Kiniksa Pharmaceuticals International PLC (KNSA) 2024 Q3 法說會逐字稿

Good day. And thank you for standing by. Welcome to the Kiniksa Pharmaceuticals third quarter, 2024 earnings conference call. At this time all participants are in a listen-only mode. Please be advised that today's conference is being recorded after the speaker's presentation. There will be a question and answer session to ask a question. Please press star 11 on your telephone and wait for your name to be announced. To withdraw your question. Please press star 11 again. I would now like to hand the conference over to your speaker today, Jonathan Kirschenbaum Investor Relations.

再會。感謝您的支持。歡迎參加 Kiniksa Pharmaceuticals 2024 年第三季財報電話會議。此時所有參與者都處於只聽模式。請注意，今天的會議將在演講者演講後進行錄製。將會有一個問答環節來提出問題。請按電話上的星號 11，等待播報您的名字。撤回你的問題。請再按星號 11。現在，我想將會議交給今天的發言人喬納森·基爾申鮑姆 (Jonathan Kirschenbaum) 投資者關係部。

Thank you operator. Good morning, everyone and thank you for joining Kiniksa call to discuss our third quarter, 2024 financial results and recent portfolio execution. A press release highlighting these results can be found on our website under the investors section.

謝謝接線生。大家早安，感謝您參加 Kiniksa 電話會議，討論我們 2024 年第三季的財務表現和最近的投資組合執行情況。您可以在我們網站的投資者部分找到一份重點介紹這些結果的新聞稿。

As for the agenda, our Chief Executive Officer Sanj K Patel will start with an introduction, Ross Moat, our Chief Commercial Officer will provide an update on our commercial execution. Then Mark Ragosa, our Chief Financial Officer will review our third quarter 2024 financial results. And finally Sanj will return for closing remarks and to kick off the Q&A session for which John Paolini, our Chief Medical Officer and Eben Tessari, our Chief Operating Officer will also be on the line. Before getting started, please note that we will be making forward-looking statements today that are subject to risks and uncertainties that may cause actual results to differ materially from these statements. Our review of such statements and risk factors can be found on this slide as well as under the caption. Risk factors contained in our SEC filings. These statements speak only as of the date of this presentation and we undertake no obligation to update such statements except as required by law. With that, I'll turn it over to Sanjh.

至於議程，我們的執行長 Sanj K Patel 將首先進行介紹，我們的首席商務長 Ross Moat 將介紹我們的商業執行情況。然後，我們的財務長馬克·拉戈薩 (Mark Ragosa) 將回顧我們 2024 年第三季的財務表現。最後，Sanj 將回來致閉幕詞並開始問答環節，我們的首席醫療官 John Paolini 和我們的首席營運官 Eben Tessari 也將出席。在開始之前，請注意，我們今天將做出前瞻性陳述，這些陳述受風險和不確定性的影響，可能導致實際結果與這些陳述有重大差異。我們對此類聲明和風險因素的審查可在此投影片及其標題下找到。我們的證券交易委員會 (SEC) 文件中包含的風險因素。這些聲明僅代表本簡報發布之日的觀點，除非法律要求，否則我們不承擔更新此類聲明的義務。說完這些，我就把麥克風交給 Sanjh。

Thanks Jonathan and good morning everyone.

謝謝喬納森，大家早安。

Kiniksa is a well capitalized growth orientated company that's well positioned for near and long term success. In the third quarter we continued to drive strong commercial performance with Arcalyst including increased prescriber adoption and repeat prescriber growth.

Kiniksa 是一家資本充足、以成長為導向的公司，為近期和長期的成功做好了準備。第三季度，我們繼續透過 Arcalyst 推動強勁的商業業績，包括處方採用率的提高和重複處方者的成長。

Patients and physicians continue to report high levels of satisfaction with Arcalyst and our market building activities are positioning us to provide that positive experience to more patients in need.

患者和醫生持續報告對 Arcalyst 的高度滿意，而我們的市場建立活動使我們能夠為更多有需要的患者提供積極的體驗。

Importantly, as we head into the end of the year, we are increasing our full year Arcalyst net sales guidance to between $410million to $420 million. From the previous guidance range of $405million to $415 million. In our pipeline we continue to enroll and dose patients in the Abiprubat phase two B study in Sjogren's disease.

重要的是，隨著年底的臨近，我們將 Arcalyst 全年淨銷售額預期上調至 4.1 億美元至 4.2 億美元之間。從先前的指導範圍4.05億美元到4.15億美元。在我們的研發過程中，我們將繼續招募並給予乾燥症患者進行 Abiprubat 第二階段 B 期研究。

Clinical development of a group art is fully funded in our current operating plan.

我們目前的營運計劃為團體藝術的臨床發展提供了全額資助。

Importantly, our robust financial position and expectation of positive annual cash flow support growth investments across our business including commercial initiatives, portfolio enhancement and value adding business development, which remains a key part of our strategy.

重要的是，我們穩健的財務狀況和對年度正現金流的預期支持了我們整個業務的成長投資，包括商業計劃、投資組合增強和增值業務發展，這仍然是我們策略的關鍵部分。

Commercially, the third quarter saw a continuation of our sequential growth.

從商業角度來看，第三季我們持續保持連續成長。

We saw a 73% year over year growth with Arcalyst. Ultimately delivering $112.2million of net product revenue for the quarter.

我們看到 Arcalyst 的年成長率為 73%。本季最終實現 1.122 億美元的淨產品收入。

The continued growth over the past 3.5 years is a testament to our team and our commercial organization.

過去三年半的持續成長證明了我們團隊和商業組織的實力。

We are well positioned to maximize the potential of Arcalyst, the only FDA approved therapy for recurrent pericarditis.

我們已做好準備，最大限度地發揮 Arcalyst 的潛力，這是 FDA 唯一批准的治療復發性心包膜炎的藥物。

The collaboration has been profitable since the fourth quarter of 2021 enabling further investments in commercial growth oriented initiatives across multiple channels including our salesforce, patient and physician disease education and brand awareness.

此次合作自 2021 年第四季以來一直獲利，使我們能夠進一步投資於跨多個管道的商業成長導向計劃，包括我們的銷售人員、患者和醫生疾病教育以及品牌知名度。

In the third quarter, the impact of these investments contributed to increases in key commercial drivers. These are total prescribers since launch increased from approximately 2,300 in Q2 to approximately 2,550 in Q3.

