argenx SE (ARGX) 2025 Q1 法說會逐字稿

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

早安.我叫羅布，今天我將擔任您的會議主持人。我歡迎大家參加電話會議。（操作員指示）

I'd now like to introduce Beth DelGiacco, Vice President, Corporate Communications and Investor Relations. You may now begin your conference.

現在我想介紹企業傳播與投資人關係副總裁 Beth DelGiacco。您現在可以開始您的會議了。

A press release was issued earlier today with our first quarter of 2025 financial results and business update. This can be found on our website along with the presentation for today's webcast.

今天稍早發布了一份新聞稿，其中包含我們 2025 年第一季的財務業績和業務更新。您可在我們的網站上找到該內容以及今天的網路廣播的簡報。

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 development, regulatory time lines, the potential success of our product candidates, financial projections and upcoming milestones. Actual results may differ materially from those indicated by these statements.

在我們開始播放第二張投影片之前，我想提醒您，本次電話會議期間可能會出現前瞻性陳述。這些可能包括關於我們未來預期、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。實際結果可能與這些聲明所示的結果有重大差異。

argenx is not under any obligation to update statements regarding the future or to conform these 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.

除非法律要求，否則 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相符。今天與我一起參加電話會議的還有執行長 Tim Van Hauwermeiren、財務長 Karl Gubitz 和營運長 Karen Massey。

I'll now turn the call over to Tim.

我現在將電話轉給蒂姆。

Thank you, Beth, and welcome, everyone. I'll begin on slide number 3. At argenx, we are building our company for the long run. Our strategic decision-making has with an agile approach, has positioned us to deliver sustained growth in a dynamic and evolving market landscape. It's with this same long-term focus that we introduced an ambitious Vision 2030 to reach 50,000 patients across 10 labeled indications and advance 550 assets.

謝謝你，貝絲，歡迎大家。我將從第三張投影片開始。在 argenx，我們正在為長遠發展而建立我們的公司。我們的策略決策採用敏捷的方式，使我們能夠在動態和不斷變化的市場環境中實現持續成長。正是基於同樣的長期關注，我們提出了雄心勃勃的“2030 願景”，旨在涵蓋 10 種適應症的 50,000 名患者並推進 550 項資產。

This quarter, we continue to execute against a bold innovation agenda, keeping us firmly on track to realize this vision. We successfully launched the pre-filled syringe in the US and Germany to reach more patients with VYVGART. We are advancing registrational and 10 proof-of-concept studies across our pipeline, and we remain on track to progress four INDs in the clinic this year with ARGX-109 and ARGX-213, now in Phase 1 studies.

本季度，我們繼續執行大膽的創新議程，堅定地朝著實現這一願景的方向前進。我們在美國和德國成功推出了預充式註射器，以便讓更多患者能夠使用 VYVGART。我們正在推進整個產品線的註冊研究和 10 項概念驗證研究，並且我們今年仍有望在臨床上推進四項 IND，其中 ARGX-109 和 ARGX-213 目前處於第 1 階段研究。

Slide 4. Our focus on execution continues to yield results. Let's begin with our commercial business, where underlying growth is exactly where we expected to be.

幻燈片 4。我們對執行的關注不斷產生成果。讓我們從商業業務開始，其潛在成長正是我們預期的。

Consistent with last year, first quarter results reflected typical seasonality following an exceptional quarter. Karen will share more details on launch dynamics later in the call with big picture, key physician and patient metrics across both GMG and CAD continue to be strong.

與去年同期相比，第一季的業績反映出了一個異常季度後的典型季節性。Karen 將在稍後的電話會議中分享有關發布動態的更多細節，從總體來看，GMG 和 CAD 的關鍵醫生和患者指標繼續保持強勁。

Looking at the full year ahead, we remain confident in our ability to drive consistent growth. First, we were thrilled to receive an optimal label in the United States with the recent FDA approval of VYVGART pre-filled syringe for self-injection.

展望未來一年，我們仍然對推動持續成長的能力充滿信心。首先，我們很高興看到 VYVGART 預充式註射器最近獲得美國食品藥物管理局 (FDA) 批准用於自我注射，從而在美國獲得了最佳標籤。

This comes at the perfect time to maintain our growth momentum and broaden our patient reach in GMG and CIDP. We are excited with the opportunity ahead for CIDP and have just launched our patient activation campaign. This will be critical to empower CIDP patients in their decision-making which is the best therapy for them.

這是保持我們的成長勢頭和擴大我們在 GMG 和 CIDP 的患者覆蓋範圍的最佳時機。我們對 CIDP 未來的機會感到非常興奮，並且剛剛啟動了我們的患者活化活動。這對於幫助 CIDP 患者做出最適合他們的治療決策至關重要。

We continue to see a demand for innovation, CMG and CIDP market. We are building the broadest offering possible to support its unmet need. This includes advancing our auto-injectors and progressing our label expansion studies in seronegative and.

我們繼續看到對創新、CMG 和 CIDP 市場的需求。我們正在建立盡可能廣泛的產品來滿足其未滿足的需求。這包括改進我們的自動注射器和推進血清陰性標籤擴展研究。

Finally, we recognize that the global market is dynamic at the moment. While it is still too early to speculate how our industry will be impacted by future policy development, we are confident that our strategic decisions have positioned Argenx to navigate a range of potential outcomes.

