Roivant Sciences Ltd (ROIV) 2025 Q2 法說會逐字稿

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

您好，感謝您的耐心等待。歡迎參加 Roivant 2025 年第二季財報電話會議（操作員說明）請注意，今天的會議正在錄音。

I will now hand the conference over to your first speaker Stefanie Lee, you may begin.

現在我將把會議交給第一位發言人史蒂芬妮李，你可以開始了。

Good morning, and thanks for joining today's call to review Roivant's financial results for the second quarter ended September 30, 2025.

早安，感謝各位參加今天的電話會議，共同回顧 Roivant 截至 2025 年 9 月 30 日的第二季財務表現。

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 investor.roivant.com. We'll also be providing the current slide numbers that we present to help you follow along. 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 filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties.

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與會者，您可以在我們的投資者關係網站 investor.roivant.com 上找到今天展示的幻燈片以及發布這些更新的新聞稿。我們也會提供目前投影片的編號，以協助您跟進會議內容。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。

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

接下來，我將把麥克風交給馬特。

Thank you, Steph, and good morning, everybody, and thank you for listening. I appreciate all your dialing in.

謝謝你，Steph，大家早安，謝謝收聽。感謝各位撥入。

So not at all a quiet quarter for us and that we put out both the Graves' data and obviously, the Phase III data for brepocitinib in DM. So just a tremendous moment of transformation for the business, but a relatively quiet earnings call as we're looking forward to getting everybody together in December for a more fulsome telling of where we are as a business, more about the future on our Investor Day on December 11. That registration link is live on our website. So look forward to seeing you all there. Today will be more of a review of what's happened in the recent quarter, and then we'll talk much more about the future when we get together in December. So looking forward to that.

所以對我們來說，這絕對不是一個平靜的季度，我們公佈了格雷夫茲病的數據，顯然還有布雷波替尼治療糖尿病的 III 期數據。因此，對於公司而言，這是一個巨大的轉型時刻，但此次財報電話會議相對平靜，因為我們期待在 12 月與大家齊聚一堂，更全面地向大家介紹我們公司的現狀，並在 12 月 11 日的投資者日上更多地談談未來。註冊連結已在我們的網站上生效。期待在那裡見到大家。今天我們主要回顧一下最近一個季度發生的事情，然後等到12月我們再次聚首時，我們會更多地討論未來。非常期待。

I want to start out on slide 5, just by taking a short victory lap because it's been a pretty wild year for us. Obviously, starting with and probably most notably the VALOR data for brepxitinib in DM, which hit on all 10 ranked endpoints and just a phenomenal data set that we think is going to transform the lives of DM patients. So that NDA filing remains on track planned for the first half of next year, and it will be the first novel oral therapeutic in DM, if approved.

我想從第 5 張投影片開始，簡單地慶祝一下，因為對我們來說，這是非常瘋狂的一年。顯然，首先也是最值得關注的是 VALOR 研究中 brepxitinib 在糖尿病中的應用數據，該研究達到了所有 10 個排名終點，這是一個非常出色的數據集，我們認為它將改變糖尿病患者的生活。因此，NDA 申請仍按計劃於明年上半年提交，如果獲得批准，它將成為 DM 的首個新型口服療法。

We also put out data in this quarter from the durable remission sort of portion of the Graves' disease trial for batoclimab, which sets us up for the future there in our 1402 Graves' program. That demonstrated disease-modifying potential for 1402. And then we think earlier this year, we put out some data in MG and CIDP that we can do a pretty nice job of validating the deeper is better idea for FcRn, from an Ig expression perspective.

本季我們也公佈了 batoclimab 治療 Graves 病的持久緩解部分試驗數據，這為我們未來的 1402 Graves 計畫奠定了基礎。這證明了 1402 具有疾病改善潛力。然後我們認為，今年早些時候，我們在 MG 和 CIDP 中發布了一些數據，從 Ig 表達的角度來看，我們可以很好地驗證 FcRn 越深越好的想法。

We also have initiated at Immunovant this year potentially registrational trials in Graves', myasthenia gravis, CIDP, [difficult-to-treat] RA and Sjogren's as well as a POC trial in CLE. So some really exciting progress there with IMVT-1402, which we hope will take us to a first-in-class in many cases and best-in-class, and we hope all -- in all indications potential.

今年，Immunovant 也啟動了針對 Graves 病、重症肌無力、CIDP、難治性 RA 和 Sjogren 病的潛在註冊試驗，以及針對 CLE 的 POC 試驗。因此，IMVT-1402 取得了一些非常令人興奮的進展，我們希望它能在很多方面使我們成為同類首創，甚至成為同類最佳，而且我們希望它在所有方面都展現出潛力。

We got a favorable Markman ruling this quarter for Genevant in the Pfizer case and just overall continued progress in the LNP litigation, with the jury trial and the Moderna case scheduled for March of 2026. And our capital position remains very strong with $4.4 billion of cash, cash equivalents, which will get our current pipeline to profitability and support pipeline expansion and potential additional capital return, including the $500 million that we have currently authorized.

本季度，Genevant 在輝瑞案中獲得了有利的 Markman 裁決，LNP 訴訟也取得了持續進展，陪審團審判和 Moderna 案定於 2026 年 3 月進行。我們的資本狀況仍然非常強勁，擁有 44 億美元的現金及現金等價物，這將使我們目前的項目實現盈利，並支持項目擴張和潛在的額外資本回報，包括我們目前已批准的 5 億美元。

On slide 6, and we've been showing this slide for a while, but it feels realer and realer with each passing quarter, just a late-stage pipeline that we are really excited about with 11 potentially registrational trials and indications with blockbuster potential. Obviously, the first of those dermatomyositis now behind us, but many more to come, setting us up for a slide that we've been showing since June on slide 7, which is just a stack 36 months ahead of us between multiple registrational data sets, first DM and NIU and brepo. And then the beginnings of a long list of them in 1402, lining up for a series of launches, again, first DM and brepo and then NIU and brepo and then very shortly thereafter, 1402 across multiple blockbuster indications, including Graves'.

在第 6 張投影片上，我們已經展示了這張投影片一段時間了，但隨著每個季度的過去，它感覺越來越真實，這是一個後期研發管線，我們對此感到非常興奮，它有 11 個潛在的註冊試驗和適應症，具有重磅炸彈般的潛力。顯然，第一例皮肌炎病例已經過去，但還有更多病例即將出現，這讓我們得以展示自 6 月以來在第 7 張幻燈片上展示的內容，這只是多個註冊數據集之間 36 個月的堆疊，包括第一例 DM 和 NIU 以及 brepo。然後，1402 開始了一系列藥物的研發，準備推出一系列新藥，首先是 DM 和 brepo，然後是 NIU 和 brepo，不久之後，1402 又推出了多種重磅適應症，包括格雷夫斯病。

So look, as I said, a moment of real change and transformation for the business. I think we recognize that. We're excited to talk more about it when we get together in December. It's something that the team internally is excited about. It's excitement that I hear from investigators, certainly and patients and docs in the DM landscape and from investors as well. So looking forward to the next leg of our journey here.

所以，正如我所說，這是企業真正改變和轉型的時刻。我想我們都意識到了這一點。我們很期待在十二月聚會時詳細討論這件事。這是團隊內部對此感到興奮的事情。我從研究人員、患者、糖尿病管理領域的醫生以及投資者那裡都聽到了這種興奮。非常期待我們接下來的旅程。

I'm going to do just a brief recap of the two major data sets from the quarter. So I won't spend a ton of time on either of these because we've talked about all of them in this setting before, but they bear rementioning just because of how exciting both of them are. Starting with the brepocitinib VALOR data on page 9. Again, we've gone through this all before. But VALOR succeeded with really highly significant, robust and consistent data across the primary and all key secondary endpoints with a nice clear dose response that sets us up for 30 milligrams to be the optimal dose here.

我將簡要回顧本季的兩大主要數據集。所以，我不會在這兩者上花太多時間，因為我們之前在這個場合已經討論過所有這些問題了，但它們都值得再次提及，因為它們都非常令人興奮。從第 9 頁的 brepocitinib VALOR 資料開始。我們之前已經經歷過這一切了。但 VALOR 試驗取得了成功，在主要終點和所有關鍵次要終點方面都獲得了非常顯著、穩健和一致的數據，並且劑量反應清晰明確，這表明 30 毫克是最佳劑量。

Responses were rapid, deep, broad, clinically meaningful across the board, a statistically meaningful and clinically important delta to placebo on mean TIS with deep responses occurring quickly and across a range of endpoints, including muscle and skin.

反應迅速、深入、廣泛，在各個方面都具有臨床意義，與安慰劑相比，平均 TIS 值有統計學意義和臨床意義的顯著差異，深度反應迅速發生，並涵蓋包括肌肉和皮膚在內的一系列終點。

And as a reminder, on slide 10, this is a patient population with very significant unmet need, and this is a story that has been underscored over and over again as our team has been out talking to physicians in the field after this data. This is a patient population that is significantly underserved by therapeutic options. 75% of these patients are on only either steroids or ISTs and are struggling to get well controlled. And many of them are requiring high doses of oral prednisone in order to be sort of be treated appropriately and are all looking for options or many of them are looking for options.

