Roivant Sciences Ltd (ROIV) 2025 Q3 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Roivant third quarter 2025 earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

您好，感謝您的耐心等待。歡迎參加 Roivant 2025 年第三季財報電話會議。（操作人員指示）請注意，今天的會議正在錄音。

I would now like to hand the conference over to your speaker today, Stephanie Lee. Please go ahead.

現在我謹將會議交給今天的演講嘉賓，史蒂芬妮李。請繼續。

Good morning, and thanks for joining today's call to review positive Phase 2 results for brepocitinib and cutaneous sarcoidosis and Roivant's financial results for the third quarter ended December 31, 2025. The I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant; and Ben Zimmer, CEO of Priovant.

早安，感謝各位參加今天的電話會議，本次會議旨在回顧 brepocitinib 治療皮膚結節病的積極 2 期臨床試驗結果以及 Roivant 公司截至 2025 年 12 月 31 日的第三季度財務業績。我是 Roivant 的 Stephanie Lee。今天為大家介紹的是 Roivant 的執行長 Matt Gline 和 Priovant 的執行長 Ben Zimmer。

For those dialing in via conference call, you can find the slides being presented today as well as the press release announcing these updates on our IR website at www.investors.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along.

對於透過電話會議撥入的各位，您可以在我們的投資者關係網站 www.investors.roivant.com 上找到今天簡報的幻燈片以及發布這些更新的新聞稿。簡報過程中，我們也會提供投影片的編號，方便您跟進。

I would like to remind you that we will be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties.

我想提醒各位，在今天的演講中，我們將做出一些前瞻性陳述。我們強烈建議您查閱我們向美國證券交易委員會提交的信息，以了解有關這些前瞻性陳述及相關風險和不確定性的更多信息。

With that, I'll turn it over to Matt.

接下來，我將把麥克風交給馬特。

Thanks, Stephanie, and thanks, everyone, for dialing in and listening this morning. I'm going to start our presentation on Slide 5. I was sitting and talked to the team, it was about a week ago today, looking at a draft of this morning's presentation and thinking it was going to be a pretty boring 10-Q. We've got together in December for the Investor Day, we had we've spoken a JPMorgan conference, and it turned out a really busy week.

謝謝斯蒂芬妮，也謝謝大家今天早上撥入收聽。我們的簡報將從第5張投影片開始。大約一週前的今天，我和團隊坐在一起，看著今天早上簡報的草稿，心想這將會是一場相當無聊的 10-Q 會議。我們在 12 月參加了投資者日活動，我們也參加了摩根大通的會議，結果那真是忙碌的一周。

So we have some great updates, obviously, most notably, the Phase 2 data in brepo and CS, which Ben is going to present on momentarily. But truth is terrific execution of progress across the board for us this quarter. Obviously, that data is a highlight. But we also can announce today that the NDA for brepo was in and Dermatomyositis that the Phase 2b study for 1402 D2T RA has fully enrolled that the Phase 2 study for mostly in PH-ILD has fully enrolled, and obviously, all of the updates that we're known for, including the Immunovant offering earlier that gets us now financed to Graves' launch all behind us.

顯然，我們有一些很棒的更新，最值得注意的是 Brepo 和 CS 的第二階段數據，Ben 馬上就要介紹這些數據了。但事實上，本季我們在各方面都取得了非常出色的進展。顯然，這些數據非常引人注目。但我們今天也可以宣布，brepo 的新藥申請已提交，用於治療皮肌炎；1402 D2T 類風濕關節炎的 2b 期研究已完成入組；主要針對肺動脈高壓-間質性肺病的 2 期研究已完成入組；當然，我們所有為人熟知的更新，包括之前 Immunovant 的融資，使我們獲得了 Cves 的資金，已完成上市資金。

So just a terrific quarter and a terrific set of updates even since early January when we last got together. On Slide 6, 2026 is, again, a very busy year for us ahead. Obviously, some major events later in the year on the brepo NIU Phase 3, the pivotal readout in the second half. We're now going to be starting this year a Phase 3 study in brepo and cutaneous sarcoidosis then we'll talk a little bit more about that. It's early days. I get that going, but that will be this year.

所以，這是一個非常棒的季度，自一月初我們上次見面以來，也取得了一系列非常棒的進展。投影片 6 顯示，2026 年對我們來說又將是一個非常忙碌的年份。顯然，今年晚些時候，brepo NIU 第三階段將發生一些重大事件，下半年將進行關鍵性讀數。今年我們將啟動布雷波和皮膚結節病的 3 期研究，之後我們會再詳細談談。現在下結論還為時過早。我會著手做這件事，但那要等到今年。

The Phase 2b data for mostly is expected firmly in the second half of this year. We now know that the study is fully enrolled, obviously. Same thing with the D2T RA data where all of that, both the open-label period and the randomized withdrawal period will be done by the second half of this year. We also are getting proof-of-concept data in 1402 and CLE.

預計大部分 2b 期數據將於今年下半年公佈。我們現在知道這項研究已經全部招募完畢，這很顯然。D2T RA 數據也是如此，所有開放標籤期和隨機撤藥期都將在今年下半年完成。我們還在 1402 和 CLE 中獲得了概念驗證資料。

And finally, we are still on track for the jury trial against Moderna starting on March 9, so just a few weeks away now. So a really, really busy year ahead for Roivant. And really, if you look at Slide 7, before we get again to the data for CS, just a pipeline we're really proud of that continues to deliver across multiple dimensions would be obviously brepo with now three indications in the pivotal registrational programs, multiple registrational programs for FcRn franchise made, which we've talked about and mostly with top line data coming in the second half.

最後，針對 Moderna 的陪審團審判仍按計劃於 3 月 9 日開始，距離現在只有幾週了。所以對 Roivant 來說，接下來的一年將會非常非常忙碌。實際上，如果你看一下幻燈片 7，在我們再次討論 CS 的數據之前，我們非常自豪的一個在多個維度上持續表現出色的項目顯然是 brepo，目前在關鍵註冊項目中已有三個跡象，FcRn 特許經營項目也已完成多個註冊，我們已經討論過，而且主要頂級數據將在下半年公佈。

So really excited about where we are as a business, really excited about the pipeline. I couldn't be working for the beginning of 2026 year. certainly stood off to a good start. And with that, what I'm going to do is turn to the Phase 2 data for brepo and sarcoidosis. So I'm just really briefly on Slide 9 of the presentation. I'm just going to walk through a couple of highlights, but most thing I'm going to hand over to Ben to take you through the data in detail.

我對公司目前的業務狀況感到非常興奮，對未來的發展前景也感到非常興奮。2026年初我沒辦法工作。不過，這確實是一個不錯的開始。接下來，我要介紹的是brepo和結節病的第二期臨床試驗數據。我現在只是簡單地講解一下簡報的第9頁。我只會簡單介紹幾個重點，大部分內容我會交給 Ben 詳細解說資料。

And the short answer, and we keep saying this, it's a tremendous fortunate thing to be able to say, this drug has done everything we could have asked for us for it in this -- or if it in this study. We had a significant (inaudible). Remember, we had said before the bar for clinical success here, we thought was sort of 5 points of C-sam was clinically meaningful.

簡而言之，我們一直強調，能夠說這種藥物在這項研究中達到了我們所能期望的一切，這是一件非常幸運的事。我們有一個重要的（聽不清楚）記住，我們之前說過，臨床成功的標準，我們認為 C-sam 達到 5 分具有臨床意義。

We got a placebo-adjusted almost 22 points, 21.6% point delta with a p-value, and again, the study was not powered for efficacy in this endpoint. 100% of patients on brepo 45 for 149 placebo had a 10 point improvement, again, clinically meaningful with 5 points. 100% of patients on our high dose had at least a 10 point improvement.

經過安慰劑校正後，我們獲得了近22分的改善，即21.6%的評分差值（p值），但需要再次強調的是，該研究並未針對此終點進行療效統計。在149名接受安慰劑治療的患者中，100%接受brepo 45治療的患者評分改善了10分，其中5分具有臨床意義。在我們接受高劑量治療的患者中，100%的患者評分至少改善了10分。

So just a tremendous outcome across the board. There's some great supportive data on some of the other endpoints as well. And with safety and tolerability completely consistent with what we've seen for the compound in the past. So a really terrific outcome. And then it isn't us that need it, where there's never been a positive placebo-controlled study in an industry-sponsored study to our knowledge. So really a terrific day for those patients.

所以，各方面都取得了巨大的成功。其他一些端點也有一些很好的支援性數據。安全性和耐受性與我們過去對該化合物的觀察結果完全一致。所以結果非常好。而且，需要它的並不是我們，據我們所知，在產業贊助的研究中，從來沒有安慰劑對照研究得出積極的結論。所以對這些病人來說，這真是美好的一天。

So with that, I'm going to hand it over to Ben to walk you through a little bit about cutaneous sarcoidosis as a reminder. And then on to the study as well.

那麼，接下來我將把麥克風交給 Ben，讓他為大家簡單介紹一下皮膚結節病，以作提醒。然後繼續進行學習。

Ben take it away.

本把它拿走。

Great. Thanks so much. Great to be here with everyone. Starting on Slide 10, I just wanted to bring back to what the disease is, walked through this at the Investor Day in December. But continuous sarcoidosis is a really debilitating skin disease. And among skin diseases stands out for its rapid progression towards permanent scarring and destruction of tissue as well as its disfiguring nature given the particular prevalence on the face and scalp of the disease.

偉大的。非常感謝。很高興能和大家在一起。從第 10 張投影片開始，我只想回顧一下這種疾病是什麼，我在 12 月的投資者日上詳細講解過這一點。但持續性結節病是一種非常嚴重的皮膚病。而這種皮膚病因其迅速發展為永久性疤痕和組織破壞，以及其毀容性（尤其常見於臉部和頭皮）而顯得尤為突出。

Turning to Slide 11. I would note that there is no approved therapies, not only for cutaneous sarcoidosis, but for any form of sarcoidosis. And so as we think about our development program in really a great opportunity for brepo to meet this overall unmet need and become the therapy of choice if we're going to be successful in Phase 3 as we hope and expect we would be on the basis data to really be a promising option for all patients with skin involvement in their sarcoidosis. That would include patients, both with only skin involvement as well as those with other organ involvement as well.

