Q4 2025 KalVista Pharmaceuticals Inc Earnings Call

March 25, 2026

Speaker #1: Good morning, and welcome to KalVista Pharmaceuticals' eight-month fiscal year 2025 financial results and corporate update conference call. All participants are in listen-only mode. Following prepared remarks, we will open the call for questions.

Operator: Good morning, and welcome to KalVista Pharmaceuticals's 8-Month Fiscal Year 2025 Financial Results and Corporate Update Conference Call. All participants are in listen-only mode. Following prepared remarks, we will open the call for questions. I would now like to turn the call over to Ryan Baker, Head of Investor Relations, for introductory comments.

Speaker #1: I would now like to turn the call over to Ryan Baker, Head of Investor Relations, for introductory comments.

Speaker #2: Thank you, Operator, and good morning. As previously announced, the company changed its fiscal year from ending April 30 of each year to ending December 31 of each year.

Ryan Baker: Thank you, operator, and good morning. As previously announced, the company changed its fiscal year from ending 30 April of each year to ending 31 December of each year. There was an eight-month transition period from 1 May 2025 to 31 December 2025. With that in mind, earlier today, KalVista issued a press release reporting financial results for the eight months ended 31 December 2025, and provided a corporate update. A copy of the release is available on the investors section of our website. Before we begin, I'd like to remind listeners that today's discussion will include forward-looking statements. These statements are subject to risks and uncertainties that may cause actual results to differ materially. Please refer to our SEC filings for discussion of these risks. KalVista undertakes no obligation to update forward-looking statements except as required by law.

Speaker #2: There was an eight-month transition period from May 1st, 2025, to December 31st, 2025. With that in mind, earlier today, KalVista issued a press release reporting financial results for the eight months ended December 31st, 2025, and provided a corporate update.

Speaker #2: A copy of the release is available on the Investor section of our website. Before we begin, I'd like to remind listeners that today's discussion will include forward-looking statements.

Speaker #2: These statements are subject to risks and uncertainties that may cause actual results to differ materially. Please refer to our SEC filings for discussion of these risks.

Speaker #2: KalVista undertakes no obligation to update forward-looking statements except as required by law. I will now turn the call over to our Chief Executive Officer, Ben Palleiko.

Ryan Baker: I will now turn the call over to our Chief Executive Officer, Benjamin Palleiko.

Ryan Baker: I will now turn the call over to our Chief Executive Officer, Ben Palleiko.

Speaker #3: Good morning, and thank you for joining us. 2025 was a pivotal year for KalVista, highlighted by the successful multinational launch of Ectorly, the first and only oral, on-demand treatment for hereditary angioedema.

Benjamin Palleiko: Good morning, and thank you for joining us. 2025 was a pivotal year for KalVista, highlighted by the successful multinational launch of EKTERLY, the first and only oral on-demand treatment for hereditary angioedema. Since launching in the US last July, we've seen high rates of early adoption, increasing physician engagement, and positive patient feedback. Together, these signals reinforce our belief that EKTERLY has the potential to transform the treatment of HAE. As we build on this foundation, we remain focused on launch execution in the US and Germany, expanding access globally, and continuing to generate clinical and real-world evidence to support the long-term growth of EKTERLY.

Ben Palleiko: Good morning, and thank you for joining us. 2025 was a pivotal year for KalVista, highlighted by the successful multinational launch of EKTERLY, the first and only oral on-demand treatment for hereditary angioedema. Since launching in the US last July, we've seen high rates of early adoption, increasing physician engagement, and positive patient feedback. Together, these signals reinforce our belief that EKTERLY has the potential to transform the treatment of HAE. As we build on this foundation, we remain focused on launch execution in the US and Germany, expanding access globally, and continuing to generate clinical and real-world evidence to support the long-term growth of EKTERLY.

Speaker #3: Since launching in the US last July, we've seen high rates of early adoption, increasing physician engagement, and positive patient feedback. Together, these signals reinforce our belief that Ectorly has the potential to transform the treatment of HAE.

Speaker #3: As we build on this foundation, we remain focused on launch, execution in the US and Germany, expanding access globally, and continuing to generate clinical and real-world evidence to support long-term growth of Ectorly.

Speaker #3: The momentum we are seeing in the launch translated into $35 million in global net product revenue in the fourth quarter, bringing revenue from launch through December 31, 2025, to $49 million, and reflecting steady and consistent growth during the first six months of launch.

Benjamin Palleiko: The momentum we are seeing in the launch translated into $35 million in global net product revenue in Q4, bringing revenue from launch through 31 December 2024 to $49 million and reflecting steady and consistent growth during the first six months of launch. Turning to the US launch. As of 28 February, we've received 1,702 patient start forms and activated 724 unique prescribers across the United States since the launch last July. These metrics reflect broad engagement across the HAE community and strong awareness among both physicians and people living with HAE. One of the most encouraging signals we are seeing reflects what we believe to be favorable utilization trends. Refills now represent the majority of prescriptions and revenue, indicating that individuals who have tried EKTERLY are continuing to use it to treat attacks.

Ben Palleiko: The momentum we are seeing in the launch translated into $35 million in global net product revenue in Q4, bringing revenue from launch through 31 December 2024 to $49 million and reflecting steady and consistent growth during the first six months of launch. Turning to the US launch. As of 28 February, we've received 1,702 patient start forms and activated 724 unique prescribers across the United States since the launch last July. These metrics reflect broad engagement across the HAE community and strong awareness among both physicians and people living with HAE. One of the most encouraging signals we are seeing reflects what we believe to be favorable utilization trends. Refills now represent the majority of prescriptions and revenue, indicating that individuals who have tried EKTERLY are continuing to use it to treat attacks.

Speaker #3: Turning to the US launch, as of February 28th, we've received 1,702 patient start forms and activated 724 unique prescribers across the United States since the launch last July.

Speaker #3: These metrics reflect broad engagement across the HAE community and strong awareness among both physicians and people living with HAE. One of the most encouraging signals we are seeing reflects what we believe to be favorable utilization trends.

Speaker #3: Refills now represent the majority of prescriptions and revenue, indicating that individuals who have tried Ectorly are continuing to use it to treat attacks. This pattern suggests sustained usage and growing confidence as people living with HAE incorporate Ectorly into their ongoing management of attacks.

Benjamin Palleiko: This pattern suggests sustained usage and growing confidence as people living with HAE incorporate EKTERLY into their ongoing management of attacks. We are also expanding the global footprint of EKTERLY. In Germany, the launch is off to a strong start, with early adoption trends tracking similarly to those we see in the United States. In Japan, our partner, Kaken Pharmaceutical, has initiated launch activities following EKTERLY being listed on the National Health Insurance Reimbursement Schedule. In Latin America, we recently announced a partnership with Multicare Pharma to commercialize sebetralstat across several key markets. Collectively, these efforts are expanding access to EKTERLY and strengthening our global commercial presence. Looking ahead, our focus this year is on advancing the pediatric opportunity for EKTERLY, extending its availability to this high unmet need population.

Ben Palleiko: This pattern suggests sustained usage and growing confidence as people living with HAE incorporate EKTERLY into their ongoing management of attacks. We are also expanding the global footprint of EKTERLY. In Germany, the launch is off to a strong start, with early adoption trends tracking similarly to those we see in the United States. In Japan, our partner, Kaken Pharmaceutical, has initiated launch activities following EKTERLY being listed on the National Health Insurance Reimbursement Schedule. In Latin America, we recently announced a partnership with Multicare Pharma to commercialize sebetralstat across several key markets. Collectively, these efforts are expanding access to EKTERLY and strengthening our global commercial presence. Looking ahead, our focus this year is on advancing the pediatric opportunity for EKTERLY, extending its availability to this high unmet need population.

Speaker #3: We are also expanding the global footprint of Ectorly. In Germany, the launch is off to a strong start, with early adoption trends tracking similarly to those we see in the United States.

Speaker #3: In Japan, our partner Kaggen Pharmaceutical has initiated launch activities following Ectorly being listed on the National Health Insurance Reimbursement Schedule. And in Latin America, we recently announced a partnership with MultiCare Pharma to commercialize Cebetralstat across several key markets.

Speaker #3: Collectively, these efforts are expanding access to Ectorly and strengthening our global commercial presence. Looking ahead, our focus this year is on advancing the pediatric opportunity for Ectorly, extending its availability to this high-need population.

Speaker #3: We plan to submit an NDA in the third quarter of 2026, seeking approval for its use in children ages 2 to 11, which could support a potential U.S. launch in 2027.

Benjamin Palleiko: We plan to submit an NDA in Q3 of 2026, seeking approval for its use in children ages 2 to 11, which could support a potential US launch in 2027. Alongside commercial progress, we continue to strengthen the clinical evidence supporting EKTERLY. At the recent AAAAI and WSAAI meetings, we presented new analyses highlighting the potential for sebetralstat to help people treat more attacks earlier with sustained efficacy and high satisfaction. By reducing barriers to treatment, sebetralstat supports early intervention, which is associated with an improved treatment response. We are particularly proud that EKTERLY was recently recommended as a first-line treatment for adolescents ages 12 and older in the International Guideline on the Diagnosis and Management of Pediatric Patients with HAE.