最後，我們認識到目前全球市場是充滿活力的。雖然現在推測我們的產業將如何受到未來政策發展的影響還為時過早，但我們相信，我們的策略決策已使 Argenx 能夠應對一系列潛在結果。

We are prepared to be growing them in our precision therapies with a robust global supply chain and a strategy to manufacture in each region for that region. This includes continued and long-standing investments in our US matching capabilities to ensure long-term scalability.

我們準備好利用強大的全球供應鏈和在每個地區為該地區生產的策略，在我們的精準治療中發展它們。這包括對我們在美國的匹配能力進行持續和長期的投資，以確保長期的可擴展性。

Slide 5. Taking a step back, the success of our commercial efforts are rooted editions and physician demand for new and innovative treatment solutions. Last month at AAM, we had the opportunity to present data that reinforce the broader potential of VYVGART and reflect our commitment to generating data that is most meaningful to the neurologist community and the patients they serve. VYVGART continues to set a high bar with its sustained efficacy and improved quality of life measures for patients living with GMG and CIDP.

幻燈片 5。退一步來說，我們商業努力的成功根植於版本和醫生對新的創新治療解決方案的需求。上個月在 AAM，我們有機會展示數據，這些數據強化了 VYVGART 的更廣泛潛力，並反映了我們致力於產生對神經病學專家社區及其服務的患者最有意義的數據的承諾。VYVGART 以其持續的療效和改善的 GMG 和 CIDP 患者生活品質指標繼續樹立高標準。

Beginning with GMG more neurologists are recognizing minimum symptom expression or MSE as the metric most relevant to patients. New data from the ADVANCE-NEXT study showed that 56.5% of patients achieved MSC at any point during treatment. We believe that individualized treatment approach is the best way to treat GMG given that each patient experiences the disease differently.

從 GMG 開始，越來越多的神經學家認識到最低症狀表現或 MSE 是與患者最相關的指標。ADVANCE-NEXT 研究的新數據顯示，56.5% 的患者在治療期間的任何時間點都實現了 MSC。我們相信，鑑於每位患者的病情不同，個人化治療方法是治療 GMG 的最佳方法。

The ADVANCE-NEXT study supports this view showing that both fixed and dosing regimens can deliver rapid, meaningful and sustained for up to 126 weeks. Recognizing that we're still early in the launch of VYVGART, we were encouraged by our relation with treating position and some of the positive patient experiences that are already seen.

ADVANCE-NEXT 研究支持這一觀點，表明固定劑量和劑量方案均可快速、有效且持續長達 126 週。我們意識到 VYVGART 的推出仍處於早期階段，但我們對治療地位的關係以及已經看到的一些積極的患者體驗感到鼓舞。

We shape new open-label showing that Hytrulo can drive sustained functional improvement and highlighted our switch study design which looks at patients switching to Hytrulo with a one week of the last antiVG treatment.

我們形成了新的開放標籤，表明 Hytrulo 可以推動持續的功能改善，並強調了我們的轉換研究設計，該設計著眼於患者在接受最後一周的抗 VG 治療後轉換到 Hytrulo。

Finally, VYVGART strong and predictable safety profile remains a critical part of its value to patients and physicians. We have over 8,000 patient years of data across studies and are proud to have a label with no vaccinations, no rent, no black box and no monitoring.

最後，VYVGART 強大且可預測的安全性仍然是其對患者和醫生的價值的關鍵部分。我們擁有超過 8,000 名患者多年的研究數據，並且很自豪能夠擁有無需接種疫苗、無需租金、無需黑盒子、無需監控的標籤。

Delivering on our Vision 2030 will also depend on the progress of our pipeline and I'm particularly energized by the breadth of indications we are pursuing across multiple first-in-class assets that opened the door to new disease areas with an unmet need.

實現我們的「2030 願景」也將取決於我們產品線的進展，而我對我們在多個一流資產中追求的廣泛適應症感到特別振奮，這些資產為尚未滿足需求的新疾病領域打開了大門。

We continue to push the boundaries of our understanding of CRM as we explore new therapeutic areas with including rheumatology with myositis and Sjögren’s and endocrinology with TAD. These are high prevalent diseases where we see a quick path to deliver meaningful differentiated benefits to patients.

我們不斷擴展對 CRM 的理解，探索新的治療領域，包括肌炎和乾燥綜合症的風濕病學以及 TAD 的內分泌學。這些都是高發生性疾病，我們發現了一條為患者提供有意義的差異化益處的快速途徑。

With empasiprubart, we have stated or advancing our C2 inhibitors into two registrational head-to-head studies against IVIg in both MMN and CIDP. These trials reflect our commitment to disrupting the treatment paradigm for each of these diseases are challenging the standard of care and bringing forward innovation for patients in need of new precision treatment options.

利用 empasiprubart，我們已經啟動或推進了我們的 C2 抑制劑在 MMN 和 CIDP 中針對 IVIg 的兩項註冊頭對頭研究。這些試驗反映了我們致力於顛覆每種疾病的治療模式，挑戰護理標準並為需要新的精準治療方案的患者帶來創新。

And finally, let's take a look at what's ahead for the rest of the year with several readouts across the pipeline. The seronegative GMG study will be the first of our 10 registrational trial readouts which has the potential to expand the breadth of GMG patients which we beyond that, we have proof-of-concept readouts in lupus nephritis with, delayed graft puncture with empasiprubart, and CMS with ARGX-119, the first clinical readout for our third asset.