第三季度，這些投資的影響推動了關鍵商業驅動力的成長。自推出以來，處方總數從第二季的約 2,300 人增加到第三季的約 2,550 人。

Importantly, we also saw an increase in the repeat prescriber rate with approximately 25% of prescribers. Since launch writing multiple prescriptions.

重要的是，我們也發現重複開藥率增加，約有 25% 的開藥者重複開藥。自推出以來開出了多種處方。

Additionally, prescribers appear to appreciate that recurrent pericarditis is a debilitating chronic disease that should be treated to the duration of the underlying autoinflammation.

此外，開藥者似乎認識到復發性心包膜炎是一種使人衰弱的慢性疾病，應根據潛在自身發炎的持續時間進行治療。

This is reflected by the increase in the total average duration of therapy to 27 months as of the end of Q3. Continued strength across our underlying fundamentals also supported the Q3 commercial performance.

截至第三季末，總平均治療持續時間已增加至 27 個月，反映出了這一點。我們基本面的持續強勁也支撐了第三季的商業表現。

We continue to observe high patient and physician satisfaction with patient compliance remaining above 85% and greater than 90% payer approval of completed cases.

我們持續觀察到患者和醫生的高度滿意度，患者依從性保持在 85% 以上，付款人對已完成病例的認可度保持在 90% 以上。

With that, I'll turn it over to Ross to provide an overview of how we plan to provide additional growth with Arcalyst. Ross.

接下來，我將把主題交給羅斯，讓他概述我們計劃如何透過 Arcalyst 實現額外的成長。羅斯。

Thank you Sanj.

謝謝你，Sanj。

As Sanj noted in Q3, Kiniksa's commercial team activated more than 250 new Arcalyst prescribers compared to the previous quarter, which is an increase of more than 1,000 additional new prescribers compared to Q3 of last year. This brings the total prescriber base to approximately 2,550 since launch and demonstrates accelerated growth in the breadth of prescribing with archivists, which is a key part of our dual commercial strategy.

正如 Sanj 在第三季所指出的，Kiniksa 的商業團隊與上一季相比啟動了超過 250 名新的 Arcalyst 處方者，與去年第三季相比增加了 1,000 多名新處方者。這使得自推出以來的總處方者群體達到約 2,550 人，並表明與檔案管理員的處方廣度加速成長，這是我們雙重商業策略的關鍵部分。

Additionally, in Q3, we also drove an acceleration in the depth of prescribing with around 640 health care professionals who have now prescribed Arcalyst for two or more patients since launch represented around 25% of the ever growing total prescriber base.

此外，在第三季度，我們也加速了處方深度，自推出以來，約有 640 名醫療保健專業人員為兩名或兩名以上的患者開出了 Arcalyst，約佔不斷增長的總處方者群體的 25%。

This growth reflects that once a physician is activated, they generally have a positive prescribing experience due to the very high payer approval rate and the significant clinical efficacy of Arcalyst, which increases the desire to identify and treat additional patients.

這種增長反映出，一旦醫生被激活，由於 Arcalyst 的付款人批准率非常高且臨床療效顯著，他們通常會有積極的處方體驗，這增加了識別和治療更多患者的願望。

The growth in both total and repeat Arcalyst prescribers speaks to the growing awareness of recurrent pericarditis and the understanding of Arcalyst as the only FDA approved treatments for the disease.

Arcalyst 總處方量和重複處方量的增加表明，人們對復發性心包膜炎的認識不斷提高，並且 Arcalyst 已成為 FDA 批准的唯一治療該疾病的藥物。

On the next slide, I'd like to highlight how we're continuing to change the treatment paradigm and how physicians are changing their future prescribing intentions towards Arcalyst.

在下一張投影片中，我想強調我們如何繼續改變治療模式以及醫生如何改變他們未來對 Arcalyst 的處方意圖。

Among surveyed cardiologists and rheumatologists, we have seen a substantial increase in the proportion of physicians who will continue who will consider prescribing Arcalyst with each additional recurrence. Importantly, on the right side of the slide, we're seeing that physicians are acting upon this intent. Since the launch of oculists in recurrent pericarditis. Just over three years ago, we have been highly targeted in our field sales efforts against the 14,000 patients on two or more recurrences while ensuring physicians also understand the broad label and ability to prescribe earlier in the disease.

在受訪的心臟科醫生和風濕病專家中，我們發現，每次復發時考慮繼續開立 Arcalyst 的醫生比例大幅增加。重要的是，在幻燈片的右側，我們看到醫生正在按照這個意圖採取行動。自從眼科醫師開始治療復發性心包膜炎以來。就在三年多前，我們針對 14,000 名復發兩次或兩次以上的患者開展了高度針對性的現場銷售工作，同時確保醫生也了解廣泛的標籤和在疾病早期開處方的能力。

In line with our promotional efforts, we are seeing around 85% of all articles prescribing is for the two plus recurrent population and around 15% of all scripts being written for patients on their first recurrence.

在我們的宣傳活動中，我們發現大約 85% 的處方是針對兩次以上復發的人群，大約 15% 的處方是為首次復發的患者開的。

Ultimately, this earlier utilization speaks not only to the stellar effectiveness of ar but also to the effectiveness of our brand and disease awareness efforts aimed at educating both patients and physicians around the chronic nature of this disease and the opportunity to prevent future flares.

最終，這種早期利用不僅證明了 ar 的卓越有效性，也證明了我們的品牌和疾病意識努力的有效性，旨在教育患者和醫生了解這種疾病的慢性性質以及預防未來爆發的機會。

These data provide further evidence that the promotion and availability of Arcalyst have driven a change in the treatment landscape away from nonspecific drug agents and towards Arcalyst as a targeted treatment directly addressing the underlying mechanism of recurrent pericarditis.

這些數據進一步證明，Arcalyst 的推廣和普及已經推動了治療領域的變革，從非特異性藥物轉向 Arcalyst 作為直接解決復發性心包膜炎潛在機制的標靶治療。

Continuing our focus on accelerating disease awareness and improving the patient journey to diagnosis. I'd like to highlight two exciting initiatives. Firstly, earlier this month, we announced the launch of life disrupted a recurrent pericarditis educational campaign with National Hockey League Hall of Famer, Henrik Lundquist. And just yesterday, we announced that Grammy Award winning singer songwriter Carly Pearce has also joined the campaign.