再次提醒大家，第 10 張投影片顯示，這是一個存在非常重大未滿足需求的患者群體，而我們的團隊在獲得這些數據後與第一線醫生交談時，也反覆強調了這一點。這部分患者族群在治療選擇方面嚴重不足。其中75%的患者僅接受類固醇或免疫抑制劑治療，且病情控制不佳。其中許多患者需要服用高劑量口服潑尼松才能得到適當的治療，他們都在尋找其他治療方案，或者說他們中的許多人都在尋找其他治療方案。

Only a relatively small percentage, only a quarter of the market is currently on other therapies at all. And of the ones that are, some of them are on very demanding IVIg regimens, multiple days a month, spent entirely in the infusion centers and others are on a series of off-label therapies, many or most of which have failed DM programs before, but are used simply because there are no better options. So we're getting a predictably enthusiastic response from all of the physicians we've engaged with on this data already and are obviously looking forward to continuing that as we go through the registration process in the coming year.

目前只有相對較小比例的患者（僅佔市場份額的四分之一）採用其他療法。而那些接受治療的患者中，有些需要接受非常嚴格的靜脈注射免疫球蛋白治療方案，每月數天，全部時間都待在輸液中心；還有一些患者正在接受一系列非適應症治療，其中許多或大多數療法以前在糖尿病治療項目中都失敗過，但之所以使用，僅僅是因為沒有更好的選擇。因此，我們已經與所有參與數據討論的醫生進行了交流，並得到了意料之中的熱烈反響，我們當然期待著在來年的註冊過程中繼續保持這種熱情。

Looking at slide 11, again, a recap from before, but this is the primary endpoint. This is mean TIS. And this is a textbook picture from my perspective of positive clinical data, statistically significant at the high dose starting at the earliest time point, nice clear separation, nice clear dose response. And one thing that bears mentioning, and we said this we put the data originally, we had originally been focused on the steroid taper as a risk mitigant in order to make sure we saw a clear benefit from the drug against the background of not really placebo, but actually actively managed background therapy. And we did that.

再來看第 11 張投影片，這是對先前內容的回顧，但這是主要終點。這是平均TIS值。從我的角度來看，這是一張典型的臨床數據陽性圖，從最早的時間點開始，高劑量就具有統計意義，分離清晰，劑量反應清晰。還有一點值得一提，我們最初也說過，我們最初將數據放在類固醇減量作為風險緩解措施上，以確保我們能夠從藥物中獲得明顯的益處，而不是在安慰劑，而是在積極管理的背景治療的背景下。我們做到了。

But the other thing we were able to show is a real dose response on steroid reduction as we were able to get a significantly greater portion of patients to lower steroid doses or off steroids on high-dose brepocitinib than on placebo. And I think that actually with the doc community has been enormously resident finding. It's something that the docs are really, really focused on DM getting these patients off high-dose steroids, and we are very excited that we were able to show this in the study, including as a part of at least one of the key secondary endpoints.

但我們也能證明，在減少類固醇方面存在真正的劑量反應，因為與安慰劑相比，高劑量布雷泊替尼能夠使更多患者降低類固醇劑量或停止使用類固醇。而且我認為，實際上醫生群一直在大力尋找合適的人選。醫生們非常非常關注如何讓糖尿病患者擺脫高劑量類固醇，我們非常高興能夠在研究中證明這一點，包括將其作為至少一項關鍵次要終點的一部分。

On slide 12, more than a third, and this is the key secondary where we were able to really hit both the TIS improvement -- or the TIS, I should say, and a minimal or no steroid burden. More than a third of brepo 30 patients were able to get to both major TIS responses and minimal or no steroid burden at week 52. So that's just a really exciting finding across the board. And more than half of patients were able to achieve a TIS40, a moderate TIS response with very low dose of oral steroids at the same time. So just a phenomenal outcome there on the combination of endpoints.

在第 12 張投影片中，超過三分之一的人，這是關鍵的次要方面，我們能夠真正實現 TIS 改善——或者應該說是 TIS，以及最小或沒有類固醇負擔。超過三分之一的 brepo 30 患者在第 52 週時能夠達到主要的 TIS 反應，且類固醇負擔極小或沒有。所以這真是一個令人振奮的發現。超過一半的患者能夠達到 TIS40，這是一種中等的 TIS 反應，同時口服類固醇劑量非常低。所以，綜合所有終點指標來看，這真是驚人的結果。

On slide 12, again, without going through them all, just a statistically robust data set, I'll say, with really low p-values across every secondary we tested benefit on muscle, benefit on skin, benefit on patient-reported outcomes like the HAQ-DI questionnaire on disability, just a terrific across-the-board outcome here.

在第 12 張投影片上，我再次強調，無需一一贅述，只需說，這是一個統計上穩健的數據集，我們測試的每個次要指標的 p 值都非常低，包括肌肉獲益、皮膚獲益、患者報告結果（如 HAQ-DI 殘疾問卷）獲益，總而言之，這是一個非常棒的全面結果。

In terms of what's next year, I think everyone is clear. The NDA submission, we're moving as fast as we can. The only real gating item here was drafting, and it's ongoing right now. We expect to get a file in the first half. Data readout from that proof-of-concept study in CS that we have ongoing will be next year. And the NIU study, which is enrolling very nicely, is currently anticipated to read out or say, guided to the first half '27 around the same time as potential registration of brepo and launch in DM. And then we submit the sNDA for NIU shortly thereafter with potential further indications and so on to come.

至於明年的計劃，我想大家都很清楚了。關於保密協議的提交，我們正在盡最大努力加快進度。唯一真正的限制因素是選秀，目前選秀仍在進行中。我們預計上半年會收到文件。我們正在進行的電腦科學概念驗證研究的資料讀取工作將於明年進行。NIU 的研究目前進展順利，預計將於 2027 年上半年公佈結果，屆時 brepo 可能也將註冊並在 DM 上市。然後，我們將很快提交 NIU 的補充新藥申請，並可能進一步提交其他適應症等申請。

So that's brepocitinib. I'm sure we'll get some questions about it. And like I said, we'll talk more about that program and what it could represent commercially on the 11th. But suffice it to say, a tremendous quarter and something we're really excited to carry forward from here.

這就是布雷泊替尼。我相信我們會收到一些相關問題。正如我所說，我們將在 11 號詳細討論該計劃及其在商業上的潛在意義。但總而言之，這是一個非常出色的季度，我們非常高興能將這種勢頭延續下去。

Next up, I'll just recap the Graves' disease remission data that we put out earlier this quarter as well. Starting on slide 16, with just a reminder, this is a very large patient population with a significant unmet need. And there's been -- I think this is an important point as people are doing their work here, a shift away from ablation over time as patients don't want to go through the surgical procedure or the radioactive iodine, but really a lack of new medical therapies that's left something like a quarter to 30% of Graves' disease patients who are relapsed, uncontrolled on or intolerant to ATDs. It's just a very high proportion of patients who are unable to get well controlled.

接下來，我將簡要回顧我們本季早些時候發布的格雷夫斯病緩解數據。從第 16 張投影片開始，再次提醒大家，這是一個非常龐大的病患群體，存在著巨大的未滿足需求。而且——我認為這一點很重要，因為人們在這裡開展工作——隨著時間的推移，人們逐漸放棄了消融治療，因為患者不想經歷手術或放射性碘治療，但實際上缺乏新的藥物療法，導致大約四分之一到 30% 的格雷夫斯病患者病情復發，對 ATD 藥物控制不佳或不耐受。只是有很高比例的患者無法得到良好的病情控制。

As a reminder, on slide 17, this is a bad disease. These patients are at much higher risk of cardiovascular events, much higher risk of preeclampsia, 4 times higher risk of preeclampsia and a 7 times higher risk of thyroid cancer than the general population. So these patients are really sick or at a high risk of developing severe comorbidities. They often go on to develop thyroid eye disease, about 40% of patients go on to develop these eye symptoms, some of which get optic neuropathy and other issues that can be pretty significant for vision.

再次提醒一下，第 17 張投影片展示的是一種嚴重的疾病。這些患者發生心血管事件的風險要高得多，發生子癇前症的風險要高得多，發生子癇前症的風險是一般人群的 4 倍，發生甲狀腺癌的風險是一般人群的 7 倍。所以這些患者病情都很嚴重，或是極有可能發展成嚴重的併發症。他們往往會發展成甲狀腺眼疾，約 40% 的患者會出現這些眼部症狀，其中一些患者會發展成視神經病變和其他可能對視力造成相當嚴重影響的問題。

And then there's a bunch of other complications here. 16% are diagnosed with thyroid storm, which has -- in patients with hospitalized for Graves' disease, 16% are diagnosed with thyroid storm, which has a 20% mortality rate. So again, potentially sort of very sick patients and again, a relatively high risk of thyroid cancer, including a high risk of progressive thyroid cancer. So disease that makes people quite sick. Again, more to come on the 11th, but just wanted to highlight that fact.