最後，讓我們透過幾份數據來展望今年剩餘時間的走勢。血清陰性 GMG 研究將是我們 10 個註冊試驗讀數中的第一個，它有可能擴大 GMG 患者的範圍，除此之外，我們還對狼瘡性腎炎、empasiprubart 延遲移植物穿刺和 ARGX-119 CMS 進行了概念驗證讀數，這是我們第三項資產的第一個臨床讀數。

We have two primary objectives with our proof-of-concept study. First, to gain confidence in the signal observed to invest in further development; and second, to thoughtfully shape the Phase 3 design.

我們的概念驗證研究有兩個主要目標。首先，對觀察到的訊號有信心，以便投資進一步發展；其次，精心製定第三階段的設計。

Before turning the call over to Karl, I want to circle back to our relation to innovation. We have always put innovation at the forefront of our decision-making, which means prioritizing what patients need and remain forward thinking to prepare ourselves for the long term. With an financial position, we are able to continue investing in our innovation engine, capitalizing on both clinical opportunities to deliver sustained long-term value.

在將電話轉給卡爾之前，我想先回顧一下我們與創新的關係。我們始終將創新放在決策的首位，這意味著優先考慮患者的需求，並保持前瞻性思維，為長遠發展做好準備。有了財務狀況，我們就能繼續投資於我們的創新引擎，並利用臨床機會提供持續的長期價值。

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

說完這些，我會把電話轉給卡爾。

Thank you, Tim. The first quarter, financial results are detailed in this morning's press release. Total operating income in the first quarter totaled $807 million. This reflects $719 million in product net sales and $17 million in our operating income.

謝謝你，提姆。第一季的財務表現已在今天上午的新聞稿中詳細說明。第一季總營業收入為8.07億美元。這反映了 7.19 億美元的產品淨銷售額和 1,700 萬美元的營業收入。

The product net sales of $790 million represents 99% growth, compared to a corresponding prior year quarter. The product net sales breakdown by region to $681 million in the US, $32 million in Japan, $57 million in the rest of the world and $20 million of product supply to Zai Lab in China.

該產品淨銷售額為 7.9 億美元，與去年同期相比成長 99%。按地區劃分，該產品淨銷售額為美國 6.81 億美元、日本 3,200 萬美元、世界其他地區 5,700 萬美元以及向中國再鼎醫藥供應 2,000 萬美元的產品。

On a quarter-over-quarter basis, where in Q1 2025 was Q4 2024, the growth is 7%, with the US growing at 5%. We saw strong underlying demand in both GMG and CIDP with growth in net sales impacted by two factors.

按季度計算，2025 年第一季與 2024 年第四季相比，成長率為 7%，其中美國成長率為 5%。我們看到 GMG 和 CIDP 的潛在需求強勁，淨銷售額的成長受到兩個因素的影響。

First, typical Q1 seasonality with reverification of benefits for patients and second Medicare redesign took effect on January 1 which accelerated the evolution of their channel mix to Part D. This had an impact on gross to net for the quarter.

首先，典型的 Q1 季節性因素包括對患者福利的重新驗證以及第二次醫療保險重新設計於 1 月 1 日生效，這加速了其通路組合向 D 部分的演變。這對本季的毛利與淨利產生了影響。

We expect PFS self-injection to further drive a shift to party, though, over time, the impact on revenues from increased gross to net were offset by patient volume growth.

我們預計 PFS 自我注射將進一步推動向派對的轉變，但隨著時間的推移，收入從總收入增加到淨收入的影響將被患者數量的增長所抵消。

Specifically our ability to reach new patient populations with PS for self injection. In pan and the rest of the world, the quarter-over-quarter growth continues to be in the high teens.

具體來說，我們有能力透過自我注射 PS 接觸新的患者群體。在北美和世界其他地區，季度環比成長率繼續保持在高位。

Next slide. Cost of sales is $81 million in Q1. This reflects a gross margin of 90%, which is in line with previous quarters. Total operating expenses in Q1 2205 $668 million, a quarter-over-quarter growth is 2%. The increase is explained by a $12 million increase in R&D, offset by a decrease of $10 million in SG&A.

下一張投影片。第一季銷售成本為 8,100 萬美元。這反映出毛利率為 90%，與前幾季持平。2205年第一季總營運費用為6.68億美元，季增2%。這一增長是由於研發費用增加了 1,200 萬美元，但銷售、一般及行政費用減少了 1,000 萬美元。

This results in operating profit for Q1 of $139 million. The quarterly net financial income is $36 million. We benefit in the quarter from unrealized exchange gains of $27 million on our non-US denominated cash balances. The effect tax rate for Q1 2025 is 16%.

這使得第一季的營業利潤達到 1.39 億美元。本季淨財務收入為3600萬美元。本季度，我們從非美元計價現金餘額的未實現匯兌收益中獲益 2,700 萬美元。2025 年第一季的實際稅率為 16%。

After tax, the profit for the quarter is $169 million. Our cash balance represented by cash, cash equivalents and current financial assets is $3.6 billion at quarter end, an increase of $238 million from Q4 2024, driven primarily by cash flow from operations. Our previously issued grants on total R&D and SG&A for the year is unchanged.