Ben Palleiko: We plan to submit an NDA in Q3 of 2026, seeking approval for its use in children ages 2 to 11, which could support a potential US launch in 2027. Alongside commercial progress, we continue to strengthen the clinical evidence supporting EKTERLY. At the recent AAAAI and WSAAI meetings, we presented new analyses highlighting the potential for sebetralstat to help people treat more attacks earlier with sustained efficacy and high satisfaction. By reducing barriers to treatment, sebetralstat supports early intervention, which is associated with an improved treatment response. We are particularly proud that EKTERLY was recently recommended as a first-line treatment for adolescents ages 12 and older in the International Guideline on the Diagnosis and Management of Pediatric Patients with HAE.

Speaker #3: Alongside commercial progress, we continue to strengthen the clinical evidence supporting Ectorly. At the recent Quad AI and Western Allergy meetings, we presented new analyses highlighting the potential for Cebetralstat to help people treat more attacks earlier, with sustained efficacy and high satisfaction.

Speaker #3: By reducing barriers to treatment, Cebetralstat supports early intervention, which is associated with an improved treatment response. We are particularly proud that Ectorly was recently recommended as a first-line treatment for adolescents ages 12 and older in the International Guideline on the Diagnosis and Management of Pediatric Patients with HAE.

Speaker #3: The first-line recommendation for Ectorly so soon after becoming commercially available underscores the strength of our clinical data and reinforces the importance of ensuring individuals have immediate access to on-demand therapy.

Benjamin Palleiko: The first-line recommendation for EKTERLY so soon after becoming commercially available underscores the strength of our clinical data and reinforces the importance of ensuring individuals have immediate access to on-demand therapy. Overall, our objective remains consistent, to establish EKTERLY as a foundational treatment for HAE worldwide. Based on feedback from physicians and patients, it is becoming increasingly clear that the ability for people to treat all attacks quickly and conveniently with an oral therapy represents a meaningful advancement in HAE management. While we are still early in the launch, we believe we have built a strong base across commercial execution, clinical evidence, and regulatory progress to drive long-term growth and deliver lasting benefit for the entire HAE community. With that, I'll turn the call over to Paul to discuss the new clinical data presented at AAAAI and the Western meetings in more detail.

Ben Palleiko: The first-line recommendation for EKTERLY so soon after becoming commercially available underscores the strength of our clinical data and reinforces the importance of ensuring individuals have immediate access to on-demand therapy. Overall, our objective remains consistent, to establish EKTERLY as a foundational treatment for HAE worldwide. Based on feedback from physicians and patients, it is becoming increasingly clear that the ability for people to treat all attacks quickly and conveniently with an oral therapy represents a meaningful advancement in HAE management. While we are still early in the launch, we believe we have built a strong base across commercial execution, clinical evidence, and regulatory progress to drive long-term growth and deliver lasting benefit for the entire HAE community. With that, I'll turn the call over to Paul to discuss the new clinical data presented at AAAAI and the Western meetings in more detail.

Speaker #3: Overall, our objective remains consistent: to establish Ectorly as a foundational treatment for HAE worldwide. Based on feedback from physicians and patients, it is becoming increasingly clear that the ability for people to treat all attacks quickly and conveniently with an oral therapy represents a meaningful advancement in HAE management.

Speaker #3: While we are still early in the launch, we believe we have built a strong base across commercial execution, clinical evidence, and regulatory progress to drive long-term growth and deliver lasting benefit for the entire HAE community.

Speaker #3: With that, I'll turn the call over to Paul to discuss the new clinical data presented at QuadAI and the Western meetings in more detail.

Speaker #2: Thank you, Ben. At the recent Western and Quad AI scientific meetings, we presented several new analyses from the Cebetralstat clinical trial program, including updated findings from the Confidence Open-Label Extension study.

Paul Audhya: Thank you, Ben. At the recent Western and AAAAI scientific meetings, we presented several new analyses from the sebetralstat clinical trial program, including updated findings from the KONFIDENT open-label extension study. These data further expand our understanding of the clinical performance of EKTERLY and the evolution of treatment patterns with an oral on-demand therapy. First, looking at the longitudinal data presented at Western, we observed that sebetralstat performed consistently and effectively in nearly 2,500 attacks treated through September 2025. What was particularly encouraging was that the use of a second dose occurred in only 19.3% of attacks and actually showed a decreasing trend over repeated attacks to about 12%. The use of conventional injectable treatments occurred in only 5.1% of attacks, which also trended downward toward 2%.

Speaker #2: These data further expand our understanding of the clinical performance of Ectorly and the evolution of treatment patterns with an oral, on-demand therapy. First, looking at the longitudinal data presented at Western, we observed that Cebetralstat performed consistently and effectively in nearly 2,500 attacks treated through September of 2025.

Speaker #2: What was particularly encouraging was that the use of a second dose occurred in only 19.3% of attacks and actually showed a decreasing trend over repeated attacks to about 12%.

Speaker #2: The use of conventional injectable treatments occurred in only 5.1% of attacks, which also trended downward toward 2%. While there have been no head-to-head trials, these data are favorable in the context of what has been published in the literature for other on-demand treatments.

Paul Audhya: While there have been no head-to-head trials, these data are favorable in the context of what has been published in the literature for other on-demand treatments. These findings are also evidence of growing confidence with sebetralstat as patients gained experience. This sustained clinical performance was mirrored by high and durable patient satisfaction, with 91.1% of attacks rated as neutral to extremely satisfied and a median overall score of very satisfied. This leads to KONFIDENT, where we reported a clear preference for sebetralstat over conventional injectable treatments in the KONFIDENT study. A unique part of the open-label real-world study design was that patients were allowed to choose either sebetralstat or their historic injectable treatment for each attack, depending on their preference. Under these conditions, participants chose to treat over 84% of their attacks with sebetralstat.

Speaker #2: These findings are also evidence of growing confidence with Cebetralstat as patients gained experience. This sustained clinical performance was mirrored by high and durable patient satisfaction, with 91.1% of attacks rated as neutral to extremely satisfied and a median overall score of very satisfied.

Speaker #2: This leads to Quad AI, where we reported a clear preference for Cebetralstat over conventional injectable treatments in the Confidence study. A unique part of the open label real-world study design was that patients were allowed to choose either Cebetralstat or their historic injectable treatment for each attack, depending on their preference.

Speaker #2: Under these conditions, participants chose to treat over 84% of their attacks with Cebetralstat. Further, as the study progressed, the preference for Cebetralstat grew as patients treated more attacks.

Paul Audhya: Further, as the study progressed, the preference for sebetralstat grew as patients treated more attacks. Collectively, these findings from KONFIDENT reinforce a powerful narrative. EKTERLY is a preferred on-demand therapy, enabling patients to treat the vast majority of attacks, treat them early, and achieve high levels of sustained satisfaction after switching from injectables. Importantly, these results also reflect the trends we are seeing commercially, including growing physician confidence and increasing adoption by people living with HAE. Finally, I am pleased to highlight that these clinical insights are already being translated into global standard of care recommendations. The newly released International Pediatric HAE Guideline recommends EKTERLY as a first-line therapy for adolescents aged 12 and older. The guideline committee issued a strong recommendation based on our robust clinical data published in high-tier peer-reviewed journals.

Speaker #2: Collectively, these findings from Confidence reinforce a powerful narrative: Ectorly is a preferred on-demand therapy, enabling patients to treat the vast majority of attacks, treat them early, and achieve high levels of sustained satisfaction after switching from injectable.

Speaker #2: Importantly, these results also reflect the trends we are seeing commercially, including growing physician confidence and increasing adoption by people living with HAE. Finally, I am pleased to highlight that these clinical insights are already being translated into global standard-of-care recommendations.

Speaker #2: The newly released International Pediatric HAE Guideline recommends Ectorly as a first-line therapy for adolescents aged 12 and older. The guideline committee issued a strong recommendation based on a robust clinical data published in High Tier peer-reviewed journals.

Paul Audhya: Importantly, the guidelines emphasize that early intervention and ready access to on-demand treatment are the keys to better outcomes. This directly supports our findings that oral therapy has the potential to remove the barriers that have historically caused adolescents to wait nearly eight hours before treating an attack with injectable therapy. With that, I'll turn the call over to Nicole to provide an update on the commercial launch.

Speaker #2: Importantly, the guidelines emphasize that early intervention and ready access to on-demand treatment are the keys to better outcomes. This directly supports our findings that oral therapy has the potential to remove the barriers that have historically caused adolescents to wait nearly eight hours before treating an attack with injectable therapy.

Speaker #2: With that, I'll turn the call over to Nicole to provide an update on the commercial launch.

Nicole Sweeny: Thank you, Paul. We launched EKTERLY in the US on 7 July 2025, and now approximately 9 months into the launch, we continue to see steady growth driven by increasing prescriber engagement and positive patient experience. As Paul outlined earlier, data presented at the AAAAI showed the high confidence healthcare providers have in prescribing EKTERLY and the high satisfaction their patients are having with the drug. Momentum to adopt EKTERLY continues to build. For January and February 2026, we recorded 384 new start forms, which brings the launch to date start form total to over 1,700. The US HAE population is estimated to include approximately 9,000 patients. Based on our current start forms, almost 20% of individuals with HAE have initiated EKTERLY.

