Q1 2026 KalVista Pharmaceuticals Inc Earnings Call

Speaker #1: Ladies and gentlemen, thank you for standing by. Welcome to KalVista Pharmaceuticals' operational update and first fiscal quarter financial results. At this time, all participants are in a listen-only mode.

Benjamin Palleiko: Ladies and gentlemen, thank you for standing by. Welcome to KalVista Pharmaceuticals' operational update and first fiscal quarter financial results. 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 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.

Speaker #1: 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 *11 on your telephone; you will then hear an automated message advising that your hand is raised.

Speaker #1: To withdraw your question, please press *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.

Speaker #1: Sir, please go ahead.

Speaker #2: Thank you, Operator. Good morning, everyone, and thank you for joining us to discuss KalVista Pharmaceuticals' fiscal year 2026 first quarter financial update and operating results.

Ryan Baker: Thank you, operator. Good morning, everyone, and thank you for joining us to discuss KalVista 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 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 Benjamin Palleiko, Chief Executive Officer, Nicole Sweeney, Chief Commercial Officer, and Brian Pikos, Chief Financial Officer. Dr. Paul Audia, our Chief Medical 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 ending July 31, 2025, including FDA approval of ECTERLEEK and other regulatory updates.

Speaker #2: Please note we'll be making certain forward-looking statements today. We refer you to KalVista's SEC filings for a discussion of the risks that may cause actual results to differ from the forward-looking statements.

Speaker #2: On the call with me today from KalVista are Ben Pelicco, Chief Executive Officer; Nicole Sweeney, Chief Commercial Officer; and Brian Picos, Chief Financial Officer.

Speaker #2: Dr. Paul Audia, our Chief Medical 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 ending July 31, 2025, including FDA approval of Ectralee and other regulatory updates.

Speaker #2: 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.

Ryan Baker: 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.

Speaker #2: With that, I will now turn the call over to Ben.

Speaker #3: Thank you, Ryan. And welcome, everyone, to our first-ever financial update conference call. It's been a momentous few months for KalVista, highlighted by our announcement on July 7th that the FDA approved Ectralee as the first and only oral-on-demand therapy for acute HAE attacks in adults and pediatric patients aged 12 and older.

Benjamin Palleiko: Thank you, Ryan, and welcome everyone to our first-ever financial update conference call. It's been a momentous few months for KalVista Pharmaceuticals, highlighted by our announcement on July 7th that the FDA approved ECTERLEEK as the first and only oral on-demand therapy for acute hereditary angioedema attacks in adults and pediatric patients aged 12 and older. This approval has positioned ECTERLEEK to transform the treatment paradigm globally for people living with hereditary angioedema. We initiated the U.S. launch immediately following approval and are pleased to report today our initial launch metrics. With ECTERLEEK, for the first time, people living with hereditary angioedema have an oral 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.

Speaker #3: This approval has positioned Ectralee 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.

Speaker #3: With Ectralee, for the first time, people living with HAE have an oral-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.

Speaker #3: Ectralee 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.

Benjamin Palleiko: ECTERLEEK breaks through the barriers imposed by injections, and we believe it is poised to become the foundational hereditary angioedema treatment globally. It enables people with hereditary angioedema 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 ECTERLEEK has been overwhelmingly positive, and early uptake is even greater than our expectations. People living with hereditary angioedema, physicians, and payers all have engaged rapidly, which speaks to the unmet need that ECTERLEEK addresses.

Speaker #3: Since initiating our U.S. launch, the community's response to Ectralee has been overwhelmingly positive, and early uptake is even greater than our expectations. People living with HAE, physicians, and payers have all engaged rapidly, which speaks to the unmet need that Ectralee addresses.

Speaker #3: In a few moments, I will turn the call over to Nicole to discuss our commercial progress in more detail. However, I 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 an outstanding fashion on a successful launch.

Benjamin Palleiko: In a few moments, I'll turn the call over to Nicole to discuss our commercial progress in more detail, but I 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. hereditary angioedema population has submitted a prescription for ECTERLEEK 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 ECTERLEEK to people living with hereditary angioedema around the world. In Europe, Cevatrelostat received a positive CHMP opinion in July for the treatment of acute hereditary angioedema attacks, with a final European Commission decision expected in October.

Speaker #3: The fact that almost 5% of the entire U.S. HAE population has submitted a prescription for Ectrilee clearly speaks to all these elements, including the quality of the commercial team we have established.

Speaker #3: Beyond the U.S., we continue to make important regulatory progress in our efforts to bring Ectralee to people living with HAE around the world. In Europe, Sevitralstat received a positive CHMP opinion in July for the treatment of acute HAE attacks, with a final European Commission decision expected in October.

Speaker #3: The Committee for Orphan Medicinal Products also confirmed the maintenance of orphan designation, underscoring the significant unmet need that Sevitralstat addresses in the EU, and granting 10 years of market exclusivity upon approval.

Benjamin Palleiko: The Committee for Orphan Medicinal Products also confirmed maintenance of orphan designation, underscoring the significant unmet need that Cevatrelostat 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 ECTERLEEK, 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 launch through our commercial partner, Kaken Pharmaceutical, in early 2026.

Speaker #3: 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 Ectralee, as well as adding it to the agency's orphan register.

