Arrowhead Pharmaceuticals, Inc. (ARWR) 2026 Q3 法說會逐字稿

Welcome to the Arrowhead Pharmaceuticals conference call. (Operator Instructions)

歡迎參加 Arrowhead Pharmaceuticals 的電話法說會。(接線員指示)

I will now hand the conference over to Vincent Anzalone, Senior Vice President of Investor Relations for Arrowhead. Please go ahead, Vince.

現在我將把會議交給 Arrowhead 投資人關係資深副總裁 Vincent Anzalone。Vince，請開始。

Thank you, and good afternoon, everyone. Thank you for joining us today to discuss Arrowhead's results for its fiscal 2026 third-quarter ended June 30, 2026. With us today from management are President and CEO, Dr. Chris Anzalone, who will provide an overview; Andy Davis, Senior Vice President and Head of the Global Cardiometabolic Franchise, who will provide an update on commercialization activities; Dr. James Hamilton, Chief Medical Officer and Head of R&D, who will discuss our development programs; and Dan Apel, Chief Financial Officer, who will give a review of the financials.

謝謝，各位下午好。感謝各位今天加入我們，一同討論 Arrowhead 於 2026 年 6 月 30 日止之 2026 會計年度第三季業績。今天與會的管理團隊包括：總裁暨執行長 Chris Anzalone 博士，將提供整體概覽；全球心臟代謝事業群資深副總裁暨負責人 Andy Davis，將更新商業化活動進展；研發主管暨首席醫療長 James Hamilton 博士，將說明我們的開發計畫；以及財務長 Dan Apel，將回顧財務表現。

Following management's prepared remarks, we will open the call to questions. Before we begin, I would like to remind you that comments made during today's call contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than statements of historical fact are forward-looking statements and are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed in any forward-looking statements. For further details concerning these risks and uncertainties, please refer to our SEC filings, including our most recent annual report on Form 10-K and our quarterly reports on Form 10-Q.

在管理團隊的準備發言結束後，我們將開放提問。在開始之前，我想提醒各位，今天電話會議中的評論包含若干前瞻性陳述，符合 1933 年《證券法》第 27A 條及 1934 年《證券交易法》第 21E 條之定義。除歷史事實陳述外，所有陳述均屬前瞻性陳述，並受多項風險與不確定性影響，可能導致實際結果與任何前瞻性陳述所表達者出現重大差異。關於這些風險與不確定性的進一步細節，請參閱我們向 SEC 提交的文件，包括最新的 Form 10-K 年度報告及 Form 10-Q 季度報告。

I'd now like to turn the call over to Chris.

現在我想把電話會議交給 Chris。

Thanks, Vince. Good afternoon, everyone, and thank you for joining us today. Arrowhead is now on the strongest footing in its history. Two weeks ago, we reported positive top line Phase 3 results from the global SHASTA-3 and SHASTA-4 studies in patients with severe hypertriglyceridemia, or sHTG, and we expect additional results to be presented later this month at the European Society of Cardiology Conference.

謝謝你，Vince。各位下午好，感謝各位今天加入我們。Arrowhead 目前正處於公司史上最穩健的基礎之上。兩週前，我們公布了全球 SHASTA-3 與 SHASTA-4 研究在重度高三酸甘油脂血症（severe hypertriglyceridemia，sHTG）患者中的第三期試驗正向主要結果（top line results），並預期本月稍晚將在歐洲心臟學會年會上公布更多結果。

These data made clear to us that REDEMPLO is a needed therapy for sHTG patients. To that end, we announced today that we have acquired a priority review voucher, which can accelerate the regulatory review process in the United States from 10 months to 6 months, potentially bringing this important medicine to patients as quickly as possible.

這些數據讓我們清楚看到，REDEMPLO 是 sHTG 患者所需要的治療。因此，我們今天宣布已取得一張優先審查憑證（priority review voucher），可將美國的法規審查時間由 10 個月縮短至 6 個月，讓這項重要藥物有機會以最快速度帶給患者。

To me, this is an expression of Arrowhead values, push to create the best medicines and be creative and aggressive to rapidly get them to patients who need them.

對我而言，這展現了 Arrowhead 的價值觀：致力打造最好的藥物，並以創新且積極的方式，迅速將藥物送到有需要的患者手中。

Let's talk about the SHASTA-3 and 4 top line results. Both studies met their primary endpoint and every prespecified secondary endpoint, a clean sweep across two pivotal trials. Median triglyceride reductions from baseline were 79% and 81% in SHASTA-3 and SHASTA-4, respectively. These results were deep, durable and remarkably consistent across both studies. Just as encouraging, safety and tolerability remained favorable and consistent with everything we've seen in prior studies. We observed no new safety signals, no clinically meaningful differences in routine laboratory measures, no clinically meaningful adverse changes in liver enzymes, no hypersensitivity cases and no thrombocytopenia signal.

接下來談談 SHASTA-3 與 SHASTA-4 的主要結果。兩項研究皆達成主要終點與所有預先指定的次要終點，兩項關鍵性試驗全面告捷。相較基線的三酸甘油脂中位數降幅，在 SHASTA-3 與 SHASTA-4 分別為 79% 與 81%。這些結果降幅深、效果持久，且在兩項研究中呈現高度一致性。同樣令人振奮的是，安全性與耐受性仍然良好，且與我們在先前研究中所見一致。我們未觀察到新的安全性訊號；例行實驗室檢測指標無臨床上具意義的差異；肝酵素未出現臨床上具意義的不良變化；未出現過敏反應案例；亦未見血小板減少症訊號。

In a prespecified MRI-PDFF subgroup, there was no statistically significant difference in mean liver fat content between plozasiran and placebo. The acute pancreatitis findings are, in our view, the standout results. Across the broad sHTG population, patients with triglycerides above 500 milligrams per deciliter with or without history of pancreatitis. Cumulative acute pancreatitis events were reduced by 78% versus placebo. And in the highest risk subgroup, patients with triglycerides above 880 milligrams per deciliter and a history of acute pancreatitis, we saw a 100% reduction in events versus placebo. Detailed results are expected to be presented at a hotline late breaker at the European Society of Cardiology Congress on August 30, followed by an Arrowhead webcast on August 31.

在一個預先指定的 MRI-PDFF 亞組中，plozasiran 與安慰劑在平均肝脂肪含量方面並無統計上顯著差異。我們認為，急性胰臟炎的發現是最突出的結果。在廣泛的 sHTG 族群中——三酸甘油脂高於 500 mg/dL、無論是否有胰臟炎病史的患者。累積急性胰臟炎事件相較安慰劑降低了 78%。而在最高風險亞組——三酸甘油脂高於 880 mg/dL 且有急性胰臟炎病史的患者——我們看到事件相較安慰劑降低 100%。詳細結果預計將於 8 月 30 日在歐洲心臟學會年會的 hotline late breaker 場次發表，隨後 Arrowhead 將於 8 月 31 日舉行網路直播說明會。

We intend to submit an sNDA to the FDA before the end of 2026, followed by additional global filings. If approved, sHTG would represent a substantially larger commercial opportunity than FCS and it would let us utilize the infrastructure we're building today for a much broader patient population. We believe the SHASTA results materially derisk our most important near-term label expansion opportunity and further strengthen the foundation of our cardiometabolic franchise. As we consider how we could fit into sHTG therapeutic paradigms, we think of REDEMPLO in three ways: safe, simple and strong.

我們計畫在 2026 年底前向 FDA 提交 sNDA，之後再進行其他全球地區的申請。若獲核准，sHTG 將代表比 FCS 大得多的商業機會，並使我們能運用目前正在建立的基礎設施，服務更廣泛的患者族群。我們相信 SHASTA 的結果在實質上降低了我們近期最重要的適應症擴增機會之風險，並進一步強化我們心臟代謝事業群的基礎。在思考我們如何融入 sHTG 的治療典範時，我們以三個面向看待 REDEMPLO：安全、簡單、強效。

Safe because of the impressive tolerability we saw in the PALISADE Phase 3 and resulting clean label in FCS, combined with what we saw in SHASTA-3 and 4 across multiple measures, including quiet liver enzymes, no hypersensitivity and no increase in liver fat. Simple because of quarterly dosing, no anticipated need for liver enzyme monitoring and a 25-milligram dose for all patients rather than having to titrate up and strong because of unprecedented reductions in triglyceride levels -- because of unprecedented reductions in triglyceride levels from baseline across multiple studies.

安全，因為我們在 PALISADE 第三期試驗中看到令人印象深刻的耐受性，並在 FCS 取得乾淨的標籤（clean label），再加上我們在 SHASTA-3 與 SHASTA-4 多項指標中所見，包括肝酵素平穩、無過敏反應、且肝脂肪未增加。簡單，因為每季一次給藥、預期不需要監測肝酵素，且所有患者皆使用 25 毫克劑量，而非必須逐步滴定加量；強效，因為在多項研究中，相較基線的三酸甘油脂降幅前所未見——因為在多項研究中，相較基線的三酸甘油脂降幅前所未見。

We see this as a clearly compelling value proposition for patients, health care providers and payers. Therefore, the speed at which we can bring plozasiran to the broader sHTG population is critical. The possibility of shaving four months off the approval process through the priority review voucher we acquired is important. We have a saying at Arrowhead that is even etched in the floor of one of our facilities. It is that every day matters. This is a driving principle for us from discovery to early development to late-stage clinical to regulatory interactions and ultimately to the last mile, getting important medicines to the patients who need them.

我們認為，這對患者、醫療照護提供者與支付方而言，都是明確且具吸引力的價值主張。因此，我們能以多快速度將 plozasiran 帶給更廣泛的 sHTG 族群至關重要。透過我們取得的優先審查憑證，讓核准流程有機會縮短四個月，意義重大。在 Arrowhead，我們有一句話，甚至刻在我們某個設施的地板上。那就是：每一天都很重要。這是驅動我們的核心原則，從藥物發現、早期開發、後期臨床、法規互動，直到最後一哩路——把重要藥物送到需要的患者手中。

Turning to execution of this last mile. Our US REDEMPLO launch for FCS continued to build real momentum during the quarter. We've seen greater than doubling of prescriptions quarter-on-quarter. Andy will talk through our progress in a moment, including prescription and market access progress, and I think you'll come away as encouraged as we are.

