argenx SE (ARGX) 2023 Q2 法說會逐字稿

Good morning. My name is Sarah, and I will be your conference operator today. I would like to welcome everyone to the call. (Operator Instructions).

早上好。我叫莎拉，今天我將擔任你們的會議操作員。我謹歡迎大家致電。 （操作員說明）。

Thank you. I'd like to introduce Bell -- sorry, Beth DelGiacco, Vice President, Global Head of Corporate Communications and Investor Relations. You may now begin your conference.

謝謝。我想介紹貝爾——抱歉，貝絲·德爾賈科 (Beth DelGiacco)，她是副總裁、企業傳播和投資者關係全球主管。您現在可以開始會議了。

Thank you, operator. A press release was issued earlier today, with our half year 2023 financial results and the second quarter business update. This can be found on our website, along with the presentation for today's webcast. Before we begin, I'd like to remind you on Slide 2 that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical development, regulatory time lines, the potential success of our product candidates, financial projections and upcoming milestones.

謝謝你，接線員。今天早些時候發布了一份新聞稿，其中包括我們的 2023 年半年財務業績和第二季度業務更新。您可以在我們的網站上找到該內容以及今天網絡廣播的演示文稿。在我們開始之前，我想在幻燈片 2 上提醒您，本次電話會議期間可能會出現前瞻性陳述。這些可能包括有關我們未來預期、臨床開發、監管時間表、我們候選產品的潛在成功、財務預測和即將到來的里程碑的聲明。

Actual results may differ materially from those indicated by these statements. Argenx is not under any obligation to update statements regarding the future or to conform those statements in relation to actual results unless required by law. I'm joined on the call today by Tim Van Hauwermeiren, Chief Executive Officer; Karl Gubitz, Chief Financial Officer; and Karen Massey, Chief Operating Officer. I'll now turn the call to Tim.

實際結果可能與這些陳述所示的結果存在重大差異。除非法律要求，Argenx 沒有義務更新有關未來的聲明或使這些聲明與實際結果保持一致。今天，首席執行官 Tim Van Hauwermeiren 也加入了我的電話會議。卡爾·古比茨，首席財務官；和首席運營官凱倫·梅西 (Karen Massey)。我現在將電話轉給蒂姆。

Thank you, Beth, and welcome, everyone. I'll begin on Slide #3. This has been an incredibly exciting time at argenx, and we are so happy to be delivering good news to the gMG and CIDP communities. And patients sitting with autoimmune disease more broadly. We have successfully achieved several key milestones that we laid out at the beginning of the year, bringing us one step closer to our mission to transform treatment for people living with severe autoimmune diseases.

謝謝你，貝絲，歡迎大家。我將從第 3 張幻燈片開始。這是 argenx 令人難以置信的激動人心的時刻，我們很高興向 gMG 和 CIDP 社區傳遞好消息。更廣泛地患有自身免疫性疾病的患者。我們已經成功實現了年初制定的幾個關鍵里程碑，使我們離改變嚴重自身免疫性疾病患者治療的使命又近了一步。

Transformation to us means patients living their lives with minimal interruption due to their disease, so they can have more time to do things that they enjoy. We see this as a sign of hope for patients who have been waiting many needs for meaningful innovation.

對我們來說，轉型意味著患者的生活不會因為疾病而受到干擾，這樣他們就可以有更多時間做自己喜歡的事情。我們認為這對於那些一直在等待有意義的創新的許多需求的患者來說是一個希望的跡象。

Slide 4. At the beginning of the year, we outlined an ambitious plan to create value for our key stakeholders by driving sustained growth across the business. Commercially, our commitment was to expand into earlier gMG patient segment and broaden into new geographies. We have made progress across both of these goals, which Karen will talk about later in the call.

幻燈片 4。年初，我們制定了一項雄心勃勃的計劃，旨在通過推動整個業務的持續增長，為我們的主要利益相關者創造價值。在商業上，我們的承諾是擴展到早期的 gMG 患者細分市場並擴展到新的地區。我們在這兩個目標上都取得了進展，凱倫稍後將在電話會議中談到這一點。

From the clinical side, we said we would advance (inaudible) programs forward to demonstrate the power of our FT fragments and the time line and a product opportunity. Our conviction in this opportunity has only grown following the positive CLP data last week, and we expect more momentum later this year with 2 Phase III leaders in ITP and (inaudible). We're also committed to continued investment in innovation. This includes both our early stage programs and (inaudible) and ARGX-119 but also our pipeline expansion through our immunology innovation program.

從臨床方面來看，我們表示我們將推進（聽不清）項目，以展示我們 FT 片段的力量以及時間線和產品機會。在上周中電的積極數據之後，我們對這一機會的信念才更加堅定，我們預計今年晚些時候，ITP 和（聽不清）的 2 個 III 期領先者將帶來更多動力。我們還致力於持續投資創新。這包括我們的早期項目和（聽不清）和 ARGX-119，還包括我們通過免疫學創新項目擴展的管道。

I'm proud to say that we are right on track with our goals for 2023, having achieved the milestones we laid out and the (inaudible). Slide 5. Very quickly, I would like to recap the recent clinical news in CIDP and MMN. Last week, we announced positive end year results. We studied a broad patient population and saw a 67% response rate in Stage A supporting our long-standing hypothesis that CIDP is an IgG mediated disease.

我很自豪地說，我們正朝著 2023 年的目標走上正軌，實現了我們設定的里程碑和（聽不清）。幻燈片 5。很快，我想回顧一下 CIDP 和 MMN 中最近的臨床新聞。上週，我們宣布了積極的年終業績。我們研究了廣泛的患者群體，發現 A 階段的緩解率為 67%，這支持了我們長期以來的假設，即 CIDP 是一種 IgG 介導的疾病。

In Stage B, the study medicine probably endpoint with an impressive p value demonstrating that VYVGART Hytrulo reduces the risk of relapse by 61% based on time to first adjusted INCAT deterioration. We had several conversations with neurologists following our announcements, which were highly encouraging around the potential for these data to create a paradigm shift. The team is now preparing for an upcoming interaction with the FDA on the data, while simultaneously working on the SBLA.

在 B 階段，研究藥物可能會以令人印象深刻的 p 值作為終點，表明根據首次調整 INCAT 惡化的時間，VYVGART Hytrulo 可將復發風險降低 61%。在我們宣布這一消息後，我們與神經科醫生進行了幾次對話，這些數據創造範式轉變的潛力非常令人鼓舞。該團隊目前正在準備即將與 FDA 就數據進行互動，同時致力於 SBLA 的工作。

Slide 6. In June, we also shared Phase II data of empa for MMN. The key highlights are: we are advancing forward with ARDA studies. This decision follows a planned safety review by an independent data monitoring committee of 22 patients in Cohort 1, including 9 who completed the full 15 big treatment period. The IBMC confirms a favorable safety and tolerability profile, consistent with results from the Phase I study and be able to go ahead to move forward.

幻燈片 6. 6 月份，我們還分享了 MMN 的 empa II 期數據。主要亮點是：我們正在推進 ARDA 研究。這一決定是在一個獨立數據監測委員會對第 1 組中的 22 名患者進行了計劃的安全審查之後做出的，其中包括 9 名完成了完整 15 個大治療期的患者。 IBMC 確認了良好的安全性和耐受性概況，與第一階段研究的結果一致，並且能夠繼續前進。

Based on this recommendation and an internal efficacy assessment, we believe we have established proof of concept in MMN and will be advancing to a second dose cohort. We plan to report top line results from the full study next year. MMN management is just the first indication for empa, but we believe this could be our second pipeline in a product opportunity. We are on track to start a Phase II study in DGF later this year and in terms of my guidance earlier next year.

根據這一建議和內部療效評估，我們相信我們已經在 MMN 中建立了概念驗證，並將推進到第二個劑量隊列。我們計劃明年報告完整研究的主要結果。 MMN 管理只是 empa 的第一個適應症，但我們相信這可能是我們產品機會中的第二個管道。根據我明年初的指導，我們有望在今年晚些時候開始 DGF 的 II 期研究。

Slide 7. The addition of our leadership in the neuromuscular space is quickly emerging. And you can see the puzzle pieces coming together with each quarter of revenue growth from VYVGART and VYVGART Hytrulo and the key data led us from our clinical programs. We have generated almost $500 million in net forecast sales this year-to-date, driven by consistent quarter-over-quarter growth. VYVGART Hytrulo was approved in June. So we now have 2 approved commercial products for gMG patients honoring our long-term commitment to this community. With ADHERE, it's important to consider what is positive outcome means to the neuromuscular community. This was the largest CIDP trial ever run and the first that included several unique design features. We hope that we will set the bar for what CIDP trials look like going forward to ensure the right patients are getting into the study. Beyond the impressive efficacy and safety we also uncovered important biology insights showing CIDP IgG-mediated. This is what we want leadership to look like for all of our indications, doing what is best for patients, physicians and to further our fundamental understanding of disease biology.