稅後，本季利潤為1.69億美元。我們的現金餘額（包括現金、現金等價物和流動金融資產）在季度末為 36 億美元，比 2024 年第四季增加 2.38 億美元，主要受營運現金流的推動。我們先前發放的年度研發總費用及銷售、一般及行政費用補助維持不變。

I will now hand it over to Karen.

現在我將把它交給凱倫。

Thank you, Karl. Our patient-centric approach to innovation continues to deliver real-world results as we have now successfully brought a first-in-class medicine to patients across multiple markets executing launches across three indications, three product presentations in over 30 countries in less than four years.

謝謝你，卡爾。我們以患者為中心的創新方法繼續帶來現實世界的成果，因為我們現在已經成功地為多個市場的患者帶來了一流的藥物，在不到四年的時間裡，我們在 30 多個國家推出了三種適應症、三次產品展示。

With this launch cadence, we have maintained momentum and delivered 13 quarters of growth. This is a remarkable achievement, and I'm incredible of the entire argenx team for the focus, dedication and the collaboration that it is possible.

透過這樣的發布節奏，我們保持了發展勢頭並實現了 13 個季度的成長。這是一個了不起的成就，我對整個 argenx 團隊的專注、奉獻和協作感到非常欽佩。

We continue to drive meaningful impact to VYVGART, expanding our reach in new patients and prescribed in both CIDP and GMG as well as ITP in Japan. With the recent approval of our pre-filled syringe which was patient access and convenience, we expect that momentum to continue.

我們將繼續為 VYVGART 帶來有意義的影響，擴大我們在日本的 CIDP 和 GMG 以及 ITP 中對新患者的覆蓋範圍和處方範圍。隨著我們的預充式註射器最近獲得批准，為患者提供了便利，我們預計這種勢頭將會持續下去。

Today, I'll walk you through the dynamics behind our performance this quarter and how we're positioned to continue to drive sustained long-term growth and lasting outcomes for patients.

今天，我將向您介紹我們本季業績背後的動態，以及我們如何繼續推動持續的長期成長和為患者帶來持久的成果。

Slide 10. We're continuing to deliver our long-term growth strategy, with 99% year-over-year revenue growth for the quarter with steady growth delivered across every region and indication. After an incredibly strong fourth quarter, we faced typical first quarter seasonality in the US, which similar to primarily due to benefit reverification.

幻燈片 10。我們將繼續推行我們的長期成長策略，本季營收年增 99%，各地區和各適應症均穩定成長。在經歷了異常強勁的第四季度之後，我們在美國面臨典型的第一季季節性，這主要歸因於福利重新驗證。

This quarter also marked the first industry-wide impact of Medicare Part D reform, which is accelerating the evolution of our channel mix towards Part B. As Kyle outlined, due to this dynamic, we saw an impact on our gross to net over the quarter.

本季也是醫療保險 D 部分改革首次對全行業產生影響的標誌，這加速了我們的通路組合向 B 部分的演變。正如 Kyle 所概述的，由於這種動態，我們看到了本季毛利對淨利的影響。

Looking beyond these technical impacts in the US, we saw a strong quarter, and we continue to deliver consistent growth. I am very pleased with our performance in new patient starts, in new prescribers and in high patient conversion rates. We believe there is significant commercial opportunity ahead of us for both GMG and CMC.

除了美國的技術影響之外，我們看到了一個強勁的季度，我們繼續實現持續成長。我對我們新患者數量、新處方數量和高患者轉換率的表現感到非常滿意。我們相信，GMG 和 CMC 都面臨著巨大的商業機會。

In GMG, VYVGART achieved the fastest market share growth amongst branded biologics, solidifying the number one position in the MG market. VYVGART, the key growth driver, contributing to a strong quarter-over-quarter increase in new patient initiations.

在GMG領域，VYVGART實現了品牌生物製劑中最快的市佔率成長，鞏固了MG市場第一的地位。VYVGART 是主要的成長動力，推動新患者數量較上季強勁成長。

In CIDP, our strong launch momentum continues with consistent quarter-over-quarter growth in new patient starts. Although we recognize the CIDP market dynamics are unique from MG, early trends reinforce our confidence in a significant long-term opportunity for VYVGART Hytrulo in this market. In addition to strong patient starts in both GMG and CIDP, we continue to see consistent new prescriber growth.

在 CIDP 領域，我們持續保持強勁的啟動勢頭，新患者數量逐季持續成長。儘管我們認識到 CIDP 市場動態與 MG 不同，但早期趨勢增強了我們對 VYVGART Hytrulo 在該市場具有重大長期機會的信心。除了 GMG 和 CIDP 的患者開始數量強勁之外，我們還繼續看到新處方者數量的持續增長。

Over the quarter, we added about 250 first-time VYVGART prescribers, bringing us to over 3,700 total prescribers, and we saw a reciprocal halo effect between GMG and CIDP. Reaching new prescribers is a critical priority to increase the breadth and depth of patients that we reach.

本季度，我們增加了約 250 名首次使用 VYVGART 的處方者，使我們的總處方者人數超過 3,700 名，並且我們看到了 GMG 和 CIDP 之間的相互光環效應。接觸新的處方者是擴大我們接觸患者的廣度和深度的關鍵優先事項。

We also saw internationally. Japan CIDP launch is up to an encouraging start echoing the US experience with patients and prescribers welcoming the first novel mechanism of CIDP treatment in 30 years. The contribution from the rest of the world continues to grow as we secure pricing and reimbursement agreements across Europe and Canada.

