For context, most injectable on-demand therapies average only three to four refills per year. This level of refill frequency is a clear indicator of growing real-world reliance and confidence in Esterly. Note that the majority of these refills are driven by patients with a high disease burden. They report experiencing two to four attacks per month, despite generally also being on prophylaxis therapy, which indicates the lack of adequate disease control. Refill quantities are consistent with this level of burden and higher than our initial expectations. That all said, as adoption expands beyond the highest burden patients, We expect refill patterns to normalize in line with the broader HA community with both a lower frequency of refills and a lower volume of refill quantities. As demand continues to build, payers are actively moving toward formal coverage for Ectorly. Since approval, patients have been able to leverage medical exception to gain access to Ectorly. The medical exception approval rate and time to page shipment are consistent with our expectations less than six months following approval. It is very encouraging that we have seen medical exceptions approved by all PBMs and all large payers for both commercial and Medicare cases. We continue to advance formal access with multiple regional and national payers already establishing actually policies. The majority of policies are PA to label, which is consistent with other branded on-demand therapies. As expected, the minority of policies require a step through a catabase which patients are able to move through quickly as most HAE patients have experience with generic Acataban. Our market access team is currently engaged with PBMs and remaining national payers with an aim to formalize access in early 2026. At this point in the launch, we are encouraged to see access to Ectorly growing as payers recognize the need for Ectorly as part of an overall HAE treatment plan. Outside the United States, we are seeing early signs of momentum as we expand the reach of Ectorly. Following EMA approval, we launched in Germany in mid-October and recorded first-day commercial sales, an immediate validation of both prescriber enthusiasm and the strength of Ectorly's differentiated oral-on-demand profile. In the UK, with approval now received, we are advancing pricing and reimbursement discussions with NICE, in preparation for a first half 2026 launch. And in Japan, we continue to progress towards the PMDA approval and launch in the first quarter of 2026 with our partner, Kappen Pharmaceutical. Taken together, accelerating utilization, repeat prescribing, and growing favorable access provide a clear signal. Actually is quickly on its way to becoming the foundational therapy for HAE treatment. What initially began with the highest burden patients is now expanding in only a few short months across the broader HE population as physicians gain confidence and patients increasingly choose Ecterly for their attacks. I'll now turn the call over to Brian to review our financial performance.

Thanks, Nicole. Our full financial results were included in the 10Q filed after the close yesterday, so I will provide a few highlights for the three-month period ending September 30th. We are pleased to announce sales directly worth $13.7 million for the launch period through September 30th, which includes the $1.4 million recorded in July and previously reported. Subsequent to the July period, our specialty pharmacy partners stocked additional locations and built inventory in a disciplined manner, supporting the growing patient demand. In the initial three-month launch period, we are seeing the average number of cartons per shipment on the high end of our expected range, which aligns with utilization among high-burden patients. the core of our early adopter base. When looking at gross to net, I'd note it came in towards the low end of our expected range this quarter, driven largely by lower copay utilization typical for this time of year. Shifting to expenses, total operating expenses for the period were $59.7 million, consisting of approximately $12 million in RDA expenses and approximately $46.5 million in SG&A expenses. Looking ahead to the remainder of 2025, we expect SG&A expenses to remain relatively consistent as we continue to invest in Hector Lee's global launch. Importantly, with our recent career-limit financing, our cash position is sufficient to fund operations through profitability. With that, I'll turn the call back to Ben for closing remarks.

Thanks, Brian. The early momentum and rapid growth we described today reinforce our belief that Ectorally is positioned for long-term success as market awareness continues to grow. Our near-term focus is on aggressive and disciplined execution, scaling in the U.S., expanding access globally, and reinforcing confidence in the role of Ectorally across the treatment landscape. We continue to believe that oral on-demand therapy should broadly displace the injectable options and that Ectoly will be the clear market leader based upon the breadth and depth of the data we have generated that shows Ectoly can benefit all people living with HAE, regardless of their attack location, frequency, or severity. We are, and will remain, the only company that has demonstrated in a clinical trial setting the effectiveness of our therapy for treatment of HAE attacks in accordance with modern treatment guidelines that call for patients to consider treating all attacks and to treat early. Through our gold standard design clinical trials and our many publications of the data, we've established a strong position as a patient-focused organization that is dedicated to improving lives. And I expect our reputation will continue to strengthen based upon our early success and our most recent data updates. With strong execution, a clear strategic runway, and fully funded path through profitability, we believe we are well on our way to establishing Ectorly as the foundational therapy for HAE and to generating long-term growth for the company. With that, we'll open the call for questions. Operator?

