argenx SE (ARGX) 2026 Q2 法說會逐字稿

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

早安。我叫 Laila，今天將擔任各位的電話會議接線員。歡迎各位參加本次電話會議。（接線員指示）謝謝。

I'd like to introduce Beth DelGiacco, Vice President of Corporate Affairs. You may now begin your call.

我想介紹企業事務副總裁 Beth DelGiacco。您現在可以開始會議。

Thank you. A press release was issued earlier today with our second quarter 2026 financial results and business update. This can be found on our website along with the presentation for today's webcast.

謝謝。我們已於今日稍早發布新聞稿，內容為 2026 年第二季財務結果與業務更新。您可在我們網站上找到該新聞稿，以及今日網路直播的簡報資料。

Before we begin, on slide 2, I'd like to remind you that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical developments, regulatory timelines, the potential success of our product candidates, financial projections, and upcoming milestones.

在開始之前，於第 2 張投影片，我想提醒各位，本次電話會議中可能會提出前瞻性陳述。這些陳述可能包括我們對未來的預期、臨床進展、法規時程、產品候選藥物的潛在成功、財務預測以及即將到來的里程碑等。

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.

實際結果可能與這些陳述所示存在重大差異。除非法律要求，Argenx 不負有更新未來相關陳述或使其與實際結果一致之義務。

I'm joined on the call today by Karen Massey, Chief Executive Officer; Karl Gubitz, Chief Financial Officer; and Sandrine Perez-Gerard, Chief Commercialization Officer. Luc Truyen, Chief Medical Officer, will be available during the Q&A.

今天與我一同參與電話會議的有：執行長 Karen Massey、財務長 Karl Gubitz，以及商業化長 Sandrine Perez-Gerard。醫務長 Luc Truyen 將在問答環節提供支援。

I'll now turn the call over to Karen.

接下來我把電話會議交給 Karen。

Thank you, Beth, and welcome, everyone. I'll begin on slide 3. The team delivered one of our strongest quarters yet, marking our 18th consecutive quarter of growth.

謝謝你，Beth，也歡迎各位。我將從第 3 張投影片開始。團隊交出我們迄今最強勁的季度之一，並達成連續第 18 個季度成長。

This momentum reflects the value VYVGART continues to deliver for patients, the continued expansion of both MG and CIDP markets, and our ability to unlock new opportunities for growth, most recently with the zero-negative MG approval. The progress we're seeing across the business brings us closer to realizing Vision 2030, our roadmap for delivering near, medium, and long-term growth.

這股動能反映了 VYVGART 持續為病患帶來的價值、MG 與 CIDP 市場的持續擴張，以及我們開啟新成長機會的能力，最近的例子是血清陰性 MG 的核准。我們在整體業務上看到的進展，使我們更接近實現 Vision 2030——這是我們推動短、中、長期成長的路線圖。

Looking ahead, we have two registrational readouts before year end, which support our goal of achieving 10 labeled indications. Together with our differentiated immunology pipeline, these programs position us to extend our growth well beyond 2030.

展望未來，在年底前我們將有兩項註冊性試驗讀出，支持我們達成取得 10 項核准適應症標示的目標。結合我們具差異化的免疫學研發管線，這些計畫使我們有望將成長延伸至 2030 年之後。

Our success today creates the opportunity to reinvest in the best science we can find, wherever we can find it during the next phase of our argenx growth. VYVGART continues to change what is possible for patients with MG and CIDP, and we see strong growth across both indications and all regions. We're reaching more patients than ever before, driven by our commitment to bring meaningful innovation to the treatment experience.

我們今日的成功，讓我們有機會在 argenx 下一階段的成長中，無論在何處，都能再投資於我們所能找到的最佳科學。VYVGART 持續改變 MG 與 CIDP 病患的治療可能性，我們在兩項適應症及所有地區都看到強勁成長。在致力於為治療體驗帶來有意義的創新驅動下，我們正觸及比以往更多的病患。

Last year, we introduced our pre-filled syringe, expanding our prescriber base and supporting our goal to reach patients earlier in their treatment journey. This year, we reached another important milestone with the approval of VYVGART for seronegative gMG.

去年，我們推出預充式注射器，擴大了開立處方的醫師基礎，並支持我們在病患治療旅程更早期觸及病患的目標。今年，我們又達成另一項重要里程碑：VYVGART 獲核准用於血清陰性 gMG。

VYVGART is now the first and only treatment approved across all serotypes of gMG, including for triple seronegative patients who previously had no approved treatment options. This is transformational for patients and physicians, removing the need for testing. With ocular MG ahead, we are moving forward in our ambition to make VYVGART a treatment of choice across all MG patients.

VYVGART 現已成為首個且唯一獲核准涵蓋所有 gMG 血清型別的治療，包括先前三重血清陰性病患在內——他們過去沒有任何已核准的治療選項。這對病患與醫師而言具有變革性意義，免除了檢測的需求。隨著眼肌型 MG（ocular MG）在前方，我們正持續推進我們的願景：讓 VYVGART 成為所有 MG 病患的首選治療之一。

Slide 5. We have two important readouts ahead that represent the next chapter of our growth strategy. broadening our leadership in urology within (inaudible) and extending the impact of FcRn into new therapeutic areas, starting with rheumatology. VYVGART has the potential to have a similar impact in rheumatology as it has had in urology. Autoimmune myositis is our entry point.

第 5 張投影片。我們即將迎來兩項重要讀出，代表我們成長策略的下一篇章：在（聽不清）中擴大我們在泌尿科的領導地位，並將 FcRn 的影響力延伸至新的治療領域，首先從風濕免疫科開始。VYVGART 在風濕免疫科的潛在影響力，可能與其在泌尿科所帶來的影響相似。自體免疫性肌炎是我們的切入點。

It represents both a near-term label expansion opportunity and the foundation for long-term leadership. What continues to motivate us is the urgent patient needs. In IMNM, patients can progress from their first symptom to meeting a wheels within a matter of months.

這同時代表一個短期的適應症標示擴張機會，以及建立長期領導地位的基礎。持續驅動我們前進的是迫切的病患需求。在 IMNM 中，病患可能在短短數月內，從首次症狀進展到需要輪椅。

We heard this at R&D day, and there are no approved treatments today. This sense of urgency to deliver the patient is what is driving our filing strategy based on the benefit risk of each subtype on it goes, which are a clear signal in both IMNM and DM in the Phase 2 and we're on track for a readout this quarter. Myositis is just the beginning. We believe a first-in-class launch in myositis can establish the foundation for broader leadership in rheumatology with Sjogren's data expected in the second half of 2027.

我們在研發日（R&D day）也聽到這點，而目前尚無任何已核准的治療。這種為病患帶來治療的急迫感，正推動我們基於各亞型的效益風險所制定的申請策略；在第 2 期試驗中，IMNM 與 DM 都出現明確訊號，我們也按計畫將於本季取得讀出。肌炎只是開始。我們相信，在肌炎領域的同類首創（first-in-class）上市，可為我們在風濕免疫科建立更廣泛的領導地位奠定基礎；預計於 2027 年下半年取得乾燥症（Sjogren's）數據。

Slide 6. Empasiprubart remains on track to become our second pipeline of products with our first registrational readout in MMN expected later this year. MMN represents one of the clearest unmet needs in neurology. Empasiprubart has the potential to operate a differentiated approach, supported by the efficacy, durability and safety profile it in the Phase 2 AD study.

第 6 張投影片。Empasiprubart 仍按計畫推進，有望成為我們第二個產品管線；今年稍晚預計將在 MMN 取得首個註冊性試驗讀出。MMN 是神經科領域最明確的未被滿足需求之一。Empasiprubart 有潛力以差異化方式發揮作用，並由其在第 2 期 AD 研究中的療效、持久性與安全性特徵所支持。

We continue to see growing enthusiasm from the neurology community, particularly around the safety profile and the sustained improvement in (inaudible) observed in the open-label extension. These are outcomes that matter in patients' daily lives.

我們持續看到神經科社群的熱情升溫，特別是對其安全性特徵，以及在開放標籤延伸試驗中觀察到（聽不清）的持續改善。這些都是對病患日常生活至關重要的結果。

Our ambition extends well beyond MMN, the unique biology of C2 inhibition has the potential to benefit a broader range of patients from our ongoing Phase 3 program in CIBC through our combination study in MG. We are focused on unlocking the full potential of this mechanism for patients.

我們的企圖心遠不止於 MMN；C2 抑制的獨特生物學機制，可能讓更廣泛的病患受益——從我們在 CIBC 的進行中第 3 期計畫，到我們在 MG 的聯合治療研究。我們專注於為病患釋放此機制的全部潛力。

Slide 7. It's an incredibly exciting time to be building a company around scientific innovation. The pace of discovery is accelerating, and our job is to find the most promising science that can change outcomes to patients. Our goal is to advance five late-stage molecules by 2030 to fuel long-term growth, and we are pursuing this through two pathways. We're extending our leadership in [SCRM] and we're broadening our immunology pipeline.

第 7 張投影片。以科學創新為核心打造一家公司，正值令人振奮的時刻。發現的速度正在加快，而我們的工作是找出最有前景、能改變病患治療結果的科學。我們的目標是在 2030 年前推進 5 個後期階段分子，以驅動長期成長；我們將透過兩條路徑來達成。我們一方面延伸在 [SCRM] 的領導地位，另一方面擴大我們的免疫學研發管線。

We are already delivering (technical difficulty) strategies. Our future CRA molecules ARGX-213 and ARGX-134 as well as our (inaudible) ARGX-121, are progressing towards late-stage development. And ARGX-118, ARGX-125 and TSP-101 now in Phase 1, each represent a new pipeline in the product opportunities. Together, these investments reflect a disciplined capital allocation strategy focusing on delivering durable growth over the long term.

我們已經在推進（技術問題）策略。我們未來的 CRA 分子 ARGX-213 與 ARGX-134，以及我們的（聽不清）ARGX-121，正朝向後期開發推進。而目前處於第 1 期的 ARGX-118、ARGX-125 與 TSP-101，各自都代表新的產品機會管線。綜合而言，這些投資反映出一項嚴謹的資本配置策略，聚焦於實現長期且可持續的成長。

And with that, I'll turn the call over to Karl.

接下來，我把電話會議交給 Karl。

Thank you, Karen. Slide 8. I am pleased to present the second quarter 2026 financial results in this morning's press release. We continue to increase the number of patients that we treat, resulting in growing revenues. Product net sales for the second quarter were $1.5 billion, representing 60% year-over-year growth and 17% quarter-over-quarter growth.

謝謝你，Karen。第 8 張投影片。我很高興在今天上午發布的新聞稿中呈報 2026 年第二季財務結果。我們持續增加治療的病患人數，帶動營收成長。第二季產品淨銷售額為 15 億美元，年增 60%，季增 17%。

By region, product net sales were $1.3 billion in the US, $102 million in Japan, $136 million across the rest of the world and $5 million related to products supplied to Zai Lab in China. Our US market grew by 15% quarter-over-quarter with a gross to net and net pricing similar to prior quarters. In Japan, quarter-over-quarter net product sales growth is 55% or $35 million. Reported sales include a one-off benefit of approximately $25 million due to a change in our distribution model.