此外，還有許多其他併發症。 16% 的格雷夫茲病住院患者被診斷出甲狀腺危象，而甲狀腺危象的死亡率高達 20%。所以，這些患者可能病情非常嚴重，而且罹患甲狀腺癌的風險相對較高，包括罹患進展性甲狀腺癌的風險也較高。這種疾病會使人非常難受。11號還有更多消息要公佈，但我想先強調一下這一點。

And then on page 18, in addition to being a severe disease, it's a disease affecting a lot of people. And so you've got every year, call it, 65,000 newly diagnosed patients, of which 20,000 of those wind up in that sort of refractory bucket. And then there's 880,000 diagnosed US patients, of which 330,000 in the prevalent population are walking around in that intolerant or unable to get well-controlled bucket. So they're just a huge patient population with a significant unmet medical need.

然後在第 18 頁，除了是一種嚴重的疾病外，它還是一種影響許多人的疾病。因此，每年約有 65,000 名新確診患者，其中 20,000 名最終被歸類在難治性病例之列。此外，美國還有 88 萬名確診患者，其中 33 萬人屬於一般人群，他們要麼對藥物不耐受，要麼無法得到良好的控制。所以他們是一個龐大的患者群體，存在著巨大的未滿足醫療需求。

What we showed earlier this year in the batoclimab study is a pretty interesting result. We showed real disease-modifying benefit in these patients. Of the 25 patients who came in at baseline, as a reminder, the way the study worked, patients were treated for 12 weeks of high-dose batoclimab followed by another 12 weeks of low-dose batoclimab and were then followed for another 24 weeks off drug entirely. And what we saw is after that first 12 weeks, 20 out of 25 of those patients were responders to therapy.

我們今年早些時候在 batoclimab 研究中展示的結果非常有趣。我們證明了這種療法能真正改善這些患者的病情。提醒一下，本研究的運作方式是，在基線時入組的 25 名患者中，患者接受 12 週的高劑量巴托克利單抗治療，然後接受 12 週的低劑量巴托克利單抗治療，之後完全停藥 24 週進行隨訪。我們看到，在最初的 12 週後，25 名患者中有 20 名對治療有反應。

After dropping to low dose after another 12 weeks, 18 out of 25 of those patients were responders. And truly remarkably, after being off drug for a further six months, 17 out of the 21 patients we were able to follow up with at week 48 were responders to therapy. So these are patients who were uncontrolled on standard of care at the beginning of the study and 17 out of the 21 of them that we were able to follow up with remain responders to therapy, having been off drug for six months. So a pretty remarkable disease-modifying benefit.

12 週後劑量降低，25 名患者中有 18 名有效。更令人驚訝的是，在停藥六個月後，我們在第 48 週能夠追蹤的 21 名患者中，有 17 名對治療有反應。因此，這些患者在研究開始時接受標準治療後病情未得到控制，在我們能夠追蹤的 21 名患者中，有 17 名患者在停藥 6 個月後仍對治療有反應。所以，這是一種非常顯著的疾病改善作用。

Of the off-drug responders on page -- of the off-drug responders on slide 20, nearly half of them were fully off ATDs and over 75% of them were on only the lowest doses of ATDs or off ATDs. So not only were we able to deliver a disease-modifying benefit for patients who are uncontrolled on ATDs before, we were able to significantly reduce or eliminate ATD need for those patients.

在第 20 頁的停藥反應者中，近一半完全停用了抗甲狀腺藥物，超過 75% 的人只服用最低劑量的抗甲狀腺藥物或停用了抗甲狀腺藥物。因此，我們不僅能夠為先前使用 ATD 治療後病情未得到控制的患者帶來疾病改善的益處，而且還能夠顯著減少或消除這些患者對 ATD 的需求。

Now this was underscored on slide 21, not just by the sort of clinical data on T3 and T4 and so on, which is obviously what's most important to the patients. But you can also see it in the TRAb reductions on slide 21. And as you can see, as you'd expect for FcRn therapy, these patients showed a rapid decline, both in general IgG and in TRAb levels, especially on high dose. The IgG levels came back a little bit as you'd expect during the lower dose period.

這一點在第 21 張投影片中得到了強調，不僅僅是透過 T3 和 T4 等臨床數據，而這些數據顯然對患者來說是最重要的。但您也可以從第 21 張投影片上的 TRAb 減少情況中看到這一點。正如你所看到的，正如你所預期的，對於 FcRn 療法，這些患者的整體 IgG 和 TRAb 水平都出現了快速下降，尤其是在高劑量下。正如預期的那樣，在低劑量治療期間，IgG 水平有所回升。

And then, what is maybe unique to Graves' disease or at least unusual among FcRn indications is while IgG bounces right back when you come off therapy, the only time points on this graph are week 24 and week 48. But by week 48, these patients were effectively back at baseline from IgG. The vast majority of these patients still had basically sort of reduced or no TRAbs. And that is a pretty remarkable finding around the durability of the benefit here.

此外，格雷夫茲病可能獨有的，或者至少在 FcRn 適應症中不尋常的是，雖然停止治療後 IgG 會立即反彈，但此圖表上的時間點只有第 24 週和第 48 週。但到第 48 週，這些患者的 IgG 水平實際上已經恢復到基線水平。這些患者中的絕大多數仍然基本上沒有或只有部分TRAb。這是關於這種益處持久性的一個相當了不起的發現。

On slide 22, the next period is absolutely stacked for us in 1402 with data coming in a variety of indications, D2T RA and CLE next year, the second part of the D2T RA study as well as Graves' and MG in 2027 and then Sjögren's in CIDP after. One small update just to flag for today. The TED study remains on track to conclude this year.

在第 22 張投影片中，接下來的 1402 年對我們來說絕對是堆積如山的數據，包括各種適應症的數據，明年將有 D2T RA 和 CLE 的數據，2027 年將有 D2T RA 研究的第二部分以及 Graves 和 MG 的數據，之後是 Sjögren 和 CIDP 的數據。今天需要更新一點資訊。TED研究仍按計畫將於今年完成。

Our last patient last visit is very close to today. But we're going to hold off reporting the top line data from that first study in all likelihood until we see the top line data for the second study in the first half of next year. The evolving competitive landscape in TED and especially in Graves' disease has led us to take a more prudent path there. And so we're going to collect that data together and report it when we have it all.

我們最後一位患者的最後一次就診時間就在今天附近。但我們很可能會等到明年上半年看到第二項研究的主要數據後，才會公佈第一項研究的主要數據。TED（治療性癲癇）領域，尤其是格雷夫茲病領域的競爭格局不斷變化，促使我們採取了更謹慎的做法。因此，我們將收集這些數據，並在收集所有數據後進行報告。

Moving on to the -- briefly to just a reminder of where we are in the LNP litigation, which I know some people are following. In the Moderna case, we are in a pretrial process around the narrowing of claims and defenses and around summary judgment, which is happening now, the judge is reviewing summary judgment briefings and there's sort of a calendar on the docket that we're hoping will take us through trial in March.

接下來——簡單提醒一下大家，我們目前在 LNP 訴訟案中處於什麼階段，我知道有些人正在關注此事。在 Moderna 案中，我們正處於審前程序階段，主要圍繞縮小訴訟請求和抗辯範圍以及簡易判決。目前，法官正在審查簡易判決的簡報，並且已經制定了日程表，我們希望能夠順利進行到三月的審判。

The trial is scheduled for March and the first international proceedings are also expected in the first half of 2026. The Pfizer case is ongoing in discovery, and there was a favorable Markman ruling issued in September that certainly sets us up nicely for what we think we need to do from there.

審判定於 3 月進行，首次國際訴訟程序預計也將在 2026 年上半年舉行。輝瑞案目前仍在取證階段，9 月發布的 Markman 裁決對我們有利，這無疑為我們接下來的工作奠定了良好的基礎。

So I'll conclude before we go to Q&A with a brief financial update. Overall, a straightforward quarter from a financial perspective, loss from continuing operations net of tax of $166 and cash, cash equivalents of $4.4 billion with no debt on the balance sheet. And obviously, a share count reflective of the significant share buybacks we've done over the last 18 months. So a strong position overall that, as I said, is expected to carry us through profitability.

那麼在進入問答環節之前，我先簡單回報一下財務狀況。整體而言，從財務角度來看，這是一個簡單的季度，持續經營業務稅後淨虧損為 1.66 億美元，現金及現金等價物為 44 億美元，資產負債表上沒有債務。顯然，股票數量也反映了我們在過去 18 個月中進行的大規模股票回購。因此，總體而言，我們處於強勢地位，正如我所說，預計這將使我們獲利。

We've got more of our financials in here and the catalyst sort of road map on slide 28. But again, just a really exciting six months or 12 months behind us and a really exciting 12 months or 36 months ahead of us. So feeling great about where the business is, feeling great about the significant transformation in our profile that we've been through in the recent months and looking forward to carrying that forward from here.

這裡麵包含了我們更多的財務數據，以及第 28 頁投影片上的催化劑路線圖。但話說回來，過去六個月或十二個月非常激動人心，未來十二個月或三十六個月也同樣令人興奮。所以，我對公司目前的狀況感到非常滿意，並對近幾個月來公司形象的重大轉變感到非常滿意，並期待從現在開始繼續發展。

Once again, as a reminder, we have an Investor Day in New York City for those that can make it in person on December 11, 2025, that registration link is live. It's in the presentation we put up as well as on our website. I hope to see many of you there to round out the year and talk about the future.