接著談最後一哩路的執行。我們在美國針對 FCS 的 REDEMPLO 上市推進，在本季持續累積實質動能。我們看到處方量較上一季成長超過一倍。Andy 稍後將說明我們的進展，包括處方與市場准入（market access）的進度，我想各位會和我們一樣感到振奮。

This launch in FCS has given us valuable experience and a scalable foundation to build on. Physicians are identifying previously untreated FCS patients, prescribing activity is broad, and our team is building the capabilities we will need for a much larger potential sHTG launch. We also continue to expand REDEMPLO's reach outside the United States.

這次在 FCS 的上市，為我們帶來寶貴經驗，也提供可擴展的基礎。醫師正在辨識先前未治療的 FCS 患者，處方活動涵蓋面廣，我們的團隊也正在建立未來可能更大規模 sHTG 上市所需的能力。我們也持續擴大 REDEMPLO 在美國以外地區的觸及。

In May, Australia's Therapeutic Goods Administration approved REDEMPLO as the first and only medicine approved for FCS in Australia, including genetically confirmed and clinically diagnosed adults. In June, the European Commission formally granted marketing authorization, making REDEMPLO the first and only siRNA-based medicine authorized by the EC for adults with FCS diagnosed through either clinical criteria or genetic testing.

5 月，澳洲治療用品管理局（Therapeutic Goods Administration）核准 REDEMPLO，成為澳洲第一個且唯一核准用於 FCS 的藥物，適用於基因確診與臨床診斷的成人。6 月，歐盟執委會正式核發上市許可，使 REDEMPLO 成為歐盟執委會核准、用於成人 FCS（可透過臨床標準或基因檢測診斷）的第一個且唯一 siRNA 藥物。

Together with our approvals in the United States, Canada, China and Australia, the EU authorization gives REDEMPLO an approved footprint across five geographies, an important achievement we are very proud of. We're now working through country-specific reimbursement and launch processes while Sanofi leads commercialization in Greater China.

加上我們在美國、加拿大、中國與澳洲的核准，歐盟的核准使 REDEMPLO 在五個地區取得核准版圖，這是一項我們深感自豪的重要里程碑。我們目前正推進各國特定的給付（reimbursement）與上市流程，而賽諾菲（Sanofi）則主導大中華區的商業化。

All of the commercial infrastructure we are building is intended not only to hopefully bring plozasiran to sHTG patients, but also to serve as the basis for our broader cardiometabolic franchise, which we expect to include zodasiran, ARO-DIMER-PA, obesity treatments and other candidates you will hear more about in coming quarters.

我們正在建置的所有商業基礎設施，不僅旨在（希望）將 plozasiran 帶給 sHTG 患者，也作為我們更廣泛心臟代謝事業版圖的基礎；我們預期其中將包括 zodasiran、ARO-DIMER-PA、肥胖症治療以及其他您將在未來幾季聽到更多消息的候選產品。

We're building a large number of potential medicines that could use the same commercial channels, hopefully providing us with substantial scalability and cost-effective growth. We view plozasiran as providing us with a strong value foundation. Our intention is to build on that aggressively, and we have made good progress recently toward that end. At EASL, we presented interim Phase 1/2a data for ARO-INHBE in obesity and NASH and the results were compelling.

我們正在打造大量潛在藥物，這些藥物可使用相同的商業通路，並有望為我們帶來可觀的規模化能力與具成本效益的成長。我們認為 plozasiran 為我們提供了堅實的價值基礎。我們的目標是積極在此基礎上擴展，且近期在朝此方向已取得良好進展。在 EASL 上，我們發表了 ARO-INHBE 於肥胖症與 NASH 的第 1/2a 期中期數據，結果相當令人信服。

ARO- INHBE achieved dose-dependent active and E reductions with a mean maximum reduction over 85% after a single 400-milligram dose with effects persisting beyond three months. In a small subgroup of obesity and elevated baseline liver fat receiving at least 200 milligrams as monotherapy, the placebo-adjusted post-dose reduction in liver fat was 44%. The program has been generally well tolerated, and we're now engaging regulators on potential Phase 2 designs and endpoints. We continue to make progress in the ARO-ALK7 Phase 1/2 program and expect to release more data from that study in the fourth quarter. Further, we expect to file a CTA for a new obesity candidate against an undisclosed target by the end of this year. Our June cardiometabolic R&D webinar highlighted Zodasiran and ARO-DIMER-PA. The Zodasiran YOSEMITE Phase 3 study in HoFH patients is fully enrolled, and we expect to have data in Q3 2027 and hopefully file an NDA by the end of 2027.

ARO-INHBE 在單次 400 毫克劑量後達到隨劑量增加的活性與 E 降幅，平均最大降幅超過 85%，且效果持續超過三個月。在一個小型亞組中（肥胖且基線肝脂肪偏高），以單藥治療接受至少 200 毫克者，其給藥後相較安慰劑調整的肝脂肪降幅為 44%。該計畫整體耐受性良好，我們目前正與監管機關就潛在的第 2 期試驗設計與終點進行討論。我們在 ARO-ALK7 第 1/2 期計畫亦持續取得進展，並預期於第四季公布該研究的更多數據。此外，我們預期在今年底前，針對一個未揭露標的的新肥胖症候選藥物提交 CTA。我們 6 月的心臟代謝研發線上說明會重點介紹了 Zodasiran 與 ARO-DIMER-PA。Zodasiran 的 YOSEMITE 第 3 期研究（HoFH 患者）已完成全數收案，我們預期於 2027 年第三季取得數據，並希望在 2027 年底前提交 NDA。

ARO-DIMER-PA is designed to silence both APOC3 and PCSK9 and therefore, reduce both LDL cholesterol and triglycerides. We believe this could be a uniquely powerful therapy for the roughly 20 million people in the United States with both elevated LDL and triglycerides. We expect to release early data from our Phase 1 study in September.

ARO-DIMER-PA 的設計目標是同時沉默 APOC3 與 PCSK9，因此可同時降低 LDL 膽固醇與三酸甘油酯。我們相信，這可能是針對美國約 2,000 萬名同時具有 LDL 與三酸甘油酯升高人群的一種獨特且強效的治療方式。我們預期於 9 月公布第 1 期研究的早期數據。

During the quarter, we also presented our subcutaneous CNS delivery work around ARO-MAPT at TIDES. This is an important piece of our pipeline, and we expect to release early data from our Phase 1 study in September.

本季期間，我們也在 TIDES 會議上發表了圍繞 ARO-MAPT 的皮下 CNS 遞送研究成果。這是我們產品線中的重要一環，我們預期於 9 月公布第 1 期研究的早期數據。

This is a potentially exciting data set, not only because of the potential of ARO-MAPT against Alzheimer's disease and other pathologies, but also because we think it could provide the first clinical proof of concept that we are able to address brain targets with RNAi using a simple subcutaneously administered conjugate. Our partnership strategy remains a key part of our model and value proposition. In May, we announced an exclusive worldwide license agreement with Madrigal for ARO-PNPLA3, a program for a genetically defined NASH population. Phase 1 data showed liver fat reductions of up to 46% after a single dose in homozygous carriers of the PNPLA3 I148M variant with rapid onset durability through at least 24 weeks and no clinically meaningful adverse events observed.

這可能是一組令人振奮的數據，不僅因為 ARO-MAPT 對阿茲海默症及其他病理的潛力，也因為我們認為它可能提供首個臨床概念驗證，證明我們能以簡單的皮下注射偶聯物，運用 RNAi 來作用於腦部標的。我們的合作夥伴策略仍是我們商業模式與價值主張的關鍵部分。5 月，我們宣布與 Madrigal 就 ARO-PNPLA3 達成全球獨家授權協議；該計畫針對具有特定基因特徵的 NASH 人群。第 1 期數據顯示，在 PNPLA3 I148M 變異之同型合子攜帶者中，單次給藥後肝脂肪最多可降低 46%，起效迅速且療效可持續至少 24 週，且未觀察到具臨床意義的不良事件。

Under the agreement, Arrowhead received a $25 million upfront payment and is eligible for up to $975 million in development, regulatory and sales milestones and tiered royalties to mid-teens. We believe that Arrowhead is something truly unique in biotech today. We have an approved product and positive pivotal data that we believe supports a potentially much larger indication that we think could drive peak sales in the $3 billion to $4 billion per year range.

依據該協議，Arrowhead 收到 2,500 萬美元的預付款，並有資格獲得最高 9.75 億美元的開發、監管與銷售里程碑款，以及分級權利金（最高至約十幾個百分點）。我們相信，Arrowhead 在當今生技領域確實是獨一無二的。我們擁有一項已獲核准的產品，以及正向的關鍵性試驗數據；我們認為這些數據支持一個潛在更大的適應症，並可能推動年峰值銷售達 30 億至 40 億美元的區間。

We have commercial infrastructure that is effective, growing and capable of being the basis for multiple additional products. We have a set of platforms that enable us to address liver, adipose, muscle, lung and CNS targets, and we believe virtually everything we have introduced to the clinic has translated from animal models to humans.

我們擁有有效、持續成長的商業基礎設施，並有能力作為多項新增產品的基礎。我們具備一系列平台，可讓我們鎖定肝臟、脂肪組織、肌肉、肺部與中樞神經系統（CNS）標的；我們相信，幾乎所有我們推進至臨床的項目都已從動物模型成功轉譯至人體。

By the end of this year, we expect to have 23 individual drug candidates in clinical trials, 11 wholly owned, 12 partnered, and we have a high degree of confidence that the overwhelming majority of these could eventually be approved products. We have the potential for substantial future partner income for our milestones and royalties, and we have the financial resources to keep this engine running and growing. So as you look to the patients we can help and the value we can create, of course, look to plozasiran, but also look to the engine we have built and the dozens of new medicines we can bring to patients.

