Kalvista Pharmaceuticals Inc (KALV) 2026 Q3 法說會逐字稿

Good day and thank you for standing by. Welcome to KalVista Pharmaceuticals 2025, third-quarter financial update, and operating results conference call. (Operator Instructions)

您好，感謝您的耐心等待。歡迎參加 KalVista Pharmaceuticals 2025 年第三季財務更新與營運業績電話會議。（操作說明）

Please note that today's conference is being recorded. I will now hand a conference over to your first speaker, Ryan Baker, Head of Investor Relations. Please go ahead.

請注意，今天的會議正在錄影。現在我將把會議交給第一位發言人，投資者關係主管瑞安貝克。請繼續。

Thank you, operator. Good morning, everyone, and thank you for joining us to discuss KalVista Pharmaceuticals 2025 third-quarter financial update and operating results. Please note we'll be making certain forward-looking statements today. We refer you to Kalvista SEC filings for discussion of the risks that may cause actual results to differ from the forward-looking statements.

謝謝接線生。各位早安，感謝各位參加本次關於 KalVista Pharmaceuticals 2025 年第三季財務更新與經營業績的討論。請注意，我們今天將發表一些前瞻性聲明。有關可能導致實際結果與前瞻性聲明差異的風險，請參閱 Kalvista 向美國證券交易委員會提交的文件。

On the call with me today from KalVista are Ben Palleiko, Chief Executive Officer; Nicole Sweeny, Chief Commercial Officer; and Brian Piekos, Chief Financial Officer; Dr. Paul Audhya, our Chief Medical Officer.

今天與我通話的 KalVista 代表有：首席執行官 Ben Palleiko；首席商務官 Nicole Sweeny；首席財務官 Brian Piekos；以及首席醫療官 Paul Audhya 博士。

Ben will begin with a review of the company's progress during the three months ended September 30, including an overview of EKTERLY early launch both in the US and abroad, as well as other regulatory updates. Paul will give an update on recently presented data from our confident KID trial in HAE for children ages 2 to 11, as well as new patient satisfaction data. Nicole will review the company's commercial progress to date, and Brian will cover the company's financial statements for the most recent quarter. We will then open the call for questions.

Ben 將首先回顧該公司截至 9 月 30 日的三個月內的進展情況，包括概述 EKTERLY 在美國和海外的早期上市情況，以及其他監管更新。Paul 將介紹我們最近公佈的 2 至 11 歲兒童 HAE 的 KID 試驗的可靠數據，以及新的患者滿意度數據。妮可將回顧公司迄今為止的商業進展，布萊恩將介紹公司最近一個季度的財務報表。接下來我們將開放提問環節。

With that, I will now turn the call over to Ben.

接下來，我將把電話交給本。

Thank you, Ryan, and thank you everyone for joining us today. And I want to wish a Happy Veterans Day to all my fellow veterans listening in. We are highly encouraged by EKTERLY's first three months on the US market. Adoption has been steady and linear, with real-world utilization tracking as we expected. The takeaways are clear. Demand for EKTERLY is strong. It is being used to treat a significant number of HAE attacks, and it is meeting the expectations of people living with HAE for a highly efficacious and safe therapeutic alternative. We continue to believe that EKTERLY will evolve to become the foundational treatment for HAE.

謝謝你，瑞恩，也謝謝今天所有到場的各位。我謹向所有正在收聽的退伍老兵們祝愿，老兵節快樂！EKTERLY 進入美國市場前三個月的表現令我們倍感鼓舞。市場採用情況一直穩定且呈線性成長，實際使用情況追蹤也符合我們的預期。結論很明確。EKTERLY 的需求強勁。它被用於治療大量的 HAE 發作，並且滿足了 HAE 患者對高效、安全的治療替代方案的期望。我們仍然相信 EKTERLY 將發展成為 HAE 的基礎治療方法。

In addition, we are executing on our mission to bring EKTERLY to people living with HAE globally. The German launch is now underway, with initial uptake validating the ex-US interest in EKTERLY. The approval footprint continues to grow, with a recent approval in Australia, adding to the existing authorizations in the US, UK, EU, and Switzerland.

此外，我們正在努力實現我們的使命，將 EKTERLY 帶給全球患有 HAE 的人。德國市場現已啟動 EKTERLY 的推廣，初步的市場反應證實了美國以外的消費者對 EKTERLY 的興趣。該產品的獲批範圍持續擴大，最近又在澳洲獲得批准，此前已在美國、英國、歐盟和瑞士獲得授權。

In parallel, we continue to evaluate optimal strategies to expand access in geographies where we won't launch on our own. In addition to the collaborations we've previously announced, we anticipate that we will be completing more agreements later this year and in early 2026. We also continue to generate important new data to help educate the HAE community generally, as well as to demonstrate the real world benefit of EKTERLY to people living with HAE.

同時，我們繼續評估擴大在我們不打算自行推出的地區的市場覆蓋範圍的最佳策略。除了我們先前宣布的合作項目外，我們預計今年稍後和 2026 年初還將達成更多協議。我們也不斷產生重要的新數據，以幫助教育 HAE 患者群體，並向 HAE 患者展示 EKTERLY 的實際益處。

Last week during the American College of Allergy, Asthma, and Immunology meeting, we provided a report on the high satisfaction rates for patients in KONFIDENT F who'd switched to sebetralstat from injectable on-demand therapies. Additionally, interim results from our KONFIDENT-KID trial show that sebetralstat enabled early, effective, and safe treatment of HAE attacks in children ages 2 to 11. Paul will provide more detail on all of that in a minute.

上週，在美國過敏、氣喘和免疫學會會議上，我們提交了一份報告，指出 KONFIDENT F 研究中從按需注射療法轉而使用 sebetralstat 的患者滿意度很高。此外，我們的 KONFIDENT-KID 試驗的中期結果表明，sebetralstat 能夠對 2 至 11 歲兒童的 HAE 發作進行早期、有效和安全的治療。保羅稍後會詳細介紹這一切。

We've also continued to grow the key capabilities of the company demonstrated by the recent hires of Bilal Arif as our Chief Operating Officer and Linea Aspesi as Chief People Officer. Both bring decades of experience that will make them important contributors as we work to evolve KalVista into a leading rare disease company.

我們也不斷提升公司的關鍵能力，最近聘請了 Bilal Arif 擔任首席營運官，Linea Aspesi 擔任首席人力資源官，就證明了這一點。他們兩人都擁有數十年的經驗，這將使他們成為我們努力將 KalVista 發展成為領先的罕見疾病公司的重要貢獻者。

Finally, with our recent convertible node offering, we are fully financed through profitability, allowing us to remain sharply focused on executing the EKTERLY launch while evaluating additional growth opportunities. I will now turn the call over to Paul, who will update you on the latest data from KONFIDENT and KONFIDENT-KID.

最後，憑藉我們最近推出的可轉換節點，我們已透過獲利實現了完全融資，這使我們能夠繼續專注於執行 EKTERLY 的發布，同時評估其他成長機會。現在我將把電話交給保羅，他將向大家介紹 KONFIDENT 和 KONFIDENT-KID 的最新數據。

Thanks, Ben. I'm pleased to highlight that we continue to generate and publish important insights from our ongoing clinical trials, further building the case for actually across various patient segments. Starting with our late breaker at ACAAI, we provided a significant update on our registration of KONFIDENT-KID trial for sebetralstat trial set in children with HAE age 2 to 11.