Speaker #3: 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.

Speaker #3: 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 launch through our commercial partner, Kakin Pharmaceutical, in early 2026.

Speaker #3: 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 Ectralee but also lays the foundation for meaningful commercial growth and long-term value creation for our shareholders.

Benjamin Palleiko: 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 ECTERLEEK 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?

Speaker #3: 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.

Speaker #3: Nicole?

Speaker #4: Thank you, Ben, and good morning, everyone. As Ben mentioned, our launch readiness activities have ensured that we are well-positioned to deliver Ectralee, the first and only oral-on-demand therapy, to patients as quickly as possible.

Nicole Sweeney: Thank you, Ben, and good morning, everyone. As Ben mentioned, our launch readiness activities have ensured that we were well positioned to deliver ECTERLEEK, 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 are observing encouraging signs across several key performance indicators. From the patient perspective, interest in ECTERLEEK 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 ECTERLEEK to the community. Within the first few weeks of approval, an additional 500 community members joined our database seeking information and updates on ECTERLEEK.

Speaker #4: While we remain in the early days of the launch, I am very pleased with the progress we have seen to date. We are observing encouraging signs across several key performance indicators.

Speaker #4: From the patient perspective, interest in Ectralee 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.

Speaker #4: It was an important opportunity to share information and introduce Ectralee to the community. Within the first few weeks of approval, an additional 500 community members joined our database seeking information and updates on Ectralee.

Speaker #4: 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 Ectralee among patients and family members.

Nicole Sweeney: 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 ECTERLEEK among patients and family members. Following our announcement of the FDA's approval of ECTERLEEK 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 Fioricet and Acadavant as expected, but also from all other on-demand therapies. We are seeing patients on all prophylactic therapies adopt ECTERLEEK 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.

Speaker #4: Following our announcement of the FDA's approval of Ectralee on July 7th, I'm excited to share that in the eight-week period ending August 29th, we received 460 patient start forms.

Speaker #4: Early demand has largely come from patients previously on Fearsier and Acadabant, as expected, but also from all other on-demand therapies. We are seeing patients on all prophylactic therapies adopt Ectralee at similar rates.

Speaker #4: 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.

Speaker #4: 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.

Nicole Sweeney: 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 ECTERLEEK is addressing. From launch through August 29, we have activated 253 unique prescribers, with 38% of those starting multiple patients on ECTERLEEK.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: 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 Ectralee is addressing.

Speaker #4: From launch through August 29th, we have activated 253 unique prescribers, with 38% of those starting multiple patients on Ectralee. Over the same time period, our field sales team has reached over 72% of the total physician base, including 96% of the tier one physicians.

Nicole Sweeney: Over the same time period, our field sales team has reached over 72% of the total physician base, including 96% of the tier one physicians. In addition to KPIs, our KalVista 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 in ECTERLEEK's 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 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?

Speaker #4: In addition to KPIs, our KalVista Care Hub services are fully operational, helping patients navigate access and financial support. Early feedback from both patients and offices is very positive.

Speaker #4: Taken together, these early signals reinforce our confidence in Ectralee's potential to become the foundational therapy for people living with HAE. Looking at future quarters as our launch progresses, we expect the launch KPIs to evolve, and so we will adjust our reporting metrics accordingly.

Speaker #4: I will now turn the call over to Brian for a review of the company's financial statements for the most recent quarter. Brian?

Speaker #2: Thanks, Nicole. Good morning. The press release we issued earlier today contains our full financial results, so I'll provide a few highlights for the three-month period ending July 31.

Brian Pikos: Thanks, Nicole. Good morning. The press release we issued earlier today contains our full financial results, so I'll provide a few highlights for the three-month period ending July 31, 2025. We are pleased to announce the first sales of ECTERLEEK, reporting $1.4 million in net revenue for the launch period, primarily from stocking orders by the specialty pharmacies in 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 ECTERLEEK launch. Looking ahead to the remainder of 2025, we expect operating expenses to remain relatively consistent as we continue to invest in the ECTERLEEK launch. Turning to the balance sheet, we had approximately $191 million of cash in investments as of July 31, 2025.

Speaker #2: We are pleased to announce the first sales of Ectralee, reporting $1.4 million in net revenue for the launch period, primarily from stocking orders by the specialty pharmacies in our commercial distribution network.

Speaker #2: 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 Ectralee launch.

Speaker #2: Looking ahead to the remainder of 2025, we expect operating expenses to remain relatively consistent as we continue to invest in the Ectralee launch. Turning to the balance sheet, we had approximately $191 million of cash and investments as of July 31, 2025.

Speaker #2: We expect that balance, together with forecasted Ectralee revenue, will 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 31.

Brian Pikos: We expect that balance, together with forecasted ECTERLEEK 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 31. As part of that transition, we will begin reporting on a traditional calendar quarter basis this fall, starting with the quarter ending September 30, which will capture the three-month period from July through September. Ben?

Speaker #2: As part of that transition, we will begin reporting on our traditional calendar quarter basis this fall. Starting with the quarter ending September 30th, which will capture the three-month period from July through September.

Speaker #2: Ben?

Speaker #3: 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.

Benjamin Palleiko: 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 ECTERLEEK. The rapid adoption we are seeing reinforces our belief that ECTERLEEK 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. We will now open the call to your questions. Operator?