Speaker #3: Thank you, Paul. We launched Ectorly in the US on July 7, 2025, and now, approximately nine months into the launch, we continue to see steady growth driven by increasing prescriber engagement and positive patient experience.

Speaker #3: As Paul outlined earlier, data presented at the Quad AI showed the high confidence healthcare providers have in prescribing Ectorly and the high satisfaction their patients are having with the drug.

Speaker #3: Momentum to adopt Ectorly continues to build. For January and February 2026, we recorded 384 new START forms, which brings the launch-to-date START form total to over 1,700.

Speaker #3: The US HAE population is estimated to include approximately 9,000 patients, and based on our current START forms, almost 20% of individuals with HAE have initiated Ectorly.

Nicole Sweeny: We have now received start forms from 49 states and have recently expanded into Puerto Rico, further broadening access to therapy. On the prescriber side, during the first two months of 2026, we added 144 prescribers, bringing the launch to date total of unique prescribers to 724. The breadth and depth of EKTERLY use across all prescriber tiers continues to grow in a linear fashion. 29 of the top 30 HAE prescribers in the country have prescribed EKTERLY for multiple patients. As is typical in the early stages of a launch, we expect some quarter-to-quarter variability in certain metrics. The severe winter weather this quarter affected physician office activity and processing of start forms. We believe this is a temporary dynamic and does not reflect any fundamental change in the underlying demand for EKTERLY. Prescriber engagement also continues to expand.

Speaker #3: We have now received START forms from 49 states and have recently expanded into Puerto Rico, further broadening access to therapy. On the prescriber side, during the first two months of 2026, we added 144 prescribers.

Speaker #3: Bringing the launch-to-date total of unique prescribers to 724. The breadth and depth of Ectorly use across all prescriber tiers continues to grow in a linear fashion.

Speaker #3: Twenty-nine of the top thirty HAE prescribers in the country have prescribed Ectorly for multiple patients. As is typical in the early stages of a launch, we expect some quarter-to-quarter variability in certain metrics.

Speaker #3: The severe winter weather this quarter affected physician office activity and processing of START forms. We believe this is a temporary dynamic and does not reflect any fundamental change in the underlying demand for Ectorly.

Speaker #3: Prescriber engagement also continues to expand. On average, we are adding approximately three new prescribers each day, and we recently recorded a milestone where 10 new prescribers activated in a single day.

Nicole Sweeny: On average, we are adding approximately three new prescribers each day, and we recently recorded a milestone where 10 new prescribers activated in a single day. These trends reflect increasing awareness and growing physician confidence as experience with EKTERLY builds. As Ben mentioned earlier, as of Q4, refills represent the majority of units and revenue. This is an important indicator of the real-world utilization patterns and growing satisfaction with EKTERLY. We are seeing uptake among both high-burden patients as well as patients with more moderate disease activity, reflecting the value of an oral therapy that can be used anytime, anywhere. This quarter, we conducted a routine market research survey with both patients and healthcare providers. Healthcare providers indicated the oral administration and ability to treat attacks early as the top drivers of EKTERLY use. Further, patients prescribed EKTERLY indicated an increase in attack treatment rate since switching to EKTERLY.

Speaker #3: These trends reflect increasing awareness and growing physician confidence as experience with Ectorly builds. As Ben mentioned earlier, as of Q4, refills represent the majority of units and revenue.

Speaker #3: This is an important indicator of the real-world utilization patterns and growing satisfaction with Ectorly. We are seeing uptake among both high-burden patients as well as patients with more moderate disease activity.

Speaker #3: Reflecting the value of an oral therapy that can be used anytime, anywhere. This quarter, we conducted a routine market research survey with both patients and healthcare providers.

Speaker #3: Healthcare providers indicated the oral administration and ability to treat attacks early as the top drivers of Ectorly use. Further, patients prescribed Ectorly indicated an increase in attack treatment rate since switching to Ectorly.

Nicole Sweeny: It is very encouraging to see initial signals that EKTERLY is delivering on its promise of enabling early treatment and treatment of all attacks for individuals living with HAE. Operationally, we remain focused on enabling broad patient access, supporting reimbursement and onboarding, and ensuring a high-quality patient experience through our support services. We believe satisfaction is driven not only by the product itself, but also by the services and support we provide to individuals and physicians. In fact, despite our relatively recent entry, our patient hub services team recently received the highest ratings from healthcare providers on the quality of patient and access support of any company in the HAE space. Overall, we continue to see growing familiarity with EKTERLY, high levels of patient and physician satisfaction, and increasing confidence in the role EKTERLY can play in HAE management.

Speaker #3: It is very encouraging to see initial signals that Ectorly is delivering on its promise of enabling early treatment and treatment of all attacks for individuals living with HAE.

Speaker #3: Operationally, we remain focused on enabling broad patient access, supporting reimbursement and onboarding, and ensuring a high-quality patient experience through our support services. We believe satisfaction is driven not only by the product itself but also by the services and support we provide to individuals and physicians.

Speaker #3: In fact, despite our relatively recent entry, our Patient Hub Services team recently received the highest ratings from healthcare providers on the quality of patient and access support of any company in the HAE space.

Speaker #3: Overall, we continue to see growing familiarity with Ectorly, high levels of patient and physician satisfaction, and increasing confidence in the role Ectorly can play in HAE management.

Nicole Sweeny: We believe EKTERLY is well-positioned to become the foundational therapy in the treatment of hereditary angioedema. With that, I will now turn the call over to Brian to review our financial results.

Speaker #3: We believe Ectorly is well-positioned to become the foundational therapy in the treatment of hereditary angioedema. With that, I will now turn the call over to Brian to review our financial results.

Brian Piekos: Thanks, Nicole. As a result of changing our fiscal year-end from 30 April to 31 December, the results we are reporting today reflect the eight-month transition period from 1 May 2025 to 31 December 2025. For comparability, we are presenting the 2025 results against unaudited financial information for the same period in 2024. As previously announced, net product revenue for the eight-month transition period ended 31 December 2025 was $49.1 million, including $35.4 million generated in the three months ended 31 December. Q4 revenue benefited from our specialty pharmacy customers adding inventory ahead of the holiday shutdowns, which they were able to work through in January. Total operating expenses were $160.2 million, compared with $117 million in the prior year period.

Speaker #4: Thanks, Nicole. A result of changing our fiscal year-end from April 30 to December 31, the results we are reporting today reflect the eight-month transition period from May 1, 2025, through December 31, 2025.

Speaker #4: For comparability, we are presenting the 2025 results against unaudited financial information for the same period in 2024. As previously announced, net product revenue for the eight-month transition period ended December 31, 2025, was $49.1 million, including 35.4 million generated in the three months ended December 31.

Speaker #4: Fourth-quarter revenue benefited from our specially pharmacy customers adding inventory ahead of the holiday shutdowns, which they were able to work through in January. Total operating expenses were $160.2 million compared with $117 million in the prior year period.

Brian Piekos: Cost of revenue was $3.1 million and reflects expenses directly associated with product sales. Inventory sold in 2025 is not reflected in the cost of revenue because it was manufactured prior to FDA approval and expensed to the R&D line at the time produced. Research and development expenses were $33.4 million, compared with $52.2 million in the prior year period. The decrease primarily reflects lower clinical trial costs as the KONFIDENT trials wind down, reduced discovery activities, the reclassification of certain medical affairs expenses from R&D to SG&A beginning in the fall of 2024, and the capitalization of manufacturing costs following FDA approval in July 2025.

Speaker #4: Cost of revenue was $3.1 million, and reflects expenses directly associated with product sales. Inventory sold in 2025 is not reflected in cost of revenue because it was manufactured prior to FDA approval and expense to the R&D line at the time produced.

Speaker #4: Research and development expenses were $33.4 million compared with $52.2 million in the prior year period. The decrease primarily reflects lower clinical trial costs as the KONFIDENT trials wind down, reduced discovery activities, the reclassification of certain medical affairs expenses from R&D to SG&A beginning in the fall of 2024, and the capitalization of manufacturing costs following FDA approval in July 2025.

Brian Piekos: SG&A expenses were $124.7 million, compared with $64.9 million in the prior year period, driven primarily by commercial launch activities and the continued build-out of infrastructure to support the commercialization of EKTERLY. Operating loss for the period was $112 million, compared with $117 million in the prior year period. As of 31 December 2025, we had $300 million in cash and investments, which we believe is sufficient to fund the company to profitability under our current operating plan. Overall, this period reflects our transition to a global commercial organization with the direct launch of EKTERLY in the United States and Germany. The investments made in 2025 position us to support continued commercial execution.

Speaker #4: SG&A expenses were $124.7 million, compared with $64.9 million in the prior year period, driven primarily by commercial launch activities and the continued buildout of infrastructure to support the commercialization of Ectorly.

Speaker #4: Operating loss for the period was $112 million compared with $117 million in the prior year period. As of December 31, 2025, we had $300 million in cash and investments, which we believe is sufficient to fund the company to profitability under a current operating plan.

Speaker #4: Overall, this period reflects our transition to a global commercial organization, with a direct launch of Ectorly in the United States and Germany. The investments made in 2025 position us to support continued commercial execution.

