KalVista Pharmaceuticals sees steady demand for Ectoly with $13.7 million in sales, bolstered by positive patient satisfaction and expansion plans.

OPERATOR - (00:02:06)

Good day and thank you for standing by. Welcome to KalVista Pharmaceuticals' 2025 third quarter financial update and operating results conference call. 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 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, Brian Baker, Head of Investor Relations. Please go ahead.

Brian Baker - Head of Investigations - (00:02:40)

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 a discussion of the risks that may cause actual results to differ from the forward looking statements on the call with me today from KalVista are Ben Paleko, Chief Executive Officer, Nicole Sweeney, Chief Commercial Officer, Brian 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 Ecter'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 KONFIDENT-Kids trial in HAE for children ages 2 to 11, as well as new patient satisfaction data. Nicole will 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.

Ben Paleko - Chief Executive Officer - (00:03:46)

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 Ecter's first three months on the US market. Adoption has been steady and linear with real world utilization tracking. As we expected, the takeaways are clear. Demand for Ecter's 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 Ecter's 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-U.S. 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 HA community generally, as well as to demonstrate the real world benefit of eckerle to people living with ha. Last week, during the American College of Allergy, Asthma and Immunology meeting, we provided a report on the high satisfaction rates for patients in KONFIDENT-S who'd switched to cevetrolastat from injectable on demand therapies. Additionally, interim results from our Confident Kid trial show that svetralstat 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 Espizi 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 note offering, we are fully financed through profitability, allowing us to remain sharply focused on executing the ecturly 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.

Paul Audia - Chief Medical Officer - (00:06:25)

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 Ecter's across various patient segments. Starting with our late breakthrough at acaai, we provided a significant update on our registrational KONFIDENT-Kids trial and for children with Hae aged 2 to 11. With 36 children enrolled, this is the largest trial ever conducted in the pediatric HAE population. 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 competent kid 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 cevetrolastat ODT in a median of 30 minutes. This option where children can actually treat themselves is a totally unique feature of KONFIDENT-Kids 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 Ectorleaf'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 31, the trial has accumulated over 2,700 attacks treated with ectrolyte. 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 1/4 of confidence participants. We noted a clear trend the proportion of patients using a second dose of 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, the use of conventional injectable therapy dropped from 8% at the beginning of the trial to 0% by ASHAC 30. We believe these marked reductions in the use of a second dose or conventional therapy reflect patients growing assurance and extra release reliability. We plan to present this important data in more detail and and 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 CEvetrolstat. The median satisfaction score for attacks treated with cevetrolastat was 2 or very satisfied on a 7 point scale ranging from - 3 which was extremely dissatisfied, to 3 which was extremely satisfied. Overall, 84% of attacks treated with cevetrolastat 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 cevetrolastat 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 Ectoly, the probability of them seeking to switch therapies in the future is expected to decrease. This supports ectoly'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 ectorly continues to build. To discuss how the launch is unfolding, I'll now pass the call to Nicole.

Nicole Sweeney - Chief Commercial Officer - (00:11:53)

Thanks Paul. I'm pleased to share that the U.S. launch of Ecter's 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 HAE patient segments, including prophylaxis users as well as adolescents. People are switching from all on demand therapies, but the greatest number have been from Pfirzir and Kalbitor, as expected given their market share. Also, as we expected, the earliest and greatest number of those switching to ecterly 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 ectorly. 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 Ecterly 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 efterly. 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 HAE 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 ECTRly. The medical exception approval rate and time to paid 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 ectorly 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 acatabat which patients are able to move through quickly as most HAE patients have experience with generic acatabat. 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 ectrly 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 Ecterly. 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 Ecterly'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 a PMDA approval and launch in the first quarter of 2026 with our partner Kakin Pharmaceutical. Taken together, accelerating utilization, repeat prescribing and growing favorable access provide a clear signal Ectrely 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 HAE population as physicians gain confidence and patients increasingly choose Ectorly for their attacks. I'll now turn the call over to Brian to review our financial performance.