再次提醒各位，我們將於 2025 年 12 月 11 日在紐約市舉辦投資者日活動，歡迎能夠親臨現場的人士參加，註冊連結已上線。我們發布的簡報和網站上都有相關資訊。我希望屆時能見到你們中的許多人，一起為這一年畫上圓滿的句號，並展望未來。

So with that, I'll say thank you again for listening. Again, a relatively quiet earnings call, but not at all a quiet quarter. And I will pass it back over to the operator for Q&A. Thank you, everybody.

那麼，最後我再次感謝大家的聆聽。財報電話會議相對平靜，但本季卻不平靜。然後我會把問題轉回給接線生進行問答。謝謝大家。

(Operator Instructions) Dave Risinger, Leerink Partners.

（操作說明）Dave Risinger，Leerink Partners。

Congrats on all the progress, Matt, and looking forward to the event on the 11th. So my question is, could you please comment on what we should be watching next with respect to Pfizer litigation? So specifically in international markets and then in the US.

恭喜你取得的所有進展，馬特，期待11號的活動。所以我的問題是，您能否就我們接下來應該關注的輝瑞訴訟案的哪些方面發表一下看法？具體來說，是在國際市場，然後是美國市場。

Thanks, Dave. I appreciate the question. And obviously, it's something that a number of people are watching. It's tough as always, to comment on ongoing litigation. I have nothing to say about any potential timing of any kind of international cases. Look, it's a busier moment coming up. I think there should be a sort of scheduling process for the Pfizer case underway, and we should learn more about the exact time line, including hopefully a trial date in the near future. And I think that's probably what I would be most watching out for in terms of what's public at this point is just getting that schedule together and progressing from here.

謝謝你，戴夫。感謝您的提問。顯然，很多人都在關注這件事。對正在進行的訴訟發表評論一如既往地困難。對於任何類型的國際案件的潛在時間安排，我無可奉告。你看，接下來會比較忙。我認為輝瑞案應該有一個進度安排流程，我們應該了解更多關於具體時間表的信息，包括希望在不久的將來能確定審判日期。我認為，就目前公開的資訊而言，我最關注的可能是製定好日程安排，然後從這裡開始前進。

Brian Cheng, JPMorgan.

Brian Cheng，摩根大通。

Just two quick ones from us. How do you feel about argenx stepping into Graves' and whether that has any impact on your strategy of 1402? And then we have a quick follow-up.

我們這裡就簡單介紹兩點。您對 argenx 收購 Graves' 有何看法？這是否會對您的 1402 策略產生任何影響？然後我們還有一個簡短的後續問題。

Thanks, Brian. It's a great question. And look, I think you heard my comment on the timing of the intended sort of production of the batoclimab TED data. Obviously, we're acutely aware of the competitive landscape in Graves' disease. And look, I think to make a gentle comment, whatever, imitation is the finest form of flattery. I think it's great to see others recognizing the importance of Graves' as a disease. It's great to see more people working on treatment options for these patients. Obviously, in our Phase II study, we studied both high and low-dose batoclimab, and we saw a great benefit to the higher dose batoclimab in the study.

謝謝你，布萊恩。這是一個很好的問題。你看，我想你聽到了我關於巴托西利單抗 TED 數據預期生產時間的評論。顯然，我們非常清楚格雷夫茲病領域的競爭格局。而且，恕我直言，模仿是最好的恭維。很高興看到其他人也認識到格雷夫茲病的重要性。很高興看到越來越多的人致力於研究這些患者的治療方案。顯然，在我們的 II 期研究中，我們研究了高劑量和低劑量 batoclimab，並且我們在研究中看到了高劑量 batoclimab 的巨大益處。

And then also, we reported in the past data breaking out the patients between that 70% cutoff below and -- above and below 70% IgG reduction. And we had 3 times as many patients getting off ATDs at the above 70% group than in the below 70% group. So we think we should have quite a competitive profile there. But most importantly, to be honest, it's a big patient population. There's a lot of sick people. And I think a rising tide there will lift all boats.

此外，我們過去也曾報告過數據，將 IgG 減少 70% 以上的患者與低於 70% 的患者進行了細分。在 70% 以上的患者組中，停用 ATD 的患者人數是 70% 以下患者的 3 倍。所以我們認為我們在那裡應該會很有競爭力。但說實話，最重要的是，這是一個龐大的患者群體。有很多病人。我認為，那裡的水位上升會帶動所有船隻的提升。

And like I said, argenx is a formidable company with a wide following and has done a great job of execution. And I know there's at least some people out there who find it, although it might be frustrating to us validating of our strategy that they're following in our footsteps. And so we'll always take it. Thanks, Brian.

正如我所說，argenx 是一家實力雄厚的公司，擁有廣泛的追隨者，並且在執行方面做得非常出色。我知道至少有些人發現了這一點，儘管這可能會讓我們感到沮喪，因為這驗證了我們的策略是正確的，他們正在追隨我們的腳步。所以我們會一直接受它。謝謝你，布萊恩。

Great. And just one quick one. So on the Investor Day next month, just curious if you can talk about what do you want investors to get out of the Investor Day? Is this more of a broader recap of your current strategy? Or do you think that there will be some unveiling of completely new data or a new strategic direction at Roivant?

偉大的。就最後一個問題。所以，在下個月的投資者日上，我很好奇您能否談談您希望投資者從投資者日中獲得什麼？這是對您當前策略的更全面的回顧嗎？或者您認為 Roivant 將會公佈一些全新的數據或新的策略方向嗎？

Yeah. Look, it wouldn't be a fun Investor Day if I revealed all of it now. But I think most importantly, this is just -- it's a moment of huge transformation for our business. I think the type of investors who are now along for the ride are different. And obviously, a lot of other things about the business are different. So I think we want to make sure we're telling that story fully that we're helping people see the course from a commercial perspective, from a patient need perspective in these indications so they can see at least the reasons why we are so excited about these indications about the certain nature of the blockbuster opportunity.

是的。你看，如果我現在把所有事情都透露出來，那投資者日就沒意思了。但我認為最重要的是，這對我們的業務來說是一個巨大的改變時刻。我認為現在參與投資的投資者類型有所不同。顯然，該業務的許多其他方面也有所不同。所以，我認為我們希望確保我們完整地講述這個故事，幫助人們從商業角度和患者需求角度了解這些適應症的發展歷程，以便他們至少能夠理解我們為什麼對這些適應症如此興奮，以及這些適應症所帶來的巨大商機。

There might be some other new things we're able to share by then in terms of updates or other things, but we'll see where we're at in a few weeks here or a month. But I think it will be an exciting opportunity to get together and take stock of the business and to talk a lot about the future and the opportunities in front of us.

到那時，我們或許還能分享一些新的進展或其他方面的信息，但我們會看看幾週或一個月後情況如何。但我認為這將是一個令人興奮的機會，大家可以聚在一起，評估公司現狀，並深入探討未來以及我們面臨的機會。

Samantha Semenkow, Citi.

Samantha Semenkow，花旗銀行。

Just for Graves', when thinking about the remission data, is there any way to tease out the impact of starting on the high-dose batoclimab in that study? And how much that actually contributed to the remission rates you saw? I'm just wondering if there's anything that you could share that you were able to tease out from the data when you analyzed it so as we think about the competitive landscape?

就 Graves 而言，在考慮緩解數據時，是否有辦法區分研究中開始使用高劑量 batoclimab 的影響？那麼，這究竟對你所看到的緩解率產生了多大影響呢？我只是想問，您在分析數據時，能否分享一些您從中發現的信息，以便我們更好地思考競爭格局？

Yeah. Look, thanks. That's a -- it's a great question. And I do think we're going to, like I said, be a little bit careful about some of what we say here because of the evolving competitive landscape, and we're going to learn more about this from the hypothyroid TED patients and so on in that study as well. But look, I think in general, remission is about TRAbs getting normal for longer. And our view is that deeper IgG reductions are going to drive towards exactly that outcome.

是的。謝謝。這是一個——這是一個很好的問題。而且我認為，正如我所說，由於競爭格局不斷變化，我們在這裡的一些言論會更加謹慎，我們也將從那項研究中的甲狀腺功能減退症 TED 患者等那裡了解更多相關信息。但是，我認為總體而言，緩解是指 TRAbs 恢復正常的時間更長。我們的觀點是，IgG 水準的進一步下降將最終導致這一結果。

And so both in terms of the speed of responses that we saw in the bato trial and the depth of responses that we saw in the bato trial in terms of TRAb lowering, I think that's going to be a significant driver for us. So I think we feel good put this way about our level of IgG suppression in that program at high dose. Thanks. It's a great question.

因此，無論是從我們在巴托試驗中看到的反應速度，還是從巴托試驗中看到的TRAb降低程度的反應深度來看，我認為這將是我們的一個重要驅動因素。所以我覺得，這樣表達我們對高劑量方案中 IgG 抑製程度的感受是好的。謝謝。這是一個很好的問題。

Yaron Werber, TD Cohen.

Yaron Werber，TD Cohen。

Great. Maybe a quick question. We've been getting a few questions about the ongoing preliminary -- the summary judgment against Moderna with respect to the US government involvement in the EUP -- I'm sorry, EUA and whether the government ever took control of the vaccines for distribution and whether that made them a commercial party and whether that impacts their involvement and as a result, would potentially provide Moderna some venue to make an argument. Any thoughts about that, if you can comment at all would be great.