翻到第11張幻燈片。需要指出的是，目前尚無核准的治療方法，不僅是針對皮膚結節病，也包括任何形式的結節病。因此，當我們考慮我們的研發計劃時，這對 brepo 來說確實是一個絕佳的機會，可以滿足這一整體未被滿足的需求，如果我們能在 3 期臨床試驗中取得成功（正如我們希望和預期的那樣），它將成為首選療法，因為根據現有數據，它對於所有患有皮膚受累的結節病患者來說都是一個非常有希望的選擇。這包括僅有皮膚受累的患者，以及同時伴有其他器官受累的患者。

Turning to Slide 12 really just briefly here on the alignment between the pathobiology of the disease and the mechanism. And I think this is important because as Matt alluded to, and I'll walk through in a bit more detail. We really have great data here that we're very excited about. And I think in a small study, the data is very compelling.

接下來，我們簡單地看一下第 12 張投影片，了解疾病的病理生物學和機制之間的一致性。我認為這很重要，因為正如 Matt 所暗示的那樣，我將更詳細地解釋一下。我們這裡有一些非常棒的數據，我們對此感到非常興奮。我認為，在小規模研究中，數據非常有說服力。

It's hard to argue it on its own, but it also really aligns with what you would expect to see given the mechanism of this drug, sarcoid sets, all of the forms of sarcoidosis, including cutaneous are driven by the polarization and recruitment of effector T-cells and particularly Th1 polarized cells and brepo really distinctively inhibits TH1related pathways by hitting both IL-12 through TYK2 and interferon gamma through JAK1. So really an opportunity here mechanistically to see the benefits of JAK1, TYK2 inhibition specifically. And I think that's really part of what's flowing through to our clinical data that I'll walk through now.

單憑這一點很難反駁，但它也確實與這種藥物的作用機制所預期的結果相符。結節性多發性硬化症的所有形式，包括皮膚結節病，都是由效應 T 細胞（尤其是 Th1 極化細胞）的極化和募集驅動的，而 brepo 透過 TYK2 抑制 IL-12，並透過 JAK1 抑制干擾素 γ，從而顯著抑制 TH1 相關通路。所以，這確實是一個從機制上了解 JAK1、TYK2 抑制具體益處的機會。我認為這正是我們臨床數據所反映出的部分內容，接下來我將詳細介紹。

Slide 13, study design, very straightforward, 31 patients in the United States, randomized 3 to 2 to 2, the brepo 45-milligrams, 15-milligrams and placebo, a 16-week study evaluated several different efficacy end points that I will walk through. On the baseline demographics and disease activity, Slide 14. I do want to highlight a few things.

第 13 張投影片，研究設計，非常簡單明了，美國有 31 名患者，以 3:2:2 的比例隨機分組，分別接受 brepo 45 毫克、15 毫克和安慰劑治療，一項為期 16 週的研究評估了幾個不同的療效終點，我將逐一介紹。關於基線人口統計和疾病活動，幻燈片 14。我想重點強調幾點。

First, if you look at the duration of disease and background damage of patients brepo 45-milligrams and placebo are very well balanced between those two arms. But 15-milligrams actually quite a bit lighter on duration of disease and damage, which would mean really a higher bar for both brepo 45 and placebo. And then I would also call attention to the plaque predominant morphology, cutaneous sarcoidosis can present through both plaques and papules.

首先，如果你觀察疾病持續時間和患者的背景損傷，你會發現服用 45 毫克 Brepo 和安慰劑的患者在兩組之間非常平衡。但 15 毫克實際上在疾病持續時間和損害方面要輕得多，這意味著 Brepo 45 和安慰劑的標準都更高。此外，我還想提請注意斑塊為主的形態，皮膚結節病可表現為斑塊和丘疹。

In general, the plaques are viewed as more treatment-resistant. And you see this plaque predominant morphology most pronounced and most common in the brepo 45-milligrams arm followed by 15-milligrams solid by placebo.

一般來說，斑塊被認為更難治療。您可以看到，這種斑塊主要形態在服用 45 毫克 brepo 的組別中最明顯、最常見，其次是服用 15 毫克固體安慰劑的組別。

So sort of punch line of this is there were some imbalances. Those amounts actually made it harder for brepo 45-milligrams to demonstrate efficacy, both as compared to placebo and as compared to brepo 15-milligrams, and in spite of that, as I walk through, we really see exceptional data from the brepo 45-milligram dose arm.

所以，這件事的重點在於，存在著一些不平衡之處。這些劑量實際上使得 brepo 45 毫克更難證明其療效，無論是與安慰劑相比，還是與 brepo 15 毫克相比。儘管如此，正如我所分析的，我們確實看到了 brepo 45 毫克劑量組的卓越數量。

So turning to Slide 15 to get into the efficacy results on the left hand of the slide, you see the [Mentesami] activity score change from baseline, both doses statistically significant separation from placebo as early as week 4, the first time point evaluated and then sustained at every visit out to week 16 at the end of the trial.

因此，請翻到第 15 張投影片，查看投影片左側的療效結果。您可以看到 [Mentesami] 活性評分從基線開始的變化，兩種劑量組早在第 4 週（首次評估時間點）就與安慰劑組出現了統計學上的顯著差異，並在每次訪視中都保持了這種差異，直到試驗結束的第 16 週。

And then on the right here, we see the achievement of investigator global assessment 1, and a 2 point reduction. So as a reminder, this is -- the IGA are a standard FDA supported endpoint for cutaneous disease. This is similar to the is used in other skin indications with from 0 to 4, clear, almost clear, mild, moderate and severe.

然後，在右邊，我們看到調查員全球評估 1 的完成情況，分數降低了 2 分。所以再次提醒一下，IGA 是 FDA 支持的皮膚病標準終點。這與其他皮膚疾病的治療方法類似，從 0 到 4，分別代表無症狀、幾乎無症狀、輕度、中度和重度。

So to achieve both the 2-point reduction and at 0 or 1 is a very high bar -- and notably, it's a high enough for that 0 placebo patients clear it. So you may be confused where the placebo line, the placebo line and the x-axis line are the same thing on this chart.

因此，要同時達到降低 2 分和達到 0 或 1 分的標準非常高——值得注意的是，這個標準高到連安慰劑組的患者都達不到。所以你可能會感到困惑，在這個圖表中，安慰劑線、安慰劑線和 x 軸線是同一回事。

And you see here, again, some early progress for both DISARM at week 4, really significant or substantial improvement at week 8 and then that big improvement at week 12 and 16. And then here on this higher bar endpoint, you do start to see brepo 15-milligrams begin to -- sorry, brepo 45-milligrams, begin to separate some from the 15-milligram dose arm.

您可以看到，DISARM 在第 4 週取得了一些早期進展，在第 8 週取得了非常顯著或實質的進步，然後在第 12 週和第 16 週又取得了很大的進步。然後，在這個更高的終點，你開始看到 brepo 15 毫克開始——抱歉，是 brepo 45 毫克，開始與 15 毫克劑量組分開。

Slide 16 has the Sesame responder data. Again, really compelling data. I think this chart on the left quite remarkable as Matt alluded to, we were hoping to see a mean improvement of 5 points and what we saw was as not only a mean far in excess of that, but we saw 100% of patients in the brepo 45-milligram arm achieve twice that, twice the minimum clinically important difference.

第 16 張投影片包含芝麻街反應者數據。再次強調，數據確實很有說服力。正如 Matt 所提到的，我認為左邊的這張圖表非常了不起，我們原本希望看到平均改善 5 分，而我們看到的不僅平均改善遠遠超過了這個數字，而且我們看到服用 brepo 45 毫克的患者中有 100% 達到了兩倍的改善，是最小臨床重要差異的兩倍。

Really every brepo 45-milligram patient, a responder in this trial and does all walk through momentarily, that that's really corroborated by an independent patient reported outcome as well. And then you see on the right-hand side of this chart, achievement of Sesame less than 5, notable there's not an improvement by less than 5. This means that the absolute score end of the trial is 5% or less, which is a standard for functional remission.

實際上，每位接受 45 毫克 Brepo 治療的患者，都是本次試驗中的有效應答者，並且所有患者都能立即康復，這一點也得到了獨立患者報告結果的證實。然後你可以看到，在這個圖表的右側，芝麻街的成就低於 5 分，值得注意的是，沒有低於 5 分的改進。這意味著試驗結束時的絕對得分低於 5%，這是功能性緩解的標準。

And you see 62% of brepo 45-milligram patients achieving that compared to no placebo patients. So again, this data are quite in line with the IGA 2-point improvement M201 that I walked through before. So again, seeing pretty consistent data here across multiple endpoints.

你會發現，服用 45 毫克 Brepo 的患者中有 62% 達到了這一目標，而未服用安慰劑的患者則沒有達到這一目標。所以，這些數據與我之前介紹的 IGA 2 點改進 M201 非常吻合。所以，從多個端點來看，數據都相當一致。

Turning now to the patient reported outcomes. Slide 17 has the Skindex-16. This is, again, a pretty established standard metric and inflammatory skin disease trials. You see excellent data here with the placebo group worsening brepo 45-milligrams and 15-milligrams, both improving substantially well above the minimum clinically important difference. Again, here with brepo 45-milligrams outperforming 15 modestly and both doses really far better than placebo.

現在來看患者報告的結果。第 17 張幻燈片展示了 Skindex-16。這再次證明，這是一個相當成熟的標準指標，也是發炎性皮膚病試驗的指標。您可以看到，安慰劑組病情惡化，而 brepo 45 毫克和 15 毫克組的病情均顯著改善，遠超最小臨床重要差異。同樣，45毫克的brepo略優於15毫克，兩種劑量都遠優於安慰劑。

Slide 18, we have the KSQ skin domain. So this is the King Sarcoidosis Questionnaire. It's a PRO for sarcoidosis overall map, just limited to skin disease. What we focused on in our initial TLR was skin-specific domains, and you see here very in line with the Skindex in terms of in terms of the data. So just yet another data point, a very compelling evidence of benefit.

第 18 張投影片，我們有 KSQ 皮膚域。這就是國王結節病問卷。這是針對結節性多發性硬化症整體圖譜的PRO，只是僅限於皮膚疾病。我們在最初的 TLR 研究中重點關注的是皮膚特異性域，您可以在這裡看到，就數據而言，它與 Skindex 非常一致。這又是一個數據點，一個非常有說服力的益處證據。

And finally, on the efficacy side, I alluded to this before, but on Slide 19, we call it the patient's global impression of change. So this is a single question where patients are asked since they started taking the study medication, how would they describe the overall change in the sarcoidosis symptoms and they can answer no change or some degree of improvement or some degree of worsening I think this is a powerful endpoint for simplicity and notably, 100% of brepo 45-milligram patients reported that they improved, again, consistent with the Sesame data where we saw 100% response rate.