Brian Picos - Chief Financial Officer - (00:17:23)

Thanks Nicole. Our full financial results were included in the 10Q filed after the close yesterday, so I will provide a few highlights. For a three month period ending September 30th, we are pleased to announce sales of Ecter's were $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 earlier adopter base. When looking at gross-to-net, I note it came in toward 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 R&D expenses and approximately 46.5 million in SG&A expenses. Looking ahead to the remainder of 2025, we expect SGA expenses to remain relatively consistent as we continue to invest in Ecter's global launch. Importantly, with our recent convertible note financing, our cash position is sufficient to fund operations through profitability. With that, I'll turn the call back to Ben for closing remarks.

Ben Paleko - Chief Executive Officer - (00:18:47)

Thanks Brian. The early momentum and rapid growth we described today reinforce our belief that Ecter's 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 US expanding access globally and reinforcing confidence in the role of Ecter's 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 - (00:20:28)

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. Withdraw your question, simply press star 11 again. Please stand by while we compiled queue roster. Now first question coming from the line of Maurie Brakehoff with Jeffrey Sealant is now open.

Maurie Brakehoff - (00:20:52)

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 to Ecter's 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?

Ben Paleko - Chief Executive Officer - (00:21:15)

Hey Maury, thanks for joining today and thanks for the question. Nice to talk to you. I guess I'll start and maybe Nicole, we'll add some other details. What was really important here when we launched Ecter's 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 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 switch to actual lead to date self report an attack rate of two or more attacks per month, which we consider to be hybrid. And that accounts for obviously a fair amount of the prescription, 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 bihector. You know, in the longer run, obviously we expect that number to decline. Right. That's a fairly small portion of the population. And as we broaden out Ecter's's reach, the. All those, all those items will go down, the refill rates will decline and the number of cartons per refill will also go down. But for now, you know, that group seems to getting a lot of benefit, just like we anticipated.

Nicole Sweeney - Chief Commercial Officer - (00:22:58)

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 firzer to kataban, which is very much in line with our expectations as in advance of approval. You know, we often heard about the shortcomings of a subcutaneous injectable, but again, very exciting and encouraging to see just the broad adoption across all of the different on demand treatments.

Maurie Brakehoff - (00:23:44)

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

Nicole Sweeney - Chief Commercial Officer - (00:23:58)

Yeah. So from an access standpoint, we are very encouraged by the continued increase in paid week to week. We see the paid 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 Ecter's policies have started to come into play, we're seeing clarity in terms of path forward for patients to gain access to Ecter's. So overall, at this point in time certainly are paid and the access dynamics are unfolding as we'd expect.

Ben Paleko - Chief Executive Officer - (00:24:37)

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

Maurie Brakehoff - (00:24:52)

All helpful. Okay, thanks for taking my questions.

OPERATOR - (00:24:56)

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

Stacy Koo - (00:25:04)

Hey, good morning. Congrats on a great quarter and thanks so much for taking your 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 quantity limits that you're seeing for chronic use of ectrly. 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 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.

Ben Paleko - Chief Executive Officer - (00:26:12)

Thanks Stacy. 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 Firazyr or Kalbitor is typically sold in packs of three. So that will typically be at least three doses and maybe multiple packs because Ecter's I think the average rate of refill is higher than that. What we've seen to date driven again by this high burden 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 freak and they are when they refill, typically refilling with multiple cartons at a time. So it's many more doses than we would expect on average. As I said in the last answer, that's because of this sub population that has come to actually early as we go over time, certainly we'd expect those rates to normalize more towards what you see in the cataban 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?

Nicole Sweeney - Chief Commercial Officer - (00:27:52)

Nicole? Sure. Glad to 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 Ectorly. Having said that, to date, the quantity limits that we're facing with Ectorly, again very consistent with the other products and have not created impediment to a patient continuing to gain access to Ectorly. 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 time 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 did you want to talk to the financials?

Ben Paleko - Chief Executive Officer - (00:28:49)

Yeah. On consensus, Stacy, you know, as what. We see on our end, you know. There'S quite a range in the consensus, I think, you know, over a threefold gap. We understand the challenges of modeling this new prescription that is an on demand therapy. It is challenging. Further complicated is, you know, we change 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.

Stacy Koo - (00:29:30)

Understood. And then just to confirm, a carton. Is two doses correct?

Ben Paleko - Chief Executive Officer - (00:29:34)

Yes.

Stacy Koo - (00:29:36)

Wonderful. Thanks so much for answering all our questions. Thanks for questions.

OPERATOR - (00:29:41)

Thank you. Our next question coming from the line of Paul Matthews with Stifel Yoland is now open.