謝謝你，本。我很高興地強調，我們不斷從正在進行的臨床試驗中獲得併發表重要見解，進一步證明了該療法對各個患者群體的實際療效。首先，我們在 ACAAI 會議上發布了最新進展，我們提供了關於 KONFIDENT-KID 試驗註冊的重大更新，該試驗旨在對 2 至 11 歲患有 HAE 的兒童進行 sebetralstat 試驗。

With 36 children enrolled, this is the largest trial ever conducted in the pediatric HAE population, and we are incredibly proud to have fully recruited it almost a year ahead of schedule. This speaks to the high level of unmet need for these children and their caregivers. A remarkable finding from the interim analysis is the extent to which this group of children is experiencing attacks. As of June 6, 2025, 65 attacks were treated by 26 children, translating to an attack rate of 0.8 attacks per patient per month. This far exceeds the historical understanding of attack frequency in this population.

本次試驗共招募了 36 名兒童，是迄今為止在兒科 HAE 族群中進行的最大規模的試驗，我們非常自豪地提前近一年完成了全部招募工作。這說明這些兒童及其照顧者存在著大量未被滿足的需求。中期分析的一個顯著發現是，這群孩子遭受攻擊的程度之深。截至 2025 年 6 月 6 日，26 名兒童共接受了 65 次攻擊治療，相當於每位患者每月發生 0.8 次攻擊。這遠遠超出了以往對該族群攻擊頻率的認知。

We believe that the high attack rate in KONFIDENT-KID reflects an accurate unmasking of the true disease burden that was previously hidden by the difficulties associated with administering and receiving injectable treatments. The invasive and burdensome nature of intravenous and subcutaneous on-demand treatments creates a powerful disincentive for children and their parents to seek treatment for anything but the most severe attacks. We believe that this has led to significant underreporting of attacks.

我們認為，KONFIDENT-KID 的高發病率準確地揭示了先前因注射治療的實施和接受困難而掩蓋的真實疾病負擔。靜脈注射和皮下注射等按需治療具有侵入性和負擔性，這使得兒童及其父母除了最嚴重的疾病發作外，幾乎沒有動力去尋求治療。我們認為這導致了襲擊事件的嚴重漏報。

The availability of an oral on-demand treatment fundamentally lowers the barrier to treatment. This allows for a high attack rate to be documented because children and their caregivers are no longer faced with the choice of enduring the trauma of an injection versus riding out a potentially worsening attack.

口服按需治療的出現從根本上降低了治療門檻。這樣一來，就可以記錄較高的發病率，因為兒童及其照顧者不再面臨忍受注射創傷還是忍受可能惡化的病情發作的選擇。

Returning to the results, treatment was rapid with caregivers or the children themselves administering sebetralstat ODT in a meeting of 30 minutes. This option, where children can actually treat themselves is a totally unique feature of KONFIDENT-KID and increases the importance of the results, as the inability to self-treat attacks by children is such a major issue with injectables.

回到結果，治療過程迅速，護理人員或兒童本人在 30 分鐘內即可服用 sebetralstat ODT。KONFIDENT-KID 的這項功能讓兒童能夠自行治療，這完全是其獨特的特點，也因此更加凸顯了治療效果的重要性，因為兒童無法自行治療是注射類藥物的一個主要問題。

The median time to symptom relief was a rapid 1.5 hours in the dosing group who experienced the vast majority of attacks. Crucially, there were no treatment-related adverse events or reports of difficulty swallowing the orally disintegrating tablets formulated for kids. These results further highlight EKTERLY's potential to expand to people of all ages living with HAE. We expect to submit the NDA for pediatrics in Q3 of 2026.

在接受治療的組別中，症狀緩解的中位數時間為 1.5 小時，該組經歷了絕大多數的發作。至關重要的是，沒有發生與治療相關的不良事件，也沒有報告兒童服用口崩片時出現吞嚥困難的情況。這些結果進一步凸顯了 EKTERLY 有望推廣至所有年齡層的 HAE 患者。我們預計將於 2026 年第三季提交兒科新藥申請。

Turning now to our long-term open label extension, confidence, we continue to amass a large volume of data collected under conditions that mimic real-world utilization. For October 31, the trial has accumulated over 22,700 attacks treated with EKTERLY. Notably, this includes 59 laryngeal attacks, 560 attacks in patients receiving long-term prophylaxis, and 584 attacks treated by adolescents. The highest number of attacks created by an individual participant is 118/23 months.

現在轉向我們的長期開放標籤擴展研究——信心，我們繼續累積在模擬真實世界使用條件下收集的大量數據。截至 10 月 31 日，該試驗已累積使用 EKTERLY 治療了超過 22,700 例癲癇發作。值得注意的是，其中包括 59 例喉部發作、560 例接受長期預防治療的患者發作，以及 584 例青少年接受治療的發作。單一參與者發動的最高攻擊次數為 118/23 個月。

As our patient experience has grown, we have observed key changes in dosing behavior. We focused on patients who reached 30 treated attacks, representing about one quarter of confidence participants. We noted a clear trend. The proportion of patients using a second dose of actually within 12 hours fell from 22.5% during the first attack to just 13.5% by the 30 attack. In the same group, the use of conventional injectable therapy dropped from 8% at the beginning of the trial to 0% by 30%.

隨著我們患者經驗的積累，我們觀察到用藥行為發生了關鍵性的改變。我們專注於接受過 30 次治療的患者，約佔信心參與者的四分之一。我們注意到一個明顯的趨勢。在第一次發作時，12 小時內使用第二劑藥物的患者比例為 22.5%，而到第 30 次發作時，這一比例僅為 13.5%。在同一組族群中，傳統注射療法的使用率從試驗開始時的 8% 下降到 30 歲時的 0%。

We believe these marked reductions in the use of a second dose or conventional therapy reflect patients' growing assurance and extra reliability. We plan to present this important data in more detail at an upcoming scientific congress.

我們認為，第二劑或常規療法使用量的顯著減少反映了患者日益增長的信心和額外的可靠性。我們計劃在即將召開的科學大會上更詳細地介紹這些重要數據。

Coming back to ACAAI, we presented new treatment satisfaction data from confidence and participants who had switched from injectable on-demand treatments to sebetralstat. The median satisfaction score for attacks treated with sebetralstat was two, or very satisfied on a seven point scale ranging from three, which was extremely dissatisfied to three, which was extremely satisfied.

回到 ACAAI，我們展示了新的治療滿意度數據，包括信心數據和從按需注射治療轉為 sebetralstat 的參與者數據。使用 sebetralstat 治療的發作的滿意度中位數為 2 分，即非常滿意（滿分 7 分），從 3 分（非常不滿意）到 3 分（非常滿意）。

Overall, 84% of attacks treated with sebetralstat were rated by participants as ranging from satisfied to extremely satisfied, with the vast majority being either very or extremely satisfied. The high satisfaction scores reported by patients who have successfully transitioned from injectable therapies to sebetralstat speak to the impact of having a simple, effective, and reliable oral on-demand treatment readily available.

總體而言，84% 的接受 sebetralstat 治療的病例被參與者評價為滿意或非常滿意，其中絕大多數病例的滿意度為非常滿意或極其滿意。從注射療法成功過渡到塞貝曲司他治療的患者所報告的高滿意度評分錶明，擁有簡單、有效、可靠的按需口服治療方案具有重要意義。

So what are the implications? We know that a patient's decision to switch medication is often a direct measure of their unmet need or dissatisfaction with their current regimen. Therefore, as patients achieve a high level of satisfaction with EKTERLY, the probability of them seeking to switch therapies in the future is expected to decrease. This supports EKTERLY's role as a foundational therapy for HAE for the long-term.