我們預期在今年底前將有 23 個個別藥物候選進入臨床試驗，其中 11 個為全資擁有、12 個為合作夥伴項目；我們高度有信心，其中絕大多數最終都可能成為獲批產品。我們在里程碑款與權利金方面具備可觀的未來合作夥伴收入潛力，且我們擁有足夠的財務資源，讓這部引擎持續運轉並擴大成長。因此，當您著眼於我們能幫助的患者與能創造的價值時，當然要看 plozasiran，但也要看我們打造的引擎，以及我們能為患者帶來的數十種新藥。

With that overview, I'd now like to turn the call over to Andy Davis. Andy?

在以上概述之後，我現在想把電話會議交給 Andy Davis。Andy？

Thank you, Chris, and good afternoon, everyone. It has now been approximately 8.5 months since the FDA approval of REDEMPLO last November, and we continue to be very pleased with the progress of the launch. Today, I'd like to first walk through where we stand with our FCS launch. First, prescription and patient dynamics; second, payer coverage; third, pricing and competitive positioning; fourth, commercial infrastructure; and fifth, international expansion. And then finally, turn to some reflections on our recent sHTG clinical trial results.

謝謝你，Chris，各位下午好。自去年 11 月 REDEMPLO 獲 FDA 核准以來，至今約 8.5 個月，我們對上市進展仍感到非常滿意。今天，我想先說明我們在 FCS 上市推進的現況。首先是處方與患者動態；第二是保險給付覆蓋；第三是定價與競爭定位；第四是商業基礎設施；第五是國際擴張。最後，我也會談談我們近期 sHTG 臨床試驗結果的一些觀察。

Let's start with prescription and patient dynamics. REDEMPLO prescription volume has more than doubled over the course of the fiscal third quarter, and that momentum has continued into the current quarter. We have supported more than 400 unique prescribers of REDEMPLO with the specialty mix continuing to be led by preventive cardiology and endocrinology, consistent with prior quarters and our expectations at launch.

先從處方與患者動態談起。在本財年第三季期間，REDEMPLO 的處方量已增加一倍以上，而這股動能也延續到本季。我們已支持超過 400 位開立 REDEMPLO 的獨立處方醫師；專科組合仍以預防心臟科與內分泌科為主，與前幾季及我們上市時的預期一致。

Patient origination remains steady from prior communications across new to therapy versus switch patients and the volume of physicians writing prescriptions and patients receiving REDEMPLO for FCS continues to exceed our internal targets. In recent market tracking studies, health care professional respondents indicate steadily increasing awareness and depth of product knowledge with consistently high marks for REDEMPLO, both in absolute terms and relative to competition.

患者來源結構相較我們先前的溝通維持穩定，涵蓋新開始治療者與轉換用藥者；而開立處方的醫師數量與接受 REDEMPLO 治療 FCS 的患者數量，持續高於我們的內部目標。在近期市場追蹤研究中，醫療專業人員受訪者表示對產品的認知度與理解深度穩步提升，且對 REDEMPLO 的評價持續維持高分，無論是絕對表現或相對於競品皆然。

Turning now to payer coverage developments. We continue to see strong momentum in the publication of payer policies and overall coverage across payer segments. REDEMPLO now has favorable policies in place for the most significant payers and overall coverage is progressing at a fast trajectory for the brand. We expect the remaining coverage gap to continue closing over the coming months. Our market access team remains focused on ensuring both genetically confirmed and clinically diagnosed FCS patients have access to REDEMPLO and nearly all published payer policies reflect the ability for physicians to diagnose FCS patients using clinical criteria alone.

接著談保險給付覆蓋的進展。我們持續看到付費方政策發布與各付費方區隔整體覆蓋率方面的強勁動能。REDEMPLO 目前已在最重要的付費方建立有利的給付政策，整體覆蓋正以快速軌跡推進。我們預期剩餘的覆蓋缺口將在未來幾個月持續縮小。我們的市場准入團隊仍專注於確保基因確診與臨床診斷的 FCS 患者皆能取得 REDEMPLO；且幾乎所有已發布的付費方政策都反映出醫師可僅依臨床標準診斷 FCS 患者。

Next, pricing and competitive positioning. As a reminder, REDEMPLO's US WAC Is USD45,000 per patient per year under our One REDEMPLO unified pricing model, and we believe the value of REDEMPLO is supported by its highly differentiated efficacy, safety profile and dosing convenience. We've said consistently that we believe REDEMPLO offers physicians and patients a best-in-class option, and we remain confident that both the clinical data and the commercial model we've built position us well in FCS as we head towards the potential launch in sHTG.

接下來是定價與競爭定位。提醒一下，依我們「One REDEMPLO」統一定價模式，REDEMPLO 在美國的 WAC 為每位患者每年 45,000 美元；我們認為 REDEMPLO 的價值有其高度差異化的療效、安全性特徵與給藥便利性作為支撐。我們一貫表示，REDEMPLO 為醫師與患者提供同級最佳（best-in-class）的選擇；我們仍有信心，臨床數據與我們建立的商業模式，將使我們在 FCS 領域具備良好定位，並在邁向 sHTG 潛在上市之際保持優勢。

Ultimately, we believe physicians and patients should have the freedom to choose the therapy that best fits a given patient's clinical profile, and we'll continue to let the product profile of REDEMPLO and FCS make our case. On our commercial infrastructure, our field organization continues to scale in a deliberate sequenced way sized for both the current FCS opportunity and the future sHTG opportunity as it unfolds.

最終，我們相信醫師與病患應有自由選擇最符合特定病患臨床特徵的治療方式，我們也將持續讓 REDEMPLO 與 FCS 的產品特性為我們的主張提供佐證。就我們的商業化基礎建設而言，我們的前線組織持續以審慎、循序漸進的方式擴編，其規模同時對應目前的 FCS 機會以及未來 sHTG 機會隨著發展而帶來的需求。

Our commercial team's tenure and productivity continue to build, and we're seeing that reflected in the prescription and payer metrics I just walked through. Importantly, if the launch timing for sHTG is accelerated as we expect, we will be ready. Just this past week, in fact, we onboarded the next wave of field personnel. This team will be in the field this month, educating stakeholders on FCS and REDEMPLO.

我們商業團隊的任職年資與生產力持續提升，這也反映在我剛才說明過的處方與付款方指標上。重要的是，若 sHTG 的上市時程如我們預期加速，我們將已做好準備。事實上，就在上週，我們完成了下一波前線人員的到職訓練與導入。這支團隊將於本月進入市場，向利害關係人宣導 FCS 與 REDEMPLO。

Lastly, a word about international expansion. REDEMPLO is now approved for FCS in the United States, Canada, China, Australia and the European Union. On the EU approval specifically, REDEMPLO's label uniquely covers both genetically confirmed and clinically diagnosed FCS patients. That is to say it's the only therapy in Europe with clinical FCS on label.

最後，談一下國際擴張。REDEMPLO 目前已在美國、加拿大、中國、澳洲及歐盟獲准用於 FCS。就歐盟核准而言，REDEMPLO 的標籤獨特地同時涵蓋「基因確診」與「臨床診斷」的 FCS 病患。也就是說，它是歐洲唯一在標籤上納入臨床診斷 FCS 的治療。

We view this as a meaningful differentiator given that a substantial share of real-world FCS patients are diagnosed clinically rather than genetically. We expect reimbursement will proceed on a country-by-country basis over approximately the next 12 months, beginning with Germany in the coming weeks.

我們認為這是一項重要的差異化因素，因為相當比例的真實世界 FCS 病患是以臨床方式診斷，而非基因檢測確診。我們預期給付將在未來約 12 個月內按國別逐一推進，並將於未來幾週先從德國開始。

I'll wrap up my remarks with some reflections on what's ahead for plozasiran in SHTG. As Chris highlighted, we recently announced top line results from the Phase 3 SHASTA-3 and SHASTA-4 studies of plozasiran in severe hypertriglyceridemia, and we believe these are best-in-class results. Both studies met their primary endpoint with median triglyceride reductions of 79% and 81% from baseline at month 12 in SHASTA-3 and SHASTA-4, respectively, compared to approximately 27% for placebo.

我將以對 plozasiran 在 sHTG 未來發展的一些看法作結。如 Chris 所強調，我們近期公布了 plozasiran 用於重度高三酸甘油脂血症的第 3 期 SHASTA-3 與 SHASTA-4 研究主要結果，我們相信這些結果屬同類最佳（best-in-class）。兩項研究皆達成主要終點：在 SHASTA-3 與 SHASTA-4 中，治療 12 個月時相較基線的三酸甘油脂中位數降幅分別為 79% 與 81%，而安慰劑約為 27%。

Just as importantly, in the preplanned pooled analysis, plozasiran achieved a statistically significant reduction in acute pancreatitis events versus placebo across the broad sHTG population study, a 78% reduction in cumulative AP events. And in the subset of patients with the very highest risk, those with triglycerides above 880 milligrams per deciliter and a prior history of pancreatitis, we saw a 100% reduction in AP events versus placebo.

同樣重要的是，在預先規劃的合併分析中，於廣泛的 sHTG 受試族群中，plozasiran 相較安慰劑在急性胰臟炎事件上達到具統計顯著性的降低，累積 AP 事件下降 78%。而在風險最高的病患子群（即三酸甘油脂高於 880 mg/dL 且有胰臟炎病史者）中，我們觀察到相較安慰劑 AP 事件降低 100%。

The safety and tolerability profile remained consistent with what we've seen across the plozasiran program to date with no new safety signals, no clinically meaningful liver findings and no hypersensitivity or thrombocytopenia signal. We see this data set as a powerful validation of plozasiran's profile across the full spectrum of SHTG, and it gives us continued confidence in our planned supplemental NDA submission, which remains on track for before the end of this year.