最後，關於療效方面，我之前提到過，但在第 19 張投影片中，我們稱之為患者對變化的整體印象。因此，這是一個單一的問題，詢問患者自開始服用研究藥物以來，如何描述結節病症狀的整體變化，他們可以回答沒有變化、有一定程度的改善或有一定程度的惡化。我認為這是一個簡單有效的終點，值得注意的是，100% 的 brepo 45 毫克患者報告病情有所改善，這再次與我們在 Sesame 研究中看到的 100% 回應率一致。

So very compelling here. Brepo 15-milligrams also very considerable improvement for most patients, although two patients in the brepo 15-milligram group, did not -- not only do not report improvement, but actually reported worsening. And then in the placebo group, a very little improvement and most patients reported either worsening or no change.

這真是太引人入勝了。Brepo 15 毫克對大多數患者來說也有相當大的改善，儘管 Brepo 15 毫克組中有兩名患者不僅沒有報告改善，反而報告病情惡化。而在安慰劑組中，病情幾乎沒有改善，大多數患者報告病情惡化或沒有變化。

Turning to Slide 20. Safety data. I think very well, brepo was very well tolerated during the study when no SAEs in the study and all adverse events were graded mild or moderate in severity. So against the backdrop of this efficacy data, in particular, certainly, the safety data we see would tee up a potentially very favorable benefit risk profile for brepocitinib for these patients.

翻到第20張投影片。安全資料。我認為，在研究期間，brepo 的耐受性非常好，研究中沒有發生嚴重不良事件，所有不良事件的嚴重程度都被評為輕度或中度。因此，在這些療效數據的背景下，特別是我們看到的安全數據，無疑將為這些患者帶來布雷泊替尼非常有利的獲益風險概況。

Obviously, we have over 1,500 patients of data in brepocitinib, and so the overall safety database is characterized by much more than just these results. But certainly here, nothing that would really add anything to what's already known about the drug from that perspective. And I think, again, starting to dose it now in this particular patient population, I think we see the early signs of a very indication-specific compelling benefit risk profile.

顯然，我們有超過 1500 名患者使用 brepocitinib 的數據，因此，整體安全性資料庫的特徵遠不止這些結果。但就目前而言，從這個角度來看，並沒有什麼能真正為人們對這種藥物的認知增添任何新內容。而且我認為，現在開始在這個特定的患者群體中進行給藥，我認為我們看到了針對特定適應症的令人信服的獲益風險概況的早期跡象。

So just to wrap up very quickly, before handing it back to Matt, really compelling evidence of benefit. The effect sizes we see here are extremely large we see them very consistently across multiple different endpoints, including independent patient reported and physician-reported assessments, very high response rates, including the 100% response rate for the brepo 45-milligrams arm and the rapid onset of action sustained over time. So really exciting results. We're really excited to move this ahead to Phase 3 and potentially have the first approved therapy for sarcoidosis.

那麼，在把任務交還給馬特之前，我快速總結一下，這確實是一個令人信服的好處證據。我們在這裡看到的效應量非常大，我們在多個不同的終點指標上都看到了非常一致的效應量，包括獨立的患者報告和醫生報告的評估，非常高的反應率，包括 brepo 45 毫克組的 100% 反應率，以及快速起效並持續一段時間。結果真是令人振奮。我們非常高興能將這項研究推進到第三階段，並有可能成為首個獲準的結節病療法。

So I look forward to discussing any questions later, and I'll hand it back to Matt.

所以我期待稍後討論任何問題，之後我會把問題交還給馬特。

Thanks, Ben. Yeah, look, we're just terrifically excited about the data about what it means for us and what it means for these patients. On Slide 22, just sort of as a reminder of what the picture for brepocitinib now looks like. People pass around the phrase pipeline and a product for a lot of different products I feel at this point, looking across the indication set for brepo, even with what we've talked about already with CSP and MINU, where we get to a very large addressable patient population.

謝謝你，本。是的，我們非常興奮地看到這些數據對我們以及對這些患者的意義。第 22 張投影片，只是為了提醒大家 brepocitinib 目前的狀況。人們常把「研發管線」和「產品」這兩個字用在很多不同的產品上。我覺得，就目前而言，縱觀 Brepo 的適應症範圍，即使考慮到我們已經討論過的 CSP 和 MINU，我們也能接觸到非常龐大的潛在患者群體。

These are patients who -- in every one of these indications lacks efficacious therapies and is in need of options, and we continue to add legs of the stool or opportunities that grow into these sort of first-in-class orphan inflammatory diseases that are high unmet needs, important areas. And I think we've got more to come there. So stay tuned. But just starting to feel it brepocitinib is a really important medicine for us and hopefully for patients, so looking forward to continuing that journey.

這些患者在所有這些適應症中都缺乏有效的治療方法，需要更多的選擇，我們不斷增加治療的​​基石或機會，以發展成為此類首創的罕見發炎性疾病，這些疾病存在著高度未滿足的需求，是重要的領域。我認為我們在這方面還有更多收穫。敬請期待。但我剛開始感受到，brepocitinib 對我們來說是一種非常重要的藥物，希望對病人也是如此，所以我期待繼續這段旅程。

I'm going to free through a couple of other highlights or updates across the portfolio, [blue quick] financial update, and then we'll do Q&A at the end. Super quickly on Slide '24. As a reminder, [42] remains a huge focus for us at Roivant. We think we've got an FcRn with potential best-in-class efficacy with a safety profile that looks favorably within the class. Obviously, convenient administration with a subcu auto-injector.

接下來我將快速介紹投資組合中的其他一些亮點或更新，[藍色快速]財務更新，最後我們將進行問答環節。非常迅速地瀏覽第 24 張投影片。提醒一下，[42] 仍然是 Roivant 的一個重點。我們認為我們擁有了一種 FcRn，它具有同類最佳的療效潛力，並且其安全性在同類產品中也表現良好。顯然，使用皮下自動注射器進行給藥非常方便。

And we phrase you again here pipeline and product potential, again, with grains among our lead indications where we're expecting pivotal data in 2027. We're now, as I mentioned earlier, expecting the DTRA data later this year, and that study is fully enrolled. We actually enrolled 170 patients in that study up from the anticipated 120 originally, and that was in part just due to speed of enrollment and the level of enthusiasm from the patient in that community.

我們再次強調管道和產品潛力，再次強調穀物是我們的主要適應症之一，我們預計將在 2027 年獲得關鍵數據。正如我之前提到的，我們現在預計將在今年稍後獲得DTRA的數據，而該研究已經全部招募完畢。實際上，我們在這項研究中招募了 170 名患者，比最初預期的 120 名患者有所增加，這部分是由於招募速度快以及該社區患者的熱情高漲。

Moving over to mosli on '25, and we'll definitely spend some time later this year talking more about PH-ILD and mostly in setting the stage for what we expect there. But that study is fully enrolled. With thanks those patients investigators in the Priovant team PH-ILD remains an exciting opportunity for us, where targeted delivery gets at a disease where long as the primary site of disease activity.

我們將於 25 日轉向 mosli，今年晚些時候我們肯定會花一些時間更多地討論 PH-ILD，主要是為了讓我們對那裡的預期做好準備。但這項研究已經招滿了。感謝 Priovant 團隊的研究人員，PH-ILD 對我們來說仍然是一個令人興奮的機會，因為標靶遞送可以治療疾病，只要疾病活動的主要部位是肺泡。

I think we have a convenient once-daily dosing regimen in a disease where existing therapies mostly have multiple daily inhalations there aren't very many existing therapies bluntly. We expect or hope for tolerability benefits. And then as I think you know, we showed really the best ever PVR reductions in the PAH population if that translates we'll be able to get some investment cost efficacy as well. So really excited about what we could do there later this year. I think it will be a really important part of our story in the coming months.

我認為，對於這種疾病，我們有一種方便的每日一次給藥方案，而現有的療法大多需要每天多次吸入，坦白說，現有的療法並不多。我們預期或希望耐受性方面能有所改善。而且，我想你也知道，我們在 PAH 族群中實現了有史以來最好的 PVR 降低，如果這能轉化成其他疾病，我們也能獲得一些投資成本效益。非常期待今年晚些時候我們能在那裡做些什麼。我認為這將是未來幾個月我們故事中非常重要的一部分。

And then finally, and as before, I'm not going to spend a ton of time talking about this today because we're so close in hearing with the jury trial in the Moderna case is scheduled for March 9. We continue to make progress there and the sort of major update there in the recent weeks is that we got earlier this week, we got the first of the summary judgment decisions, which covered a few things and puts and takes generally.

最後，和以前一樣，我今天不會花太多時間談論這件事，因為 Moderna 案的陪審團審判定於 3 月 9 日舉行，聽證會即將開始。我們繼續在這方面取得進展，最近幾週的主要更新是，本週早些時候，我們收到了第一份簡易判決決定，其中涵蓋了一些事項以及一般的買賣交易。

And one doing we were quite happy with is a favorable decision on section 1498 which sets us up for the case that we were sort of hoping for in this trial, where almost all of the doses that we had asserted are going to be covered in mystery trial. So looking forward to that and obviously, more to come there.

我們非常滿意的一件事是，第 1498 條的有利裁決，這為我們在這個審判中希望的案件奠定了基礎，我們主張的幾乎所有劑量都將在神秘審判中得到涵蓋。非常期待，而且顯然，未來還會有更多精彩內容。

Finally, just a really brief financial update on Slide 28. R&D expense of $165 million adjusted non GAAP of $147 million for the quarter. G&A of $175 million, adjusted non-GAAP of $71 million, for total non-GAAP net loss of $167 million. Cash remains very strong, $4.5 billion of consolidated cash in the business. So plenty of capital to get us to profitability with dry powder to do other things as well. As a reminder, we still have share buyback authorization and are happy to have that sort of capability.

最後，在第 28 頁投影片上做一個非常簡短的財務更新。本季研發費用為 1.65 億美元，調整後的非 GAAP 費用為 1.47 億美元。一般及行政費用為 1.75 億美元，經調整的非公認會計準則費用為 7,100 萬美元，非公認會計準則淨虧損總額為 1.67 億美元。公司現金流依然非常充裕，合併現金總額達45億美元。因此，我們有足夠的資金來實現盈利，還有閒置資金可以做其他事情。再次提醒大家，我們仍然擁有股份回購授權，很高興能擁有這種能力。

On Slide 30, as discussed just a really catalyst-rich period ahead of us. A couple of these things checked off now. Obviously, at the beginning of the summer does but also make progress and just feeling good across the board with a lot more updates to come this year to be a big year for us.

如同幻燈片 30 所述，我們即將迎來一個催化劑非常豐富的時期。其中幾件事已經完成了。顯然，在夏季伊始，我們取得了一些進展，整體感覺良好，今年將有更多更新，這將是我們意義重大的一年。

And a big few years on Slide 31 before I go to DNA commercial launches potential in the coming years, obviously, brepo and DM would be first with that NDA now in multiple NDA and BLA filings. We continue to have even sort of more future POC study reads even among the ones we've already announced and now 9 or more pivotal study readouts, including cutaneous sarcoidosis coming over this time line, which is just a really exciting slate for us to build on.