我們將繼續致力於提高疾病意識並改善患者的診斷過程。我想強調兩項令人興奮的舉措。首先，本月早些時候，我們宣布與國家冰球聯盟名人堂成員亨利克·倫德奎斯特 (Henrik Lundquist) 合作啟動“生活被打亂，復發性心包炎”教育活動。就在昨天，我們宣布葛萊美獎獲獎歌手兼作曲家卡莉·皮爾斯也加入了這項活動。

Disease Awareness is a key component in our commercialization strategy for Arcalyst.

疾病意識是 Arcalyst 商業化策略的關鍵組成部分。

One of the key drivers behind our life disrupted campaign is that despite the profound impact the disease has on patients, 96% of patients report that they were initially incorrectly diagnosed with other conditions.

我們進行「擾亂生活」活動的主要驅動力之一是，儘管這種疾病對患者產生了深遠的影響，但 96% 的患者報告說，他們最初被錯誤地診斷為患有其他疾病。

On average patients reported 2.7 misdiagnoses prior to receiving a diagnosis of recurrent pericarditis. This results in a delayed diagnosis and we believe we have an opportunity to increase education and improve the patient journey and optimize patient care.

患者在確診為複發性心包膜炎前平均有 2.7 次誤診。這會導致診斷延遲，我們相信我們有機會加強教育，改善患者旅程並優化患者護理。

In addition to life disrupted, we're also sponsoring the American Heart Association's addressing recurrent pericarditis initiative. This initiative seeks to improve the quality of care for recurrent pericarditis patients by identifying and disseminating best practices for the diagnosis and treatment of the disease. Specifically through our sponsorship, 15 centers of excellence have been identified across the US and are working together to improve referral pathways and develop solutions that can be shared with other pericardial disease clinics across the country.

除了擾亂生活之外，我們也贊助美國心臟協會應對復發性心包膜炎的倡議。該計劃旨在透過確定和傳播診斷和治療該疾病的最佳實踐來提高復發性心包膜炎患者的護理品質。具體來說，透過我們的贊助，美國各地已確定了 15 個卓越中心，並正在共同努力改善轉診途徑並開發可與全國其他心包疾病診所共享的解決方案。

Based on our market experience, the streamlining of referral pathways could reduce the barriers to care and ultimately improve outcomes for patients. In a Harris poll, 71% of recurrent pericarditis patients stated they would be highly likely to seek care at a recurrent pericarditis focus clinic, If one were available in that area. we're looking to address that need and aim to continue advancing the support for patients suffering from this debilitating disease.

根據我們的市場經驗，簡化轉診途徑可以減少護理障礙並最終改善患者的治療效果。在哈里斯民調中，71％的複發性心包膜炎患者表示，如果該地區有復發性心包膜炎專科診所，他們很可能會前往該診所就診。我們希望滿足這一需求，並致力於繼續為患有這種使人衰弱的疾病的患者提供支持。

In Q3, the kita team continued to drive sequential growth in Arcalyst revenue. As a result, we've increased our full year 2024 Arcalyst net sales guidance to $410million to $420 million from $405milion to $450 million with that. And I'll turn it over to mark to discuss our third quarter financial results mark.

第三季度，kita 團隊持續推動 Arcalyst 營收的持續成長。因此，我們將 Arcalyst 2024 年全年淨銷售額預期從 4.05 億美元至 4.5 億美元上調至 4.1 億美元至 4.2 億美元。我將把它交給馬克來討論我們的第三季財務表現。

Thanks Ross. Our detailed third quarter, 2024 financial results can be found in the press release we issued earlier today.

謝謝羅斯。我們的 2024 年第三季詳細財務業績可在我們今天稍早發布的新聞稿中找到。

There are several items on the slide that I'd like to call your attention to this morning.

今天早上我想提請大家注意投影片上的幾項內容。

First total revenue in the third quarter of 2024 was driven entirely by acla net product revenue which grew 73% year over year to 112.2 million.

2024 年第三季的總營收完全由 acla 淨產品收入推動，營收年增 73% 至 1.122 億美元。

Second Arcalyst collaboration operating profit in the third quarter grew 68% year over year to $58.2 million and largely drove total collaboration expenses of $29.3 million.

第二，Arcalyst 第三季合作營業利潤年增 68% 至 5,820 萬美元，並在很大程度上推動了 2,930 萬美元的總合作費用。

Third on a year over year basis. In the third quarter, operating expense growth was due to cost of goods sold driven by Arcalyst revenue growth as well as expenses related to the ongoing Arcalyst tech transfer collaboration, expenses driven by Arcalyst collaboration, operating profit growth and R&D and SG&A driven largely by personnel costs, manufacturing of clinical supply and Arcalyst commercialization.

與去年同期相比，位居第三。第三季度，營業費用成長是由於 Arcalyst 營收成長所推動的銷售成本以及與正在進行的 Arcalyst 技術轉移合作相關的費用、Arcalyst 合作推動的費用、營業利潤成長以及主要受人員成本、臨床供應製造和 Arcalyst 商業化推動的研發和銷售、一般及行政費用 (SG&A)。

Fourth net loss in the third quarter of 2024 was $12.7 million compared to a net loss of $13.9 million in the third quarter of 2023.

2024 年第三季淨虧損為 1,270 萬美元，而 2023 年第三季淨虧損為 1,390 萬美元。

Lastly net cash flow in the third quarter was $5 million. Bringing end of period cash balance to $223.8 million.

最後，第三季的淨現金流為 500 萬美元。期末現金餘額達 2.238 億美元。

We continue to expect our cash reserves as well as strong commercial execution and financial discipline to fund our current operating plan and we expect to remain cash flow positive on an annual basis.

我們繼續期望我們的現金儲備以及強大的商業執行力和財務紀律能夠為我們當前的營運計劃提供資金，並且我們預計年度現金流將保持為正。

With that, I'll turn the call back to Sanj for closing remarks.

