Roivant Sciences Ltd (ROIV) 2025 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Roivant First Quarter 2025 Earnings Call. (Operator Instructions)

您好，感謝您的耐心等待。歡迎參加 Roivant 2025 年第一季財報電話會議。（操作說明）

Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Stephanie Lee. Please go ahead.

請注意，今天的會議正在錄影。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 Roivant's financial results for the first quarter ended June 30, 2025. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant. 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.investor.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along.

早安，感謝各位參加今天的電話會議，共同回顧 Roivant 截至 2025 年 6 月 30 日的第一季財務表現。我是 Roivant 的 Stephanie Lee。今天為大家介紹的是 Roivant 的執行長 Matt Gline。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.investor.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'd 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 have 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。

Now with that, I'll turn it over to Matt.

現在，我將把麥克風交給馬特。

Thank you, Stephanie, and thank you, everybody, for joining this morning. I appreciate it. It is a relatively quiet quarter before it promises to be a very busy fall. So I look forward to sharing some updates and then taking some Q&A. I will start on page 5, just a reminder of sort of where we are for this year.

謝謝斯蒂芬妮，也謝謝大家今天早上的參與。謝謝。這是一個相對平靜的季度，預計秋季將非常繁忙。所以我很期待和大家分享一些最新進展，然後回答一些問題。我將從第 5 頁開始，簡單回顧我們今年的工作進展。

So three main themes for calendar year 2025. The first of those is the continued progress that we're making with IMVT-1402 and Immunovant where we are developing what we hope will be the best-in-class anti-FcRn antibody. We put out data earlier this year in etokimab, our first-generation drug in MG and CIDP. And now it's really a story of that team focused clinical execution getting the grade study enrolled and beginning to progress with other indications that we've announced there.

所以，2025 年曆年有三大主題。首先，我們與 IMVT-1402 和 Immunovant 合作取得了持續進展，我們正在開發我們希望成為同類最佳的抗 FcRn 抗體。今年早些時候，我們公佈了etokimab的數據，這是我們治療重症肌無力和慢性發炎性脫髓鞘性多發性神經病變的第一代藥物。現在，這實際上是一個關於團隊專注於臨床執行，成功招募 GRED 研究受試者，並開始推進我們已經宣布的其他適應症的故事。

The second major theme for the year, which is approximately imminent is the registrational (inaudible) data from brepocitinib, which we hope will set the stage for a commercial launch of that drug in that indication. That pivotal trial is now at last patient last visit completed as of last month. So that data will come as we've guided before in the second half pretty shortly.

今年的第二個主要主題是 brepocitinib 的註冊（聽不清楚）數據，我們希望這將為該藥物在該適應症中的商業化上市奠定基礎。這項關鍵性試驗目前已於上個月完成最後一位患者的最後一次訪視。因此，正如我們之前預告的那樣，這些數據將在下半年很快公佈。

And then finally, the other ongoing major stream that we've been driving attention to is the LNP litigation with Moderna, which is in the latest innings, at least are the first game here as we approach trial and that scheduled for March of 2026 as well as the ongoing pro with Pfizer and biotech, and we'll give a brief update there on this call.

最後，我們一直關注的另一個主要進展是與 Moderna 的 LNP 訴訟，該訴訟目前已進入最新階段，至少這是我們接近審判的第一場比賽，審判定於 2026 年 3 月進行。此外，還有與輝瑞和生技公司正在進行的訴訟，我們將在本次電話會議上簡要介紹最新進展。

On slide 6, just as a reminder, we are really proud of the pipeline that we are operating it today. Obviously, first and foremost, with brepocitinib with that registrational data coming shortly and with multiple indications. Clinical progress I'm going in with a bunch of registration trials, 5 registrational trials for 1402 currently ongoing. And then obviously, also mostly (inaudible) on our hypertension program, the take on the second half of next year and ongoing PD as well.

在第 6 張投影片中，再次提醒大家，我們為今天運作的這條管道感到非常自豪。顯然，首先也是最重要的是，brepocitinib 的註冊數據即將公佈，並且具有多種適應症。臨床進展 我正在進行一系列註冊試驗，目前有 5 項針對 1402 的註冊試驗正在進行中。然後，顯然，主要（聽不清楚）還有我們的高血壓項目，對明年下半年的看法以及正在進行的PD。

On slide 7, I'm not a superstitious person, I'm not going to spend that much time talking about the future beyond the brepocitinib data. But suffice it to say, our next few years ahead are really, really exciting, starting with this flat DM and then with multiple potential registrational data sets and launches first in brepocitinib and then across the SARM portfolio. I feel like a few years from now, we could be on these calls describing a pretty different company with quite a large commercial footprint. So we're looking forward to getting started on that, hopefully shortly.

在第 7 張投影片中，我不是一個迷信的人，我不會花太多時間談論 brepocitinib 數據之外的未來。但總而言之，我們接下來的幾年真的非常令人興奮，首先是這個平坦的DM，然後是多個潛在的註冊資料集和產品發布，首先是brepocitinib，然後是整個SARM產品組合。我覺得幾年後，我們可能會在電話會議上描述一家截然不同、擁有相當大商業版圖的公司。所以，我們期待著盡快開始這項工作。

Finally, on slide 8 a brief update on our share repurchase program. As I think you're all aware, we completed the $1.5 billion authorized share repurchase program from last year as of June of 2025. We repurchased just under 150 million shares at an average price of just over $10 a share. So we reduced our share count by over 15%.

最後，在第 8 張投影片中，簡要介紹了我們的股票回購計畫的最新進展。我想大家都知道，我們已在 2025 年 6 月完成了去年核准的 15 億美元股票回購計畫。我們以平均每股略高於 10 美元的價格回購了近 1.5 億股股票。因此，我們的股票數量減少了15%以上。

In the same period, we have meaningfully expanded our pipeline and so we're excited to have increased our own exposure to our shareholders all your exposure to shareholders to be upcoming catalysts over the next 36 months. As you likely saw, once we completed that program, the Board authorized an additional $500 million repurchase program, which we plan to continue evaluating for opportunistic use, especially as the market remains a little bit up and down.

同期，我們大幅擴展了產品線，因此我們很高興能夠增加我們自身對股東的曝險，所有股東都將在未來 36 個月內獲得即將到來的催化劑。正如您可能已經看到的，在我們完成該計劃後，董事會批准了一項額外的 5 億美元回購計劃，我們計劃繼續評估其機會性用途，尤其是在市場仍然有些波動的情況下。

On slide 9, just a period of real progress across the entire pipeline. We continue to rapidly advance brepocitinib press indications. We'll talk more about RPO in just a moment. But obviously, completed last patient last visit for Valor and DM and are enrolling patients in registrational trials in non-infectious uveitis at a good pace as well as our approved consensus (inaudible) acidosis.

第 9 張投影片展示了整個流程取得真正進展的時期。我們繼續快速推進布雷泊替尼的適應症。我們稍後會詳細討論RPO（招募流程外包）。但顯然，Valor 和 DM 的最後一位患者已經完成了最後一次就診，並且正在以良好的速度招募患者參與非感染性葡萄膜炎的註冊試驗，以及我們批准的共識（聽不清）酸中毒。

We are intensely focused on clinical execution for IMVT-1402, probably most importantly, with enthusiasm around our Grave's disease study with the second registrational trial (inaudible) trial has begun and enrollment is picking up nicely there as well. And then we expect additional data from (inaudible) Phase II trial in Grave's disease with the 6-month remission data that presented at ATA next month, we've initiated now our potential registrational program in (inaudible) disease.