偉大的。或許我想問個小問題。我們收到了一些關於正在進行的初步裁決的問題——針對 Moderna 的簡易判決，涉及美國政府參與 EUP（抱歉，應該是 EUA）以及政府是否曾經控制疫苗的分發，這是否使他們成為商業實體，這是否會影響他們的參與，從而可能為 Moderna 提供一些辯解的途徑。如果您能就此發表任何看法，那就太好了。

Yeah. Thanks, Yaron. And again, as usual, it's difficult to comment in depth about an ongoing litigation, and it's ultimately going to be the judge's decision on the 1498 question. I'll point out that the two things that are worth keeping in mind. One is the Moderna case in the US Moderna sales of COVID vaccines in the US in total is a bit less than half of Moderna's total global COVID vaccine sales and Moderna's total global COVID vaccine sales are a bit less than half of the total, inclusive of Pfizer.

是的。謝謝你，亞倫。再次強調，像往常一樣，很難對正在進行的訴訟進行深入評論，最終將由法官對第 1498 號問題作出裁決。我要指出兩點值得注意。一是美國 Moderna 的案例。 Moderna 在美國銷售的新冠疫苗總額略低於其全球新冠疫苗總銷售額的一半，而 Moderna 的全球新冠疫苗總銷售額又略低於包括輝瑞在內的全球新冠疫苗總銷售額的一半。

And so -- and then what Moderna has claimed in their own briefings is that we asked for about $5 billion in damages in the U.S. case, and Moderna has claimed that a little bit less than half of those damages could be subject to 1498 in Moderna's view. And so I think you're talking about a little bit less than half of a little bit less than half of a little bit less than half of the total is the issue in summary judgment on 1498. Our position is pretty clearly laid out in our motions.

因此——然後 Moderna 在他們自己的簡報中聲稱，我們在美國案件中要求約 50 億美元的賠償，而 Moderna 聲稱，在 Moderna 看來，其中略低於一半的賠償金可能受 1498 條款的約束。所以我認為，你所說的總金額的一半還不到一半，這就是 1498 號簡易判決中的問題所在。我們的立場在我們的行動中已經闡述得非常清楚了。

And frankly, Moderna's position has also laid out in their motions. Obviously, we feel like we have a strong case to make here, but it's ultimately going to be up to the judge to determine. But I just wanted to sort of scope out the magnitude of the question as well.

坦白說，Moderna 的立場也已在其動議中闡明。顯然，我們覺得我們有充分的理由，但最終將由法官來決定。但我只是想大致了解一下這個問題的嚴重程度。

Prakhar Agrawal, Cantor Fitzgerald.

普拉哈·阿格拉沃爾，坎托·菲茨杰拉德。

Congrats on the progress in the quarter. Maybe firstly, on Sjogren's disease. Recently, there has been a lot of excitement around Sjögren's market opportunity, especially with the recent data from Novartis' BAFF drug, ianalumab. Maybe you can contextualize how FcRns can differentiate on ESSDAI scores or other specific endpoints? And do you think you could be first-in-class in this indication? And secondly, just quickly on Brepo and DM, do you plan to apply for FDA's National Priority Voucher for Brepo?

恭喜本季的進展。或許首先，可以談談乾燥症。最近，人們對乾燥症的市場機會感到非常興奮，尤其是諾華公司的 BAFF 藥物 ianalumab 的最新數據。或許您可以解釋一下 FcRns 如何在 ESSDAI 評分或其他特定終點指標上反映差異？你認為你能在這項指標上取得第一名嗎？其次，關於 Brepo 和 DM，請問您是否計劃申請 FDA 的 Brepo 國家優先券？

Thank you. Those are both great questions. Look, I think on Sjögren's, we are also excited about the market opportunity. It's a large patient population with a very significant unmet need and just a lot of people kind of going through it as it were. There have been a variety of therapeutic classes that have shown some benefit. Obviously, the in-class data was positive and the J&J data, in particular, showed that lower is better.

謝謝。這兩個問題都很好。你看，我認為 Sjögren's 也對市場機會感到興奮。這是一個龐大的患者群體，存在著非常大的未滿足需求，而且很多人都在經歷類似的困境。多種治療方法都顯示出一定的療效。顯然，課堂數據是積極的，特別是強生公司的數據表明，數值越低越好。

So we think we have a real shot at best-in-class. We are working to launch as close to first-in-class as possible. I don't think we're here to commit that we'll beat our competitors. We obviously got a little bit of a head start on us, but I think we're trying to be kind of within a window small enough such that it shouldn't matter who comes first, and we can differentiate based on our profile.

所以我們認為我們很有機會成為同類最佳。我們正努力使產品盡可能達到同類首創的水平。我認為我們來這裡並不是為了承諾我們會擊敗競爭對手。我們顯然已經取得了一點領先優勢，但我認為我們正在努力將時間窗口控制在一個足夠小的範圍內，這樣誰先到達終點就無關緊要了，我們可以根據我們的產品特點來脫穎而出。

And I'll just say, I think, first of all, I think the Novartis data was positive, but probably left room for even better as I think have all of the Sjögren's data produced to date. And I think the FcRn data to date has sort of been competitive with other classes of drugs. And so if our deeper IgG expression yields a better benefit than other FcRns, I think we should have a truly important opportunity in the space. A lot of excitement about new therapies from KOLs and from our investigators. The unmet need is significant. The overall market is a significant number of patients. So it's a great place for us to be in our view.

我只想說，首先，我認為諾華的數據是正面的，但可能還有進步的空間，因為我認為迄今為止所有關於乾燥症的數據都是如此。我認為迄今為止，FcRn 的數據已經與其他類別的藥物相比具有競爭力。因此，如果我們的 IgG 表現量比其他 FcRn 能帶來更好的效果，我認為我們在這個領域將迎來一個非常重要的機會。專家和研究人員對新療法都非常興奮。未滿足的需求十分巨大。整個市場擁有數量龐大的患者群。所以從我們的視角來看，這裡是個絕佳的地點。

And then sorry, you asked about the CNPV program for brepo. We haven't said. Look, this is an orphan population with high unmet need. So I think we're thinking through all of the different ways we can get through FDA and out to patients as quickly as possible and thinking about the puts and takes of them all, but stay tuned.

然後，抱歉，您問到了關於 brepo 的 CNPV 專案。我們還沒說過。你看，這是一群孤兒，他們的需求遠遠未能滿足。所以，我認為我們正在考慮所有不同的方法，以便盡快通過 FDA 審批並讓患者用上我們的產品，同時也在考慮每種方法的利弊，敬請期待。

Corrine Johnson, Goldman Sachs.

科琳·約翰遜，高盛集團。

Maybe following up on an earlier question about competitive intensity in Graves' disease. I think it goes beyond argenx in terms of number of companies that have announced plans there. So how are you thinking about the kind of competitive clinical landscape that's evolving? And what do you expect to inform sequencing decisions in that space over time? And then maybe separately, just on business development. Curious if you could give an update on what you're seeing on that front.

或許可以作為先前關於格雷夫茲病競爭強度問題的後續討論。我認為，就已宣布計劃的公司數量而言，Argenx 的情況已經超出了 Argenx。那麼，您如何看待這種不斷變化的、競爭激烈的臨床環境？隨著時間的推移，您認為哪些因素會影響該領域的定序決策？然後或許可以單獨討論一下業務拓展方面的問題。很想了解您在這方面看到的最新情況。

Yeah. Thanks, Corinne. Look, I think the first question -- and obviously, we see the competitive landscape. Similarly, there's a number of people trying different things, which is exciting. It's exciting Graves' space. It's exciting to be there. One comment about that is, I think we've watched the myasthenia gravis landscape play out, and there's a lot of competitive intensity and a lot of new mechanisms and also that FcRn has been, a, a pretty undisputed king so far. And b, that the first FcRn to launch with the quality of that data has been a tremendous head start. And we think we've built something similar in Graves' disease, which is a market obviously a multiple of the potential size of the MG market.

是的。謝謝你，科琳。你看，我認為第一個問題是──顯然，我們看到了競爭格局。同樣，也有很多人在嘗試不同的事物，這令人興奮。格雷夫斯的空間令人興奮。能身處其中真是令人興奮。關於這一點，我想說的是，我們已經見證了重症肌無力領域的發展，競爭非常激烈，出現了許多新的機制，而且到目前為止，FcRn 一直是無可爭議的王者。其次，第一個以如此高品質的數據推出的 FcRn 已經取得了巨大的領先優勢。我們認為我們在格雷夫茲病領域也建立了類似的市場，而格雷夫茲病的市場規模顯然是重症肌無力市場潛在規模的數倍。

So we feel great about our position, both from a timing perspective as well as a mechanism. It's a well-understood mechanism, FcRn. And it's pretty exquisitely well suited to treating the biology of Graves' disease. So you think about some of the other mechanisms outside of FcRns have something in common with ATDs, which is that at high doses, they will cause patients to go hypothyroid, which is a miserable thing as well.

因此，無論從時機或機制上來說，我們都對自己的處境感到非常滿意。FcRn 是一種人們已經充分了解的機制。而且它非常適合治療格雷夫茲病的生物特性。所以你會想到，FcRns 以外的一些其他機制與 ATD 有一些共同之處，那就是在高劑量下，它們會導致患者甲狀腺功能減退，這也是一件非常痛苦的事情。

And so I think one of the great things about FcRn biology is other than maybe for a very short period of time, because what you're really doing is getting at the root cause of the disease with these autoantibodies, you're not going to like cause the thyroid to react in the other direction sort of directly. It's not like a TSHR targeted mechanism or something like that.