Thank you. Ladies and gentlemen, as a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. If we draw your question, simply press star 11 again. Please stand by while we compile again your roster. Now, first question coming from the line of Maureen Rakoff with Jefferies. Your line is now open.

Hi, good morning. Congrats on the great quarter, and thanks for taking my questions. Maybe to start off, wondering if you could talk more about trends for types of patients who are switching doctorally early on, particularly the high-burden patients. Are you putting percentages on how the 937 start forms break down, and how could these trends change over time?

Hey, Maury.

Thanks for joining today, and thanks for the question. Nice to talk to you. I guess I'll start, and maybe Nicole will add, you know, some other details. What's been, what was really important here when we launched EctorLeap was we always presumed that the most rapid adopters would be the people living with HAE who have a very high treatment burden. And we've talked about this for a long time, and I think there's been substantial questions, you know, in some quarters about whether that patient population exists and also how severe their attack rates are. What we found through the third quarter was that actually those people do exist, and they are transitioning just as we would have expected. Roughly half of all the patients who have switched to active lead-to-date are self-report an attack rate of two or more attacks per month, which we consider to be high birth. And that accounts for, you know, obviously a fair amount of the prescriptions, but also those people refill at higher rates and in larger quantities as well. So clearly the discovery we've made here is that that group really does exist, that they actually aren't well controlled on prophylaxis, and that their needs are being met biaxially. In the longer run, obviously, we expect that number to decline. That's a fairly small portion of the population. And as we broaden out Ectoly's reach, all those items will go down. The reflow rates will decline, and the number of cartons per refill will also be down. But for now, that group seems to be getting a lot of benefit from Ectoly, just like we anticipated.

Yeah, just to add some further color on the patient base, You know, as Ben was describing, these are patients with a high burden of disease who are also on prophylaxis and continue to have unmanaged HAE. In terms of the product that they've been switching from, we see broad adoption or broad switching across all of the on-demand therapies. The vast majority of patients are switching from B or 0 to Cataban, which is very much in line with our expectations as in advance of approval. You know, we often heard about the shortcomings of a sub-Q injectable. But again, very exciting and encouraging to see just the broad adoption across all of the different on-demand treatments.

Got it. Helpful perspective there. And then maybe one follow-up just for the 937 news starts. Are you seeing more in what proportion is converting to drug? And are you breaking down paid versus free drug at this time?

Yeah, so from an access standpoint, we are very encouraged by the continued increase in pain. Week to week, we see the pain rate continue to grow, and we've seen successful use of the medical exception, both in terms of consistency over time, as well as, I should add, more recently, as the Ecterly policies have started to come into play, we're seeing clarity in terms of path forward for patients to gain access to Ecterly. So overall, at this point in time, certainly our paid and the access dynamics are unfolding as we'd expect.

And more for perfect clarity, because I don't know if this is where we're going, all those start forms reflect prescriptions. Those are people who are actually switching to actively. A start form is inherently tied to a prescription for that person to switch.

Got it. All helpful. Okay. Thanks for taking my questions.

Thank you. Our next question coming from the line of Stacy Ku with TD Cowan. Your line is now open.

Hey, good morning. Congrats on a great quarter and thanks so much for taking our questions. So the first is just a follow-up. Are you willing to talk a little bit more about these refill rates or maybe disclose on average number of doses for these high burden patients and maybe help us compare that to where you would expect things to normalize, especially given your work with claims data? And of course, as it relates to payer willingness to treat these high burden patients, maybe talk about the quality quantity limits that you're seeing for chronic use of Ecterly. So that's the first question. And then the second question is just maybe as we look to the commentary you're kind of trying to highlight for us around those patient bolus dynamics that you're seeing, just help us understand what that means for the remainder of the year versus what we've seen in Q3. And of course, putting you a little bit on the spot here. As we look to next year, again, still really early days, we totally understand that, but just your level of comfort around consensus as we think about the 937 patient start forms that you've already grabbed in 25. Thanks so much.