我們正全力以赴地推進 IMVT-1402 的臨床實施，尤其重要的是，我們對格雷夫茲病的研究充滿熱情，第二次註冊試驗（聽不清楚）已經開始，而且招募工作也進展順利。然後，我們期待從格雷夫斯病的 II 期試驗中獲得更多數據，包括下個月在 ATA 上公佈的 6 個月緩解數據，我們現在已經啟動了針對格雷夫斯病的潛在註冊計劃。

And then finally, continued progress on our LNP litigation. We'll talk more about it in just a few slides. So I'm going to take just a very brief moment here to refresh everyone on repo as we sort of stir down the barrel of this upcoming data, starting on slide 11.

最後，我們針對 LNP 的訴訟也取得了持續進展。我們將在幾張投影片中詳細討論這個問題。所以，我將花一點時間，給大家簡單回顧一下倉庫的概念，因為我們將從第 11 張投影片開始，逐步深入探討即將到來的數據。

We're really proud of how brepocitinib reflects the Roivant journey. We feel like we've rapidly expanded it into multiple orphan immologica conditions with -- at this point, in a drug now with a well-established safety profile in over 1,500 patients dosed. As a reminder, we in-licensed this program in the summer of 2021, when -- but with the verdict on JAK inhibitors were still out and there were some questions of what BlackRock was going to be. As that field has evolved favorably, obviously, some of our competitors are now selling literally many, many billions of dollars with the target. We have separately advanced in now 2 pivotal programs, from concept program, and we're super excited about some additional indications that we're still doing some work on.

我們為 brepocitinib 能夠體現 Roivant 的發展歷程而感到非常自豪。我們感覺我們已經迅速將其擴展到多種罕見免疫疾病領域——目前，該藥物已在超過 1500 名接受給藥的患者中建立了良好的安全性。提醒一下，我們在 2021 年夏季引進了該項目，當時——但 JAK 抑制劑的判決尚未出爐，而且貝萊德的未來發展方向也存在一些疑問。隨著該領域的良好發展，顯然，我們的一些競爭對手現在憑藉該目標產品實現了數十億美元的銷售額。我們目前已分別推進了兩個關鍵項目，從概念項目發展到實際應用，並且我們對一些仍在進行研究的其他跡象感到非常興奮。

Brepocitinib on slide 12 with the VALOR study could redefine the standard of care for patients specifically with dermatomyositis. So we talked about this a fair amount in this forum, but DM is a truly debilitating disease with major unmet medical lesions, affected in our analysis, 40,000 about US adults. There's obviously some slightly higher numbers coming out of some of our competitors.

投影片 12 中的 Brepocitinib 與 VALOR 研究一起，可能會重新定義皮肌炎患者的標準治療。所以我們在這個論壇上對此進行了相當多的討論，但DM是一種真正使人衰弱的疾病，存在著重大的未滿足的醫療需求，根據我們的分析，約有40,000名美國成年人受到影響。顯然，我們的一些競爭對手的數據略高一些。

It's a skin and muscle disease that is debilitating to patients' quality of life. They are currently heavily treated with high-dose chronic steroids and other immunosuppressants don't work that well overall. Brepo is the only oral therapy in late-stage development that will be first advanced novel therapy of any modality for patients with DM or from IVIG.

這是一種嚴重影響患者生活品質的皮膚和肌肉疾病。他們目前接受的是大劑量慢性類固醇治療，其他免疫抑制劑整體效果並不理想。Brepo 是目前處於後期研發階段的唯一口服療法，它將成為第一個用於治療糖尿病或靜脈注射免疫球蛋白患者的先進新型療法。

And then the VALOR study is designed to truly establish our profile there, there's good pharmacological rationale for TYK2 and JAK1 inhibition. This is the largest interventional trial in DM ever conducted with a variety of useful endpoints for showing how we benefit quality of life for these patients. And as we announced a call in June, have seen good success with our steroid paper, which should help us ensure a strong differentiation from (inaudible).

然後，VALOR 研究旨在真正確立我們在該領域的地位，TYK2 和 JAK1 抑制具有良好的藥理學原理。這是迄今為止在糖尿病領域開展的最大規模的干預性試驗，它採用了多種有用的終點指標，以展示我們如何改善這些患者的生活品質。正如我們在六月宣布的電話會議一樣，我們的類固醇論文取得了良好的成功，這應該有助於我們確保與同類論文形成鮮明的差異化。（聽不清楚）

The VALOR study on slide 13, there's a schematic test 2 doses of brepocitinib, 30 milligrams and 15 milligrams over a 52-week period with a mandatory steroid taper as I mentioned. It requires both active skin and muscle disease. And the primary endpoint is mean tests for placebo (inaudible) 52.

VALOR 研究在第 13 張投影片上，有一個示意圖，測試了 52 週內 2 劑 brepocitinib（30 毫克和 15 毫克），並如我所提到的強制減少類固醇用量。它需要同時存在活躍的皮膚和肌肉疾病。主要終點是安慰劑的平均檢定（聽不清楚）52。

On slide 14, you can see the baseline characteristics of the study and we put these out again at our brepocitinib specific PM specific call in June, which by the way, if you haven't watched is a really nice team for the Roivant team on the study in the indication. I think we're pretty happy on slide 14 with the baseline characteristics map to the other successful late-stage study run intermediates the proteom study of IVIG and so again, we're looking forward to those results.

在第 14 張投影片中，您可以看到該研究的基線特徵，我們在 6 月針對 brepocitinib 的 PM 特別電話會議上再次發布了這些特徵。順便說一句，如果您還沒有觀看，Roivant 團隊在該適應症研究方面是一個非常優秀的團隊。我認為我們對第 14 張投影片中的基線特徵圖非常滿意，它與其他成功的後期研究運行中間體（即 IVIG 的蛋白質組學研究）相吻合，因此我們再次期待這些結果。

One thing we've been quite focused on slide 15 is the steroid taper here, which, again, is designed to help us manage some of the inherent variability and test as an end point. And again, this is all information we put out in June. But we had good success with 98% of patients achieving the mandatory taper over 40% fully eliminating -- sorry, oral (inaudible) steroids and over 60% assuming greater than 75 percentile versus percent reduction from baseline. So really good progress on getting these patients off steroids, which should give brepocitinib a truly fair shot in the trial.

我們在第 15 張投影片中重點關注的一點是類固醇減量，這再次是為了幫助我們控制一些固有的變異性，並將測試作為終點。再次強調，以上資訊均來自我們六月發布的公告。但我們取得了良好的效果，98% 的患者實現了強制減量，超過 40% 的患者完全停用了——抱歉，口服（聽不清）類固醇，超過 60% 的患者假設減量幅度大於 75 百分位，與基線相比的百分比減少量相比。因此，在幫助這些患者擺脫類固醇方面取得了非常好的進展，這應該能讓布雷波替尼在試驗中獲得真正的公平機會。

On slide 16, since we began our DM program, I'd say DM has been increasingly recognized as a commercial opportunity and as a market with high unmet need.

在第 16 張投影片中，自從我們開始 DM 專案以來，我認為 DM 越來越被認為是一個商業機會和一個具有高度未滿足需求的市場。

Obviously, there's multiple programs ongoing at this point. (inaudible) Pfizer macromolecule we know well with (inaudible) and (inaudible) AstraZeneca. We are the only oral, we are the soonest of those readouts, and there's multiple Phase II programs that have initiated since the beginning of the VALOR study across a variety of mechanisms and companies. Brepo has an overall pretty busy couple of years ahead here.