其安全性與耐受性概況與我們迄今在 plozasiran 計畫中所見一致，未出現新的安全性訊號、未見具臨床意義的肝臟發現，亦未出現過敏反應或血小板減少的訊號。我們認為這組資料強而有力地驗證了 plozasiran 在 SHTG 全範圍族群中的產品特性，並使我們對既定的補充新藥申請（sNDA）送件計畫持續有信心；該計畫仍按進度，預計於今年底前完成送件。

With that, I'll turn the call over to James.

接下來，我把電話會議交給 James。

Thank you, Andy. I'd like to share our plans for R&D milestones and data readouts throughout the rest of the year. But first, let's review the R&D team's accomplishments over the last quarter and beyond. We made large strides in advancing our cardiometabolic programs. Specifically, the Arrowhead team locked databases and analyzed data for MUIR-3, SHASTA-3 and SHASTA-4 ahead of schedule, culminating in the release of top line SHASTA-3 and SHASTA-4 data at the end of last month. As already mentioned, plozasiran achieved deep and durable reductions in triglycerides, translating into statistically significant reduction in acute pancreatitis events. Plozasiran also demonstrated a favorable safety profile with no statistically significant difference in liver fat in the treatment group versus placebo.

謝謝你，Andy。我想分享我們在今年剩餘時間內的研發里程碑與資料揭露規劃。但首先，讓我們回顧研發團隊在上一季及更早期間的成果。我們在推進心代謝（cardiometabolic）計畫方面取得重大進展。具體而言，Arrowhead 團隊提前完成 MUIR-3、SHASTA-3 與 SHASTA-4 的資料庫鎖定與數據分析，並在上月底發布 SHASTA-3 與 SHASTA-4 的主要結果。如前所述，plozasiran 在降低三酸甘油脂方面達到深度且持久的效果，並轉化為急性胰臟炎事件具統計顯著性的降低。plozasiran 亦展現良好的安全性概況，治療組相較安慰劑在肝脂肪方面未出現具統計顯著性的差異。

We remain excited about sharing detailed results, which are planned for presentation at the upcoming European Society of Cardiology meeting later this month. The MUIR-3 trial achieved its intended purpose as a study designed to build the plozasiran safety database. We plan on presenting data from this study at a future medical conference. Additionally, during the quarter, plozasiran received Australian and European Commission approval as an adjunct to diet in FCS patients.

我們仍期待分享更詳細的結果，並計畫於本月稍晚即將舉行的歐洲心臟學會（European Society of Cardiology）年會上發表。MUIR-3 試驗達成其預期目的，作為一項用於建立 plozasiran 安全性資料庫的研究。我們計畫在未來的醫學會議上發表該研究數據。此外，在本季期間，plozasiran 亦獲澳洲與歐盟執委會核准，作為 FCS 病患飲食控制的輔助治療。

Switching gears to zodasiran in the development for the treatment of homozygous familial hypercholesterolemia or HoFH. We completed enrollment of the Phase 3 YOSEMITE study in mid-July. Importantly, the study was designed to enroll 60 HoFH patients. However, due to strong demand, we ended up enrolling 70 patients, all with genetically confirmed or clinically defined HoFH. This is a one year study, so we expect study completion mid-2027 with data in the second half of '27.

接著談 zodasiran，其正開發用於治療同型合子家族性高膽固醇血症（HoFH）。我們已於 7 月中旬完成第 3 期 YOSEMITE 研究的受試者收案。重要的是，該研究原設計收納 60 名 HoFH 病患。然而，由於需求強勁，我們最終收納了 70 名病患，且皆為基因確診或臨床定義之 HoFH。這是一項為期一年的研究，因此我們預期研究將於 2027 年年中完成，並於 2027 年下半年取得數據。

Also in cardiometabolic, the ARO-DIMER-PA Phase 1/2a study in patients with mixed hyperlipidemia is nearing full enrollment, and we plan to share top line data in September. Elsewhere in our pipeline, we continue to make progress with both the ARO-INHBE and the ARO-ALK7 programs. As Chris already highlighted, we presented data from the ARO-INHBE Phase 1 study demonstrating a 44% reduction in liver fat in patients with hepatic steatosis at baseline. As a reminder, liver fat reductions of better than 30% are generally thought to translate into histologic and potentially clinical benefit.

在心代謝領域方面，針對混合型高脂血症病患的 ARO-DIMER-PA 第 1/2a 期研究即將完成收案，我們計畫於 9 月分享主要結果。在我們的其他產品線中，ARO-INHBE 與 ARO-ALK7 計畫也持續取得進展。如 Chris 先前所提，我們已發表 ARO-INHBE 第 1 期研究數據，顯示在基線即有肝脂肪變性的病患中，肝脂肪降低 44%。提醒一下，一般認為肝脂肪降低超過 30% 通常可轉化為組織學（histologic）且可能具有臨床上的效益。

An ARO-INHBE Phase 2b clinical trial protocol has been submitted to regulators. The trial is designed to evaluate the effects of various doses of ARO-INHBE on liver fat, liver histology, body weight and body composition in obese patients with NASH.

ARO-INHBE 第 2b 期臨床試驗方案已提交監管機關。該試驗旨在評估不同劑量 ARO-INHBE 對肥胖且患有 NASH 病患之肝脂肪、肝臟組織學、體重與身體組成的影響。

The study is intended to evaluate diabetic and nondiabetic patients as well as those on and not on stable Incretin therapy. As the study is under regulatory review, we plan on sharing trial details once agreed upon with regulators. We intend to provide an obesity data update primarily focused on ALK7 towards the end of this year.

本研究擬納入糖尿病與非糖尿病病患，以及正在使用或未使用穩定腸泌素（Incretin）治療的病患。由於研究仍在監管審查中，我們將在與監管機關達成一致後分享試驗細節。我們預計在今年底前提供一次肥胖症數據更新，內容將主要聚焦於 ALK7。

Moving on to CNS. We've long held the belief that the CNS represents the next frontier for siRNA therapeutics with a large number of gene targets amenable to a gene silencing approach. Historically, the field has been severely limited by the requirement of intrathecal administration. This is a limitation Arrowhead hopes to remove with pioneering technology designed to deliver siRNA therapeutics across the blood-brain barrier. ARO-MAPT is Arrowhead's first molecule based on this delivery platform. MAPT gene encodes for the tau protein and abnormal tau accumulation is widely believed to be a critical component of the pathologic cascade leading to Alzheimer's disease.

接著談中樞神經系統（CNS）。我們長期以來相信，CNS 將是 siRNA 治療的下一個前沿領域，因為有大量基因標的適合以基因沉默策略處理。歷史上，該領域一直受到必須進行鞘內（intrathecal）給藥的要求而嚴重限制。Arrowhead 希望透過開創性技術移除此限制，該技術旨在將 siRNA 治療遞送穿越血腦障壁。ARO-MAPT 是 Arrowhead 基於此遞送平台的第一個分子。MAPT 基因負責編碼 tau 蛋白，而 tau 的異常累積被廣泛認為是導致阿茲海默症之病理級聯反應中的關鍵組成部分。

Additionally, other forms of abnormal tau accumulation are known to directly cause MAPT variant frontotemporal dementia as well as progressive supranuclear palsy.

此外，其他形式的 tau 異常累積已知會直接導致 MAPT 變異型額顳葉失智症，以及進行性核上性麻痺。

A Phase I clinical trial of ARO-MAPT in healthy volunteers is reaching full enrollment and the second phase of this study in Alzheimer's patients is actively enrolling. As Chris mentioned, we are targeting this September for top line data release from the healthy volunteers. This will be a very important data readout as it could pave the way for later-stage tauopathy clinical trials. Additionally, achieving successful MAPT gene silencing will validate the platform for use in numerous additional CNS programs in our preclinical pipeline, which includes our partnered programs.

ARO-MAPT 於健康受試者進行的第一期臨床試驗正接近完成全數收案，而本研究在阿茲海默症患者中的第二階段也正在積極收案中。如 Chris 所提及，我們目標在今年 9 月公布健康受試者的主要（top line）數據。這將是一項非常重要的數據揭露，因為它可能為後期 tau 蛋白病（tauopathy）的臨床試驗鋪路。此外，若能成功達成 MAPT 基因沉默，將可驗證本平台可用於我們臨床前研發管線中的多項其他中樞神經系統（CNS）專案，其中也包含我們的合作專案。

I will now turn the call over to Daniel.

接下來我把電話會議交給 Daniel。

Thank you, James, and good afternoon, everyone. As we reported today, net loss for the quarter ended June 30, 2026, was $194.3 million or a loss of $1.36 per share based on 143.4 million fully diluted weighted average shares outstanding. This compares to a net loss of $175.2 million or a loss of $1.26 per share for the prior year quarter ended June 30, 2025, based on 139 million fully diluted weighted average shares outstanding in that quarter. Revenue for the quarter totaled approximately $75 million compared to $28 million in the prior year quarter. Revenue was driven by our license and collaboration agreements with Sarepta, Madrigal, Novartis and Sanofi, together with commercial sales of REDEMPLO. Of the total, approximately $26 million related to the Sarepta collaboration, mainly from ongoing recognition of initial consideration under that agreement as well as reimbursement of certain clinical and manufacturing expenses.