幻燈片 7。我們在神經肌肉領域的領導地位正在迅速顯現。您可以看到 VYVGART 和 VYVGART Hytrulo 每個季度收入增長的拼圖以及臨床項目引導我們的關鍵數據。在季度環比持續增長的推動下，今年迄今為止，我們的淨預測銷售額已接近 5 億美元。 VYVGART Hytrulo 於 6 月獲得批准。因此，我們現在有 2 種獲批用於 gMG 患者的商業產品，兌現了我們對這個社區的長期承諾。對於 ADHERE，重要的是要考慮積極的結果對神經肌肉界意味著什麼。這是有史以來規模最大的 CIDP 試驗，也是首次包含多項獨特設計功能的試驗。我們希望能夠為 CIDP 試驗的未來設定標準，以確保合適的患者參與研究。除了令人印象深刻的功效和安全性之外，我們還發現了 CIDP IgG 介導的重要生物學見解。這就是我們希望領導層能夠針對我們所有的適應症，做對患者、醫生最有利的事情，並加深我們對疾病生物學的基本理解。

The next (inaudible) of readouts within our neuromuscular franchise will be myositis where we are also innovating with our (inaudible) . -- by including 3 unique subsets, macro timing, antisynthetase and dermatomyositis. These subsets are unified by muscle deterioration associated the progression of the disease that can present very differently with other physical manifestations in the joints, lung, skin or other compartments. Each subset is also characterized by the own unique IgG autoantibodies. And we believe the field is ready to use the IgG auto antibody signature to reclassify myositis. We expect a GO/NO GO decision next year, which will inform us whether to advance all these subsets into the Phase III, and will provide clear underlying biology insights into the broad treatment of myositis.

我們的神經肌肉系列中的下一個（聽不清）讀數將是肌炎，我們也在其中進行創新（聽不清）。 -- 包括 3 個獨特的子集：宏觀時序、抗合成酶和皮肌炎。這些子集通過與疾病進展相關的肌肉退化而統一起來，其表現可能與關節、肺、皮膚或其他部位的其他身體表現非常不同。每個子集還具有自己獨特的 IgG 自身抗體的特徵。我們相信該領域已準備好使用 IgG 自身抗體特徵來重新分類肌炎。我們預計明年會做出“繼續/不繼續”的決定，這將告訴我們是否將所有這些子集推進到 III 期，並將為肌炎的廣泛治療提供清晰的基礎生物學見解。

We are also building up our pipeline opportunities with empa and ARGX-119. We are thrilled to have proof of concept in MMN that have also published significant ventilation data on the underlying biology. From a franchise perspective, MMN (inaudible) squarely into the core capabilities we are building. We are currently in the Phase I healthy volatile study with ARGX-119, and for which we will be evaluating its potential income general in (inaudible) syndrome and (inaudible) as part of a Phase Ib patient cohorts.

我們還通過 empa 和 ARGX-119 建立我們的管道機會。我們很高興在 MMN 中獲得概念證明，並且還發布了有關基礎生物學的重要通氣數據。從特許經營的角度來看，MMN（聽不清）完全融入了我們正在構建的核心能力。我們目前正在進行 ARGX-119 的 I 期健康揮發性研究，為此我們將評估其在（聽不清）綜合徵和（聽不清）作為 Ib 期患者隊列的一部分的潛在收入。

Our commitment within neuromuscular extends across our business. First, the relation is per building commercially with the neuromuscular community, including patients, physicians and other entity groups. We are also building a reputation clinically in how we design clinical trials to be patient-friendly, and unlock key translation biology insights. And all of this is included in the scientific foundation we are building in the space, partnering with leading neuro disease biologists, and seeking out opportunities to innovate and expand our pipeline going forward within neuromuscular.

我們對神經肌肉領域的承諾延伸到我們的整個業務。首先，這種關係是與神經肌肉社區的商業關係，包括患者、醫生和其他實體團體。我們還在如何設計對患者友好的臨床試驗以及解鎖關鍵的轉化生物學見解方面建立了臨床聲譽。所有這些都包含在我們正在該領域建立的科學基礎中，我們與領先的神經疾病生物學家合作，並尋找機會創新和擴展我們在神經肌肉領域的產品線。

And with that, I'm going to turn the call over to Karl to talk about our 2Q and half year financials and our recent equity rates.

接下來，我將把電話轉給卡爾，討論我們第二季度和半年的財務狀況以及我們最近的股本利率。

Thank you, Tim. Slide 8. Our second quarter 2023 financial results are detailed in our press release from this morning, so I will only highlight the key points here. The continued momentum of our launch is well reflected in our second quarter revenues, we generated $281 million total revenues, including $269 million global net product sales and $12 million in collaboration and other revenues.

謝謝你，蒂姆。幻燈片 8。我們今天上午的新聞稿中詳細介紹了 2023 年第二季度的財務業績，因此我在此僅強調要點。我們推出的持續勢頭很好地反映在我們第二季度的收入中，我們創造了 2.81 億美元的總收入，其中包括 2.69 億美元的全球產品淨銷售額以及 1200 萬美元的合作和其他收入。

In looking at the regional breakdown of our global product sales, you can see that $244 million was from the U.S., $13 million from Japan and $12 million from Europe and our distributor markets. The launch in Europe is largely Germany. Remember that beginning in March, we started to accrue revenue in Germany at a projected negotiated price, which we will learn in September. This accounts for the lower quarter-over-quarter growth in Europe. Other markets will start to contribute in Q3 onwards, following our launch in Italy.

從我們全球產品銷售的區域細分來看，您可以看到 2.44 億美元來自美國，1300 萬美元來自日本，1200 萬美元來自歐洲和我們的分銷商市場。在歐洲的推出主要是在德國。請記住，從 3 月份開始，我們開始按照預計的協商價格在德國累積收入，我們將在 9 月份得知這一情況。這就是歐洲季度環比增長較低的原因。繼我們在意大利推出後，其他市場將在第三季度開始做出貢獻。

Our total expenses were $383 million for the second quarter, indicating an operating loss of $102 million for the quarter. We ended the quarter with $2 billion in cash, cash equivalents and current financial assets. This excludes gross proceeds of approximately $1.3 billion from the global offering we completed last week, which will allow us to execute on the many opportunities ahead, specifically on the heels of positive at year data and our growing conviction in VYVGART and the rest of our pipeline.

我們第二季度的總支出為 3.83 億美元，這表明該季度的運營虧損為 1.02 億美元。本季度結束時，我們擁有 20 億美元的現金、現金等價物和流動金融資產。這不包括我們上週完成的全球發行中約13 億美元的總收益，這將使我們能夠抓住未來的許多機會，特別是在去年積極的數據以及我們對VYVGART 和我們的其他產品的信心不斷增強之後。

We are still in the process of reviewing, how our increased ambition level will change our operational spend. So, as of today, we are not able to confirm our prior cash burn guidance of $500 million. I will provide an update at a later date. I'll now, hand the call to Karen for a commercial update.

我們仍在審查我們不斷提高的雄心水平將如何改變我們的運營支出。因此，截至今天，我們無法確認之前 5 億美元的現金消耗指引。我將在稍後提供更新。我現在將電話轉給凱倫以獲取商業更新。

Thank you, Karl. Let's go to Slide 9. We started the year with a clear and simple vision commercially to reach more patients with VYVGART globally. We plan to do this by driving multidimensional expansion in gMG, including geographic expansion, the launch of our subcutaneous product and by driving usage into earlier gMG treatment lines.

謝謝你，卡爾。讓我們看幻燈片 9。我們以清晰而簡單的商業願景開始了新的一年，即在全球範圍內惠及更多 VYVGART 患者。我們計劃通過推動 gMG 的多維擴張來實現這一目標，包括地域擴張、皮下產品的推出以及推動早期 gMG 治療系列的使用。

We also look ahead to the multiple data readouts expected this year, and how this would drive expansion into new patient segments over time. I'm going to talk today about the continued strong performance from our gMG launch, but also about the pivot point we are facing, as we look ahead to the evolving opportunity before us. The outstanding results for mid-year have strengthened our conviction that we will be a leader beyond MG in neuromuscular. And that we can start to leverage the launch capabilities we have built to prepare for multidimensional expansion across product presentations, new geographies and towards a portfolio of indications.

我們還展望了今年預計的多個數據讀數，以及隨著時間的推移，這將如何推動向新患者群體的擴張。今天我將談論我們的 gMG 發布帶來的持續強勁表現，同時也會談論我們面臨的關鍵點，因為我們展望著擺在我們面前不斷發展的機會。年中的出色業績更加堅定了我們將成為神經肌肉領域超越 MG 的領導者的信念。我們可以開始利用我們已經建立的發布能力，為跨產品展示、新地域和適應症組合的多維擴張做好準備。

Slide 10. Starting with our recent commercial performance. We had a great first half of the year, generating $489 million in net VYVGART sales, over the first 2 quarters. This impressive revenue number translates to more patients getting access to VYVGART and more opportunity for us to change patients' lives. We are incredibly happy with the results. We can point to several key drivers of the momentum we saw in the second quarter.

幻燈片 10。從我們最近的商業表演開始。今年上半年我們表現出色，前兩個季度的 VYVGART 淨銷售額達到 4.89 億美元。這一令人印象深刻的收入數字意味著更多的患者能夠獲得 VYVGART，也讓我們有更多機會改變患者的生活。我們對結果非常滿意。我們可以指出第二季度這一勢頭的幾個關鍵驅動因素。

First, we are seeing consistent growth looking at month-over-month new patient starts. We are reaching patients in earlier lines of therapy, though we're still at the front end of reaching the 17,000 patients, we believe we can address the VYVGART. The task before us is to shift into earlier lines of treatment and overcome neurologists inertia. This will take time, as neurologists gain deeper experience with VYVGART and will also require persistence from our field teams.

首先，我們看到逐月新增患者數量持續增長。我們正在接觸早期治療的患者，儘管我們仍處於接觸 17,000 名患者的前端，但我們相信我們可以解決 VYVGART 問題。我們面前的任務是轉向早期治療並克服神經科醫生的惰性。這需要時間，因為神經科醫生在 VYVGART 方面獲得了更深入的經驗，並且還需要我們現場團隊的堅持。

We have seen consistent prescriber growth, both in terms of breadth and depth. We now have more than 2,100 prescribers in the U.S. and a greater percentage of them each quarter are moving beyond that first script and putting additional patients on treatment. We also think that VYVGART Hytrulo will help with this shift.