顯然，目前有多個項目正在進行中。（聽不清楚）輝瑞大分子，我們很熟悉（聽不清楚）和（聽不清楚）阿斯特捷利康。我們是唯一一家進行口服給藥的公司，我們的數據公佈時間最早，而且自 VALOR 研究開始以來，已有多家公司針對各種機制啟動了多個 II 期臨床試驗計畫。布雷波未來幾年將會非常忙碌。

Obviously, starting with STM data coming soon. And then following thereafter a regulatory filing producing the -- we'll then next year, get our proof-of-concept data in cutaneous sarcoidosis as well as first half 2027 top line data in an IU and around the same time, launching then, hopefully. And then following that, regulatory following in the second half of '27 within IU. So quite a lot coming there.

顯然，首先是即將發布的STM數據。然後，我們將提交一份監管文件，明年我們將獲得皮膚結節病的概念驗證數據，以及 2027 年上半年在 IU 的主要數據，並希望屆時能夠推出。然後，在 2027 年下半年，印第安納大學內部出現了監管方面的變化。所以那裡會有不少東西要運過來。

The last deeper dive update I'm going to give on this call, and as I said, a relatively brief call, given the quite quarter here is on the L&P litigation. So on slide 19, as a reminder, we are in a pivotal period for our LNP litigation overall.

我將在本通電話中提供的最後一個深入更新，正如我所說，鑑於本季度的平靜局面，本次通電話相對簡短，是關於 L&P 訴訟的。因此，在第 19 張投影片中，提醒大家，我們正處於 LNP 訴訟的關鍵時期。

In the Moderna cases, we are in a pre-trial process to narrow the scope of claims and defenses with an ongoing what's called summary judgment phase which I'll talk more about in a moment. The US jury trial is currently scheduled for March of 2026. So we're obviously looking forward to that. And we also expect major international hearings in the first half of next year as well. The Pfizer case is ongoing and inactive discovery. The market hearing was held in similar to last year and the ruling could come this year. So looking forward to that progress also.

在 Moderna 案件中，我們正處於審前程序中，以縮小索賠和抗辯的範圍，目前正在進行所謂的簡易判決階段，我稍後會詳細介紹。美國陪審團審判目前定於2026年3月進行。所以，我們當然很期待。我們也預計明年上半年也將舉行重要的國際聽證會。輝瑞案目前仍在審理中，證據開示工作已暫停。市場聽證會的舉行方式與去年類似，裁決可能在今年公佈。我也非常期待這方面的進展。

Probably the biggest update on the case in recent weeks has been on slide 20, the summary judgment motions that were filed in the US Moderna case. As a reminder, at this point, we are asserting 4 patents, 3 related to lipid composition, the 359435 and 378 patents that which lipids make sort of balloon the outside of the LNP inside of which the mRNA is encapsulated and then the 651 patent on mRNA LNP compositions that describes the encapsulation of mRNA moving in LNP.

最近幾週，該案最大的進展可能要數第 20 張幻燈片了，即美國 Moderna 案中提交的簡易判決動議。提醒一下，目前我們正在主張 4 項專利，其中 3 項與脂質組合物有關，分別是 359435 和 378 號專利，該專利涉及脂質如何使包裹 mRNA 的 LNP 外部膨脹，以及 651 號專利，該專利涉及 mRNA LNP 組合物，描述了在 LNP 中移動的 mRNA 的封裝。

We (inaudible) filed three motion summary judgment related to the relitigation of obviousness arguments that were resolved in the IPR process and appeal that that we don't want Moderna to be able to assert certain invalidity arguments related to a prior arc and that the 651 patent is now put on certain specific grounds.

我們（聽不清楚）提交了三份與重新審理顯而易見性論點相關的簡易判決動議，這些論點已在IPR程序中得到解決，並提出上訴，表示我們不希望Moderna能夠主張與先前弧相關的某些無效論點，並且現在651專利是基於某些特定理由被駁回的。

Moderna also filed three motions for summary judgment, probably the most talked about is the motion of $14.98, which is Moderna's attempted to defray liability to the US government under a 1 patent statute. Secondly, claims around our ability to use the doctoral equivalents based on the prosecution history of the patents. And finally, they're asking for a summary judgment on claims of indefiniteness around the 651 patent. So we look forward to all of those issues being resolved this fall in summary judgment.

Moderna 還提交了三份簡易判決動議，其中最受關注的可能是 14.98 美元的動議，這是 Moderna 試圖根據專利法減少對美國政府的責任。其次，我們根據專利的審查歷史，提出了關於我們使用博士學位等同物的能力的說法。最後，他們要求對 651 號專利的不確定性主張作出簡易判決。因此，我們期待所有這些問題都能在今年秋季透過簡易判決得到解決。

Some other developments, the case was assigned to a new judge in the same court with trial scheduled for March 2026 and upcoming opposition motions in the summary judgments are due August 22, and then there'll be a value of replies back and forth in September before those summary judgment new likes are made by the judge.

其他一些進展是，該案已分配給同一法院的一名新法官，審判定於 2026 年 3 月進行，即將提交的簡易判決反對動議將於 8 月 22 日到期，之後在 9 月份將有一段時間的來回答復，然後法官才會做出新的簡易判決。

Finally, before we wrap up and go to Q&A, just a quick financial update. Relatively straightforward quarter on an adjusted basis, net loss of $170 million, cash utilization of about $200 million outside of the share repurchase program and other throughout these onetime events. Our balance sheet remains incredibly strong. We're privileged. We have $4.5 billion of cash as of June 30, no debt and a significantly reduced share count, thanks to share purchase program. So that's where we are from a financial perspective.

最後，在結束會議進入問答環節之前，先簡單報告一下財務狀況。經調整後，本季業績相對簡單，淨虧損 1.7 億美元，除股票回購計畫和其他一次性事件外，現金使用量約為 2 億美元。我們的資產負債表依然非常穩健。我們很幸運。截至6月30日，我們擁有45億美元現金，沒有債務，並且由於股票購買計劃，我們的股票數量大幅減少。這就是我們目前的財務狀況。

Look, hopefully, we'll be able to talk more about the upcoming year two and three in terms of upcoming catalysts once we have the brepocitinib data in hand. And I'm really excited for what that commercial franchise could look like, what that could mean for patients is an opportunity of what everything else coming beyond it can look like, but we'll wait to talk about that. And so we can talk more about what that data looks like once we've seen it.

希望我們拿到 brepocitinib 的數據後，就能多討論第二年和第三年即將到來的催化劑。我非常期待這個商業特許經營計畫的發展前景，它能為患者帶來機遇，也能預示著未來一切的發展方向，但我們暫且不談這個。這樣，我們就可以在看到數據之後，進一步討論這些數據的具體情況了。

So in the meantime, I'll just say thank you again for listening to the prepared portion of this call, and I'm looking forward to take questions. Operator, over to you.

所以，在此期間，我再次感謝大家收聽這次電話會議的準備部分，我期待回答大家的問題。操作員，請接通。

(Operator Instructions)

（操作說明）

Brian Cheng, JPMorgan.

Brian Cheng，摩根大通。

Hey, guys. Thanks for taking our questions this morning. Matt, just on VM. Can you talk about just how much data we could get at the time of your top line, assuming the data is positive, how far are you from filing for approval? And what are some of the remaining gating factors from filings? I have a follow-up. Thank you.

嘿，夥計們。感謝您今天上午回答我們的問題。Matt，就在虛擬機器上。您能否談談在您公佈初步結果時，我們能獲得多少數據？假設數據是正面的，您距離提交審批申請還有多遠？那麼，還有哪些因素會阻礙文件提交呢？我還有一個後續問題。謝謝。

Yes. Perfect. Thank you. Great questions.

是的。完美的。謝謝。問得好。

Look, I think obviously, we haven't seen the data yet, but my expectation is we'll have top line, all the key secondary reason, the major safety data the share approximately contemporaneously with the data. And beyond that, we'll see. But I think all of that obviously gets now analyzed roughly at the same time.