所以我認為 FcRn 生物學的一大優點是，除了可能在很短的時間內，因為你實際上是在用這些自身抗體找出疾病的根本原因之外，你不會直接導致甲狀腺朝相反的方向產生反應。它不像 TSHR 標靶機制之類的東西。

And so I think that will be a big benefit to FcRn. The other thing that I think is maybe underappreciated in some communities about FcRns is just how safe and well tolerated they are. And I think in a Graves' patient population, that is going to be an important fact that I think will be great for FcRns as a mechanism. So I think that those will all be sort of good guides towards FcRns being important and early line therapy for these patients who can't manage it with standard of care today.

所以我認為這對FcRn來說將是一個巨大的優勢。我認為在某些群體中，FcRns 的另一個優點可能被低估了，那就是它們的安全性和良好的耐受性。我認為對於格雷夫茲病患者群體來說，這將是一個重要的事實，我認為這對 FcRns 作為一種機制來說將是件好事。所以我認為這些都很好地說明了 FcRns 對於目前無法透過標準治療控制病情的患者的重要性以及早期第一線治療的重要性。

In general, as I said, I think lots of activity in the space is actually going to be good for everybody. These are docs who haven't run a lot of clinical trials. These are docs who haven't had a lot of new treatment options. And I think the more voices there are out there talking about this stuff, the better we'll be able to get out to the patient population. So thanks. It's a great question.

總的來說，正如我所說，我認為這個領域的活躍實際上對每個人都有好處。這些醫生並沒有進行過許多臨床試驗。這些醫生並沒有太多新的治療方案可供選擇。我認為，越多的人談論這些事情，我們就越能更好地將訊息傳遞給患者群體。謝謝。這是一個很好的問題。

And then you asked for BD update. Look, we remain extremely well capitalized. We remain very excited about the opportunities for pipeline expansion. We are incredibly excited about the things we currently have in our pipeline. And obviously, you hear that in our voice. You see that in the way that we're talking about our data. Obviously, we're thinking about indication expansion for those programs and then always looking in the world for programs, especially programs that are of a size and scale that can move the needle against the backdrop of our existing pipeline. And I think we've got some exciting ideas.

然後你詢問了BD的最新情況。你看，我們的資金依然非常充裕。我們對管道擴建的機會仍然感到非常興奮。我們對目前正在籌備的項目感到無比興奮。很顯然，你從我們的聲音就能聽出來。從我們談論數據的方式就能看出這一點。顯然，我們正在考慮擴大這些項目的適應症範圍，並且一直在世界各地尋找項目，特別是那些規模和範圍足以在我們現有研發管線中取得突破的項目。我認為我們有一些很棒的想法。

Dennis Ding, Jefferies.

丹尼斯丁，傑富瑞集團。

We have two, if we may. Number one is on Pulmovant. So you guys will have Phase II PH-ILD data in the second half of next year. I guess, how confident are you about the translatability from PAH to PH-ILD? And how should we think about that update? And what's the positive delta on PVR? And secondly, on the LNP litigation, I'm curious if you've done any work on what percentage of the US doses were given to actual federal government employees as we think about a middle scenario for summary judgment?

如果可以的話，我們有兩個。第一名是Pulmovant。所以你們將在明年下半年獲得 PH-ILD II 期數據。我想問的是，您對 PAH 到 PH-ILD 的可轉化性有多大信心？我們該如何看待這次更新？PVR的正向增量是多少？其次，關於 LNP 訴訟，我很好奇您是否研究過，在美國的疫苗劑量中，有多少百分比是提供給聯邦政府僱員的，因為我們正在考慮一種折衷的簡易判決方案？

Thanks, Dennis. I appreciate it. Both great questions. Thanks for the question about Pulmovant. We're obviously super excited about mosli. Look, I think -- you have correctly identified the risk that exists in the mosli data that is we don't have data in the PH-ILD patient population, and that's sort of the nature of this study. In general, PVRs have translated well. And so I think that's an important backdrop fact between these indications. And where they haven't, it's mostly been, for example, because of the VQ mismatch issues associated with vasodilation in lung disease patients. And we think the format of mosli addresses that issue.

謝謝你，丹尼斯。謝謝。兩個很好的問題。感謝您提出關於Pulmovant的問題。我們當然對mosli感到非常興奮。你看，我認為——你已經正確地指出了 mosli 數據中存在的風險，那就是我們沒有 PH-ILD 患者群體的數據，而這正是這項研究的本質。整體而言，PVR 的翻譯效果不錯。所以我認為這是這些跡象之間一個重要的背景事實。而那些沒有出現這種情況的地方，主要是因為肺病患者血管擴張引起的通氣/灌注不匹配問題。我們認為 mosli 的形式解決了這個問題。

So we are, I'd say, cautiously optimistic about that translation, but obviously, I feel a lot better when that Phase IIb data is in hand. And my hope is that we see pretty significant PVR reductions and pretty significant clinical benefit in those patients. So looking forward to that data in the second half of next year. That's another area where there's quite a lot of enthusiasm for the program and for new opportunities, especially with the overall growth from the prostacyclins in PH-ILD, leaving plenty of room for additional mechanisms.

所以，我認為我們對這個結果持謹慎樂觀態度，但顯然，拿到 IIb 期數據後，我會感覺好得多。我希望我們能看到患者的肺血管阻力顯著降低，並獲得顯著的臨床效益。非常期待明年下半年的數據。這也是人們對該計劃和新機會充滿熱情的另一個領域，尤其是在前列環素在 PH-ILD 中的整體成長，為其他機制留下了充足的空間。

The other thing I'll point out is just the 38% PVR reduction we saw in pulmonary hypertension, even if PVR reductions are for some reason a little bit lower in PH-ILD, obviously, there's still a lot of room for a very significant amount of benefit for these patients.

我還要指出一點，我們在肺動脈高壓患者中觀察到的 PVR 降低幅度為 38%，即使在 PH-ILD 患者中 PVR 降低幅度由於某種原因略低一些，顯然，這些患者仍然有很大的獲益空間。

Your second question, what percent of doses given to federal employees? I don't think our best estimates of that are in any of our motions. But I think you can imagine, as you think about the number of federal employees that it's a relatively small percentage.

你的第二個問題是，聯邦僱員接種的劑量佔總劑量的百分之多少？我認為我們目前的任何一項決議中都沒有給出對此的最佳估計。但我想你可以想像，考慮到聯邦僱員的數量，這只是一個相對較小的比例。

Got it. And if I can sneak one more in about the LNP litigation. Maybe remind us what's the status in terms of the OUS trials. We're not that familiar with the OUS process. So I guess, can you remind us how many cases you filed, which one is the furthest along? And can you get an initial decision in 2026?

知道了。如果我能再補充一條關於自由黨訴訟的資訊就好了。或許可以提醒我們一下，OUS審判的進展如何。我們對 OUS 流程不太熟悉。所以我想問一下，能否提醒我們您一共立案多少起，哪一起進展最快？你能在 2026 年得到初步決定嗎？

Yes. So thanks. It's a great question. In the case of Moderna, we filed a number of OUS actions, including in the UPC in Europe as well as in Canada and Japan and a couple of other places. Those litigations are all ongoing. There are important hearings in 2026. And the nice thing about some of these European jurisdictions is they can move quickly. So it is possible that we would get outcomes of various kinds within 2026 in some of those jurisdictions and obviously look forward to saying more when there's more to say.

是的。謝謝。這是一個很好的問題。就 Moderna 案而言，我們提起了多項美國境外訴訟，包括在歐洲的統一專利法院 (UPC)、加拿大、日本以及其他一些地方提起的訴訟。這些訴訟目前仍在進行中。2026年將舉行重要聽證會。歐洲某些司法管轄區的好處在於，它們可以迅速採取行動。因此，在 2026 年，我們有可能在某些地區獲得各種結果，顯然，當有更多消息時，我們會進一步說明。

Yasmeen Rahimi, Piper Sandler.

亞斯敏·拉希米，派珀·桑德勒。

Congrats on a great quarter. This is Dominic, on for Yasmeen Rahimi. We just had a question going into the TED data. Could you help us understand what you're thinking about with the expectations for the studies that are reading out here soon? And what do you hope to see to consider development considering the competitive landscape?

恭喜你本季表現出色。我是Dominic，替Yasmeen Rahimi上場。我們剛才對 TED 資料有一個疑問。您能否幫助我們了解您對即將發布的研究結果的預期？考慮到當前的競爭格局，您希望看到哪些發展趨勢？

Yeah. Thanks. It's a great question. We're looking forward to having that data relatively shortly for sharing it next year. Look, I think the competitive bar in TED is relatively high with IGF-1Rs being pretty efficacious. That said, they certainly leave room from a safety perspective, et cetera. And so I think we're looking to see data that makes sense in the context of the competitive landscape there.