我們也在國際上看到。日本 CIDP 的推出取得了令人鼓舞的開端，與美國的經驗相似，患者和處方醫生對 30 年來首個新型 CIDP 治療機製表示歡迎。隨著我們在歐洲和加拿大達成定價和報銷協議，來自世界其他地區的貢獻持續成長。

In Europe, VYVGART subcutaneous continues to expand our GMG uptake including initial free syringe use in Germany. Lastly, we're close to resist to its second indication in the EU with positive CHMP opinion last month in CIDP.

在歐洲，VYVGART 皮下繼續擴大我們的 GMG 吸收，包括在德國首次免費使用注射器。最後，由於上個月 CHMP 在 CIDP 中給出了積極的評價，我們幾乎可以抵制該藥物在歐盟的第二個適應症。

Slide 11. The recent approval of our prefilled syringe for self-injection in the US comes at the perfect time to enable our continued growth momentum in MG and CIDP. The label we received is an optimal outcome. Patients now have the ability to self-inject in as little as 20 to 30 seconds after being trained with proper instructions and they can do so at home or in the HCC office.

幻燈片 11。我們的預充式註射器最近在美國獲得批准用於自我注射，這恰逢其時，有利於我們在 MG 和 CIDP 領域繼續保持成長勢頭。我們獲得的標籤是一個最佳結果。現在，患者在接受正確的指導培訓後，只需 20 到 30 秒就可以自行注射，並且可以在家中或在 HCC 辦公室進行注射。

Patients will have the flexibility and independence to manage their treatment in a way that fits their lifestyle and continue to benefit from VYVGART Hytrulo strong efficacy and favorable safety profile. The first patients have already been dosed with PFS cell injection in the US and Germany. Reception to date has been very positive with encouraging initial patient prescriptions.

患者將能夠靈活、獨立地以適合自己生活方式的方式管理治療，並繼續受益於 VYVGART Hytrulo 的強大功效和良好的安全性。首批患者已在美國和德國接受了PFS細胞注射。迄今為止，接待情況一直非常積極，鼓勵患者首次開處方。

You'll recall, we are not the serial conversion strategy with CFS injection, while our goal is to reach more patients earlier in the treatment parade. We're seeing that play out already with 50% of initial enrollment first time VYVGART users. Patients have been vocal in their positive feedback often referencing the PFS as game changing.

您會記得，我們​​不是採用 CFS 注射的連續轉換策略，而我們的目標是在治療過程中儘早接觸更多患者。我們已經看到這種情況，50% 的初始註冊用戶是首次使用 VYVGART。患者們紛紛表達了正面的回饋，經常稱 PFS 改變了遊戲規則。

One patient commented that he was now ready to take back control of his life and get to travel with his family. Another patient shared her relief to be able to manage our work schedule instead of taking off significant time for weekly infusion. We're just at the beginning of this launch, and we continued market expansion in the US and future expansion opportunities in Canada, China and Japan.

一位患者表示，他現在已經準備好重新掌控自己的生活並與家人一起旅行。另一位患者表示，她很高興能夠安排好工作日程，而不必花費大量時間進行每週的輸液。我們才剛開始推出該產品，我們將繼續在美國市場進行擴張，並在未來拓展加拿大、中國和日本的市場。

Slide 12. We're transforming the MG and CIDP treatment paradigm of VYVGART and VYVGART Hytrulo. We're empowering patients to expect more from their treatment. This is especially true for CIDP patients who have not -- a new novel mechanism of action in the space for close to 30 years. Physicians are more concerned in switching to CIDP patients between missions in general and often prefer an active request from the patient before doing so.

幻燈片 12。我們正在改變 VYVGART 和 VYVGART Hytrulo 的 MG 和 CIDP 治療模式。我們致力於幫助患者從治療中獲得更多期望。對於 CIDP 患者來說尤其如此，他們近 30 年來一直沒有在該領域發現新的治療機制。一般來說，醫生更關心在任務之間轉換 CIDP 患者，並且通常希望在轉換之前先得到患者的主動請求。

In February, we successfully launched our patient activation campaign which is empowering patients to ask their neurologists about VYVGART Hytrulo. We are seeing a very high grant rate to these requests, demonstrating that believe in the value proposition of VYVGART Hytrulo to CIDP. Our patient engagement efforts across both GMG and CIDP led to a significant increase in patients actively requesting VYVGART or VYVGART Hytrulo over the quarter by the team.

今年 2 月，我們成功啟動了患者活化活動，讓患者能夠向神經科醫生諮詢有關 VYVGART Hytrulo 的資訊。我們看到這些請求的批准率非常高，表明我們相信 VYVGART Hytrulo 對 CIDP 的價值主張。我們在 GMG 和 CIDP 上進行的患者參與工作使得團隊在本季度主動要求 VYVGART 或 VYVGART Hytrulo 的患者數量顯著增加。

What excites me most is the tremendous opportunity ahead to expand the impact of our precision medicine. We are exactly where we need to be, if the right strategy in place to reach patients earlier in their treatment journey. We successfully launched our prefilled syringe, and we're generating the data needed to position VYVGART in both GMG and CIDP.