你看，我認為很明顯，我們還沒有看到數據，但我預計我們會獲得初步數據、所有關鍵的次要原因以及主要安全數據，這些數據將與數據大致同時公佈。至於其他方面，我們拭目以待。但我認為所有這些顯然現在都會大致同時進行分析。

Assuming that, I think what we've guided to in terms of filing is maybe the very beginning of next year. And I think there's nothing sort of specific and unusual gating other than all of the normal NDA prep activities, which are significant. Obviously, we've been doing as much of that in parallel as we can and we'll be looking to hit the gas on that as much as we possibly can get that filing as early as we can once we've got the data in hand.

假設情況屬實，我認為我們目前預計的報稅時間可能是明年年初。我認為除了所有正常的 NDA 準備活動（這些活動非常重要）之外，沒有什麼特別的、不尋常的門檻。顯然，我們一直在盡可能地並行這些工作，一旦掌握了數據，我們將盡最大努力加快進度，盡快提交文件。

I got it. And then just on the Grave's trial, the second trial, can you talk about the trial design that we saw posted here in your latest deck. We noticed that there is 300 milligrams that you're testing. What's the rationale of testing a lower dose in that second Grave's trial? Thank you.

我得到了它。然後，關於墓地審判，也就是第二次審判，你能談談我們在你最新牌組中看到的審判設計嗎？我們注意到您正在測試的劑量為 300 毫克。在第二次格雷夫斯試驗中測試較低劑量的理由是什麼？謝謝。

Yes. Thanks. It's a great question. And I appreciate your pointing out actually that we have posted that great trial design.

是的。謝謝。這是一個很好的問題。我很感謝您指出我們已經發布了那個很棒的試驗設計。

The short answer among other things is, as Grave's may be the first trial renewed in the first registration files or neck and neck with some of the others. We wanted to make sure we had a trial that would ensure FDA approval, and they make sure to tell us that we work for them without issue with the lower dose. It's really about ensuring that we can advocate for minimally efficacious dose with FDA in that process. Thank you.

簡而言之，格雷夫的案件可能是第一批登記文件中第一個重新審理的案件，或者與其他一些案件不分伯仲。我們希望確保進行一次能夠獲得 FDA 批准的試驗，而他們也向我們保證，使用較低劑量進行試驗不會有任何問題。關鍵在於確保我們能夠在向 FDA 申請最低有效劑量的過程中做到這一點。謝謝。

Dennis Ding, Jefferies.

丹尼斯丁，傑富瑞集團。

Hi. Good morning. Thanks for taking our questions up.

你好。早安.感謝您回答我們的問題。

I have two on the -- the first question is just around how is a flare defined in the trial and how does the flare get treated on it? And can you give as much color as you can on how patients who require steroid rescue will be treated?

我有兩個問題──第一個問題是，試驗中如何定義病情發作，以及如何治療病情發作？您能否詳細介紹一下需要使用類固醇藥物進行搶救治療的患者將如何接受治療？

And then my second question, you guys mentioned 40% of patients had eliminated steroids. That's a blinded or pool estimate correct? And can you hypothesize on what impact, if any, could an imbalance have on the primary endpoint of TIF between the 2 arms, meaning as more patients are able to eliminate steroids in the brepo arm versus the placebo arm. Could that mask the potential improvements on a placebo-adjusted basis? Thank you.

我的第二個問題是，你們提到 40% 的患者已經停止使用類固醇。這是盲估價還是合計估價？您能否假設一下，如果兩組患者中有更多患者能夠擺脫類固醇，那麼這種不平衡會對 TIF 的主要終點產生什麼影響（如果有的話）？這是否會掩蓋安慰劑調整後的潛在改善？謝謝。

Yes. Thanks, Dennis. These are obviously good questions that get at what we've discussed is obviously a risk in the trial, which is ensuring correct management of placebo patients. We haven't shared all of that detail, and I'm not sure we're going to do it all now. But look, I think, obviously, there's an active protocol for managing these patients as they progress in the trial, it's study.

是的。謝謝你，丹尼斯。這些問題顯然很好，它們觸及了我們討論過的試驗中一個顯而易見的風險，那就是確保對安慰劑患者進行正確的管理。我們還沒有透露所有細節，而且我也不確定我們現在是否會全部透露出來。但是，我認為，很顯然，對於這些在試驗和研究中進展的患者，有一個積極的管理方案。

These patients worsen, they get better and there are sort of allowances for the doctors to treat them as they come and go. There are sort of different definitions for rescue depending on whether the investigator calls it a rescue or whether they're simply treating the patient. And again, I think all of it is designed to make sure that we're really identifying patients who are flaring and worsening versus those who aren't.

這些病人的病情時好時壞，醫生可以根據他們的病情變化靈活治療。對於「救援」一詞，根據調查人員是稱之為「救援」還是僅僅指對患者進行治療，其定義略有不同。而且，我認為所有這些措施都是為了確保我們能夠真正識別出病情正在惡化的患者，而不是那些病情沒有惡化的患者。

In terms of the potential impact of an imbalance, look, I think this is the first DM study ever run with a steroid taper. And a number of previous trials have been successful without a steroid taper. So it's not necessary that steroid taper do anything bluntly in order to have a positive study. Again, you're correct that, that is a blinded pool number and that we've only seen any of this data on a blinded pool basis.

就失衡的潛在影響而言，我認為這是第一個採用類固醇減量方案進行的糖尿病研究。先前的多項試驗在沒有逐漸減少類固醇劑量的情況下也取得了成功。所以，類固醇減量療法並不需要採取任何激進的措施才能獲得正面的研究結果。您說得對，那是一個匿名池號碼，我們之前也只在匿名池的基礎上看到過這些資料。

Obviously, if it turned out that steroid doses were much higher in the placebo on than the drug arm, that could result in better kits for the placebo arm. But as I said, I think all of this is this is call it belt and suspenders to try and maximize the opportunity for the trial. And I think it goes sort of handing of with your first question on rescue therapy. But I think in general, we're managing these patients carefully to try and get the most benefit we can out of the steroid taper. These are great questions. Thank you.

顯然，如果安慰劑組的類固醇劑量比藥物組的劑量高得多，那麼安慰劑組的試劑盒可能會更好。但正如我所說，我認為這一切都是為了最大限度地提高審判機會而採取的雙重保障措施。我認為這和你關於急救療法的第一個問題有點關聯。但我認為總的來說，我們正在謹慎地管理這些患者，以期從類固醇減量治療中獲得最大益處。這些都是很好的問題。謝謝。

Great. Thank you.

偉大的。謝謝。

Corinne Johnson, Goldman Sachs.

科琳·約翰遜，高盛集團。

Morning, guys. Thanks. Maybe could you provide some context around the upcoming grades remission data? What does clinically meaningful outcomes look like there? And how does that fit into the broader clinical strategy in Grave's?

早上好，各位。謝謝。您能否提供一些關於即將公佈的成績減免數據的背景資訊？臨床上有意義的結果具體是什麼樣的？那麼，這如何融入格雷夫茲病的整體臨床策略呢？

And then maybe one on just business development. You obviously have quite the balance sheet at your disposal. So how should we think about kind of the outlook for BD from here and the type size or structure of deals you're most interested in? Thanks.

然後或許可以專門寫一篇關於業務拓展的文章。顯然，你手上擁有相當雄厚的資產負債表。那麼，我們應該如何看待 BD 的未來前景，以及您最感興趣的交易類型、規模或結構呢？謝謝。

Yes. Thanks for both. Both are really good questions.

是的。謝謝你們兩位。這兩個問題都非常好。

On Grave's, look, I think the short answer to that question is Grave's patients and (inaudible) tell us that really any amount of meaningful remission would be practice changing for them. I mean, literally, we have docs telling us if even 10% of these patients were able to go on mission. Remember, these are patients who couldn't adequately be controlled on (inaudible) so remission of these patients is a truly extraordinary outcome.