Thanks, Stacey, for all the questions. We'll work our way around the room here to answer them. So on the first one, you asked about refill rates. Our presumption going into this when you look at claims data is that The average person with HAE is refilling about once every three to four months. And that will normally be with a catapent that's typically sold in packs of three. So that will typically be at least three doses and maybe multiple packs. Because actually, I think the average rate of refill is higher than that. What we've seen to date, driven again by this high burn population, has been refill frequencies of probably less, you know, kind of a third that frequent, you know, maybe once a month or even more frequently than that. So these people are very, very high or, you know, have in some cases very high attack rates. And so they're refilling quite frequently and they are, and they are when they refill, typically refilling with multiple cartons at a time. So it's, It's many more doses than we would expect on average. As I said in the last answer, that's because of this subpopulation that has come down really early. As we go over time, certainly we'd expect those rates to normalize more towards what you see in the Catabana-type marketplace, where you've got refills that are multiple months apart. And probably on average, volumes will be lower. In terms of quantity limits, Ashley, why don't you take it from there?

Sure, let's step in. You know, quantity limits are certainly the norm for the current branded on-demand treatments. And it is something that we're seeing and expected to see with Acterly. Having said that, to date, the quantity limits that we're facing with Acterly, again, very consistent with the other products and have not created impediments to a patient continuing to gain access to Acterly. And historically, there are means to overcome quantity limits should we end up in that situation on a patient basis. Also, just to transition to your question regarding demand for the remainder of the year, certainly we recognize going into the holiday season, there are times out of office for physicians and for staff, as well as just a very busy time for all of us. So, we do anticipate potential disruption. to demand in the remainder of 2025.

And if you want to talk to us about it.

Yeah, on consensus, Stacy, you know, as what we see, you know, there's quite a range in the consensus. I think, you know, over a three-fold gap, we understand the challenges of modeling this new prescription that is an on-demand therapy. It is challenging. As far as the complicated is, you know, we changed our fiscal year now to a calendar year basis, and I'm not sure all the estimates have caught up to that. And so, you know, I think that dispersion in estimates is warranted as we kind of really figure out what utilization will look like over the long term.

Yeah, understood. And then just to confirm, a carton is two doses, correct?

Yes.

Wonderful. Thanks so much for answering all our questions.

Thanks for the question.

Thank you. Our next question, coming from the line of Paul Mattes with Stiefel, your line is now open.

Hi, this is Matthew on for Paul. Thanks so much for taking our question, and congrats on all the progress. I guess I just wanted to better understand, you know, with the multiple cartons per shipment, Do you think there's any stockpiling behavior within the patients, just given how convenient it is to have this oral and the storage is easier? And, you know, I guess, yeah, how do you see that evolving in the future? Thank you.

Factually, we don't know. I understand. Well, factually, we don't know. We got put on mute by accident for a second there. People don't have to tell us what's happening. Given that self-reported attack rate among these folks is quite high, you know, we do think there's obviously a high level of utilization there. But I don't know that we could allocate between how much they're storing it up, like as they probably should really, to have a place where they can access it when they have attacks versus actually using it. Again, you know, stepping back a little bit, whether it's because of initial, you know, some type of initial stock file, although, again, these reflow rates have been pretty consistent. or usage, like I said, as we expand further into the population, we do expect the overall attack rates to normalize more towards what you see in the population as a whole. That means that, again, usage will probably be less on average, refills will be less frequent on average, and the volumes per refill will come down to some extent. Even people that don't really have high attack rates, when they do refill, seem to be refilling at higher levels than we expected. That's probably maybe more indicative of stockpiling than I think the really high attack rate is.