Brian Piekos: Looking ahead, we expect operating expenses to remain relatively consistent when adjusted for a 12-month period, with the exception that cost of revenue will increase meaningfully as we sell through the remaining zero-cost inventory. With respect to the non-financial KPIs, starting with the Q1 2026 earnings call, we will report patient start forms and unique prescribers for the three-month period ended that corresponds to the financial results of that reporting period. With that, I'll turn the call over to Ben for closing remarks. Ben?

Speaker #4: Looking ahead, we expect operating expenses to remain relatively consistent when adjusted for a 12-month period, with the exception that cost of revenue will increase meaningfully as we sell through the remaining zero-cost inventory.

Speaker #4: With respect to the non-financial KPIs, starting with the first quarter 2026 earnings call, we will report patient START forms and unique prescribers for the three-month period ended that corresponds to the financial results of that reporting period.

Speaker #4: With that, I'll turn the call over to Ben for closing remarks. Ben?

Nicole Sweeny: Thank you, Brian. We are very encouraged by the early launch trajectory of EKTERLY and the strong response from people living with HAE and physicians. With continued US growth, expanding international launches, and a pediatric filing ahead, we believe we are well-positioned for 2026 and beyond. Our focus remains on disciplined execution, expanding access globally, and delivering on the full potential of EKTERLY for the HAE community. Operator, we'll now open the call for questions.

Speaker #5: Thank you, Brian. We are very encouraged by the early launch trajectory of Ectorly and the strong response from people living with HAE and physicians.

Speaker #5: With continued US growth, expanding international launches, and a pediatric filing ahead, we believe we are well positioned for 2026 and beyond. Our focus remains on disciplined execution, expanding access globally, and delivering on the full potential of Ectorly for the HAE community.

Speaker #5: Operator will now open the call for questions.

Operator: Our first question comes from Tazeen Ahmad with Bank of America.

Speaker #6: If you'd like to ask a question at this time, please press star one-one on your telephone and wait for your name to be announced.

Speaker #6: To withdraw your question, please press star 11 again. Our first question comes from Tazeen en Ahmad with Bank of America.

Operator: Our first question comes from Tazeen Ahmad with Bank of America.

Tazeen Ahmad: Hi, guys. Can you hear me?

Benjamin Palleiko: Yeah. Hi, Tazeen. Good morning.

Ben Palleiko: Yeah. Hi, Tazeen. Good morning.

Speaker #7: Hi, guys. Can you hear me?

Tazeen Ahmad: Good morning. Thanks for taking my question. Congrats on another strong quarter. Can you talk to us about how do we think about the uptake for the ex-US launches? You guys have made it to 20% of US patients in a short amount of time. Can you maybe talk about the nuances in the countries, specifically, let's say, Germany and Japan, to help us with how to think about uptake in general? For peak sales, what do you expect the split to be for revenue between US and ex-US? Thank you.

Speaker #8: Hi, Tazeen. Good morning.

Speaker #7: Good morning. Thanks for taking my question. Congrats on another strong quarter. Can you talk to us about how do we think about the uptake for the ex-US launches?

Speaker #7: You guys have made it to 20% of US patients in a short amount of time. So can you maybe talk about the nuancing in the countries specifically, let's say Germany and Japan, to help us with how to think about uptake in general?

Speaker #7: And then for peak sales, what do you expect the split to be for revenue between US and ex-US? Thank you.

Benjamin Palleiko: Sure. Thanks for the question, Tazeen. I'll start off and then I think Nicole can give some more detail. At a high level, the German trends we've seen are tracking more or less US trends. It's obviously a much smaller marketplace, but the patient uptake has been quite strong. I think we're comfortable that growth is gonna look a lot like it looks in the US, again, just that from a smaller base point. Japan, we did launch, but just factually, it's really too early to tell. We had our first sale in Japan last week, it's probably a little early to extrapolate from that trend at this point. More to come here as that launch progresses.

Ben Palleiko: Sure. Thanks for the question, Tazeen. I'll start off and then I think Nicole can give some more detail. At a high level, the German trends we've seen are tracking more or less US trends. It's obviously a much smaller marketplace, but the patient uptake has been quite strong. I think we're comfortable that growth is gonna look a lot like it looks in the US, again, just that from a smaller base point. Japan, we did launch, but just factually, it's really too early to tell. We had our first sale in Japan last week, it's probably a little early to extrapolate from that trend at this point. More to come here as that launch progresses.

Speaker #8: Sure. Thanks for the question, Tazeen. I'll start off, and then I think Nicole can give some more detail. So, at a high level, the German trends we've seen are tracking more or less with US trends.

Speaker #8: It's obviously a much smaller marketplace, but the patient uptake has been quite strong. And I think we're comfortable that growth is going to look a lot like it looks in the US—again, just from a smaller base point.

Speaker #8: Japan, we did launch, but just factually, it's too early to tell. We did—our—we had our first sale in Japan last week, so it's probably a little early to extrapolate from that trend at this point.

Speaker #8: But more to come here as that launch progresses. And then, with regard to peak sales splits, in general, the US obviously represents the vast majority of sales for effectively any pharmaceuticals product.

Benjamin Palleiko: With regard to peak sales splits, in general, the US obviously represents the vast majority of sales for effectively any pharmaceuticals product, and so it will be somewhere in the 85-15, ± a few points in either direction, US sales over time. As we've said consistently, ex-US, the vast majority of the world is overwhelmingly on demand only. You don't see a lot of modern prophylaxis use outside the US. But again, just because the pricing dynamics tend to be so much different from a unit standpoint, it may be pretty sizable, but from a dollar standpoint, it will always be a relatively small proportion. Nicole, I don't know if you want to talk about it some more in Germany.

Ben Palleiko: With regard to peak sales splits, in general, the US obviously represents the vast majority of sales for effectively any pharmaceuticals product, and so it will be somewhere in the 85-15, ± a few points in either direction, US sales over time. As we've said consistently, ex-US, the vast majority of the world is overwhelmingly on demand only. You don't see a lot of modern prophylaxis use outside the US. But again, just because the pricing dynamics tend to be so much different from a unit standpoint, it may be pretty sizable, but from a dollar standpoint, it will always be a relatively small proportion. Nicole, I don't know if you want to talk about it some more in Germany.

Speaker #8: And so it will be somewhere in the 85, 15-plus or minus a few points in either direction. US sales over time as we've said consistently, ex-US, the vast majority of the world is overwhelmingly on demand only.

Speaker #8: You don't see a lot of modern prophylaxis use outside the US. But again, just because the pricing dynamics tend to be so much different—from a unit standpoint, it may be pretty sizable.

Speaker #8: But from a dollar standpoint, it will always be a relatively small proportion. Nicole, I don't know if you want to talk about anything more in Germany?

Nicole Sweeny: No, all set.

Benjamin Palleiko: Okay. There we go.

Ben Palleiko: Okay. There we go.

Speaker #9: Nope. All set.

Tazeen Ahmad: Thank you.

Speaker #8: Okay. Here we go.

Benjamin Palleiko: Yeah. Good talking to you, Tazeen.

Ben Palleiko: Yeah. Good talking to you, Tazeen.

Speaker #7: Thank you.

Operator: Question comes from Paul Matteis with Stifel.

Speaker #8: Yeah. Good talking to you, Tazeen.

Speaker #6: Next question comes from Paul Matisse with Stifel.

[Analyst] (Stifel): Hey there. This is Julian for Paul. Thanks so much for taking our question, and congrats on the strong progress. Can you just tell us a little bit about the types of patients that have started on therapy over the last couple months in terms of phenotype, and how they may compare to the end of last year? Further, you also talked about how, you know, the end of the year may have been impacted by the holidays, and you still showed some linear growth in start forms. Just curious over the next couple of months if you know, expect to continue to see you know, increased linear growth, and anything that you know, we should think about going into Q1 with respect to inventory or Gross-to-Net would be helpful. Thank you.

Speaker #10: Hey there, this is Julian for Paul. Thanks so much for taking our question, and congrats on the strong progress. Can you just tell us a little bit about the types of patients that have started on therapy over the last couple of months in terms of phenotype, and how they may compare to the end of last year?

Speaker #10: And further, you also talked about how the end of the year may have been impacted by the holidays and you still showed some linear growth in START forms.

Speaker #10: Just curious, over the next couple of months, if you expect to continue to see increased linear growth, and anything that we should think about going into Q1 with respect to inventory or GTN would be helpful.

Benjamin Palleiko: Go on, Nicole.

Ben Palleiko: Go on, Nicole.

Speaker #10: Thank you.

Nicole Sweeny: Sure. Thanks for your question. In terms of patients adopting EKTERLY, we're very pleased to continue to see that the high burden segment we continue to increase our share with that segment in particular, as we look at the past few months of 2026. We're also very encouraged to see the broadening, though, of our patient base growing those patients with mild and moderate burden of disease. To us, that just really signals the broad appeal of EKTERLY to the entire population. Then in terms of the holidays, certainly we do believe that demand is very strong, the fundamentals in terms of just the attractiveness of the profile for both patients and physicians.

Speaker #8: Or Nicole.

Speaker #9: Sure, so thanks for your question. In terms of patients adopting Ectorly, we're very pleased with the high-burn segment, where we continue to increase our share with that segment in particular, as we look at the past few months of 2026.