按地區劃分，產品淨銷售額在美國為13億美元、日本為1.02億美元、世界其他地區合計為1.36億美元，另有500萬美元與供應給中國再鼎醫藥（Zai Lab）的產品相關。我們的美國市場較上一季成長15%，毛到淨（gross-to-net）與淨定價水準與前幾季相近。在日本，產品淨銷售額較上一季成長55%，或增加3,500萬美元。已報告的銷售額包含一次性收益，約2,500萬美元，源於我們分銷模式的變更。

Next slide, slide 9. Total operating expenses in the second quarter were $1 billion, representing an increase of $129 million compared to the first quarter. We have stepped up our combined R&D and SG&A investment to $903 million in the quarter. This increase is delivered and reflects disciplined investment in multiple mid- and late-stage clinical development programs and commercialization capabilities to support our growing multiproduct portfolio.

下一張投影片，第9頁。第二季總營運費用為10億美元，較第一季增加1.29億美元。本季我們將研發（R&D）與銷售、一般及行政（SG&A）的合計投資提高至9.03億美元。這項增加已到位，並反映我們在多項中後期臨床開發計畫與商業化能力上的紀律性投資，以支持我們日益成長的多產品組合。

Operating profit in the second quarter is $494 million, an increase of 146% year-over-year. Tax for the quarter is 11% of profit before tax. We ended the quarter with a cash balance of $5.2 billion, including cash, cash equivalents and current financial assets, an increase of more than $744 million from the beginning of the year.

第二季營業利益為4.94億美元，年增146%。本季稅負為稅前利益的11%。本季末現金餘額為52億美元（包含現金、約當現金及流動金融資產），較年初增加超過7.44億美元。

Our capital allocation priority continues to be building durable long-term revenue growth. At the same time, we are well on track to deliver a financial profile that includes increasing operating margins, sustained earnings growth and a significant cash generation.

我們的資本配置首要任務仍是建立可持續的長期營收成長。同時，我們也正穩步達成一個財務輪廓，包括營業利潤率提升、獲利持續成長，以及顯著的現金創造能力。

I now turn the call over to Sandrine who will provide details on the commercial front.

接下來我把電話交給Sandrine，她將就商業面提供細節。

Thank you, Karl. I'll begin on slide 7. What continues to set argenx support is our ability to translate the patient-first approach into execution across the entire treatment journey. From educating health care providers to supporting patients who ongoing care we are focused on removing friction at every step. And it is an approach that continues to deliver results.

謝謝你，Karl。我將從第7頁開始。持續讓argenx脫穎而出的是，我們能將以病患為先的理念，落實到整個治療旅程的執行。從教育醫療照護提供者到支持需要持續照護的病患，我們專注於在每一步移除摩擦。而這種做法持續帶來成果。

More HCPs are choosing to prescribe VYVGART and the preferred biologists for MD and CIDP. More patients are requesting VYVGART, and other results getting on treatment earlier. Patients are remaining on treatment because VYVGART continues to make a meaningful difference in all-day feel and function in their daily life.

越來越多醫療照護提供者（HCP）選擇開立VYVGART，且其為MD與CIDP的首選生物製劑。越來越多病患主動要求使用VYVGART，因此也更早開始接受治療。病患持續留在治療上，因為VYVGART在他們日常生活中「整天的感受與功能」方面，持續帶來有意義的改善。

Today, we have patients who started in our very first quarter of launch and remain on therapy 18 quarters later. These strong fundamentals are reflected in our performance this quarter and we continue to position us well for future growth.

目前，我們有病患自上市的第一個季度開始用藥，18個季度後仍持續接受治療。這些強勁的基本面反映在我們本季的表現上，也持續讓我們在未來成長方面處於有利位置。

Slide 11. This quarter, we continued to see growth driven by both MG and CIDP across all regions. Renew patient demand remaining at a consistently higher level. The prefilled syringe continues to be an important driver of this demand across both MG and CIDP. Its convenience and flexibility are supporting broader adoption of these parts in the second quarter, approximately 80% of prefilled syringe patients in the US have been new to VYVGART.

第11頁。本季，我們持續看到由MG與CIDP在各地區共同帶動的成長。續用病患需求維持在一個持續較高的水準。預充式注射器持續是推動MG與CIDP需求的重要驅動因素。其便利性與彈性支持第二季更廣泛的採用；在美國，約80%的預充式注射器病患為VYVGART新病患。

We also see increasing breadth and depth of prescriptions for VYVGART. Physician confidence in VYVGART is reflected in a repeat prescriber base of more than 5,000 neurologists and increasing yield earlier in the treatment journey.

我們也看到VYVGART處方在廣度與深度上持續提升。醫師對VYVGART的信心，反映在超過5,000位神經科醫師的重複開立者基礎，以及在治療旅程更早階段的使用率提升。

While early into launch, we also saw a contribution to growth from our seronegative expansion in gMG. VYVGART is now the first and only biologic approval across all serotypes of generalized MG, significantly expanding our addressable market in MG by 11,000 patients.

此外，雖然仍在上市初期，我們也看到在gMG血清陰性擴適應症方面對成長的貢獻。VYVGART目前已成為首個且唯一獲准涵蓋所有血清型的全身型重症肌無力（generalized MG）生物製劑，將我們在MG的可觸及市場顯著擴大11,000名病患。

Slide 12. Our recent approval across all serotypes in gMG, mass positive, triple-negative and LRP4 positives, strengthened VYVGART leadership in MG and advances our goal of reaching the broadest patient population. We are pleased with the early response to the legal expansion with extremely positive situation and ACP feedback.

第12頁。我們近期在gMG獲准涵蓋所有血清型（MuSK陽性、三陰性以及LRP4陽性），強化了VYVGART在MG的領導地位，並推進我們觸及最廣泛病患族群的目標。我們對此次標籤擴增的早期反應感到滿意，並收到極為正面的情況回饋與ACP回饋。

We have established relationships with more than 80% of seronegative MG treaters and see the recent VYVGART label expansion having a halo effect on all gMG prescriptions, also driving increased uptake by prescribers in the seropositive population.

我們已與超過80%的血清陰性MG治療醫師建立關係，並看到近期VYVGART標籤擴增對所有gMG處方產生光環效應，同時也帶動血清陽性族群中開立者的使用提升。

On the payer side, we leverage the credibility and relationships we have built to secure policies covering approximately 55% of of US commercial lives, all within 10 weeks since launch. Most plants are removing the serology testing requirements, making it simpler for physicians to prescribe VYVGART as the good option in MG.

在支付方方面，我們運用已建立的可信度與關係，在上市後10週內即取得涵蓋約55%美國商業保險人群的給付政策。多數方案正在移除血清學檢測要求，使醫師能更簡便地將VYVGART作為MG的良好選擇來開立。

There is also tremendous excitement and hope among patients, particularly triple-seronegative patients who previously had no approved therapies available. One of these patients as Zack shared I sat on my computer cried, hope, this is finally real hope of the seronegative community.

病患之間也充滿極大的興奮與希望，特別是過去沒有任何核准療法可用的三重血清陰性病患。其中一位病患如Zack所分享的：「我坐在電腦前哭了，這是希望，這終於是真正的希望，屬於血清陰性社群的希望。」

As we look ahead in energy, we see significant opportunity to reach patients earlier in the treatment journey and pending approvals expand into ocular MG. These patients continue to face a meaningful garden of disease, underscoring the need for additional treatment options and reinforcing our commitment to serving the full MG community.

展望未來，我們看到在治療旅程更早階段觸及病患的重大機會，且待核准後可擴展至眼肌型MG。這些病患仍面臨顯著的疾病負擔，凸顯需要更多治療選項，也強化我們服務整個MG社群的承諾。

Slide 13. Let's move to the opportunity in CIDP. Within our initial 12,000 patient addressable population in the US, we are driving further adoption through physician education and continued evidence generation. At the same time, we are laying out the groundwork to expand beyond this. Today, approximately 24,000 patients are being treated for CIDP in the US and roughly half are considered to well-managed only current therapy.

第13頁。接著談CIDP的機會。在美國初始可觸及的12,000名病患族群中，我們透過醫師教育與持續產出證據來推動進一步採用。同時，我們也在為超越此範圍的擴張奠定基礎。目前，美國約有24,000名病患正在接受CIDP治療，其中約一半被認為在現行治療下管理良好。

Yes, what we consistently hear is that many have learned to live around their disease, often without realizing how much function they have lost. And this is exactly why generating data that shows many consumptional improvement matters. Our (inaudible) results demonstrate the impact VYVGART can have on outcomes that are important in patient life and meaningful to the physicians treating them. Similarly, we have generated evidence that help physicians navigate practical treatment decisions, including transitioning appropriate patients from IVIG to VYVGART.

我們一再聽到的是，許多人已學會在疾病周邊生活，往往沒有意識到自己失去了多少功能。這也正是為什麼產生能顯示功能性改善的數據很重要。我們的（聽不清）結果顯示，VYVGART能對病患生活中重要、且對治療醫師具有意義的結局帶來影響。同樣地，我們也產出證據，協助醫師做出實務治療決策，包括將合適病患從IVIG轉換至VYVGART。

We presented recently at PNS, the results of a Phase 4 Switch study, showing that 87% of patients on IVIG, which successfully to VYVGART helping address the questions, how do I (Inaudible - microphone inaccessible) to VYVGART?

我們近期在PNS發表第4期Switch研究結果，顯示在使用IVIG的病患中，有87%成功轉換至VYVGART，協助回答「我該如何（聽不清——麥克風無法收音）轉換到VYVGART？」等問題。

Finally, we continue to explore the opportunity to reach patients earlier in [IVIG] journey. We see significant potential among the large population of untreated patients where OLED suggests that treatment-naive patients midrise meaningful benefits from earlier treatment.

最後，我們持續探索在[IVIG]治療旅程更早階段觸及病患的機會。在龐大的未治療病患族群中，我們看到顯著潛力；OLED資料顯示，未曾治療的病患可能會因更早開始治療而獲得有意義的效益。

Slide 14. Looking ahead, we are preparing the organization for the next (inaudible)growth . We view autoimmune myositis as a strategic entry point into rheumatology with the potential for regard to establish early leadership as the first FcRn.

第14頁。展望未來，我們正為下一階段（聽不清）的成長做組織準備。我們將自體免疫性肌炎視為進入風濕免疫領域的策略性切入點，並有潛力作為首個FcRn療法而建立早期領導地位。

We are augmenting our best-in-class launch playbook in MG and CIDP to be launched ready for myositis. We are already engaging with 650 treating auto and myositis, advancing disease state education, engaging patient communities and getting ready to expand our field force footprint.

我們正在強化我們在 MG 與 CIDP 的同級最佳上市作戰手冊，以確保在肌炎（myositis）上市時已做好萬全準備。我們已經與 650 位治療自體免疫疾病與肌炎的醫師展開互動，推進疾病狀態教育、與病友社群互動，並準備擴大我們的外勤團隊覆蓋範圍。

With that, let me turn the call back to Karen for closing remarks.

