KalVista Pharmaceuticals, Inc.

Ladies and gentlemen, thank you for standing by. Welcome to CalVista Pharmaceuticals operational update and first fiscal quarter financial results. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you would need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to Ryan Baker, Head of Investor Relations.

Sir, please go ahead.

Thank you, Operator. Good morning, everyone, and thank you for joining us to discuss CalVista Pharmaceuticals Fiscal Year 2026 First Quarter Financial Update and Operating Results. Please note we'll be making certain forward-looking statements today. We refer you to 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 Palako, Chief Executive Officer, Nicole Sweeney, Chief Commercial Officer, and Brian Picos, Chief Financial Officer. Dr. Paul Audia, our Chief Clinical Officer, will be joining us for the Q&A portion of the call. Ben will begin with a review of the company's progress during the three months into July 31st, 2025, including FDA approval of Ectorly and other regulatory updates. Nicole will then review the company's commercial progress to date, and Brian will cover the company's financial statements for the most recent quarter. We will then open the call for questions. With that, I will now turn the call over to Ben.

Thank you, Ryan, and welcome everyone to our first ever financial update conference call. It's been a momentous few months for Calavista, highlighted by our announcement on July 7th that the FDA approved Ecterly as the first and only oral on-demand therapy for acute HAE attacks in adults and pediatric patients aged 12 and older. This approval has positioned Ecterly to transform the treatment paradigm globally for people living with HAE. We initiated the U.S. launch immediately following approval and are pleased to report today our initial launch metrics. With Exily, for the first time, people living with HAE have an all-on-demand therapy they can take at the first signs of an attack, achieving symptom relief in the same timeframe as injectable therapies with a pristine safety profile. Ectoly breaks through the barriers imposed by injections, and we believe it is poised to become the foundational HAE treatment globally. It enables people with HAE to adhere to treatment guidelines, which recommend treating attacks early and considering treatment of all attacks, with the goal of achieving total disease control and normalizing lives. Since initiating our U.S. launch, The community response to Efterly has been overwhelmingly positive, and early uptake is even greater than our expectations. People living with HAE, physicians, and payers all have engaged rapidly, which speaks to the unmet need that Efterly addresses. In a few moments, I'll turn the call over to Nicole to discuss our commercial progress in more detail. but it will say that we are already seeing the results of the investments we made prior to approval in our commercial infrastructure, and we are executing in outstanding fashion on a successful launch. The fact that already almost 5% of the entire U.S. HAE population has submitted a prescription for Ectorally clearly speaks to all these elements, including the quality of the commercial team we have established. Beyond the U.S., We continue to make important regulatory progress in our efforts to bring equity to people living with HAE around the world. In Europe, Sebitralstat received a positive CHMP opinion in July for the treatment of acute HAE attacks, with a final European Commission decision expected in October. The Committee for Orphan Medicinal Products also confirmed maintenance of orphan designation, underscoring the significant unmet need that Sebitralstat addresses in the EU and granting it 10 years of market exclusivity upon approval. We anticipate a staged launch in Europe over the next 12 to 18 months, commencing with Germany, pending approval. Also in July, the UK MHRA granted marketing authorization of Ectorly, as well as adding it to the agency's orphan register. With regulatory approval secured, the process now moves to NICE for a health technology assessment to determine patient access and reimbursement. These discussions are essential to ensure broad availability. Based on the current timeline, we anticipate a UK commercial launch in the first half of 2026. We continue to progress towards anticipated approval in Japan at the end of this year. and launched through our commercial partner, Katten Pharmaceutical, in early 2026. Our Canadian partnership is also progressing towards a regulatory filing, and we are currently in discussions with multiple other potential partners worldwide. We believe this progress not only validates the universal need for Ectorally, but also lays the foundation for meaningful commercial growth and long-term value creation for our shareholders. With that, I'll now turn the call over to Nicole, who will share more detail on early launch progress and some of the performance indicators we will be building on in the quarters ahead. Nicole?