Speaker #3: The level of engagement from people living with HAE and physicians underscores both the unmet need in HAE and the transformational potential of Ectralee. The rapid adoption we are seeing reinforces our belief that Ectralee can redefine the standard of care for people living with HAE.

Speaker #3: 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.

Speaker #3: And with that, we will now open the call to your questions. Operator?

Speaker #1: Thank you. As a reminder, to ask a question, please press *11 on your telephone and wait for your name to be announced. To withdraw your question, please press *11 again.

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. To withdraw your question, please press star 11 again. The first question comes from Stacy Koo with CV Co. Your line is now open.

Speaker #1: And the first question comes from Stacey, who would be going. Your line is now open.

Speaker #4: Well, 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 help us and other investors understand the process on prior authorizations and medical exemptions?

Stacy Koo: 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 maybe help us and other investors understand the process on prior authorizations and medical exemptions? Maybe just talk through your expectations for timing to paid drug and really how should we think about that translation of the really impressive patient start forms to eventually getting paid drugs. Just help us understand that piece. On top of the quick start program, 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. Help us understand, are patients going to be able to have chronic use of ECTERLEEK as needed? That's the first question on the quick start program and dynamics there.

Speaker #4: Maybe just talk through your expectations for timing to pay for drugs and really how should we think about that translation of the really impressive patient start forms to eventually getting paid for drugs.

Speaker #4: 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 to help us understand our patients going to be able to have chronic use of Ectralee as needed.

Speaker #4: So, that's kind of the first question on the quick start program and dynamics there. And then another is maybe another just expectations on timing.

Stacy Koo: Another is maybe just expectations on timing. We get a lot of questions from investors on that 4,000, let's say, patients and caregivers that have signed up for ECTERLEEK updates. 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? Maybe what's the frequency of current patient visits? 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.

Speaker #4: We get a lot of questions from investors about that $4,000, let's say, patients and caregivers that have signed up for Ectralee 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?

Speaker #4: 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.

Speaker #4: Thank you. Sure. Thanks so much, Stacey, for the question. So first off, to go back to that, you know, we've been consistent that we look at the first six months as continuing to develop their policies.

Nicole Sweeney: Sure. Thanks so much, Stacy, for the question. First off, to give a background, I guess from the access and maintenance, we've been consistent that we look at the first six months as patients typically develop their policies. If you're taking every of those months, access may be limited in months four, five, and six, which is really why we started this program. In terms of quick start, the mechanics of it, if you will, the quick start program immediately provides access to ECTERLEEK at no charge. The caregivers submit the quick start form. They submit the start form. When the start form comes in, it allows KalVista to work with the physician office to pursue a medical exception to gain paid access. The patient has quick start again while we work with the office to gain paid access.

Speaker #4: So, during each of those months, access may be limited, particularly in months four, five, and six. This is really why we started this program. In terms of a quick start, the mechanics of it, if you will, the quick start program immediately provides access to Ectralee at no charge.

Speaker #4: The parallel can submit the Quick Start form; they submit the Start form. And so when the Start form comes in, it allows KalVista to work with the physician's office to pursue a medical exception to gain patient access.

Speaker #4: So, the patient has a 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 the government payer.

Nicole Sweeney: Once the medical exception is approved, the patient's next shipment will be sent without by both the provider or the government payer. If medical exception that time period wasn't anticipated, the patient refill, then they contact KalVista. The second shipment should be provided by KalVista. I think it's important that this team maintains the status of that medical exception approval so that we can ensure that the patients that shipment is being submitted and obviously when they're paid quickly as possible. I think just to.

Speaker #4: If a medical exception that time period, you know, goes unanticipated, the patient refill, then they contact KalVista, and a second quick start shipment is provided by KalVista.

Speaker #4: So I think it's important that the KalVista team maintains a view that the data from the medical exception approval ensures that the patient's next shipment is paid.

Speaker #4: And obviously, when they're in access, physicians get paid as quickly as possible. So, was there anything coming in a little garbled, by the way?

Stacy Koo: Was there another? 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.

Speaker #4: It's tough for me to, and I'm guessing others to hear.

Speaker #2: Well, the next question was on the patterns and the timing.

Serge Bellinger: Yeah.

Speaker 9: I'll go ahead and skip over the beginning. The next question was on the patterns and the timing.

Speaker #4: Sure, absolutely. In terms of the patient database, we've been encouraged to grow so quickly after approval. It was the majority of patients, with some members and caregivers as well.

Nicole Sweeney: Sure. Absolutely. In terms of the patient database, we were very encouraged to grow so quickly after approval. It was a majority patients, some member caregivers as well. What's most interesting is that when we look at the demography, the clustered group around the office are onboarding in our tier two physicians. To us, that's very interesting. The representatives that are going in are connecting with the physicians that treat these patients. A number of our in-person education programs for patients have their pet programs so that we can engage in person and in those same geographies. It's going to be much to engage with those patients at a local level and help them advance to therapy. The third point that you had is, I believe, on the visiting for a prescriber standpoint.

Speaker #4: What's most interesting is that when we look at the clustering around the office, one of our tier two physicians stands out. So to us, that's very interesting.