最讓我興奮的是，未來我們將有巨大的機會擴大精準醫療的影響力。如果制定正確的策略，能夠在治療過程的早期階段為患者提供幫助，那麼我們就達到了我們需要的目標。我們成功推出了預充式註射器，並且正在產生將 VYVGART 定位在 GMG 和 CIDP 中所需的資料。

And this is just the beginning. With multiple potential launches ahead, we're ready to expand into new high unmet need indications for therapy to thousands more patients and advancing our vision to redefine the standard of care in auto immunity.

而這只是個開始。隨著多項潛在產品的推出，我們已準備好拓展新的未滿足需求適應症，為數千名患者提供治療，並推進我們重新定義自體免疫護理標準的願景。

With that, I'll turn the call back to Tim.

說完這些，我就把電話轉回給提姆。

Thank you, Karen. We have an incredibly strong foundation to deliver significant growth this year and beyond, which puts us perfectly on track to achieve our Vision 2030. We have the benefit of a strong financial position to continue investing in our commercial and early innovation.

謝謝你，凱倫。我們擁有極其堅實的基礎，能夠在今年及以後實現顯著成長，這讓我們完全有望實現 2030 願景。我們擁有強大的財務狀況，可以繼續投資我們的商業和早期創新。

With multiple expansion opportunities ahead, we sustain our growth trajectory in GMG and CIDP. Additionally, we have a steady cadence of several milestones for the robust pipeline, which will further contribute to patient growth and support our leadership in autoimmunity.

隨著未來出現多個擴張機會，我們將維持 GMG 和 CIDP 的成長軌跡。此外，我們強大的產品線正在穩步推進多個里程碑，這將進一步促進患者的成長並支持我們在自體免疫領域的領導地位。

Execution has always been a key strength of our company, and therefore, we entered the remainder of the year confident in our ability to deliver value to our patients and shareholders whose long-term support has been critical to our success.

執行力一直是我們公司的主要優勢，因此，在進入今年剩餘時間時，我們對自己為患者和股東創造價值的能力充滿信心，他們的長期支持對我們的成功至關重要。

We will now open the call for questions.

我們現在開始提問。

(Operator Instructions) Tazeen Ahmad, Bank of America.

（操作員指示） Tazeen Ahmad，美國銀行。

I wanted to ask a more broad one on the profile of the GNG patients at this stage of the launch that are starting with VYVGART therapy. So can you just tell me what portion of the curve you're on in terms of onboarding the patients that are there -- that are not currently receiving therapy? And then also, are you noticing any changes in discontinuation rates and any impact from competing products so far?

我想問一個更廣泛的問題，關於在啟動的這個階段開始接受 VYVGART 療法的 GNG 患者的概況。那麼，您能否告訴我，就目前尚未接受治療的患者入院治療而言，您處於曲線的哪個部分？另外，到目前為止，您是否注意到停產率有任何變化以及競爭產品有任何影響？

Thanks for the question, Tazeen. Appreciate it. And as you say, I mean, where I come from with 13 quarters into the launch for GMG, and I'm really proud of the fact that we've continued to deliver growth quarter over quarter despite of a very high last -- in Q4.

謝謝你的提問，Tazeen。非常感謝。正如你所說，GMG 已經推出 13 個季度了，儘管第四季度的業績非常高，但我們仍繼續實現逐季度增長，對此我感到非常自豪。

And I think what that indicates is that we're still early in the launch curve for MG. What we see in terms of the patient profile, to your the question, we still see about 60% of patients coming to VYVGART from orals. So it shows that we're still moving into earlier lines of treatment, which is exactly the strategy that we're pursuing as we expand the market.

我認為這表明我們仍處於 MG 發布曲線的早期階段。從患者概況來看，針對您的問題，我們仍然看到約 60% 的患者透過口服藥物來到 VYVGART。這顯示我們仍在進入更早期的治療領域，而這正是我們擴大市場時所追求的策略。

And what we're seeing is the market for biologics is growing and VYVGART is leading that growth. We maintain the number one market share amongst biologics in MG. So we're expanding our leadership and prefilled syringe and the launch of prefilled syringe is only going to accelerate this as we continue in the launch.

我們看到生物製劑市場正在成長，而 VYVGART 正引領這一成長。我們在 MG 生物製劑領域保持第一的市佔率。因此，我們正在擴大我們的領導地位和預充式註射器，而隨著我們繼續推出預充式註射器，預充式註射器的推出只會加速這一進程。

So I would say we're at the early phase -- early stages of the launch curve at this point. Thanks for the question.

所以我想說我們目前正處於早期階段——發布曲線的早期階段。謝謝你的提問。

James Gordon, JPMorgan.

摩根大通的詹姆斯戈登。

Can you hear me?

你聽得到我嗎？

Yes, we mean. Yes, we can hear, James.

是的，我們的意思。是的，我們能聽到，詹姆斯。

Whether you can hear me?

你聽見我說話嗎？

We're experiencing some technical difficulty with that line. Alex Thompson, Stifel.

我們在使用該線路時遇到了一些技術問題。亞歷克斯·湯普森（Alex Thompson），Stifel。

Congrats on the quarter. I guess as we think about the PFS launch now with three VYVGART in the market, can you talk about how we should think about net price over time?

恭喜本季取得佳績。我想，當我們考慮現在在市場上推出三款 VYVGART 的 PFS 時，您能否談談我們應該如何考慮一段時間內的淨價？

Yes. Thanks. Happy to talk about the PFS launch. Maybe I'll just start by saying that we're really pleased with the let we received as part of the approval and I want to share a huge congratulations to the team. We did get the optimal label.