Thank you, Ben, and good morning, everyone. As Ben mentioned, our launch readiness activities have ensured that we were well positioned to deliver actually the first and only oral on-demand therapy to patients as quickly as possible. While we remain in early days of the launch, I am very pleased with the progress we have seen to date. We observed encouraging signs across several key performance indicators. From the patient perspective, interest in Ectorally has been strong and continues to grow. Just days after launch, we attended the HAEA Patient Advocacy Summit in Baltimore, where over 1,400 people living with HAE were present. It was an important opportunity to share information and introduce Ectorally to the community. Within the first few weeks of approval, an additional 500 community members joined our database seeking information and updates on Ectorally. Through the end of August, more than 4,000 individuals have joined our patient database. Additionally, we continue to host local and virtual education events to increase awareness of Ectorally among patients and family members. Following our announcement of the FDA's approval of Ecterly on July 7th, I'm excited to share that in the eight-week period ending August 29th, we received 460 patient start forms. Early demand has largely come from patients previously on Firzir and Icataban, as expected, but also from all other on-demand therapies. And we are seeing patients on all prophylactic therapies adopt Ecterly at similar rates. On the access front, we know that formal coverage policies typically take up to six months to be established. Even so, we are pleased to see some patients gain paid access, consistent with our expectations. The quick start program and medical exception processes are proceeding as planned, and we are confident in our ability to secure broad access over time. For prescribers, our field sales organization is focused on engaging the top 1,000 HAE treating physicians who account for roughly 90% of prescriptions written in the U.S. As expected, early prescriptions have come from KOLs who manage the highest number of HAE patients. Importantly, however, adoption has not been limited to the KOLs. we are observing strong interest in prescribing from a broad base of providers, even outside that top 1,000, which underscores the strength of our educational efforts and the clear unmet need Esterly is addressing. From launch through August 29th, we have activated 253 unique prescribers, with 38% of those starting multiple patients on Esterly. Over this same time period, our field sales team has reached over 72% of the total physician base, including 96% of the Tier 1 physicians. In addition to KPIs, our Telvisa Care Hub services are fully operational, helping patients navigate access and financial support. Early feedback from both patients and offices is very positive. Taken together, These early signals reinforce our confidence and X release potential to become the foundational therapy for people living with HAE. Looking at future quarters as our launch progresses, we expect the launch KPIs will evolve, and so we will adjust our reporting metrics accordingly. I will now turn the call over to Brian for a review of the company's financial statements for the most recent quarter. Brian?

Thanks, Nicole. Good morning. The press release we issued earlier today contains our full financial results, so I will provide a few highlights for the three-month period ended July 31st. We are pleased to announce the first sales of Ectorly, reporting $1.4 million in net revenue for the launch period, primarily from stocking orders by the specialty pharmacies and our commercial distribution network. Total operating expenses for the period were $60.4 million, consisting of approximately $15 million in R&D expenses and approximately $45 million in SG&A expenses. The quarter-over-quarter increase in SG&A was driven primarily by external spending related to the equity launch. Looking ahead to the remainder of 2025, we expect operating expenses to remain relatively consistent as we continue to invest in the equity launch. Turning to the balance sheet, we had approximately $191 million of cash and investments as of July 31, 2025. We expect that balance, together with forecast equity revenue, to fund the company's operations into 2027. Before turning it over to Ben for closing remarks, I'd like to remind everyone that, as previously announced in March, we are changing our fiscal year end to December 31st. As part of that transition, we will begin recording on a traditional calendar quarter basis this fall, starting with the quarter ending September 30th, which will capture the three-month period from July through September. Ben?

Thank you, Brian. As Nicole described, we are pleased with the strong response we are seeing in the early days of our U.S. commercial launch. The level of engagement from people living with HAE and physicians underscores both the unmet need in HAE and the transformational potential of Eckerle. The rapid adoption we are seeing reinforces our belief that Eckerle can redefine the standard of care for people living with HAE. We remain focused on executing our commercial strategy with discipline, driving global expansion, and continuing to deliver on our vision of bringing this meaningful, life-changing treatment to people worldwide. And with that, we will now open the call to your questions. Operator?

Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. And to withdraw your question, please press star 11 again. And the first question comes from Stacey Koo with BB Cohen. Your line is now open.