那麼，這意味著什麼？我們知道，患者決定更換藥物通常直接反映了他們未被滿足的需求或對當前治療方案的不滿。因此，隨著患者對 EKTERLY 的滿意度提高，預計他們將來尋求更換療法的可能性會降低。這支持了 EKTERLY 作為 HAE 長期基礎療法的地位。

To conclude, the breadth and depth of our clinical data coupled with a high level of patient satisfaction is translating into early commercial momentum. We're seeing strong uptake and growing confidence among prescribers as awareness actually continues to build. To discuss how the launch is unfolding, I'll now pass the call to Nicole.

總之，我們臨床數據的廣度和深度，以及患者的高度滿意度，正在轉化為早期的商業動能。我們看到處方醫生對該產品的接受度很高，信心也不斷增強，因為人們對該產品的認識確實在不斷提高。為了討論發布會的進展情況，我現在將電話交給妮可。

Thanks, Paul. I'm pleased to share that the US launch of EKTERLY continues to accelerate with sustained demand and growing enthusiasm among prescribers and patients. In less than four months since launch, we have received 937 start forms representing more than 10% of the HAE community. This level of early engagement is strong by any launch standard and reflects an extraordinary level of community adoption.

謝謝你，保羅。我很高興地宣布，EKTERLY 在美國的上市進程持續加速，處方醫師和病患的需求不斷增長，熱情也日益高漲。自推出以來不到四個月，我們已收到 937 份申請表，佔 HAE 社區的 10% 以上。這種早期參與度以任何發布標準來看都非常高，反映了社群的非凡接受度。

Importantly, this demand is broad-based. We are seeing rapid uptake across all HAE patient segments, including prophylaxis users as well as adolescents. People are switching from all on-demand therapies, but the greatest number have been from Frazier and Carbylan as expected, given their market share. Also, as we expected, the earliest and greatest number of those switching to EKTERLY have been high burden patients who experienced frequent attacks, whether or not they're on prophylactic therapy.

重要的是，這種需求基礎廣泛。我們看到 HAE 患者群體（包括預防性用藥者和青少年）對所有 HAE 患者的接受度都在迅速提高。人們正在從所有按需療法轉向其他療法，但正如預期的那樣，Frazier 和 Carbylan 的療法流失人數最多，這與它們的市場份額相符。此外，正如我們所預期的那樣，最早且數量最多的改用 EKTERLY 的患者是病情嚴重的患者，他們經常發作，無論他們是否接受預防性治療。

Provider activation is also expanding rapidly. We have 423 unique prescribers and continue to add three to four new prescribers each day. Awareness levels are exceptionally high, with 100% of Tier 1 HCPs and 95% of all target HCPs reporting awareness of EKTERLY . These metrics reflect both the strength of our field execution and the enthusiasm of the medical community for EKTERLY .

供應商啟動也在迅速擴展。我們有 423 位不同的處方醫生，每天都會新增三到四位處方醫生。民眾認知度極高，一級醫護人員的認知度為100%，所有目標醫護人員的認知度為95%。。這些指標既反映了我們現場執行的有效性，也反映了醫療界對 EKTERLY 的熱情。。

As prescribers gain more experience with EKTERLY and hear from their patients who have switched, their confidence continues to rise. Launched to date, repeat prescribers account for 75% of all EKTERLY start forms, a strong indicator of familiarity and trust in EKTERLY's profile.

隨著處方醫生對 EKTERLY 的使用經驗不斷積累，並聽取了改用該藥的患者的回饋，他們的信心也持續增強。迄今為止，重複處方醫生佔 EKTERLY 所有起始處方的 75%，這有力地表明了他們對 EKTERLY 的熟悉度和信任度。

This provider enthusiasm is matched by a strong depth of utilization in patients. Though the data is early, patients that are refilling their prescriptions, including those on quick start and paid therapy, are doing so every three to four weeks. For context, most injectable on-demand therapies average only three to four refills per year. This level of refill frequency is a clear indicator of growing real-world reliance and confidence in EKTERLY .

醫療服務提供者的熱情與患者的積極就診率相符。雖然數據還處於早期階段，但正在續開處方的患者，包括那些接受快速啟動和付費治療的患者，平均每三到四周續開處方。作為參考，大多數按需注射療法平均每年只需補充三到四次。這種高頻率的補貨顯示消費者對 EKTERLY 的實際依賴和信心正在不斷增強。。

Note that the majority of these refills are driven by patients with a high disease burden. They report experiencing two to four attacks per month, despite generally also being on prophylaxis therapy, which indicates the lack of adequate disease control.

請注意，這些續藥申請大多來自疾病負擔較重的患者。他們報告說，儘管通常也接受預防性治療，但每月仍會經歷兩到四次發作，這表明疾病控制不足。

Refill quantities are consistent with this level of burden and higher than our initial expectations. That all said, as adoption expands beyond the highest burden patients, we expect refill patterns to normalize in line with the broader HA community with both a lower frequency of refills and a lower volume of refill quantities. As demand continues to build, payers are actively moving toward formal coverage for EKTERLY .

補充裝的數量與目前的負擔程度相符，並且高於我們最初的預期。綜上所述，隨著普及範圍擴大到負擔最重的患者之外，我們預期續藥模式將與更廣泛的HA族群保持一致，續藥頻率和續藥量都會降低。隨著需求持續成長，支付方正積極推動將 EKTERLY 納入正式健保範圍。。

Since approval, patients have been able to leverage medical exception to gain access to EKTERLY . The medical exception approval rate and time of paid shipment are consistent with our expectations less than six months following approval. It is very encouraging that we have seen medical exceptions approved by all PBMs and all large payers for both commercial and medicare cases.

自獲批以來，患者已能夠利用醫療豁免獲得 EKTERLY 的使用權。。醫療豁免批准率和付費發貨時間均符合我們的預期，批准後不到六個月即可完成。令人鼓舞的是，我們看到所有藥品福利管理機構和所有大型支付方都已批准了商業保險和醫療保險的醫療例外情況。

We continue to advance formal access with multiple regional and national payers already establishing EKTERLY policies. The majority of policies are PA to label, which is consistent with other branded on-demand therapies. As expected, the minority of policies require a step through Acadiban, which patients are able to move through quickly as most HAE patients have experienced with generic Acadiban .

我們繼續推進正式准入，多家區域和國家支付方已經制定了 EKTERLY 政策。大多數政策是 PA 到標籤，這與其他品牌按需療法一致。正如預期的那樣，少數保險政策要求患者先使用阿卡地班，但由於大多數HAE患者之前都使用過阿卡地班仿製藥，因此他們通常能夠很快完成這一步驟。。

Our market access team is currently engaged with PBMs and remaining national payers with an aim to formalize access in early 2026. At this point in the launch, we are encouraged to see access to EKTERLY growing as payers recognize the need for EKTERLY as part of an overall HAE treatment plan.

我們的市場准入團隊目前正與藥品福利管理機構 (PBM) 和其餘國家支付方接洽，目標是在 2026 年初正式確定准入條件。在產品上市的這個階段，我們欣喜地看到，隨著支付方認識到 EKTERLY 作為 HAE 整體治療方案的一部分的必要性，EKTERLY 的可及性正在不斷提高。

Outside the United States, we are seeing early signs of momentum as we expand the reach of EKTERLY . Following EMA approval, we launched in Germany in mid-October and recorded first day commercial sales, an immediate validation of both prescriber enthusiasm and the strength of EKTERLY's differentiated oral on-demand profile.

