Q3 2025 KalVista Pharmaceuticals Inc Earnings Call
Speaker #1: 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 on the list and only mode.
Speaker #1: After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone.
Speaker #1: You will then hear an automated message advising that 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 Investigations.
Speaker #1: Please go ahead.
Speaker #2: Thank you, operator. Good morning, everyone, and thank you for joining us to discuss KalVista Pharmaceuticals' 2025 third-quarter financial update and operating results. Please note we'll be making certain forward-looking statements today.
Speaker #2: We refer you to KalVista's SEC filings for discussion of the risks that may cause actual results to differ from the forward-looking statements. On the call with me today from KalVista are Ben Paleko, chief executive officer; Nicole Sweeney, chief commercial officer; Ryan Piekos, chief financial officer; and Dr. Paul Audia, our chief medical officer.
Speaker #2: Ben will begin with a review of the company's progress during the three months ended September 30th, including an overview of actually its early launch, both in the US and abroad, as well as other regulatory updates.
Speaker #2: Paul will give an update on recently presented data from our Confident Kid trial in HAE for children ages 2 to 11, as well as new patient satisfaction data.
Speaker #2: 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.
Speaker #2: With that, I will now turn the call over to
Speaker #2: Ben, thank you. Ryan, and thank you.
Speaker #3: 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 Ectaly's first three months on the US market.
Speaker #3: Adoption has been steady and linear, with real-world utilization tracking as we expected. The takeaways are clear. Demand for Ectaly 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.
Speaker #3: We continue to believe that Ectaly will evolve to become the foundational treatment for HAE. In addition, we are executing on our mission to bring Ectaly to people living with HAE globally.
Speaker #3: The German launch is now underway, with initial uptake validating the ex-US interest in Ectaly. The approval footprint continues to grow, with a recent approval in Australia adding to the existing authorizations in the US, UK, EU, and Switzerland.
Speaker #3: 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.
Speaker #3: 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 Ectaly to people living with HAE.
Speaker #3: 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 the seven trial stat from injectable on-demand therapies.
Speaker #3: Additionally, interim results from our confident kid trial show that seven trial stat enabled early, effective, and safe treatment of HAE attacks in children ages 2 to 11.
Speaker #3: 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 Azpizi as chief people officer.
Speaker #3: bring decades of experience that will make them Both important contributors as we work to evolve KalVista 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 Ectaly launch while evaluating additional growth opportunities.
Speaker #3: I will now turn the call over to Paul, who will update you on the latest data from confident S and confident kid.
Speaker #2: 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 Ectaly across various patient segments.
Speaker #2: Starting with our late breakthrough ACAAI, we provided a significant update on our registrational CONFIDENT KID trial for seven trial sites in children with HAE ages 2 to 11.
Speaker #2: 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.
Speaker #2: 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 has experienced attacks.
Speaker #2: As of June 6th, 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.
Speaker #2: We believe that the high attack rate in confident kid reflects an accurate unmasking of the true disease burden that was previously hidden by the difficulties associated with administering and receiving injectable treatments.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: Returning to the results, treatment was rapid, with caregivers or the children themselves administering seven trial stat ODT in a median of 30 minutes. This option, where children can actually treat themselves, is a totally unique feature of Confident Kid and increases the importance of the results.
In less than 4 months since launch we have received 937, start forms representing more than 10% of the ha 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 the patient segments, including prophylaxis users as well as adolescents.
People are switching from all on demand therapies but the greatest number have been from fears there in a cat event as expected given their market share.
Also, as we expected the earliest and greatest number of those switch inductor League, 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 3 to 4 new prescribers each day.
Awareness levels are exceptionally high, with 100% of Tier 1 HCPs and 95% of all target HCPs reporting awareness of Eerie. These metrics reflect both the strength of our field execution and the enthusiasm of the medical community for Eerie.
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 QuickStart and paid therapy are doing so every 3 to 4 weeks,
For context, most injectable OnDemand therapies, average, only 3 to 4 references.