是的。謝謝。這是一個很好的問題。我們期待盡快獲得這些數據，以便明年與大家分享。你看，我認為 TED 的競爭標準相對較高，而 IGF-1R 的療效則相當顯著。也就是說，從安全角度來看，它們確實留有餘地。所以我認為，我們正在尋找在當地競爭格局背景下有意義的數據。

The other thing that I think -- and this is part of the reason why we're focused on the sort of competition in Graves' disease, I think we'll learn a lot about hyperthyroid Graves' patients from this study as well as the possible ways in which Graves' and TED might interact with one another. And so I think we're looking forward to the data from that perspective as well. We'll obviously make a final decision on a launch in batoclimab once we've got the TED data in hand and in consultation with our partner. Thanks. It’s a great question. Thank you.

我認為另一件事——這也是我們關注格雷夫斯病競爭的原因之一——我認為我們將從這項研究中了解很多關於甲亢格雷夫斯病患者的信息，以及格雷夫斯病和甲狀腺眼病可能相互作用的方式。所以，我認為我們也很期待從這個角度獲得數據。我們顯然會在拿到 TED 數據並與合作夥伴協商後，對 batoclimab 的上市做出最終決定。謝謝。這是一個很好的問題。謝謝。

Douglas Tsao, HC Wainwright.

Douglas Tsao，HC Wainwright。

I guess, Matt, maybe as another follow-up on Graves' and TED. As you referenced, the two diseases are obviously sort of very interrelated with interplay. And I guess when we think about argenx, they will potentially come to market with VYVGART being both Graves' and TED hypothetically. Obviously, you have a big head start with 1402 in Graves'. So I'm just curious how you're thinking about potentially pursuing TED with 1402 versus, as you just noted, potentially thinking about batoclimab and the sort of disadvantage of maybe sort of coming at those dual markets with two different molecules.

我想，馬特，或許可以作為對格雷夫斯和 TED 的後續報導。正如你所提到的，這兩種疾病顯然是相互關聯、相互作用的。我想，當我們想到 argenx 時，他們可能會帶著 VYVGART 進入市場，理論上，VYVGART 既是 Graves 的，也是 TED 的。顯然，你在格雷夫斯隊中擁有 1402 分的巨大優勢。所以我很好奇，您是如何考慮用 1402 進行 TED 治療的，而不是像您剛才提到的那樣，考慮用 batoclimab 治療，以及用兩種不同的分子同時進入這兩個市場可能存在的劣勢。

Yeah. Look, thanks. It's a great question. And a couple of comments about this. One is it's -- we'll be speaking in the abstract now. We're going to know a lot more about the TED data that will inform the answer to this exact question, and we will be in possession of more information than anybody else will have at this moment in time on the sort of overall treatment landscape and on what FcRns can deliver. And so I think that will set us up really nicely to think about the possible options. They're totally different call point in terms of the physicians who treat these things and there are different stages of disease. And so I think they get treated at different times in different ways.

是的。謝謝。這是一個很好的問題。關於這一點，我有幾點要補充說明。一是──我們現在要抽像地談論這個問題了。我們將對 TED 資料有更深入的了解，以便能夠回答這個問題。目前，我們將掌握比任何人都多的信息，了解整體治療格局以及 FcRns 能帶來什麼。所以我認為這將為我們思考各種可能的選擇奠定很好的基礎。就治療這些疾病的醫生而言，它們的呼叫點完全不同，而且疾病也分為不同的階段。所以我認為他們在不同的時期會受到不同的對待。

And I think being able to talk to endos who are treating Graves' patients about the benefit in forestalling TED, for example, is an important potential thing to be able to discuss when we get to it. In terms of thinking about the sort of TED versus Graves' market dynamics, I'd say let's just wait and see what the TED data looks like, and then we can talk more about it. As a reminder, the Graves' population is meaningfully bigger and it's upstream of the TED population. And so I think there's a reason that was our first focus once we got into the clinic with 1402. Great question.

我認為，能夠與治療格雷夫茲病患者的內分泌科醫生討論預防甲狀腺眼疾（TED）的好處，例如，是我們將來可以討論的一個重要的潛在問題。至於 TED 與 Graves 的市場動態有何不同，我認為我們不妨先等等看 TED 的數據如何，然後再多討論一下。需要提醒的是，格雷夫斯河的人口數量明顯多於 TED 河，而格雷夫斯河位於 TED 河的上游。所以我覺得，當我們帶著 1402 號病例進入臨床後，這成為我們首要關注是有原因的。問得好。

Okay. Great. And Matt, if I can, on a follow-up with brepo. Obviously, incredibly impressive results in DM. I'm just curious if you have given thought just given sort of somebody alluded to sort of the competitiveness in Sjögren's, have you ever thought of that as an indication because I think there is a mechanistic rationale and obviously, an oral option would be very attractive.

好的。偉大的。如果可以的話，Matt，我想就 brepo 做個後續報道。顯然，DM 取得了非常令人印象深刻的成果。我只是好奇，鑑於有人暗示了乾燥綜合徵的競爭性，你是否考慮過這是否是一個跡象，因為我認為這其中存在機制上的合理性，而且顯然，口服藥物會非常有吸引力。

Yes, thanks. I appreciate the question. Look, I think the short answer is, we have thought pretty exhaustively about possible indications for brepo. We have a number that we think are exciting beyond what we've talked about. I think if you look at the indications we've chosen so far, they've been indications where we can really chart a market-defining course.

好的，謝謝。感謝您的提問。簡而言之，我認為我們已經非常詳盡地考慮了brepo的可能適應症。我們還有一些想法，我們認為這些想法比我們之前討論過的更令人興奮。我認為，如果我們看看我們目前選擇的指標，就會發現這些指標確實能夠幫助我們制定一個具有市場決定性意義的路線。

And I think there are maybe more to do in that story. But the short answer is there's an embarrassment of riches in terms of the indication set available for brepo, and we feel very privileged with the data we have in hand for what we've got. As a reminder, it has worked almost everywhere it has been tested. And so I think we feel like it's a great molecule and with a lot of great places to go. Thanks for the question.

我覺得這個故事可能還有更多可以挖掘的地方。但簡而言之，就 brepo 的適應症集而言，我們擁有非常豐富的數據，我們感到非常榮幸。需要提醒的是，它在幾乎所有測試過的地方都有效。所以我覺得它是一種很棒的分子，有很多很好的應用前景。謝謝你的提問。

Derek Archila, Wells Fargo.

Derek Archila，富國銀行。

This is a Hao, calling in for Derek Archila from Wells Fargo. I guess we have a question on brepo. We were at AACR. So very positive feedback from all the KOLs. So question is about really the competitive landscape. I guess we've seen VYVGART having data next year and the CAR-T is also starting their pivotal trials. How do you see the kind of the treatment paradigm evolve over the years? And brepo, do you have also plan to explore in other subtypes of myositis like IMNM and AS?

我是郝，請問富國銀行的德瑞克‧阿奇拉在嗎？我想我們這裡有個關於brepo的問題。我們當時在AACR。所有KOL都給了非常正面的回饋。所以問題其實是關於競爭格局的。我想我們已經看到 VYVGART 明年將公佈數據，CAR-T 也即將開始關鍵性試驗。您認為治療模式這些年來會如何演變？brepo，您​​是否也有計劃探索其他亞型的肌肉炎，例如免疫介導壞死性肌炎（IMNM）和僵直性脊椎炎（AS）？

Yeah, perfect. So look, I think on the deal on competitive landscape, similar comment to, frankly, my comment in Graves', which is that I think it's a great opportunity to be able to get out in front of it. And obviously, first and foremost, it may be the easiest. And oral is always going to have a huge place. The majority of these patients are on oral therapy now. And so I think just like the overall profile that makes us unique.

對，完美。所以你看，我認為關於競爭格局，我的看法與我在格雷夫斯的評論類似，那就是我認為這是一個搶佔先機的絕佳機會。而且顯然，首先，這可能是最簡單的。口交始終會佔有非常重要的地位。目前這些患者中的大多數都在接受口服治療。所以我覺得，正是這種整體形象使我們獨一無二。

I'll say the CAR-Ts, that's not, in my opinion, going to play for the same patients mostly that we are. That's obviously a much different sort of intervention. And there's still plenty of open questions about benefit there. Look, I think that's also sort of a little bit about that landscape. FcRn could be a compelling option. Obviously, IVIg is used.

我認為，CAR-T療法主要針對的並不是我們現在治療的這類患者。這顯然是一種截然不同的干預方式。關於這方面的益處，仍有許多懸而未決的問題。你看，我覺得這在某種程度上也與那裡的風景有關。FcRn可能是個很有吸引力的選擇。顯然，這裡使用了靜脈注射免疫球蛋白。

But I'd say, first of all, it's good to have what we think of as a multiyear head start in DM. And we think the patient population that we have access to, given the nature of our therapy is really basically the entire DM patient population, which gives us a lot of room to go. So we think, again, similar to VYVGART and MG, we think we get to define that market and be the heart of it.

但我想說，首先，在數位行銷領域擁有多年的先發優勢是件好事。鑑於我們療法的性質，我們認為我們能夠接觸到的患者群體實際上基本上就是整個糖尿病患者群體，這給了我們很大的發展空間。所以我們認為，和 VYVGART 和 MG 類似，我們有機會定義這個市場，並成為它的核心。

And so I think that's all great. We also suspect that the data we have in DM specifically may be just the best overall, and that's the biggest part of the myositis market. Obviously, argenx is studying in other subtypes of myositis as well, and some of those may be more directly appropriate for an FcRn.