Speaker #4: 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. This program is designed so that we can engage in a plan in those same geographies.

Speaker #4: It's going to be much to engage with those patients at a local level and help them from the market advance to therapy. The third point that you had is, I believe, on the visiting for prescriber standpoint.

Speaker #4: And so what we have heard is that physicians have a fixed approach in terms of some physicians requiring a visit, using telehealth, and some not requiring a visit in order to prescribe therapy.

Nicole Sweeney: What we observed is that physicians are approached in terms of some physicians requiring a visit using telehealth and some not requiring a visit in order to prescribe therapy. Stacy, did I address your question?

Speaker #4: Stacey, did I address your question?

Speaker #1: And our next question comes from Paul Matthias with Steeple. Your line is open.

Operator: Our next question comes from Paul Matthys with State Fool. Your line is open.

Speaker #3: Hey there. Thank you so much for taking our questions; we really appreciate it. A couple of questions from us. You talked about how the launch metrics may evolve.

Ryan Baker: Hey there. Thank you so much for taking our questions. Really appreciate it. A couple of questions from us. You talked about how the launch metrics may evolve as you move forward with this launch. Just curious what your expectations are moving forward. Later this year, is it possible that we could be getting an actual number of doses prescribed, for example, versus just start forms? Also, this may have been answered, it 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 patients first receive two doses initially and then also afterwards receive two doses of paid drug automatically if their insurance is approved? Just wanted to confirm that. If so, how does that inform your perspective on the launch kinetics moving forward this year? Thanks so much.

Speaker #3: As you move forward with this launch, I'm just curious what your expectations are moving forward. Is it possible that later this year we could be getting, you know, actual numbers of doses prescribed, for example, versus just star forms?

Speaker #3: And also, and again, this may have been answered. It was a little bit difficult with the audio, but I'm just curious—are you able to confirm sort of what we've heard previously on the insurance process? That, you know, patients first receive two doses initially and then, afterwards, receive two doses of the paid drug automatically if their insurance is approved?

Speaker #3: Just wanted to confirm that. And if so, you know, how does that inform your perspective on the launch kinetics moving forward this year?

Speaker #3: Thanks so much.

Speaker #4: Sure. So in terms of the scripts to address reverse 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.

Nicole Sweeney: Sure. In terms of the script to address your first question, we recognize that as we get into months four, five, and six later in the year, certainly some of the KPIs will be evolving and more interest in repeat prescribers as well as refills and talking more about utilization of the product or consumption of a product on a per-patient basis. We certainly recognize that. As the year unfolds, we plan to share more in terms of a view into other KPIs. It may be helpful, I know there was an audio glitch, so it may be helpful to take a step back on quick start as well as paid. I think it's important to appreciate that when a prescriber, a physician, writes a script for ECTERLEEK, they write that start form and send it into the KalVista Care Hub.

Speaker #4: And, you know, there's more interest in repeat prescribers as well as refills. We're certainly talking more about the utilization of the product or consumption of the product on a per-patient basis.

Speaker #4: 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.

Speaker #4: As well as paid. And so, I think it's important to appreciate that when a prescriber, a physician, writes a script for Ectralee, they write that start form and they send it into the KalVista hub.

Speaker #4: In parallel, they do send in a request for a quick start. And how this works is that the quick start provides immediate access to treatment for Ectratee at no charge.

Nicole Sweeney: In parallel, they send in a request for quick start. How this works is that the quick start provides immediate access to treatment for ECTERLEEK at no charge. 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, we as a company will send a second shipment. 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. The refill is very much dependent on how that physician writes the prescription.

Speaker #4: And then our staff works with the physician's office to pursue a 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 for by the commercial or the government payer, depending on who they have.

Speaker #4: 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.

Speaker #4: And then, the refill is very much dependent on how that physician writes the prescription. If the refill is written as needed, a patient may receive two boxes, or they may receive more, depending on their burden of disease.

Nicole Sweeney: If the refill is written as needed, a patient may receive two boxes or they may receive more depending on their burden of disease. 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.

Speaker #4: And so that is something that, again, it's up to the physician as to how they write. Typically, they prescribe p.r.n. for refills to allow patients flexibility to adjust the number of boxes in the future based on their burden of disease.

Speaker #3: Thank you for the color.

Ryan Baker: Thank you for the color.

Speaker #1: And the next question will come from Taseen Ahmed with Bank of America. Your line is open.

Operator: The next question will come from Tizine Ahmed with Bank of America. Your line is open.

Speaker #5: Hi, guys. Good morning. And congrats to me as well on a good start to the launch. I'm sorry if you already said this before, but maybe you can clarify.

Tizine Ahmed: Hi guys. Good morning and congrats from me as well and 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 % were through a quick start, what % are reimbursed, and what % 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. Are we still going to be able to track these numbers quarter to quarter? The second question is, is it too early to know what the re-treatment rates are? You're just still a few weeks into the launch, but any kind of anecdote you can share from feedback from your sales board would be helpful. Thank you.

Speaker #5: Have you broken down the 460 start forms? What percent were through a quick start, what percent are reimbursed, and what percent may be coming from, you know, another source?

Speaker #5: I just want to get a sense of where you are in the early stages of reimbursement. Are we still going to be able to track these numbers quarter to quarter?