接下來，讓我把電話交回給 Karen 做結語。

Thank you, Sandrine. As you saw today, we continue to see strong momentum across the business with significant opportunities ahead for VYVGART and a pipeline position to sustain refers well into the future. And while there is much to be proud of in the first half of the year, there is even more ahead. We entered the second half of 2026 with multiple opportunities to advance innovation and further our mission of transforming the lives of people living with autoimmune disease.

謝謝你，Sandrine。如同各位今天所見，我們在整體業務上持續展現強勁動能，VYVGART 前方仍有顯著機會，而我們的產品線（pipeline）布局也足以支撐未來很長一段時間的成長。雖然上半年有許多值得自豪之處，但前方還有更多可期。我們以多項推進創新的機會進入 2026 年下半年，並進一步推動我們「改變自體免疫疾病患者生活」的使命。

I want to thank our teams, patients and strategic partners for their continued commitment as we continue to commission together with us.

我要感謝我們的團隊、病患以及策略夥伴持續的投入與承諾，因為我們將持續與各位一同推進這項使命。

And with that, operator, we'll open the call for questions.

那麼，接下來請接線員開放提問。

(Operator Instructions)

(接線員指示)

Myles Minter.

Myles Minter。

Thanks very much and congrats on the quarter. Looking forward to the myositis data in the third quarter here as well. I'll keep it to one on the commercial business. You've delivered quarter-over-quarter sort of mid-teens percentage growth if you take out the first quarter seasonality. I just had a question on whether that sort of future growth trajectory might change with the launch in the seronegative population here and whether there's any sort of tailwinds that we should think about from the broader population now that most plants are not requiring the serology testing for that population. Thanks very much.

非常感謝，也恭喜本季表現。我也很期待第三季的肌炎數據。我只問一題、關於商業端。如果排除第一季的季節性因素，你們已經連續幾季呈現季對季約中十位數百分比的成長。我想請教的是，隨著在血清陰性（seronegative）族群的上市，未來的成長軌跡是否可能改變？以及在更廣泛的族群中，現在多數方案不再要求該族群進行血清學檢測，是否會帶來任何我們應該考量的順風因素？非常感謝。

Yes. Thanks for the question, Myles. And I would agree with you. It is incredible 18 quarters in that we're still delivering consistent growth quarter-over-quarter. And what I would say related to the quarterly trends. Of course, every quarter has its own dynamics. And after Q1 seasonality, we generally see some rebound in but we expect the shape of the curve for the remainder of the year to look pretty consistent to what you've seen in prior years.

是的。謝謝你的問題，Myles。我也同意你的看法。在第 18 個季度，我們仍能持續交出穩定的季對季成長，確實令人驚豔。至於季度趨勢，我想說的是：當然，每一季都有各自的動態。而在第一季的季節性之後，我們通常會看到一些回升；我們也預期今年剩餘期間的曲線形狀，會與你在過去幾年看到的相當一致。

We're off to a strong start. Of course, with seronegative but you, we've had the same dynamic in prior years with the launch of the PFS and that type of thing. So I would expect to look, continue to look to grow and to look similar to prior years.

我們今年開局很強勁。當然，血清陰性族群的上市也帶來助力，但你也知道，我們在過去幾年例如 PFS 上市等情況下，也出現過類似的動態。因此我預期我們會持續成長，且走勢看起來會與過去幾年相近。

Thanks for the question Myles.

謝謝你的提問，Myles。

Derek Archila, Wells Fargo.

Wells Fargo 的 Derek Archila。

Hey, good morning and congrats on the quarter here. Excellent results. I just wanted to understand, where do things stand with the ocular MG filing? And I guess maybe going to more tailwinds, but assuming approval, I guess, how do you think ocular could be a growth driver? And does that really materially change VYVGART's revenue trajectory? Thanks.

嗨，早安，也恭喜本季表現。成果非常出色。我想了解一下，眼肌型 MG（ocular MG）的申請進度目前到哪裡了？另外，假設獲批，眼肌型適應症會如何成為成長驅動力？它是否會實質改變 VYVGART 的營收成長軌跡？謝謝。

Yes. Thanks for the question. We're moving forward with urgency on ocular MG filing, I mean there's a big patient unmet need in ocular MG. Of course, there's no advanced therapies approved in this patient population. So we will be the first and only approved treatment in this population. So we're on track with the filing. We'll update you when we have a PDUFA date, but maybe, Sandrine, you could comment a little bit on how you see the outlook if we do have an ocular approval.

是的。謝謝你的問題。我們正以高度緊迫感推進眼肌型 MG 的申請；眼肌型 MG 的病患確實存在很大的未被滿足需求。當然，在這個病患族群中，目前沒有任何已核准的進階療法。因此我們將會是此族群第一個、也是唯一一個核准的治療選項。所以我們的申請進度如期推進。等我們拿到 PDUFA 日期時會再向各位更新；不過 Sandrine，也許你可以談談若我們獲得眼肌型核准，你對前景的看法。

So thank you, Chairman, and Derek, for the question. So I see the ocular MG potential approval as another way to continue and to support our growth momentum. Over the last five years, we basically have had five launches when you think about that. So this would give us another launch to continue that growth momentum.

謝謝，主席，也謝謝 Derek 的提問。我認為眼肌型 MG 的潛在核准，是延續並支撐我們成長動能的另一種方式。過去五年，從某種角度來看，我們基本上完成了五次上市。因此這將帶來另一個上市機會，延續這股成長動能。

And we are well positioned because many of these patients are being treated by neurologists, and this is already a population of providers that we visit and that have experience with the drug. So I'm very confident that this will be another -- I think another leg to our growth for the long term.

而且我們的布局很到位，因為許多這類病患是由神經科醫師治療，而這些醫師本來就是我們會拜訪、且對此藥物已有使用經驗的醫療提供者族群。所以我非常有信心，這會成為另一個——我認為是長期成長的另一個支柱。

Tazeen Ahmed, BofA.

BofA 的 Tazeen Ahmed。

Hi, good morning. Thanks for taking my questions. So Karen or maybe Sandrine, I wanted to get your thoughts about the competitive landscape. So you're right, your 18 quarter is in and you've had commanding share, but there continue to be new launches and upcoming launches. And some of the competitors that are talking about what advantages their products might have include comments such as efficacy may not necessarily be where it needs to be with FcRn in general and that patients might be dropping off therapy due to safety observation.

嗨，早安。謝謝回答我的問題。Karen 或 Sandrine，我想請教你們對競爭態勢的看法。你們說得沒錯，已經進入第 18 個季度且市占領先，但市場上仍持續有新產品上市以及即將上市的產品。有些競品在談其產品優勢時，會提到例如：FcRn 整體而言療效可能未必達到所需水準，以及病患可能因安全性觀察而停止治療。

So can you maybe share with us your feedback from the field about what doctor's satisfaction is vis-a-vis the patient commentary on both efficacy? And can you talk to us about dropouts as a result of any safety concerns? Thanks.

你們能否分享一下來自第一線的回饋：醫師的滿意度相對於病患對療效的評論如何？另外，能否談談是否有因任何安全性疑慮而導致的停用（dropouts）？謝謝。

Yes. Thank you, Tazeen, for the question. Let me just comment broadly on competition and then I'll hand it over to Sandrine.

是的。謝謝你，Tazeen 的提問。我先就競爭做一個較宏觀的回應，然後再交給 Sandrine。

But we've had this question a lot. I would say we launched in MG. And I'd like to say that argenx put MG on the map, and there has been a lot of competition that has followed us into the space. And throughout that, we've maintained our leadership in the market. And you can see, for example, four out of five physicians continue to say that they choose VYVGART before any other biologics.

我們常被問到這個問題。我會說，我們是在 MG 領域上市的先行者。我也常說 argenx 讓 MG 這個領域受到關注，之後有許多競爭者跟進進入這個市場。在這整個過程中，我們一直維持市場領導地位。例如，你可以看到五位醫師中有四位仍表示，他們會在任何其他生物製劑之前先選擇 VYVGART。

But Sandrine, maybe you want to comment on specifically the efficacy advantage and any other dynamics you see in the market?

Sandrine，也許你可以特別就療效優勢以及你在市場上看到的其他動態做些評論？

Yes. So VYVGART, I mean, like Karen has been seen and it's being used today earlier than the others. The others I use more in refractory populations and it's been used in earlier lines. And the reason is that the label supports it and the data supported.

好的。VYVGART——如同 Karen 所說——在臨床上被更早採用、也更早使用於治療流程的前段。其他產品更多用在難治（refractory）族群，而 VYVGART 則被用在更早線別。原因在於：適應症標籤支持這樣的使用方式，數據也支持。

And when you look at the data, I wonder if anybody else can demonstrate an MSC that we have. We have 60% of patients that have reached minimal symptom expression. And then that MSC is sustained over time, -- so I haven't seen until now other competitors being able to demonstrate MSC or even speak about MSC. And so that's really what stands out when you speak about the efficacy of VYVGART.

而當你看數據時，我會想：是否還有人能展示我們所擁有的 MSC？我們有 60% 的病患達到「最小症狀表現」（minimal symptom expression）。而且這個 MSC 能隨時間維持——到目前為止，我還沒看到其他競品能夠證明 MSC，甚至能談論 MSC。因此，當你談到 VYVGART 的療效時，這就是最突出的差異點。

And then if you combine that with its safety, over more than 25,000 patient years. I mean this is a very strong combination of a safety and efficacy profile that puts us in a position to be used earlier lines. And that's why until now, we haven't really seen a meaningful impact on our growth trajectory.

然後如果你把這與其安全性結合起來，累計超過25,000個病人年。我的意思是，這是一個非常強的安全性與療效特徵組合，使我們具備在更早治療線別使用的條件。也因此直到目前為止，我們尚未真正看到對我們成長軌跡造成有意義的影響。

Alex Thompson, Stifel

Alex Thompson，Stifel

Hey, great. Thanks for taking our questions. Maybe for Karen, could you walk us through sort of what we should expect to see now at the top line for myositis in terms of both primary endpoint clinical data as well as the potential path to filing, particularly in DM. Thanks.

嗨，很好。謝謝你們回答我們的問題。也許請Karen說明一下，關於肌炎（myositis）在整體（top line）結果方面，我們現在應該期待看到什麼——包括主要終點的臨床數據，以及潛在的申報路徑，特別是在DM方面。謝謝。

Yes. Thanks, Alex. We're really looking forward to the readout in Q3, and we're on track. Just to set the stage, what we see as success from myositis is positive readout on the primary endpoint in one or more subset, and that's the data that we'll share. So you'll remember from our Myositis Day, that we shared that we see both of these indications on their own as potential blockbuster indications.

是的。謝謝你，Alex。我們非常期待第三季（Q3）的讀出，而且目前進度如期。先鋪陳一下，我們認為肌炎的成功標準，是在一個或多個子集（subset）的主要終點出現正向讀出，而這些就是我們將分享的數據。你會記得在我們的Myositis Day上，我們分享過：我們認為這兩個適應症各自都有成為重磅（blockbuster）適應症的潛力。

They both have significant unmet need. And they're both actually strategically important to us. If we proceed with an approval, this will be important because it will be the first-in-class FcRn approval in rheumatology. So we'll be looking for positive data on the primary endpoint in one or more subset.