Speaker #9: We're also very encouraged to see the broadening, though, of our patient base—growing both those patients with mild and moderate burden of disease. To us, that just really signals the broad appeal of Ectorly to the entire population.

Speaker #9: And then in terms of the holidays, certainly, we do believe that demand is very strong and the fundamentals in terms of just the attractiveness of the profile for both patients and physicians. But we did certainly see earlier this year, as did many companies, that the severe weather that impacted several states with multiple storms certainly did have a negative impact on demand in terms of the ability for patients to get into the offices to see their physician, as well as for staff to complete administrative steps to complete paperwork for START forms.

Nicole Sweeny: We did certainly see, earlier this year, as many companies that the severe weather that impacted several states with multiple storms certainly did have a negative impact on demand in terms of the ability for patients to get into the offices to see their physician, as well as for staff to complete administrative steps to complete paperwork for start forms.

Benjamin Palleiko: Brian, you want to talk about Q1?

Ben Palleiko: Brian, you want to talk about Q1?

Brian Piekos: Sure. We, like other high price specialty medicines, will have a small impact to Q1 gross-to-net associated with co-pay assistance. You know, it's kind of small in order of magnitude and temporary in terms of just getting through the deductible reset process.

Speaker #8: And Brian, do you want to talk about Q1?

Speaker #10: Sure. We, like other high-priced specialty medicines, will have a small impact to Q1 gross-to-net associated with co-pay assistance. It's kind of small in magnitude and temporary, in terms of just getting through the deductible reset process.

Operator: Our next question comes from Stacy Ku with TD Cowen.

Speaker #6: Our next question comes from Stacy Gu with TD Cowen.

Stacy Ku: Hey, good morning. Thanks so much for taking our questions. We have a couple. First, maybe could you comment on how refill trends are progressing in 2026 and where you think things could settle, just given really the high demand you're seeing for EKTERLY. That's the first question. Then a couple of quick follow-ups. Are you able to comment on the high burden patients, where you are in the penetration of that patient pool. That's the second question. The third, we appreciate you providing forms through February. Are you able to comment high level if the rate of patient start form adds is similar in March. Are you seeing kind of the same dynamic that we've seen in Q4. Appreciate you following up on that.

Speaker #11: Hey, good morning. Thanks so much for taking our questions. We have a couple. So first, maybe could you comment on how refill trends are progressing in 2026 and where you think things could settle?

Speaker #11: Just given really the high demand you're seeing for Ectorly, so that's the first question. And then a couple of quick follow-ups: are you able to comment on the high-burn patients—where you are in the penetration of that patient bolus?

Speaker #11: So that's the second question. And then the third, we appreciate you providing forms through February. Are you able to comment, high level, if the rate of patient START form adds is similar in March?

Speaker #11: Are you seeing kind of the same dynamic that we've seen in Q4? Appreciate you following up on that. And Nicole, aligned with the processing of START forms, could you just further discuss your comment there?

Benjamin Palleiko: Nicole.

Ben Palleiko: Nicole.

Stacy Ku: Align with the processing of start forms. Could you just further discuss your comment there? Is it just the normal seasonality around high deductible resets, payer changes, et cetera? Thank you so much.

Speaker #11: Is it just a normal seasonality around high-deductible resets, payer changes, etc.? Thank you so much.

Nicole Sweeny: Sure, absolutely, and appreciate the question. In terms of refills, we're very pleased to see that we're really maintaining the trends that we've discussed on previous calls and that refills, we're seeing patients, you know, anywhere between 1 to 3 cartons per refill, as well as the high burden patients continue to refill more frequently than when we look at those of more mild and moderate burden. We've seen, you know, again, we've discussed that looking at claims data for some of the other on-demand therapies, those more mild to moderate burden patients are refilling just a few times a year. We see the high burden patients refilling certainly more frequently. In terms of the share of the high burden patients, we continue to grow.

Speaker #9: Sure. Sure. Absolutely. And appreciate the question. So, in terms of refills, we're very pleased to see that we're really maintaining the trends that we've discussed on previous calls.

Speaker #9: And that refills were seeing patients anywhere between 1 to 3 cartons per refill, as well as the high-burn patients continue to refill more frequently than when we look at those with more mild and moderate burden.

Speaker #9: And we've seen again, we've discussed that looking at claims data for some of the other on-demand therapies, those more mild to moderate burn patients are refilling just a few times a year.

Speaker #9: And we see that the high-burn patients are refilling certainly more frequently. In terms of the share of the high-burn patients, we continue to grow. We're roughly around one-third at this point in time.

Nicole Sweeny: We're roughly around 1/3 at this point in time, and so we're pleased to see that continue to grow quarter-over-quarter and really just see the attractiveness of the profile continue to draw that particular segment of the market. Could you just remind me of your questions with regards to seasonality, just to make sure that we're answering it appropriately?

Speaker #9: And so we're pleased to see that continue to grow quarter over quarter, and really just see the attractiveness of the profile continue to draw that particular segment of the market.

Speaker #9: And then, just looking, could you just remind me of your questions with regards to seasonality, just to make sure that we're answering it appropriately?

Stacy Ku: Yep. I just wanna make sure we then maybe further dissect your comment of processing of start forms, just the processing aspect of it. Is it around the normal seasonality from high deductible resets, payer changes, as we think about kind of the short-term Q1 dynamics?

Speaker #11: Yep. I just want to make sure we can maybe further just dissect your comment on the processing of START forms—just the processing aspect of it.

Speaker #11: Is it around the normal seasonality from high-deductible resets, payer changes, as we think about kind of the short-term Q1 dynamics?

Benjamin Palleiko: Stacy, hey, it's Ben. So just I think there's a couple seasonality things we've tried to highlight here, and maybe we're mixing them a little bit together. The first is the fact that in Q4, we've said fairly consistently, the wholesalers, the PBMs—the wholesalers ended up with higher than average stock toward the end of the year. We do think that patients took on more drug in Q4, whether that was for increased need or just an anticipation of the kind of standard Q1 deductible resets. You know, we'll never really know. We've fairly consistently said the volumes were probably higher in Q4, driven by some of these seasonal factors. That some of that resets in Q1.

Ben Palleiko: Stacy, hey, it's Ben. So just I think there's a couple seasonality things we've tried to highlight here, and maybe we're mixing them a little bit together. The first is the fact that in Q4, we've said fairly consistently, the wholesalers, the PBMs—the wholesalers ended up with higher than average stock toward the end of the year. We do think that patients took on more drug in Q4, whether that was for increased need or just an anticipation of the kind of standard Q1 deductible resets. You know, we'll never really know. We've fairly consistently said the volumes were probably higher in Q4, driven by some of these seasonal factors. That some of that resets in Q1.

Speaker #8: Stacy, hey, it's Ben. I just think there are a couple of seasonality things we've tried to highlight here, and maybe we're mixing them a little bit together.

Speaker #8: The first is the fact that in Q4, we've said fairly consistently the wholesalers, the PBMs, the wholesalers ended up with higher-than-average stock toward the end of the year.

Speaker #8: And also, we do think that patients took on more drug in Q4, whether that was for increased need or just in anticipation of the kind of standard Q1 deductible resets.

Speaker #8: We'll never really know. But we fairly consistently said the volumes were probably higher in Q4, driven by some of these seasonal factors. And some of that resets in Q1.

Benjamin Palleiko: We've just been trying to tell people that that's kind of a normal course activity. With regard to the start forms, we've consistently said, and we believe this trend will continue, that, you know, we expect launch to be consistent and linear. That does not mean, I think, when Nicole was trying to highlight those, it will be consistent and linear, but there will be fluctuations quarter to quarter, and we don't attach any fundamental significance to them. It's just driven by a number of factors. What she was actually trying to highlight was the fact in January and February, you had several bouts of extreme weather in the US, and that absolutely impacted physicians' offices.

Ben Palleiko: We've just been trying to tell people that that's kind of a normal course activity. With regard to the start forms, we've consistently said, and we believe this trend will continue, that, you know, we expect launch to be consistent and linear. That does not mean, I think, when Nicole was trying to highlight those, it will be consistent and linear, but there will be fluctuations quarter to quarter, and we don't attach any fundamental significance to them. It's just driven by a number of factors. What she was actually trying to highlight was the fact in January and February, you had several bouts of extreme weather in the US, and that absolutely impacted physicians' offices.

Speaker #8: And so we've just been trying to tell people that that's kind of a normal course of activity. With regard to the START forms, we've consistently said, and we believe this trend will continue, that we expect launch to be consistent and linear.

Speaker #8: That does not mean, I think, when Nicole was trying to highlight those, it will be consistent and linear. But there will be fluctuations quarter to quarter, and we don't attach any fundamental significance to them.

Speaker #8: It's just driven by a number of factors, which she was, I think, trying to highlight was the fact that in January and February, you had several bouts of extreme weather in the US.

Benjamin Palleiko: There were certainly days in January and February when we had zero start forms simply because all the offices were closed. That, you know, does have a little bit of impact on some of the numbers we've talked about so far. Again, it's not a fundamental thing. It's just a weather thing. She was trying to highlight the fact that when physicians' offices are closed, the start forms which the physicians' offices have to process just don't get processed, and to convert them to commercial. There's just some factors like that we're just trying to make sure everyone's aware of as we enter well through Q1.