Good morning. Thanks so much for taking our questions, and congratulations on a wonderful early update. We had a few questions, mostly towards Nicole. Can you just further speak to the Quick Start program and just maybe help us and other investors understand the process on prior authorizations and medical exemptions? Maybe just talk through your expectations for timing to pay drug, and really how should we think about the translation of the really impressive patient start forms to eventually getting paid drug. So just help us understand that piece. And then on top of the Quick Start program, just maybe if you're willing to, on top of the details you've provided so far, just talk about the type of prescribing patterns you're seeing. Just help us understand are patients going to be able to have chronic use of Ecterly as needed? So that's kind of the first question on the quick start program and dynamics there. And then another is maybe another expectations on timing. We get a lot of questions from investors on that 4,000, let's say, patient and caregivers that have signed up for actual updates. So just give us a sense of how many are individual patients or caregivers. As a new treatment, would you expect most clinicians would want to see their patients in the office? And maybe what's the frequency of current patient visits? Just help us understand that cadence. as we think about the high patient demand and how you all have to work through that patient number. Thank you so much. Sure.

Thanks so much, Stacey, for the question. So, you know, we've been consistent that we look at the first six months, you know, pay to develop their policy. So, every of those months, access, may be done in the months four, five, and six, which is really why we started this program. And so in terms of Quick Start, the mechanics of it, if you will, the Quick Start program immediately provides access to Esterly at no charge. If the parent submits a Quick Start form, they submit the start form. And so when the SAR form comes in, it allows CalVista to work with the physician office to pursue a medical exception to gain paid. And so the patient has quick start again while we work with the office to gain paid access. Once the medical exception is approved, the patient's next shipment will be sent without by the government payer. If medical exception, that time period, you know, who is anticipating the patient's refill, then they contact CalVista, and the second expense should be provided by CalVista. So I think it is important that CalVista's team maintains the data that the medical physician is responsible for, so that we can ensure that the patient's next shift is being completed when they need it. And obviously, when they create a new physician, pay as quickly as possible.

So, and I think it's... I think you're coming in a little garbled, by the way. It's tough for me to, and I'm guessing others to hear.

Well, the next question is on the patterns, and the

Sure, absolutely. In terms of the patient database, we were encouraged to grow so quickly after approval, and that was the majority of patients, some of our caregivers as well. What's most interesting is that when we look at the geography, the cluster around the opposite our tier two physicians. So to us, that's very important. The representatives that are going in are connecting with the physicians that treat these patients, and a number of our in-person education programs for patients that have their programs so that we can engage in those same geographies. It's very much to engage with those patients at a local level and help them if from advanced to therapy. The third that you had is, I believe, on the visiting from a prescriber standpoint. And so physicians are approach in terms of some physicians requiring a visit using telehealth and some not requiring a visit in order to prescribe therapy.

Thank you. Did I address your question?

And our next question comes from Paul McTice with . Your line is open.

Hey there. Thank you so much for taking our questions. Really appreciate it. Um, a couple of questions from us. You talked about how the launch metrics may evolve. Um, as you move forward with this launch, just curious what your expectations are moving forward. And I guess later this year is, is it possible that we could be getting, you know, actual number of doses prescribed, for example, um, versus just start forms. Um, and also, um, And, again, this may have been answered, was a little bit difficult with the audio. But just curious, are you able to confirm just sort of what we've heard previously on the insurance process that, you know, patients first receive, you know, two doses initially and then also afterwards receive two doses of paid drug automatically if their insurance is approved? Just wanted to confirm that. And if so, you know, how does that inform, you know, your perspective on the launch kinetics moving forward this year. Thanks so much.

Sure. So, in terms of the script to address your first question, you know, we recognize that as we get into months four, five, and six later in the year, that certainly, you know, some of the KPIs will be evolving and, you know, more interest in repeat prescribers as well as refills and certainly talking more about utilization of the product or consumption of a product on a per patient basis. So, Certainly recognize that, and as the year unfolds, plan to share more in terms of a view into other KPIs. And then it may be helpful just to – I know there was an audio glitch, so it may be helpful just to kind of take a step back on Quick Start as well as paid. And so I think it's important to appreciate that when a prescriber – A physician writes a script for Ectorally. They write that start form, and they send it into the CalVista hub. In parallel, they do send in a request for Quick Start. And so how this works is that the Quick Start provides immediate access to treatment for Ectorally at no charge, and then our staff works with the physician office to pursue medical exception and gain paid access. While a patient is on Quick Start, once that medical exception is approved, The patient's next shipment will be sent without delay and paid by the commercial or the government payer, depending on who they have. If that exception requires more time, then we as a company will send a second shipment. And in terms of the other question I believe you asked, just in terms of script, yes, patients are typically receiving two boxes for their initial prescription, and then it's really the refill is very much dependent on how that physician writes the prescription. And so if the refill is written as needed, a patient may receive two boxes or they may receive more depending on their burden of disease. And so that is something that, again, it's up to the physician as to how they write. Typically they prescribe PRN for refills to allow patients flexibility to adjust the number of boxes in the future based on their burden of disease.