在美國以外，隨著 EKTERLY 業務範圍的擴大，我們已經看到了初步的發展動能。。在獲得 EMA 批准後，我們於 10 月中旬在德國上市，並記錄了首日商業銷售額，這立即驗證了處方醫生的熱情以及 EKTERLY 差異化的按需口服特性的優勢。

In the UK, with approval now received, we are advancing pricing and reimbursement discussions with NICE in preparation for a first half 2026 launch. And in Japan, we continue to progress towards the PMDA approval and launch in the first-quarter of 2026 with our partner [Kain] Pharmaceuticals. Taken together, accelerating utilization, repeat prescribing, and growing favorable access provide a clear signal.

在英國，我們已獲得批准，正在與 NICE 推進定價和報銷方面的討論，為 2026 年上半年上市做準備。在日本，我們正與合作夥伴 [Kain] Pharmaceuticals 繼續推進獲得 PMDA 批准，並於 2026 年第一季上市。綜合來看，藥物利用率的提高、重複處方以及日益增長的良好可及性都發出了一個明確的信號。

EKTERLY is quickly on its way to becoming the foundational therapy for HAE treatment. What initially began with the highest burden patients is now expanding. In only a few short months across the broader HAE population, as physicians gain confidence and patients increasingly choose EKTERLY for their attacks.

EKTERLY 正迅速成為 HAE 治療的基礎療法。最初只針對負擔最重的患者，現在範圍正在擴大。在短短幾個月內，隨著醫生信心增強，越來越多的患者選擇 EKTERLY 來治療 HAE 發作，EKTERLY 在更廣泛的 HAE 人群中迅速普及。

I'll now turn the call over to Brian to review our financial performance.

現在我將把電話交給布萊恩，讓他來回顧我們的財務表現。

Thanks, Nicole. Our full financial results were included in the 10-Q filed after the close yesterday. So I will provide a few highlights for the three month period ending September 30.

謝謝你，妮可。我們的完整財務表現已包含在昨天收盤後提交的 10-Q 表格中。因此，我將重點放在截至9月30日的三個月期間的情況。

We are pleased to announce sales of equity were $13.7 million for the launch period through September 30, which includes the $1.4 million recorded in July and previously reported. Subsequent to the July period, our specialty pharmacy partners stocked additional locations and built inventory in a disciplined manner, supporting the growing patient demand.

我們很高興地宣布，截至 9 月 30 日的發行期內，股權銷售額為 1370 萬美元，其中包括 7 月份記錄的 140 萬美元，此前已報告。7 月之後，我們的特藥藥房合作夥伴有條不紊地在更多地點補充庫存，並建立了庫存，以滿足不斷增長的患者需求。

In the initial three month launch period, we are seeing the average number of cartons per shipment on the high end of our expected range, which aligns with utilization among high burden patients, the core of our early adopter base. When looking at gross to net, I note it came in toward the low end of our expected range this quarter, driven largely by lower copay utilization typical for this time of year.

在最初的三個月上市期內，我們發現每次發貨的平均紙箱數量處於預期範圍的高端，這與高負擔患者的使用情況相符，而高負擔患者正是我們早期採用者群體的核心。從毛利到淨利的比率來看，我注意到本季度該比率接近我們預期範圍的低端，這主要是由於每年這個時候的自付費用通常較低。

Shifting to expenses, total operating expenses for the period were $59.7 million, consisting of approximately $12 million in R&D expenses and approximately $46.5 million in SG&A expenses. Looking ahead to the remainder of 2025, we expect SG&A expenses to remain relatively consistent as we continue to invest in EKTERLY's global launch.

轉看支出，該期間的總營運支出為 5,970 萬美元，其中包括約 1,200 萬美元的研發支出和約 4,650 萬美元的銷售、一般及行政費用。展望 2025 年剩餘時間，我們預期銷售、一般及行政費用將保持相對穩定，因為我們將繼續投資 EKTERLY 的全球推廣。

Importantly, with our recent convertible note financing, our cash position is sufficient to fund operations through profitability. With that, I'll turn the call back to Ben for closing remarks.

重要的是，憑藉我們最近獲得的可轉換債券融資，我們的現金狀況足以支撐營運直至獲利。接下來，我將把電話轉回給本，請他作總結發言。

Thanks, Brian. The early momentum and rapid growth we described today reinforce our belief that EKTERLY is positioned for long-term success as market awareness continues to grow. Our near term focus is on aggressive and disciplined execution, scaling in the US, expanding access globally, and reinforcing confidence in the role of EKTERLY across the treatment landscape.

謝謝你，布萊恩。我們今天所描述的早期勢頭和快速增長，更加堅定了我們對 EKTERLY 的信念，即隨著市場認知度的不斷提高，EKTERLY 將迎來長期的成功。我們近期的重點是積極、有紀律地執行，在美國擴大規模，在全球範圍內擴大應用範圍，並增強人們對 EKTERLY 在整個治療領域中的作用的信心。

We continue to believe that oral on-demand therapy should broadly displace the injectable options and that EKTERLY will be the clear market leader based upon the breadth and depth of the data we have generated that shows EKTERLY can benefit all people living with HAE regardless of their attack location, frequency, or severity. We are and will remain the only company that has demonstrated in a clinical trial setting the effectiveness of our therapy for treatment of HAE attacks in accordance with modern treatment guidelines that call for patients to consider treating all attacks and to treat early.

我們仍然相信，按需口服療法應該會廣泛取代注射療法，並且根據我們產生的數據的廣度和深度，EKTERLY 將成為明顯的市場領導者，這些數據表明，無論 HAE 發作部位、頻率或嚴重程度如何，EKTERLY 都能使所有 HAE 患者受益。我們是並將永遠是唯一一家在臨床試驗中證明我們的療法能夠有效治療 HAE 發作的公司，符合現代治療指南，該指南要求患者考慮治療所有發作並儘早治療。

Through our gold standard design clinical trials and our many publications of the data, we've established a strong position as a patient-focused organization that is dedicated to improving lives, and I expect our reputation will continue to strengthen based upon our early success and our most recent data updates.

透過我們黃金標準的臨床試驗設計以及我們發表的大量數據，我們已確立了以患者為中心、致力於改善人們生活的強大組織地位，我預計基於我們早期的成功和最新的數據更新，我們的聲譽將繼續增強。

With strong execution, a clear strategic runway, and fully funded path through profitability, we believe we are well on our way to establishing EKTERLY as a foundational therapy for HAE and to generating long-term growth for the company.

憑藉強有力的執行力、清晰的策略規劃和充足的資金支持，我們相信，我們正朝著將 EKTERLY 確立為 HAE 的基礎療法並為公司帶來長期成長的目標穩步前進。

With that, we'll open the call for questions. Operator ?

接下來，我們將開始接受提問。操作員？

Thank you ladies and gentlemen. (Operator Instructions)

謝謝各位女士、先生。（操作說明）

Maury Raycroft, Jeffries.

莫里‧雷克羅夫特，傑弗里斯。

Hi, good morning. Congrats on the great quarter and thanks for taking my questions. Maybe to start off wondering if you could talk more about trends for types of patients who are switching back early on, particularly the high burden patients. Are you putting percentages on how the 937 forms break down and how could these trends change over time?