我們看到處方者在廣度和深度上都在持續增長。目前，我們在美國有超過 2,100 名處方醫生，其中每個季度都有更大比例的醫生超越第一個處方，讓更多患者接受治療。我們還認為 VYVGART Hytrulo 將有助於實現這一轉變。

Slide 11. We're now a couple of weeks into the Hytrulo launch, and have received our first scripts and shipped our first vials. We will say specifics through our third quarter call, but I was very impressed by the team's readiness at the time of approval to get drug into the channel, and to patients as quickly as possible.

幻燈片 11。 Hytrulo 發布已經幾週了，我們已經收到了我們的第一個腳本並發貨了我們的第一批小瓶。我們將通過第三季度的電話會議透露具體細節，但令我印象深刻的是，該團隊在批准時準備將藥​​物進入渠道並儘快提供給患者。

Our goal with VYVGART Hytrulo is to honor our long-term commitment to the gMG community with a second product option, now subcutaneous. And also to drive growth into early line patients by simplifying or democratizing the treatment of gMG. We believe our positioning should be first line after oral therapy, and that will require further expansion into community practices. The diagnosis and treatment of MG patients can be complex, and can be associated with a trial and error approach or a battery of tests.

我們與 VYVGART Hytrulo 的目標是兌現我們對 gMG 社區的長期承諾，提供第二種產品選擇，現在是皮下注射。並通過簡化或民主化 gMG 治療來推動早期一線患者的增長。我們相信我們的定位應該是口服治療之後的一線，這將需要進一步擴展到社區實踐。重症肌無力患者的診斷和治療可能很複雜，可能需要反複試驗或一系列測試。

Current treatment options often come safety and tolerability challenges, which require the patients to decide between symptom control, emerging side effects or long-term safety concerns. This all requires close management from a gMG specialist, which is why patients are often referred to specialist centers.

當前的治療方案常常面臨安全性和耐受性挑戰，這要求患者在症狀控制、新出現的副作用或長期安全問題之間做出決定。這一切都需要 gMG 專家的密切管理，這就是為什麼患者經常被轉診到專科中心的原因。

Our conviction is that with the efficacy of VYVGART, established safety and tolerability and now 30 to 90 seconds injection with Hytrulo, we can expand usage deeper into the community of patients and prescribers. And the more experienced community prescribers gain, the more expert they will become a diagnosing MG and treating VYVGART.

我們堅信，憑藉 VYVGART 的功效、已確定的安全性和耐受性以及現在 Hytrulo 的 30 至 90 秒注射時間，我們可以將使用範圍擴大到患者和處方者社區。社區處方者經驗越豐富，他們就越能成為診斷 MG 和治療 VYVGART 的專家。

Now that we have the results of the VIB trial, we can take many of the same themes that we've seen with gMG and apply them to CIDP as well. The CIDP community has been waiting for innovation for over 30 years. And with these data, we believe we can bring transformational change to patients. For me, one of the most compelling data points from ADHERE was the 91% of eligible patients, who rolled over into the open-label extension study including patients who relapsed in Part B and were given the option to go back to their prior therapy or to stay on VYVGART.

現在我們已經有了 VIB 試驗的結果，我們可以採用許多與 gMG 相同的主題並將它們應用到 CIDP 中。 CIDP 社區 30 多年來一直在等待創新。有了這些數據，我們相信我們可以為患者帶來革命性的改變。對我來說，ADHERE 最引人注目的數據點之一是 91% 的符合條件的患者轉入開放標籤擴展研究，其中包括 B 部分中復發的患者，並且可以選擇返回之前的治療或留在VYVGART 。

We see this as a good indication that the patient experience with VYVGART is different. We know that there will also be unique challenges associated with the CIDP market based on the comfort level and loyalty associated with current treatment. But, we also see the opportunity to raise the bar on what a treatment can offer, taking into account the full patient experience, efficacy, safety and the burden associated with administration.

我們認為這是一個很好的跡象，表明 VYVGART 的患者體驗有所不同。我們知道，基於與當前治療相關的舒適度和忠誠度，CIDP 市場也將面臨獨特的挑戰。但是，我們也看到了提高治療水平的機會，同時考慮到患者的完整體驗、療效、安全性和與給藥相關的負擔。

Slide 12. Before I wrap up and turn the call back to Tim, I want to shift to the progress we're making with our global geographic expansion. We've had 3 key updates, since our last call and still more ahead this year, demonstrating the speed at which we are executing on our global launch strategy. First, we received approval for VYVGART in China through our partner Zai Lab at the end of June. This means we will be eligible to apply to the NRDL in 2024, which is important from a timing perspective because it will open the opportunity to patients who are not privately insured. Zai Lab also submitted the BLA to (inaudible), and it was accepted.

幻燈片 12。在結束並將電話轉回蒂姆之前，我想談談我們在全球地理擴張方面所取得的進展。自上次電話會議以來，我們已經進行了 3 項關鍵更新，今年還將進行更多更新，這展示了我們執行全球發布戰略的速度。首先，我們於 6 月底通過我們的合作夥伴再鼎醫藥獲得了 VYVGART 在中國的批准。這意味著我們將有資格在 2024 年申請國家醫保目錄，從時機角度來看，這很重要，因為它將為沒有私人保險的患者提供機會。 Zai Lab 還向（聽不清）提交了 BLA，並被接受。

Earlier in July, we also successfully completed reimbursement negotiations in Italy, marking the second country within Europe to have officially launched VYVGART. I'm incredibly proud of the team expanding access for Italian patients just 11 months after European approval. And last, we finalized the commercial and distribution agreement in South Korea with Handok a team with a great track record as a commercial partner. Similar to our other distribution agreements Handok will take the lead on all regulatory and commercial activities associated with VYVGART in South Korea.

7 月初，我們還在意大利成功完成了報銷談判，成為歐洲第二個正式啟動 VYVGART 的國家。我對團隊在歐洲獲得批准後僅 11 個月就擴大對意大利患者的訪問範圍感到非常自豪。最後，我們與 Handok 敲定了韓國的商業和分銷協議，Handok 是一個作為商業合作夥伴擁有良好記錄的團隊。與我們的其他分銷協議類似，Handok 將主導韓國與 VYVGART 相關的所有監管和商業活動。

Slide 13. I want to close with the wide behind all of our expansion strategies, which are the patients who are living with severe autoimmune disease. On the heels of another strong quarter, and a positive outcome in CIDP, we are more motivated than ever to drive a paradigm shift in how autoimmune is treated. Current autoimmune treatments come with many trade-offs and now is the opportunity for transformative change.

幻燈片 13。最後，我想談談我們所有擴張戰略背後的廣泛因素，即患有嚴重自身免疫性疾病的患者。在又一個強勁的季度以及 CIDP 取得積極成果之後，我們比以往任何時候都更有動力推動自身免疫治療方式的範式轉變。當前的自身免疫治療需要進行許多權衡，現在是變革的機會。

We want to take the full patient experience into account; efficacy, safety and treatment burden and give patients more days within not reminded of their disease. It's the right time to meaningful change, and we believe we have a unique medicine, patient-centric strategies and a talented team to deliver. I'll hand it back to Tim. .

我們希望考慮到患者的完整體驗；療效、安全性和治療負擔，並讓患者有更多的天數不被提醒他們的疾病。現在是進行有意義的變革的正確時機，我們相信我們擁有獨特的藥物、以患者為中心的策略和一支才華橫溢的團隊。我會把它還給蒂姆。 。

Thank you, Karen. Slide 14. Coming back to where we started which is to look back at the plan 3 set forth at the start of the year. We have delivered on our promise to execute and drive sustained growth across our business. I'm incredibly proud of the team for these achievements. They do not come without a lot of hard work. We continue to show in all that we do, our commitment to involve innovation and execution on the hand of patients. Our work is now done, and we still have a lot to look forward to by end of 2023, on our path to transforming treatment of (inaudible) autoimmune diseases .

謝謝你，凱倫。幻燈片 14。回到我們開始的地方，即回顧年初制定的計劃 3。我們兌現了執行並推動整個業務持續增長的承諾。我為團隊取得的這些成就感到無比自豪。他們的到來離不開大量的努力。我們繼續在我們所做的一切中展現我們對患者創新和執行的承諾。我們的工作現已完成，到 2023 年底，在改變（聽不清）自身免疫性疾病治療方法的道路上，我們仍然有很多值得期待的事情。

We will now begin the question-and-answer session. (Operator Instructions) Your first question comes from the line of Tazeen Ahmad with Bank of America.

我們現在開始問答環節。 （操作員說明）您的第一個問題來自美國銀行的 Tazeen Ahmad 線路。

Maybe, I just wanted to focus on one of the two data catalysts that you have in the fourth quarter, specifically for the pemphigus readout. Maybe, Tim, can you frame for us what to expect in terms of the top line results that you're going to be presenting? And in terms of feedback that you've gotten from physicians, what would be considered good data? .