This level of refill frequency is a clear indicator of growing real-world reliance and confidence in the afterlife.
Note that the majority of these refills are driven by patients with a high disease burden. They report experiencing 2 to 4 attacks per month despite generally also being on prophylaxis therapy, which indicates the lack of adequate Disease Control.
Refilled, quantities or 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 the man continues to build, payers are actively moving toward formal coverage for Eerie. Since approval, patients have been able to leverage medical exceptions to gain access to Eerie. The medical exception approval rate and time to page shipment are consistent with our expectations, less than 6 months following approval. It is very encouraging that we have seen medical.
Receptions approved by all PVMS and all large payers for both commercial and Medicare cases.
We continue to advance formal access, with multiple regional and national payers already establishing active policies.
The majority of policies are paid to label which is consistent with other branded on demand Therapies.
As expected, the minority of policies, require a step through a katabon which patients are able to move through quickly and most agents have experience with generic accountability.
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 actively growing as payers recognize the need for afterlife 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 elderly,
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 elderly is 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 CAP and Pharmaceutical.
Taken together, accelerating utilization, repeat prescribing, and growing favorable access provide a clear signal that it 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 AC population as Physicians gain confidence, and patience increasingly choose after league 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 10 to you filed after the close yesterday. So I'll provide a few highlights but a 3-month period and a September 30th.
We are pleased to announce sales eventually with 13.7 million for the launch period, through September 30th, which includes the 1.4 million recorded in July and previously, recorded.
subsequent to the July period, especially Pharmacy Partners stock additional locations and built inventory in a disciplined manner, supporting the growing patient demand,
An initial 3 months launch period. We are seeing the average number of cartons per shipment on the high end of our expected range which aligns with the utilization among High burden patients, the core of our earlier doctor base.
When looking at gross to net, I know it came in toward the low end of our expected range this quarter, driven largely by lower co-pay 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 Rd expenses and approximately 46.5 million in sgna expenses.
Looking ahead to the remainder of 2025, we expect sgna expenses to remain relatively consistent as we continue to invest in after release Global launch.
Through profitability.
With that, I'll turn the call back to Ben for closing remarks.
Thanks Brian.
The earlier, momentum and rapid growth. We described today. Reinforced our belief that Eerie 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 eerie across the treatment landscape.
We continue to believe that oral on demand therapy, should broadly displaced injectable options and that ECT will be the clear market leader based upon the breadth and depth of the data. We've generated that shows echoey can benefit, all people living with hie regardless of their attack, location frequency or severity.
We are and Will Remain the only company that is 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 runaway and fully funded path through profitability. We believe we are well on our way to establishing equally as a 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 1, 1 on your telephone and wait for your name to be announced.
We try your question, simply press star 11 again.
Please stand by while we compile. Can your Wester
The first question coming from the line of Maury break off with Jeffrey seal. Let us know when
Hi, good morning, uh, congrats on the great quarter and thanks for taking my questions. Um, maybe to start off wondering, if you could talk more about trends for types of patients who are switching to accurately early on particularly the high burden patients, are you putting percentages on how the 9377 start forms break down and how could these Trends change over time?
Hey, my, uh, thanks, uh, for joining today. And thanks for the question. Nice to talk to you. I guess I'll start. This is, maybe Nicole we'll, um, we'll have, you know, some other details. Um, what's been, what was really important here? When we launched after League was, we always presume that the most rapid adopters would be the people living with ha who have a very high treatment burden. Um, and we've talked about this for a long time and I think this 1,
Answer your questions. You know, in some quarters about whether that patient population exists and and also how severe their their attack rates are what we found through the third quarter was that um, that actually, those people do exist and and they are transition just as we would have expected roughly half of all the patients who have switched to actively to date. Um self-report and attack rate of 2 or more attacks per month which we consider to be high birth.
Um and that and that accounts for, you know, obviously a fair amount of the prescriptions but also those people refill, it higher rates in in a larger quantities as well. Um, so clearly the the the discovery we've made here is that that group really does exist that they actually aren't well controlled on prophylaxis um and um and that their their needs are are being met by electrolytes.