Ben Palleiko: There were certainly days in January and February when we had zero start forms simply because all the offices were closed. That, you know, does have a little bit of impact on some of the numbers we've talked about so far. Again, it's not a fundamental thing. It's just a weather thing. She was trying to highlight the fact that when physicians' offices are closed, the start forms which the physicians' offices have to process just don't get processed, and to convert them to commercial. There's just some factors like that we're just trying to make sure everyone's aware of as we enter well through Q1.

Speaker #8: And that absolutely impacted physicians' offices. There were certainly days in January and February when we had zero START forms simply because all the offices were closed.

Speaker #8: And so, that does have a little bit of impact on some of the numbers we've talked about so far. But again, it's not a fundamental thing.

Speaker #8: It's just a weather thing. And also, she was trying to highlight the fact that when physicians' offices are closed, the START forms, which the physicians' offices have to process, just don't get processed.

Speaker #8: And to convert them to commercial. And so there are just some factors like that we're just trying to make sure everyone's aware of as we answer well through Q1.

Benjamin Palleiko: The high-level message is, we believe in the linearity of the launch, you know, to a greater or lesser degree. I think we're very comfortable with the way things are progressing, and nothing about this we're trying to suggest suggests any shift in our anticipation of the future growth.

Ben Palleiko: The high-level message is, we believe in the linearity of the launch, you know, to a greater or lesser degree. I think we're very comfortable with the way things are progressing, and nothing about this we're trying to suggest suggests any shift in our anticipation of the future growth.

Speaker #8: But the high-level message is, we believe in the linearity of the launch, two-way to a greater or lesser degree. And I think we're very comfortable with the way things are progressing, and nothing about this we're trying to suggest suggests any shift in our anticipation of future growth.

Stacy Ku: Okay. Wonderful. Incredibly clear. We really appreciate it. Thank you.

Speaker #11: Okay, wonderful. Incredibly clear. We really appreciate it. Thank you.

Benjamin Palleiko: Yeah. Of course. It was good talking to you.

Ben Palleiko: Yeah. Of course. It was good talking to you.

Speaker #8: Yep. Of course. Always good talking to you.

Operator: Our next question comes from Maury Raycroft with Jefferies.

Speaker #6: Our next question comes from Maury Raycroft with Jefferies.

[Analyst] (Jefferies): Hi. This is Amy on for Maury. Thank you for taking our questions, and congratulations on the strong quarter. We have two questions. One is a follow-up. Can you talk more about actually currently the refill rate and the dynamics, and how do you think the refill pattern will evolve in 2026 as the patient base broadens? The second question is, can you talk more about how you see the sales shaping up for the rest of the year, and would you be possible to share guidance at some point? If not, what are the possible gating factors to do that? Thank you.

Speaker #12: Hi, this is Amy from Maury. Thank you for taking our questions, and congratulations on the strong quarter. We have two questions—one is a follow-up.

Speaker #12: Can you talk more about Ectorly, currently the refill rate and the dynamics? And how do you think the refill pattern will evolve in 2026 as the patient-based burdens?

Speaker #12: The second question is can you talk more about how you see the sales shaping up for the rest of the year? And would you be possible to share guidance at some point?

Speaker #12: And if not, what are the possible gating factors to do that? Thank you.

Benjamin Palleiko: Yeah. I'll start with the second question, then Nicole will pick up on the refill rates. You know, again, I think as is the norm with companies of our stage in a launch and activity level, we're just not in a position to provide guidance at this point. Again, for us, every quarter is the first quarter we've done this, and so for us to make any long-term projections right now, I think we would probably not be helpful and maybe defeating to everybody's activities.

Ben Palleiko: Yeah. I'll start with the second question, then Nicole will pick up on the refill rates. You know, again, I think as is the norm with companies of our stage in a launch and activity level, we're just not in a position to provide guidance at this point. Again, for us, every quarter is the first quarter we've done this, and so for us to make any long-term projections right now, I think we would probably not be helpful and maybe defeating to everybody's activities.

Speaker #13: Yeah, I'll start with the second question, and then Nicole will pick up on the refill rates. Again, I think, as is the norm with companies of our stage in the launch and activity level, we're just not in a position to provide guidance at this point.

Speaker #13: Again, for us, every quarter is the first quarter we've done this. And so, for us to make any long-term projections right now, I think would probably not be helpful and maybe defeating to everybody's activities.

Benjamin Palleiko: What we do try to, though, is just convey what we are seeing that's been consistent, and that just ties back to what I said to Stacy a minute or two ago, just about how the launch continues to be quite consistent in terms of patient demand metrics, and all the other metrics that flow from that. Patient commercial starts, refill rates, all that stuff also continues to trend in a favorable direction with really no dramatic shifts noted or expected. With that, I'll turn it over to Nicole to talk about the refill question.

Ben Palleiko: What we do try to, though, is just convey what we are seeing that's been consistent, and that just ties back to what I said to Stacy a minute or two ago, just about how the launch continues to be quite consistent in terms of patient demand metrics, and all the other metrics that flow from that. Patient commercial starts, refill rates, all that stuff also continues to trend in a favorable direction with really no dramatic shifts noted or expected. With that, I'll turn it over to Nicole to talk about the refill question.

Speaker #13: So what we try to do is just convey what we do, what we are seeing that's been consistent, and that just ties back to what I said to Stacy a minute or two ago, just about how the launch continues to be quite consistent in terms of patient demand metrics.

Speaker #13: And all the other metrics that flow from that, patient commercial starts, refill rates, all that stuff. Also continues to trend in a favorable direction with really no dramatic shifts noted or expected.

Speaker #13: With that, I'll turn it over to Nicole to talk about the refill question.

Nicole Sweeny: Sure. Absolutely. As mentioned earlier with refills, we typically see 1 to 3 cartons per refill. When we discuss our high burden patients, those individuals are typically receiving more on the 2 to 3 cartons, on a regular basis, and that regular basis being, you know, every 1 to 2 months. When we take a look at those that have more mild to moderate burden of disease.

Speaker #12: Sure, absolutely. So, as mentioned earlier, with refills, we typically see one to three cartons per refill. And so, when we discuss our high-burn patients, those individuals are typically receiving more in the two to three carton range.

Speaker #12: On a regular basis—and that regular basis being every one to two months. And then when we take a look at those that have more mild to moderate burden of disease, they're really averaging more on the lower end of that, one to three.

Nicole Sweeny: They're really averaging more on the lower end of that 1 to 3, so typically 1 to 2 cartons. The frequency of which we would expect would really line up more with what we see with some of the other on-demand therapies in terms of them refilling approximately 3 to 4 times a year. Okay, thank you. Sure.

Speaker #12: So, typically, one to two cartons. And the frequency that we would expect would really line up more with what we see with some of the other on-demand therapies, in terms of them refilling approximately three to four times a year.

Speaker #6: Okay. Thank you.

Speaker #8: Sure.

Operator: Our next question comes from Joseph Schwartz with Leerink.

Speaker #6: Our next question comes from Joseph Schwartz with Leerink.

[Analyst] (Leerink Partners): Hey, everyone. This is Will on for Joe. Thanks for taking our questions today. Congrats on the progress this quarter. It's great to see the penetration into the US market continue to grow at such a strong rate at this very early stage in the launch. As we think about it moving forward, where do you expect things to eventually settle out? And how does that inform the growth of the on-demand market from $650 million to $1.5 billion? Thank you.

Speaker #14: Hey, everyone. This is Will. I'm for Joe. Thanks for taking our questions today. Congrats on the progress this quarter. So it's great to see the penetration into the US market continue to grow at such a strong rate at this very early stage in the launch.

Speaker #14: And as we think about it moving forward, where do you expect things to eventually settle out? And what kind of peak penetration are you targeting?

Speaker #14: And how does that inform the growth of the on-demand market from $650 million to $1.5 billion? Thank you.

Benjamin Palleiko: Yeah, sure. Will, we believe this market over time should overwhelmingly convert to oral therapies. The injectables, obviously, everyone knows this, they're quite efficacious. They've served patients well for the past decade. You know, I think it's fairly obvious from just how EKTERLY's done to date, we've entered a new era here of therapeutics in HAE and orals that offer all the benefits of the injectables with none of the burdens of the injectables, just are a better option for patients, just the classic sort of dominant choice. We do believe that over the next several years, to a very high rate, the market should transition to orals. You know, that's a key underlying expectation here.

Ben Palleiko: Yeah, sure. Will, we believe this market over time should overwhelmingly convert to oral therapies. The injectables, obviously, everyone knows this, they're quite efficacious. They've served patients well for the past decade. You know, I think it's fairly obvious from just how EKTERLY's done to date, we've entered a new era here of therapeutics in HAE and orals that offer all the benefits of the injectables with none of the burdens of the injectables, just are a better option for patients, just the classic sort of dominant choice. We do believe that over the next several years, to a very high rate, the market should transition to orals. You know, that's a key underlying expectation here.

Speaker #13: Yeah. Sure. Will, we believe this market over time should overwhelmingly convert to oral therapies. The injectables, obviously, everyone knows this. They're quite efficacious. They've served patients well for the past decade.

Speaker #13: But I think it's fairly obvious from just how Ectorly has done to date. We've entered a new era here of therapeutics in HAA. And orals that offer all the benefits of the injectables with none of the burdens of the injectables.