它們都有顯著的未被滿足醫療需求。而且它們對我們在策略上也都非常重要。如果我們推進並取得核准，這將很重要，因為這會是風濕免疫領域首個同類（first-in-class）的FcRn核准。因此我們會尋求在一個或多個子集的主要終點上看到正向數據。

But maybe, Beth, do you want to share a little bit more about what they can expect to see a top line results.

不過也許，Beth，你想再多分享一點他們可以期待看到哪些整體（top line）結果嗎？

Yes. I mean we're still working out the specific details of what the communication will look like. But what we know is that this is an important event with positive data for argenx. It's our entry into rheumatology, and we'll want to capture that in our communication, and we'll also want to capture the primary endpoint analysis on -- in IMM and in DM. So the details are still to come, but you can assume that those are the key topics of the communication.

是的。我的意思是，我們仍在敲定溝通內容會以什麼形式呈現的具體細節。但我們知道，這對argenx而言是一個重要事件，且會有正向數據。這是我們進入風濕免疫領域的起點，我們會希望在對外溝通中呈現這一點，同時也會呈現在IMM與DM上的主要終點分析。所以細節仍待公布，但你可以假設這些會是溝通的關鍵主題。

Akash Tewari, Jefferies.

Akash Tewari，Jefferies。

Hey, thanks so much. Can you give a little more color on your stat plan for mytosis. Based on your public comments, it seems like there is no alpha split. Basically, DM and IMM are now being run independently at two separate trials. Is that the correct read here? And then if the effect size in DM for your Phase 2 trials was replicated in Phase 3, would the trial hit static or not? And if not, what are some reasons that efficacy could improve from Phase 2 to Phase 3. Thank you.

嗨，非常感謝。你們能否就肌炎（myositis）的統計計畫多提供一些說明？根據你們公開的評論，看起來沒有alpha分割。基本上，DM和IMM現在是在兩個獨立試驗中各自獨立進行。這樣理解正確嗎？另外，如果你們第二期試驗在DM的效果量（effect size）在第三期被複製，該試驗會達到統計顯著（stat sig）嗎？如果不會，從第二期到第三期療效可能改善的一些原因是什麼？謝謝。

Yes. Thanks for the questions, Akash. We have Luc here. So asking him to comment.

是的。謝謝你的問題，Akash。Luc也在這裡。所以請他來回應。

Yes. And thanks, Akash. So you are correct,. So the way we now approach the analysis of the Phase 3 is that we will independently analyze the subsets. So each has their own chance to win. As you also know from the Research Day, of course, the enrollment differed between subsets, so that will affect the intrinsic power

是的。也謝謝你，Akash。所以你說得沒錯。我們目前對第三期分析的做法，是會獨立分析各個子集。因此每個子集都有各自成功的機會。如你也從Research Day所知，各子集的收案（enrollment）不同，因此會影響其內在檢定力（intrinsic power）。

Nevertheless, the analysis plans are completely in parallel. With respect to your question on FX size, if we see FX size in Phase 3 in the end that will be observed in Phase 2, you could make the assumption that because it's twice as long and twice as big, that would increase the chance for statistics sites, which is certainly true, but not a guarantee. We just will have to turn the data cards see what we have and then determine our path forward. But with a stat/sig or stat negative, we are working on a plan for DM.

儘管如此，分析計畫是完全平行進行的。關於你對效果量（FX size）的問題，如果我們在第三期最終看到的FX size與第二期觀察到的一樣，你可以假設因為試驗時間是兩倍長、規模是兩倍大，達到統計顯著的機會會提高，這當然是對的，但並非保證。我們只能等數據出來看看結果，然後再決定後續路徑。不過無論是統計顯著或統計不顯著，我們都在為DM制定計畫。

Rajan Sharma, Goldman Sachs.

Rajan Sharma，Goldman Sachs。

Hi, thanks for taking my question. I've actually got one on (inaudible) approval. Could you just provide a little more color on the DGF update, please? So it seems like you're progressing development but not in DGF itself. So can you maybe help us understand what the forward path is here in terms of indications and when you may be in a position to move through a pivotal trial and what it was that you saw in the 52-week data that gives you confidence to move forward. And I'm just wondering if there's any additional reassurance into MMN based on what you've seen in the DGF trial. Thank you.

嗨，謝謝讓我提問。我其實有一個關於（聽不清）核准的問題。可以請你們就DGF的更新多提供一些說明嗎？看起來你們在推進開發，但不是在DGF本身。所以能否幫我們理解一下，未來在適應症上的前進路徑是什麼、你們何時可能具備推進到關鍵性（pivotal）試驗的條件，以及你們在52週數據中看到了什麼，讓你們有信心繼續往前？另外我也想知道，基於你們在DGF試驗中看到的結果，對MMN是否有任何額外的支持訊號。謝謝。

Yes. Happy to have Luc comment on this. Just a reminder, this was a Phase 2 proof-of-concept study. And what we wanted to do was use it to explore and learn about Empasiprubart in the transplant setting broadly with a focus on DGF in the particular study but Luc maybe you can talk about what we saw on the path forward.

是的。很樂意請Luc來回應。提醒一下，這是一項第二期概念驗證（proof-of-concept）研究。我們想做的是把它用來在移植（transplant）情境中更廣泛地探索並了解Empasiprubart，雖然在這項研究中特別聚焦於DGF；但Luc，也許你可以談談我們看到的結果以及後續路徑。

Yes. Thanks, Karen. Thanks for the question. So as I already said, is a relatively small trial. Basically, evaluating hypothesis whether we could influence reperfusion injury with this mechanism. And the transplant situation lends itself to this. And we have chosen as a target which is a relatively short-term goal. So when we saw the data at 24 weeks, we found an entreatment signal, which made us decide let's continue the exploration of the study after 52 weeks, which more or less confirmed that there is something in the renal parameters here that is affected, which gives us an interesting perspective on exploring the transplant. However, it does not support DGS, which as I said, is a short-term readout to be continued as an indication.

是的。謝謝你，Karen。謝謝你的問題。如我先前所說，這是一個相對小型的試驗。基本上是在評估一個假設：我們是否能透過這個機制影響再灌流損傷（reperfusion injury）。而移植情境很適合用來檢驗這點。我們選擇了一個目標，屬於相對短期的目標。因此當我們在24週看到數據時，發現有治療訊號（treatment signal），這讓我們決定在52週後繼續探索；而52週的結果或多或少確認了腎臟相關參數確實受到影響，這讓我們對於在移植領域進一步探索有一個有趣的視角。然而，這些結果並不支持DGS（原文如此），如我所說，DGS是一個短期讀出，不適合作為適應症繼續推進。

And maybe just to comment on the second part of your question around MMN read-through. I don't think I would take any read-throughs for MMN other than we did see some effect of the drug. But in particular for MMN with the readout in Q4, I think the most important data point to look at there was our positive Phase 2 study where on the endpoint of group strength in the -- both in the initial Phase Part A as well as the open-label extension, we saw positive results. Thanks for the question.

另外回應你問題的第二部分，關於對MMN的延伸解讀（read-through）。我認為除了我們確實看到藥物有一些作用之外，我不會把DGF的結果延伸解讀到MMN。但就MMN而言，第四季（Q4）的讀出最重要的數據點，我認為是我們正向的第二期研究：在肌力（group strength）的終點上，無論是在初始的第一部分A（Phase Part A），或是在開放標籤延伸（open-label extension）中，我們都看到正向結果。謝謝你的問題。

Yatin Suneja, Guggenheim.

Yatin Suneja，Guggenheim。

Hey, guys. Thanks for taking my question. An excellent results. So congrats again. So quick one on the pipeline, specifically on ARGX-121, the IEN program. Could you maybe talk about a little bit about the profile that you have seen in Phase 1 that is enabling you to move into Phase 2, what level of IgA reduction you saw? How should we think about frequency, all of that? Thank you.

嗨，各位。謝謝讓我提問。結果非常出色。所以再次恭喜。我想快速問一下產品線（pipeline），特別是ARGX-121，也就是IEN計畫。你們能否談談在第一期看到的特徵（profile），是什麼讓你們能夠推進到第二期？你們看到IgA降低到什麼程度？我們應該如何看待給藥頻率等各方面？謝謝。

Yes. Thanks for the question about ARGX-121. We're really excited about 121 and broadening our pipeline with the IgA sweep. And we had shared data specifically from Phase 1 from -- and with the profile that showed that ARGX-121 reduces IgA by about 90% within the matter of days and that reduction is maintained all the way out until day 28, we haveone single dose. So very impressive data. And we're moving very quickly with urgency into IgN.

是的。感謝關於 ARGX-121 的提問。我們對 121 以及透過 IgA 清除（IgA sweep）來擴展我們的產品線感到非常興奮。我們也分享了第一期的特定數據——其特徵顯示 ARGX-121 可在數天內將 IgA 降低約 90%，且在單次給藥的情況下，這種降低可一路維持到第 28 天。因此這是非常令人印象深刻的數據。而我們正以非常快、非常迫切的速度推進到 IgN。

And perhaps Luc you could share your thoughts on the IgN program, clinical development program.

或許 Luc，你可以分享一下你對 IgN 計畫、臨床開發計畫的看法。

Well, with such a (inaudible) in Phase 1, we are pretty excited to keep this really moving fast. When we show those later key opinion leaders, they were also very enthusiastic that this speed and depth really puts it aside from, as we all know, IgN has quite some efforts going on. But our signature of the drug here really set us apart and it's really offering us great hopes for the Phase 2 and the Phase 3 that we can bring a meaningful drug to patients.

嗯，第一期有如此（聽不清）結果，我們相當興奮，會讓這個專案持續快速推進。當我們把這些結果展示給後續的關鍵意見領袖時，他們也非常熱情，認為這樣的速度與深度確實讓我們在 IgN 領域中脫穎而出——如大家所知，IgN 目前有不少研發工作正在進行。但我們這個藥物的特徵確實使我們與眾不同，也讓我們對第二期與第三期充滿期待，能為病患帶來一個具有實質意義的藥物。

Yaron Werber, Cowen.

Yaron Werber，Cowen。

Great. Thanks so much. Congrats on a really nice quarter. Just a question for you on MMN, and thanks for putting that slide into the deck that shows the group strength change from baseline. What we hear from clinicians is that 8 points is clinically meaningful? And I believe the primary is not inferiority and then you have superiority. Can you maybe just talk about that Phase 3 trial design, maybe a little bit of the powering or whatever you can share as to, how do you -- what do you expect from baseline? Thank you.

很好。非常感謝。恭喜你們交出非常漂亮的一季。我有一個關於 MMN 的問題，也謝謝你們把那張顯示握力相對基線變化的投影片放進簡報。我們從臨床醫師那裡聽到的是，8 分在臨床上具有意義？而我相信主要終點是非劣性，然後你們還有優效性。你們能否談談這個第三期試驗設計，也許包括樣本數估算（powering）或任何你們能分享的內容：你們如何看待——你們對基線的預期是什麼？謝謝。

Yes. Maybe Luc, I can pass it over to you to talk about Phase 1.