Speaker #5: And then the second question is, is it too early to know what the retreatment rates are? You're just, it's still a few weeks into the launch, but any kind of anecdotes you can share from feedback from your sales force would be helpful.

Speaker #5: Thank you.

Speaker #4: Sure, absolutely. So, when we start from a number of 460, it is that 100% of those individuals also received Quick Start. And so, again, as the programs are designed, the forms come in together, so patients have immediate access to therapy.

Nicole Sweeney: Sure. Absolutely. When we share a start form number of 460, it is that 100% of those individuals also received quick start. As the programs are designed so that the forms come in together, 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. That is something that we continue to watch and it does grow week to week. 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 sign 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.

Speaker #4: 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.

Speaker #4: The medical exception process went through rather quickly. Certainly, that's something we continue to watch, and it does grow week to week. More recently, we have also seen our first refills for the paid side of things, which was very encouraging.

Speaker #4: 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.

Speaker #3: And with regard to retreatment, Taseen, I mean, we've certainly heard some anecdotal feedback from the field already. It's all been, I think, very positive.

Ryan Baker: With regard to re-treatment, Tizine, we've certainly heard some anecdotal feedback from the field already. It's all been, I think, very positive. We haven't really heard anything about any kind of second dosing. We continue to think that's not really an issue. The open label, we've talked about this probably multiple times, the re-dose rate, you know, somewhere in the vicinity of the low 20s, 22, 23%, which is actually even below the zero rate. We don't think that represents any issues with anyone, whether it's patients or payers. It just absolutely falls at the lower end of what's seen in the world nowadays.

Speaker #3: We haven't really 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.

Speaker #3: The re-dose rate is somewhere in the vicinity of the low 20s, around 22% to 23%, which is actually even below the fair zero rate. Therefore, we don't think that represents any issues for anyone, whether it's patients or payers.

Speaker #3: And again, because it just absolutely falls between the lower end of what's seen in the world nowadays.

Speaker #4: Okay. And then, last question for me. Any feedback on side effects observed thus far? Any laryngeal attacks or any kind of GI discomfort? Thanks.

Tizine Ahmed: Okay. Last question for me. Any feedback on side effects observed thus far? Any laryngeal attacks or any kind of GI discomfort? Thanks.

Speaker #2: This is Paul. I do. 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 reports, which have been pretty minimal.

Ryan Baker: 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 reports, which have been pretty minimal. Typically, in the first six months of a launch, that's the period in which it's most intense when the prescribers are getting used to the therapy. There's nothing that's come forward to date. Certainly, in terms of GI-related adverse events, we haven't heard about any during the course of the launch. Actually, over the open label extension, we've seen almost 1,000 abdominal attacks. Even in that setting, we're seeing extremely low GI adverse event rates. I think really this is a drug that's not associated with GI adverse events.

Speaker #2: Typically, in the first six months of a launch, that's the period in which it's most intense when the prescribers are getting used to the therapy.

Speaker #2: And so, there's nothing that has come forward to date. Certainly, in terms of GI-related adverse events, we haven't heard about any during the course of the launch.

Speaker #2: And actually, over the open-label extension, we treated almost a thousand abdominal attacks. And even in that setting, we're seeing extremely low GI adverse event rates.

Speaker #2: So, I think, really, this is a drug that's not associated with GI adverse events.

Speaker #3: I really think the only anecdote we've heard so far has actually been favorable, which was that 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.

Ryan Baker: 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'd said it had worked quite well for them. Limited stories and tough to extrapolate, but everything so far has been favorable.

Speaker #3: They'd said it had worked quite well for them. So, limited stories and talk to extrapolate, but everything so far has been favorable.

Speaker #1: And the next question is going to come from Maury Raycroft with Jeffrey. Your line is open.

Operator: The next question is going to come from Maury Raycroft with Jefferies. Your line is open.

Speaker #2: Hi, good morning. Congrats on the progress and the update today, and thanks for taking my question. I'll ask one about the 460 start forms as well.

Ryan Baker: Hi, good morning. Congrats on the progress and the update today, and thanks for taking my question. I'll ask one about the 460 start 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, Maury. 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 how the trajectory is going to go. What I would say is, and we were quite pleased with this, this doesn't just simply represent a sort of a one-time bolus of rollover people or something.

Speaker #2: Just wondering if you can provide a July versus August breakdown. I'm just 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.

Speaker #3: Yeah, hey, thanks, Maury. Nice to hear from you. We chose to put out the August number because we had it. You know, I think there have been a lot of questions about how the trajectory is going to go.

Speaker #3: What I would say is, and we were quite pleased with this, this doesn't just simply represent a sort of a one-time bolus of rollover people or something.

Speaker #3: You know, 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.

Ryan Baker: First of all, the open label extension, even though it's big for HAE, isn't super big. The people coming off who could plausibly move on are measured in dozens, not hundreds. What this really represents is a sustained, continually growing level of interest from people. Demand certainly started off, I think, higher than we anticipated, and it's continued to go from there. The curve has been a 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. It 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 even broader than we thought it would be in terms of just people on prophylaxis as well as people with high or low attack rates. We've seen a really terrific breadth of prescriptions.

Speaker #3: What this really represents, and is a, you know, sustained continually growing level of interest from people. And so demand certainly started off, I think, higher than we anticipated, and it's continued to go from there.