說完這些，我將把電話轉回給 Sanj，請他做最後發言。

Thanks Mark. We are as ever dedicated to helping as many patients as possible with our Arcalyst and advancing the development of our clinical portfolio to help bring additional therapies to patients that are suffering from debilitating diseases.

謝謝馬克。我們一如既往地致力於透過 Arcalyst 幫助盡可能多的患者，並推動我們的臨床產品組合的發展，為患有衰弱性疾病的患者提供額外的治療方法。

Both of these important goals are integral to our ongoing efforts to create sustainable value and grow connects into a generational company.

這兩個重要目標對於我們持續努力創造永續價值並將 Connects 發展成為世代公司至關重要。

With that. I'll now turn the call back to the operator for questions.

就這樣。我現在將把電話轉回給接線員以回答問題。

Thank you.

謝謝。

(Operator Instruction)

（操作員指令）

Our first question comes from Roger Song with Jefferies. He may proceed.

我們的第一個問題來自 Jefferies 的 Roger Song。他可以繼續。

Great. Congrats for the quarter and thank you for taking our question. Maybe the first one is regarding the the penetration of the market share in the first recurrent patient. That's interesting. You have 15% of your prescription is coming from the first recurrence which is in the label. Just curious how you can keep driving the penetration into that population. I know your initial target is in the multiple recurrence. Thank you.

偉大的。恭喜本季取得的成績，並感謝您回答我們的問題。也許第一個是關於首例復發患者的市佔率滲透率。那很有意思。您處方中的 15% 來自於標籤上標示的第一次復發。我只是好奇你如何能夠繼續推動該人群的滲透。我知道你的初始目標是多次復發。謝謝。

Thanks Roger. Yeah, this is Ross. So thank you very much for the question. So you're absolutely right that our primary focus is the 14,000 patient population. They're the patients that are suffering from two or more recurrences that's been our key target ever since since we launched more than three years ago. The reason for that is that they're the patients that are ultimately suffering the highest burden of the disease. And they're the patients that are most resembling the patients that were studied in the Rhapsody data sets as well. At the end of Q2, we announced that we'd reached around 11% penetration into that target population. So I think that speaks to the huge opportunity that we still have ahead within the two plus recurrence. But having said that as we highlighted in the prepared remarks, it's also encouraging that healthcare professionals are understanding how broad the label is for recurrent pericarditis and some of them are seeking to use it on the first occurrence. So we're very pleased with that. We think it speaks to just the efficacy of Arcalyst and ultimately the desire to help patients by reducing the risk of future flares, which is one of the key components of a treatment. So we, we're pleased with that. I think one thing to note is that on the duration, in terms of the natural history, the disease, the median duration of those patients that are on their first recurrence is often shorter. It's around six months for the patients on the first recurrence compared to a median of around three years for those patients that are on two or more recurrences. Which is another reason why, you know, a key target audiences is those that are on their 2 plus recurrences. But we're very pleased to have announced that additional insight today into how physicians are treating earlier in the disease and you know, see an Arcalyst being used to really prevent, prevent future flares within that. So we continue to focus on disease education and, and you know, reaching further into the penetration of you know, all of the, the recurrence groups within our label. But as we've mentioned, it's really the 14,000 patients that are the key target and I guess seeing the additional 26,000 population that are on their first recurrence as a to that case.

謝謝羅傑。是的，這是羅斯。非常感謝您的提問。所以您說得完全正確，我們的首要關注點是 14,000 名患者。他們是復發兩次或兩次以上的患者，自從三年多前我們推出這項服務以來，他們一直是我們的主要目標。原因是他們是最終承受疾病最嚴重負擔的患者。他們也是與 Rhapsody 資料集中研究的患者最相似的患者。在第二季末，我們宣布我們已經達到了目標族群的約 11% 的滲透率。所以我認為這說明我們在兩次復發中仍然擁有巨大的機會。但正如我們在準備好的評論中所強調的那樣，令人鼓舞的是，醫療保健專業人員正在了解復發性心包炎的標籤有多廣泛，並且他們中的一些人正在尋求在第一次發生時使用它。所以我們對此感到非常高興。我們認為這恰恰說明了 Arcalyst 的功效，並最終希望透過降低未來發作的風險來幫助患者，這是治療的關鍵組成部分之一。所以我們對此感到高興。我認為需要注意的一點是，就疾病的自然病程而言，首次復發的患者的病程中位數通常較短。第一次復發的患者等待時間約為六個月，而復發兩次或兩次以上的患者的等待時間中位數約為三年。這也是為什麼關鍵目標受眾是那些重複 2 次以上的人群的原因。但我們今天非常高興地宣布，我們對醫生如何在疾病早期進行治療有了更多的了解，並且您知道，Arcalyst 可以真正用於預防，防止未來的爆發。因此，我們將繼續關注疾病教育，並進一步深入滲透我們標籤內的所有復發組。但正如我們所提到的，這 14,000 名患者才是真正的重點目標，我想另外 26,000 名首次復發的患者也是重點目標。

Got it. Yeah, thank you for the comment. I think that's the upside coming from this even larger population there. Okay. And then my follow up question is related to the the QonQ growth rate. I understand the year on year growth rates continue to be very strong. And then how should we think about the growth rate from from here in terms of the fourth quarter and the next year? Are we reaching the steady state for the growth from here? Thank you.

知道了。是的，謝謝你的評論。我認為這是那裡人口更多帶來的好處。好的。然後我的後續問題與 QonQ 成長率有關。據我了解，年成長率持續保持強勁。那麼我們該如何看待第四季和明年的成長率呢？從現在起我們是否達到了成長的穩定狀態？謝謝。

Yeah, thanks Roger. I'm not sure whether we're reaching a, you know, a steady state in the growth rate or not, we'll see as things progress, but obviously we're, we're intent on continued growth and we think we've got a very large opportunity ahead knowing where we are with the current penetration and the trajectory that we've been on launched to date. I guess we've always said that it's a, you know, this is a build and a steady growth as we identify patients. But we're pleased to have landed at $112.2 million in Q3, which is around 8.5% growth versus Q2, which was a quite a large Q2 that we announced. So we were pleased to be able to increase the guidance due to that, that rate of growth now up to $410million to $420 million.