是的。也許 Luc，我把問題交給你來談談第一期。

Yes. Thanks for the question because it allows us to talk to what have we been trying to achieve in argenx. So with the Phase 2 data, as you will remember, we had like an 81% reduction in the need for rescue with IVIg based for those that received (inaudible), is to the point where we said, if every rescue, we need to take forward as on IVIg, you might as well do IVIg head-to-head, which would also provide the most meaningful data for prescribers.

好的。謝謝這個問題，因為這讓我們可以談談我們在 argenx 一直想達成的目標。所以就第二期數據而言，如你所記得的，我們看到在接受（聽不清）治療的患者中，基於 IVIg 的救援需求降低了約 81%；這讓我們認為，如果每次需要救援都要以 IVIg 來處理，那不如直接做一個與 IVIg 的頭對頭試驗，這也能為處方醫師提供最具意義的數據。

So we designed this trial where after stabilization on IVIg and optimizing that we initiate either a continuation of the IVIg regimen or switch to (inaudible) . The endpoints here is indeed grip strength, which we picked in conversation with actually the agencies because there were quite meaningful data available. which allows us to define a non-inferiority margin.

因此我們設計了這項試驗：在以 IVIg 穩定並完成最佳化之後，開始讓患者要嘛持續 IVIg 的療程，要嘛改為（聽不清）。此處的終點確實是握力，我們是在與主管機關的討論中選定的，因為已有相當有意義的既有數據可用，這使我們能夠界定非劣性界值。

And the non-inferiority margin is set, I think, pretty relevantly, but we also have the opportunity to go to superior it. And I think based on the Phase 2 data and what we learned on IVIg that there is in my opinion, a great chance that we could show that, but the noninferiority at least gives us the ability to at least provide that information.

而非劣性界值的設定，我認為相當具有相關性，但我們也有機會進一步檢驗優效性。我想基於第二期數據以及我們對 IVIg 的了解，我個人認為有很大機會能夠證明優效；但至少非劣性讓我們能夠提供這方面的資訊。

Yes. Thanks, Luc. And just to wrap it up, what I would say is what we see is success is a positive readout on the primary endpoint, noninferiority and obviously, upside would be superiority. But when we speak to KOLs and prescribers, we certainly hear excitement about the fact that we have a head-to-head versus IVIg. And certainly, with our experience in CIDP, we have some experience competing in that space as well. So I think we're set up for success, assuming a positive readout towards the end of the year with MMN.

是的。謝謝你，Luc。總結來說，我會說我們所謂的成功，是主要終點讀出為正、達到非劣性；當然，上行空間則是顯示優效性。但當我們與關鍵意見領袖與處方醫師交流時，我們確實聽到他們對於我們能與 IVIg 進行頭對頭比較感到興奮。而且，憑藉我們在 CIDP 的經驗，我們也有在該領域競爭的經驗。因此我認為，只要在今年年底 MMN 有正向讀出，我們就已具備成功的條件。

Danielle Brill, Truist.

Danielle Brill，Truist。

This is Alex on for Daniel. Congrats on the quarter. Just a question on CIDP as it pertains to the current commercial dynamics as well as the ongoing AMPA trials. As far as it relates to the commercial read-through of the CIDP launch in the regions where VYVGART is available, who are the types of patients who are enrolling in the Empasiprubart trials instead of trial in VYVGART? Thanks.

我是 Alex，代 Daniel 提問。恭喜本季表現。我想問一個關於 CIDP 的問題，涉及目前的商業動態以及正在進行的 AMPA 試驗。就 CIDP 在 VYVGART 已可取得地區的上市解讀而言，哪些類型的患者會選擇加入 Empasiprubart 試驗，而不是在 VYVGART 上進行試用？謝謝。

Yes. So maybe to start, just to lay out our strategy with CIDP. So we see that CIDP is a heterogeneous disease, and there is significant unmet need until VYVGART launched, there hadn't been innovation in the space for 30 years, and we've seen the strong uptick of VYVGART in CIDP. What we know is with the disease heterogeneity that there is also IgMs driving the disease. And so that's why we have the study within passive treat where we think we have strong biology rationale.

是的。那我先從 CIDP 的策略談起。我們認為 CIDP 是一種異質性疾病，且存在顯著未被滿足的需求；在 VYVGART 上市之前，這個領域已經 30 年沒有創新，而我們也看到 VYVGART 在 CIDP 的使用快速上升。我們知道，由於疾病的異質性，也有 IgM 在驅動疾病。因此我們在被動治療（passive treat）中的研究設計裡納入相關研究，因為我們認為其生物學理據很強。

So our hypothesis is that there are some patients that -- we have a 70% response rate with VYVGART. So those patients that don't respond to VVYVGART iv gut might have more IgM driven disease. And so we think that there's an opportunity for impact in those patients. There also might be patients where they have certain drivers of the disease, and so an overlap that might be between eligible for both VYVGART and Empasiprubart.

因此我們的假設是：有些患者——我們在 VYVGART 的反應率約為 70%。所以那些對 VVYVGART iv gut 沒有反應的患者，可能是更偏 IgM 驅動的疾病。因此我們認為在這些患者身上存在可帶來影響的機會。也可能有些患者具有特定的疾病驅動因素，因此可能同時符合 VYVGART 與 Empasiprubart 的資格，存在重疊。

So our strategy here is to study in Empasiprubart, and we're enrolling in Empasiprubart in a broad patient population so we can understand what impact -- the impact of Empasiprubart on the disease. And then once we have the data readout, we can analyze that data as well as the VYVGART data and really understand what is driving the best outcome for patients and move forward with the commercial strategy from there.

因此我們在這裡的策略是研究 Empasiprubart，並在 Empasiprubart 中納入廣泛的患者族群，以便了解——Empasiprubart 對疾病的影響。接著一旦我們取得數據讀出，我們就能分析這些數據以及 VYVGART 的數據，真正理解什麼因素能為患者帶來最佳結果，並在此基礎上推進後續的商業策略。

Thanks for the question.

謝謝你的提問。

Thomas Smith, Leerink Partners.

Thomas Smith，Leerink Partners。

Hey, guys. Good morning. Thanks for taking our question. Let me add my congrats on a really strong quarter here. On the pipeline, could you just provide some update us on how you're thinking about advancement between your next-gen FcRn in (inaudible). Any additional color on the target profile you're aiming for 124 with respect to IgG leveling or dosing interval or other potential differentiation? And how do you think about indication selection between life cycle management and potential expansion opportunities across those candidates. Thanks so much.

嗨，各位。早安。謝謝接受我們的提問。也讓我補上一句，恭喜你們這一季表現非常強勁。關於產品線，你們能否更新一下你們如何看待在下一代 FcRn（聽不清）之間的推進節奏？（聽不清）。另外，能否補充一些你們對 124 目標產品特徵（target profile）的想法，例如 IgG 降幅（leveling）或給藥間隔或其他可能的差異化？以及在這些候選藥物之間，你們如何在適應症選擇上權衡：生命週期管理與潛在擴張機會？非常感謝。

Yes. Thanks for the question. Our goal with FcRn is to maintain our leadership and even advance our leadership for decades to come. And we have a few pieces or parts to that strategy. Our next-generation molecules, 213 and 124 that you referred to.

是的。謝謝你的提問。我們在 FcRn 的目標是維持我們的領導地位，甚至在未來數十年進一步強化領導地位。而我們的策略包含幾個部分。你所提到的下一代分子 213 與 124。

213 is we call Phase 3 ready and 124, we're in Phase 1 at the moment and by the end of the year, we'll be in a position to move it into late-stage clinical development. So at the moment, we're working with our teams based on that data to assess the two molecules.

213 我們稱之為第 3 期就緒，而 124 目前處於第 1 期；到今年年底，我們將具備把它推進至後期臨床開發的條件。因此目前我們正根據這些數據與團隊合作，評估這兩個分子。

Of course, ARGX-213, we know has a Q4 weekly dosing schedule. ARGX-124, we're further categorizing the advantages that it will bring over VYVGART at the moment. And then we'll be in a position where we can lay out what the strategy is for the full portfolio between VYVGART 213 and 124. The other component of our strategy that's really exciting is that we are in development of an oral FcRn, and that program also moves forward with quickly at the moment. Thanks for the question.

當然，ARGX-213 我們知道是每週一次、按 Q4 的給藥時程。至於 ARGX-124，我們目前正在進一步界定它相較於 VYVGART 能帶來的優勢。接著我們就能清楚說明在 VYVGART、213 與 124 之間，整體產品組合的策略為何。我們策略中另一個非常令人振奮的部分，是我們正在開發口服 FcRn，而該計畫目前也在快速推進。謝謝你的提問。

Sean Laaman, Morgan Stanley.

Sean Laaman，摩根士丹利。

Good morning, Karen. Team, hope everyone is doing well. Just going back to the seronegative gMG impact. What's specifically prescribing trends have most exceeded your expectations? And how should investors think about the revenue contribution from seronegative patients over the next 12 to 24 months?

早安，Karen。各位團隊成員，希望大家都一切順利。我想回到血清陰性 gMG 的影響。具體而言，哪些處方趨勢最超出你們的預期？投資人應如何看待未來 12 到 24 個月血清陰性患者對營收的貢獻？

Yes. Thanks for the question. And I'll hand it over to Sandrine in a moment, but I'd be remiss if I didn't just say, first of all, that I'm really proud to see seronegative launch. It really is the argenx playbook in action. We made a commitment to this patient population many years ago when we launched VYVGART that we would bring this innovation to a negative patients and to see that happening in the market and being so positively responded to is really exciting.

是的。謝謝你的提問。我等一下會把問題交給 Sandrine，但我若不先說一句就太失職了：首先，我真的很自豪看到血清陰性適應症的上市。這確實是 argenx 劇本的實際展現。我們在多年前推出 VYVGART 時就對這群患者做出承諾：我們會把這項創新帶給血清陰性患者；如今看到它在市場上發生、且獲得非常正面的回應，真的令人振奮。

But Sandrine, maybe you could comment a little bit more on the dynamics you're seeing with the launch.

不過 Sandrine，也許你可以再多談一些你們在上市推進上看到的動態。

Thank you, Karen, and thank you for asking a question on seronegative because for me, this is a big event in the second quarter. So it's great to have someone asking that question. So I spent time in the field over the last few weeks to listen directly and hear the feedback from prescribers also from patients. And although we are only 10 weeks in, so it's still very early. The feedback is overwhelmingly positive.

謝謝你，Karen，也謝謝你問到血清陰性，因為對我來說，這是第二季的一件大事。所以很高興有人問到這個問題。過去幾週我花了時間到第一線，直接聆聽並收集處方醫師以及患者的回饋。雖然我們才進入第 10 週，仍然非常早期。但回饋幾乎是一面倒地正面。

I mean you saw the quote I had in the presentation from the patients. Many were actually waiting for more solutions because they have been excluded from clinical trials, especially the triple-seronegative patients, and they were really waiting for an option. And so a lot of hope, lot of antigens for the patient side. Some of them were calling the physicians to make sure that they were had access to the product as soon as possible.