謝謝你，James，各位下午好。如我們今天所報告，截至 2026 年 6 月 30 日止季度的淨損為 1.943 億美元，或每股虧損 1.36 美元，係以 1.434 億股完全稀釋後加權平均流通股數計算。相較之下，前一年度截至 2025 年 6 月 30 日止季度的淨損為 1.752 億美元，或每股虧損 1.26 美元，當季完全稀釋後加權平均流通股數為 1.39 億股。本季度營收合計約 7,500 萬美元，較前一年度同期的 2,800 萬美元增加。營收主要來自我們與 Sarepta、Madrigal、Novartis 及 Sanofi 的授權與合作協議，以及 REDEMPLO 的商業銷售。在總額中，約 2,600 萬美元與 Sarepta 合作相關，主要來自該協議下初始對價的持續認列，以及特定臨床與製造費用的補償。

For the Novartis collaboration, we recognized approximately $20 million in the quarter, bringing fiscal year-to-date revenue recognition to approximately $75 million. As of June 30, of the initial $200 million of cash received upfront, approximately $125 million of consideration remains in deferred revenue and will be recognized over time as we fulfill our preclinical research and development obligations. We also recognized the full $25 million upfront payment from Madrigal following completion of the license and technology transfer for ARO-PNPLA3.

就 Novartis 合作而言，我們於本季度認列約 2,000 萬美元，使本會計年度截至目前的累計營收認列約達 7,500 萬美元。截至 6 月 30 日，在先前預收的 2 億美元現金中，約 1.25 億美元的對價仍列為遞延收入，並將隨著我們履行臨床前研發義務而逐期認列。在完成 ARO-PNPLA3 的授權與技術移轉後，我們亦認列了來自 Madrigal 的 2,500 萬美元一次性預付款全額。

As previously announced, Arrowhead remains eligible to receive up to $975 million in development, regulatory and sales milestones as well as tiered royalties on future commercial sales ranging from the high single digits to the mid-teens.

如先前所公告，Arrowhead 仍有資格獲得最高達 9.75 億美元的開發、法規核准與銷售里程碑款，並可就未來商業銷售收取分級權利金，比例範圍約自高個位數百分比至十幾個百分比中段。

Finally, we recognized approximately $1.2 million for transitional services and commercial FCS supply to Sanofi under our license agreement for Greater China. As previously mentioned, we are not intending to headline specific REDEMPLO product sales numbers until they become a meaningful driver to our financials. That said, commercial revenue can be derived from our disclosures as a difference between total revenue and collaboration revenue and represented approximately $2.4 million for the quarter. This is more than double the approximately $1 million recorded in fiscal quarter two, and we have been very encouraged by the continued progress we are seeing in the launch.

最後，依據我們針對大中華區的授權協議，我們就提供 Sanofi 的過渡性服務與商業用 FCS 供應認列約 120 萬美元。如先前所提及，在 REDEMPLO 產品銷售成為我們財務表現的重要驅動因素之前，我們不打算在對外溝通中強調特定的 REDEMPLO 產品銷售數字。不過，商業收入可由我們揭露資訊推算，即總營收減去合作收入之差額；本季度約為 240 萬美元。這一數字較第二會計季度所記錄的約 100 萬美元增加逾一倍，我們也對上市推進所見到的持續進展感到非常鼓舞。

Turning now to expenses. Total operating expenses for the quarter were approximately $245 million compared to $193 million in the prior year quarter. The $52 million year-over-year increase was driven by approximately $36 million of higher R&D expense and $16 million of higher SG&A expense.

接著談費用。本季度總營運費用約為 2.45 億美元，較前一年度同期的 1.93 億美元增加。年增 5,200 萬美元主要來自研發費用增加約 3,600 萬美元，以及銷售、一般及行政（SG&A）費用增加約 1,600 萬美元。

R&D expense was approximately $198 million. The increase year-over-year was primarily attributed to a $32 million increase in candidate costs, reflecting continued progression of our pipeline through clinical development, including the Phase 3 registrational program for plozasiran in SHTG as well as increased manufacturing and clinical supply activity.

研發費用約為 1.98 億美元。年增主要歸因於候選藥物相關成本增加 3,200 萬美元，反映我們的研發管線持續推進至臨床開發階段，包括 plozasiran 於 SHTG 的第三期註冊性計畫，以及製造與臨床供應活動的增加。

In line with our forecast, this also contributed to the pickup in expenses when compared to fiscal quarter two. Salaries were also higher, driven by increased head count to support manufacturing operations and a broader clinical pipeline.

依照我們的預測，這也使得相較於第二會計季度，費用有所上升。薪資亦較高，主要由於為支援製造營運與更廣泛的臨床研發管線而增加人力。

As James discussed, SHASTA-3 and SHASTA-4 have now read out with positive top line results. Accordingly, we expect costs associated with active execution of those studies to begin to moderate down over time, beginning in fiscal 2027. At the same time, we will continue to invest in regulatory activities, commercial supply readiness for potential SHTG launch and advancement of our broader pipeline. The quarterly R&D expense will continue to be highly influenced by program timing of clinical activity. SG&A expense was approximately $47 million in the quarter compared to $31 million in the prior year quarter. The increase was primarily driven by ongoing investments supporting the commercialization of REDEMPLO, including commercial headcount, marketing and launch support and other outside services.

如 James 所討論，SHASTA-3 與 SHASTA-4 現已公布正向的主要（top line）結果。因此，我們預期與這些研究積極執行相關的成本將自 2027 會計年度起，隨時間推移開始趨於下降。同時，我們將持續投入法規相關活動、為潛在的 SHTG 上市做商業供應準備，以及推進更廣泛的研發管線。季度研發費用仍將高度受臨床活動的專案時程影響。本季度 SG&A 費用約為 4,700 萬美元，較前一年度同期的 3,100 萬美元增加。增加主要來自持續投入以支援 REDEMPLO 商業化，包括商業團隊人力、行銷與上市支援，以及其他外部服務。

Given the opportunities we are seeing in FCS, we have expanded and are continuing to expand our commercial footprint and our capabilities where appropriate. We're building these capabilities to support the current FCS launch, but we've designed them to scale, supporting potential future indications for plozasiran and ultimately plozasiran in HoFH.

鑑於我們在 FCS 所看到的機會，我們已擴大並將在適當情況下持續擴大我們的商業佈局與能力。我們建置這些能力是為了支援目前的 FCS 上市，但也將其設計為可擴充，以支援 plozasiran 未來可能的適應症，並最終支援 plozasiran 於 HoFH 的應用。

Turning to the balance sheet. Cash and investments on hand totaled approximately $1.6 billion as of June 30, 2026. Common shares outstanding at quarter end were 141.1 million. As we have disclosed, we have entered into an asset purchase agreement for an issued FDA priority review voucher, which we plan to use with our upcoming SNDA submission for plozasiran in sHTG. Under the terms of the APA, we will pay the current holder $215 million at closing, which we expect to occur in our fiscal fourth quarter following HSR Clearance.

接著看資產負債表。截至 2026 年 6 月 30 日，我們持有的現金與投資合計約 16 億美元。季度末普通股流通在外股數為 1.411 億股。如我們已揭露，我們已簽訂資產購買協議（APA），購買一張已核發的 FDA 優先審查憑證（PRV），並計畫用於我們即將提交的 plozasiran 用於 sHTG 的 SNDA 申請。依據 APA 條款，我們將於交割時支付現持有人 2.15 億美元；我們預期在取得 HSR 核准後，於本公司第四會計季度完成交割。

According to our projections, should we gain approval in SHTG, the increase in present value of REDEMPLO simply as a result of shifting our launch aspirations and uptake curve forward by four months, provides a greater than 3 times return on the PRV investment. Further, it is easy to layer on top of that incremental value that we might expect to achieve commercially should we be able to shorten our competitors' first-mover advantage.

依據我們的推估，若我們在 SHTG 獲得核准，僅因將我們的上市目標與滲透（uptake）曲線提前四個月，REDEMPLO 的現值增加就可為 PRV 投資帶來超過 3 倍的報酬。此外，也很容易在此基礎上再疊加我們可能在商業上取得的增量價值，若我們能縮短競品的先行者優勢。

As a concluding remark, we believe that our strong balance sheet provides significant financial flexibility to support ongoing clinical development, current and future commercialization activities and our long-term strategic priorities.

作為結語，我們相信強健的資產負債表提供了顯著的財務彈性，可支援持續的臨床開發、目前與未來的商業化活動，以及我們的長期策略優先事項。

With that brief overview, I will now turn the call back to Chris.

以上為簡要說明，接下來我把電話會議交回給 Chris。

Thanks, Dan. We've made so much progress during the first half of the year and the second half of 2026 is equally packed with potentially important and value-creating events. First, we want to move as quickly as possible to get our SNDA submitted for plozasiran, supported by the strong clinical data from the SHASTA-3 and SHASTA-4 studies. The priority review voucher we acquired could help us get this important new medicine to patients with FHTG as rapidly as possible.

謝謝你，Dan。我們在上半年取得了非常多的進展，而 2026 年下半年同樣安排了許多可能重要且能創造價值的事件。首先，我們希望盡可能快速提交 plozasiran 的 SNDA，並以 SHASTA-3 與 SHASTA-4 研究的強勁臨床數據作為支持。我們取得的優先審查憑證可協助我們盡快將這項重要的新藥帶給 FHTG 患者。

Physicians and patients are eagerly anticipating this medicine, so we are working hard to make it happen. Beyond plozasiran, we have some important data readouts and events planned before the end of the year that could represent important derisking and potential value-creating events. These readouts include the following: one, the first clinical readout of ARO-DIMER-PA, the first dual functional siRNA candidate targeting both PCSK9 and APOC3 for LDL and TG lowering is expected in September.

醫師與患者都熱切期待這項藥物，因此我們正全力以赴促成此事。除了 plozasiran 之外，在今年底前我們也規劃了幾項重要的數據揭露與事件，可能代表關鍵的去風險（derisking）與潛在的價值創造事件。這些揭露包括：第一，ARO-DIMER-PA 的首次臨床數據揭露，這是首個同時靶向 PCSK9 與 APOC3、用於降低 LDL 與 TG 的雙功能 siRNA 候選藥物，預計於 9 月公布。

Two, the first clinical readout for ARO-MAPT being developed as a potential treatment for tauopathies, including Alzheimer's disease, representing our first program using the subcutaneously administered CNS delivery platform designed to cross the blood-brain barrier after systemic delivery. This is expected in September.