是的，謝謝羅傑。我不確定我們是否達到了成長率的穩定狀態，隨著事態的發展，我們會看到這一點，但顯然我們致力於繼續成長，我們認為，根據目前的滲透率和迄今為止的發展軌跡，我們面前有非常大的機會。我想我們總是說，隨著我們識別患者，這是一個建立和穩定的成長過程。但我們很高興第三季的營收達到了 1.122 億美元，比第二季成長了約 8.5%，這是我們宣布的第二季營收相當可觀的。因此，我們很高興能夠提高指導價，成長率現在達到 4.1 億美元至 4.2 億美元。

Got it. Yes, your Q2 is a big number. Thank you. That's all from us. Congrats again.

知道了。是的，你的 Q2 是一個很大的數字。謝謝。我們就講到這裡。再次恭喜。

Thanks Roger.

謝謝羅傑。

Thank you.

謝謝。

Our next question comes from Liisa Bayko with Evercore ISI. You may proceed.

我們的下一個問題來自 Evercore ISI 的 Liisa Bayko。您可以繼續。

Hi there. Thanks for taking the question. Just a couple from us. First, can you I don't know if you said this but remind us what gross to nets were for the quarter?

你好呀。感謝您回答這個問題。距離我們只有幾對。首先，我不知道您是否說過這個，但您能否提醒我們本季的毛利潤與淨利潤之比是多少？

Yeah, sure, Lisa. So year-to-date gross net through the third quarter was was 9.8% which is down from 10.8% in the, in the second quarter of this year.

是的，當然，麗莎。因此，今年第三季的總淨利率為 9.8%，低於今年第二季的 10.8%。

Okay, great. And then just thinking about the flow of patients and, and you have an incredible amount of you know, kind of prescribers, repeat prescribers and a really nice long kind of mean duration of of 27 months. How many patients if you could qualify or what percentage you know, started and maybe discontinued or sort of did stop at some point. I'm just trying to get a sense of, you know, how many people have been on therapy thus far. Thanks.

好的，太好了。然後想想病人的流動情況，你會發現，有大量的處方者、重複處方者，平均持續時間非常長，達到 27 個月。如果您符合條件，有多少患者或您知道有多少比例的患者開始接受治療，然後可能停止了治療或在某個時候停止了治療。我只是想知道，到目前為止有多少人接受了治療。謝謝。

Yeah, thanks Liisa. So we just haven't shared some of those those kind of more granular insights that we do have a slide on our our corporate deck, which speaks to the duration, both in terms of the total duration, which is now up to 27 months from 26 months at the last earnings call, as well as looking at the drop off of those patients that are on their first treatment period. And from that, you can see that even out at this time since launch and a half years ago now, and we've still got, you know, around 20% or so of the patients who started in the initial launch quarter and are still on their initial treatment period. So they, you know, they've obviously not stopped therapy at any point throughout that time period. So clearly, we have patients that, you know, start therapy and will remain on therapy for a long period of time as the natural history showed us as well. But then also, you know, obviously we do have patients that drop off much sooner than that. We still see that there's around 45% restart rate in totality. So all those patients who stop, regardless of which time point they stop therapy at about 45% of them restart therapy. Still the vast majority of those when they do restart it within an eight week time period, showing that if there is underlying auto inflammation, still ongoing within the patient. You know, symptomology can come back pretty quickly. As after this washes off and the need to restart treatment, which is a generally a very easy process for patients. But it just again, speaks to the need that this is really a, a chronic disease as Sanj was saying in the remarks and we really do need to treat to the underlying duration of the disease. But the totality now of the treatment duration is around 27 months, up to the most recent information.

是的，謝謝 Liisa。因此，我們還沒有分享一些更細緻的見解，我們在公司簡報中確實有一張幻燈片，其中談到了治療持續時間，包括總持續時間，從上次收益電話會議時的 26 個月增加到現在的 27 個月，同時也關注了處於第一個治療期的患者人數的下降。從中你可以看到，自從一年半前推出以來，我們仍然有大約 20% 的患者在最初的推出季度就開始接受治療，並且仍處於初始治療期。所以，您知道，他們顯然在那段時間內沒有停止過治療。顯然，我們有一些患者開始接受治療，並且會長期堅持治療，正如自然病程所顯示的那樣。但同時，您也知道，顯然我們確實有一些病人比這更早去世。我們仍然看到總體重啟率約為 45%。因此，所有停止治療的患者，無論他們在哪個時間點停止治療，其中約有 45% 會重新開始治療。當他們在八週內重新開始治療時，絕大多數患者的情況仍然如此，這表明如果存在潛在的自身炎症，那麼患者體內的炎症仍會持續存在。你知道，症狀可能很快就會復發。因為洗掉之後就不需要重新開始治療，這對患者來說通常是一個非常容易的過程。但這再次表明，正如桑吉在評論中所說，這確實是一種慢性疾病，我們確實需要根據疾病的潛在持續時間進行治療。但根據最新消息，目前整個治療時間約為 27 個月。

Okay. And it seems like it's, it's helpful to get more feet on the ground on more sales force. You're obviously being able to, you know, find more patients and there's still so many more out there. Do you think that you're right size? Do you think we might see additional growth in the sales force over time? Just curious how you're thinking about that longer term? And that's my last question. Thanks.

好的。看起來，這有助於讓更多的銷售人員腳踏實地。顯然，你可以找到更多的病人，而且還有很多病人。您認為您的尺寸合適嗎？您認為隨著時間的推移，我們的銷售團隊會進一步成長嗎？我只是好奇你對長期發展有何看法？這是我的最後一個問題。謝謝。

Yeah thanks Liisa, This is Sanj. I mean, obviously we've thought about, you know, you've obviously tracked that we from the initial launch, we've actually expanded that from the initial 29 to around 50 then most recent reported around 85-90. And that's just based on a lot of analytics. So we'll continue to look at it and apply what we think is right. You know, we do this in a very data driven manner. It's important to get the balance just right. So we'll continue to look at it and we'll do what's needed.

是的，謝謝 Liisa，我是 Sanj。我的意思是，顯然我們已經考慮過了，你知道，你顯然已經追蹤了我們從最初的發布開始的情況，我們實際上已經將其從最初的 29 個擴展到大約 50 個，然後最近報告的數量約為 85-90 個。這只是基於大量分析。因此，我們會繼續研究並採取我們認為正確的措施。你知道，我們以數據驅動的方式來實現這一點。取得適當的平衡非常重要。因此，我們會繼續關注此事並採取必要的措施。

Great.