也許，我只是想關注第四季度的兩個數據催化劑之一，特別是天皰瘡讀數。蒂姆，您能否為我們描述一下您將要展示的主要結果？就您從醫生那裡得到的反饋而言，什麼被認為是好的數據？ 。

Thank you for the time for this question. It's some of the key catalysts, I think, of the remaining part of the year. In pemphigus, the primary endpoint is mainly (inaudible) around showing a statistically significant delta versus placebo. So we're testing a (inaudible) versus placebo in a background of steroid tapering. So the idea is to show statistically significant win on the primary endpoint, on an endpoint, which is complete remission on minimum therapy, that means a minimum dose of steroids. In the key secondary end points, we're going to unpack elements which are really critical to patients. That means now, what is the extent to which we can take steroids. It's very important, that's what patients care about. And also, what is the speed to disease control, that means stopping the formation of new lesions and then followed by the closing of the lesion. So this is in a nutshell, the key end points blending what the regulators care about and what patients care about. Thanks for the question. .

感謝您抽出時間回答這個問題。我認為，這是今年剩餘時間的一些關鍵催化劑。對於天皰瘡，主要終點主要是（聽不清）與安慰劑相比顯示出統計學上顯著的差異。因此，我們正在類固醇逐漸減少的背景下測試（聽不清）與安慰劑的對比。因此，我們的想法是在主要終點上顯示出統計上顯著的勝利，即在最低治療（即最小劑量的類固醇）下完全緩解的終點上。在關鍵的次要終點中，我們將解析對患者真正至關重要的元素。這意味著現在我們可以服用類固醇的程度是多少。這非常重要，這是患者關心的。另外，疾病控制的速度是多少，這意味著停止新病灶的形成，然後病灶的閉合。簡而言之，關鍵終點融合了監管機構關心的內容和患者關心的內容。謝謝你的提問。 。

Your next question comes from the line of Derek Archila with Wells Fargo. .

您的下一個問題來自富國銀行的德里克·阿奇拉 (Derek Archila)。 。

I actually have two brief questions, if I may. So first, I was just hoping you could talk a little bit about the sales momentum for VYVGART. You talked about some of the ex U.S. geos coming online. You've launched Hytrulo now, and this push into earlier lines. So I guess, as you think about the second half, which of these do you think is going to be the biggest incremental contributor to sales growth And then the second question, you stated in the PR, you're going to start the TED trial for VYVGART. Given what we're seeing with Tepezza's recent performance in the thyroid eye disease market, mean has your optimism around that commercial opportunity changed at all? And when will you communicate the full details of that trial design? .

如果可以的話，我實際上有兩個簡短的問題。首先，我只是希望您能談談 VYVGART 的銷售勢頭。您談到了一些前美國地理人士即將上線。您現在已經推出了 Hytrulo，並且這將推進到早期的產品線。所以我想，當你考慮下半年時，你認為其中哪一個將成為銷售增長的最大增量貢獻者 然後第二個問題，你在公關中提到，你將開始 TED 試驗對於維沃加特。考慮到 Tepezza 最近在甲狀腺眼病市場的表現，您對這一商業機會的樂觀態度是否發生了變化？您什麼時候會傳達該試驗設計的完整細節？ 。

Thank you, Derek, and thanks for being us today. I'll give your question 1A to Karen, and then I will take your question 1B, okay?

謝謝你，德里克，也謝謝你今天成為我們的一員。我將你的問題 1A 交給凱倫，然後我將回答你的問題 1B，好嗎？

Thanks Tim. Thanks for the question. And as you say, I think we continue to see strong momentum and I'd say consistent momentum in the launch of VYVGART. And actually, I would say that in the second half of the year, we'll continue to see that consistency across all of the factors that you mentioned. I think, we continue to see that we're penetrating earlier lines of treatment and expanding that prescriber base.

謝謝蒂姆。謝謝你的提問。正如您所說，我認為我們繼續看到強勁的勢頭，而且我認為 VYVGART 的推出保持了一致的勢頭。事實上，我想說，在今年下半年，我們將繼續看到你提到的所有因素的一致性。我認為，我們繼續看到我們正在滲透早期的治療方案並擴大處方者基礎。

I see, no reason why that won't continue through the year. We have pricing reimbursement discussions ongoing in Europe, and so we believe those will continue through the year. And the Hytrulo only indications that we have positive feedback, and that will also contribute to our growth. So I think, one of the strengths that we have is that we are driving growth across all of those dimensions. And I think that should help us to maintain some consistent momentum. .

我明白了，這種情況沒有理由不會持續一整年。我們正在歐洲進行定價報銷討論，因此我們相信這些討論將持續到今年。 Hytrulo 僅表明我們得到了積極的反饋，這也將有助於我們的成長。所以我認為，我們擁有的優勢之一是我們正在推動所有這些方面的增長。我認為這應該有助於我們保持一致的勢頭。 。

Thank you, Karen. On the TED question Derek, I can just invite you to be a bit patient. We are on track to start the trial once we're there to vial trial design. I think they can also start to talk a little bit about how we think about positioning. We do believe that is an IgG-driven disease. We do believe the establishment of a linger correlation between the type of your auto antibody on the one hand, and your clinical symptoms on the other hand. And I think (inaudible) is well placed to shine on all the dimensions of efficacy, safety and convenience. So stay tuned on the TED story. Thank you. .

謝謝你，凱倫。關於 TED 問題 Derek，我請您耐心一點。一旦我們完成了小瓶試驗設計，我們就有望開始試驗。我認為他們也可以開始談談我們如何看待定位。我們確實相信這是一種 IgG 驅動的疾病。我們確實相信，一方面您的自身抗體類型與另一方面您的臨床症狀之間存在持續相關性。我認為（聽不清）在功效、安全性和便利性的所有方面都表現出色。請繼續關注 TED 故事。謝謝。 。

SP1 Your next question comes from the line of Yaron Werber with TD Cowen.

SP1 您的下一個問題來自 Yaron Werber 和 TD Cowen。

Congrats on a great quarter. Maybe, as we look into the (inaudible) GO/NO GO decision early next year, it's in Q1 now, can you give us any parameters at all, as to what you're looking for from a powering perspective in those first 30 or 40 patients? And what is the actual GO/NO GO metric?

恭喜您度過了一個出色的季度。也許，當我們明年初研究（聽不清）繼續/不繼續的決定時，現在是第一季度，您能給我們任何參數嗎，關於您從前 30 或40個病人？實際的 GO/NO GO 指標是什麼？

Yes. Thank you, Yaron. I mean the best anology to draw is actually the anology (inaudible) trials. So I think we need to see a minimum level of response in these first 40 patients, which give us conviction that this is not a placebo response, we're seeing. And that actually which confirms that this is a true IgG-mediated diseases, we believe. So think of a seamless Phase II, Phase III, where we need to meet a minimum criteria from an efficacy point of view. Of course, we will look at the totality of the data, including safety, but it's a seamless Phase II/III design in order not to lose time in order not to have white space between Phase II and Phase III.

是的。謝謝你，亞龍。我的意思是，最好的類比實際上是類比（聽不清）試驗。因此，我認為我們需要在前 40 名患者中看到最低水平的反應，這讓我們確信這不是我們所看到的安慰劑反應。我們相信，這實際上證實了這是一種真正的 IgG 介導的疾病。因此，考慮一個無縫的第二階段、第三階段，從功效的角度來看，我們需要滿足最低標準。當然，我們會關注數據的整體性，包括安全性，但這是一個無縫的二期/三期設計，以免浪費時間，以免二期和三期之間出現空白。

You know that we have conviction in [BP] -- we think that configures actually serves to a certain extent as a derisking step for (inaudible) . And we believe, based on all the homework, this is fully IgG-mediated disease. Very exciting indication actually to focus on -- very high unmet medical needs, very little innovation and the safety profile, I think the VYVGART will turn out to be even more important with the valuable than it will be (inaudible) . So we're very much looking forward to the decision for us. Thank you.

您知道我們對 [BP] 有信心——我們認為配置實際上在一定程度上起到了降低風險的作用（聽不清）。根據所有的功課，我們相信這是完全由 IgG 介導的疾病。實際上值得關注的非常令人興奮的跡象 - 非常高的未滿足醫療需求，很少的創新和安全狀況，我認為 VYVGART 的價值將變得更加重要（聽不清）。所以我們非常期待我們的決定。謝謝。

And is it just based on placebo? Or are you thinking a little bit on the corollary of some of the competition out there? There isn't necessarily a time but some of it is showing robust responses? Or are you sort of -- do you have that in your sights as well into the GO/NO GO decision? .

它只是基於安慰劑嗎？或者您是否對一些競爭的必然結果進行了一些思考？不一定有時間，但其中一些表現出強烈的反應？或者你在做出“繼續/不繼續”的決定時也考慮到了這一點？ 。

The GO/NO GO will basically look at the initial picture, which is emerging. I mean, we are not positioned there to look at long-term effects of the drug. Maybe you're alluding to the long-term clinical benefit we have seen in some of the (inaudible) in Phase II, where we actually did change is the course of disease. These are the data which we will also collect in the BP trial but they will not be part of the GO/NO GO decision point. Okay? .

繼續/不繼續基本上將著眼於正在出現的初始情況。我的意思是，我們的定位不是為了觀察該藥物的長期影響。也許您指的是我們在第二階段的一些（聽不清）中看到的長期臨床益處，我們實際上改變的是病程。這些是我們還將在 BP 試驗中收集的數據，但它們不會成為 GO/NO GO 決策點的一部分。好的？ 。

Your next question comes from the line of Danielle Brill with Raymond James. .

你的下一個問題來自 Danielle Brill 和 Raymond James 的對話。 。

I have a follow-up on the growth outlook for VYVGART in the second half. I'm just curious, from a modeling perspective, how we should think about the growth momentum. You've been seeing a consistent mid-20% quarter-over-quarter growth in the U.S. Is it fair to model that moving forward? And what kind of impact, if any, should we expect from the recent march of UCB's CRM?