Speaker #3: So the curve has been 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.

Speaker #3: We've been very, and as the 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.

Speaker #3: Certainly, you know, even broader than we thought it would be. In terms of just people on prophylaxis, as well as people with high or low attack rates, we've seen a really terrific breadth of prescriptions.

Speaker #3: And again, through ever since the launch and even continuing now past August, we've continued to see the same trends.

Ryan Baker: Again, through ever since the launch and even continuing now past August, we've continued to see the same trends. Got it. That's helpful. 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 Pikos.

Speaker #2: Got it. That's helpful. And maybe just going forward, as we focus more on revenue numbers, how should we think about stockpiling as a dynamic there?

Speaker #3: That's probably a good question for Brian Picos.

Speaker #2: In terms of inventory at the SPs, you know, like most rare disease launches, we expect long-term averages to hold two to four weeks of inventory.

Brian Pikos: In terms of inventory at the SPs, like most rare disease launches, we expect long-term averages for SPs to hold two to four weeks of inventory. In the early part of the launch, that can move around a bit, but we don't expect anything different as compared to other rare disease launches, especially medicines.

Speaker #2: I think, you know, in the early part of the launch, that can move around a bit. But we don't expect anything different as compared to other rare disease launches, especially medicines.

Speaker #3: Got it. Okay, thanks for taking my questions. Thanks, Maury.

Ryan Baker: Got it. Okay, thanks for taking my questions.

Brian Pikos: Thanks, Maury.

Speaker #1: And the next question will come from Joseph Schwartz with Lyrinc. Your line is open.

Operator: The next question will come from Joseph Schwartz with Leerink. Your line is open.

Speaker #5: Hey, guys. This is Willan for Joe today. Congrats on the great quarter and strong start to the launch. So, one question for us: I just want to drill down a bit more on the patient profile.

Ryan Baker: Hey guys, this is Will on for Joe today. Congrats on the great quarter and strong start to the launch. One question for us, just want to drill down a bit more on the patient profile. 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.

Speaker #5: So could you share anything beyond what their prior therapy might have been? And are you seeing any meaningful patterns on attack rate severity, attack frequency, and what their typical attack rate might have been before initiating treatment?

Speaker #5: Thank you.

Speaker #4: Sure, I'm glad to take that question. And you know, heading into the launch, I think we had conducted 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 I would say array of patient types in terms of the burden of disease.

Nicole Sweeney: Sure. I'm glad to take that question. Heading into the launch, I think we had conducted a great deal of market research that indicated those patients with more severe burden of disease would be some of our earliest adopters. We see adoption across a wide array of patient types in terms of the burden of disease. We have seen, and are very pleased with, the adoption with those high-burden patients. The profile of the product was attractive to them. We have seen that population be some of our earliest adopters. We absolutely have seen adoption across the burden of disease base, if you will.

Speaker #4: But we have seen in a very pleased with the adoption with those high burden patients. And the profile certainly of the product was attractive to them.

Speaker #4: And we have certainly seen that population be some of our earliest adopters. But we absolutely have seen adoption across the burden of disease base, if you will.

Speaker #3: And across all prophylaxis therapies.

Ryan Baker: Across all prophylactic therapies.

Speaker #4: Yeah, just something else to add is that, you know, we've seen, when 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 overall.

Nicole Sweeney: Yeah. Just something else to add is that, you know, we've seen, when 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 prophylaxis overall. We actually see the brand share for prophylaxis line up as well with the patient base we have launched to date. It is very encouraging to just see this use by a very broad population, whether it's based on burden of disease or previous on-demand or current prophylactic treatment.

Speaker #4: And then we actually see the brand share for prophylaxis line up as well with the patient base we have launched to date. So again, it's very encouraging to just see this use by a very broad population, whether it's based on burden of disease or previous on-demand or current prophylactic treatment.

Speaker #5: Great. Thank you so much, guys.

Ryan Baker: Great. Thank you so much, guys.

Speaker #1: And our next question will come from Pete Severopulos with Cantor Fitzgerald. Your line is open.

Operator: Our next question will come from Pete Stavropoulos with Cantor Fitzgerald. Your line is open.

Speaker #6: Yeah, hi, Ben and team. Congratulations on the quarter. Can you just remind us how many patients are in the OLE or actually U.S.-based? You know, I know you said somewhere in the dozens.

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

Speaker #6: And you know, what is the expected cadence or timeline to shift the majority of these patients to 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 of Ectralee's profile?

Speaker #6: And do you have a sense of the proportion of patients from the 460 start forms that were directed from these efforts?

Speaker #3: I guess I'll do the first one, Nicole, and you can do the second. The so Pete, in terms of the OLE rollover, right, I mean, it's important to note that the OLE lead from a US patient perspective was, you know, several dozen patients, not several hundred patients, for example.

Benjamin Palleiko: I could tell you the first one, Nicole, and you can do the second. So Pete, in terms of the OLE rollover, it's important to note that the OLE, at least from a U.S. patient perspective, was several dozen patients, not several hundred patients, for example. Some of whom had already gone on to the early access program and they finished, and some of whom are still actually continuing on the OLE for a while longer. There is no dramatic sort of burst of people that would immediately switch on to commercial. I think that's why I was saying earlier, our view is that these folks are coming on as part of this generalized demand uptake. Effectively, their numbers are kind of subsumed by the larger demand we're seeing. They're certainly out there, and I think we're comfortable they're moving over.