我的意思是，你們在簡報中看到我引用的患者說法。很多人其實一直在等待更多解決方案，因為他們被排除在臨床試驗之外，尤其是三重血清陰性患者，他們真的在等待一個選項。因此在患者端有很多希望、很多期待。其中一些人甚至會打電話給醫師，確認他們能盡快取得這個產品。

On the provider side, what is interesting is that when you look at what the providers are saying is that they consider now that the fact that we have so negative to the label is that we now have a fully loaded gMG label and that had simplicity in decision making, streamlining decision-making. They quote I consider now VYVGART as the go-to option for all my gMG. And so one of the things we've observed over the first few weeks is that it has really a strong halo effect beyond the seronegative patients onto the positive serotype patient.

在醫療提供者端，有趣的是，當你看醫師怎麼說，他們認為我們把血清陰性納入標籤後，現在等於擁有一個「完整覆蓋」的 gMG 標籤，讓決策更簡單、決策流程更精簡。他們的說法是：「我現在把 VYVGART 視為我所有 gMG 患者的首選方案。」因此我們在前幾週觀察到的一點是：它對血清陰性患者之外，對血清陽性患者也產生了非常強的光環效應。

And that was something that we were expecting, but it's great to see it confirmed. What we are also very, very happy about is that the payers have been approving quite quickly and or single policy VYVGART and seronegative , where we have roughly 55% of the covered lives yet already less than three months after launch. And I have said that it would take three to six months to get to roughly 90%, and we are well on track to get there. And so what is also very important is not just the quantity of coverage but also the quality.

這是我們原本就預期會發生的，但看到被證實仍然很棒。我們也非常、非常高興的是，保險支付方核准速度相當快，且/或已將 VYVGART 與血清陰性納入單一給付政策；在上市不到三個月的時間，我們已覆蓋約 55% 的受保人數。我之前說過大約需要三到六個月才能達到約 90%，而我們目前進度完全在軌道上。因此同樣非常重要的不只是覆蓋的「量」，也包括覆蓋的「質」。

And I think that the majority of the plants are removing the testing requirements for the serotype is also making the life of the providers easy. So if I would summarize, it's all about leadership in MG with that approval, but also simplicity of decision-making for the providers. So great feedback until now.

我認為多數方案正在移除對血清型檢測的要求，這也讓醫療提供者的工作更容易。如果要我總結：這次核准讓我們在 MG 領域的領導地位更明確，同時也讓醫師的決策更簡化。到目前為止回饋非常好。

Thank you.

謝謝。

Samantha Semenkow, Citi.

Samantha Semenkow，花旗。

Hi, good morning and thanks very much for taking my question. Just one on CIDP for me. You outlined in your slides market expansion opportunity. I'm wondering what you're seeing in the data about treatment-naive patients utilizing VYVGART as a first line. Are you seeing a shift towards these patients being treated more frequently? And if so, how should we think about the progression of the launch in that segment going forward? Thanks very much.

嗨，早安，也非常感謝讓我提問。我只有一題關於 CIDP。你們在投影片中提到市場擴張的機會。我想了解你們從數據中看到，未治療（treatment-naive）患者把 VYVGART 作為第一線治療的使用情況如何。你們是否看到這類患者更頻繁地接受治療、出現轉移趨勢？若是如此，我們應如何看待未來該細分市場的上市推進節奏？非常感謝。

Yes. Thanks for the CIDP, questions. Sandrine, maybe you can comment

是的。謝謝關於 CIDP 的問題。Sandrine，也許你可以回應一下。

Yes. So it's indeed a very big opportunity for us to -- we make sure that VYVGART as early as possible because still the majority of the patients start with IVIg when they start the treatment for CIDP. So we publish data and we are generating more and more evidence to show that if you are prescribing VYVGART for treatment-naive patients actively you see clinical benefits and we presented study at (inaudible) where we showed at 87.5% of the patients that were treatment naive benefited from a clinical response. And we are using data encourage physicians to try VYVGART in earlier line patients and so, and they are seeing good results.

好的。這確實是我們非常大的機會——我們要確保 VYVGART 能盡可能早期使用，因為目前多數 CIDP 患者在開始治療時仍是先從 IVIg 開始。因此我們已發表數據，並持續產出越來越多的證據，顯示若在未治療患者中積極處方 VYVGART，能看到臨床效益；我們也在（聽不清）會議上發表研究，顯示 87.5% 的未治療患者獲得臨床反應的受益。我們正運用這些數據鼓勵醫師在更早線的患者嘗試 VYVGART，而他們也看到了良好結果。

Now it's taking time. It's taking time because you have to change entrench habits. And you have also to make sure that payers are supporting that because the majority of them are requiring some kind of experience with IVIg. So that's what we are working on. But you see more and more traction in the treatment-naive population as well as in the patients that are seen as well managed, but need some more functional improvement.

不過這需要時間。需要時間，因為必須改變根深蒂固的用藥習慣。同時也要確保保險支付方支持，因為多數支付方會要求先有某種 IVIg 的使用經驗。這就是我們正在努力的方向。但你確實會看到在未治療族群的動能越來越強，同時也包括那些被認為控制得不錯、但仍需要更多功能改善的患者。

Gavin Clarke-Gartner, Evercore ISI.

Gavin Clarke-Gartner，Evercore ISI。

Hey, thanks for taking the question. Just following the recent (inaudible) update, are you considering any changes to your CIDP development plans for EMPA. And I guess on this point, did this outcome change what you think the likelihood of EMPA meeting superiority versus IVIg in either CIDP or NMN. Thank you.

嗨，謝謝讓我提問。接續近期（聽不清）的更新，你們是否考慮調整 EMPA 在 CIDP 的開發計畫？另外就這點而言，這個結果是否改變你們對 EMPA 在 CIDP 或 NMN 中，相較 IVIg 達到優效性的可能性判斷？謝謝。

Yes. Thanks for the question, Gavin. As a reminder, before I hand it over to Luc, our clinical development program, the CIDP for Empasiprubart has two studies. One is the head-to-head versus IVIg and the other is a placebo-controlled study. And so I think it's around the placebo-controlled study that you're particularly asked before, but also maybe you can comment Luc on that on your confidence in the IVIg study as well.

是的。謝謝你的問題，Gavin。提醒一下，在我把問題交給 Luc 之前，我們的臨床開發計畫中，Empasiprubart 的 CIDP 有兩項研究。一項是與 IVIg 的頭對頭比較，另一項是安慰劑對照研究。因此我想你特別在問的是安慰劑對照那項研究；不過 Luc，你也可以一併評論一下，對 IVIg 研究的信心如何。

Yes. And what is important to realize CIDP, and we use the term already is a heterogeneous disease also. And therefore, your selection of patients matters. We took particular care in the (inaudible) study to install, for example, that clinical (inaudible) committee, which now has become the standard, but we continue to exclude possible CIDP patients, for example, is one of the differences.

是的。而且需要認清的一點是，CIDP（我們已經在使用這個術語）同樣是一種異質性疾病。因此，你對病患的選擇很重要。我們在（聽不清）研究中格外謹慎，例如設置了臨床（聽不清）委員會，這如今已成為標準；但我們仍持續排除可能的 CIDP 病患，例如這就是其中一個差異。

And then if you then, on top of that, so it's really refractory patients, you may come in a situation where the disease has burned out more or less and then about is the ability to change. We, of course, want to learn, and we will be looking more closely at the data and evaluate is there anything we need to do to optimize our studies, but we are continuing with our plans to continue both.

此外，如果你再加上一層，也就是這些確實是難治型病患，你可能會遇到疾病或多或少已經「燒盡」的情況，然後就涉及到改變的能力。當然，我們希望學習，我們也會更仔細地檢視數據並評估是否需要做任何事來優化我們的研究，但我們會按計畫繼續推進兩者。

And maybe just one more comment on that, that it's made me reflect on is that it's very clear from this that it's not easy to run successful clinical trials in CIDP and one advantage that we have is that we do have the VYVGART experience, and we've been able to demonstrate that ability. So that gives me additional confidence as well.

也許再補充一點，這件事讓我反思的是：從中非常清楚可以看出，在 CIDP 中要成功執行臨床試驗並不容易；而我們的一個優勢是，我們確實有 VYVGART 的經驗，並且已經能夠證明我們具備那樣的能力。所以這也讓我更有信心。

Sophia Graeff, JPMorgan.

Sophia Graeff，摩根大通。

Thanks for taking my questions. One on the upcoming myositis trial. You commented that you currently no longer see a path forward for polymyositis patients. But given the strong evidence that ASyS is autoantibody-driven, would there be scope to run an ASyS specific trial in future? Or is this population still a bit too small to target?

謝謝回答我的問題。第一個是關於即將進行的肌炎試驗。你提到目前你們不再看到針對多發性肌炎（polymyositis）病患的前進路徑。但鑑於 ASyS 有強而有力的證據顯示其由自體抗體驅動，未來是否有空間進行一個 ASyS 特定的試驗？還是說這個族群規模仍然太小，不適合鎖定？

Yes. Thank you for that question. We, of course, want to reach as many patients as we can just from a technical point of view in this trial with the enrollment numbers, we just can't get there, but we will learn. And so ASyS is not just confined with DM and (inaudible) itself is heterogeneous and been a bit kind of being more and more allocated to the other subsets as we get to know more. So we will definitely look at the data as they come and determine the plan forward for ASyS.

是的。謝謝你的問題。當然，我們希望從技術層面來說，在這項試驗的收案人數上能涵蓋盡可能多的病患，但我們就是做不到；不過我們會從中學習。而且 ASyS 並不僅限於 DM，（聽不清）本身也是異質性的，隨著我們了解更多，它也逐漸被更多地歸類到其他子群。因此，我們一定會在數據出來後加以檢視，並決定 ASyS 的後續計畫。

Thank you.

謝謝。

Victor Floch, BNPP.

Victor Floch，BNPP。

Thank you for taking our question. So maybe just one on the PFS, your side that the proportion of PFS patients new to VYVGART actually increased to 80% from 68% in Q1, which is quite impressive. So I was just wondering whether it makes you incrementally more bullish about the auto-injector opportunity? And whether there is any chance you can share more details on the remaining development milestone for the VYVGART and the expected launch timing. Thank you very much.

謝謝讓我們提問。我想問一個關於 PFS 的問題：你們提到新使用 VYVGART 的 PFS 病患比例，從第一季的 68% 提升到第二季的 80%，這相當令人印象深刻。所以我想知道，這是否讓你們對自動注射器（auto-injector）的機會更為看多？以及你們是否有機會分享更多關於 VYVGART 剩餘的開發里程碑細節與預期上市時程？非常感謝。

Yes. So thanks for the question on PFS. I'll hand over to Sandrine in a moment. But just to confirm, auto-injector is on target or on schedule for 2027 launch. But maybe some of the dynamics you're seeing with prefilled syringe in the market Sandrine.

是的。謝謝你關於 PFS 的問題。我等一下把問題交給 Sandrine。不過先確認一下，自動注射器仍按目標、按時程推進，預計 2027 年上市。至於你在市場上看到的預充式注射器（prefilled syringe）的動態，Sandrine 你來補充一下。

Yes. So thank you for your question, Victor. So indeed, I wrote on the slide 80% of the patients that are on PFS in the second quarter in US are new to VYVGART. So it's true expansion for us and you compare to last time where we said 68 %.