在第 31 頁幻燈片中，我將討論 DNA 商業化在未來幾年的潛力，顯然，brepo 和 DM 將率先獲得 NDA，目前已提交了多份 NDA 和 BLA 申請。我們還有更多未來的 POC 研究結果公佈，即使在我們已經宣布的研究中也有，而且目前還有 9 項或更多關鍵研究結果公佈，包括皮膚結節病，這將在我們未來的發展道路上帶來令人興奮的成果。

So with that, thank you again for listening. I'm going to stop talking and open up the line for Q&A. Thank you. Operator?

那麼，再次感謝各位的收聽。我將停止講話，開放問答環節。謝謝。操作員？

Thank you, operator. (Operator Instructions)

謝謝接線生。（操作說明）

Corinne Johnson, Goldman Sachs.

科琳·約翰遜，高盛集團。

Good morning guys, and thanks for the question. I think you've mentioned today and previously that you consider further development extension opportunities for brepocitinib. And I'm curious how these data can inform the direction you'd like to go. Maybe you could also help us kind of size the opportunity set, particularly with respect to like what percent of the patient population you think are great candidates for this relative to NIO and dermatomyositis.

各位早安，感謝你們的提問。我認為您今天和之前都提到過，您正在考慮進一步開發擴展brepocitinib的機會。我很想知道這些數據如何能為你們未來的發展方向提供參考。或許您也可以幫助我們評估一下機會範圍，特別是您認為相對於 NIO 和皮肌炎，有多少百分比的患者群體非常適合接受這種治療。

Thanks.

謝謝。

Yeah. Perfect trend. Thanks. It's a great question. Look, I think the first thing is we are absolutely enthusiastic about further development in brepo. We have other indications that Ben and the team are hard at work at. I don't -- I think the -- but I would say the main thing about this data is just that it continues to underscore how strong an agent brepo can be in these patient populations that need it. and sort of drives enthusiasm, but I don't know that it reveals anything specific or new.

是的。完美潮流。謝謝。這是一個很好的問題。首先，我認為最重要的是我們對 brepo 的進一步發展充滿熱情。我們還有其他跡象表明，本和他的團隊正在努力工作。我不——我認為——但我想說，這些數據的主要意義在於它繼續強調了布雷普羅（brepo）這種藥物在這些需要它的患者群體中的強大療效，這在某種程度上激發了人們的熱情，但我認為它並沒有揭示任何具體或新的信息。

Other than we're continuing to think about continuing to think about other forms of targets, et cetera. CS is another indication where we will be first and only drug approved if we're successful from here. And then on patient population, look, I think this is right in the sweet spot of what we've been trying to do, not just globally for brepo, but across the different drugs we're developing, where we're in this kind of large orphan market.

除此之外，我們還在繼續思考其他形式的目標等等。CS 是另一個跡象，表明如果我們接下來的進展順利，我們將成為第一個也是唯一一個獲得批准的藥物領域。至於患者群體，我認為這正處於我們一直努力的方向，不僅在全球範圍內對 brepo 而言如此，而且在我們正在開發的各種藥物中也是如此，因為我們正處於一個龐大的孤兒藥市場。

And again, we might do things outside of this category, but it's been a really good space for us and for others with tens of thousands of patients, a big opportunity, high unmet need. And we think it will be the kind of thing that we can attractively launch and that we can that we can make a successful franchise around. So it feels great from an ability to benefit these patients perspective and from a commercial perspective as well.

再說一遍，我們可能會做一些超出這個範疇的事情，但對於我們和其他擁有數萬名患者的機構來說，這是一個非常好的領域，這是一個巨大的機會，存在著很高的未滿足需求。我們認為這將是一款極具吸引力的產品，我們可以圍繞它打造一個成功的特許經營品牌。所以，從造福患者的角度來看，以及從商業角度來看，這都感覺很棒。

Ben, anything you'd add there?

本，你還有什麼要補充的嗎？

I would just add that I think -- and this is something we've felt already, but this data really enforces that the alignment of TYK2, JAK1 inhibition to T-cell polarization both as we see here, predominantly Th1 driven, but also Th17 driven. And the mechanism of TYK2, JAK1 inhibition really does aligned to that through IL-12 and interferon gamma for TH1, IL-6 and IL-23 for Th17.

我只想補充一點，我認為——這也是我們已經感受到的——但這些數據確實強化了 TYK2、JAK1 抑制與 T 細胞極化之間的一致性，正如我們在這裡看到的，主要是 Th1 驅動的，但也包括 Th17 驅動的。TYK2、JAK1 抑制的機制確實與此相符，透過 IL-12 和乾擾素γ 抑制 TH1，透過 IL-6 和 IL-23 抑制 Th17。

And I think that's really one of the mechanistic hypotheses around the distinctive benefits of TYK2, JAK1 inhibition, others are obviously the type 1 interferon suppression that's very important in dermatomyositis, in addition to the T-cell polarization. But I would kind of highlight that this data really enforces that NIU has some overlapping mechanism as well, where obviously, we had really strong Phase 2 data, excited to see that Phase 3 result.

我認為這確實是 TYK2、JAK1 抑制的獨特益處的機制假說之一，其他假說顯然還包括對皮肌炎非常重要的 1 型乾擾素抑制，以及 T 細胞極化。但我想強調的是，這些數據確實證實了北伊利諾大學也有一些重疊機制，顯然，我們在第二階段的數據非常強勁，很期待看到第三階段的結果。

But I think just as we think about not just kind of the unmet need of indications, as Matt articulated, but also diseases where TYK2, JAK1 inhibition is going to really be, in our view, potentially better than any other form of immunosuppression. I think this data kind of as some of our hypotheses there.

但我認為，正如 Matt 所闡述的那樣，我們不僅要考慮尚未滿足的適應症需求，還要考慮 TYK2、JAK1 抑制劑在某些疾病中可能比任何其他形式的免疫抑制都更有效。我認為這些數據在某種程度上驗證了我們的一些假設。

Dave Risinger, Leerink Partners.

Dave Risinger，Leerink Partners。

Thanks very much and let me add my congrats as well, Matt and team. So obviously, the data was phenomenal. I had a couple of questions. First, with respect to the headline Sesame numbers, they were similar between the two arms. The press release, obviously, you mentioned different baseline characteristics.

非常感謝，也請容許我向馬特和他的團隊表示祝賀。顯然，這些數據非常驚人。我有幾個問題。首先，就芝麻街的頭條新聞而言，兩家電視台的數據是相似的。顯然，您在新聞稿中提到了不同的基準特徵。

Could you just add a little more color on that? Second, with respect to the FDA timeline, obviously, Octagam is approved for dermatomyositis. But is there a chance for the FDA to elect to grant priority review? Could you talk about that a little bit? Thanks so much.

能不能再給它加點顏色？其次，就 FDA 的時間表而言，顯然 Octagam 已獲準用於治療皮肌炎。但FDA是否有可能選擇給予優先審查權？能稍微談談這方面嗎？非常感謝。

In DM, I'm talking about. Thank you.

在私訊裡，我指的是。謝謝。

Yeah. Thanks, David. Both great questions. On the same point, I think Ben hit on this well in his presentation as well. Look, I think if you look at the table, I can pull up a slide to second, but if you look at the table in the presentation, on baseline characteristics, I'd say there are some relatively -- it's a small proof-of-concept study, it's a relatively small energy arm.

是的。謝謝你，大衛。兩個很好的問題。關於這一點，我認為本在他的演講中也很好地闡述了這一點。你看，我覺得如果你看一下表格，我可以調出一張幻燈片來補充說明，但是如果你看一下演示文稿中的表格，關於基線特徵，我會說有一些相對而言——這是一個小規模的概念驗證研究，這是一個相對較小的能源部門。

And so you can see some relatively significant differences on some aspects, including duration of disease. As well as morphology of disease with more a plaque predominant patients, which are those more recalcitrant patients on our 45 arm than on our 15 arm. And I think that's probably in part what's responsible for the sort of headline numbers looking similar.

因此，在某些方面，包括疾病持續時間，可以看到一些相對顯著的差異。除了疾病形態學上以斑塊為主的患者外，我們 45 組的患者比 15 組的患者更難治癒。我認為這可能在一定程度上導致了新聞頭條數據看起來比較相似。

And you can see that they separate more, again, I've been hit pretty well in the presentation. On the more stringent endpoints like the proportion of patients hitting a 10 or more point season benefit. So we feel pretty good about that translating into Phase 3. And then on the FDA time line, look, I think the answer to that question is DM is a severe disease with not a lot of options. And so there's certainly a chance, but that ultimately is up to FDA.

你可以看到它們之間的距離越來越遠了，再次說明，我在演示中表現得相當出色。更嚴格的終點指標，例如達到賽季獲益 10 分或以上的患者比例。所以我們對第三階段的進展感到非常樂觀。至於 FDA 的審批時間表，我認為這個問題的答案是：DM 是一種嚴重的疾病，治療選擇並不多。所以肯定存在這種可能性，但最終取決於美國食品藥物管理局（FDA）。

Thank you.

謝謝。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Great, thanks so much and congrats, really nice to see this data. I got a couple of questions. One is price. The IVIG is around $180, but the concomitant sort of price for VIVGard for these indications around $870 gross. So maybe help us understand how you're thinking about pricing of brepo.

太好了，非常感謝，恭喜！很高興看到這些數據。我收到了一些問題。一是價格。IVIG 的價格約為 180 美元，但用於這些適應症的 VIVGard 的價格約為 870 美元（毛價）。所以，或許您可以幫我們了解一下您對brepo定價的看法。

And then secondly, as you -- and I know this might be a little premature, but from Pfizer owns 25% of the JV, you'll obviously consolidate all sales of brepo. How do we handle their 25% ownership because you're not going to be paying a dividend, but I imagine you'll have to sort of given there 25% of the profits. Where is that going to hit the P&L?

其次，我知道這可能有點為時過早，但由於輝瑞擁有合資公司 25% 的股份，你們顯然會合併所有 brepo 的銷售額。我們該如何處理他們持有的 25% 的股份呢？因為你不會支付股息，但我認為你必須給他們 25% 的利潤。這將對損益表產生什麼影響？

Thank you.

謝謝。

Yeah. Thanks, Yaron. Those are both good questions. Look, I think on price, we obviously have not decided on the price yet, it's too early to have an answer to that question. What we've said before is taking bookings that are not so different from the ones you quoted there.