您好，早安。恭喜你本季取得佳績，謝謝你回答我的問題。或許可以先問問您是否能多談談早期轉回治療的患者類型趨勢，特別是高負擔患者。您是否對 937 表格的組成比例進行了統計，並分析了這些趨勢會如何隨時間變化？

Hey, Maury, thanks for joining today and thanks for the question. Nice to talk to you. I guess I'll start and maybe Nicole will add some other details. What's been, what was really important here when we launched EKTERLY was we always presumed that the most rapid adopters would be the people living with HAE who have a very high treatment burden. And we've talked about this for a long time, and I think there's been substantial questions, in some quarters about whether that patient population exists and also how severe their attack rates are.

嗨，莫里，感謝你今天參與節目，也感謝你提出的問題。很高興和你聊天。我想我會先開始，也許妮可會補充一些細節。一直以來，我們在推出 EKTERLY 時真正重視的一點是，我們始終認為最快接受產品的是患有 HAE 且治療負擔非常重的人。我們已經討論這個問題很長一段時間了，我認為在某些方面，人們對是否存在這樣的患者群體以及他們的發病率有多嚴重存在著相當大的疑問。

What we found through the third-quarter was that actually those people do exist and they are transitioning just as we would have expected. Roughly half of all the patients who have switched to EKTERLY to date, self-report an attack rate of two or more attacks per month, which we consider to be high burn.

我們在第三季發現，這些人確實存在，而且他們的轉變也正如我們所預期的那樣。迄今為止，大約有一半改用 EKTERLY 的患者自述每月發作兩次或兩次以上，我們認為這是高燒傷率。

And that accounts for, obviously a fair amount of the prescription, but also those people refill at higher rates and in larger quantities as well. So clearly the discovery we've made here is that that group really does exist, that they actually aren't well controlled on prophylaxis, and that their needs are being met by EKTERLY.

這顯然可以解釋相當一部分的處方藥用途，但這些人續藥的頻率更高，每次的續藥量也更大。因此，我們在這裡發現的顯然是，這個群體確實存在，他們的預防性治療效果並不理想，而 EKTERLY 正在滿足他們的需求。

In the longer run, obviously we expect that number to decline, right? That's a fairly small portion of the population, and as we broaden out EKTERLY's reach, the all those items will go down. The refill rates will decline, and the number of cartons per refill will also go down, but for now, that group seems to be getting a lot of benefits effectively just like we're anticipating.

從長遠來看，我們顯然預期這個數字會下降，對吧？這只佔人口的一小部分，隨著 EKTERLY 業務範圍的擴大，所有這些商品的銷售量都會下降。補充裝的次數將會減少，每次補充裝的紙盒數量也會減少，但就目前而言，該群體似乎確實像我們預期的那樣，獲得了許多實際的好處。

Yeah, just to add some further color on the patient base, as Ben was describing, these are patients with a high burden of disease who are also on prophylaxis and continue to have unmanaged HAE.

是的，為了進一步說明患者群體的情況，正如 Ben 所描述的那樣，這些患者疾病負擔很重，他們也在接受預防性治療，而 HAE 仍然沒有控制。

In terms of the product that they've been switching from, we see broad adoption or broad switching across all of the on-demand therapies. The vast majority of patients are switching from Firazyr [tocativan], which is very much in line with our expectations as in advance of approval. We often heard about the shortcomings of a subcu injectable. But again, very exciting and encouraging to see just the broad adoption across all of the different on-demand treatments.

就他們之前使用的產品而言，我們看到所有按需療法都得到了廣泛的採用或廣泛的轉換。絕大多數患者正在從 Firazyr [託卡替凡] 轉用，這與我們獲批前的預期非常吻合。我們常聽到皮下注射的缺點。但再次強調，看到各種需要治療方案被廣泛採用，真的令人非常興奮和鼓舞。

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

知道了。這是一個很有幫助的觀點，然後或許可以針對 937 個新項目做一個後續跟進。您是想進一步說明有多少人最終會染上毒癮，還是想細分一下付費毒品和免費毒品的情況？

Yeah, so from an access standpoint, we are very encouraged by the continued increase in paid. Week to week, we see the pay rate continue to grow and we've seen successful use of the medical exception, both in terms of consistency, over time as well as I should add, more recently as the EKTERLY policies have started to come into play, we're seeing clarity in terms of path forward for patients to gain access to EKTERLY. So overall at this point in time, certainly our paid and the access dynamics are unfolding as we'd expect.

是的，從准入角度來看，付費用戶持續成長令我們感到非常鼓舞。每週我們都看到支付率持續增長，而且我們看到醫療例外條款得到了成功運用，無論是從穩定性方面來看，還是從最近 EKTERLY 政策開始實施來看，我們都看到了患者獲得 EKTERLY 的途徑變得更加清晰。所以總的來說，就目前而言，我們的付費和訪問動態肯定是按照我們預期的那樣展開的。

And more for perfect clarity because I don't know if this is where we're going, all those start forms reflect prescriptions. Those are people who are actually switching to EKTERLY as the form is inherently tied to a prescription for that person to switch.

而且，為了更清晰地表達，因為我不知道我們是否要朝著這個方向發展，所有這些起始形式都反映了處方。這些人實際上是在改用 EKTERLY，因為這種劑型本身就與該人的處方有關，所以他們才能改用 EKTERLY。

Got it all helpful. Okay, thanks for taking my questions.

都很有用。好的，謝謝您回答我的問題。

Stacy Ku, TD Cowan.

Stacy Ku，TD Cowan。

Hey, good morning. Congrats on a great quarter and thanks so much for taking your questions. So the first is just a follow-up. Are you willing to talk a little bit more about these refill rates or maybe disclose on average number of doses for these high burden patients and maybe help us compare that to where you would expect things to normalize, especially given your work with claims data. And of course, as it relates to pair willingness to treat these high burden patients, maybe talk about the quantity limits that you're seeing for chronic use of EKTERLY. So that's the first question.

嘿，早安。恭喜你本季表現出色，非常感謝你回答大家的問題。所以第一點只是後續。您能否再詳細談談這些續藥率，或透露這些高負擔患者的平均劑量，並幫助我們將其與您預期情況正常化時的劑量進行比較，特別是考慮到您在理賠數據方面的工作經驗。當然，就治療這些高負擔患者的意願而言，或許可以談談你看到的 EKTERLY 長期使用的數量限制。這是第一個問題。

And then the second question is just maybe, as we look to the commentary, you're kind of trying to highlight for us around this patient bolus dynamics that you're seeing. Just help us understand what that means for the remainder of the year versus what we've seen in Q3. And of course, putting you a little bit on the spot here as we look to next year, again, still really early days, we totally understand that, but just your level of comfort around consensus as we think about the 937 patient platform forms that you've already grabbed in '25. Thanks so much.

那麼第二個問題是，當我們查看評論時，您是否試圖向我們重點介紹您所觀察到的患者推注動力學？請幫助我們理解，與第三季的情況相比，這對今年剩餘時間意味著什麼。當然，展望明年，現在還處於非常早期的階段，我們完全理解這一點，但考慮到您在 2025 年已經獲得了 937 個患者平台表格，您對達成共識的接受程度如何？非常感謝。

Thanks, Stacy, for all the questions. We'll work our way around the room here to answer them. So on the first one you asked about refill rates. Our presumption going into this when you look at claims data is that the average person with HAE is refilling about once every three to four months. And that will normally be with, Firazyr, or Acadibanis typically sold in packs of three. So that will typically be at least three doses, and maybe multiple packs because actually, I think the average rate of refill is higher than that.