好的。Victor，謝謝你的問題。確實，我在投影片上寫到：美國第二季使用 PFS 的病患中，有 80% 是 VYVGART 的新病患。所以對我們而言這是真正的擴張；而你對照上次我們說的 68%。

Last time, 68% was launched today. So these were the patients since the launch this time, we should actually adjust for Q2. If you look at launch-to-date, to compare apples with apples, we would be at 70%. So it's a slight increase, but it's not 80%. 80% is really the last quarter. And it shows that actually more and more of the patient start with VYVGART actually are truly new and starting PFS or are new to VYVGART. So thank you for the question.

上次的 68% 是以「上市至今」來看的。所以這次其實應該針對第二季做調整。如果你用上市至今來看、做同類比較，我們會是 70%。所以是小幅增加，但不是 80%。80% 真的是指上一個季度。而這顯示，實際上越來越多開始使用 VYVGART 的病患，確實是全新病患，並且是從 PFS 開始，或是對 VYVGART 而言是新病患。謝謝你的問題。

Andy Chan, Wolfe.

Andy Chan，Wolfe。

Hi, thank you for taking my question. This is Jason taking in for Andy. I just wanted to ask a question in terms of seronegative approval and what its effect on this quarter's earnings had? And also, I wanted to ask in terms of the launch curve of seronegative and ocular. Will they be similar or what might there be in terms of like subtle differences, and anything to look, think about when we're looking at the uptick of ocular? Thank you.

嗨，謝謝讓我提問。我是 Jason，代替 Andy 提問。我想問一下關於血清陰性（seronegative）核准，以及它對本季獲利的影響。另外我也想問，血清陰性與眼肌型（ocular）的上市曲線會相似嗎？或是可能有哪些細微差異？以及在我們觀察眼肌型的上升趨勢時，有沒有什麼需要留意或思考的點？

Yes. Thanks for the question. Karl, maybe you can comment on the dynamics of the quarter.

是的。謝謝你的問題。Karl，也許你可以評論一下本季的動態。

Thank you, Karen. And thank you, Jason, for the question. Yes. Sandrine already mentioned in the prepared remarks, the quarter was driven by strong fundamentals and PFS was the key driver of growth. However, seronegative, of course, is also a contributor, in particular, the seronegative -- the triple-negative patients where we see the huge unmet need and also the halo effect the seronegative had on the broader gMG market.

謝謝你，Karen。也謝謝你，Jason，提出這個問題。是的。Sandrine 在事先準備的發言中已提到，本季是由強勁的基本面所驅動，而 PFS 是成長的關鍵驅動因素。不過，血清陰性當然也是貢獻者之一，特別是血清陰性——三陰性（triple-negative）病患，我們在那裡看到巨大的未被滿足需求；此外，血清陰性也對更廣泛的 gMG 市場帶來光環效應（halo effect）。

So I think what -- and of course, we expect that to also flow into (inaudible). In terms of ocular, I think as we always said, you need continued innovation to maintain the growth and regular new launches, of course, is what we need. And I think we are very excited, but we're going to continue to deliver that for patients. Thank you for the question.

所以我認為——而且當然，我們也預期這會進一步反映到（聽不清）。至於眼肌型，我想我們一直都說，你需要持續創新來維持成長，而定期推出新適應症/新上市當然是我們所需要的。我們非常興奮，但我們也會持續為病患交付這些。謝謝你的問題。

Luca Issi, RBC Capital Markets.

Luca Issi，RBC 資本市場。

Good morning, guys. Thanks for taking our question. Congrats on another great quarter. Maybe, Luc, I just want to circle back on a prior question on myositis, you mentioned that IMNM and DM are independent analysis, each of them has its own change of (inaudible). But the FDA still ask you to split the alpha between two trials, given that this was originally structured as an all-comer trial that enrolled both populations together, or our each trial at this point, completely independent from one another and there's absolutely no cross talk between the two trials.

各位早安。謝謝讓我們提問。恭喜又一個很棒的季度。Luc，我想回到先前關於肌炎的一個問題：你提到 IMNM 和 DM 會做獨立分析，各自都有自己的（聽不清）變化。

I guess the other way to ask the question, are these trial successful the p-value is below 0.05? Or do you need to hit value below 0.025 because, again, splitting alpha between two trials. Any color there much appreciated. Thank you.

換個方式問：這些試驗若成功，p 值是低於 0.05 就可以嗎？還是你需要達到低於 0.025，因為同樣地，要在兩個試驗之間分配 alpha？若能提供一些說明將非常感謝。謝謝。

Yes. So I want to stay consistent with how we answered that at the R&D Day, which is we're not going to comment on a specific alpha value because even in these rare diseases, even with alpha that are in between 0.05 and 0.1 even, you can have a conversation. It's not that we go in there, but I'm just saying we're not going to disclose the actual alpha value. Today the cart is to be turned soon.

是的。因此我想與我們在研發日（R&D Day）對此的回答保持一致，也就是我們不會就特定的 alpha 值發表評論，因為即使在這些罕見疾病中，即便 alpha 介於 0.05 到 0.1 之間，你仍然可以進行討論。並不是說我們會在那裡做什麼，但我只是說我們不會披露實際的 alpha 值。今天很快就會翻牌。

Yes. And maybe just to give you some additional insight and color on the strategy and the filing strategy. So as Luc shared earlier, the analysis plan is independent of each other. So IMNM and the DM separately. So they are two separate analysis plans and our filing path -- our filing strategy and top forward is in IMNM recall that there are no approved treatments in IMNM.

是的。也許再補充一些關於策略與申報策略的背景與說明。如 Luc 先前分享的，分析計畫彼此獨立。也就是 IMNM 與 DM 分開。因此它們是兩個獨立的分析計畫，而我們的申報路徑——我們的申報策略以及後續推進——會先聚焦在 IMNM，請記得 IMNM 目前沒有已核准的治療。

And so we have breakthrough designation with the FDA and has had significant, and have had those communications based on that with FDA. In DM, what we'll be looking for, of course, is statistical significance. And once we have that data, we'll be able to continue discussions with the FDA on what the path forward is there.

因此我們已獲得 FDA 的突破性療法認定，並且基於此與 FDA 進行了重要且持續的溝通。在 DM 方面，我們當然會尋求統計顯著性。一旦我們拿到那些數據，我們就能與 FDA 繼續討論那邊的後續路徑。

But what I want to come back to is that with this myositis study, what we've given ourselves the opportunity to do is have two opportunities for label expansion, both or each of them individually as blockbuster in potential blockbuster indications, IMNM and DM. So we're on track for Q3. We'll turn the data card and we'll determine the path forward from there.

但我想回到一點：透過這項肌炎研究，我們讓自己有機會獲得兩次擴大適應症標籤的機會，兩者各自都可能成為重磅、具潛在重磅的適應症——IMNM 與 DM。所以我們仍按計畫在第三季（Q3）推進。我們會揭曉數據，並從那裡決定後續路徑。

Thanks so much.

非常感謝。

Sebetian (inaudible), Kempen.

Sebetian（聽不清），Kempen。

Hi, guys. Congrats on the excellent quarter and thanks for taking question. Can you maybe share your latest thinking on your ambitions regarding business development M&A? What should we not expect in this aspect for the next 12 to 24 months? And can you maybe describe the profile of assets that you will be looking for to add to your pipeline? Thank you.

嗨，各位。恭喜這個出色的季度，也謝謝讓我提問。你們能否分享一下你們對業務發展與併購（BD/M&A）目標的最新想法？在未來 12 到 24 個月，在這方面我們不應該期待什麼？另外，你們能否描述一下你們希望納入產品線（pipeline）的資產輪廓？謝謝。

Yes. Thanks for the question. So our overall capital allocation strategy is very much focused on delivering growth, growth in the short, mid and long term. And in line with that, our capital allocation strategy focuses on number one, fueling VYVGART growth. Number two, funding and accelerating our internal pipeline. That includes our FcRn assets that I was talking about earlier, but also beyond FcRn.

好的。謝謝你的問題。我們整體的資本配置策略非常聚焦於帶來成長——短期、中期與長期的成長。與此一致，我們的資本配置策略第一是推動 VYVGART 的成長。第二是資助並加速我們的內部產品線。這包括我先前提到的 FcRn 資產，也包括 FcRn 以外的項目。

And then, of course, with the strength of our balance sheet, we also have the opportunity to look at business development. Now looking at business development opportunities in order to identify potential new assets, it's not a new strategy for us. I always the approach that argenx has taken has been to partner to look for novel biology, new mechanisms of action where there's significant unmet patient needs.

當然，憑藉我們資產負債表的強勁，我們也有機會評估業務發展。而為了辨識潛在新資產而尋找業務發展機會，對我們來說並不是新策略。我一直認為 argenx 採取的方法是透過合作來尋找新穎的生物學、全新的作用機轉，且聚焦於存在重大未被滿足病患需求的領域。

And in the past, we always, we partnered with academic institutions in order to identify that biology and build those molecules. With the strength of our balance sheet and our continued profitability, we can now widen the lens and also look at biotech companies that are pursuing. But we use the same bar, for those business development opportunities as we do for our internal pipeline.

過去我們一直與學術機構合作，以辨識這些生物學並打造那些分子。隨著我們資產負債表的實力以及持續獲利能力，我們現在可以擴大視野，也會看正在推進相關工作的生技公司。但我們對這些業務發展機會所採用的門檻，與我們對內部產品線的門檻相同。

And that bar is that it has to be novel biology, and it has to be in areas where there is significant unmet patient needs. So we're holding that we hold the bar high, but I can tell you, when we find those opportunities where we can have an impact for patients, we will leverage the flexibility of the balance sheet to be able to go after them and continue to build our pipeline.

而這個門檻是：必須是新穎的生物學，且必須在存在重大未被滿足病患需求的領域。所以我們把標準訂得很高；但我可以告訴你，當我們找到能對病患產生影響的機會時，我們會運用資產負債表的彈性去把握它們，並持續擴充我們的產品線。

Thanks for the question.

謝謝你的提問。

Douglas Tsao, H.C. Wainwright.

Douglas Tsao，H.C. Wainwright。

Hi, good morning. Thanks for taking our questions. Just I'm curious in terms of the CIDP opportunity and the slide where you indicate that the number of patients who are diagnosed but not treated, and I'm just curious if your sense is as those patients aren't being treated just given the sort of tolerability issues related to IVIg? And is VYVGART sort of sort of tolerability become an attractive sort of attribute that you are going to sort of try to sell to clinicians in terms of bringing those patients back into treatment.

嗨，早安。謝謝回答我們的問題。我想請教關於 CIDP 的機會，以及你們投影片中提到「已被診斷但未接受治療」的病患人數；我想了解你們是否認為這些病患未治療是因為與 IVIg 相關的耐受性問題？以及 VYVGART 的耐受性是否會成為一個有吸引力的屬性，你們會嘗試向臨床醫師推廣，以便讓這些病患重新回到治療中。

Yes. Thanks for the question, Douglas. And I think what you can see from that slide that I find exciting is that it's clear we're just at the beginning of the growth curve for CIDP, and there's a lot of opportunity for continued growth.