是的。謝謝你，亞倫。這兩個問題都很好。關於價格，我們顯然還沒有決定價格，現在回答這個問題還為時過早。我們之前說過，我們接受的預訂與你提到的那些預訂並沒有太大區別。

I think our view is IDH is probably a little bit more expensive than that in practice. Those bookends are a reasonable place to think about in terms of the pricing envelope for these indications is what we said before, and I think that continues to stand. And I think it gives us a lot of room.

我認為，在實際應用中，IDH 的成本可能比這更高。正如我們之前所說，這些首尾兩端是考慮這些適應症定價範圍的合理起點，我認為這一點仍然成立。我認為這給了我們很大的迴旋餘地。

So I think stay tuned, but this will be an orphan price drug. And then on the -- what I think is really sort of an accounting math question, so we'll fully consolidate all of the results, losses, sales of everything, and then there'll be a below-the-line minority interest that attributes a portion of Pfizer's earnings. But again, it will be below the net income line. And then in terms of how cash comes out, obviously, if we distribute cash out, Pfizer, we'll get their portion of that cash, and we'll get out a portion of that cash.

所以我覺得大家還是繼續關注吧，但這款藥的價格將會非常低廉。然後，我認為這實際上是一個會計數學問題，所以我們將全面合併所有結果、虧損、銷售額，然後會有一個線下少數股東權益，該權益歸屬於輝瑞公司的一部分收益。但同樣，它將低於淨收入線。至於現金如何發放，很顯然，如果我們發放現金，輝瑞公司會得到他們那部分現金，而我們會得到其中的部分現金。

The only other comment I'll make there is -- and we said this elsewhere, the early portion of the relationship with Pfizer had dilution protection for their ownership stake. That's been exhausted now. And so for any further capital into private and fit really the need to match their portion of our spend or will be diluted and we'll wind up owning more.

我唯一要補充的是──我們在其他地方也說過──與輝瑞公司合作的早期階段，他們的股權受到稀釋保護。現在已經耗盡了所有資源。因此，任何進一步的私人資本投入都需要真正匹配他們在我們的支出中所佔的份額，否則將被稀釋，最終我們將擁有更多股份。

Brian Cheng, JPMorgan

Brian Cheng，摩根大通

Hi, madam then, congrats on the data here. Two questions from us. As we think about the Phase 3, what's your latest thinking about the size and the dose that you have take. And just curious if you have any thoughts about how we should think about the stability of efficacy going from a Phase 2 to Phase 3 for this indication, it seems that you have a pretty large gap going from 22 to the 5 point Delta destem clinically meaningful. How should we think about deterioration, and I have one quick follow-up as a housekeeping question. Thank you.

您好，女士，恭喜您獲得這些數據。我們有兩個問題。當我們考慮第三階段試驗時，您對試驗劑量和試驗規模有什麼最新想法？我很好奇，對於該適應症從第 2 期到第 3 期的療效穩定性，我們該如何看待？從 22 到 5 個臨床意義顯著的 Delta destem 之間存在相當大的差距。我們該如何看待劣化？我還有一個後續問題，算是例行公事。謝謝。

Yeah. Thanks, Brian. Look, I'm also going to hand over to Ben for these questions, but I'll just say it feels like we've got a fair amount of cushion in the quality of this data. And also, a, this was a relatively small study. You either aren't a lot of other studies to go on in CS.

是的。謝謝你，布萊恩。聽著，這些問題我也要交給本來回答，但我只想說，感覺我們這些數據的品質還是相當有保障的。而且，這項研究的規模相對較小。你可能沒有太多其他電腦科學的研究方向了。

So we kind of got to take our guidance from here. But it was nice to see a local super response. Ben, do you want to talk a little bit about that and about whatever we can share at this point on Phase 3 design?

所以，我們只能根據這裡的指示行事了。但很高興看到當地超市的正面回應。本，你想稍微談談這方面嗎？以及關於第三階段設計，我們現在可以分享些什麼？

Yeah, sure. I mean, first, just on erosion, obviously, would be hard to do any better than this. But I think that the minimum clinical (inaudible) differences, as we've discussed the slide points here, we have over 20 points we could have significant erosion and still have a very compelling data set and a very compelling product profile for patients and physicians.

當然可以。我的意思是，首先，就侵蝕而言，顯然很難做得比這更好了。但我認為，正如我們在這裡討論的幻燈片要點，最小的臨床（聽不清楚）差異，我們有超過 20 個要點，即使出現重大偏差，我們仍然可以擁有非常有說服力的數據集和對患者和醫生來說非常有說服力的產品概況。

That said, I would also note this was -- it was the US-only study, but 15 sites for the 31 patients. So this was a multicenter, multidose, placebo-controlled trial, very rigorous for a smaller proof of-concept study. So while I think that there's always some risk of erosion in particular, while the very low placebo rate is consistent with natural disease course, you can never be sure of the behavior of placebo and these inflammatory disease trials, particularly when you move to larger global trials.

也就是說，我還想指出，這是一項僅限美國的研究，但有 15 個地點，涉及 31 名患者。所以這是一項多中心、多劑量、安慰劑對照試驗，對於規模較小的概念驗證研究來說，其嚴謹性非常高。因此，雖然我認為總是存在一些侵蝕的風險，特別是安慰劑效應非常低，這與疾病的自然進程一致，但你永遠無法確定安慰劑在這些發炎性疾病試驗中的表現，尤其是在進行更大規模的全球試驗時。

But broadly speaking, I think this data gives us an incredible cushion to still have an effect size in Phase 3 that maybe is large or maybe is not quite as large, but still would be extremely compelling. As far as the design of the Phase 3 in terms of size, I think we would probably be looking at a sort of similar size per arms to the DM trial roughly, but we need to kind of take this data into consideration and think more about the powering and have final discussions with FDA on it, including as related to the in indication safety safety set that they would want to see to support approval. So we'll have more to share on that after we engage with FDA.

但總的來說，我認為這些數據給了我們極大的緩衝空間，讓我們在第三階段仍然能夠獲得可能很大也可能沒那麼大的效果，但仍然會非常有說服力。就 3 期試驗的規模設計而言，我認為我們可能會考慮每組與 DM 試驗大致相似的規模，但我們需要將這些數據考慮在內，更多地考慮統計效力，並與 FDA 就此進行最終討論，包括與他們希望看到的適應症安全性指標集相關的指標，以支持批准。所以，在與FDA溝通之後，我們會分享更多相關資訊。

And the same is true on dose, I would say that I think our incoming hypothesis to this trial is that 45-milligrams based on the totality of the 1,500 patient data we have, a very compelling potential option for these patients balancing benefit and risk. And certainly, I would say, in totality, this data reinforces that, you see really excellent efficacy results from the 45-milligram arm, including on some of these higher bar, more stringent endpoints, starting to see real separation with 15-milligrams.

劑量方面也是如此，我認為我們此次試驗的假設是，根據我們掌握的 1500 名患者的全部數據，45 毫克劑量對於這些患者來說是一個非常有吸引力的潛在選擇，可以平衡獲益和風險。當然，我認為，總體而言，這些數據強化了這一點，45 毫克組的療效結果非常出色，包括一些更高標準、更嚴格的終點，開始與 15 毫克組出現真正的差距。

And then certainly, in terms of the safety data, nothing that would suggest the overall safety profile of 45-milligrams that we've seen across all of the different indications in which it's been studied, that nothing in this data to suggest there's anything specific to cutaneous sarcoidosis separate from those. So I think broadly speaking, I would say we're very excited about 45-milligrams coming into the study.

當然，就安全性數據而言，沒有任何跡象表明 45 毫克劑量在所有已研究的不同適應症中都具有整體安全性，也沒有任何跡象表明皮膚結節病與其他適應症有任何不同。所以總的來說，我認為我們對 45 毫克劑量進入研究領域感到非常興奮。

We're even more excited about it coming out of the study 15-milligrams also performed very well, and that's great to see. It really just speaks to the overall efficacy potential of the product. And so we'll kind of have a final update on that after we engage with the agency.

更讓我們興奮的是，研究結果顯示 15 毫克劑量也表現得非常好，這真是個好消息。這充分說明了該產品的整體功效潛力。所以，在與該機構溝通之後，我們會就此事給出最終的更新。

Got it. Thanks, Ben. And maybe just one quick one on the housekeeping side. So looking at the 10-Q from Immunovant, can you give us a little bit more color on the return for certain rights around batoclimab back to and all? Is there any read-through to how we should think about the setup for the tech data readout later this year?

知道了。謝謝你，本。或許還需要在客房服務上做一點簡單的調整。那麼，根據 Immunovant 的 10-Q 報告，您能否更詳細地介紹與 batoclimab 相關的某些權利的回報情況等等？對於今年稍後的技術數據發布安排，我們是否有任何參考依據？

Thank you.

謝謝。

No, it was the short answer to that question. Meaning there's no read-through anything. It's just as we get closer to that data, depending on what we decide to do with batoclimab, if we decide to further development, we have to make a decision around how to work together within all our next steps there. So that's really nothing to say.

不，這就是對這個問題的簡短回答。也就是說，沒有任何通讀內容。就在我們越來越接近這些數據的時候，根據我們對 batoclimab 的決定，如果我們決定繼續開發，我們必須決定如何在接下來的所有步驟中協同合作。所以其實沒什麼好說的。

Dennis Ding, Jefferies

丹尼斯丁，傑富瑞

Good morning. This is Anthea on for Dennis. And congratulations on the data. I wanted to ask two questions on upcoming catalysts. First on Daubert, can you explain how important Dr. Mitchell's testimony is to the case improving direct infringement and whether or not there's any risk to that being taken out, so to speak, ahead of trial?

早安.這裡是安西亞替丹尼斯報道。恭喜你獲得了這些數據。我想問兩個關於即將到來的催化劑的問題。首先，關於 Daubert 案，您能否解釋一下 Mitchell 博士的證詞對於改進直接侵權案件的重要性，以及在審判前將其刪除是否存在任何風險？

And then on PH-ILD, thoughts on the competitive landscape and if sotatercept could work in the disease as well?

那麼關於PH-ILD，您如何看待目前的競爭格局，以及索他西普是否也能用於治療這種疾病？

Thanks, both great questions. Look, on Daubert, as we said, we really can't talk too much about an ongoing litigation. There are a variety of Daubert motions in front of the court, what they are or visible and the judge will make a decision on all of them and anything within the range as possible. Obviously, we're hoping for favorable test outcomes in case.