Thank you for the color.

And the next question will come from Tazeen Ahmed with Bank of America. Your line is open.

Hi, guys. Good morning, and congrats for me as well on a good start to the launch. I'm sorry if you already said this before, but maybe you can clarify. Have you broken down of the 460 start forms what percent? we're through a quick start, what percent are reimbursed and what percent may be coming from, you know, another source. I just want to get a sense of where you are in the early stages of reimbursement. And are we still going to be able to track these numbers quarter to quarter? And then the second question is, is it too early to know what the retreatment rates are? You're just still a few weeks into the launch, but Any kind of anecdotes you can share from feedback from your field supports would be helpful. Thank you.

Sure, absolutely. So when we share a START form number of 460, it is that 100% of those individuals also received Quick START. And so, again, as the programs are designed so that the forms come in together so patients have immediate access to therapy. We certainly were very encouraged and have been encouraged to see that we have started just a few weeks after approval actually paid shipments starting to go out to patients, where the medical exception process went through rather quickly. Certainly, that's something that we continue to watch, and it does grow week to week. And also, even more recently, seeing our first refills for on the paid side of things was also very encouraging. Because to us, that just signals not only positive signs from the payer side of things, but also that that individual is really continuing to utilize the product and adopt it as their primary on-demand therapy.

And with regard to treatment, I mean, we've certainly heard some anecdotal feedback from the field already. It's all been, I think, very positive. We haven't heard anything about any kind of second dosing. But, again, we continue to think that's not really an issue. The open label, we've talked about this publicly multiple times, the redose rate, you know, somewhere in the vicinity of below 22%, 23%, which is actually even below the fear of zero rate. So we don't think that represents any issues with anyone, whether it's patients or pairs. And, again, because it just absolutely falls. It's probably the lower end of what's seen in the world nowadays is

Okay. And the last question for me, any feedback on side effects observed thus far, any laryngeal effects or any kind of GI discomfort?

Thanks. Paul, no. Actually, we've been hearing overall consistency between what we observed in the open-label extension. And what we're seeing in terms of just any adverse event, of course, we should be pretty minimal. Typically, prescribers are getting used to the therapy. And so, it's not a couple of days. During the course of the launch, actually, over the open-label extension, we treated almost 1,000 abdominal impacts. And even in that setting, we're seeing extremely low GI adverse event rates. So, I think, really, this is a drug that's not associated with GI adverse events.

I really think the only anecdote we've heard so far has actually been favorable, which was we did have one person call our patient hub to let people know that they'd had a laryngeal attack and were very pleased with the outcome. They said it had worked quite well for them. So limited stories and talk to extrapolate, but everything so far has been favorable.

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

Hi, good morning. Congrats on the progress and the update today, and thanks for taking my question. I'll ask one about the 460 SAR forms as well. Just wondering if you can provide a July versus August breakdown, just in trying to get perspective into how much was from rollover from clinical studies or a bolus waiting for the launch and whether you think this early demand could suggest a linear trajectory. Yeah, hey, thanks, Warren.

Nice to hear from you. We chose to put out the August number because we had it, and, you know, I think there have been a lot of questions about whether how the trajectory is going to go. What I would say is, and we're quite pleased with this, this doesn't just simply represent a sort of a one-time bolus of rollover people or something. First of all, the open label extension, even though it's big for HAE, isn't super big. So the people coming off who could plausibly move on are, you know, measured in dozens, not hundreds. What this really represents is a, you know, sustained, you know, continually growing level of interest from people. And so, you know, demand certainly started off, I think, higher than we anticipated and has continued to go from there. So the curve has been up. you know, fairly linear growth from here with really no surges along the way that would represent to us this was any sort of one-time event. And this a little bit goes to the fact, and we talked about this a little bit in the comments, the fact that patient interest has been very broad, certainly, you know, even broader than we thought it would be. in terms of just people on prophylaxis as well as people with higher or lower attack rates. We've seen a really terrific breadth of prescriptions. And again, ever since the launch and even continuing now past August, we've continued to see the same trends.