Yeah, just a reminder that the treatment guidelines do, that physicians have developed both in the U.S. and around the world, do encourage that patients keep products on hand to treat multiple attacks. two to three attacks. And so that is something that is fairly common in terms of practice here with patients in the U.S.

Okay, thank you. That's very helpful.

Thank you. Our next question coming from the line of Joe Schwartz with Learing Partners. Your line is now open.

Great, thanks very much. It's great to see that, according to our math, the rate of PSF has stayed fairly constant through your first couple of updates so far. Do you expect this relatively linear PSF growth rate to continue? At what point, either months into the launch or overall penetration-wise, do you expect PSF growth to taper off? And then, ex-US, it was great to see the German launches underway. What is the price you agreed upon in Germany and how does that compare to the U.S.? Thanks.

Thanks for the questions. So the PSF rates have been quite consistent, you know, as we've indicated through the first now four months of the launch. As Nicole said a few minutes ago, the fourth quarter here, and especially the November, December as you get to the holidays, is definitely a time when we wouldn't be surprised if, if the numbers slow a bit, right? I mean, people just aren't going to be going to their physicians for this type of thing over the holidays. So, we would expect that there'll be some slowing in the fourth quarter, really just driven by the kind of seasonality of the thing. As we get into 2026, again, we think the fundamentals on demand are really good, right? People seem to be still getting these appointments at quite a consistent clip. Inexorably, over time, the rate of start forms will slow down to some extent, just as we get deeper into the patient population. But at this point, we really don't have enough information to give an indication of when that's earlier or later in 2026.

But the clip we're on now, while we're quite happy with it, certainly we wouldn't really expect it to be this fast-paced. all the way to 2026. So that's the first part. Okay.

So the German price, that's something that is not disclosed at this time. We're early in the days of launch there and will be in ongoing negotiations and discussions with German authorities. So that's something certainly we could revisit in the new year.

Okay. What about other European countries in 2026? What are the plans there?

Certainly. We have approval in the UK, and so that is something we're in active discussions with NICE and planning for a launch in the first half of 2026, as well as moving out to some of the other larger countries in Europe towards the end of 2026.

Great. Thanks again.

Thank you. Our next question coming from the line of John Wallerman with Citizens Bank. Your line is now open.

Congrats on the progress, and thanks for taking the question. When you guys talk about kind of normalization of these rates, I'm wondering if you talk a little bit about your expectations for, you know, how many patients do you expect to ultimately be trialing externally? Because the high burden makes sense now, but do you think that this is going to be broad across people with low burden as well, or is it going to be a majority of these high burden patients over time? And then in the prepared remarks, you mentioned gross net towards the low end of your expected range. I was hoping you could just remind us of what that expected range is. Thanks. Sure, I'll do the first part.

The, again, John, you know, we do fundamentally expect oral therapies to displace the injectables. I think we've fairly, you know, conclusively shown that Ectoly offers all the benefits of the existing HA therapies with much better, equivalent efficacy in all likelihood, right? We haven't, it hasn't been done, shown head to head, but I think people generally accept that. The state has been pristine so far. there's really no advantage to anyone to continue using the injectable or an IV therapy. So on a fundamental level, we do expect the orals to overtake the injectables over time. And so there's the sort of high level, how the market evolves in our viewpoint. That does, to your point about whether the rate slows as you move into lower usage people, that's certainly possible. Likely. There's definitely, just like there's a very high burden population, there's, we presume, a commensurate very low burden population that may be less inclined to move over time. Today, we have seen people across the board switching to Ectoly. I mean, again, we've seen certainly the high population be through the third quarter, half of those folks, but the other half are much more of a distribution of attack rates. So, the urgency may not be as high as we move deeper into the market, but we do think the fundamentals are that people will switch over time. I mean, there's certainly a lot of folks who we believe are still a little bit in see how it's working for someone they know before they switch. Some of these folks will have tried Rolodeo before and maybe not have a satisfactory response. And so we do anticipate there could be a little bit of initial caution about another oral therapy. But again, just given the anecdotal reports we've seen so far and just the commentary we've heard from physicians who've talked to their patients, we think people are exceedingly satisfied right now. And we do believe that that will play through over time and that will bring these people who may be less motivated for whatever reason right initially to move, to switch over to Ectolian. You know, it's in a timely fashion.