謝謝，兩個問題都很好。關於 Daubert 案，正如我們所說，由於訴訟仍在進行中，我們真的不能過多談論此事。法庭上會提出各種各樣的 Daubert 動議，這些動議的內容或可見之處，法官將對所有動議以及任何在規定範圍內的動議作出裁決。顯然，我們希望檢測結果能夠令人滿意。

On PH-ILD question, look, I think the answer is, in theory, any drug that improves PVR could work in PH-ILD, systemic -- vasodilation has not, in and of itself, a been a great approach in PH-ILD but sotatercept certainly could work in PH-ILD. Right now, we are slated, I believe, to be the first non-prostacyclin non-prostanol in PH-ILD. I suspect given the amount of unmet patient need, there will be others behind us, but I think we have a really favorable profile as we enter that space.

關於 PH-ILD 的問題，你看，我認為答案是，理論上，任何能改善 PVR 的藥物都可能對 PH-ILD 有效，全身性血管擴張本身並不是 PH-ILD 的一種很好的治療方法，但索他西普肯定可能對 PH-ILD 有效。我相信，目前我們有望成為首個用於治療 PH-ILD 的非前列環素類非前列腺素類藥物。我懷疑，鑑於目前未滿足的患者需求量巨大，我們身後還會有其他企業，但我認為，當我們進入這個領域時，我們擁有非常有利的條件。

Yasmeen Rahimi, Piper Sandler.

亞斯敏·拉希米，派珀·桑德勒。

Good morning team. Thank you so much for all the color. As an immune event, covering analysts would love to spend time on 1402 and get some color around here near term or a readout. Obviously, the study is upsized. Help us understand as the studies coming to end reading out what you hope to see and how you're sort of preparing for filing and how soon you could actually get ready for that first Phase 2 registrational study to be shared? And then I'll jump back in the queue.

各位同事，早安。非常感謝你帶來的繽紛色彩。作為免疫事件，分析師們很樂意花時間關注 1402，並了解近期的一些情況或相關數據。顯然，這項研究的規模擴大了。請幫助我們了解，隨著研究接近尾聲，您希望看到什麼，您是如何準備提交申請的，以及您何時才能真正準備好分享第一個二期註冊研究的結果？然後我再重新排隊。

Thanks.

謝謝。

Thanks. I appreciate the question. Look, I think in terms of expectations for RA, I think the short answer to that question is, on the one hand, these are patients with high unmet need. And so in some sense, the bar for efficacy is relatively low compared to what we may be used to seeing in RA.

謝謝。感謝您的提問。我認為，就類風濕關節炎的預期而言，這個問題的簡短回答是，一方面，這些患者存在著很高的未滿足需求。因此，從某種意義上說，與我們在 RA 中可能習慣看到的療效標準​​相比，療效標準相對較低。

On the other hand, there's just very little precedent data for drugs in late-stage RA with sort of this level of pretreatment. And so it's hard to know. I think we're doing some work on that very question now, and we will share some guidance on what would cause us to run the second study before we put out that data. So it's a stay tuned for that. Remember, these are burned out patients with pretty tough disease at this point.

另一方面，對於晚期類風濕性關節炎患者，尤其是經過這種程度預處理的患者，藥物治療的先例數據非常少。所以很難知道。我認為我們現在正在研究這個問題，在公佈數據之前，我們會分享一些指導意見，說明什麼情況下我們會進行第二次研究。所以，敬請期待。請記住，這些患者此時已經精疲力竭，而且病情非常嚴重。

So obviously, if we're excited about the data, there's a potential for it to be a big product. Obviously, we will engage with the agency once we've got the data and think about what a plan looks like. I think the base case expectation should be that this is one of a couple of studies that we'll have to run just because this is a relatively smaller randomized withdrawal trial, but we'll see the data, and then we'll have better answer that question.

顯然，如果我們對數據感到興奮，它就有可能成為一款熱門產品。顯然，一旦我們掌握了數據，就會與相關機構接洽，並考慮制定一個方案。我認為基本預期應該是，這只是我們需要進行的幾項研究之一，因為這是一個相對較小的隨機撤藥試驗，但我們會查看數據，然後更好地回答這個問題。

Prakhar Agrawal, Cantor.

Prakhar Agrawal，坎托爾。

Hi, good morning and thanks for all my questions and congrats on these main results. So maybe on brepo and CS, just wanted to better understand the market opportunity here. You've talked about 40,000 eligible patients. would all of these be eligible for brepo therapy and meet the inclusion/exclusion criteria for the trial. And if that's the case, do you think this is a similar size opportunity as dermatomyositis?

您好，早安，感謝您提出的所有問題，並祝賀您取得這些主要成果。所以，或許關於 Brepo 和 CS，我只是想更了解這裡的市場機會。您提到有 40,000 名符合條件的患者。所有這些患者都符合 Brepo 療法的條件並滿足試驗的納入/排除標準嗎？如果真是這樣，你認為這和皮肌炎一樣具有規模上的機會嗎？

And maybe just one follow-up on the Phase 3 design. Would the time point of the endpoint the 16-week similar to your Phase 2, given your -- you already have the safety database. Or would you have to test longer, just trying to figure out if there's any ways to accelerate development here?

或許還需要對第三階段設計進行一次後續跟進。鑑於您已經擁有安全資料庫，終點時間點是否與第 2 期類似，即 16 週？或者你需要進行更長的測試，只是想弄清楚是否有任何方法可以加快開發速度？

Yeah. Thanks, Prakhar. Great questions. Look, I think the short answer of our market opportunity is this is a patient population that's sick with high unmet need. And assuming our Phase 3 data looks similar to our Phase 2 data, I think a lot of these patients are going to be enthusiastic about a better treatment option.

是的。謝謝你，普拉卡爾。問得好。簡而言之，我認為我們市場機會的關鍵在於，這是一個患病患者群體，他們的醫療需求尚未得到充分滿足。假設我們的 3 期數據與第 2 期數據相似，我認為許多患者都會對更好的治療方案感到興奮。

It's probably a modestly smaller indication than dermatomyositis just in terms of total end. I mean, obviously, DM is 40,000 patients in treatment with 70,000-plus total patients. So I'd probably think of this as an exciting opportunity, but a little bit smaller than the DM opportunity, although, again, depends on the Phase 3 data.

從整體來看，它可能比皮肌炎的症狀要輕微一些。我的意思是，很明顯，DM 有 40,000 名患者正在接受治療，而總患者人數超過 70,000 人。所以我覺得這或許是一個令人興奮的機會，但比DM的機會小一些，當然，這也要取決於3期數據。

And then I think the short answer on Phase 3 design is let's just wait until we've had the conversation with FDA before we sort of talk about final outcomes, but we're going to be looking to leverage as much as we can of what we've learned from the Phase 2 study. And obviously, to the extent that we can match parameters on which we're confident we'll do that.

至於 3 期臨床試驗的設計，我認為簡短的回答是，在與 FDA 進行溝通之前，我們最好等到溝通結束後再討論最終結果，但我們會盡可能地利用從 2 期臨床試驗中學到的知識。顯然，前提是我們能夠匹配我們有信心實現這一目標的參數。

Samantha Semenkow, Citi

薩曼莎·塞門科夫，花旗銀行

Hi, good morning. Thanks very much for taking the question and congrats on this very good safe data. I'm wondering what percentage of patients in the [BEGIN] study had organ involvement if you have that? And were you able to collect any data that would allow you to assess whether brepocitinib impacted organ-specific manifestations? And then just as a follow-up there, do you see a path to expand into other forms of sarcoidosis with brepocitinib?

您好，早安。非常感謝您回答這個問題，也祝賀您獲得如此優秀且安全的數據。我想知道[BEGIN]研究中有多少比例的患者出現器官受累？您是否收集到任何數據，以便評估布雷泊替尼是否對器官特異性表現產生影響？那麼，作為後續問題，您認為布雷泊替尼有可能擴展到其他類型的結節病嗎？

Thank you.

謝謝。

Yeah. Thanks. Look, I'll take the second of those questions, which is certainly something we will evaluate in terms of further places to study brepo. And we -- as I said before, we have ideas inside and outside sarcoidosis that are exciting. So stay tuned we'll be back with it. On the first question, in terms of patients with organ involvement and what we can learn from it,

是的。謝謝。好的，我來回答第二個問題，這當然是我們評估未來研究布雷波（brepo）方向的一個面向。正如我之前所說，我們在結節病領域內外都有一些令人興奮的想法。敬請期待，我們稍後會帶來更多消息。關於第一個問題，即關於器官受累患者以及我們可以從中學到什麼，

Ben, anything you'd share about that?

本，有什麼想分享的嗎？

Yeah. Around 60% of the patients had some pulmonary involvement and around 30% inclusive of that 60% had some other organ involvement, mostly ocular involvement we did take some exploratory endpoints related to those in the trial. We haven't analyzed that yet. Ultimately, the study was not designed or set up to evaluate benefit in those other organ systems.

是的。約 60% 的患者有肺部受累，其中約 30% 的患者（包括這 60% 的患者）有其他器官受累，主要是眼部受累。我們採取了一些與試驗相關的探索性終點。我們尚未對此進行分析。歸根究底，這項研究的設計和設立目的並非為了評估對其他器官系統的益處。

So I don't expect us to learn anything too meaningful from that, but it's certainly something we will take. I look at it, and I think the important point to note is this is a real-world cutaneous sarcoidosis population, given these -- many of these patients do have multiple organs and involved.

所以我並不指望我們能從中學到什麼特別有意義的東西，但這肯定是我們將會學到的教訓。我仔細觀察了一下，我認為需要注意的重要一點是，這是一個真實的皮膚結節病患者群體，考慮到這些情況——許多患者確實涉及多個器官。

Yatin Suneja, Guggenheim.

Yatin Suneja，古根漢美術館。

Hey guys, thank you for taking my question. A quick one for me on brepo on the data that you provided. Like if you look at the curves, they continue to deepen over 16 weeks. So I'm just curious understand from you how should we think about further -- do you expect further deepening for the separation.

各位好，感謝你們回答我的問題。我需要根據您提供的數據快速回答一個關於 brepo 的問題。如果你觀察這些曲線，你會發現它們在 16 週內持續加深。所以我很好奇，想聽聽您的意見，我們應該如何進一步考慮這個問題——您是否預期這種分離會進一步加深？

Just talk about if somebody gets treated for a year, how should we think about it? And then if you can just talk about the scope and the side. I don't know if you touched on that already of the Phase 3 study, should it be similar to what you did in DM.

假設有人接受一年的治療，我們該怎麼看待這件事？然後，如果你能談談範圍和麵向就更好了。我不知道您是否已經談到過 3 期研究，它是否應該與您在 DM 中所做的類似。

Thank you so much.

太感謝了。

Yeah. I mean, just to reiterate on Phase 3, and I think Ben shared a thought about that. But I think in general, we talked to FDA, it's like it's hard to commit to a specific study design. So I think like let us get through that, and then we'll be back with a full recounting of the study design.