第二，ARO-MAPT 的首次臨床讀出，該項目正被開發作為治療 tau 蛋白病（包括阿茲海默症）的潛在療法；這也代表我們第一個使用皮下注射給藥的中樞神經（CNS）遞送平台之項目，該平台設計為在全身性給藥後可穿越血腦屏障。預計將於九月公布。

And three, additional ARO-INHBE and ARO-ALK7 data releases are planned in the fourth quarter for this novel non-incretin strategy, which has quite encouraging early data in obesity and NASH.

第三，針對這一新穎的非腸泌素（non-incretin）策略，我們計畫在第四季額外發布 ARO-INHBE 與 ARO-ALK7 的數據；該策略在肥胖與 NASH 方面已有相當令人鼓舞的早期數據。

With that, thank you for joining us today, and I would now like to open the call to your questions. Operator?

以上，感謝各位今天與會，我現在想開放電話會議進入提問環節。接線員？

(Operator Instructions) Maurice Raycroft, Jefferies.

(接線員指示) Maurice Raycroft，Jefferies。

Congrats on the progress and on the SHASTA data. With a question on just the sNDA, getting that submitted by year-end '26, can you bookend what that time line could look like and what the gating factors are forgetting that in? And separately, can you talk about expectations for the ESC late-breaker data? There's been some debate on median versus mean TG reduction magnitude. And even though there are no static differences on safety, were there any imbalances in liver fat, ALT elevations or glycemic parameters you want to comment on?

恭喜你們的進展以及 SHASTA 數據。我有一個關於 sNDA 的問題：你們提到會在 2026 年底前提交，能否就這個時程可能的範圍做個上下界說明，以及推動（或限制）達成該時程的關鍵因素是什麼？另外，能否談談對 ESC late-breaker 數據的預期？目前對於 TG 降幅的幅度（以中位數 vs 平均數）有一些爭論。此外，即使安全性沒有顯著差異，你們是否觀察到肝脂肪、ALT 升高或血糖相關參數方面的任何不平衡，想要評論一下？

Yes, sure. Maury, this is James. I'll answer the second question, the ESC data, you'll have to wait and see at ESC that we really are under embargo until the conference, so we can't discuss any details around the study. In terms of rate limiters for the sNDA, we do plan to have a pre-sNDA meeting with FDA and then subsequent to our discussions with the agency would file the submission. So for the time being, for our team, it's really all about generating sNDA modules and study reports and whatnot and finalizing the data that we need for the by the end of the year.

好的，當然。Maury，我是 James。我先回答第二個問題、也就是 ESC 的數據：你得等到 ESC 才能看到；在會議之前我們確實處於禁運期，因此無法討論研究的任何細節。至於 sNDA 的時程限制因素，我們確實計畫與 FDA 進行 pre-sNDA 會議，並在與主管機關討論之後提交申請。因此就目前而言，對我們團隊來說，重點在於產出 sNDA 的各個模組、研究報告等，並在年底前完成我們所需的數據定稿。

Mike Ulz, Morgan Stanley.

Mike Ulz，Morgan Stanley。

Congratulations on all the progress as well. Maybe just one on ARO-MAPT. Just if you can remind us what top line data you might share with us in September? And what level of knockdown are you looking for? And has that sort of evolved at all now that we've seen some of the Biogen data?

也恭喜你們的各項進展。我想問一個關於 ARO-MAPT 的問題。能否提醒我們九月你們可能會分享哪些頂線（top line）數據？你們希望看到多大程度的 knockdown？以及在看到一些 Biogen 的數據後，這個目標是否有任何演變？

Yes, sure. I can take that one also. So this will only be healthy volunteer data. We'll be discussing primarily safety and then total tau knockdown. There's not a lot of other biomarkers that we can measure in the healthiest. So it's just a safety and pharmacodynamic dose range finding study in the healthiest.

好的，當然。這題我也可以回答。這將僅是健康受試者（healthy volunteer）的數據。我們主要會討論安全性，以及總 tau（total tau）的 knockdown。在最健康的受試者身上，我們能測量的其他生物標記不多。因此這就是一項在健康受試者中進行的安全性與藥效動力學（pharmacodynamic）劑量範圍探索研究。

And then sorry, what was the other part of the question?

然後不好意思，問題的另一部分是什麼？

What knockdown.

想問 knockdown 的程度。

Yes. So I think that we still -- we're still aiming for probably that 50% to 60% knockdown. I mean that level of knockdown seem to achieve some level of clinical improvement in the CELIA study. So I think we've said that all along, and we're kind of sticking with that benchmark of 50% to 60% knockdown.

是的。我想我們仍然——我們仍然可能以 50% 到 60% 的 knockdown 為目標。我的意思是，那樣的 knockdown 水準在 CELIA 研究中似乎能帶來某種程度的臨床改善。所以我想我們一直都是這麼說的，也會維持以 50% 到 60% knockdown 作為基準。

Brian Cheng, JPMorgan.

Brian Cheng，JPMorgan。

Let us add our congrats into the -- on the SHASTA data. Early in the call, you talked about the sequencing scale up of your sales force. How big of a sales force do you envision that you'll need to reach? And how does that sequence look over the course of the next several months heading into the label expansion decision?

也讓我們加入對 SHASTA 數據的祝賀。在電話會議前段，你們談到銷售團隊的分階段擴編。你們預期最終需要多大規模的銷售團隊？而在接下來幾個月、邁向標籤擴增決策的過程中，這個分階段會如何展開？

Thanks, Brian. This is Andy. Good question. While I won't go into the details of the size of our field force for SHTG, I would tell you that we'll be moving from effectively addressing over 5,000 HCP targets to a world will be addressing over 20,000 HCP targets across both the specialists that I've mentioned previously and also potentially those primary care physicians who act like specialists. So we would anticipate the final onboarding of the optimization of our field force to happen before the end of the year as we prepare for a potential accelerated launch in SHTG in the second quarter of next year.

謝謝，Brian。我是 Andy。好問題。雖然我不會詳談我們針對 SHTG 的外勤團隊（field force）規模細節，但我可以說，我們將從目前實際上覆蓋超過 5,000 名醫療照護專業人員（HCP）目標，擴展到一個將覆蓋超過 20,000 名 HCP 目標的狀態；涵蓋我先前提到的專科醫師，也可能包括那些行為模式類似專科醫師的基層照護醫師。因此，我們預期在年底前完成外勤團隊的最終到職（onboarding）與最佳化，以便為明年第二季在 SHTG 可能的加速上市做準備。

Luca Issi, RBC.

Luca Issi，RBC。

Congrats on all the progress. Maybe a quick one for James again. Again, you're not commenting on whether there is or there's not a trend in terms of like increasing liver fat, again, rightly so, given that the data is still embargo at ESC.

恭喜你們的各項進展。我想再快速問 James 一題。同樣地，你們不會評論是否存在肝脂肪增加的趨勢——這點可以理解，因為 ESC 前數據仍在禁運期。

But maybe can you remind us what proportion of all patients in SHASTA-3 and SHASTA-4 actually received an MRI at baseline in year one? Just trying to understand what's the sample size here and how meaningful that analysis will be. So that will be much appreciated. And then maybe super quickly, now that you have SHASTA-3 and SHASTA-4 in-house, how should we be thinking about SHASTA-5? Will you still continue that trial? Or maybe will you wind that down? Any thoughts there, much appreciated.

但你能否提醒我們，在 SHASTA-3 與 SHASTA-4 中，第一年在基線時實際接受 MRI 的患者比例是多少？我只是想了解這裡的樣本數，以及該分析會有多大的意義。若能說明將非常感謝。另外很快一題：現在你們已經拿到 SHASTA-3 與 SHASTA-4 的完整資料，我們應該如何看待 SHASTA-5？你們還會繼續該試驗嗎？或是可能會逐步收尾？若能分享想法，將不勝感激。

Yes, sure. Thanks, Luca. Initial question, like I said before, we're under embargo. I can't really give any details around the SHASTA-3 or SHASTA-4 study, but we'll present all of that at ESC. For SHASTA-5, we don't have any plans to terminate that study right now. The plan would be to continue that and maybe get a better idea of what our label is going to look like before we make any decisions to stop the study. So for the time being, it's kind of status quo. We're continuing to enroll that study and continuing to run the study without any changes.

好的，當然。謝謝，Luca。第一個問題，如我先前所說，我們處於禁運期。我無法提供任何關於 SHASTA-3 或 SHASTA-4 研究的細節，但我們會在 ESC 完整呈現。至於 SHASTA-5，我們目前沒有任何計畫要終止該研究。計畫是繼續進行，並且在我們對標籤最終會長什麼樣有更清楚的概念之後，再決定是否停止研究。因此就目前而言，基本上維持現狀。我們會持續招募並持續執行該研究，不做任何變更。

Jason Gerberry, Bank of America.

Jason Gerberry，Bank of America。

This is Dina, on for Jason. Congrats on the progress this quarter. Just the first one is on REDEMPLO and SHTG. Just curious if you guys have a view on which TG responder analysis you view as maybe more important for establishing that REDEMPLO is a very strong TG lowering. Is it below that 500 threshold or below that 150?

我是 Dina，代 Jason 提問。恭喜你們本季的進展。第一題是關於 REDEMPLO 與 SHTG。想請教你們是否有看法：在用以證明 REDEMPLO 具有非常強的 TG 降低效果時，你們認為哪一種 TG 反應者（responder）分析可能更重要？是降到 500 以下的門檻，還是降到 150 以下？

And then just a second one, if I could squeeze it in. Will your priority review voucher allow you to get Part D coverage for REDEMPLO for most of 2027? Or is it just the second half of 2027.