Speaker #3: And some of whom had already gone on to the early access program, and they finished, and some of whom are still actually continuing on the OLE for a while longer.

Speaker #3: So there is no, there is no dramatic sort of burst of people that, you know, that 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 effectively their numbers are kind of subsumed by the larger demand we're seeing.

Speaker #3: 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 I said, they're not an enormous immediate transition group.

Benjamin Palleiko: It's very hard for us to track just based upon the fact that, like I said, they're not an enormous immediate transition group. Over to you on the second one.

Speaker #2: And over to you on the second one.

Speaker #4: 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 clustered around our tier one and tier two physicians.

Nicole Sweeney: Yeah. In terms of your second question, certainly we see the earliest patient adopters, as I mentioned earlier, are, when we've mapped them from a geography standpoint, obviously clustered around our tier one and tier two physicians, which connects back to our marketing list. We had a tremendous opportunity with the HAEA Patient Summit. We announced our approval on Monday. We went to that summit on Friday. There were 1,400 members of the community there. That was also a chance for us to engage with full family members. 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 provide more education and adoption for that individual, but also to help introduce ECTERLEEK to the family.

Speaker #4: Which connects back to our marketing list. We also had a tremendous opportunity with the HAEA Patient Summit, where we announced our approval on Monday.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: Certainly, with the intent to, you know, provide more education and adoption for that individual, but also to help introduce Ectralee to the family. And so that's certainly something that we've been doing since launch at the in-person conference and the dinner program sense, and we will carry that approach certainly into the fall.

Nicole Sweeney: That's certainly something that we've been doing since launch at the in-person conference and the dinner program sense. We'll carry that approach certainly into the fall, in addition to other non-personal marketing efforts, emails, and things like that.

Speaker #4: In addition to other non-personal marketing efforts, emails, and things like that.

Speaker #6: Thank you very much for taking one of our questions.

Ryan Baker: Thank you very much for taking our questions.

Speaker #3: Thanks, Pete.

Benjamin Palleiko: Thanks, Pete.

Speaker #1: And the next question will come from Serge Bellinger with Needham. Your line is open.

Operator: The next question will come from Serge Bellinger with Needham. Your line is open.

Speaker #7: Hi, good morning. First 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 be at parity versus other products in terms of step-throughs, prior auths, and quantity limits.

Serge Bellinger: Hi, good morning. First question regarding securing formulary coverage. Maybe just give us an update on where you are and where you expect to be. Our expectations are that you'll still be at parity versus other products in terms of step-throughs, prior auths, and quantity limits. I noticed on slide 14 of your updated slide deck, you increased the size of the projected market growth by about 25%. Maybe just talk about the assumptions behind that increased growth expectation. Thanks.

Speaker #7: And then just another quick one, I noticed on slide 14 of your updated slide deck, you increased the size of the projected market growth by about 25%.

Speaker #7: And you just talked about the assumptions behind that increased growth expectation. Thanks.

Speaker #4: 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.

Nicole Sweeney: Sure. Absolutely. I think in terms of the access side of things, I would say at this point in time, things are certainly progressing how we anticipated, utilizing medical exception and that we would see access to paid happen on a more limited basis rather quickly. That would grow over time, and we certainly anticipate 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. Certainly going into launch, we were aware that there may be some exceptions where a payer might choose to require a step-through generic Acadavant. There's been one instance that we've seen to date. It's really important to note that even where that instance has come up, patients actually have ECTERLEEK and are getting it paid.

Speaker #4: You know how we anticipated utilizing a medical exception and that we would see access to paid happen on a more limited basis rather quickly.

Speaker #4: But certainly that that would grow over the time. And we certainly anticipate 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.

Speaker #4: And certainly going into launch, we were certainly aware that there may be some exceptions where a payer might choose to require step-through generic acadabant; there's been one instance that we've seen to date.

Speaker #4: But it's really important to note that even where that instance has come up, patients actually have Ectralee and are getting it paid. The reason for that is because 80% of patients have either been on generic acadabant or are on generic acadabant, you know, previous to Ectralee.

Nicole Sweeney: The reason for that is because 80% of patients have either been on generic Acadavant or are on generic Acadavant previous to ECTERLEEK. 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 ECTERLEEK in hand paid for. For us, we're continuing to advance our efforts. At this point, we maintain the view that parity access to the other branded therapies will be expected.

Speaker #4: 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 Ectralee in hand paid for.

Speaker #4: 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.

Speaker #3: And on the market number, Serge, you know, first of all, kudos to you for reading the deck in detail before the call. Thank you for that.

Ryan Baker: On the market numbers, Serge, 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 an estimate of the market size, total market doses, which we've talked about a lot, and also a branded price, which was down closer to the standard fair zero price. As part of the update, we revised all that to reflect the fact that the branded price in our expectation is meaningfully higher based upon our WAC and where the market sits nowadays. It's just a fairly straightforward exercise to market back to an updated expectation on the pricing, and then you grow it a little bit from there. That's really what it reflects.