是的。我的意思是，再次重申第三階段，我認為本也表達過類似的想法。但總的來說，我們和FDA溝通過，感覺很難確定具體的試驗方案。所以我想我們先把這個問題解決掉，然後再回來全面回顧研究設計。

But I think we're prepared to run and enroll a nice sizable study, if that's what we need to do. I think we feel good about what we need there. And then in terms of -- look, in terms of continued deepening, we're just looking at the data for the first time this week. So I think we're continuing to explore all the various features. I think it's funny, one of the KOLs was also involved with the study gave a quote to some journalists.

但我認為，如果需要的話，我們已經準備好進行並招募一項規模可觀的研究。我認為我們對那裡需要的東西感到滿意。至於──你看，就持續加深而言，我們本週才第一次查看相關數據。所以我覺得我們將繼續探索所有不同的功能。我覺得很有趣，其中一位 KOL 也參與了這項研究，並向一些記者提供了引述。

When I think his comment was if the data had been half as good and there have been twice as many side effects still would have been a great outcome. Look, obviously, Well, it's very short. There are certainly potential ways for this data to be even better with long with therapy with other parameters, but I think the answer is if we can come close to replicating this in a Phase 3 program, it would be a huge win. So I think we should be offset there.

我認為他的評論是，即使數據只有現在的一半好，副作用也翻了一倍，那仍然會是一個很好的結果。你看，很明顯，嗯，它很短。當然，透過延長治療療程並結合其他參數，這些數據還有很大的改進空間，但我認為，如果我們能在 3 期臨床試驗中接近複製這一結果，那將是一個巨大的勝利。所以我認為我們應該在這方面做出讓步。

Douglas Tsao, H.C. Wainwright.

道格拉斯·曹，H.C. 溫賴特。

Hi, good morning. Thanks for taking the questions. I guess, Matt, I'm just curious with brepo, how broad are you now thinking about the opportunity, right? I mean I think we've seen great results, obviously -- [yesterday], on DM as well as NIU.

您好，早安。謝謝您回答問題。我想問的是，Matt，我只是好奇關於 brepo，你現在對這個機會的看法有多廣泛，對吧？我的意思是，我認為我們已經看到了很好的結果，顯然——[昨天]在DM和NIU。

There is obviously a lot of data with JAK inhibitors in various indications, but not necessarily full randomized trials or proof of concept. I mean is that the breadth of universe? Or is there other white space that you're also thinking about where JAK hasn't been explored at all but perhaps it's worth exploration just given the magnitude of effect that you're starting to see.

顯然，JAK抑制劑在各種適應症方面有很多數據，但不一定有完整的隨機試驗或概念驗證。我的意思是，這就是宇宙的廣度嗎？或者，您是否也在考慮其他一些空白領域，JAK 尚未涉足，但考慮到您開始看到的巨大影響，或許值得探索一下。

Thank you.

謝謝。

Could you, yeah, how broad are you thinking about the [reup] opportunity? Thank you. Great question. Thank you. Great question.

請問，您對[重新供貨]機會的考慮範圍有多廣？謝謝。問得好。謝謝。問得好。

Doug. Great question. Look, I think the short answer is, I think you can see from our indication selection already that we've been creative and thoughtful in going after indications with high unmet need, including lots of places where JAKs have not been explored. And I think there's a lot of opportunity here.

道格。問得好。簡而言之，我認為從我們選擇的適應症中可以看出，我們在選擇具有高度未滿足需求的適應症方面一直富有創造力和深思熟慮，包括許多尚未探索過 JAK 的領域。我認為這裡有很多機會。

I'll just reiterate something Ben said. And Ben, if you want to do it again as well, I think it's a really good point to hit. Look, I think anywhere that TYK and JAK are both important is a particular area of focus for it because it gets the uniqueness of our mechanism, but I think we've done a really nice job, again, thanks to Ben and much of people retinas well. The private team on exploring that biology. I think we have more ideas in that category.

我只想重複一下本說過的話。本，如果你也想再做一次，我認為這是一個很好的切入點。我認為，TYK 和 JAK 都很重要的任何地方都是我們特別關注的領域，因為它體現了我們機制的獨特性，但我認為我們做得非常好，再次感謝 Ben 和許多人的視網膜。私人團隊正在探索這種生物學特性。我認為我們在這個領域還有更多想法。

Ben, anything to add there mechanistically or otherwise?

本，還有什麼補充嗎？無論是機制方面還是其他方面？

No. I mean, I think I covered it earlier. I would say that the answer is both. I think there are some indications where there's maybe some IITs or clinical reports from off-label use of other JAK inhibitors, where we think TYK2, JAK1 inhibition is really optimally suited for it. And I think those are indications we're evaluating that would obviously be highly de-risked.

不。我的意思是，我覺得我之前已經講過了。我認為答案是兩者兼具。我認為有一些跡象表明，在其他 JAK 抑制劑的非適應症使用中，可能存在一些 IIT 或臨床報告，我們認為 TYK2、JAK1 抑制劑才是真正最適合這種情況的。我認為這些跡象表明，我們正在評估的這些措施顯然風險很低。

I also think as we -- to your point, as we continue to see more and more excellent data here, I think we're definitely looking into some obviously, higher risk but also exciting potential opportunities where there's less proof of concept, and we would see what we end up with there.

我也認為，正如你所說，隨著我們不斷看到越來越多的優秀數據，我們肯定會關註一些風險更高但又令人興奮的潛在機會，這些機會的概念驗證較少，我們會看看最終結果如何。

And Matt, if I can one follow-up, just obviously, business development has always been such a big part of the Woven story. But just given the sort of expanding horizons for both Brepo as well as [INV] 1402, how are you thinking about capital allocation in terms of external versus sort of just internal R&D investment?

馬特，如果我可以追問一點，很顯然，業務拓展一直是 Woven 發展歷程中非常重要的一部分。但鑑於 Brepo 和 [INV] 1402 的發展前景都在不斷擴大，您是如何考慮外部研發投資與內部研發投資之間的資本配置的？

Thank you, [Dollars] go to the best opportunity wherever they are, the sort of answer to that question. Look, we're funded through profitability on our existing portfolio obviously, things like running the Phase 3 program in cutaneous sarcoidosis are no-brainers at this point. We were definitely going to do it.

謝謝，[美元]會流向任何地方的最佳機會，這就是對這個問題的回答。你看，我們顯然是透過現有投資組合的獲利能力來獲得資金的，所以像開展皮膚結節病三期計畫這樣的事情，在目前來說是理所當然的。我們肯定會這麼做的。

And adding additional indications, brepo or 1402 or for mostly are attractive options because those mechanisms are strong, and we'll work in other places. That said, and I'm sitting across the table from a right now, the world is full of attractive opportunities, and we look at all of them. So I think we've absolutely got opportunities to deploy sort of externally as well, and it continues to be a core part of what we believe we are good at.

此外，增加其他適應症，如 Brepo 或 1402 或大多數情況下都是有吸引力的選擇，因為這些機制很強大，我們將在其他地方開展工作。話雖如此，我現在就坐在你對面，世界充滿了誘人的機會，我們會仔細審視所有這些機會。所以我認為我們絕對有機會向外部部署，而且這仍然是我們認為我們擅長的核心部分。

Derek Archila, Wells Fargo.

德里克·阿奇拉，富國銀行。

Hey, good morning, and, congrats on the data. So just quickly on Immunovant in terms of we saw positive data for nipocalimab in systemic lupus. So curious about how you think about the read-through to cutaneous?

嘿，早上好，恭喜你獲得這些數據。那麼，關於 Immunovant，我們簡單地說一下，我們看到了 nipocalimab 在系統性紅斑狼瘡治療中的積極數據。很好奇您是如何看待從表皮到皮膚的轉化過程的？

And then second question, just in terms of commercial synergy between brepo and 1402, Obviously, we're Immunovant covering analysts. So just curious how you think about fielding a sales force in the most cost-effective manner to leverage both brepo and 1402 between the two companies?

第二個問題，就 Brepo 和 1402 之間的商業協同效應而言，顯然，我們是 Immunovant，正在關注分析師。所以，我很好奇您認為如何以最具成本效益的方式組建銷售團隊，從而在兩家公司之間同時利用 Brepo 和 1402 系統？

Thanks.

謝謝。

Yeah. Thanks. Look, these are both really good questions and important areas for us. On SLE, first of all, I was on record long before the brepo study in SLE saying that anybody who isn't afraid of a lupus study, I think the word I used in it. And so I'll say congrats to J&J on the positive data in SLE, it's always impressive when people were able to deliver those kind of results.

是的。謝謝。你看，這兩個問題都非常好，對我們來說也是非常重要的領域。關於 SLE，首先，早在 SLE 的 brepo 研究之前，我就公開表示，任何不害怕狼瘡研究的人，我想我當時用的詞是…因此，我要祝賀強生公司在系統性紅斑狼瘡（SLE）方面取得積極成果，當人們能夠取得這樣的結果時，總是令人印象深刻的。

It certainly supports the use of FcRns in diseases with a lot of complicated immune activity going on at the same time. There's probably some read-through to CLE in the sense that in the sense that there's some physiological overlap there. But every lupus study of any kind is its own special flower and we'll have to be successful in CLE on our own.

這無疑支持在同時存在許多複雜免疫活動的疾病中使用 FcRns。從某種意義上說，CLE 可能與此有一些共通之處，因為兩者在生理方面存在一些重疊。但每一項關於狼瘡的研究都是獨一無二的，我們必須靠自己才能在 CLE 中取得成功。

We like cutaneous lupus in part because we know that forms are pretty good at reading those kinds of endpoints. And so we feel good about that. Again, CLE is a different competitive landscape in SLE and we're watching that bar as well.

我們喜歡皮膚狼瘡，部分原因是我們知道表單非常擅長讀取這類終點。所以，我們對此感到很滿意。再次強調，CLE 的競爭格局與 SLE 不同，我們也關注這個領域。

On the commercial question, look, the first thing I'll say is even bluntly within a big pharma company these days, the truth is that for de novo launches, mostly you deploy a field apparatus that is specific to the program because you want to engage with those very specific physicians because you want sort of full voice share of your field force on the product.

關於商業問題，首先我要坦率地說，即使在如今的大型製藥公司內部，事實是，對於全新上市的產品，你通常會部署專門針對該項目的現場團隊，因為你想與那些特定的醫生互動，因為你想讓你的現場團隊在產品方面擁有充分的話語權。

And so I'm not sure I think of like sales force as the most important commercial synergy, but we are definitely thinking about things like contracting expansively to make sure that we can get maximum benefit from commercial scale across the portfolio, and there definitely are areas where that is top of mind for us, but I think will translate to benefit both for the commercial performance of brepo and for the commercial performance of 1402 as those launches progress.