第二題，如果我可以再塞一題：你們的優先審查憑證（priority review voucher）是否能讓 REDEMPLO 在 2027 年的大部分時間取得 Part D 給付？還是只能涵蓋 2027 年下半年？

I'll take the first question around responder analysis. I mean, again, we're going to have to wait until ESC to see the actual data on the responder analysis. But I mean, for SHTG, 500 mg per deciliter is the threshold and it's thought to be below that, you should reduce the risk for acute pancreatitis, which is really where we're focused with the drug right now.

我來回答第一題、關於反應者分析。我的意思是，同樣地，我們得等到 ESC 才能看到反應者分析的實際數據。但就 SHTG 而言，500 mg/dL 是門檻；一般認為降到該門檻以下，應可降低急性胰臟炎的風險，而這正是我們目前使用該藥物所聚焦的重點。

Yes. I think both 150 and 500 are important. It's our goal to get as many below 500 as possible. But certainly, if we can normalize a large percentage of these patients, that's a very attractive tool for physicians. And on the -- sorry, what was the question on the priority voucher?

是的。我認為 150 和 500 這兩個門檻都很重要。我們的目標是讓盡可能多的患者降到 500 以下。但當然，如果我們能讓其中很大比例的患者回到正常範圍，對醫師而言就是一個非常有吸引力的工具。另外關於——抱歉，剛才優先審查憑證的問題是什麼？

If your PRV will allow you to get Part D coverage for most of 2027? Or is it just the second half of the year, like more towards the end of the year?

你的 PRV 是否能讓你在 2027 年大部分時間取得 Part D 給付？還是只涵蓋下半年，例如更接近年底？

Yes. So Dina, as we normally would, we'll be pursuing both payer policies and coverage for SHTG as rapidly as possible. So our market access team, as soon as the data is published in the coming months or so, we'll be interacting with payers to inform them of the data and prepare for eventual policy development and coverage throughout 2027.

是的。所以 Dina，依照我們一貫的作法，我們會盡可能快速地同時推進 SHTG 的保險支付方政策與給付。因此，我們的市場准入團隊會在未來幾個月左右、資料一旦發表後，就與支付方互動，向他們說明數據並為 2027 年全年的政策制定與給付做準備。

Joseph Thome, TD Cowen.

Joseph Thome，TD Cowen。

Congrats on the progress. For the SHTG market, how would you see the difference in prescribing between the US and European markets or any changes in practice guidelines between the two that we should be thinking about? And maybe of that $3 billion to $4 billion range that you indicated for plozasiran, how much of that is US-based versus international markets?

恭喜進展。就 SHTG 市場而言，你們如何看待美國與歐洲市場在處方行為上的差異，或兩者在臨床實務指引上是否有任何變化是我們需要納入考量的？另外，你們提到 plozasiran 的 30 億到 40 億美元區間中，有多少來自美國、多少來自國際市場？

Yes, I'll take the easy question -- the second question, the majority of that is in the United States, the overwhelming majority of that.

是的，我先回答比較簡單的——第二個問題，其中大多數來自美國，絕大多數都在美國。

Yes. And this is Andy. As far as European market dynamics versus US market dynamics related to triglycerides and acute pancreatitis, both are extremely important. These markets from a payer perspective are very outcomes-based. So the fact that we demonstrated a statistically significant reduction in the pooled analysis for SHASTA-3 and SHASTA-4 is incredibly important to demonstrating value in the European market.

是的。我是 Andy。就與三酸甘油脂與急性胰臟炎相關的歐洲市場動態相較於美國市場動態而言，兩者都極其重要。從支付方角度來看，這些市場非常以臨床結果為導向。因此，我們在 SHASTA-3 與 SHASTA-4 的合併分析中證明了具統計顯著性的降低，對於在歐洲市場展現價值至關重要。

But those health care practitioners in Europe recognize that AP and ongoing AP is a function of elevated triglycerides and whether or not you have a prior history of AP. And so that's the same as the health care providers in the United States as well.

但歐洲的醫療從業人員也認知到，AP 以及反覆發作的 AP 與三酸甘油脂升高有關，並且也取決於你是否有 AP 的既往病史。因此，這點與美國的醫療提供者也是相同的。

We'll be the 65th company to tell you that given the uncertainty around MFN, it's very difficult for us to -- at this point to know how these are going to be pursued in ex US markets and what kind of revenue we're going to see outside the US markets.

我們會是第 65 家告訴你：鑑於 MFN 的不確定性，目前我們很難——在此時此刻——判斷在美國以外市場會如何推進，以及我們在美國以外市場能看到什麼樣的營收。

James Condulis, Stifel.

James Condulis，Stifel。

Congrats on all the progress. Maybe one on TRIGS and just specifically as it relates to sort of your expectations around the commercial opportunity. With your data out there now, the Ionis launch is sort of underway. Just wanted to get your latest on kind of how we should think -- how we should be thinking about what the right analogs are here? And maybe more specifically, like how important do you think the initial quarters for this class are just sort of validating or reading on to the size of the overall opportunity here?

恭喜各項進展。我想問一個關於 TRIGS 的問題，特別是與你們對商業機會的預期相關。現在你們的數據已經出來，Ionis 的上市推進也正在進行中。想請教你們最新看法：我們應該如何思考——應該用哪些合適的同類案例（analog）來對照？更具體地說，你們認為這個類別在最初幾個季度的重要性有多高，是否能用來驗證或判讀整體機會的規模？

Yes, happy to take that. This is Andy. And as with any launch, of course, you want to get out of the gates quickly. So we'll be hyper-focused on ensuring that our providers are well educated on the value of REDEMPLO and SHTG. And we'll also simultaneously, of course, be working with payers to get policies published and coverage in place in order to accelerate the ramp of REDEMPLO and SHTG.

是的，很樂意回答。我是 Andy。如同任何產品上市，當然希望一開始就能快速起跑。因此，我們會高度聚焦，確保醫療提供者充分了解 REDEMPLO 與 SHTG 的價值。同時，我們也會與支付方合作，推動政策發布並建立給付，以加速 REDEMPLO 與 SHTG 的放量。

As you would know, there's a high degree of overlap between those prescribers who are writing for familial chylomicronemia syndrome and those who will also write for SHTG. These are, of course, those who have an interest in lipidology. There are about 1,500 of those individuals in the United States across specialties. So we think the ramp that we're seeing in FCS bodes well for the ramp we would expect to see in SHTG also.

如你所知，開立家族性乳糜微粒血症候群（FCS）處方的醫師，與也會為 SHTG 開立處方的醫師之間有高度重疊。這些當然是對脂質學有興趣的醫師。在美國跨不同專科約有 1,500 位這樣的醫師。因此，我們認為在 FCS 看到的放量趨勢，對我們預期在 SHTG 看到的放量也有正面指標意義。

And I'll give you a qualitative answer also. But we think that SHTG is a very large market opportunity. There's an awful lot of patients who have triglycerides that we really need to help get out of control. We're convinced of that. Our KOLs are convinced of that. However, this is going to be a relatively slow ramp because this is a brand-new market. We are in the education business.

我也給你一個定性的回答。我們認為 SHTG 是一個非常大的市場機會。有非常多三酸甘油脂失控的患者，我們確實需要協助他們把數值控制下來。我們對此深信不疑。我們的 KOL 也深信不疑。不過，因為這是一個全新的市場，放量會相對較慢。我們是在做教育的工作。

And so it's going to take a bit of time for us to get the word out because, look, the world is not used to looking at TGs closely because there has been -- in part at least because there have been no good ways to really reduce triglycerides until now. And so this is all a good thing for patients. It's just going to take a bit of time to educate those patients and educate physicians.

因此，我們需要一些時間把訊息傳遞出去，因為你看，過去大家並不習慣密切關注 TG，部分原因至少是因為直到現在之前，並沒有很好的方法能真正降低三酸甘油脂。所以這對患者而言都是好事。只是教育患者與教育醫師都需要一些時間。

Madison El-Saadi, B. Riley Securities.

Madison El-Saadi，B. Riley Securities。

Congrats on the progress. Maybe how should we think about the doubling of REDEMPLO prescriptions, I guess, in terms of weekly run rate, I think 30 per week maybe was the last disclosure you guys put out. And then relatedly, has the prescription-to-drug and arm conversion rate kind of hit the steady state for FCS? And if not, kind of just what are the drivers there?

恭喜進展。我們應該如何看待 REDEMPLO 處方量翻倍這件事——我想以每週的運行速率來看，你們上次披露可能是每週 30 張左右。另外相關地，FCS 的「處方到實際用藥」以及「arm 轉換率」是否已經達到穩態？如果還沒有，主要驅動因素是什麼？

And then secondly, if I can quickly, for ESC, I know you're under embargo. So just a general question. Do you expect the learnings there are more academic in nature? Or is it something that really kind of facilitates a naive cross-trial comparison and really kind of informs the label?

第二個問題，如果我可以快速問一下，關於 ESC，我知道你們仍在 embargo 之下。所以問一個比較一般性的問題。你們預期那邊的收穫會比較偏學術性嗎？還是它其實能促成某種跨試驗的比較，並且在某種程度上對標籤（label）提供資訊？

Madison, this is Andy again. Thanks for your question. Yes, we do see approximately 20 to 30 new prescriptions a week that has been the run rate and consistent with what we have communicated previously. Of course, our teams are very focused on also ensuring that those prescriptions find their way through the funnel ultimately to shipments to patients. And so our market access team is working incredibly hard to support our payer and our physicians and offices around compliantly navigating the prior authorization process and appeal process.

Madison，我又是 Andy。謝謝你的問題。是的，我們確實看到每週約 20 到 30 張新處方，這一直是目前的運行速率，也與我們先前溝通的一致。當然，我們的團隊也非常專注於確保這些處方能一路通過漏斗，最終轉化為對患者的出貨。因此，我們的市場准入團隊非常努力地支持支付方、醫師與診所，在合規前提下協助完成事前授權流程與申覆流程。

But as I mentioned, we will have new field personnel in the field educating stakeholders as early as this month. And so I would expect to see also an inflection point both in prescriptions at the top of the funnel, but also in the way those prescriptions filter through the funnel to ultimately those patient shipments.