是的。謝謝你的問題，Douglas。我認為你從那張投影片可以看到、也讓我感到興奮的是，很明顯我們才剛站在 CIDP 成長曲線的起點，未來仍有很大的持續成長空間。

But maybe Sandrine, you can share what you're seeing in the market around those patients.

不過 Sandrine，也許你可以分享一下你在市場上對這些病患的觀察。

Yes. Thank you, Karen. So in the DP lots of opportunities for further growth within the addressable market will start with a launch but also way beyond that. And so what I noticed when I discussed CIDP with patients, but most importantly with providers that is a disease which is not well understood. And when there is not really a true dialogue between the patients and the providers where actually the unmet need is underestimated. And even when a patient is being treated and his thought has been well managed, actually, it's not the case because there is not dialogue.

好的。謝謝你，Karen。所以在 CIDP 上，在可觸及市場（addressable market）內仍有許多進一步成長的機會，會從上市啟動開始，但也遠不止於此。我注意到，當我與病患、但更重要的是與醫療提供者討論 CIDP 時，這是一個並未被充分理解的疾病。而當病患與醫療提供者之間沒有真正的對話時，未被滿足的需求其實會被低估。甚至當病患正在接受治療、且被認為控制得很好時，實際上可能並非如此，因為缺乏對話。

And I often use an example like you would ask somebody, are you doing okay? Can you brush your hair in the morning, and the person said, yes, I can. And then when you ask all the do that, they say I'm on my best to brush my head, which shows that there is really a muscle weakness there and that we must show (technical difficulty) provider that you can make a difference by putting them on treatment like VYVGART.

我常用一個例子：你問某人「你還好嗎？你早上能梳頭髮嗎？」對方說「可以」。但當你追問「你是怎麼做到的？」他們會說「我會盡全力去梳頭」，這顯示其實存在肌力無力，而我們必須讓（技術問題）醫療提供者看到：把病患放到像 VYVGART 這樣的治療上，你是可以帶來改變的。

And this is the same happening for patients who are not on treatment and that have been diagnosed because they kind of underestimate the level of functional, all the function every day. They have accommodated the life. They have moved from a house to an apartment.

同樣的情況也發生在那些已被診斷但未接受治療的病患身上，因為他們某種程度低估了日常功能受影響的程度。他們已經去適應那樣的生活。他們從房子搬到公寓。

They don't drive anymore. They have just lower the bar of what their life should look like, what the condition life should look like. And what we are trying to do is generate data to show that you can get your life back if you really take that seriously. This takes time. This take a lot of data generation, and it takes also patient to go and have the discussion with their providers. So that's what we are trying to do.

他們不再開車。他們只是把對生活應有樣貌、對疾病狀態下生活應有樣貌的標準降低了。而我們正在做的是產生數據，去證明如果你真的嚴肅看待並接受治療，你可以把生活拿回來。這需要時間。這需要產生大量數據，也需要病患去和他們的醫療提供者進行討論。所以這就是我們正在努力的方向。

Qize Ding, Redburn.

Qize Ding，Redburn。

Hi, thanks for taking my question. Can I just ask a quick follow-up question on the BD. Are you interested in the assets within the same therapy areas that could further strengthen your existing portfolio, or are you looking for complementary assets that could broaden your portfolio? Thank you so much.

嗨，謝謝回答我的問題。我想就業務發展（BD）再追問一個簡短問題。你們是對同一治療領域內、能進一步強化既有產品組合的資產更感興趣，還是你們在尋找互補性資產，以擴大你們的產品組合？非常感謝。

Yes. Thanks for the question. So when we build our pipeline, whether it's with internal assets or through business development, we're focused on immunology assets, but we are focused on diversifying our pipeline beyond FcRn. And so you can see that within our internal pipeline, of course, we have Empasiprubart, we have ARGX-121. We also have molecules in early stage development that are very exciting.

是的。謝謝你的提問。因此，當我們建立研發管線時，不論是透過內部資產或商務拓展，我們都聚焦於免疫學資產，但同時也著重於讓管線在 FcRn 之外更加多元化。因此你可以看到，在我們的內部管線中，當然有 Empasiprubart，也有 ARGX-121。我們也有一些處於早期開發階段、非常令人振奮的分子。

When we look at internal and external molecules, we set the bar as what we're looking for is novel biology, and we need to have clarity on how we can derisk that novel biology to move into patients, and we keep the bar high on that as well as these areas of high unmet patient need where we could be bringing the first-in-class all the best-in-class assets forward for patients. And so that's the strategy that we have for both our internal pipeline as well as business development.

當我們檢視內部與外部的分子時，我們設定的門檻是：我們尋找的是新穎生物學（novel biology），而且我們必須清楚知道如何降低這種新穎生物學的風險，才能推進到病患端；在這方面我們也維持很高的標準。同時，我們也聚焦於那些病患未被滿足需求很高的領域，在那裡我們可以為病患帶來同類首創（first-in-class）或同類最佳（best-in-class）的資產。這就是我們對內部管線以及商務拓展所採取的策略。

Xian Deng with UBS.

UBS 的 Xian Deng。

Thanks for taking my question. One on DM, please. So just wondering, there are some studies or evidence kind of suggesting DM is more sort of interferon one driven disease and the role of autoantibodies is not as clear as that as in IMNM. So just wondering for your DM study, but I think on the other hand, especially DM some autoantibodies have very strong predictive power to prognosis and symptoms, et cetera, et cetera. So just wondering, do you see some several subtypes of DM that potentially have better response? And are you enriching those for the study? Thank you.

謝謝讓我提問。想請教一題關於 DM。我在想，有一些研究或證據似乎顯示 DM 比較像是由第一型干擾素（interferon-1）驅動的疾病，而自體抗體的角色不像在 IMNM 那麼明確。所以想請問，在你們的 DM 研究中——但另一方面，尤其在 DM 中，有些自體抗體對預後與症狀等具有很強的預測力，等等。因此想請問，你們是否看到某些 DM 亞型可能反應更好？以及你們是否在研究中針對這些亞型進行富集（enrich）？謝謝。

Yes. Thanks for the question. Maybe I can just start by sharing at a high level what we shared at R&D Day, which is we see a clear biology rationale for both IMNM and DM. They are both autoantibody-driven diseases.

是的。謝謝你的提問。也許我可以先從高層次分享我們在 R&D Day 所分享的內容：我們認為 IMNM 與 DM 都有明確的生物學理據。它們都是由自體抗體驅動的疾病。

But maybe, Luc, you can provide a little more detail.

不過也許 Luc，你可以再提供一些更詳細的說明。

Yes. hence, again, the theme of these diseases are not driven by just one mechanism, which is why we bought that multiple (inaudible) moving forward. The (inaudible) molecule clearly is more in the (inaudible) pathway, as you indicate, which we feel is clearly a demonstrated driver mostly in skin pathophysiology, but some in muscle.

是的。因此，再次呼應一個主題：這些疾病並不是只由單一機制所驅動，這也是為什麼我們在往前推進時採取了多重（聽不清）的方法。（聽不清）這個分子很明顯更偏向（聽不清）路徑，如你所指出的；我們認為這已被清楚證明主要是皮膚病理生理的驅動因素，但在肌肉方面也有一些影響。

We feel that given the demonstrated level of how antibodies present in these diseases and their targets that addressing primarily the autoantibodies has a role to play. And in that sense, our Phase 2 subset data and demonstrate that there was a signal in the end, which could not be driven by Interferon-1. So yes, there is place for more than one approach here.

我們認為，鑑於這些疾病中抗體的存在程度及其標的已被證實，主要針對自體抗體的處置仍有其角色。就此而言，我們的第二期子集資料顯示，最終確實有一個訊號，而這不太可能是由第一型干擾素所驅動。所以是的，這裡確實有空間採取不只一種方法。

Yes. And that was what I was going to just close out with. I think that's important, Luc. I mean there's been really very limited innovation in the myositis space for many, many years. And so I think if you take -- if you zoom out, there is room for more than one mechanism of action in DM.

是的。而這正是我想做結的重點。我認為這點很重要，Luc。我的意思是，在肌炎（myositis）領域，多年來創新其實非常有限。因此我認為，如果你把視角拉遠來看，在 DM 中確實容得下不只一種作用機轉。

And in particular, what I think is going to be important is to look at the muscle involvement and the impact of these mechanisms of action on the muscle because that is the defining feature of this disease, and that's something that we'll be looking for in our Phase 3 readout. Thanks for the question.

而我認為特別重要的是，要看肌肉受累（muscle involvement），以及這些作用機轉對肌肉的影響，因為那是這個疾病的定義性特徵；這也是我們在第三期讀出時會關注的重點。謝謝你的提問。

Niall Alexander, Deutsche Bank.

德意志銀行（Deutsche Bank）的 Niall Alexander。

Hi, good afternoon. It's Niall Alexander from Deutsche Bank. Thanks for taking my question. So just one on the VYVGART pricing and channel mix. It'd be helpful seeing if you can provide the actual realized list price per average subcutaneous patient at present. Any color you can give on gross to net pricing and discount, and in addition, it would be great to get a sense of the channel split for VYVGART sales right now? Thank you.

嗨，午安。我是德意志銀行的 Niall Alexander。謝謝讓我提問。我想問一題關於 VYVGART 的定價與通路組合。如果你們能提供目前每位平均皮下注射病患實際實現的牌價（realized list price），會很有幫助。也希望你們能說明一下總額到淨額（gross-to-net）的定價與折扣情況；另外，也很想了解目前 VYVGART 銷售的通路拆分（channel split）大概是怎樣？謝謝。

Thank you Yes, of course, I mean the list price in the US is public information, and we can -- you can go also reach-out us if you need the help of it. I think what is important is that, but the gross to net and the net price per patient will continue to be stable. It's the same in Q2 as it was in prior quarters.

謝謝。是的，當然——美國的牌價是公開資訊，我們也可以——如果你需要協助，你也可以聯絡我們取得。我認為重要的是，總額到淨額（gross-to-net）以及每位病患的淨價將會持續保持穩定。第二季與前幾季是一樣的。

Over time, you'll see a slight increase in gross to net quarter-over-quarter, and that is because PFS preferring for self-injection do have a slightly higher gross to net than the other presentations, but that, of course, is offset by higher adherence. So I think what we can say is that the net price per patient continues to be stable and the business is, there's nothing really new to say. So thank you for the question.

隨著時間推移，你會看到總額到淨額在季度間略有上升，而這是因為偏好自我注射的預充式注射器（PFS）其 gross-to-net 會比其他劑型略高；但當然，這會被更高的依從性（adherence）所抵銷。因此我想我們可以說的是：每位病患的淨價仍然穩定，業務方面也沒有什麼新的可補充。所以謝謝你的提問。

There are no further questions. This concludes our conference for today. Thank you for participating. You may now disconnect.

沒有其他問題了。今天的電話會議到此結束。感謝各位參與。您現在可以掛線。