是的。謝謝。很高興談論 PFS 的發布。也許我首先要說的是，我們對獲得的批准感到非常高興，我想向團隊表示熱烈的祝賀。我們確實得到了最佳標籤。

And what we're seeing already is positive feedback from the PFS launch from both prescribers and from patients saying that it's a game changer. So we think that this will be an expansion opportunity and that it will drive growth -- continued growth for VYVGART through the year. So maybe, Karl, you want to comment on that.

我們已經看到處方醫生和患者對 PFS 推出的正面回饋，他們表示這是一個改變遊戲規則的產品。因此，我們認為這將是一個擴張的機會，它將推動成長——VYVGART 全年持續成長。所以，卡爾，也許你想對此發表評論。

Yes. Thank you, Alex. PFS will, of course, be pharmacy benefit and the gross to net will have a dynamic in the pharmacy benefit versus the medical benefit due to the 20% manufacturers have to pay four patients in the catastrophic phase.

是的。謝謝你，亞歷克斯。當然，PFS 將是藥房福利，由於 20% 的製造商必須在災難階段向四名患者支付費用，因此藥房福利與醫療福利的總額與淨額之間將存在動態關係。

Therefore, the net price per patient for PFS o patients will be lower than for patients in the medical benefit, which will largely be IV and VYVGART Hytrulo. At the moment, we will maintain the 225,000 for an MG patients and the 454 CIDP patients, but over time, that will evolve, and we're going to give you updates later on.

因此，PFS 患者的人均淨價將低於醫療福利患者，後者主要為 IV 和 VYVGART Hytrulo。目前，我們將維持 225,000 名 MG 患者和 454 名 CIDP 患者，但隨著時間的推移，情況將會發生變化，我們稍後會向您提供最新資訊。

Do you want to also just answer the question from the last --

你想回答上一個問題嗎？--

Yes, Tazeen, sorry. I think you asked about discontinuation as well. And so just to come back to that, we're not seeing any shift in discontinuation. In fact, we see the consistent discontinuation rates, and I would say given that it's a maintenance therapy and chronic treatment, it's quite strong, and you can see that the patients are definitely appreciating staying in MSC and the adverse event profile. So no shift in discontinuation rates for MG.

是的，Tazeen，對不起。我想您也問過有關停產的問題。回到這個問題，我們沒有看到任何停產的轉變。事實上，我們看到了一致的停藥率，我想說，鑑於它是一種維持療法和慢性治療，它相當強勁，你可以看到，患者肯定很欣賞留在 MSC 和不良事件概況。因此 MG 的停藥率沒有改變。

Vikram Purohit, Morgan Stanley.

摩根士丹利的維克拉姆·普羅希特（Vikram Purohit）。

Ours is on CIDP. If you could just help us understand in a bit more detail. The cadence of new patient starts, where you ended 1Q with in terms of patients on therapy and how you might expect that to trend at the course of the year.

我們的是在 CIDP 上。如果您能幫助我們更詳細地了解一下的話。新患者開始的節奏，第一季結束時接受治療的患者數量，以及您預計這一趨勢在全年將如何發展。

Yes. Thanks for the question on the CIDP launch. So we're really excited about where we are with the CIDP launch. What we've seen is continued momentum since the beginning of launch and through Q1 the execution continues to be strong. When you look at the underlying fundamentals, to your question, what we see is continued new patient adds quarter over quarter.

是的。感謝您提出有關 CIDP 發布的問題。因此，我們對 CIDP 的發布感到非常興奮。我們看到的是，自發布以來，其發展勢頭一直持續，並且在第一季度，執行力仍然強勁。當您查看基本面時，對於您的問題，我們看到的是新患者數量逐季度持續增加。

We also continue to see new prescriber growth quarter over quarter, which is a really important measure to demonstrate that we're reaching more prescribers and therefore, reaching more patients. And the other really important feedback that we have from this quarter is the consistent patient story, but we're hearing about the transformational impact that VYVGART is having on their CIDP.

我們也看到新處方數量逐季度增長，這是一個非常重要的指標，表明我們接觸到了更多的處方者，從而接觸到了更多的患者。本季我們收到的另一個非常重要的回饋是一致的病患故事，但我們聽說了 VYVGART 對其 CIDP 產生的變革性影響。

So I mean, patients are at the center of our launch and are the key to the CIDP launch. We launched our DTC campaign in Q2 and what we're seeing is that more and more patients are initiating the request to switch with their prescribers and in the majority of cases, their neurologists are granting that switch request.

所以我的意思是，患者是我們發布的中心，也是 CIDP 發布的關鍵。我們在第二季度啟動了 DTC 活動，我們看到越來越多的患者向他們的處方醫生提出轉換請求，並且在大多數情況下，他們的神經科醫生都會批准該轉換請求。

And what that shows us is that neurologists believe in the profile of VYVGART for CIDP. So all of the underlying metrics for CIDP continue to be very strong.

這顯示神經學家相信 VYVGART 對 CIDP 的療效。因此，CIDP 的所有基本指標仍然非常強勁。

Rajan Sharma, Goldman Sachs.