關於格雷夫氏症，我認為這個問題的簡短答案是格雷夫氏症患者和（聽不清楚）告訴我們，任何有意義的緩解都將改變他們的治療方式。我的意思是，實際上，有醫生告訴我們，即使只有 10% 的患者能夠執行任務。請記住，這些患者在服用（聽不清楚）藥物後病情無法得到充分控制，因此這些患者的病情緩解是一個真正非凡的結果。

These are patients who would have been likely potentially on lifelong ATD therapy. And instead, you're putting them here on a new drug on not only getting them off ATD, but getting them off therapy altogether. So I think any amount of remission would be appealing to docs. So I think that's the answer in terms of the bar.

這些患者很可能需要終身接受抗甲狀腺藥物治療。相反，你們卻讓他們服用一種新藥，不僅是為了讓他們擺脫抗結核藥物，更是為了讓他們徹底停止治療。所以我認為任何程度的緩解對醫生來說都很有吸引力。所以我覺得這就是酒吧方面的答案。

And only, I'm not actually sure how closely the street is following this data, I don't know. I think I say people care about it, it's (inaudible). But I think if you talk to Grave's docs, I think they are very interested in this data, and I think good data here would be helpful for patient enthusiasm, doc enthusiasm enrollment in the trial. So I think it's a pretty important readout for us.

只是，我不太確定市場對這些數據有多重視，我不知道。我覺得人們很關心這件事，這是事實。（聽不清楚）但我認為，如果你和格雷夫的醫生們談談，他們會對這些數據非常感興趣，而且我認為，好的數據將有助於提高病人和醫生參與試驗的動機。所以我認為這對我們來說是一個非常重要的數據。

On the BD question, and thanks for asking it. Look, I think this remains an attractive market for an asset hunter. The market is choppy. There's a lot of uncertainty big pharma companies are obviously going through it in terms of P&L and restructuring and that creates a good opportunity for us. We have been opportunistic. We will continue to be opportunistic and the things we see on our racket are really exciting sort of potentially transformational late-stage opportunities in some cases. And we're looking forward to connecting those rackets to the ball.

關於BD的問題，謝謝你的提問。我認為，對於資產收購者來說，這仍然是一個很有吸引力的市場。市場波動劇烈。大型製藥公司在損益和重組方面顯然面臨著許多不確定性，這為我們創造了一個很好的機會。我們一直都在投機取巧。我們將繼續抓住機會，我們看到的那些機會確實令人興奮，在某些情況下，它們甚至是具有變革意義的後期機會。我們期待著將這些球拍與球連接起來。

Prakhar Agrawal, Cantor.

Prakhar Agrawal，坎托爾。

Hi. Congrats on the quarter and thank you so much for taking my questions.

你好。恭喜你本季取得好成績，非常感謝您回答我的問題。

I had two, first a follow-up on the DM question on the flare up. So when the patient gets a flare up, what's typical steroid dose that these patients get? Is it close to their baseline or something even higher and is the steroid dose on a disease flare of defined in the protocol or is it up to investigator discretion?

我有兩個問題，第一個是針對DM關於病情發作的問題的後續提問。那麼，當患者病情發作時，這些患者通常會接受多大劑量的類固醇治療呢？該劑量接近他們的基線水平還是更高？疾病發作時的類固醇劑量是否在方案中規定，還是由研究者自行決定？

And secondly, a follow-up on BD. We've seen so many assets in autoimmune as well coming out of China, whether it's in licensing by pharma or formation of NewCo. Is the market an interest for your BD strategy? And what's your latest take on the China market as it relates to competition, the quality of assets and the valuation these assets are commanding now? Thank you.

其次，關於BD的後續報道。我們看到，中國在自體免疫領域湧現許多資產，無論是製藥公司授權或成立新公司。該市場是否符合您的業務拓展策略？那麼，您對中國市場的競爭格局、資產品質以及這些資產目前的估值有何最新看法？謝謝。

Yes. Perfect. Those are great questions.

是的。完美的。這些都是很好的問題。

On the DM questions, just to be clear, because the term flare has come up a couple of times on this call. The trial is -- sort of trial design in stackings less about sort of the definition of a flare and more about what constitutes rescue therapy. And I think the answer is the physicians will treat these patients in a variety of ways, depending on the patient's experience and on the practice. And what we are trying to make sure is that we treat rescue therapy consistently across different docks.

關於DM的問題，為了明確起見，因為「flare」這個詞在這次通話中出現了幾次。該試驗－某種程度上是一種疊加式試驗設計，與其說是關於「爆發」的定義，不如說是關於「搶救療法」的構成。我認為答案是，醫生會根據患者的經驗和醫療實踐，以各種方式治療這些患者。我們正在努力確保在不同的碼頭對救援治療採取一致的對待。

So it's not like there's some magic number around which if the patient looks this way they get this much incremental steroid dose. And obviously, there are some patients who get treated at high doses, and there are some patients just get bumped up a little bit. And I think what we're really trying to get at with the definitions is making sure that we're capturing patients who are worsening in getting steroids because they are worsening, and that's what all the definitions are designed to capture.

所以並不是說存在一個神奇的數字，如果病人看起來是這種狀態，他們就會接受這種劑量的類固醇。顯然，有些病人需要接受高劑量治療，而有些病人只需要稍微增加劑量。我認為我們制定這些定義真正想要達到的，是確保我們能夠捕捉到那些病情惡化而接受類固醇治療的患者，因為這些患者的病情確實在惡化，而這正是所有定義旨在捕捉到的情況。

On the BD question, look, we're agnostic hunters, so we look everywhere. We've done a fair amount of looking in China over the last 18 months. I expect we will continue to look there. There are things that are attractive. There are things that we are close to there. It's an interesting market, as you mentioned, in autoimmune and other areas as well.

關於BD問題，你看，我們是不可知論的獵人，所以我們到處尋找。在過去18個月裡，我們在中國進行了相當多的考察。我預計我們會繼續在那裡進行考察。有些東西很有吸引力。有些東西我們離那裡很近。正如您所提到的，這是一個很有趣的市場，在自體免疫疾病和其他領域都是如此。

I think one thing that's super impressive about that market now is the lead among programs has significantly shortened because you get high-quality drugs coming out of China, high-quality drug candidates coming out of China very quickly, at least in certain targets. And so I think we're thinking broadly about mechanisms like the FcRn or JAK1, 2 mechanism where you can do a lot with the mechanism through creative clinical development, and we think that's going to be an important battlefield for the future across big pharma and biotech. Thanks for the question.

我認為現在中國市場最令人印象深刻的一點是，各個項目之間的領先優勢已經大大縮短，因為中國能夠非常迅速地推出高品質的藥物和高品質的候選藥物，至少在某些靶點上是如此。因此，我認為我們正在廣泛地思考像 FcRn 或 JAK1、2 機制這樣的機制，透過創造性的臨床開發，你可以利用這些機製做很多事情，我們認為這將是未來大型製藥公司和生物技術公司之間一個重要的戰場。謝謝你的提問。

Sam Slutsky, LifeSci Capital.

Sam Slutsky，LifeSci Capital。

Hey. Good morning, everyone. Thanks for the questions. Just two for me.

嘿。各位早安。謝謝大家的提問。我只有兩個。

I guess on Brepo and DM, since physicians you're overall comfortable with the efficacy of JAK inhibitors and the disease, do you get the sense from doctors that the borrowers just hit that year so that they have it at their disposal to use on label or is there a specific bar on what they would consider when on the primary end point?