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

That's probably a good question for Brian Picos.

In terms of inventory at the SPs, you know, like most of these launches, we expect long-term averages to hold four weeks of inventory. I think, you know, NetPro is part of the launch. You know, that can move around a bit, but we don't expect anything different.

But, oh, it has to connect to other rare disease launches, especially medicines.

Got it. Okay. Thanks for taking my questions. Thanks, Warren.

And the next question will come from Joseph Schwartz with Lyric. Your line is open.

Hey, guys. This is Will on for Joe today. So, one question for us, just wanted to drill down a bit more on the patient profile. So, could you share anything beyond what their prior therapy might have been? Are you seeing any meaningful patterns on attack rate severity, attack frequency, and what their typical attack rate might have been before initiating treatment? Thank you.

Sure. I'm glad to take that question. And, you know, heading into the launch, I think we had conducted a a great deal of market research that indicated those patients with more severe burden of disease, that those would be some of our earliest adopters. And certainly we see adoption across a wide array of patient types in terms of the burden of disease. But we have seen and are very pleased with the adoption with those high burden patients. And the profile certainly of the product was attractive to them. And we have certainly seen that population increase. be some of our earliest adopters. But we absolutely have seen adoption across the burden of disease base, if you will. And across all prophylaxis therapies. Yeah. Just something else, too, to add is that, you know, we've seen – we look at the current use of prophylaxis with our patients. We do see that the utilization really lines up with the market share in terms of use of prophy overalls. And then we actually see the brand share for prophylaxis lineup as well with the patient base we have launched to date. So, again, it's very encouraging to just see this used by a very broad population, whether it's based on burden of disease or previous on-demand or current prophylactic treatment.

Great. Thank you so much, guys.

And our next question will come from Sarah. Pete Severopoulos with Cancer Fitzgerald. Your line is open.

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

I guess I'll do the first one, Nicole, and you can do the second. So, Pete, in terms of the OLE rollover, I mean, it's important to note that the OLE, at least from a U.S. patient perspective, was, you know, several dozen patients, not several hundred patients, for example. and some of whom had already gone on to the early access program, and they finished, and some of whom were still actually continuing on their OLE for a while longer. So, there is no dramatic sort of burst of people that, you know, they would immediately switch on to commercial. I think, and that's why I was saying earlier, you know, our view is that these folks are coming on as part of this generalized demand uptake, and then the fact that their number is kind of subsumed by the larger demand we're seeing. So, you know, they're certainly out there, and I think we're comfortable they're moving over, but it's very hard for us to track just based upon the fact that, like you said, they're not in the immediate transition group. And over to you on the second one.

Yeah, so in terms of your second question, you know, certainly we see the earliest patient adopters, as I mentioned earlier, are, you know, when we've mapped them from a geography standpoint, you know, obviously cluster around our Tier 1 and Tier 2 physicians. which connects back to our marketing list. But also we had a tremendous opportunity with the AJEA Patient Summit. We announced our approval on Monday. We went to that summit on Friday. There were 1,400 members of the community there. So that was also a chance for us to engage with full family members. And so, you know, since that time, our education efforts have been very much driven to do local education programs, trying to invite family members to come out. certainly with the intent to, you know, provide more education and adoption for that individual, but also to help introduce actorly to the family. And so that's a thing that we've been doing since lunch at the in-person conference and the dinner program sense, and we'll carry that approach certainly into the fall, in addition to other, you know, non-personal marketing efforts, e-mails, and things like that.

Thank you for taking our questions.

Thanks, Pete.

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

Hi. Good morning. For a question regarding securing formulary coverage, maybe just give us an update on where you are and where you expect to be. And then our expectations that you'll still get parity versus other products in terms of step-throughs, prior odds, and quantity limits. And then just another quick one. I know it's on slide 14 of your update slide deck. You increased the size of the projected market growth by about 25%. Can you just talk about the assumptions behind that increased growth expectation? Thanks.