所以我覺得這一切都很棒。我們也懷疑，我們掌握的 DM 數據可能是整體上最好的，而 DM 又是肌炎市場中最大的部分。顯然，argenx 也在研究其他亞型的肌肉炎，其中一些可能更適合 FcRn。

As to your question about other subtypes of myositis for us, I'll just say again, we thought about a whole bunch of different places to go. There's a lot of exciting places to go, and we have an embarrassment of riches in terms of where we can take the molecule from here.

至於你問到的我們是否患有其他類型的肌炎，我只想再次說明，我們考慮過很多不同的治療方案。有很多令人興奮的地方可以去探索，就我們可以把這個分子帶到何方而言，我們擁有太多選擇，真是令人眼花撩亂。

Tess Smith, Leerink Partners.

Tess Smith，Leerink Partners。

Congrats on the progress. Just with respect to the TED program and the competitive landscape, could you comment on some of the data we recently saw from the IL-6 class, whether you think Sat is approvable with that data set and sort of your expectations for batoclimab relative to those results? And then secondly, is there any update you could provide from the overseas study that you're running with 1402? And any sort of timing guidance for when we might see data from additional indications from that study?

恭喜你取得進展。就 TED 專案和競爭格局而言，您能否評論一下我們最近看到的 IL-6 類藥物的一些數據？您認為 Sat 能否根據這些數據獲得批准？您對 batoclimab 相對於這些結果的預期是什麼？其次，您能否提供您正在進行的與 1402 合作的海外研究的最新進展？對於該研​​究的其他指標數據，是否有任何時間的指導？

Yeah, thanks. Those are, look, obviously great questions. I'll say, obviously, not our place to make comments on the approvability of other mechanisms. There was a notably high placebo response in the IL-6 study, which is something we've paid attention to. But overall, no specific comments on where that program goes from here. From a competitive landscape perspective, I think the competitive intensity in TED is real, as I said earlier.

嗯，謝謝。這些問題顯然都很好。很顯然，我們不該對其他機制的可接受性發表評論。IL-6 研究中出現了明顯的安慰劑效應，我們對此非常關注。但總的來說，目前還沒有關於該項目未來發展方向的具體評論。從競爭格局的角度來看，我認為 TED 的競爭強度是真實存在的，正如我之前所說。

And the IGF-1Rs are efficacious, although they have safety and tolerability concerns associated with them. And so I think we're sort of focused on where we could play in TED. And then as we said a minute ago, thinking about Graves', an opportunity to impact the disease much earlier in its course. And I think that's an important thing to the way that we are approaching that with 1402.

雖然IGF-1R受體具有療效，但其安全性和耐受性存在一些問題。所以我覺得我們現在比較關注的是我們能在 TED 大會上扮演什麼角色。正如我們剛才所說，考慮到格雷夫茲病，這是一個在疾病早期階段對其產生影響的機會。我認為這對我們處理 1402 號法案的方式來說非常重要。

On the sort of second overseas study, look, I think we, obviously, at this point, have a number of large registrational programs running in 1402 that are big global studies. We continue to like the option of small, fast POCs overseas and feeding that information into bigger studies. If and when we have anything to share from those ongoing efforts, we'll share it. But mostly, it's being used to inform either indication selection or design decisions of the bigger studies.

關於第二次海外學習，你看，我認為，很明顯，目前我們在 1402 學年開展了許多大型註冊項目，這些都是大型全球性研究項目。我們仍然喜歡在海外進行小型、快速的 POC 研究，並將這些資訊回饋到更大規模的研究中。如果這些正在進行的工作有任何進展，我們會及時分享。但主要用途是為更大規模研究的適應症選擇或設計決策提供資訊。

Brandon Frith, Wolfe Research.

Brandon Frith，Wolfe Research。

This is Brandon on for Andy. Have you provided any analogs for the DM launch? And we're curious to know what to expect for the cadence out of the gate in longer term.

這是布蘭登替安迪發言。你們有沒有提供DM發射的類似案例？我們很想知道從長遠來看，開局的節奏會是什麼樣的。

Yeah, perfect. Look, I think DM is an area with high unmet need, but also not a lot of novel therapies recently launched. So first of all, there aren't great analogs to look at, specifically in DM. And second of all, I think the appropriate course for any public company is to guide cautiously on launch speed and to say that we're going to do everything we can to get this drug out there and to get docs excited about it.

對，完美。我認為，糖尿病是需求尚未充分滿足的領域，但最近推出的新療法卻不多。首先，沒有很好的類比可以參考，尤其是在數位媒體領域。其次，我認為任何上市公司都應該謹慎地指導產品上市速度，並表示我們將盡一切努力讓這種藥物上市，並讓醫生對它感到興奮。

And the thing that we're most confident in is that the overall market opportunity is large, that there is high unmet patient need and that when we get to peak penetration, there's a really big and exciting opportunity. Exactly how long it takes to get there, I think we're going to see is the answer, and we're going to do everything we can to make it as successful as we can. Obviously, the real value add is the stuff to get the long-term trajectory here right. So that's probably how I think about the launch.

我們最有信心的是，整體市場機會巨大，患者的需求尚未得到滿足，而且當我們達到市場滲透率峰值時，將會出現一個真正巨大而令人興奮的機會。至於究竟需要多長時間才能到達那裡，我想我們很快就會知道答案，我們將盡一切努力使其盡可能成功。顯然，真正的價值在於如何確保公司的長期發展軌跡正確。所以，這大概就是我對這次發表會的看法。

Sam Slutsky, LifeSci Capital.

Sam Slutsky，LifeSci Capital。

This is Gaurav, on for Sam from LifeSci. So just a question on Graves' here. Based on all the market research done to date, as you compare the uncontrolled Graves' disease opportunity versus what FcRns have shown in the MG market, I guess, how do you size these up? How are you thinking about the opportunity? Is it bigger, smaller, similar as we think about MG for FcRns?

我是 Gaurav，替我接聽來自 LifeSci 的 Sam 的電話。所以，關於格雷夫斯，我有個問題。根據迄今為止的所有市場調查，當您將不受控制的格雷夫斯病市場與 FcRns 在 MG 市場所展現的市場前景進行比較時，您如何評估這些市場前景？你如何看待這個機會？它比我們想像中的 FcRns 的 MG 更大、更小還是更相似？

I mean, look, it's hard to -- the MG market has been tremendous. And so I think it's hard to call it one way or another. But obviously, there's a lot of uncontrolled Graves' patients, and it's an exciting place to be. And I think we have a real opportunity to build something big. There's just lots and lots and lots of uncontrolled patients is the answer.

我的意思是，你看，這很難——MG市場一直非常火爆。所以我覺得很難一概而論。但很顯然，有很多格雷夫茲病患者病情不受控制，這是一個令人興奮的地方。我認為我們確實有機會成就一番大事業。答案是：有很多很多很多未受控制的病人。

The other thing I'll say is we'll talk more about the commercial opportunity in Graves' disease on December 11. And I think we're excited with what we see. And I think we can make -- I think the most important thing is there are hundreds of thousands of patients for whom we could make a meaningful difference and a lot of different ways for us to get into that market and establish different toeholds in places. And so we're looking forward to all of that.

另外，我要說的是，我們將在 12 月 11 日詳細討論格雷夫茲病的商業機會。我認為我們對目前所看到的感到興奮。我認為我們可以做到——我認為最重要的是，有成千上萬的患者，我們可以為他們帶來有意義的改變，而且我們有很多不同的方法可以進入這個市場，並在不同的地方站穩腳跟。所以，我們非常期待這一切。

We're also learning, and I want to highlight this as an important advantage that we have from being first, so much about the Graves' opportunity by being out there with these docs enrolling patients in the study, looking out at what we're finding. And I think that competitive benefit is going to set us up really well to make sure we've got the right product on the market as well.

我們也在不斷學習，我想強調這是我們作為先行者所擁有的重要優勢，透過與這些醫生一起招募患者參與研究，觀察我們發現的情況，我們能夠更好地了解格雷夫斯病的機會。我認為這種競爭優勢將使我們能夠更好地確保將合適的產品推向市場。

There are no further questions at this time. I will now turn the call back over to Mr. Matthew Gline for any closing remarks.

目前沒有其他問題了。現在我將把電話轉回給馬修‧格萊恩先生，請他作總結發言。

Thank you. Thank you, everybody, for listening this morning. Once again, a phenomenal quarter for us in terms of the results we delivered. And super importantly, looking forward to getting together on the 11th to talk about the future and address in further detail some of the very same questions we got on today's call. So I hope to see many of you there. And I hope you all have a great end to your year apart from that. Thanks very much and have a good day.

謝謝。謝謝大家今天早上收聽。就我們所取得的業績而言，這又是一個非常棒的季度。更重要的是，期待在 11 號聚在一起討論未來，並更詳細地解答我們在今天電話會議上提出的一些問題。所以，我希望在那裡見到你們中的許多人。除此之外，我希望你們今年都能有個美好的結尾。非常感謝，祝您今天過得愉快。

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

今天的電話會議到此結束。感謝您的參與，您現在可以斷開連接了。再見。