我對VYVGART下半年的增長前景進行了跟踪。我只是好奇，從建模的角度來看，我們應該如何看待增長動力。您已經看到美國的季度環比增長持續在 20% 左右。未來的模型是否公平？如果有的話，我們應該期待 UCB CRM 最近的進展帶來什麼樣的影響？

Danielle, it's Karl. Thank you for your question. I mean, I think that as the dollar numbers become bigger, we cannot expect a continued 20% growth quarter-over-quarter, of course. Also we invite (inaudible) launch, I think it's really important that we are patient while we get those payer contracts in place. It will take a quarter or 2 to get back. Remember, that's how long it took us with VYVGART, 18 months ago.

丹妮爾，是卡爾。謝謝你的問題。我的意思是，我認為隨著美元數量的增加，我們當然不能指望季度環比持續增長 20%。我們還邀請（聽不清）啟動，我認為在我們簽訂付款人合同時保持耐心非常重要。需要一兩個季度才能回來。請記住，這就是我們在 VYVGART 上花費的時間，即 18 個月前。

In terms of competition, yes, we now do have competition in terms of (inaudible) . And of course, I think there comes a daily C5 later on. So the market is getting more competitive and also -- we have another C5 who has started a TV campaign and it's getting a little bit more crowded. Overall, of course, we still expect to grow, but I think the growth will probably be tempered as we look into the second half of the year.

在競爭方面，是的，我們現在確實在（聽不清）方面存在競爭。當然，我想以後還會有每日 C5。因此，市場競爭變得更加激烈，而且——我們還有另一位 C5 開始了電視宣傳活動，市場變得更加擁擠。當然，總體而言，我們仍然預計會增長，但我認為，隨著我們展望下半年，增長可能會有所放緩。

Your next question comes from the line of Thomas Smith with Leerink Partners. .

您的下一個問題來自 Thomas Smith 和 Leerink Partners。 。

And let me add my congrats on a great quarter. Just wanted to ask a little bit of a high-level question. You have a really strong balance sheet, pretty incredible launch momentum in gMG. Can you just comment on how you're thinking about strategic priorities here, given your significant cash balance, how you're thinking about investment between commercial infrastructure or VYVGART indication expansion or early pipeline development? Are you considering any other BD opportunities .

讓我對這個偉大的季度表示祝賀。只是想問一個高層次的問題。你們擁有非常強大的資產負債表，gMG 的啟動勢頭非常令人難以置信。鑑於您擁有大量現金餘額，您能否評論一下您如何考慮這裡的戰略優先事項，您如何考慮商業基礎設施或 VYVGART 適應症擴張或早期管道開發之間的投資？您是否正在考慮任何其他 BD 機會？

Thomas, thank you for the question, and thank you for being with us today. The answer is that we're going to fire from all cylinders. So, the effect that we have such a strong cash balance puts us in a position to fully invest in the commercial dimension. We're leaving nothing on the table of the immense opportunity we have in front of us. .

托馬斯，謝謝你提出這個問題，也感謝你今天和我們在一起。答案是我們要全力以赴。因此，我們擁有如此強勁的現金餘額，使我們能夠充分投資於商業領域。我們不會在擺在我們面前的巨大機遇上留下任何東西。 。

We do have an incredible pipeline. We have more than 60 clinical trials running now, but there's a massive volume, where we see a sense of urgency to move forward with innovative trial designs and unpacking the clinical potential of our drugs.

我們確實擁有令人難以置信的管道。我們目前正在進行 60 多項臨床試驗，但由於數量龐大，我們迫切需要推進創新試驗設計並釋放我們藥物的臨床潛力。

You can see that ARGX-117 has proven to be a drug with the first efficacy data in MMN and ARGX-119 is swiftly dose escalating to the Phase I study, so a lot to come. And we have a wave of innovation, which is progressing through big clinical towards the clinic. So firing from all cylinders. That also means that we are in a position of strength, I think there's a ton of innovation, which we're bringing forward from our platform through our pipeline and into the marketplace.

您可以看到 ARGX-117 已被證明是一種在 MMN 中擁有第一個療效數據的藥物，而 ARGX-119 正在迅速劑量升級至 I 期研究，因此還有很多工作要做。我們有一波創新浪潮，正在從大臨床走向臨床。所以所有氣缸都在點火。這也意味著我們處於優勢地位，我認為有大量的創新，我們正在將這些創新從我們的平台通過我們的管道推向市場。

But we are, of course, always externally focused looking carefully for opportunities which we like that we're entrepreneurial as a company. We also do not suffer from the (inaudible) syndrome. So if and when we see things, it's (inaudible) light. -- we will, without any doubt, enter into partnership conversations. Remember that our discovery model the IIP program, the immunology innovation program by definition, is a partnership model. So partnering is in the DNA of the company.

但當然，我們始終關注外部，仔細尋找我們喜歡的機會，因為我們是一家具有創業精神的公司。我們也沒有患有（聽不清）綜合症。因此，當我們看到事物時，它就是（聽不清）光。 ——毫無疑問，我們將進行合作對話。請記住，我們的發現模型 IIP 計劃（顧名思義，免疫學創新計劃）是一種合作夥伴關係模式。因此，合作是公司的基因。

Your next question comes from the line of Myles Minter with William Blair. .

你的下一個問題來自邁爾斯·明特和威廉·布萊爾的對話。 。

Just a question on the potential self-administration of VYVGART Hytrulo. Did you have those conversations during labeling when the product got approved for myasthenia gravis and what it would take data-wise to get self-administration in the label? Would the ability to potentially self-administer in the open-label extension efforts here be sufficient to get a self-administration option on that label for both CIDP and myasthenia gravis. .

只是關於 VYVGART Hytrulo 潛在自我管理的問題。當產品被批准用於治療重症肌無力時，您在標籤過程中是否進行過這些對話，以及在標籤中獲得自我管理需要哪些數據？在開放標籤擴展工作中潛在的自我管理能力是否足以在該標籤上獲得 CIDP 和重症肌無力的自我管理選項？ 。

Thanks for being with us today, and thank you for the question. Just a quick recap on the MG situation. I think here for the first-generation subcu, we've seen a combination of relative complex interface, a few steps you need to do with specifics of the disease indication like double vision, limited dexterity, muscle weakness and the combination of the 2 made it probably 2 high barriers for self-administration in the United States. Remember that the discussions are still ongoing in Japan and in Europe on the label, and we need to see what they will deliver. It's too early to get ahead of ourselves, I think for CIDP, we need to go for a pre-BLA meeting with the FDA calibrating expectations.

感謝您今天接受我們的採訪，也感謝您提出問題。快速回顧一下 MG 的情況。我認為對於第一代 subcu，我們已經看到了相對複雜的界面的組合，您需要根據疾病適應症的具體情況執行一些步驟，例如復視、靈活性有限、肌肉無力以及兩者的組合這可能是美國自我管理的兩個高障礙。請記住，日本和歐洲關於該標籤的討論仍在進行中，我們需要看看他們會提供什麼。現在就超出自己的預期還為時過早，我認為對於 CIDP，我們需要召開 BLA 前會議，與 FDA 一起調整預期。

We need to prepare the SBLA file submitted -- and as part of these conversations, I think we will also tackle the topic of self-administration. Importantly, you need to know that we're working very hard on the second generation of the subcutaneous product presentation of (inaudible). That is a prefilled syringe. That is a simplification of the user interface. And I think there, we have, again, a real goal to go to self-administration. But stay tuned step by step. I think the current VYVGART Hytrulo was already a significant step forward, helping us to penetrate on the market because it's decoupling the patient for the infusion change so with avoiding infusion chain bottlenecks, and we are simplifying access for the patient to the drug because now any ACP can administer the drug anywhere. Thank you for the question. .

我們需要準備提交的 SBLA 文件——作為這些對話的一部分，我認為我們還將解決自我管理的主題。重要的是，您需要知道我們正在非常努力地開發第二代皮下產品演示（聽不清）。那是一個預充式註射器。這是用戶界面的簡化。我認為，我們再次有一個真正的目標，即進行自我管理。但還是要一步一步來。我認為目前的 VYVGART Hytrulo 已經向前邁出了重要的一步，幫助我們滲透市場，因為它使患者與輸液更換脫鉤，從而避免了輸液鏈瓶頸，而且我們正在簡化患者獲得藥物的途徑，因為現在任何ACP 可以在任何地方給藥。感謝你的提問。 。

Congrats on the quarter. .

恭喜本季度。 。

Your next question comes from the line of Yatin Suneja with Guggenheim Partners. .

您的下一個問題來自古根海姆合夥人公司的 Yatin Suneja。 。

Just two quick ones for me. In terms of the patient mix currently on the drug, can you just comment, where are we in terms of refractory patient -- and what percentage of the patients are getting retreatment and at what frequency? And then, the second question is thoughts on providing revenue guidance now that you have over a year worth of experience with the launch.

對我來說只有兩個快速的。就目前使用該藥物的患者組合而言，您能否評論一下，我們在難治性患者方面處於什麼位置，以及接受再治療的患者比例是多少以及頻率是多少？然後，第二個問題是既然您已經擁有一年多的發布經驗，那麼對提供收入指導的想法是。

Yes. Thank you, Yatin, and thanks for being with us -- and I will give the question on percentage of reflective patients and numbers of the treatment to add to Karen. And then may be Karl can very quickly comment on your revenue question.