Matthew - (00:29:50)

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 is 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.

Ben Paleko - Chief Executive Officer - (00:30:21)

Really, we don't know 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 the 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 they're storing it up like as they probably should really to have in 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 stockpile. Although again these refill rates have been pretty consistent or usage. Like I said, as the, 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 would 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 stockpile than I think the really high attack rate folks. I don't know if you have any.

Nicole Sweeney - Chief Commercial Officer - (00:31:42)

Yeah, just a reminder that the treatment guidelines do that physicians have developed both in the US 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.

OPERATOR - (00:32:05)

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

Joe Schwartz - (00:32:14)

Great, thanks very much. It's great to see that according to our math, the rate of patient start form has stayed fairly constant through your first couple of updates so far. Do you expect this relatively linear patient start form growth rate to continue at what point either months into the launch or overall penetration wise, do you expect patient start form 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 Joe.

Ben Paleko - Chief Executive Officer - (00:32:51)

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, we do 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 the numbers slow a bit. Right? I mean people just aren't going to be going to their positions 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 a 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 whether 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 2026. So that's the first part. Okay.

Nicole Sweeney - Chief Commercial Officer - (00:34:15)

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

Joe Schwartz - (00:34:29)

Okay, what about other European countries in 26? What are the plans there?

Nicole Sweeney - Chief Commercial Officer - (00:34:36)

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.

Joe Schwartz - (00:34:54)

Great, thanks again.

OPERATOR - (00:34:58)

Thank you. Our next question coming from the line of John Wolven with Citizens Bank, Jolenis Nalpin.

John Wolven - (00:35:07)

Congrats on the progress and thanks for taking the question. When you guys talk about kind of. Normalization of these rates, wondering if you talk a little bit about your expectations for 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.

Ben Paleko - Chief Executive Officer - (00:35:38)

I'll do the first part. Again. John, you know we do fundamentally expect oral therapies to displace the injectables. I think we've fairly conclusively shown that ectoly offers all the benefits of the existing HA therapies with much better equivalent efficacy in all likelihood. Right. It has been done shown head to head. But I think People generally accept that the safety's been pristine so far. There's really no advantage to anyone to use and continue to use injectable or an IV therapy. So on a fundamental level, we do expect 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 certainly 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. To date, we have seen people across the board switching to actually, I mean, again, we said we've seen certainly the high population be, you know, through the third quarter, half of those folks, but the other half are, 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, a lot. 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 Roladeo 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 talk 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 ectolyum and in a timely fashion. Now, if you want to add anyone.

Nicole Sweeney - Chief Commercial Officer - (00:38:00)

Yeah, I would just offer that building upon Ben's point anecdotal feedback. 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, more moderate or lower. 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.

Brian Picos - Chief Financial Officer - (00:38:29)

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

John Wolven - (00:38:40)

Got it. All right. Thanks for the color, guys. Nice, John.

OPERATOR - (00:38:44)

Thank you. Our next question coming from the lineup, Sergey Ballinger with Needham and company. Your line is now open.

Sergey Ballinger - (00:38:53)

Hi, good morning. Congrats 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.

Nicole Sweeney - Chief Commercial Officer - (00:39:38)

Sure. So in terms of the high burden patients, these are the patients that spend most of their time with their physician. So 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 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, it enabled them to test actorly 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 star 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.

Sergey Ballinger - (00:41:10)

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 and did you exit the quarter at steady state on that front?

Brian Picos - Chief Financial Officer - (00:41:28)

Yeah, we're seeing obviously with the first month 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 with view of growth. It's not steady state. It's going to continue building in front of expected demand.

OPERATOR - (00:42:01)

Thank you. Our next question coming from the line of the Panchana Chatterjee with Jones Trading Ilan is now open.

Panchana Chatterjee - (00:42:10)

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?

Nicole Sweeney - Chief Commercial Officer - (00:42:27)

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 ectorly 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 and PBMs with an aim to have policies in place again early in 2026. Sure.

Panchana Chatterjee - (00:43:12)

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

Brian Picos - Chief Financial Officer - (00:43:33)

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 that. 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, a 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.

Panchana Chatterjee - (00:44:13)

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

OPERATOR - (00:44:18)

Thank you. And there are no further questions in the queue at this time. Ladies and gentlemen, this concludes today's conference call. Thank you for participating and you may now disconnect.