但如我提到的，我們最早在本月就會有新的外勤人員在第一線教育各方利害關係人。因此，我預期不僅在漏斗頂端的處方量會出現拐點，同時這些處方在漏斗中的通過率、最終轉化為患者出貨的情況也會出現拐點。

And on the ESC question, again, I'm just hesitant to make any additional comments on the data just given the embargo. So we'll see at the end of the month.

至於 ESC 的問題，基於 embargo 的緣故，我仍然不太願意對數據做任何額外評論。所以我們月底再看。

Patrick Trucchio, H.C. Wainwright.

Patrick Trucchio，H.C. Wainwright。

This is Luis, in for Patrick. We're thinking about the launch in SHTG, Will it be in the highest risk patients, will be segmented to the highest risk patients or more broadly across patients with TGs above 500. And the question is directed at how would this reflect on the commercial build? Will it be a step function or will be an incremental expansion of the existing FCS field force?

我是 Luis，代 Patrick 提問。我們在思考 SHTG 的上市策略：會先聚焦在最高風險患者、對最高風險患者做分層，還是更廣泛地涵蓋 TG 高於 500 的患者？這個問題主要想了解這會如何反映在商業化建置上。會是階躍式的變化，還是對既有 FCS 外勤團隊的逐步擴編？

Yes. Thanks for your question. This is Andy. Certainly, while we think the top line results support REDEMPLO across the spectrum of SHTG patients, naturally, we'll be focused on those high-risk SHTG patients out of the gate. These are, of course, those patients who have the highest unmet need in the view of health care professionals and also the highest willingness to pay by payers. And so that will be our initial focus at launch.

是的。謝謝你的提問。我是 Andy。當然，雖然我們認為最上線（top line）的結果支持 REDEMPLO 可涵蓋整個 SHTG 患者族群，但很自然地，我們在一開始推出時會聚焦於那些高風險的 SHTG 患者。這些當然是醫療專業人士認為未被滿足需求最高、同時也是付款方支付意願最高的患者。因此，這將是我們上市初期的重點。

As far as scaling of the field force, as I mentioned, we did implement effectively a step function increase in the field force that will go into the field this month, and we'll continue to look to optimize our field force as we head towards SHTG.

至於外勤團隊的擴編，如我提到的，我們確實已有效地以「階梯式」方式增加外勤人力，這批人員將在本月進入市場，我們也會在邁向 SHTG 的過程中持續尋求最佳化外勤團隊配置。

And let's be clear, I think that our data suggests that it is important to get people's triglycerides down if they have triglyceride levels above 500, full stop. We had people who had triglycerides below 880 who had episodes of pancreatitis. I think that's important. So while we think that, that population at greatest risk is going to be the initial market, there is a broader market to address here that I think is important and there are patients that need to be treated. But again, as I mentioned earlier, this is going to be an education play, and it's just going to take a bit of time to help physicians and patients understand the risk here.

另外要說清楚，我認為我們的數據顯示：只要三酸甘油脂高於 500，就必須把三酸甘油脂降下來，就這麼簡單。我們曾看到三酸甘油脂低於 880 的人也發生胰臟炎發作。我認為這點很重要。因此，雖然我們認為最高風險族群會是初期市場，但這裡其實還有更廣泛的市場需要被涵蓋，我認為這很重要，而且確實有患者需要治療。但同樣地，如我先前提到，這將是一個教育推廣的策略，需要一些時間來協助醫師與患者理解其中的風險。

Keay, Chardan Capital Markets.

Keay，Chardan Capital Markets。

Now that you have your data, how are you thinking about price differential versus Tryngolza?

現在你們已經有數據了，你們如何看待相對於 Tryngolza 的定價差異？

Yes. This is Andy. So I won't go into price details or contracting strategy only to say that you would be aware of the wholesale acquisition cost for REDEMPLO USD45,000 per year. That does differ from our competitor, and we've communicated previously that we believe that premium is justified based on the product attributes of REDEMPLO across efficacy, safety and convenience.

是的。我是 Andy。我不會深入談定價細節或簽約策略；只想說你應該知道 REDEMPLO 的批發取得成本（WAC）為每年 45,000 美元。這確實與競品不同，我們先前也已溝通過，我們認為基於 REDEMPLO 在療效、安全性與便利性等產品特性上所展現的優勢，這樣的溢價是合理的。

If the question is, do we intend to move that price now that we have these data, the answer is no. We believe this is the right price for this drug. We think that there is a real reason to price this at a slight premium to our competitor, given what we see as a better safety profile, a better reduction in triglycerides from baseline, a simpler approach with quarterly dosing rather than monthly dosing, a lack of need to -- we believe a lack of need to follow liver enzymes because we just haven't seen those issues and a simple 25 milligram dose for all patients rather than having to titrate up.

如果問題是：在我們拿到這些數據後，是否打算調整這個價格？答案是否定的。我們認為這是這款藥物的正確價格。我們認為，鑑於我們看到更好的安全性特徵、相較基線更佳的三酸甘油脂降低幅度、以每季給藥而非每月給藥的更簡化方式、我們認為不需要追蹤肝酵素（因為我們尚未看到那些問題），以及所有患者皆採用簡單的 25 毫克劑量而不必逐步滴定上調，因此以略高於競品的價格定價是有其充分理由的。

Jennifer Jia, Cantor Fitzgerald.

Jennifer Jia，Cantor Fitzgerald。

This is Jennifer Jia. Congrats on the SHASTA results. So for the neuro programs, what other TMS targets are you excited about if the Phase 1/2 for MAPT is positive?

我是 Jennifer Jia。恭喜 SHASTA 的結果。那麼針對神經領域的專案，如果 MAPT 的第 1/2 期結果是正面的，你們還對哪些其他 TMS 標的感到興奮？

Are you asking what other gene targets are we interested in?

你是在問我們還對哪些其他基因標的有興趣嗎？

Yes. Yes, for knockdown, if the MAPT works out.

是的。是的，針對 knockdown（基因表現抑制），如果 MAPT 進展順利的話。

Sure. So we have a lot of different targets. We haven't disclosed any of those in terms of wholly owned programs, we probably won't disclose those until around the time of the CTA filing, just given the competitive nature in the siRNA space right now. So stay tuned.

當然。我們有很多不同的標的。就完全自有（wholly owned）的專案而言，我們尚未披露任何標的；考量目前 siRNA 領域競爭激烈，我們可能要到大約提交 CTA 申請前後才會披露。敬請期待。

Edward Tenthoff, Piper Sandler.

Edward Tenthoff，Piper Sandler。

I just wanted to retreat a little bit and go back through sort of what the plans are for marketing now that you're approved in US, Canada, Australia and Europe. Are you directly marketing in each of those? And how -- or are you using distributors? And how does -- are you going to recognize revenues from each of those geographies and then pay out a distributor fee in SG&A? Just want to understand those dynamics more.

我想稍微退一步，回頭梳理一下：既然你們已在美國、加拿大、澳洲與歐洲獲批，接下來行銷方面的規劃是什麼？你們會在每個地區都直接行銷嗎？還是會使用經銷商？另外，你們將如何認列各地區的營收，然後在 SG&A 中支付經銷商費用嗎？我只是想更了解這些運作機制。

Thanks for the question, Edward. Good question. This is Andy again. So we are marketing into those countries that you mentioned using commercial partners. So REDEMPLO not out-licensed nor have we established distributor relationships in those markets. It's effectively Arrowhead in operation with our commercial partners in those markets that you mentioned with the exception of China.

謝謝你的提問，Edward。問得很好。我又是 Andy。我們在你提到的那些國家是透過商業合作夥伴來進行行銷。因此，REDEMPLO 並未在那些市場對外授權（out-licensed），我們也沒有在那些市場建立經銷商關係。基本上是 Arrowhead 與我們在你提到的那些市場的商業合作夥伴共同運作（中國除外）。

And in terms of revenue recognition?

那在營收認列方面呢？

So in terms of revenue recognition, we just follow the standard. This is Dan here, follow the standard revenue recognition. So as we complete a sale to customers in those countries, we will recognize revenue. So nothing unique in that regard.

在營收認列方面，我們就是遵循標準做法。我是 Dan，我們遵循標準的營收認列。因此，當我們在那些國家完成對客戶的銷售時，就會認列營收。所以在這方面沒有任何特殊之處。

Is it a net revenue? Or is there a fee that's paid in SG&A?

那是淨營收嗎？還是會在 SG&A 裡支付一筆費用？

Yes. No, it's -- I mean it's similar to the US, so it will be a gross sale. And then we have -- in the gross to net, you have to deduct out sort of distribution costs and the like. But if you're asking about the cost to support that is being offered by our commercial partners there, which is kind of like a contract marketing contract sales, that would show up in marketing and sales costs. So that would not be -- part of net.

是的。不，這——我的意思是，這跟美國類似，所以會以總銷售額（gross sale）呈現。然後在由總額到淨額（gross to net）的調整中，你必須扣除例如配送成本等項目。但如果你問的是：我們在當地由商業合作夥伴提供支援的成本（有點像合約行銷、合約銷售），那會列在行銷與銷售費用中。所以那不會是——淨額的一部分。

This concludes the question-and-answer session. I would now like to turn the call back to Chris Anzalone for closing remarks.

問答環節到此結束。現在我想把電話交回給 Chris Anzalone 作結語。

Thanks very much for joining us today, and we look forward to speaking with you later in August after ESC and then in September around the ARO-DIMER-PA disclosures as well as in MAPT. Have a great summer.

非常感謝各位今天加入我們。我們期待在 8 月稍晚、ESC 之後與各位再度交流，並在 9 月就 ARO-DIMER-PA 的揭露以及 MAPT 的進展與各位更新。祝各位夏日愉快。

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

感謝各位參與今天的電話會議。本次議程到此結束。您現在可以掛線。