Speaker #3: And the second thing would be, it's pretty straightforward. When we've done those numbers, which was a while ago, we had obviously done it based on an estimate of the market size, total market doses, which we've talked about a lot, and also a branded price, which was down closer to the standard Fera zero price.

Speaker #3: As part of the update, we revised all that to reflect the fact that the branded price is now our expectation, which is meaningfully higher based upon our WAC and where the market sits nowadays.

Speaker #3: And so it's just a fairly straightforward exercise to market back to an updated expectation on the pricing. And then you grow it a little bit from there.

Speaker #3: So that's really what it reflects.

Speaker #2: Got it. Thanks.

Serge Bellinger: Got it. Thanks.

Speaker #3: Yep.

Ryan Baker: Yep.

Speaker #1: And the next question is going to come from Devanjana Chatterjee. With Jones, your line is now open.

Operator: The next question is going to come from Devanjana Chatterjee with Jones. Your line is now open.

Speaker #8: 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 acadabant to approve Ectralee?

Tizine Ahmed: Hi. Thanks for taking my question and congrats on the quarter. 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 branded therapies to approve ECTERLEEK? I have a quick follow-up.

Speaker #8: And I have a quick follow-up.

Speaker #4: Sure. Well, one, as I just mentioned, it's important that the vast majority of patients have experience on generic acadabant, so they can move through that step rather quickly.

Nicole Sweeney: Sure. As I just mentioned, it's important that the vast majority of patients have experience on generic Acadavant so they can move through that step rather quickly. For that minority, which would be 20% of patients, the feedback that we hear from physicians is that actually describing a fail or a failure of Acadavant to a payer is quite simple. 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 subcutaneous in the abdomen is difficult and challenging. They could have difficulties with hand swelling, therefore administering a subcutaneous is really quite difficult. Again, we see that being an absolute minority of cases where an individual would face it.

Speaker #4: So for them, minority, which would be 20% of patients, you know, the feedback that we hear from physicians is that actually describing a fail or a failure of acadabant to a payer is quite simple.

Speaker #4: 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 subcutaneous injection in the abdomen is difficult and challenging.

Speaker #4: They could have difficulty with hand swelling; therefore, administering a subcutaneous injection is quite difficult. So again, we see that this is an absolute minority of cases where an individual would face it. However, there is experience in the market with, again, those examples I gave you for overcoming and establishing that a patient has failed generic acadabant and can quickly move on to Ectralee in this instance.

Nicole Sweeney: There is experience in the market with those examples I gave you for overcoming and establishing that a patient has failed generic Acadavant and can quickly move on to ECTERLEEK in this instance.

Speaker #8: That's helpful. Thank you. At some point, in terms of the KPI, will we be sharing the percentage of life covered?

Tizine Ahmed: That's helpful. Thank you. At some point, in terms of the KPIs, will you be sharing % life covered?

Speaker #4: I think that's something that, as we continue through launch, we'll certainly share more progress in terms of our efforts from the payer side of things.

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

Speaker #4: The exact details and 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.

Speaker #4: 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.

Speaker #8: Thank you.

Tizine Ahmed: Thank you.

Speaker #1: And our next question will come from John Wolbin with Citizens. Your line is open.

Operator: Our next question will come from John Woben with Citizens. Your line is open.

Speaker #9: Hi, this is Katherine on for John. I have a quick question about the number of scripts and patients that essentially account for the revenues report in July.

Nicole Sweeney: Hi, this is Catherine on for John. I have a quick question about the number of scripts and patients that essentially account for the revenues reported in July. I noticed about $1.4 million reported. Also, when did ECTERLEEK become available in July? Was it immediately post-approval? Thank you.

Speaker #9: I know there are about 1.4 million reported cases. Also, when does Ectralee become available in July? Was it immediately post-approval? Thank you.

Speaker #3: Brian can answer the second question regarding revenues. Ectralee was available roughly 10 days following approval. We had it on the first day.

Benjamin Palleiko: Brian can answer the second question with regard to revenues. ECTERLEEK was available roughly 10 days following approval. We had the first shipment.

Speaker #3: Sorry.

Speaker #2: Yeah, and in a second. I'm sorry, go ahead.

Ryan Baker: Yeah, in respect to revenues, we were getting—I'm sorry, go ahead.

Speaker #3: Oh, and just to tie that out though, 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 we announced it.

Benjamin Palleiko: Just to tie that to start forms, 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 we announced it. Start forms did predate actual shipments by 10 days.

Speaker #3: So start forms did predate actual shipments by 10 days.

Speaker #2: And just on the revenue recognition side, you know, we have ASC 606, as every other pharmaceutical company does. You'll see that our customer base is especially pharmacy.

Ryan Baker: On the revenue recognition side, we have a follow-up 606 that every other pharmaceutical company does. You'll see that our customer base is specialty pharmacies. We recognize revenue when a product is received by the specialty pharmacies, and then there is a lag from there when they go out and reach the patients.

Speaker #2: We recognize revenue when the product is received by the specialty pharmacies. There is then a lag before they go out and reach the patients.

Speaker #9: Thank you so much.

Tizine Ahmed: Thank you so much.

Operator: I am showing no further questions at this time. This does conclude today's conference call. Thank you for your participation. You may now disconnect.