You know, in the longer, run. Obviously, we expect that number to decline, right? That's a fairly small portion of the population. And, um, and as we broaden out, uh, actively Reach the, the all those, all those items will go down in the refill, rate will Decline and the and the number of cards per refund will also be done but
For now um, you know that group seems to be getting a lot of benefit from regularly just like we anticipating.
Yeah, just to add some further caller on the patient base. Um, 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.
Uh very exciting and encouraging to see just the the broad adoption uh across all of the different monuments.
Helpful perspective there and then maybe 1 1 follows 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?
Yeah. So
They're very encouraged by the continued, increase in pain. Um, we, we, we see the paid rate continue to, um, grow and, and we've seen successful use of the medical exception, uh, both in terms of consistency, um, over time as well, as I should, add more recently, as the actorly policies have started to come into play, we're seeing Clarity in terms of path for patients to gain access to actively. So overall, at this point of time, certainly our, our paid and the access Dynamics are unfolding as we expect
And more at the 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 a start form is inherently tied to a prescription, um, 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 with
hey, good morning. Uh, congrats on a great quarter and thanks so much for taking your questions. So the first is is just a follow-up. Um, are you willing to talk a little bit more about these refill rates or, or maybe disclose on average, number of doses for these hybrid and patience and maybe help us compare that to where you, where you would expect things to normalize. Um, especially given your work with claims data. Um, and, and of course, as it relates to pair, willingness to treat these hybrid and patience, maybe talk about the quality quantity limits that you're seeing um for chronic use of Dr. Lee, so that's the first question. And then the second question is is just maybe uh as we as we look to the commentary your your kind of trying to highlight for us around this patient bless 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, um, putting you a little bit on the spot here as we look to next year. Again, still really early days, we we totally understand that but just your level of
Comfort around consensus. As we think about the 937, patients art forms that you've already grabbed in 25 Thanksgiving.
Uh thanks Stacey for all the questions. We'll we'll we'll our way around the room here to answer them. So on the first 1, you asked about refill rates, um, our presumption going into this when you look at claims data is that the average person with h is refilling about once every 3 to 4 months, um, and that will normally be with, uh, Thursday with or a katabon, just typically, sold in packs of 3. So that would be at least 3 doses. Um, uh, and maybe multiple packs that, I guess actually. I think the average rate of refills higher than that.
What we've seen today. Um, driven Again, by this High burn, population has been refilled, frequencies of probably, um, uh, less, you know, kind of a third that of frequent, you know, maybe once a month or or even more frequently than that. So, these people are very are very high. Um, are, you know, have has in some cases, very high attack rates. And so the refill is quite frequently and they are frequent and they are when they refill typically refilling with multiple cards at a time. Um, so it's it's you know, many more doses than than we would expect on average. Um,
As I said, you know, the last answer. That's that's because of this sub population, that 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 in the, you know, katabon type marketplace. Where you've got refills. That are multiple months, um, apart. And, uh, and probably on average volumes will be lower.
We recognize that going into the holiday season, there will be time out of office for physicians and for staff, as well as a very busy time for all of us. So, we do anticipate potential disruption to demand for the remainder of 2025.
And if you want to talk to someone else, yeah. On consensus, Stacy, um, you know, as what we see on our end, um, you know there's quite a range in the consensus. I think, you know, over a 3-fold gap. We understand, um, the challenges of modeling this new, new, new.
Prescription that is an on demand therapy, it is challenging. Um, as far as the complicated is, you know, we change our fiscal year now to a calendar year basis and I'm not sure all all the estimates of caught up to that. Um, and so,
You know, I think that that dispersion in an estimates um, is warranted as we kind of really figure out what utilization will look like over the long term.
Understood and then just to confirm a carton is 2 doses. Correct.
Yes.
Wonderful. Thanks so much for for answering all of our questions.
Thanks so much.
Thank you.
Our next question, coming from the line of call my taste with Steve Allen is Nathan.