偉大的。

Thank you.

謝謝。

Our next question comes from Paul Choi with Goldman Sachs. You may proceed.

下一個問題來自高盛的 Paul Choi。您可以繼續。

Hi. Thanks, good morning and thanks for taking our questions. My first one is just with regard to the, the patients who are the 15% of patients who are treated as, as their first recurrence. Can you maybe just comment on sort of guideline awareness of Arcalyst as a first treatment option for their first recurrence and just kind of where the physician community is and sort of understanding that.

你好。謝謝，早安，謝謝您回答我們的問題。我的第一個問題是關於 15% 的患者，他們是第一次復發並接受治療。您能否評論一下指南對 Arcalyst 作為首次復發的首選治療方案的認識，以及醫生群體的現狀和理解。

And my second question is, thanks for the Abiprubart update. Can you maybe comment if you have sort of any visibility on timing for enrollment here? And when, when the last patient you think might be enrolled, at least based on what what you can see in the patient recruiting now. Thanks for taking our questions.

我的第二個問題是，感謝 Abiprubart 的更新。如果您對這裡的入學時間有任何了解，您能否評論一下？您認為最後一位患者可能入組的時間是什麼時候，至少根據您現在看到的患者招募情況來看是這樣。感謝您回答我們的問題。

Sure. Thank you, Paul. And I appreciate the questions. Maybe I'll just answer quickly the Abiprubart question first and then go back to the question about first line therapy. So with regard to the Abiprubart phase two B study and children's disease, Yes, we're very excited about that study, which has, which is now enrolling and dosing patients. At this point in time, we have not given any specific guidance about enrollment timelines because of the fact that the study is, is just starting. But by way of a reminder, this is a 24 week study to the primary efficacy endpoint. So six months of treatment followed by an additional six months long term extension. And what's unique about this study is that it is the only study in the space testing monthly subcutaneous dosing of CD 40 antagonist. So that's the Abiprubart study. Now, back to your your first question about guideline awareness and treatment of of patients as you know, is as early as their first recurrence. So as you'll remember, there, the last treatment guidelines that were written were actually from Europe that were written in 2015. So of course, that predated all of the work in in interleukin one and the awareness of interleukin one alpha and beta is key driver of of recurrent per card.

當然。謝謝你，保羅。我很感謝你們提出這些問題。也許我會先快速回答 Abiprubart 的問題，然後再回到有關第一線治療的問題。因此，關於 Abiprubart 第二階段 B 研究和兒童疾病，是的，我們對這項研究感到非常興奮，目前正在招募患者並進行給藥。目前，由於研究才剛開始，我們還沒有給出任何有關入學時間表的具體指導。但需要提醒的是，這是一項為期 24 週的主要療效終點研究。因此，六個月的治療之後又進行六個月的長期延長。這項研究的獨特之處在於，它是該領域唯一一項測試每月皮下注射 CD 40 拮抗劑的研究。這就是 Abiprubart 的研究。現在，回到您的第一個問題，關於患者的指南意識和治療，如您所知，最早是在他們第一次復發時。所以你會記得，最後寫的治療指南其實是來自歐洲，於 2015 年寫的。因此，當然，這早於白細胞介素 1 的所有工作，並且對白細胞介素 1 α 和 β 的認識是每張卡復發的關鍵驅動因素。

And so since then, of course, with all of the work that we've done with Arcalyst and Rhapsody and the ultimate approval of Rilonacept Abiprubart is the first and only treatment, you know, treatment for recurrent pericarditis and also reduction in risk. What that has done is it has left, as you mentioned, you know, a broad label. So what that means is that patients can be treated as soon as there is a diagnosis. So how does that then translate into how physicians have been treating patients? So, in the absence of guidelines and we hear that European guidelines may be updated in the next few years. But in the meantime, what has happened is thought leadership has been writing in the literature more about an evidence, this evidence based approach of treating patients with Ian pathway inhibition and specifically rhapsody tested not only basically two paradigms or two different ways of steroids bearing paradigm. The first one of course is that for patients who are on steroids to get them off of steroids. But then more importantly for patients who are failing nsaids and colchicine. So a strategy of inflamax inhibition to get them onto one pathway inhibition right away. And so that often translates if you will into many patients who are at their first recurrence who are breaking through nsaids and colchicine with aggressive disease. And so clinicians are looking to that. In terms of how that's translated into the real world, our data from the Residentid Registry, you know, shows that since the time of Arcalyst launch, you know, a real rise in second line use of Arcalyst as second line therapy such that two thirds of prescriptions of patients that were treated with, you know, with who are failing NSAIDS and co we actually managed with IO one pathway inhibition. So I think that's where you're seeing this evidence based approach of translating the label into practice.

當然，從那時起，我們在 Arcalyst 和 Rhapsody 上所做的所有工作以及 Rilonacept Abiprubart 的最終批准是第一個也是唯一的治療方法，你知道，它可以治療復發性心包炎並降低風險。正如您所說，它留下了一個廣泛的標籤。這意味著患者一旦確診就可以接受治療。那麼這又如何轉化為醫師治療患者的方式呢？因此，在沒有指導方針的情況下，我們聽說歐洲指導方針可能會在未來幾年內更新。但同時，思想領袖們已經在文獻中撰寫了更多關於證據的文章，這種基於證據的治療伊恩通路抑制患者的方法，特別是狂想曲不僅測試了基本上兩種範式或兩種不同的類固醇承載範式。第一個當然是讓正在服用類固醇的患者停止服用類固醇。但更重要的是，對於那些非類固醇抗發炎藥和秋水仙鹼治療失敗的患者來說。因此，inflamax 抑制策略可以立即讓它們進入一種路徑抑制狀態。因此，這通常意味著許多患者在第一次復發時就已開始服用非類固醇抗發炎藥和秋水仙鹼，但病情仍然十分嚴重。因此臨床醫生正在關注這一點。至於如何將其轉化為現實世界，我們從居民登記處獲得的數據顯示，自 Arcalyst 推出以來，Arcalyst 作為二線療法的二線使用量確實有所上升，以至於三分之二接受過 NSAIDS 治療的患者處方藥失敗，我們實際上通過 IO 單通路抑制進行管理。所以我認為這就是您看到的將標籤轉化為實踐的基於證據的方法。

Okay, great. Thank you.