是的。謝謝你，Yatin，也感謝你和我們在一起——我將向凱倫提出關於反思患者的百分比和治療數量的問題。然後卡爾可能可以很快評論您的收入問題。

Yes. Thanks for the question. So I would say the patient mix and in particular, refractory, we at the early stages of launch, we were seeing a lot high usage in the refractory patients when physicians are just starting to get experience with the medicine. And what we've seen over time is consistent movement into those earlier lines of treatment, and we continue to see that shift and that momentum, as we execute on our plans.

是的。謝謝你的提問。所以我想說的是患者組合，特別是難治性患者，我們在推出的早期階段，當醫生剛剛開始獲得藥物經驗時，我們看到難治性患者的使用率很高。隨著時間的推移，我們看到的是早期治療方案的持續進展，並且在我們執行計劃時，我們將繼續看到這種轉變和勢頭。

On the -- in terms of the retreatment of frequency, what you can imagine is, of course, it's a bell curve, some patients are -- it's individualized dosing. So some are very frequent, some are less frequent. But what we see in the data is that it's right in line with what our assumptions were and what we provided before, which is around 5 cycles for a patient that has significantly changed. .

就頻率的再治療而言，你當然可以想像，這是一個鐘形曲線，有些患者是個體化劑量。所以有些很頻繁，有些則不太頻繁。但我們在數據中看到的是，它與我們的假設和我們之前提供的數據完全一致，對於一個發生顯著變化的患者來說，這大約是 5 個週期。 。

Yatin , it's Karl here. Thank you for your question. In terms of finance guidance, I mean, we're not ready yet. I think, there are still too many variables. The German price will be really important. The China launch, we have omnichannel launching the subcu. So I think we need to see a few quarters of that, then we'll get back to you on finance guidance. Thank you. .

雅汀，我是卡爾。謝謝你的問題。在財務指導方面，我的意思是，我們還沒有準備好。我想，變數還是太多了。德國的價格非常重要。在中國推出時，我們通過全渠道推出了 subcu。所以我認為我們需要看到幾個季度的情況，然後我們會向您回复財務指導。謝謝。 。

Your next question comes from the line of Vikram Purohit with Morgan Stanley.

您的下一個問題來自 Vikram Purohit 與摩根士丹利的對話。

So we just had one on the recent launch of subcu VYVGART into myasthenia gravis. Understanding it's early, but is there any color you could provide on the demand trends you're seeing from prescribers and patients towards subcu versus IV and -- and if you've been able to green any trends at this phase of the launch on the types of patients that are leaning more towards subcu. And on that same topic, are you able to provide any commentary at this point on how you're finding early receptivity towards the subcu option from payers. .

我們剛剛報導了最近推出的 subcu VYVGART 治療重症肌無力的情況。了解現在還為時過早，但是您是否可以提供有關您從處方者和患者那裡看到的 subcu 與 IV 的需求趨勢的任何信息，以及 - 如果您能夠在發布的這一階段將任何趨勢綠色化更傾向於subcu 的患者類型。關於同一主題，您現在是否能夠就您如何發現付款人對 subcu 選項的早期接受度提供任何評論。 。

Yes. Thank you, Vikram, I'm going to try and limit the question to one. I mean, Karen, can you comment on subcu launch dynamics and any trends which we would see.

是的。謝謝你，維克拉姆，我將嘗試將問題限制為一個。我的意思是，凱倫，您能否評論一下 subcu 的發布動態以及我們將看到的任何趨勢。

Yes, absolutely. I mean it's really too early to tell, any of the details that you asked about. But what we are seeing, we believe we have a strong value proposition and the outlook is strong. We are getting early positive signals. Those are mobile from when we're out speaking with neurologists and the feedback we're getting from our field force. Obviously, it takes a while, as Karl said, to get the payer policies in place. We have had one policy to be point but we need to continue to work on those.

是的，一點沒錯。我的意思是，現在判斷你所詢問的任何細節都還為時過早。但就我們所看到的情況而言，我們相信我們擁有強大的價值主張並且前景廣闊。我們正在收到早期的積極信號。當我們外出與神經科醫生交談時以及我們從現場人員那裡得到的反饋時，這些都是移動的。顯然，正如卡爾所說，需要一段時間才能製定付款人政策。我們有一項政策要重點，但我們需要繼續致力於這些政策。

So that impacts the uptake rate at this moment. But we are seeing enrollments come in. We are seeing positive feedback, and we strongly believe we still have the conviction that the 30 to 90 seconds is a real advantage for patients and will really start to open the market up for community neurologists. And we'll keep you updated as we learn more.

所以這會影響此時的吸收率。但我們看到註冊人數不斷增加。我們看到了積極的反饋，我們堅信我們仍然堅信 30 到 90 秒對患者來說是一個真正的優勢，並將真正開始為社區神經科醫生打開市場。當我們了解更多信息時，我們會及時通知您。

Your next question comes from the line of Allison Bratzel with Piper Sandler.

你的下一個問題來自艾莉森·布拉澤爾（Allison Bratzel）和派珀·桑德勒（Piper Sandler）的台詞。

Maybe, just a follow-up on an earlier question on the prefilled syringe. Could you just remind us of the expected cadence of updates on the subcu prefilled syringe. It does look like you've been enrolling out a Phase I bioequivalence trial in healthy volunteers for the PFS for a few months based on clintrials.gov, just curious, though, what other clinical work would need to be carried out for that to be fileable? And if you could just outline the expected data flow and development path there, that would be helpful.

也許，只是對先前有關預充式註射器的問題的跟進。您能否提醒我們 subcu 預充式註射器的預期更新節奏？根據 clintrials.gov 的數據，您似乎已經在健康志願者中進行了幾個月的 PFS I 期生物等效性試驗，不過只是好奇，需要開展哪些其他臨床工作才能實現這一目標可歸檔嗎？如果您可以概述預期的數據流和開發路徑，那將會很有幫助。

Allison, thank you for being with us today. And I'm going to comment on the question. So there are a couple of data (inaudible) which need to be generated in parallel in order to faster the PFS. So we have the bioequivalent study which you currently call out to be ongoing. We have the human factor studies, you need to complete. But then, of course, there's a whole invisible train of CMC work, which seems to happen with our CDMOs. So it's when these three come together and generate all the data, including stability data that you're actually ready to submit. We will be getting more granular on time line over the course of next year, but the prefilled syringe really is the priority for us because we think it's going to be an enabler of the long-term rollout of VYVGART and of course, a key enabler for cell administration. So stay tuned, once we work through these three data team generations. .

艾莉森，謝謝你今天和我們在一起。我將對這個問題發表評論。因此，需要並行生成一些數據（聽不清），以便加快 PFS。因此，我們正在進行生物等效性研究，您目前稱該研究正在進行中。我們有人為因素研究，需要您完成。當然，還有一整套看不見的 CMC 工作，這似乎發生在我們的 CDMO 身上。因此，當這三者結合在一起並生成所有數據時，包括您實際上準備提交的穩定性數據。我們將在明年的時間線上變得更加細化，但預充式註射器確實是我們的首要任務，因為我們認為它將成為 VYVGART 長期推出的推動者，當然，也是一個關鍵推動者用於細胞管理。因此，一旦我們完成了這三代數據團隊的工作，請繼續關注。 。

Your next question comes from the line of Alex Thomson with Stifel. .

您的下一個問題來自 Alex Thomson 與 Stifel 的對話。 。

I guess I had a quick follow-up on pemphigus. As we think about steroid tapering in the drug arm, what does good look like there in your view? Is it no steroid? Or what is a good dose of steroids in these patients look like to be clinically meaningful?

我想我對天皰瘡進行了快速隨訪。當我們考慮藥物類別中類固醇逐漸減少時，您認為什麼是好的？不是類固醇嗎？或者說，對於這些患者來說，服用多少劑量的類固醇才具有臨床意義？

Alex, thanks for that question. And just to get it clear, it's not just on the drug arm that we do steroid tapering. We actually test active versus placebo. And in both arms, the background is steroid tapering protocols. So all patients start on the same amount of steroids. And then, with a predefined protocol, you need to step down in your steroid use and the endpoint actually is a complete remission that means that your free of skin lesions on the minimum dose of steroids and there's a minimum dose the way it is used in pemphigus. So it's a very stringent endpoint to reach. And actually, you need to be at 8 weeks in CR on minimum dose of steroids in order to effectively hit the input.

亞歷克斯，謝謝你提出這個問題。需要澄清的是，我們不僅僅在藥物方面進行類固醇逐漸減少。我們實際上測試了活性藥物與安慰劑。在兩隻手臂中，背景都是類固醇逐漸減少的方案。因此，所有患者一開始就使用相同量的類固醇。然後，按照預定義的方案，您需要減少類固醇的使用，終點實際上是完全緩解，這意味著您在使用最小劑量的類固醇時不會出現皮膚損傷，並且使用它的方式也有最小劑量天皰瘡。所以這是一個非常嚴格的終點。實際上，您需要使用最小劑量的類固醇達到 CR 8 週，才能有效地達到輸入效果。

So the bar is very high. We cannot expect to a very high response rate in active, but it's really designed to push placebo as close to 0 as possible. So let's look for the delta, the statistically significant benefit between active and placebo. And this will mean on the primary end point -- in the secondary endpoint is acceptable unpack other information, which actually is very relevant for patients in terms of total cumulative use of steroids, and the ability to effectively taper meaningfully and then, of course, speed to disease control and absolute of formation of new lesions. So that is the full extent, which we will be able to impact in the top line data.