我想，關於 Brepo 和 DM，既然醫生們對 JAK 抑制劑治療該疾病的療效總體上比較滿意，那麼您是否從醫生那裡感覺到，借款人只是到了那一年，所以他們就可以按照標籤說明使用該藥物，還是說在主要終點方面，他們會考慮一些特定的限制？

And then second question is for batoclimab in TED. How might you leverage that data is positive, whether it's to help the positioning of FcRns in Graves disease or would you even consider a future program in TED with1402? Thanks.

第二個問題是關於 TED 中的 batoclimab。如果這些數據是正面的，您會如何利用它們，無論是幫助確定 FcRns 在格雷夫茲病中的定位，還是您會考慮未來與 1402 合作在 TED 上開展一個專案？謝謝。

Thanks, Sam. I appreciate both questions.

謝謝，山姆。感謝兩位提出的問題。

Look, on the -- and we said this before, but it's a great reminder. We think and we think docs think that a simple statistic trial on tests is the bar for efficacy. And part of that boldly is, as you said, docs are generally pretty exposed to the mechanism. But I think part of it also is the test is an artifact of clinical trials as an endpoint.

聽著，關於──我們之前說過，但這是一個很好的提醒。我們認為，醫生也認為，對檢測進行簡單的統計試驗是衡量療效的標準。而其中一部分原因，正如你所說，是醫生通常很容易接觸到這種機制。但我認為部分原因也是因為測驗本身就是臨床試驗的產物，它被當作了終點指標。

And so I think doctors just focused on good options for these patients that overall improve the way the patients feel and their quality of life. And I think we've got, frankly, a variety of endpoints in the study that will underscore that. So I think the answer is the bar is pretty clearly a statin trial and not any specific number.

所以我認為醫生們只是專注於為這些患者提供良好的治療方案，從而全面改善患者的感受和生活品質。坦白說，我認為這項研究中有很多終點指標可以佐證這一點。所以我認為答案很明顯，這個指標代表的是他汀類藥物試驗的結果，而不是任何特定的數值。

Look, for [Batoc] and TED, obviously, we will learn a lot in that TED study that informs our Graves' disease development. There will be patients in the study that upgrades patients so we'll learn a lot that informs Grave's. As far as TED itself is concerned, we're going to be informed by the data as we see it, and we'll make decisions on together with our partner and all once we have that data at hand. Thank you.

顯然，對於巴托克和TED來說，我們將從TED研究中學到很多東西，這將為我們的格雷夫茲病發展提供資訊。這項研究將納入病情升級的患者，因此我們將了解許多關於格雷夫茲病的資訊。就 TED 本身而言，我們將根據我們所看到的數據做出決定，一旦掌握了這些數據，我們將與我們的合作夥伴一起做出決定。謝謝。

Douglas Tsao, H.C. Wainwright.

道格拉斯·曹，H.C. 溫賴特。

Hey. Good morning. Thanks for taking the questions. Just Matt, on the DM study, I'm just curious in terms of the steroid paper, what's the goal for patients to get off steroids?

嘿。早安.謝謝您回答問題。Matt，關於DM研究，我只是好奇關於類固醇論文的部分，病人停止使用類固醇的目標是什麼？

Sorry. Yes. So the question is on sorry -- taper, what's the goal for patients to get off steroids -- in terms of timing how the (multiple speakers) yes, the patient begins at week 12. The taper begins at week 12 and the mandatory taper concludes at week 36. So 98% of patients actually were -- were below 5 at week 36. Obviously, once you start tapering at week 12, the goal in general is to get these patients as low as possible by week 36. So that's the sort of goal. And again, the point here is to make sure that the drug has its time to do its thing.

對不起。是的。所以問題在於——抱歉——減量，患者停止使用類固醇的目標是什麼——就時間安排而言（多位發言者）是的，患者從第 12 週開始。減量期從第 12 週開始，強制減量期在第 36 週結束。所以，98% 的患者在第 36 週時實際上低於 5。顯然，一旦從第 12 週開始逐漸減量，總體目標是到第 36 週將這些患者的劑量降至盡可能低的水平。這就是我們的目標。再次強調，關鍵在於確保藥物有足夠的時間發揮作用。

And I'm just curious, a lot of the data for brepocitinib has been -- or positive data with the 30-milligram dose, which is obviously included. Just curious if you have -- what your expectations are at the 15-milligram dose.

我只是好奇，關於 brepocitinib 的許多數據都是——或者說是 30 毫克劑量下的積極數據，這顯然也包括在內。我只是好奇，如果你服用過 15 毫克劑量，你有什麼預期效果？

Yes. So on the one hand, thanks to your question. 15 has been an active dose of brepocitinib in other programs and other indications. On the other hand, and we've said before, I think the main reason for the inclusion of 15 here was regulatory in nature. And I don't think we're particularly focused on what 15 looks like, and I think it's not sort of 100% obvious, whether it's we expect to hit on 15 or not. The primary is on 30, and I think we're really focused on generating the best possible data that we can at the 30-milligram dose.

是的。一方面，感謝您的提問。 15 毫克一直是其他項目和其他適應症中布雷泊替尼的有效劑量。另一方面，正如我們之前所說，我認為這裡納入 15 的主要原因是出於監管方面的考慮。而且我認為我們並沒有特別關注第 15 個目標會是什麼樣子，而且我認為我們是否期望達到第 15 個目標也不是 100% 顯而易見的。主要劑量是 30 毫克，我認為我們真正關注的是在 30 毫克劑量下獲得盡可能最好的數據。

Okay, great. Thank you so much.

好的，太好了。太感謝了。

Yatin Suneja, Guggenheim.

Yatin Suneja，古根漢美術館。

Hey, guys. Thank you for taking my question. Two for me.

嘿，夥計們。感謝您回答我的問題。我兩個。

One 1401, I mean, all these registration studies that you're running, would you please give us an update on how the enrollment is shaping up for all these studies, whether it's the CIDP myosin gravis over the Grave's? And also, if you can comment on the spend rate, particularly as it relates to the end piece. I saw a little bit of a bump up in R&D. Just curious how it's going to shape up for both R&D and G&A as we go into later this year and next year. Thank you.

1401，我的意思是，你們正在進行的所有這些註冊研究，能否請您向我們介紹一下所有這些研究的入組情況，無論是 CIDP 肌球蛋白重症還是 Graves 病？另外，如果您能就支出率發表意見，特別是與最終產品相關的支出率。我看到研發投入略有成長。我只是好奇，隨著今年下半年和明年的到來，研發和一般及行政費用將會如何改變。謝謝。

Yes. Thanks. Great question. I assume you mean 1402 for the enrollment. But obviously, the 1401 trials are all rolled at this point.

是的。謝謝。問得好。我猜您指的是入學人數 1402 人。但很顯然，1401項審判到此為止全部結束了。

For 1402, look, I think we feel good about enrollment across all of the trials. Obviously, Eric has now been on the ground since April. I think that team is really humming. Obviously, there's a lot of enthusiasm across most of these indications for FcRn. And I think we see that in the site activation and the speed of enrollment. So I think we feel good. We're on track to hit all of our publicly stated timelines. So we're feeling good about it normal altogether.

對於 1402 號試驗，我認為我們對所有試驗的入組情況都感到滿意。顯然，埃里克從四月起就一直在當地。我覺得那隊狀態非常好。顯然，在大多數適應症中，人們對 FcRn 都表現出了極大的熱情。我認為我們可以從網站啟動率和註冊速度看出這一點。所以我覺得我們感覺不錯。我們正按計劃推進，預計將實現所有已公開宣布的時間表。所以，我們感覺一切都很正常。

On spend, our guidance remains that we're comfortably set up here to hit Grave's data on the current balance sheet. Obviously, we will see an uptick in our new here because we now have so many ongoing registrational studies for 1402 but feeling good. Spend should be pretty stable, a little bit of an adverse working capital this quarter and some one-time [SPC]-related stuff that obviously doesn't get to firms. So overall, feeling good about those timelines and about our cash guidance.