謝謝斯黛西提出的所有問題。我們將依序回答這些問題。所以，你第一個問題問的是補充率。根據理賠數據，我們假設患有 HAE 的普通人大約每三到四個月需要補充一次藥物。而且通常會與 Firazyr 或 Acadibanis 一起出售，通常以三包的形式出售。所以通常至少需要三劑，甚至可能需要多盒，因為實際上，我認為平均補充頻率會更高。

What we've seen to date, driven again by this high burn population has been refill frequencies of probably, less, kind of a third that frequent, maybe, once a month or even more frequently than that. So these people are very high, are have in some cases very high attack rates, and so they're refilling quite frequently, and they are frequent and they are when they refill, typically refilling with multiple cartons at a time. So it's many more doses than we would expect on average.

到目前為止，我們看到的情況是，在高消費人口的推動下，補充頻率可能減少了三分之一，也許一個月一次，甚至更頻繁。所以這些人的水平很高，在某些情況下攻擊率也很高，因此他們補充毒品的頻率相當高，而且他們補充毒品的頻率很高，通常一次補充好幾箱。所以劑量比我們預期的平均劑量多得多。

As I said, in the last answer, that's because of this subpopulation that has come naturally early as we go over time, certainly we'd expect those rates to normalize more towards what you see in the catavan type marketplace where you've got refills that are multiple months apart and probably on average volumes will be lower. In terms of quantity limits, and they actually want you to take it the landing.

正如我在上一個回答中所說，這是因為隨著時間的推移，這個亞群自然而然地提前出現，我們當然希望這些比率能夠更加正常化，更接近你在卡塔萬類型的市場中看到的情況，在那裡，補給間隔數月，平均數量可能會更低。就數量限製而言，他們實際上希望你把它帶到著陸點。

Sure, I'm glad to step in. Quantity limits are certainly the norm for the current branded on-demand treatments, and it is something that we're seeing and expected to see with EKTERLY. Having said that, to date, the quantity limits that we're facing with EKTERLY again very consistent with the other products and have not created impediment to a patient continuing to gain access to EKTERLY. And historically there are means to overcome quantity limits should we end up in that situation on a patient basis.

當然，我很樂意幫忙。目前品牌按需護理產品的數量限制已成為常態，我們已經看到 EKTERLY 也採用了這種做法，並且預計未來也會如此。話雖如此，到目前為止，我們面臨的 EKTERLY 數量限制與其他產品非常一致，並沒有對患者繼續獲得 EKTERLY 造成阻礙。從歷史上看，如果我們最終陷入這種局面，也有辦法以病人為單位克服數量限制。

Also just to transition to your question regarding demand for the remainder of the year, certainly we recognize going into the holiday season, there are time out of office for physicians and for staff as well as just a very busy time for all of us. So we do anticipate potential disruption, to demand in the remainder of 2025.

另外，關於您提出的今年剩餘時間的需求問題，我們當然知道，進入假期後，醫生和工作人員都會有休假時間，而且對我們所有人來說，那也是一段非常忙碌的時期。因此，我們預計 2025 年剩餘時間內需求可能會受到干擾。

And did you want to talk to (technical difficulty)

你想跟誰談？（技術難題）

Yeah, on consensus, Stacy, as what we see on our end, there's quite a range in the consensus, I think, over a threefold GAAP we understand the challenges of modeling this new prescription that is an on demand therapy, it is challenging, the slow and complicated is we changed our fiscal year now to a calendar year basis, and I'm not sure all the estimates have caught up to that, and so.

是的，Stacy，就我們這邊看到的共識而言，我認為共識的範圍相當大，超過三倍的GAAP，我們理解對這種按需療法進行建模的挑戰，這很有挑戰性，緩慢而復雜，因為我們現在將財政年度改為日曆年，我不確定所有的估計都已經跟上了，所以。

I think that dispersion in estimates is warranted as we kind of really figure out what utilization will look like over the long-term.

我認為，在真正弄清楚長期利用率會是什麼樣子之前，估計值出現差異是合理的。

Okay, understood. And then just to confirm, a carton is two doses, correct?

好的，明白了。最後再確認一下，一盒是兩劑，對嗎？

Yes.

是的。

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

精彩的。非常感謝您解答我們所有的問題。

Paul Matteis, Stifel.

Paul Matteis，Stifel。

Hi, this is Matthew on for Paul. Thanks so much for taking our question and congrats on all the progress. I guess I just wanted to better understand with the multiple cartons per shipment, is -- do you think there's any stockpiling behavior within the patients just given how convenient it is to have this oral and the storage is easier, and, I guess, yeah, how do you see that evolving in the future? Thank you.

大家好，我是馬修，替保羅報道。非常感謝您解答我們的問題，也恭喜您取得的所有進展。我想更了解一下，每次出貨都使用多個紙箱，您認為病患是否會因為口服藥物的便利性和儲存的便利性而出現囤積行為？我想，您認為這種情況未來會如何發展？謝謝。

That we don't know. Understand. Well, factually we don't know, right? We got put on mute by accident for a second there. People don't have to tell us what's happening. Given that the self-reported attack rate among these folks is quite high, we do think there's obviously a high level of utilization there, but I don't know that we could allocate between how much they're storing it up like as they probably should really to have in place where they can access it when they have attacks versus actually using it.

我們不知道。理解。事實上我們並不知道，對吧？我們剛才不小心被靜音了一秒鐘。人們不必告訴我們發生了什麼事。鑑於這些人的自我報告攻擊率相當高，我們認為顯然存在很高的利用率，但我不知道我們能否區分他們儲存了多少資料（他們可能真的應該這樣做，以便在遭受攻擊時可以存取這些資料），以及他們實際使用了多少資料。

Again, stepping back a little bit, whether it's because of initial, some type of initial stockpile, although again, these refill rates have been pretty consistent or usage. Like I said, as the -- as we expand further into the population, we do expect the overall attack rates to normalize more towards what you see in the population as a whole. That means that again usage would probably be less on average, refills will be less frequent on average, and the volumes per refill will come down to some extent.

再退一步說，無論是由於最初的某種初始儲備，還是由於其他原因，儘管這些補充速度一直相當穩定，或者說是使用情況。正如我所說，隨著我們進一步擴大研究範圍，我們預計整體感染率將更加趨於正常化，與整個人群的感染率相符。這意味著平均使用量可能會減少，平均補充頻率會降低，每次補充的量也會下降。

But even people that don't really have a high attack rates when they do. Refill seem to be refilling at higher levels than we expected. That's probably maybe more indicative of stockpile than I think the really high attack ratefills. I don't know if you

但即使是那些攻擊率不高的人，他們也會這樣做。補貨速度似乎比我們預期的還要快。這或許更能說明庫存問題，而不是像我認為的那樣，是高攻擊率填充的問題。我不知道你是否

Yeah, it's just a reminder that the treatment guidelines that physicians have developed both in the US and around the world do encourage the patients keep products on hand to treat multiple attacks, two to three attacks, and so that is something that is fairly common in terms of practice here with patients in the US.

是的，這只是提醒大家，美國和世界各地的醫生製定的治療指南都鼓勵患者隨身攜帶藥物以應對多次發作（兩到三次），因此，這在美國的患者中是一種相當常見的做法。

Okay, thank you. That's very helpful.

好的，謝謝。那很有幫助。

Joe Schwartz, Leering Partners.

Joe Schwartz，Leering Partners。

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

太好了，非常感謝。很高興看到，根據我們的計算，PSS 的成長率在您目前的前幾次更新中保持相當穩定。你認為這種相對線性的PSF成長率會持續下去嗎？您認為在產品上市幾個月後或整體滲透率達到一定程度後，PSF 的成長速度會逐漸放緩嗎？

And then, XUS, it was great to see the German launches underway. What is the price you agreed upon in Germany and how does that compare to the US. Thanks.