Speaker #13: Orals are a better option for patients, just the classic sort of dominant choice. And so we do believe that over the next several years, to a very high rate, the market should transition to orals.

Speaker #13: So, that's a key underlying expectation here. And as part of that transition to orals, what you should also see is treatment rates go higher.

Benjamin Palleiko: As part of that transition to orals, what you should also see is treatment rates go higher. Right now, again, it's kinda commonly accepted, and this has been talked about many times in many different venues, that something between, you know, 50% and 65%, you know, call it 60% plus or minus of attacks are treated at all nowadays. Setting aside the fact that late treatment is rife, you've only got, you know, slightly more than half the attacks under any circumstance that are treated, period. The point there is that as that attack rate goes up, obviously the usage of therapeutics to treat these attacks, you know, will obviously be substantially increased as well. The point there is that the market overall just gets larger.

Ben Palleiko: As part of that transition to orals, what you should also see is treatment rates go higher. Right now, again, it's kinda commonly accepted, and this has been talked about many times in many different venues, that something between, you know, 50% and 65%, you know, call it 60% plus or minus of attacks are treated at all nowadays. Setting aside the fact that late treatment is rife, you've only got, you know, slightly more than half the attacks under any circumstance that are treated, period. The point there is that as that attack rate goes up, obviously the usage of therapeutics to treat these attacks, you know, will obviously be substantially increased as well. The point there is that the market overall just gets larger.

Speaker #13: Right now, again, it's kind of commonly accepted and this has been talked about many times in many different venues that something between 50 and 65 percent, call it 60% plus or minus if attacks are treated at all nowadays.

Speaker #13: So, setting aside the fact that late treatment is rife, you've only got slightly more than half the attacks, under any circumstance, that are treated, period.

Speaker #13: And so the point there is that as that attack rate goes up, obviously the usage of therapeutics to treat these attacks will obviously be substantially increased as well.

Speaker #13: And so the point there is that the market overwhelm overall just gets larger. And that's really again, just driven by the fact that when you have the better option, to treat your attacks with, you'll treat more of your attacks.

Benjamin Palleiko: That's really, again, just driven by the fact that when you have a better option to treat your attacks with, you'll treat more of your attacks. We think the story of the on-demand market, coming back to your dollar size, is driven largely by just the, you know, that central fact that you now have just a much better choice. When you get to those numbers you just talked about, really, that's not even in our minds an aggressive growth belief. If you took the units that are sold today, which were right around 87,000 units last year, at the moment, the vast majority of those units are, in fact, generic to icatibant.

Ben Palleiko: That's really, again, just driven by the fact that when you have a better option to treat your attacks with, you'll treat more of your attacks. We think the story of the on-demand market, coming back to your dollar size, is driven largely by just the, you know, that central fact that you now have just a much better choice. When you get to those numbers you just talked about, really, that's not even in our minds an aggressive growth belief. If you took the units that are sold today, which were right around 87,000 units last year, at the moment, the vast majority of those units are, in fact, generic to icatibant.

Speaker #13: So we think the story of the on-demand market coming back to your dollar size is driven largely by just that—that centers have just a much better choice.

Speaker #13: And so when you get to those numbers you just talked about, really that's not even in our minds an aggressive growth belief. If you took the units that are sold today, which is right around last year was right around 87,000 units, at the moment, the vast majority of those units are in fact generic and catapath.

Benjamin Palleiko: That's the reason for the dollar size of the market today isn't anything having to do with lack of demand. It's just the fact that most of that demand is sold at a low price. Clearly, as we've talked about before, we're converting patients in this marketplace over to EKTERLY from all the therapies, which includes a lot of folks coming from generic. So obviously every time those folks switch from a generic, they're moving to a branded therapy. The overall market dollar size, if you will, increases with each conversion. Really that $0.5 billion TAM you mentioned a minute ago isn't, in our minds, an enormous lift. It's really just presuming that you convert the vast majority of the market over to orals.

Ben Palleiko: That's the reason for the dollar size of the market today isn't anything having to do with lack of demand. It's just the fact that most of that demand is sold at a low price. Clearly, as we've talked about before, we're converting patients in this marketplace over to EKTERLY from all the therapies, which includes a lot of folks coming from generic. So obviously every time those folks switch from a generic, they're moving to a branded therapy. The overall market dollar size, if you will, increases with each conversion. Really that $0.5 billion TAM you mentioned a minute ago isn't, in our minds, an enormous lift. It's really just presuming that you convert the vast majority of the market over to orals.

Speaker #13: And so that's the reason for the dollar size of the market today— it isn't anything having to do with lack of demand. It's just the fact that most of that demand is sold at a low price.

Speaker #13: Clearly, as we've talked about before, we're converting patients in this marketplace over to Ectorly from all the therapies, which includes a lot of folks coming from generic.

Speaker #13: And so, obviously, every time those folks switch them to generic, they're moving to a branded therapy. And so the overall market dollar size, if you will, increases with each conversion.

Speaker #13: And so really that one and a half billion dollar TAM you mentioned a minute ago isn't in our minds an enormous lift. It's really just presuming that you convert the vast majority of the market over to orals.

Benjamin Palleiko: Again, a lot of generic moves to branded pricing, and you have some. And that, the number you mentioned doesn't really become terribly ambitious in this manner, but it assumes that there's some growth in the marketplace based upon this higher treatment rate we talked about. Then on top of that, we've talked about a number of other more marginal impacts, people coming off of prophylaxis, things like that. But fundamentally, that number is really just reflecting more or less the current units converting over to branded, and then some increased treatment share, which again, I don't believe in the context of that number you talked about is terribly ambitious.

Ben Palleiko: Again, a lot of generic moves to branded pricing, and you have some. And that, the number you mentioned doesn't really become terribly ambitious in this manner, but it assumes that there's some growth in the marketplace based upon this higher treatment rate we talked about. Then on top of that, we've talked about a number of other more marginal impacts, people coming off of prophylaxis, things like that. But fundamentally, that number is really just reflecting more or less the current units converting over to branded, and then some increased treatment share, which again, I don't believe in the context of that number you talked about is terribly ambitious.

Speaker #13: So again, a lot of generic moves to branded pricing. And you have some and the number you mentioned doesn't really become terribly ambitious in this manner.

Speaker #13: But it assumes that there's some growth in the marketplace based upon this higher treatment rate we talked about. And then on top of that, we've talked about a number of other more marginal impacts.

Speaker #13: People coming off of prophylaxis. Things like that. But fundamentally, that number is really just reflecting more or less the current units converting over to branded and then some increased treatment share, which again, I don't believe in the context of that number you talked about is terribly ambitious.

[Analyst] (Leerink Partners): Super appreciate the color. Thank you.

Benjamin Palleiko: Happy to talk to you.

Ben Palleiko: Happy to talk to you.

Speaker #14: Super appreciate the color. Thank you.

Speaker #13: Happy to talk to you.

Operator: Our next question comes from Serge Bélanger with Needham.

Speaker #6: Our next question comes from Serge Belanger with Needham.

Serge Bélanger: Hi, good morning. Thanks for taking my questions and, nice Q1 preview. I guess first, regarding payer reimbursement and access, any updates there? I think in the past you had mentioned that most of the patient starts or prescriptions were being almost universally covered under medical exception. Just curious if there's been any change on that front. Secondly, I think in the past you've talked about potential use of EKTERLY as a short-term prophylactic. What does that market opportunity look like? And do you need to conduct clinical trials to capture that opportunity? Thanks.

Speaker #15: Hi. Good morning. Thanks for taking my questions. And nice 1Q preview. I guess first, regarding pay or reimbursement and access, any updates there? And I think in the past, you had mentioned that most of the patients' starts are prescriptions were being almost universally covered under medical exceptions.

Speaker #15: Just curious if there's been any change on that front. Secondly, I think in the past, you've talked about the potential use of Vectorly as a short-term prophylactic?

Speaker #15: What does that market opportunity look like? And do you need to conduct clinical trials to capture that opportunity? Thanks.

Benjamin Palleiko: Hey, Serge. It's good to hear from you, and thanks for all the questions. I think maybe Nicole can talk a bit about the reimbursement metrics. Then, I think we'd like to bring Paul into the conversation here and have him talk about the short-term prophylaxis, the work we're doing in that space and why we think it's important.

Ben Palleiko: Hey, Serge. It's good to hear from you, and thanks for all the questions. I think maybe Nicole can talk a bit about the reimbursement metrics. Then, I think we'd like to bring Paul into the conversation here and have him talk about the short-term prophylaxis, the work we're doing in that space and why we think it's important.

Speaker #13: Hey, Serge. Good to hear from you. And thanks for all the questions. I think moving to Cole can talk a bit about the reimbursement metrics.

Speaker #13: And then I think we'd like to bring Paul into the conversation here and have him talk about the short-term prophylaxis the work we're doing in that space and why we think it's important.

Nicole Sweeny: Sure. I'm glad to speak to you about the access side of things.