好的，太好了。謝謝。

Thank you.

謝謝。

Our next question comes from Eva Forteo Verdejo with Wells Fargo. You may proceed.

下一個問題來自富國銀行的 Eva Forteo Verdejo。您可以繼續。

Good morning. Congrats on the quarter and thanks for taking our question. A couple from us, the first one you mentioned mean duration of 27 months. Should we expect some differences here on mean duration for patients on first recurrence versus 2nd and 3rd recurrence?

早安.恭喜本季取得佳績，感謝您回答我們的問題。我們中的一對夫婦，您提到的第一對平均持續時間為 27 個月。我們是否應該預期第一次復發的患者與第二次和第三次復發的患者的平均持續時間會有些差異？

And the second question is what's driving the current increase in patient? As is it mostly coming from these patients on first recurrence or are you seeing similar growth on this like three buckets of like first versus 2nd and 3rd? Thanks.

第二個問題是，是什麼原因導致目前患者數量增加？它主要來自這些首次復發的患者嗎？或者您看到這三個組別中第一次、第二次和第三次的患者有類似的成長？謝謝。

Thanks Eva, so this is Ross. Maybe I'll take the your, your last question first and then I'll hand over to John to, to talk through the first part of the question regarding patient ads, I mean, we're seeing patients added both from new prescribers that are coming on board. We've seen quite a healthy clip of increase of new prescribers quarter on quarter. So most recently, you know, around 250 additional new prescribers, we're also seeing the repeat prescriber basis increase as well. So as a result of that, we're certainly driving, you know, more total patients that are on therapy. So by the time you account for those patients who have stopped therapy for about a quarter after having come to the natural cessation of, of disease and, and drug. Obviously we're putting on far more new patients than we are losing at the other end each, each quarter. And then the increased total duration of therapy is also helping with that as well. So we're seeing, you know, we're seeing a good kind of increase there which we're happy to, to report.

謝謝 Eva，這是 Ross。也許我會先回答你的最後一個問題，然後我會交給約翰來討論有關患者廣告的問題的第一部分，我的意思是，我們看到患者從新加入的處方者那裡增加。我們看到，新開處方的數量逐季呈現健康成長態勢。最近，您知道，大約有 250 名新開處方者，我們也看到重複開處方者的數量也在增加。因此，我們肯定會推動更多接受治療的患者。因此，當您計算出那些在疾病和藥物自然停止後停止治療約四分之一的患者時。顯然，我們每季接收的新患者數量遠遠多於我們失去的患者數量。而延長治療的總時長也有助於此。所以我們看到，你知道，我們看到了一種良好的增長，我們很高興地報告。

So maybe John, do you want to make?

那麼也許約翰，你想做嗎？

Yeah. No, you, you've asked a very interesting question about the the epidemiology of recurrent pericarditis.

是的。不，你問了一個關於復發性心包膜炎流行病學的非常有趣的問題。

So you know what we know from our data is that for patients who have two or more recurrences that the median disease duration is three years with a third of patients still suffering in five years and a quarter of patients still suffering at eight years. And so you know that as as you might imagine is a key driver of a strategy treatment throughout the duration of the disease. And that's been shown repeatedly with clinical trials data as well that premature cessation of therapy, whether at three months, 18 months or even 28 months results at a very high rate of recurrence and need for advanced targeted therapy. Now, with regard to the earlier recurrence patients, yes, the epidemiology there is slightly different that it's taken in the aggregate the median duration of disease for patients with one recurrence is six months. But it's important to note that that includes all of those patients that will a number of patients who will run to the course of their disease relatively quickly within the 1st year. But it also includes those patients who will in fact go on to have long term disease. And those patients tend to have a more aggressive presentation, you know, at the time of their first recurrence. And that's why again, going back to that literature that I cited earlier, the second line use of Iowa pathway inhibition in that patient population who are failing nsaids and colchicine usually reflect a treatment strategy on the part of the physician that they believe that nsaids and colchicine will be inadequate to manage those patients. And so those tend to be the longer duration patients.

因此，我們從數據中得知，對於復發兩次或兩次以上的患者，疾病持續時間的中位數為三年，三分之一的患者在五年內仍在遭受痛苦，四分之一的患者在八年後仍在遭受痛苦。因此，正如您可能想像的那樣，這是整個疾病持續期間策略治療的關鍵驅動因素。臨床試驗數據也反覆證明，過早停止治療，無論是 3 個月、18 個月或 28 個月，都會導致非常高的復發率，需要先進的標靶治療。現在，對於早期復發的患者，是的，那裡的流行病學略有不同，總體而言，一次復發的患者的疾病持續時間中位數為六個月。但值得注意的是，這包括所有在第一年內病情會相對較快進展的患者。但它也包括那些實際上會長期患病的患者。你知道，這些患者在第一次復發時往往表現得更具侵略性。這就是為什麼再次回到我之前引用的文獻，在非類固醇抗發炎藥和秋水仙鹼治療失敗的患者群體中，愛荷華通路抑制的二線使用通常反映了醫生的治療策略，他們認為非類固醇抗發炎藥和秋水仙鹼不足以治療這些患者。所以這些患者往往病程較長。

Yeah, and maybe just to add on to the end of that John, thank you. Is that that ultimately the key driver of the new patient adds is really those patients that are on two or more recurrences. While it's pleasing to hear and understand that there are physicians utilizing earlier on in the disease on their first recurrence, you know, the more than 85 well around 85% on the two or plus recurrence. And then if you take into account the duration of the disease as John has spoken to, you can see that it's a two plus recurrence group that are really the main driver of the disease. If you look back at the first recurrence, you know, there's around 33% of physicians now that we have surveyed that inform us that it was their intention to consider ARS on the first recurrence. So it's good that arch is being considered earlier on in the disease. That's not to say, obviously, ALL 33% will go on and prescribe within that first recurrence. But at least it's an indication that the awareness of Arcalyst is growing physicians are considering using it early. And also now that we see around 15% of the Arcalyst prescriptions or enrollments that are within the first recurrence. So it's pleasing data, but ultimately, it's the two plus recurrence group that's really driving the business here.