在支出方面，我們仍然認為，根據目前的資產負債表，我們完全有能力達到格雷夫的數據。顯然，我們的新產品數量將會上升，因為我們現在有很多針對 1402 的註冊研究正在進行中，但感覺很好。支出應該相當穩定，本季營運資本略有不利，還有一些與[SPC]相關的一次性事項，顯然不會影響到公司。總的來說，我對這些時間表和我們的現金流預期感到滿意。

Thank you.

謝謝。

Yasmeen Rahimi, Piper Sandler.

亞斯敏·拉希米，派珀·桑德勒。

This is Dominic on for Yasmeen Rahimi. Congrats on a great quarter and thank you for taking our question.

這是Dominic代替Yasmeen Rahimi發言。恭喜你們本季業績出色，感謝你們回答我們的問題。

So we just had a question on 1402. We are excited to see the additional data and six-month remission data from the Grave's disease program will be presented at ATA in September. So what do you hope to report at ATA? And could you walk us through how, I guess, you're thinking more about the importance of this? I know you talked a little bit about the documentations perspective? Thank you.

我們剛剛收到一個關於 1402 的問題。我們很高興看到格雷夫茲病計畫的補充數據和六個月緩解數據將在 9 月的 ATA 會議上公佈。那麼，你希望在ATA大會上報告哪些內容呢？能否請您詳細解釋一下，您是如何看待這件事的重要性的？我知道你之前稍微談到了文檔方面的問題？謝謝。

Yes. Thanks. Great question. We are also looking forward to that data for sure.

是的。謝謝。問得好。我們當然也很期待這些數據。

I think, look, what we're hoping to report, we got it a little bit with the question of what the quote unquote bar is earlier, is to highlight that this is a really paradigm shifting opportunity for Grave's patients that this will help and those who treat these patients realize that this is not an incremental tool, but it's transformative and that can get patients who are currently going to be on lifelong medicine to remission which something is possible for milder patients with ATPs, but has never really been possible for these more severe recalcitrant patients. And this is an ability then to avoid surgeries to avoid radioactive in to treat these patients timely.

我認為，我們希望報告的內容，正如我們之前在討論「標準」問題時所了解到的，是要強調這對格雷夫斯病患者來說是一個真正具有範式轉變意義的機會，它將幫助那些治療這些患者的醫生意識到，這不是一個漸進的工具，而是一個變革性的工具，它可以使目前需要終身服藥的患者達到更頑固的患者達到更頑固的患者可能，這對於患者來說是更嚴重的患者達到可能更頑固的患者達到更頑固的患者。這樣一來，就可以避免手術，避免放射性物質的傷害，以便及時治療這些病人。

So my hope is that any amount of remission showed is just patients who get like have their lives really changed. And I think even small levels of permission will be super meaningful of the docs in that context. So I think that's really the goal. And I think the importance there -- look, it's threefold at some level. It gets to the commercial opportunity and how enthusiastic we expect docs and patients will be when FcRns are hopefully approved engraves disease.

所以我希望，任何程度的緩解都只是代表患者的生活發生了真正的改變。我認為，在這種背景下，即使是很小的權限級別，這些文件也會非常有意義。所以我認為這才是真正的目標。我認為其中的重要性──你看，在某種程度上是三重的。這涉及商業機會，以及我們期望當 FcRns 獲得批准時，醫生和患者會有多麼熱情，這加劇了疾病的嚴重性。

It gets to the enrollment of the study that is. It gets to how exciting patients are to get in the trial, how excited docs are to be pushing, and I think that will be helpful as well. And then it just gets to the clinical profile of the drug. It gets to what we're able to do versus other classes versus other mechanisms versus the current standard of care in a way that I think as far as the gold here is always to drive benefit for patients, it gives us an opportunity to point to what we're doing there. So we're really looking forward to that as a meaningful stat. Thank you.

問題就出在研究的招募環節。這取決於患者對參與試驗的熱情，醫生們對推動試驗的熱情，我認為這也會有所幫助。然後就到了藥物的臨床概況部分。它涉及到我們能夠做到的事情，與其他類別、其他機制以及當前的標準治療相比，我認為，就其本質而言，始終是為患者帶來益處，這給了我們一個機會來指出我們在這方面所做的工作。所以，我們非常期待這項數據能成為一項有意義的統計數據。謝謝。

David Risinger, Leerink Partners.

David Risinger，Leerink Partners。

Yes. Thanks very much. Sorry about the background noise. Congrats on all the progress. My questions have been asked. So I'm curious just about Brepo and IU. If you could give us a road map for the pivotal development and the potential filing year. Thanks very much.

是的。非常感謝。抱歉，背景噪音有點大。祝賀你們取得的所有進展。我的問題已經問完了。所以，我對 Brepo 和 IU 這兩件事很感興趣。如果您能為我們提供一份關鍵發展階段和潛在申報年份的路線圖。非常感謝。

Perfect. Thanks. We are super excited about Brepo and IU. It's obviously an indication where we developed our help, we generate our own Phase II data last year, and it was quite good data that we were very proud of. So the enrollment of that trial is going extremely well.

完美的。謝謝。我們對 Brepo 和 IU 感到非常興奮。這顯然表明了我們在哪裡發展了我們的幫助，我們去年產生了自己的 II 期數據，而且這些數據相當不錯，我們為此感到非常自豪。所以，該試驗的招募工作進展得非常順利。

Our guidance remains data first half of 2027. We're certainly on track to hit those timelines, and we're hoping we can file a relatively shortly after we get that data, and this would be an SNDA. So it's a shorter review timeline than the original NDA. So we are really looking forward to that.

我們的預測數據仍為2027年上半年。我們肯定能夠按時完成這些目標，我們希望在獲得數據後不久就能提交一份補充保密協議 (SNDA)。因此，審查時間比原保密協議短。我們對此非常期待。

And I think the hope there, again, in the first half of 2017, we would be getting data in IU right around the time that we were launching in DM and so we get to kind of stack those indications in a way that should be additive overall and give us an opportunity to get our feed set and DM and then relatively quickly to pivot into or add the NIU patient population, a doc population.

而且我認為，我們希望在 2017 年上半年，在印第安納大學 (IU) 獲得數據，正好與我們在糖尿病管理 (DM) 領域推出產品的時間相吻合，這樣我們就可以以一種整體上具有疊加效應的方式將這些適應症疊加起來，讓我們有機會建立我們的糖尿病管理 (DM) 數據，然後相對快速地轉向伊利諾伊州或北伊利諾大學醫生群體 (NIU) 患者群體和北伊利諾伊大學 (NIU) 患者群體。

And one of the nice things about both of these commercial opportunities is they're quite tractable. The patients are treated to concentrate set of sites. We have a pretty good sense of who we need to talk to from that perspective. So we feel really good about both of those commercial opportunities.

這兩個商業機會的優點之一是它們都比較容易操作。患者接受治療的重點在於特定部位。從這個角度來看，我們已經很清楚需要和誰談談了。所以我們對這兩個商業機會都感到非常樂觀。

Thanks, Dave. I really appreciate the question.

謝謝你，戴夫。非常感謝你的提問。

Thank you.

謝謝。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Hi. Good morning, guys. This is (inaudible) on for Yaron. Quick question on (inaudible) in the prior data with JAK1. They've shown really impressive efficacy in the exploratory open-label studies, so how informative is that prior data for brepocitinib? Thank you.