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 for 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. Um, and you know, I guess.
Yeah. How do you see that evolving in the future? Thank you.
We don't know.
Understand. So factually we don't know but we got put on mute by accident for a second there. Um uh people don't have to tell us what's happening. Um, given that the self-reported attack rate along these spokes is quite High, you know, we do think there's obviously a, a high level of utilization there, um, 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 a tax versus actually using it. Um, 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 refill rates have been pretty consistent or, uh, or usage,
Like I said, as the, as we expand further into the population, we do expect the, the overall attack rates to, to normalize more towards what you see in the, in the population, as a whole, that means that again users would probably be less on average. Um, refills will be less frequent on average and the, and the volumes per refill will come down to some extent. But even people that don't really have a high tap rates when they do refill seem to be refilling at higher levels than we expected. Um, that's probably maybe more indicative of stockpile than I think the really high top rating, folks. I don't know if you. Yeah, it's just a reminder that the treatment guidelines, do that Physicians have developed both in the US and around the world, do encourage the patients, key products on hand, to treat multiple attacks uh 2 to 3 attacks. And so that is something that is fairly common. In terms of practice here with patients in the US.
Okay, thank you. That's very helpful.
Partners CL and is now open.
Great, thanks very much. Um, it's great to see that according to our Mass, the rate of PSS has stayed fairly constant through your first couple of updates so far. Do you expect this relatively linear? Psf growth rate to continue? Um, at what point either months into the launch or overall penetration wise, do you expect psf growth to
Taper off.
Um, and and then, um,
Xus. 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 US?
Um, thanks.
Yeah, thanks for the questions. Uh so the psf rates have been quite consistent, you know as we've indicated through the first uh now 4 months of the launch. Um as the call said a few minutes ago we do.
Uh the fourth quarter here in especially the no government to summarize you get to the holidays is is definitely um an a time when we wouldn't be surprised if if the number's slow that right. I mean people just aren't going to be going to their positions for
This type of thing over the holidays. So,
Ity of the thing as we get into 2026. Um again we think the fundamentals on demand are really good, right? People seem to be still getting these apartments at a, at a, quite a consistent clip. Um, uh, inexorably over time the the rate of of start forms will slow down, um, to some extent. Uh, just just as we get deeper into the into the patient population. Um, but at this point we really don't have enough information to to give any indication of whether that's earlier or later in 2026. But
the clip the clip right now, while we're quite happy with it certainly
we wouldn't really expect it to be this fast-paced, all the 2026.
So that's the first part. Okay. So the German price, that that's something that is not disclosed at this time. Uh, we're early in the days of launch there and will be an ongoing negotiation, the discussions with German authorities. So, that's something certainly we can revisit in the in the New Year. Okay. And what about other European countries in 26? Um, what what are the plans there?
Certainly we, uh, we start, we have approval in the UK and so that is something. We're an active discussion 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 woolman with Citizens Bank. Your line is now open
Hey, congrats on the progress and thanks for taking the question. When you guys talk about kind of normalization of these rates wondering. If you could talk a little bit about your expectations for you know, how many patients do you expect to ultimately be? Um trialing externally because the 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 majority of these high burn patients over time? And then in the prepared remarks, you mentioned that 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 um, uh again John, you know, we do fundamentally expect oral therapies to displace the injectables. I, I think we're fairly, you know, conclusively shown that actively offers all the benefits of of the existing ha therapies with much much much, much better, equivalent advocacy and all likelihood, right we haven't. It hasn't been had done Sean had to head but I think people generally accept that the safety is then pristine so far. There's really no advantage to anyone to use and continue to use them injectable or an IV therapy. So, um, so on a fundamental level, we do expect the oils to, um, to overtake the injectables over time. Um, uh, you know, it's so there's the, there's the sort of high level how the market evolves in our viewport.