Yeah, I would just offer that building upon Ben's point, anecdotal feedback, as well as market research we've conducted with patients, we see very high satisfaction ratings, both with patients who have a high burden of disease, as well as patients with, you know, a more moderate or lower burden of disease. And that satisfaction relates specifically to actorly, as well as with our patient support services that receives high marks in terms of supporting patients to gain access.

And suspected gross to net, John, like other specialty medicines, we expect to see gross to net to be on average upper teens, low 20s.

Got it. All right. Thanks for the call, guys. Thanks, John.

Thank you. Our next question coming from the line of Sergey Ballinger with Needham & Company. Your line is now open.

Hi. Good morning. Rats on the quarter. First question, I wanted to, go back to your initial focus on high burden patients. Is that just a function of the market or the docs that you prescribers that you have initially targeted? And are they using these higher burden patients as leveraging them to get experience with the product and familiarity? Secondly, when prescribers are writing patient start forms or prescriptions, Are these PRNs or are they limiting them to a certain number of boxes or cartons? Thanks.

Sure. So, in terms of the hybrid patients, these are the patients that spend most of their time in with their physician. So, these have, these are individuals that are typically on prophylaxis and have HAE that is largely uncontrolled. And so, given the high need that they have, they're very much on the physician's radar. Having said that, these are also the patients who are most informed. So in advance of approval, they're actively seeking new treatments. And with the approval, actually, we know that they made appointments and went into their physician's offices to discuss. So I will say that it's a bit of the patient's demand due to the burden of the disease, as well as certainly significant awareness on the physician side that they need to support those patients. And yes, I think to some extent, your point You know, it enabled them to test actually in some of the most difficult cases to really validate that what the profile we saw in the clinical trials really playing out in the real world, which we know has increased confidence of physicians as we see the majority of SART forms that are coming from repeat prescribers. Just in terms of how they write the prescription, typically a prescription is written for PRN. So that that allows the flexibility for the patients to gain access to refills at the frequency and the magnitude of which they need. That's historically how it's been done with the other on-demand treatments and what we see with Ectorlead today.

Okay, great. One quick one for Brian, just on inventory. Out of the 13.7 million that was reported this quarter, how much of that was inventory? Did you exit the quarter at steady state on that front?

Yeah, we're seeing obviously with the first two months of launch inventory build coming in by the specialty pharmacies, particularly as they added additional locations as the launch gained momentum. We think our specialty pharmacy partners are forming in a disciplined manner. you know, with view of growth. It's not steady state. It's going to continue, you know, building in front of expected demand.

Thank you.

Our next question coming from the line of the Panjana Chatterjee with Jones Trading. Your line is now open.

Hi. Thanks for taking my question, and congrats on the quarter. So can you talk a little bit more about how your insurance negotiations are progressing and how we should think about the cadence of payers coming online in the first half of next year?

Sure, absolutely. You know, leading into launch, we anticipated that it would take roughly six months to both drive demand and for payers to assess accurately and establish policies. What we're seeing at this point in time is that, yes, we are leveraging medical exception on a consistent basis to gain access, but we're also seeing some of the regional and national payers create policies for Efterly that are largely favorable. Looking towards the end of this year and into the early part of next year, we are planning to, I would say, wrap up discussions with some of the larger payers in PBMs. with an aim to have policies in place, again, early in 2026.

Sure. And a quick follow-up. So, you've also mentioned that in the early quarters, revenues can be a bit bumpy as research rates stabilize. So, can you talk about how we should think about revenue trajectory in the immediate, like, next couple of quarters?

I mean, it's a hard question as we just talked about. You know, we continue to expect initial fills to come through. You know, we've talked about as adoption expands, you know, the burden of disease on patients will, on average, go down. That'll impact both initial fill amounts as well as refill rates. You know, this is an on-demand therapy. We're going through you know, holiday period, it's really hard to understand exactly kind of, you know, the nature of the revenue to kind of comment on what trajectory should look like.

Okay, thanks. Thanks for the details. Take care. Thank you.

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