是的，也許只是想補充約翰的話，謝謝你。最終，新患者增加的關鍵驅動因素實際上是那些復發兩次或兩次以上的患者。雖然很高興聽到並了解到有些醫生在疾病早期第一次復發時就利用這種方法，但你知道，在兩次或兩次以上復發時，這種方法的治癒率大約為 85%。然後，如果考慮到約翰所說的疾病的持續時間，您會發現兩個以上的復發組是疾病的主要驅動因素。如果回顧第一次復發，您就會知道，我們調查過的約 33% 的醫生告訴我們，他們打算在第一次復發時考慮 ARS。因此，在疾病早期就考慮使用拱門是件好事。顯然，這並不是說所有 33% 的患者都會在第一次復發時繼續開藥。但這至少表明人們對 Arcalyst 的認識正在提高，醫生們正在考慮儘早使用它。而且現在我們發現大約 15% 的 Arcalyst 處方或註冊是在第一次復發期間。所以這是令人滿意的數據，但最終，真正推動這裡業務的是兩個加重複的群體。

Thank you.

謝謝。

Our next question comes from David Nierengarten with Wedbush Securities. You may proceed.

我們的下一個問題來自 Wedbush Securities 的 David Nierengarten。您可以繼續。

Thanks for taking the question most have been asked, but I did have a follow up on the, you know, the first recurrence and not to be labor the point, but maybe it's early. But are there any trends towards the doctors who are prescribed or more repeat prescribers prescribing earlier or is it scattered across the board amongst doctors? Thanks.

感謝您回答大多數人提出的問題，但我確實對第一次復發進行了跟進，雖然不是重點，但也許還為時過早。但是，是否有任何趨勢表明，接受處方的醫生或重複開處方的醫生會更早開處方，還是這種趨勢在醫生中是分散的？謝謝。

Yeah, thanks, David. It's a great question. I think we see it really scattered across the board and I don't see any particular correlations of notes yet, which is why we haven't really shared anything around that topic. You know, we, we do obviously have a clear understanding that the patients are very widely dispersed across the US. And there is a need for patients to get diagnosed earlier in the disease rather than suffering from all the misdiagnoses that we see. So that often elongates the journey through to diagnosis. And obviously, there's a knock on effect of that through to treatment as well. So we think that's, you know, a key component for us to look at and consider how we can partner with people to try to get, you know, diagnosis. Earlier, as we mentioned, the initiative that we sponsored through the American Heart Association to focus on, you know, 15 Centers of Excellence. Now really focusing on the pericardial diseases of which current pericarditis being one of them is a an interesting initiative that really aims to shorten that treatment pathway. And the the pathway through to accurate diagnosis and how the learnings from those expert centers can really be shared throughout the rest of the the community. So we think that's an important initiative that also kind of goes into a part of our strategy around increasing the awareness and just helping patients to get an earlier diagnosis.

是的，謝謝，大衛。這是一個很好的問題。我認為我們看到它確實分散在各個方面，而且我還沒有看到任何特定的註釋相關性，這就是為什麼我們還沒有真正分享有關該主題的任何內容。你知道，我們確實清楚地了解到患者分佈在美國各地。我們需要讓患者儘早得到診斷，以免遭受我們所見到的各種誤診。因此，這通常會延長診斷過程。顯然，這也會對治療產生連鎖反應。因此，我們認為這是我們需要研究的關鍵因素，並考慮如何與人們合作以嘗試獲得診斷。正如我們之前提到的，我們透過美國心臟協會發起了一項倡議，重點關注 15 個卓越中心。現在真正關注心包疾病（其中一種是心包膜炎）是一項有趣的舉措，旨在縮短治療途徑。以及如何透過準確診斷的途徑以及這些專家中心的經驗能夠真正與整個社區分享。因此，我們認為這是一項重要舉措，也是我們提高意識和幫助患者儘早得到診斷的策略的一部分。

Thank You.

謝謝。

Thank you. And as a reminder to ask a question, please press star 11 on your telephone. And our next question comes from Anupam Rama with JP Morgan. You may proceed.

謝謝。提醒一下，如果您要提問，請在電話上按星號 11。我們的下一個問題來自摩根大通的 Anupam Rama。您可以繼續。

Hey guys, thanks so much for taking the question and congrats on the quarter. Last year you guys pre announced and gave forward your guidance at a small health care conference in January in San Francisco. Just wondering if that's still the plan moving forward. Thanks so much.

嘿，大家好，非常感謝你們回答這個問題，並祝賀本季取得的成績。去年 1 月，你們在舊金山的一個小型醫療保健會議上預先宣布並提出了指導意見。我只是想知道這是否仍然是未來的計劃。非常感謝。

You're assuming we're going to the small healthcare conference in January. Now, thanks a, you know, at this point, we're not quite sure what we're going to do, but certainly that was the case last year. You know, as always, we look at it very carefully and we will do it when we do it. But at this point, we've not made any final decisions, but thank you for the reminder.

您假設我們將參加一月份的小型醫療保健會議。現在，謝謝，你知道，在這一點上，我們還不太確定我們要做什麼，但去年的情況肯定是這樣的。你知道，一如既往，我們會非常仔細地考慮這個問題，並且會在需要的時候去做。但目前我們還沒有做出任何最終決定，不過還是感謝您的提醒。

Thanks for taking your question.

感謝您提出問題。

Thanks.

謝謝。

Thank you. I would now like to turn the call back over to Sanj Patel for any closing remarks.

謝謝。現在我想將電話轉回給 Sanj Patel，請他做最後發言。

No, thank you everybody for for being on the call today. Thanks for all the questions and joining us. We look very much forward to the remainder of the year and then obviously providing additional updates as just as I just said seminar and then hopefully in the near future. So thank you very much.

不，感謝大家今天的通話。感謝大家的提問與參與。我們非常期待今年剩餘時間的進展，然後顯然會提供更多更新，就像我剛才在研討會上說的那樣，並希望在不久的將來提供更多更新。非常感謝。

Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.

謝謝。會議到此結束。感謝您的參與。您現在可以斷開連線。