Nicole Sweeny: Sure. I'm glad to speak to you about the access side of things. We continue to convert paid patients across all the payers. Right now, we are leveraging a mix of medical exceptions as well as the EKTERLY policies where we have them in place. Those policies commonly are PA to label. There are some instances where we do have a step through icatibant, but given the experience that people have with that product, we're able to move those patients through, without delay. Right now, our payer team is very much focused on really those remaining large PBMs who we expect to formalize policies in the coming months. From our view, we're very much on track and looking to have really that steady state access realized later this year in 2026.

Speaker #16: Sure. I'm glad to speak to you about the access side of things. We continue to convert paid patients across all the payers. Right now, we are leveraging a mix of medical exception, as well as the Ectorly policies where we have them in place.

Benjamin Palleiko: We continue to convert paid patients across all the payers. Right now, we are leveraging a mix of medical exceptions as well as the EKTERLY policies where we have them in place. Those policies commonly are PA to label. There are some instances where we do have a step through icatibant, but given the experience that people have with that product, we're able to move those patients through, without delay. Right now, our payer team is very much focused on really those remaining large PBMs who we expect to formalize policies in the coming months. From our view, we're very much on track and looking to have really that steady state access realized later this year in 2026.

Speaker #16: Those policies commonly are PA to label. There are some instances where we do have to step through a Cataban. But given the experience that people have with that product, we're able to move those patients through without delay.

Speaker #16: Right now, our payer team is very much focused on really those remaining large PBMs who we expect to formalize policies in the coming months.

Speaker #16: So from our view, we're very much on track and looking to have really that steady-state access realized later this year and in 2026.

Paul Audhya: In terms of the STP opportunity, we currently still are thinking about this from a research perspective. There are ongoing studies. We've currently seen use in about 50 procedures that are fairly invasive, and so far the medication seems to work quite well. We're gonna share the data at upcoming clinical conference. We are initiating an additional trial to look at use in short-term prophylaxis. The reality is today, similar to the more general framework that injectable therapies are challenging to use in the setting of short-term prophylaxis, where the recommendation remains strong that for patients undergoing procedures that they have an STP, that is typically recommended as an IV C1 inhibitor. This gives patients an additional option to consider using their oral on-demand therapy in its stead.

Speaker #13: And Serge, in terms of the STP opportunity, we currently still are thinking about this from a research perspective. And so there are ongoing studies we've currently seen use in about 50 procedures that are fairly invasive and so far the medication seems to work quite well.

Speaker #13: We're going to share the data in the upcoming clinical conference. And we are initiating an additional trial to look at use in short-term prophylaxis. The reality is today, similar to the more general framework that injectable therapies are challenging to use, in the setting of short-term prophylaxis, where the recommendation remains strong that for patients undergoing procedures, that they have an STP, that is typically recommended as an IVC1 inhibitor.

Speaker #13: This gives patients an additional option to consider using their oral on-demand therapy in its stead. And so we're still evaluating what the opportunity there is, but the data to date are pretty encouraging.

Paul Audhya: We're still evaluating what the opportunity there is. The data to date are pretty encouraging, and it's a space to watch. I don't know if you want to add anything to that.

Speaker #13: And it's a space to watch. I don't know if you want to add anything to that. Yeah. Serge, it's really just to tie STP.

Benjamin Palleiko: Yeah. It's really just tied to STP. I mean, STP pediatrics, you know, at a high level, what we're really looking to do is continue to provide EKTERLY in places where we think it can address a meaningful unmet need. We haven't talked much about pediatrics today, but clearly that's a space where it's not a lot of patients. But the current options are very much undesirable. We think that EKTERLY, even though it's not going to come for another year or so, still will offer an opportunity for folks to really address the unmet need in this young population in a much better way than they can currently.

Ben Palleiko: Yeah. It's really just tied to STP. I mean, STP pediatrics, you know, at a high level, what we're really looking to do is continue to provide EKTERLY in places where we think it can address a meaningful unmet need. We haven't talked much about pediatrics today, but clearly that's a space where it's not a lot of patients. But the current options are very much undesirable. We think that EKTERLY, even though it's not going to come for another year or so, still will offer an opportunity for folks to really address the unmet need in this young population in a much better way than they can currently.

Speaker #13: I mean, STP, pediatrics—at a high level, what we're really looking to do is continue to provide Ectorly in places where we think it can address a meaningful unmet need.

Speaker #13: We haven't talked much about pediatrics today, but clearly, that's a space where it's not a lot of patients. But the current options are very much undesirable.

Speaker #13: And so we think that Ectorly, even though it's not going to come for another year or so, still will offer an opportunity for folks to really address that the unmet need in this young population in a much better way than they can currently.

Benjamin Palleiko: It may not be a huge economic pickup for us, but in terms of just expanding the availability of EKTERLY to populations that really could get benefit from it, we think it's substantial. STP is exactly the same thing. I don't think we're presenting this as an enormous step shift in terms of revenue opportunities. There's a high need nowadays for better ways for patients to treat themselves prior to their procedures. Based upon the data we've seen so far, we think EKTERLY holds a lot of promise in there. This really all just comes under the tent of EKTERLY really we do expect to become the foundational therapy for HA management. This is just two more ways that we expect to accomplish that.

Ben Palleiko: It may not be a huge economic pickup for us, but in terms of just expanding the availability of EKTERLY to populations that really could get benefit from it, we think it's substantial. STP is exactly the same thing. I don't think we're presenting this as an enormous step shift in terms of revenue opportunities. There's a high need nowadays for better ways for patients to treat themselves prior to their procedures. Based upon the data we've seen so far, we think EKTERLY holds a lot of promise in there. This really all just comes under the tent of EKTERLY really we do expect to become the foundational therapy for HA management. This is just two more ways that we expect to accomplish that.

Speaker #13: And so it may not be a huge economic pickup for us, but in terms of just expanding the availability of Ectorly to populations that really could get benefit from it, we think it's substantial.

Speaker #13: And STP is exactly the same thing. I don't think we're presenting this as an enormous step shift in terms of revenue opportunities, but there's a high need nowadays for better ways for patients to treat themselves prior to their procedures.

Speaker #13: Based upon the data we've seen so far, we think Ectorly holds a lot of promise in there. And so this really all just comes onto the tent of Ectorly really, we do expect to become the foundational therapy for HAD management.

Speaker #13: And this is just two more ways that we expect to accomplish that.

Operator: Our next question comes from Jonathan Wolleben with Citizens.

Speaker #6: Our next question comes from John Wallerman with Citizens.

[Analyst] (Citizens JMP Securities): It's Catherine on for John. I just have kind of a quick follow-up question to the kind of thought of patients switching from icatibant. Is it too early to be seeing any dent in the amount of prescriptions for generic icatibant? And is any of that data going to be kind of captured by you guys and shown, just kind of tracked how the launch of EKTERLY is impacting that generic market?

[Analyst] (Citizens): It's Catherine on for John. I just have kind of a quick follow-up question to the kind of thought of patients switching from icatibant. Is it too early to be seeing any dent in the amount of prescriptions for generic icatibant? And is any of that data going to be kind of captured by you guys and shown, just kind of tracked how the launch of EKTERLY is impacting that generic market?

Speaker #17: Thanks, Catherine, on for John. I think kind of a quick follow-up question to the kind of thought of patients switching from iCataban. Are you seeing any is it too early maybe to be seeing any dent in the amount of prescriptions for generic iCataban?

Speaker #17: And is any of that data going to be kind of captured by you guys and shown to kind of track how the launch of Ectorly is impacting that generic market?

Benjamin Palleiko: A couple things here. First of all, the vast majority, as you would expect at this point in the launch of people who are transitioning to EKTERLY still are in the process of switching over to EKTERLY. It's largely when we talk about the 1,700 start forms, it's start forms. Not all those people have moved to commercial. The number is still small enough that I think you probably wouldn't see a tremendous impact to date in that data if you were to look at it. I do think that as you play through the year, that will start to become more apparent.

Ben Palleiko: A couple things here. First of all, the vast majority, as you would expect at this point in the launch of people who are transitioning to EKTERLY still are in the process of switching over to EKTERLY. It's largely when we talk about the 1,700 start forms, it's start forms. Not all those people have moved to commercial. The number is still small enough that I think you probably wouldn't see a tremendous impact to date in that data if you were to look at it. I do think that as you play through the year, that will start to become more apparent.

Speaker #13: So a couple of things here. First of all, the vast majority as you would expect at this point in the launch, of people who are transitioning Ectorly still are in the process of switching over to Ectorly.

Speaker #13: And so, it's largely when we talk about the 1,700 start forms and all, it's start forms. Not all of those people have moved to commercial.

Speaker #13: And so you would—the number is still small enough that I think you probably wouldn't see a tremendous impact to date in that data if you were to look at it.

Speaker #13: But I do think that as you play through the year, that will start to become more apparent. But factually, we're still relatively early in the launch from a commercial shipments perspective.

Benjamin Palleiko: You know, factually, we're still relatively early in the launch, from a commercial shipments perspective, and so it's gonna take a little bit longer for what you talk about to play through.

Ben Palleiko: You know, factually, we're still relatively early in the launch, from a commercial shipments perspective, and so it's gonna take a little bit longer for what you talk about to play through.

Speaker #13: And so, it's going to take a little bit longer for what you talk about to play through.

[Analyst] (Citizens JMP Securities): Thanks, Joe.

[Analyst] (Citizens): Thanks, Joe.

Speaker #17: Thank you.

Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

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