Sure, absolutely. You know, I think in terms of the access side of things, I would say at this point in time, things are certainly progressing, you know, how we would have anticipated, utilizing medical exception and that we would, you know, see access to paid happen on a more limited basis rather quickly, but certainly that that would grow over the time, any paid that. If we think about steady state from the access side of things, yes, we do still anticipate parity access to branded therapies in the market. And certainly going into launch, you were, you know, certainly aware that there may be some exceptions where a payer might choose to require a step-through generic catabant. There's been one instance that we've seen to date. But it's really important to note that even where that instance has come up, patients actually have appellate and are getting it paid. And the reason for that is because 80% of patients have either been on generic catabant or are on generic catabant, you know, pre-dissectorly. So even in that instance where we have faced that one step in a policy, the patients have been able to move forward and already have their actuarial in hand paid for. So certainly for us, we're continuing to advance our efforts. But again, at this point, we maintain the view that parity access to the other branded therapies will be expected.

And on the market number surge, first of all, kudos to you for reading the deck in detail before the call. Thank you for that. The second thing would be it's pretty straightforward. When we'd done those numbers, which was a while ago, we had obviously done it based on the market size, total market doses, which we've talked about a lot, and also a branded price, which was, you know, down closer to the standard fair zero pricing. as part of the update, we revised all that to reflect the fact that the branded prices in our expectation is meaningfully higher based upon our WAC and where the market sits nowadays. And so, it's just a fairly straightforward exercise to market back to an updated expectation on the pricing, and then you go a little bit from there. So, that's really what it reflects. Got it.

Thanks.

Yep. And the next question is going to come Devanjana Chatterjee with Jones. Your line is now open.

Hi. Thanks for taking my question, and congrats on the quarter. So as you mentioned about the generic step-through that might be required by certain insurers, what do you think these payers would like to see in terms of either safety or efficacy failure on ICAPI bands to approve accurately? And I have a quick follow-up.

Sure. Well, one, as I just mentioned, it's important that the vast majority of patients have experience on generic Acatabant, so they can move through that step rather quickly. So, for the minority, which would be 80% of patients, you know, the feedback that we hear from physicians is that actually describing fail or failure of Acatabant to a payer is quite simple, and it could come down to injection site reactions. It could also be, for instance, that someone has a history of abdominal attacks and administering a sub-Q in the abdomen is difficult and challenging. They could have difficulties with hand swelling, so therefore administering a sub-Q is really quite difficult. So, again, we see that being absolute minority cases where an individual would face it, but there is experience in the market with, again, those examples I gave you for overcoming and establishing that a patient has failed generic cat event and can quickly move on to to act early in this instance.

That's helpful. Thank you. And at some point, in terms of the KPI, will you be sharing percentage life cover?

I thought that as we continue through launch, we'll certainly share, you know, more progress in terms of our efforts from the payer side of things. The exact details in KPIs, I think that's probably to be determined at this point in time, but certainly we recognize there's interest in providing more clarity on our efforts to ensure that there's ongoing paid access and establishing those policies. So I would just say, stay tuned for further updates from the company, but certainly we appreciate that there's a need to do so. Thank you.

And our next question will come from John Wolbin with Crescent. Your line is open.

Hi, this is Catherine on for John. I have a quick question about the number of Crescent patients that account for the revenues reported in July. I noticed about $1.4 million reported. And also, when did ECTO-E become available in July? I think immediately post-approval. Thank you.

Brian can answer the second question with regard to revenues. ECTO-E was available roughly 10 days following approval. We had it in the first episode.

Yeah, and there's type of revenue. Sorry, go ahead.

Oh, and just to tie that up, but just to tie that to start forms, though, just to be clear, we were getting start forms actually the day of approval. Our first start form came in before lunchtime on the day of the announcement. So start forms did predate actual shipments by 10 days.

And just on the revenue recognition side, you know, we have fall 606, as every other pharmaceutical company does, you'll see that our customer base is the specialty pharmacies, so we recognize revenue when a product is received by the specialty pharmacies, and then there is lag from there when they go out and reach the patients.

Thank you so much.

I am showing no further questions at this time. This does conclude today's conference call, and thank you for your participation, and you may now disconnect.