所以門檻非常高。我們不能指望活性藥物的反應率非常高，但它的設計目的確實是為了將安慰劑的反應率盡可能接近 0。因此，讓我們尋找 delta，即活性藥物和安慰劑之間在統計上顯著的益處。這意味著在主要終點上 - 在次要終點上可以接受其他信息，這些信息實際上與患者的類固醇總累積使用量以及有效地有意義地逐漸減少的能力非常相關，然後，當然，疾病控制速度和新病灶形成的絕對速度。這就是我們能夠影響頂線數據的全部範圍。

Your next question comes from the line of Akash Tewari with Jefferies. .

您的下一個問題來自 Akash Tewari 與 Jefferies 的對話。 。

This is Amy on for Akash. Just two from us. First, on non-COVID pops. Do you envision as far taken not to be given chronically as long-term maintenance? Or would it be more of a onetime treatment -- and then finally, on your expectations, could you revisit your expectations for when you'll reach profitability? .

這是艾米為阿卡什主持的節目。離我們只有兩個人。首先，關於非新冠流行音樂。您是否認為不要像長期維持那樣長期給予？或者這更像是一次性治療——最後，根據您的期望，您能否重新審視您對何時實現盈利的期望？ 。

Thank you,. And again, this is two questions for the price of one. So -- but I'll give the second question very quickly to Karl, but let me comment on pops first. This is a key question in non-COVID pop. So if my colleague and Chief Medical Officer, look would be here on the call, he would say, look, we need to learn whether it's sufficient to cleanse the body in a one-off treatment sign or VYVGART to then be symptom-free or indeed, when you need to go into a more chronic dosing in non-COVID pops to basically effectively take care of the patients -- this is one of the key questions we need to address next to the biology question in this Phase II proof-of-concept trial -- and so stay tuned to all years to learn about that. And Karl, would you mind briefly commenting on the question on 1B? .

謝謝你，。再說一次，這是兩個問題的代價。所以——但我會很快向卡爾提出第二個問題，但讓我先評論一下流行音樂。這是非新冠流行病中的一個關鍵問題。因此，如果我的同事兼首席醫療官，你看，他會說，看，我們需要了解是否足以通過一次性治療標誌或 VYVGART 清潔身體，從而消除症狀或事實上，當你需要對非新冠流行病進行更長期的給藥以基本上有效地照顧患者時——這是我們在第二階段證明中除了生物學問題之外需要解決的關鍵問題之一-概念試驗——所以請繼續關注所有年份以了解這一點。 Karl，您介意簡單評論一下 1B 上的問題嗎？ 。

Thank you, Amy. Yes, part to profitability, I mean, we're not going to comment on that in terms of timing. What I will say is that we are a sustainable company. We stand on legs. And yes, I think that's all we will say for now. Thank you. .

謝謝你，艾米。是的，部分是為了盈利，我的意思是，我們不會在時間方面對此發表評論。我要說的是，我們是一家可持續發展的公司。我們用腿站立。是的，我想這就是我們現在要說的。謝謝。 。

Your next question comes from the line of Joon Lee with Truist Securities.

您的下一個問題來自 Truist Securities 的 Joon Lee。

My apologies. Your next question comes from the line of Rehan Sharma with Goldman Sachs.

我很抱歉。你的下一個問題來自 Rehan Sharma 與高盛的對話。

It's Rajan. Just on CIDP and posed data, is it safe to assume that you're going to be positioning VYVGART got as a first-line option there to compete directly with IgG. And then, what kind of additional work do you think you need to do to convince the treating community that there is more pathogenic IgG activity in the disease than they may have previously assumed?

這是拉詹。僅根據 CIDP 和提出的數據，可以安全地假設您將把 VYVGART 定位為一線選項，直接與 IgG 競爭。然後，您認為您需要做哪些額外工作才能讓治療界相信該疾病中的致病性 IgG 活性比他們之前假設的要多？

Yes. Thanks for that question. I think there will be just like for MG, a lot of education going on, educating our audience on the fact that it is in IgG-mediated disease based on to data in hand. And I think, you correctly called out that the way the trial is designed and the way the data panned out is that there's no need to niche this product into a refractory line or a line of IVIg phases. I think the drug was equally effective in patients which were on a steroid background therapy, which has been on IVIg or SCIg and background therapy, all of which were either newly diagnosed or even in the last 6 months. So equal efficacy equal to respond to the drug across the board. So we do not see any reason to actually go and actively reach ourselves in what we think is a sizable opportunity. .

是的。謝謝你提出這個問題。我認為，就像 MG 一樣，我們會根據現有數據進行大量教育，讓觀眾了解它是 IgG 介導的疾病這一事實。我認為，您正確地指出了試驗的設計方式和數據的得出方式，即無需將該產品定位到耐火線或 IVIg 相線中。我認為該藥物對於接受類固醇背景治療的患者同樣有效，這些患者一直在接受 IVIg 或 SCIg 和背景治療，所有這些患者要么是新診斷的，要么是在過去 6 個月內確診的。因此，同等功效等於對藥物全面反應。因此，我們認為沒有任何理由去真正去主動接觸我們認為是一個相當大的機會。 。

Your next question comes from the line of Joon Lee of Truist Securities. .

您的下一個問題來自 Truist Securities 的 Joon Lee。 。

Congrats on the progress. With CIDP data on hand, how are you thinking about commercial competitiveness of (inaudible) versus IVIG and CIDP and at steady state, how do you think -- how do you see the breakdown of IVIg versus FcRn targeted products in CIDP?.

祝賀取得的進展。有了 CIDP 數據，您如何看待（聽不清）相對於 IVIG 和 CIDP 的商業競爭力，以及在穩定狀態下，您如何看待 CIDP 中 IVIg 與 FcRn 靶向產品的細分？

Yes. Thanks for the question, and I can take that. It's a little bit too early for us to comment on sort of IVIG versus FcRn market share, if you will. We still need to continue to do the work up on the commercialization plan. But what I can say to your first question, we see a really strong value proposition, when we look at the holistic -- the holistic picture of VYVGART in CIDP. When you think about the efficacy, and Tim just talked about the strength of the data there.

是的。謝謝你的提問，我可以接受。如果您願意的話，我們現在評論 IVIG 與 FcRn 的市場份額還為時過早。我們還需要繼續做好商業化計劃的工作。但對於你的第一個問題，我可以說的是，當我們審視 CIDP 中 VYVGART 的整體情況時，我們看到了一個非常強大的價值主張。當你考慮功效時，蒂姆只是談到了數據的強度。

With safety and tolerability, I think, was incredibly impressive. We -- it was weekly dosing -- and we feel that the safety profile continues to hold up. The tolerability is really clear. And then obviously, the 30 to 90 seconds injection. So we believe that we have a full package that we'll be able to compete really well in the market, and we have conviction in the product, and we'll do the work up and share some of our thoughts around what that might look like versus IVIG in the coming months.

我認為，安全性和耐受性令人難以置信。我們是每週給藥一次，我們認為安全狀況仍然有效。耐受性真的很明顯。然後顯然是 30 到 90 秒的注射。因此，我們相信我們有一個完整的方案，我們將能夠在市場上真正競爭，並且我們對產品充滿信心，我們將做好工作並分享我們對產品外觀的一些想法就像未來幾個月與IVIG 的對比一樣。

Your next question comes from the line of Samantha Semenkow with Citigroup.

您的下一個問題來自花旗集團的 Samantha Semenkow。

Just a follow-up on pemphigus. Assuming the data is positive on the primary and some of the secondary endpoints and the read on the fourth quarter. How do you envision VYVGART fitting into the treatment paradigm? Just curious, with your conversations with physicians and how you design the trial and if there are any barriers, you would have to overcome with current treatment patterns?

只是天皰瘡的後續行動。假設主要終點和一些次要終點的數據以及第四季度的讀數都是積極的。您如何看待 VYVGART 融入治療模式？只是好奇，通過您與醫生的對話以及您如何設計試驗，如果存在任何障礙，您必須克服當前的治療模式？

I'm excited about our opportunity in the autoimmune listing disease space. The interesting thing about pemphigus is that actually, it's an area which is wide open. So the only thing in option these patients have today is actually steroids, which they hit with a passion and then rituximab which has a slow onset of action, significant side effects and actually a real-world efficacy, which is significantly lower than what they have shown in the clinical trials. .

我對我們在自身免疫疾病領域的機會感到興奮。關於天皰瘡的有趣之處在於，它實際上是一個廣闊的領域。因此，這些患者今天唯一的選擇實際上是類固醇，他們熱情地使用類固醇，然後是利妥昔單抗，它起效緩慢，副作用顯著，而且實際上的療效明顯低於他們的實際療效。臨床試驗中顯示。 。

So if you now look at the Phase II clinical data for (inaudible) patient with a very fast onset of action, a very high response rate and an unexpected durability it's not difficult to see that you can start to drive a wedge between steroids and rituximab. And so, I think there's a unique opportunity here to go and rethink into the treatment paradigm, but let's not get ahead of ourselves. Let's wait for the Phase III data because they will inform us about the best way to position the drug going forward. But excited about the opportunity, and thank you for the question.

因此，如果您現在查看（聽不清）患者的II 期臨床數據，這些患者俱有非常快的起效、非常高的反應率和意想不到的持久性，那麼不難看出您可以開始在類固醇和利妥昔單抗之間產生分歧。 。因此，我認為這是一個獨特的機會來重新思考治療模式，但我們不要超前。讓我們等待 III 期數據，因為它們將告訴我們未來定位藥物的最佳方法。但我對這個機會感到興奮，並感謝您的提問。

Your next question comes from the line of Joel Beatty of Baird.