That does to your point about whether the, the rates lows As you move into lower usage people, um, that's the only likely, right? There's definitely just like there's a very high burden population. There's we presume a commensurate very low burn population. Um, that may be less inclined. To move over time. Today, we have seen people
Are switching to actively it. 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, um, of a distribution of attack rates. Um, so the urgency may not be as high as we move deeper into the market, but we do think the fundamentals are that, 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, um, uh, uh, you know, some of these, you know, folks will have tried for a day or before and maybe not have a satisfactory response and and so, you know, we we don't, we do anticipate, there could be a little bit of initial caution about about another oil therapy. But
But again just given the anecdotal reports we've seen so far and just the the commentary we've heard from positions and talked to locations. We think people are exceedingly satisfied right now and we do believe that that will play for over time. And that will bring these people who may be less motivated for whatever reason, right? Initially to move, uh, to switch over to actively and, and um, uh, you know, and it's in a timely fashion now if you wanted anyone, but yeah, I would just offer that.
With our patient support services that receives High marks in terms of supporting patients to gain access.
And you should expect it, grows to net John uh, like other specially medicines. We expect to see uh, protest to be on average upper teens low 20s.
Got it. All right. Thanks for the color, guys.
Thank you. Our next question coming from the lineup. Okay. Bellinger with any Hammond company Ilana snow open.
Hi, good morning. Um, Rats on the, on the quarter, first question. Uh, I wanted to go back to your initial focus on high burden patients, is that just a function of the market or the the docks that you prescribers that you have initially targeted, and are they using these higher burden patients as
Um, leveraging leveraging them to to get experience with the product and familiarity. Um, secondly when prescribers are writing patients, start forms or prescriptions, um, are these prns or are they limiting them to, um,
A certain number of boxes or cartons.
Thanks.
George. 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 probable access 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, and with the approval of actively, we know that they may appointments and went into their phys, went into their Physician's offices to discuss. So I will say that it's it's a bit of the patients 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 actively 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 positions, as we see the majority of star forms that are coming from repeat prescribers. Um, just in terms of how they write the prescription, um, typically a prescription is written for PRN, uh, so that that allows the flexibility for the patient to gain access to refills at the frequency and the magnitude of which they need.
um, that's historically how it's been done with the other on demand treatments and what we see with actively today,
Okay, great. Um, 1 quick 1 for Brian just on inventory out of the 13.7 million, that was reported this quarter. Um, how much of that was inventory and did you exit the quarter at steady state on that front?
Yeah, we're we're seeing obviously with the the first 2 months of launch inventory, build, um, coming in by the specialty pharmacies particularly as they, you know, added additional locations as the launch game momentum. Um, we think our, our Specialty Pharmacy partners are are forming in a disciplined manner. Um, you know, with with view of growth it's 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 panchana chatty with joints Jones trading, and let us know open
Hi. Thanks for taking my question and congrats on the quarter. So uh, can you talk a little bit more about how your insurance negotiations are progressing, and how we should? Uh, think about the Cadence of payers coming online in the first half of next year.
Sure absolutely. Um you know leading into launch, we anticipated that it would take roughly 6 months to both Drive demand and for payers to assess actively and establish policies. Uh 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 elderly that are largely favorable looking towards the end of this year and into the early part of next year. Um, we are planning to I would say wrap up discussions with some of the larger payers in pbms um, with an aim to have policies in place again early in 2026.
Is, uh, revenue can be a bit bumpy as the refill rate stabilizes. So, uh, can you talk about how we should think about the revenue trajectory in the immediate next couple of quarters?
Um, I I mean, it's a hard question as we just talked about. Um, you know, we continue to expect initial fills to come through. You know, we've talked about the, the, as a doctrine that expands, you know, the burden of disease on patients will on average go down. Um, that'll impact both initial, uh, Phil amounts as well as refill rates. Um, you know, this is an on demand therapy, we're going through uh, you know, a holiday period. It it's it's really hard to understand exactly kind of um, you know, the
The nature of the revenue to to kind of comment on what trajectory should look like.
Okay, thanks. Thanks for the details. Take care.
Thank you.
And there are no further questions in the queue at this time, ladies and gentlemen, today's conference call, thank you for participating and you may now disconnect