你好。各位早安。這是（聽不清楚）給亞倫的。關於先前數據中 JAK1 的（聽不清楚）問題，請快速提問。他們在探索性開放標籤研究中展現了令人印象深刻的療效，那麼先前的數據對 brepocitinib 的參考價值有多大呢？謝謝。

Thank you. Appreciate the question. Obviously, we hope the answer to that question is if it is highly informative.

謝謝。感謝您的提問。顯然，我們希望這個問題的答案是它是否具有很高的資訊量。

Look, I think you can learn a certain amount from open-label studies. And the fact that they're so consistent at this point is comforting. The fact there's a bunch of case reports as well. The fact that -- and this is a question we used to get more, but the number of case reports and the number of studies showing benefit on both muscle and skin has been significant. So I think that's all comforting.

我認為，從開放標籤研究中可以學到一些東西。他們在這一點上表現得如此一致，這令人感到欣慰。此外，還有大量的病例報告。事實是——我們以前經常收到這個問題——病例報告的數量和顯示肌肉和皮膚均有益處的研究數量非常顯著。所以我覺得這些都讓人感到欣慰。

Next, these are not placebo-controlled studies. There's a lot of variability in tests. And so ultimately, I will bite my nails and new sleep until I see the placebo-controlled data just the same. We obviously also hope to see benefit sort of from both JAK1 and TIK2. And so hopefully, that gives us some additional edge even relative to those studies.

其次，這些研究並非安慰劑對照研究。測試結果存在很大的差異。所以最終，我會焦急地等待，徹夜難眠，直到看到安慰劑對照數據為止。我們當然也希望JAK1和TIK2都能帶來一些好處。因此，希望這能讓我們相對於那些研究獲得一些額外的優勢。

But again, comfort among docs and great open-label data from present studies is not faced to get a drug approved. So until we see the Phase III data, we'll be nervous, and you could all be nervous with us. Thank you.

但是，即便醫生們感到放心，並且現有研究也提供了大量開放標籤數據，但這並不意味著一種藥物就能獲得批准。所以在看到 III 期數據之前，我們會感到緊張，你們可能也會和我們一樣緊張。謝謝。

Thank you.

謝謝。

Emma Gutstein, Wolfe Research.

艾瑪·古斯坦，沃爾夫研究公司。

Hi, this is Emma for Andy. Thanks for taking our question. Two questions from us.

你好，我是艾瑪，我是安迪的。感謝您回答我們的問題。我們有兩個問題。

Just looking at slide 16 and numerous companies are targeting DM. Can you elaborate on your approach for navigating this highly competitive market? And also in the press release, you mentioned preparations for potential launch in DM. Are there specific preparations or key milestones you're planning for in the next 6 to 12 months? Thank you.

光是看第 16 張投影片，就會發現許多公司都將目標瞄準了直接行銷。您能否詳細說明一下您如何應對這個競爭激烈的市場？另外，在新聞稿中，您也提到了為可能在DM上線所做的準備工作。在接下來的 6 到 12 個月裡，您是否有具體的準備工作或關鍵里程碑計畫？謝謝。

Yes. Thank you. I appreciate the question.

是的。謝謝。感謝您的提問。

One thing I'll say is in a highly competitive commercial market, but I can't say this everywhere in our portfolio, but I can say it here, our view is that it helps to be first. And so I think the fact that we're in the lead of this pack is helpful.

我想說的是，在競爭激烈的商業市場中（雖然我不能對我們投資組合中的所有產品都這麼說，但我可以在這裡這麼說），我們的觀點是，搶佔先機總是有幫助的。所以我認為我們處於領先地位是件好事。

Obviously, we have -- look, I think JAK inhibitors to your point, have shown impressive efficacy in other settings. I think he poked to have good strong clinical benefit for these patients. I think that's obviously a part of the strategy, although given the high level of comfort these stocks have, I think there will be a benefit of -- we're obviously an oral therapy, which is different from all of these other mechanisms.

顯然，正如你所說，JAK抑制劑在其他情況下已經顯示出了令人印象深刻的療效。我認為他採取的措施對這些患者來說具有良好的臨床療效。我認為這顯然是策略的一部分，儘管考慮到這些股票所受到的高度信任，我認為這將帶來好處——我們顯然是一種口服療法，這與其他所有機制都不同。

Remember, these patients are often managed. If they're not on IVIg, they are managed on oral steroids. And so there used to taking regular on medication. So I think we should have a great profile in addition to being first. Obviously, given comfort with the class, given thousands of patients do for that molecule, we think we should be well set up with the stock community.

請記住，這些患者通常是可以治療的。如果不進行靜脈注射免疫球蛋白治療，則使用口服類固醇進行治療。所以他們以前習慣定期服用藥物。所以我認為，除了排名第一之外，我們還應該擁有出色的形象。顯然，考慮到我們對這類藥物的熟悉程度，以及成千上萬的患者對該分子的依賴，我們認為我們應該能夠很好地融入股票市場。

In terms of preps for launch, look, there's only so much you can do before you have the Phase III data in hand, but there's a lot of -- there's a lot of, at this point, a road map to follow from other highly successful commercial launches by biotech companies that we've got to watch. I think one of the things that clearly matters is great engagement with the physician community and the Riovant team has been out engaging in the context of the trial and otherwise with the physician community super actively.

就上市準備而言，你看，在拿到 III 期數據之前，你能做的事情非常有限，但是目前有很多——有很多可以藉鑑的路線圖，來自其他生物技術公司非常成功的商業上市，我們必須密切關注。我認為，其中一件非常重要的事情是與醫生群體進行良好的互動，而 Riovant 團隊一直在試驗過程中以及其他方面積極與醫生群體互動。

And I think we have a reputation with that community that I'm very proud of, and I think has been hard one, both in terms of the sort of expectation around what the drug can do and in the quality of the team that we have in private. So I think those docs are super important. I think we will continue to engage with them. And once we have the data, we'll be able to do a bit more. Thank you.

我認為我們在這個群體中建立了良好的聲譽，我為此感到非常自豪。我認為這很不容易，無論是在人們對這種藥物的期望方面，還是在我們私下擁有的團隊的素質方面。所以我認為這些文件非常重要。我認為我們會繼續與他們保持溝通。一旦我們掌握了數據，我們就能做更多的事情了。謝謝。

Thank you. This concludes the Q&A session. I would now like to hand the call back over to Matt Gline for closing remarks.

謝謝。問答環節到此結束。現在我謹將電話交還給馬特·格林，請他作總結發言。

This concludes the Q&A session. I would now like to hand the call back over to Matt G for closing remarks.

問答環節到此結束。現在我謹將電話交還給 Matt G，請他作總結發言。

Yes. Thank you again, everybody, for listening this morning. Again, a relatively quiet quarter, but a really exciting few months ahead for the business. So looking forward to getting back on the phone and talking about a number of updates as they come. I hope to speak again soon.

是的。再次感謝大家今天早上的收聽。本季度相對平靜，但未來幾個月對公司來說將非常令人興奮。期待盡快恢復通話，並與大家討論後續的各項更新。我希望很快能再次發言。

I want to say thank you again to obviously, the Roivant and (inaudible) teams (inaudible), et cetera, who are working hard to get these studies enrolled in working hard to generate clinical data. I want to thank, obviously, our shareholders, and I want to thank all the investigators and patients who trust us with their care, and we're looking forward to sharing some of that patient data as soon as we get it. So thank you, everybody, and have a great Monday.

我再次要感謝 Roivant 和（聽不清楚）團隊（聽不清楚）等等，他們正在努力招募這些研究參與者，努力產生臨床數據。當然，我要感謝我們的股東，也要感謝所有信任我們並把他們的健康託付給我們的研究人員和患者，我們期待著盡快與大家分享一些患者數據。謝謝大家，祝大家週一愉快。

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

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線了。