還有XUS，很高興看到德國的發表會正在進行中。你們在德國談妥的價格是多少？與美國的價格相比如何？謝謝。

Joe, thanks for the questions. So the PSF rates have been quite consistent, as we've indicated through the first now four months of the launch. As Nicole said a few minutes ago, we do, the fourth-quarter here and especially the November, December as we get to the holidays is definitely a time when we wouldn't be surprised if the numbers slow a bit, right? I mean, people just aren't going to be going to their physicians for this type of thing over the holidays.

喬，謝謝你的提問。因此，正如我們在推出後的前四個月所指出的那樣，PSF 價格一直相當穩定。正如妮可幾分鐘前所說，我們確實認為，第四季度，特別是 11 月和 12 月，隨著假期的臨近，如果數字有所放緩，我們不會感到驚訝，對吧？我的意思是，人們在假期期間根本不會因為這種小病去看醫生。

So, we would expect that there'll be some slowing in the fourth-quarter really just driven by the kind of seasonality of the thing. As we get into 2026, again, we think the fundamentals on demand are really good, right? People seem to be still getting these appointments at a quite a consistent clip. Inexorably over time, the rate of par forms will slow down to some extent, just as we get deeper into the patient population.

因此，我們預計第四季度會出現一些放緩，這主要是由季節性因素造成的。展望 2026 年，我們認為需求的基本面依然非常好，對吧？人們似乎仍然能夠以相當穩定的速度預約到這些服務。隨著我們對患者群體了解的深入，隨著時間的推移，部分病例的發生率必然會在一定程度上放緩。

But at this point, we really don't have enough information to give any indication of whether that's earlier or later in 2026. But the clip we're on now, while we're quite happy with it, certainly we wouldn't really expect it to be this fast paced all of 2026. So that's the first part, okay.

但目前我們還沒有足夠的資訊來表明這會在 2026 年的早期還是晚期發生。但就我們目前所處的階段而言，雖然我們對此相當滿意，但我們當然不會期望 2026 年全年都保持這種快節奏。好了，第一部分就到這裡。

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

所以德國的售價，目前還不能透露。目前我們才剛開始在德國開展業務，我們將與德國當局進行持續的談判和討論。所以這當然是我們可以在新的一年重新探討的問題。

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

好的，那麼1926年其他歐洲國家的情況又是如何呢？那裡有什麼計劃？

Certainly we have approval in the UK and so that is something we're in active discussions with NICE and planning for a launch in the first half of 2026 as well as moving out to some of the other larger countries in Europe towards the end of 2026.

當然，我們已獲得英國的批准，因此我們正在與 NICE 積極討論此事，並計劃在 2026 年上半年推出，同時在 2026 年底推廣到歐洲其他一些較大的國家。

[John Walleran, Citizens Bank].

[約翰‧沃勒蘭，公民銀行]

Hey, congrats on the progress and thanks for taking the question. When you guys talk about kind of normalization of these rates, I'm wondering if you talk a little bit about your expectations for how many patients do you expect to ultimately be trialing externally because the high burden makes sense now, but do you think that this is going to be broad across people with low burden as well, or is it going to be a majority of these high burden patients over time?

嘿，恭喜你取得進展，謝謝你回答這個問題。當你們談到這些比率的正常化時，我想知道你們能否談談你們對最終會有多少患者參與外部試驗的預期，因為目前高負擔是合理的，但你們認為這也會廣泛適用於低負擔人群，還是隨著時間的推移，只會是這些高負擔患者中的大多數？

And then in the prepared remarks you mentioned gross net towards the low end of your expected range. I was hoping you could just remind us of what that expected range is. Thanks.

然後在事先準備好的發言稿中，您提到毛利潤淨額接近預期範圍的下限。我希望您能提醒我們一下預期範圍是多少。謝謝。

Sure, I'll do the first part. The, again, John, we do fundamentally expect oral therapies to displace the injectables. I think we're fairly, conclusively shown that EKTERLY offers all the benefits of the existing [AA] therapies with much better, equivalent efficacy in all likelihood, right? We haven't, it hasn't been done, shown head to head, but I think people generally accept that the safety's been pristine so far. There's really no advantage to anyone's use, continue to use an injectable or an IV therapy.

當然，我會做第一部分。約翰，我們再次強調，從根本上講，我們確實預期口服療法將取代注射療法。我認為我們已經相當確鑿地證明，EKTERLY 具有現有 [AA] 療法的所有優點，而且很可能療效更好、相當，對嗎？還沒有，也沒有人做過直接對比，但我認為人們普遍認為到目前為止，安全性方面做得非常完美。繼續使用注射劑或靜脈輸液療法對任何人都沒有實際好處。

So on a fundamental level, we do expect the orals to overtake the injectables over time. And so there's the -- there's a sort of high level, how the market evolves in our viewpoint. That does, to your point about whether the rate slows as you move into lower usage people, that's certainly likely, right? There's definitely just like there's a very high burden population, there's, we presume a commensurate very low burden population. That may be less inclined to move over time.

因此從根本上講，我們預計口服藥物最終會超過注射藥物。所以，從某種宏觀層面來說，這就是我們眼中市場的發展演變。確實如此，關於隨著使用量降低的人群數量增加，增長率是否會放緩的問題，這當然很有可能，對吧？就像存在一個疾病負擔非常重的群體一樣，我們推測也存在一個疾病負擔非常輕的群體。隨著時間的推移，它可能不太容易移動。

To date we have seen people across the board switching actively. It, I mean, again, we said we've seen certainly the high population be, up through the third-quarter half of those folks, but the other half are much more of a of a distribution of attack rates. So the urgency may not be as high as we move deeper into the market, but we do think the fundamentals are that people will switch over time.

到目前為止，我們已經看到各行各業的人們都在積極地進行轉換。我的意思是，我們再次說過，我們已經看到人口數量確實很高，到第三季度為止，這些人中有一半感染了病毒，但另一半的感染率分佈則更加分散。因此，隨著我們深入市場，緊迫性可能不會那麼高，但我們認為，從根本上來說，人們會隨著時間的推移而轉變。

I mean, a lot, there's certainly a lot of folks who we believe are still a little bit and see how it's working for someone they know before they switch, some of these, folks will have tried or [adeo] before and maybe not have a satisfactory response and so, we don't, we do anticipate there could be a little bit of initial caution about another oral therapy.

我的意思是，確實有很多人，我們相信他們仍然會有些猶豫，看看他們認識的人使用後效果如何，然後再決定是否要更換藥物。這些人中有些可能以前嘗試過其他藥物，但可能沒有得到滿意的回饋。因此，我們預計，對於另一種口服療法，人們最初可能會有些謹慎。

But again, given the anecdotal reports we've seen so far and just the commentary we've heard from physicians who talked to their patients, we think people are exceedingly satisfied right now and we do believe that that will play through over time and that will bring these people who may be less motivated for whatever reason, right, initially to move, to switch over to EKTERLY and it's in a timely fashion, if you want.

但話說回來，根據我們目前看到的軼事報導以及我們從與患者交談過的醫生那裡聽到的評論，我們認為人們現在非常滿意，我們相信隨著時間的推移，這種滿意度會持續下去，這將促使那些最初可能由於各種原因動力不足的人，及時地轉向 EKTERLY，如果你願意的話。

Yeah, I would just offer that, building upon Ben's point, anecdotal feedback as well as market research we've conducted with patients. We see very high satisfaction ratings both with patients who have a high burden of disease as well as patients with a more moderate or lower burden of disease and that satisfaction relates specifically to EKTERLY as well as with our patient support services that receives high marks in terms of supporting patients to gain access.