因此，我不確定我是否認為銷售團隊是最重要的商業協同效應，但我們肯定會考慮擴大合約範圍，以確保我們能夠從整個產品組合的商業規模中獲得最大收益，而且這絕對是我們最關注的領域，但我認為這將轉化為brepo和1402商業業績的收益，隨著這些產品的上市進展，這些收益也將隨之而來。

Thanks, Derek.

謝謝你，德里克。

Ash Verma, UBS

阿什維爾馬，瑞銀集團

Hi, thanks for your questions. So for [Barrow's], just upcoming the TED results, the data that you're expecting. Just curious how you're thinking about that in the light of recently got set back in TED. In your case, how confident are you that a positive grade disease readout would translate to success in Thyroid Eye Disease?

您好，感謝您的提問。所以對於[巴羅]來說，即將公佈的TED結果，也就是你所期待的數據。只是好奇你最近在TED演講中遭遇挫折後，你對此有何看法。就您的情況而言，您對甲狀腺眼疾的陽性疾病分級結果能轉化為治療成功的信心有多大？

Thanks. Look, I appreciate the question. Obviously, TED is out there, and that data is coming when we have both studies in the first half of this year. I don't think there's like a ton of -- a ton to say about that at this point. Those studies are going to happen and will put the data out.

謝謝。我很感謝你的提問。顯然，TED 已經公佈，相關數據將在今年上半年兩項研究完成後公佈。我覺得目前關於這一點沒什麼太多好說的。這些研究將會進行，並將公佈數據。

Obviously, we know from our own Phase 2 study in TED as well as from our own Phase 2 work in grade that the drug is active in patients with hyperthyroidism. And I think that should translate in both indications to some degree of efficacy. And we don't think there's a lot of read-through from TED either in organic case Argenx obviously also doesn't as well or in our own situation in Graves disease in the sense that we have -- look, obviously, both where we have all of our Phase 2 data in Graves and the diseases are pretty different. Like the TED study enrolled mostly thyroid patients.

顯然，我們從我們自己在 TED 中的 2 期研究以及我們自己在 grade 中的 2 期工作中得知，該藥物對甲狀腺功能亢進患者有效。我認為這應該在兩種適應症中都轉化為某種程度的療效。我們認為，無論是有機案例，或是Argenx，都無法從TED中獲得太多啟示。顯然，在我們自身治療格雷夫茲病的案例中，情況也是如此——顯然，我們擁有格雷夫茲病的所有2期數據，而這兩種疾病截然不同。與 TED 研究類似，研究主要招募了甲狀腺疾病患者。

So they're pretty different fundamentally through the boohoo was in the studies. So I feel like we are confident in the efficacy or potential efficacy of FcRns and Graves disease and not particularly focused on what information there is from TED.

所以從根本上來說，它們與 boohoo 在研究中的情況非常不同。所以我覺得我們對 FcRns 和格雷夫茲病的療效或潛在療效充滿信心，並沒有特別關注 TED 提供的資訊。

Obviously, once we get the TED data and can talk about it, there will be information there from patients who happen to be hyperthyroid at various points in that study and how those patients look and we'll take full advantage of that data in optimizing our grades program. But beyond that, I'd say not much read-through between the programs and looking forward to getting all that data together once we've got it.

顯然，一旦我們獲得 TED 數據並可以進行討論，其中將包含研究期間不同階段患有甲亢的患者的信息，以及這些患者的狀況，我們將充分利用這些數據來優化我們的評分方案。但除此之外，我認為這些程式之間並沒有太多共同點，期待我們收集到所有資料後將它們匯總起來。

Thanks, Ash.

謝謝你，阿什。

Thomas Smith, Leerink Partners.

Thomas Smith，Leerink Partners。

Hey guys, good morning. Thanks so much for the update. Great to see the rapid enrollment and the over enrollment for 1402 from D2T RA and I appreciate the update on the data timing I just wanted to clarify, should we expect that you'll report both the open-label and randomized data from this study together? Or is there potential we could see some of that open-label period one data first?

嘿，各位，早安。非常感謝您提供的最新資訊。很高興看到 D2T RA 的 1402 研究快速入組且超額入組，感謝你們提供的關於數據發佈時間的更新。我只是想確認一下，你們是否會同時報告這項研究的開放標籤資料和隨機資料？或者我們有可能先看到一些開放標籤第一階段的資料？

And then as a follow-up, we noticed on Slide 31, the expectation for Graves launched by the end of '28, but not although you're expecting Phase 3 data for both indications in '27. I just wanted to ask if that's purely a function of data timing there? Or if there's some other strategic considerations with respect to pricing or competitive landscape?

然後，作為後續，我們在第 31 張幻燈片中註意到，預計 Graves 將在 2028 年底推出，但儘管您預計 2027 年將獲得兩種適應症的 3 期數據。我只是想問一下，這是否完全取決於數據時序？或者在定價或競爭格局方面還有其他策略考量嗎？

Thanks so much.

非常感謝。

Thanks. I appreciate both questions. Look, I think on the data release timing for the RA study, I don't think we've made a final decision on how exactly we'll put that data out and when, but I think it's reasonably likely now that we know both are coming this year. That we'll wait for the randomized draw period before we talk about it. Obviously, that first period is open label, so we'll get some information from it as we go on.

謝謝。感謝兩位提出的問題。關於 RA 研究的數據發佈時間，我認為我們還沒有最終決定如何以及何時發布這些數據，但既然我們知道這兩項研究都將在今年進行，我認為發布數據的可能性相當大。我們將等到隨機抽籤期結束後再討論此事。顯然，第一階段是開放標籤的，所以我們會從中獲得一些資訊。

And then I don't think there's much to read into the exclusion from MG and 2028. In fact, there's probably some possibility it actually does, in fact, also launch in 2028. And so I think stay tuned once we get that data once those studies are use we go the exact time under those studies, we'll be able to provide more guidance on specific launch time lines.

而且，我認為 MG 和 2028 年的排除並沒有什麼特別的意義。事實上，它很可能真的會在 2028 年推出。所以我認為，一旦我們獲得這些數據，一旦這些研究被使用，我們就能根據這些研究得出確切的時間，屆時我們將能夠提供更多關於具體上市時間表的指導。

Alex Thompson, Stifel.

Alex Thompson，Stifel。

Hey, great, thanks for taking my question. Maybe one on sort of the competitive landscape in Graves. I guess with Argenx entering the area and maybe trying to follow their strategy of chasing fast follower indications here. Like how confident are you that you can maintain your lead in Graves' if Argenx were to run maybe 26 week studies or even one instead of two studies.

嘿，太好了，謝謝你回答我的問題。或許可以談談格雷夫斯的競爭格局。我猜想 Argenx 進入這個領域，可能是想效仿他們之前追逐快速跟進股的策略。如果 Argenx 進行 26 週的研究，甚至只進行一項研究而不是兩項研究，你有多大信心能夠保持你在 Graves 病領域的領先地位？

Thanks.

謝謝。

Obviously, the extent of our leading -- thank you for the question. The extent of our lead time in Graves will depend a little bit on organic study design and what they decide to do. And until we know what that design is, it's going to be hard to say.

顯然，我們的領先程度——謝謝你的提問。我們在格雷夫斯的準備時間長短，將在一定程度上取決於有機研究的設計以及他們最終的決定。在我們知道設計方案是什麼之前，很難妄下斷言。

Certainly, shorter studies will be faster than longer studies mechanically. I think we have a lead in Graves that will be significant, roughly no matter what design organic runs. We have great relationships with those KOLs that community. We've been out there. One of our studies is also 26 weeks.

當然，從機械角度來看，較短的研究肯定比較長的研究速度更快。我認為無論最終的陣容如何變化，我們在格雷夫斯身上都擁有顯著的領先優勢。我們與該領域的那些KOL建立了良好的關係。我們去過那裡。我們的一項研究也是 26 週。

As a reminder, the [2503 study] is 26 weeks. So look, I think the answer is we will have a significant lead in Graves disease. How significant that we do may depend a little bit on what the competitive competition does. But this is also one of those -- whatever one or the bar situations or whatever. I think mostly our focus is just getting those studies done and out as quickly as we can and getting out to that population, and it's such a large and exciting population that it doesn't really matter.

提醒一下，[2503 研究] 為期 26 週。所以你看，我認為答案是我們在格雷夫茲病方面將擁有顯著優勢。我們能取得多大的成就，可能在某種程度上取決於競爭對手的行動。但這也是其中之一——無論是什麼情況，酒吧裡的那種情況，或者其他什麼情況。我認為我們主要關注的是盡快完成這些研究並公佈結果，讓更多人了解這些研究，而這是一個如此龐大且令人興奮的群體，所以時間早晚其實並不重要。

The other thing I'll say is, as a reminder, we showed pretty conclusively in our Phase 2 data at the deeper IgG suppression that we expect to deliver will matter in this population. And I think especially on remission. And I think that will also be a significant factor in Graves disease. So looking forward to getting all that data together.

我還要提醒大家，我們在 2 期臨床試驗數據中已經非常明確地表明，我們預期能夠實現的更深層的 IgG 抑制對於該族群來說至關重要。我覺得尤其是在緩解期。我認為這對格雷夫茲病也是一個重要因素。非常期待能把所有這些數據整理出來。

Thank you. And this concludes the question-and-answer session. I'd now like to turn the call back over to Matthew Gline for closing remarks.

謝謝。問答環節到此結束。現在我把電話交還給馬修‧格萊恩，請他作總結發言。

Great. Thank you, operator. Thank you, everybody, for the good questions. Thank you all for listening this morning. I want to once again thank everybody involved in all of this, including particularly with the cutaneous sarcoidosis data, the patients and investigators involved in that program.

偉大的。謝謝接線生。謝謝大家提出的好問題。感謝大家今天早上的收聽。我再次感謝參與這一切的所有人，特別是皮膚結節病數據方面的人員、參與該計畫的患者和研究人員。

As well as the private team or our execution there, but also everybody at Roivant, all the patient investigators on all of our studies. And look, we've got a lot more to come this year. So I'm sure we'll be back together soon, and I'm looking forward to continuing the discussion.

除了我們在那裡的私人團隊或執行團隊之外，還有 Roivant 的所有人，以及我們所有研究中的所有患者研究人員。而且，今年我們還有更多精彩內容即將推出。所以我相信我們很快就會再次見面，我期待著繼續討論。

Thank you, everybody, and have a great day.

謝謝大家，祝大家今天過得愉快。

This concludes today's conference. Thank you for your participation. You may now disconnect

今天的會議到此結束。感謝您的參與。您現在可以斷開連線了。