您的下一個問題來自貝爾德 (Baird) 的喬爾·比蒂 (Joel Beatty)。

What's -- for the patients starting on Hytrulo, what's the mix of patients you're seeing switching from IV VYVGART versus patients for which the Hytrulo is there are first experience with (inaudible) .

對於開始使用 Hytrulo 的患者，您所看到的從 IV VYVGART 轉為使用 Hytrulo 的患者與首次使用 Hytrulo 的患者的混合情況（聽不清）。

So, I think I heard your question that it was around switches from Hytrulo or from VYVGART to Hytrulo. And it's just too early to tell. We haven't seen the data on that yet, but I don't see we're getting strong feedback on the value proposition of Hytrulo.

所以，我想我聽到了你的問題，這是關於從 Hytrulo 或從 VYVGART 到 Hytrulo 的切換。現在下結論還為時過早。我們還沒有看到這方面的數據，但我認為我們沒有得到關於 Hytrulo 價值主張的強烈反饋。

Joel, it would be disappointing within this would just be a switch dynamic. Yes, Karen? .

喬爾，這將是令人失望的，因為這只是一個切換動態。是的，凱倫？ 。

Yes, absolutely. I can comment on that. I think we've commented on that before. The strategy here is not that we're switching to a VYVGART to VYVGART Hytrulo, but rather, we're trying to open up access for patients in the community and elsewhere where the 30 to 90 second injection is a better option for fitting into their lives. So yes. .

是的，一點沒錯。我可以對此發表評論。我想我們之前已經對此發表過評論。這裡的策略並不是我們要從 VYVGART 切換到 VYVGART Hytrulo，而是我們試圖為社區和其他地方的患者開放通道，在這些地方，30 到 90 秒的注射是適合他們的更好選擇。生活。所以是的。 。

Your next question comes from the line of Douglas Tsao with H.C.Wainwright. .

你的下一個問題來自 Douglas Tsao 和 H.C.Wainwright 的對話。 。

Just -- just following up on Hytrulo. You've obviously spoken about the opportunity now to get into the community more. I'm just curious, as you've been in the field more, what percentage of the market does this now open up, meaning how many patients were sort of community-based and we didn't really have great access to VYVGART for whatever reason. .

只是——只是跟進 Hytrulo。您顯然已經談到了現在更多地融入社區的機會。我只是很好奇，隨著您在該領域的接觸越來越多，現在這個市場開放了多少百分比，這意味著有多少患者是基於社區的，而我們實際上並沒有很好地獲得 VYVGART 的機會原因。 。

Yes. Look, it's a great question. I mean, I think the -- we still see the addressable market of VYVGART and VYVGART Hytrulo as that 17,000 that we shared before. And we think Hytrulo allows us to really penetrate more into the community, get closer to being used after the oral, and so really opened up that segment as a market. But the way that I would think about it is that the addressable market is $17,000. And we're on the front end of that, as we -- at this point in launch. .

是的。聽著，這是一個很好的問題。我的意思是，我認為 - 我們仍然認為 VYVGART 和 VYVGART Hytrulo 的潛在市場是我們之前分享的 17,000 個。我們認為 Hytrulo 使我們能夠真正深入社區，更接近在口頭後被使用，從而真正打開該細分市場作為市場。但我認為潛在市場是 17,000 美元。我們正處於這一點的前端，因為我們在發布的這個階段。 。

Your next question comes from the line of Leland Gershell with Oppenheimer.

你的下一個問題來自利蘭·格謝爾和奧本海默的對話。

With respect to empasiprubart, as you look forward to the Phase II second cohort MMN next year, is there a particular bar you're looking to meet? Or is that the data merely to inform next steps? And I also want to ask with respect to that asset, are you expecting to start either both of the POC studies in DM or kidney this year? .

關於 empasiprubart，當您期待明年的 I​​I 期第二批 MMN 時，您有沒有特別想見到的酒吧？或者這些數據只是為了告知後續步驟？我還想問，關於該資產，您是否預計今年開始針對 DM 或腎臟的 POC 研究？ 。

Yes. Thank you. I mean empasiprubart pronounced the name of empa. I mean, I would like to recall that. So empa is an excited molecule -- the Phase II trial is redesigned to generate PK/PD data and efficacy and safety data to inform our model. Ideally, the 2 dose cohorts give us sufficient information to triangulate what the dose should be. What we have said publicly is that on a dose cohort number one, we not only passed an independent data review committees are blessing from a safety and tolerability point of view.

是的。謝謝。我的意思是 empasiprubart 發音為 empa。我的意思是，我想回憶一下。因此，empa 是一個令人興奮的分子——II 期試驗經過重新設計，可生成 PK/PD 數據以及功效和安全性數據，為我們的模型提供信息。理想情況下，兩個劑量組為我們提供了足夠的信息來三角測量劑量應該是多少。我們公開表示，在第一劑量隊列中，我們不僅通過了獨立的數據審查委員會，從安全性和耐受性的角度來看，這也是值得祝福的。

But I think, we also saw confining efficacy allowing us to venture into dose cohort 2. The ideas that we see a separation between the 2 dose cohorts. So the PK/PD model is fully informed. But, I believe that based on the efficacy we have seen already, we think we have a drug in MMN. The remaining question is what is the dose going to be for Phase III, contingent document, of course, safety -- and yet this is a pipeline product opportunity and the management exciting as an indication.

但我認為，我們也看到了有限的功效，使我們能夠冒險進入劑量組 2。我們看到 2 個劑量組之間存在分離的想法。因此 PK/PD 模型是完全知情的。但是，我相信，根據我們已經看到的療效，我們認為我們有一種 MMN 藥物。剩下的問題是第三階段的劑量是多少，附帶文件，當然還有安全性——但這是一個管道產品機會，管理層作為一個跡象令人興奮。

But for the other 2 indications, which we're lining up are equally exciting. We are on track to start both trials, as we line out in the press release. So soon this molecule will be playing already in 3 indications, and we think there is more to unpack in terms of opportunities. So please stay tuned. Thank you for the question.

但對於我們正在列出的其他兩個跡象同樣令人興奮。正如我們在新聞稿中所述，我們有望開始這兩項試驗。因此，很快該分子將在 3 個適應症中發揮作用，我們認為在機會方面還有更多的機會。所以請繼續關注。感謝你的提問。

(Operator Instructions) Your next question comes from the line of Xian Deng of UBS.

（操作員指令） 您的下一個問題來自瑞銀集團的鄧賢。

So you have quite a few catalysts coming up, BP, pemphigus TED, et cetera, and there are many more indications in the pipeline. Just wondering, with so many indications, is there anyone that you would like to highlight, I think if there's any one that's higher risk others or if there's anyone that if you make it, that will be much bigger than others in terms of commercial opportunities. Yes, anyone that you would like to highlight in particular?

因此，有相當多的催化劑出現，英國石油公司（BP）、天皰瘡 TED 等等，並且還有更多的跡象正在醞釀中。只是想知道，有這麼多跡象，有沒有你想強調的人，我認為是否有任何人比其他人風險更高，或者是否有任何人如果你成功了，在商業機會方面會比其他人大得多。是的，您想特別強調誰？

Yes, that's a really challenging question to me because I'm equally excited about all the indications. And it's very difficult to tell you which one is going to be ultimately the biggest one. But I know that when I sum them up, this is going to be in its totality, a very sizable 500 product -- let me quickly call out ITP will be wrong track to get our marketing authorization in Japan.

是的，這對我來說是一個非常具有挑戰性的問題，因為我對所有跡像都同樣感到興奮。很難告訴你哪一個最終會成為最大的。但我知道，當我總結它們時，這將是一個非常大的 500 個產品——讓我快速指出，ITP 在日本獲得營銷授權的道路將是錯誤的。

So soon, we'll have two indications on the market then I'm very excited about our myositis trial, which is very innovative. It's a basket trial, the first one where legal (inaudible) distinct subpopulation in myositis where these people are in very high unmet medical needs is not really effective treatment options at all. So we're really looking forward to the myositis trial, and I'm paying close attention to it.

很快，我們將在市場上推出兩種適應症，然後我對我們的肌炎試驗感到非常興奮，這是非常創新的。這是一項籃子試驗，這是第一個針對肌炎的合法（聽不清）獨特亞群的試驗，這些人的醫療需求未得到滿足非常高，但根本不是真正有效的治療選擇。所以我們真的很期待肌炎試驗，我正在密切關注它。

I'm very excited about the universe of opportunity in the autoimmune listing diseases it both pemphigus and bullous pemphigoid progressing very well. And then, of course, they have a whole third wave of indications. But frankly speaking, we're not taking on more biology risks. We still in all in the sweet spot of the drug where there is strong conviction on biology, clear and feasibility from a clinical (inaudible) execution point of view and reveal commercial opportunity to transform the last of these patients. So this is the universe opportunity, which we're approaching. Thank you for the question.

我對自身免疫性疾病領域的機遇感到非常興奮，天皰瘡和大皰性類天皰瘡都進展順利。當然，他們還有第三波跡象。但坦率地說，我們並沒有承擔更多的生物學風險。總的來說，我們仍然處於該藥物的最佳位置，對生物學有堅定的信念，從臨床（聽不清）執行的角度來看清晰且可行，並揭示了改變最後一批患者的商業機會。這就是我們正在接近的宇宙機遇。感謝你的提問。

As there are no further questions at this time, this will conclude today's conference call. Thank you for joining us. You may now disconnect your lines.

由於目前沒有其他問題，今天的電話會議將結束。感謝您加入我們。您現在可以斷開線路。