是的，我只想補充一點，在 Ben 的觀點基礎上，結合一些軼事回饋以及我們對患者的市場調查。我們看到，無論是疾病負擔較重的患者，或是疾病負擔較輕或中等的患者，都對 EKTERLY 的滿意度非常高。這種滿意度尤其體現在 EKTERLY 本身，以及我們為患者提供支持服務方面，這些服務在幫助患者獲得治療方面獲得了很高的評價。

And suspected gross to net, John, like other specialty medicines, we expect to see gross to net to be on average, upper 10s, low 20s.

約翰，我們懷疑毛利淨利與其他專科藥物一樣，預計平均毛利淨利將在 10% 到 20% 之間。

Got it. All right, thanks for the call guys.

知道了。好的，謝謝各位來電。

Sergey Belanger, Needham, and Company.

Sergey Belanger，Needham公司。

Good morning. Congrats on the quarter. First question, I wanted to go back to your initial focus on high burden patients. Is that just a function of the market or the docs that you prescribers that you have initially targeted, and are they using these higher burden patients as leveraging them to get experience with the product and familiarity.

早安.恭喜你本季取得佳績。第一個問題，我想回到您最初關注的高負擔患者群體。這僅僅是市場或你最初瞄準的醫生們的功勞嗎？他們是否利用這些負擔較重的患者來累積產品經驗和熟悉度？

Secondly, when prescribers are writing patient start forms or prescriptions, are these PRNs or are they limiting them to a certain number of boxes or cartons? Thanks.

其次，當處方醫生填寫病人起始表格或處方時，這些是按需處方還是限制為一定數量的盒裝或箱裝藥品？謝謝。

Sure. So in terms of the high burden patients, these are the patients that spend most of their time in with their physician. So these have, these are individuals that are typically on prophylaxis and have HAE that is largely uncontrolled. And so given the high need that they have, they're very much on the physician's radar.

當然。因此，就高負擔患者而言，這些患者的大部分時間都花在了與醫生相處上。所以這些患者通常都在接受預防性治療，並且患有 HAE，但病情很大程度上無法控制。鑑於他們有很高的需求，他們非常受到醫生的關注。

Having said that, these are also the patients who are most informed. So in advance of approval, they're actively seeking new treatments and with the approval actually we know that they made appointments and went into their went into their physician's offices to discuss. So I will say that it's a bit of the patient demand due to the burden of the disease as well as certainly significant awareness on the physician side that they need to support those patients.

話雖如此，這些患者也是最了解狀況的。因此，在獲得批准之前，他們積極尋求新的治療方法；而獲得批准後，我們知道他們已經預約並前往醫生的辦公室進行討論。所以我認為，這在一定程度上是由於疾病帶來的負擔，患者提出了需求，當然，醫生方面也強烈意識到他們需要支持這些患者。

And yes, I think to some extent your point, it enabled them to test actly in some of the most difficult cases to really validate that what the profile we saw in the clinical trials really playing out in the real world, which we know has increased confidence of physicians as we see the majority of start forms that are coming from repeat prescribers. Just in terms of how they write the prescription, typically a prescription is written for PRN, so that that allows the flexibility for the patients to gain access to refills at the frequency and the magnitude of which they need.

是的，我認為在某種程度上，你的觀點是正確的，這使得他們能夠在一些最困難的案例中進行測試，從而真正驗證我們在臨床試驗中看到的特徵是否真的在現實世界中得到體現，我們知道這增強了醫生的信心，因為我們看到大多數起始表格都來自重複處方醫生。就處方開立方式而言，通常處方是按需開立的，這樣患者就可以靈活地根據自己的需要，並按頻率和數量獲得續藥。

That's historically how it's been done with the other on-demand treatments and what we see with EKTERLY today.

從歷史上看，其他按需治療都是這樣進行的，而我們今天在 EKTERLY 上也看到了這一點。

Okay, great. One quick one for Brian just on inventory out of the $13.7 million that was reported this quarter. How much of that was inventory and did you exit the quarter at steady state on that front?

好的，太好了。布萊恩，我只想快速回答一下關於本季報告的 1,370 萬美元庫存的問題。其中有多少是庫存？本季末庫存是否處於穩定狀態？

Yeah, we're seeing obviously with the first month of launch inventory build, coming in by the specialty pharmacies, particularly as they, added additional locations as the launch gained momentum, we think our specialty pharmacy partners are forming in a disciplined manner with view of growth, it's not steady state, it's going to continue building in front of expected demand.

是的，我們顯然看到，在產品上市的第一個月，庫存正在增加，這主要得益於專科藥房的增貨，尤其是在產品上市勢頭強勁的情況下，他們增加了更多門市。我們認為，我們的專科藥局合作夥伴正在以有條不紊的方式進行擴充，著眼於未來的成長。目前還不是穩定狀態，庫存將持續成長，以滿足預期的需求。

Debanjana Chatterjee, Jonestrading Institution.

Debanjana Chatterjee，Jonestrading Institution。

Thanks for taking my question and congrats on the quarter. So, can you talk a little bit more about how your insurance negotiations are progressing and how we should think about the cadence of payers coming online in the first half of next year.

感謝您回答我的問題，並祝賀您本季取得佳績。那麼，您能否再詳細談談您的保險談判進度，以及我們應該如何看待明年上半年付款方陸續上線的節奏？

Sure, absolutely. Leading into launch, we anticipated that it would take roughly six months to both drive demand and for payers to assess accurately and established policies. What we're seeing at this point in time is that yes, we are leveraging medical exception on a consistent basis to gain access, but we're also seeing some of the regional and national players create policies for EKTERLY that are largely favorable.

當然可以。在產品上市之前，我們預計大約需要六個月的時間來推動需求，並讓支付方準確評估和製定相關政策。目前我們看到的情況是，我們確實在持續利用醫療豁免來獲得准入，但我們也看到一些地區和國家級的參與者為 EKTERLY 制定了總體上有利的政策。

Looking towards the end of this year and into the early part of next year, we are planning to I would say, wrap up discussions with some of the larger payers in PBMs, with an aim to have policies in place again early in 2026.

展望今年年底和明年年初，我們計劃與一些大型藥品福利管理機構 (PBM) 的付款方完成討論，目標是在 2026 年初再次製定相關政策。

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

當然，還有一個後續問題。所以，您也提到過，在初期幾個季度，由於轉售價格尚未穩定，收入可能會有些波動。那麼，您能否談談我們應該如何看待未來幾季的營收走勢？

I mean, it's a hard question, as we just talked about. We continue to expect initial fills to come through. We've talked about that as the doctrine expands, the burden of disease on patients will on average, go down. That'll impact both initial fill amounts as well as refill rates. This is an on-demand therapy. We're going through the holiday period, it, it's really hard to understand exactly kind of the nature of the revenue to kind of comment on what trajectory should look like.

我的意思是，正如我們剛才討論的那樣，這是一個很難回答的問題。我們仍然期待首批訂單能夠順利到位。我們已經討論過，隨著理論的擴展，疾病對患者帶來的負擔平均而言會減輕。這將影響初始填充量和補貨速度。這是一種按需治療。我們正處於假期期間，因此很難準確了解收入的性質，也無法對未來的發展軌跡做出評論。

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

女士們、先生們，目前排隊沒有其他問題了。今天的電話會議到此結束。感謝您的參與，您現在可以斷開連接了。