高盛的拉詹·夏爾馬。

Just to just follow up on the Q1 effect. I mentioned that there were three factors that you talked to as being headwinds to revenue growth for the quarter. So that was a reverification and then the Medicare reline impact. Could I just push you a little bit on relative magnitude of each of those and which was the larger impact in Q1?

只是為了跟進 Q1 的影響。我提到，您提到的三個因素對本季的收入成長構成了阻礙。所以這是一次重新驗證，然後是醫療保險重新調整的影響。我能否稍微向您說明一下它們各自的相對大小以及哪一個對第一季的影響更大？

So Rajan, thank you for question. Let me talk about the gross-to-net impact. In prior quarters, we've seen a gradual increase quarter over quarter of Part D at the first of Q4 2024, it was a minority, a small portion of patients.

拉詹，謝謝你的提問。讓我來談談總額對淨額的影響。在前幾季度，我們看到 2024 年第四季初 D 部分的數量逐漸逐漸增加，但這只是少數患者，只佔一小部分。

At the last earnings call, we discussed that in 2025, we have a launch of PFA self injections, patients under pharmacy benefit, which is Medicare Part D, will grow. And as that mix evolve between medical and pharmacy the gross to net will increase.

在上次收益電話會議上，我們討論了在 2025 年推出 PFA 自我注射，享受藥房福利（即醫療保險 D 部分）的患者數量將會增長。隨著醫療和藥房之間的整合不斷發展，總收入與淨收入將會增加。

What we've seen now in Q1 is with a Medicare redesign is an acceleration of patients choosing to receive Hytrulo at home even before PFS. This underscores the need we will be filling with PFS self injection that it will expand the market.

我們在第一季看到的是，隨著醫療保險的重新設計，患者選擇在 PFS 之前在家中接受 Hytrulo 治療的人數增加。這強調了我們將透過 PFS 自我注射來滿足需求，從而擴大市場。

So in terms of the magnitude of a gross to net, we can't get into more detail now. We will provide probably more detail at the end of Q2, but you did see an increase in gross to net. But the majority of impact you're referring to is to do a seasonality relating to the reverification of benefits. That is an industry benefit -- industry impact which you always see.

因此，就總額與淨額的比例而言，我們現在無法談論更多細節。我們可能會在第二季末提供更多細節，但您確實看到了總額與淨額的成長。但您所指的主要影響是與福利重新驗證相關的季節性影響。這是一種行業優勢——您總是能看到的行業影響。

Maybe, Karen, do you want to talk about that?

也許，凱倫，你想談談這個嗎？

Yes. Thanks, Karl, I think that's really clear. And I think that's important to note. What we saw in Q1 is similar to what we saw in Q1 last year and the normal industry dynamics of seasonality related to better reverification, impacting the volume. But remember, VYVGART is a growth story.

是的。謝謝，卡爾，我認為這很清楚。我認為這一點值得注意。我們在第一季看到的情況與去年第一季看到的情況類似，正常的產業季節性動態與更好的重新驗證有關，從而影響了交易量。但請記住，VYVGART 是一個成長故事。

We saw growth in Q1. We had the PFS approval in Q1 and what we expect to see is continued growth and continued cadence of growth through the remainder of the year as we continue to launch both MG and CIDP.

我們在第一季看到了成長。我們在第一季度獲得了 PFS 批准，隨著我們繼續推出 MG 和 CIDP，我們預計在今年剩餘時間內將繼續成長並保持持續的成長節奏。

James Gordon, JPMorgan.

摩根大通的詹姆斯戈登。

Hello. Thanks, James, again. Thanks for questions. very with me for any technical issues here. The question was most favored nations has come into focus again, and there were some concerns around different list prices with VYVGART in different places.

你好。再次感謝你，詹姆斯。感謝您的提問。如有任何技術問題，請隨時與我聯絡。問題是最惠國待遇再次成為焦點，人們對 VYVGART 在不同地方的標價不同感到擔憂。

So can you remind me how to go to list price areas between the US, EU and Japan, and also, have you already set the PFS price outside the US? So how the rise pays there? And if I could also just ask a follow-up question. So as has been discussed, some impact this quarter from patients shifting to Part D and that comes in with a catastrophic discount from the company.

那麼你能提醒我如何進入美國、歐盟和日本之間的定價區域嗎？另外，你是否已經在美國以外設定了 PFS 價格？那麼那裡的漲幅如何呢？我是否還可以問一個後續問題。如同已經討論過的，本季患者轉向 D 部分會產生一些影響，而這會導致公司出現災難性的折扣。

But looking to Q2 and the rest of the year, are you significant further incremental headwinds from this Part D shift and the holding net price that we need to be very old when we're thinking about Q2 and the rest of the year?

但展望第二季和今年剩餘時間，當我們考慮第二季和今年剩餘時間時，D 部分轉變和保持淨價是否會帶來進一步顯著的增量阻力，以至於我們需要非常老練？

Or is one way of thinking about it looking like the thing we saw last year in 2024, where Q1 was a bit softer sequentially within Q2 saw quite acceleration because you didn't have the recertification headwind. And then you've got PFS coming in and you've got more CIDP peaking in. So should we look at last year's phasing for a bit of a guide for what this year's phasing looks like?

或者可以這樣想，就像我們去年在 2024 年看到的那樣，第一季環比略微疲軟，但第二季卻出現了相當大的加速，因為沒有重新認證的逆風。然後你就會有 PFS 出現，並且會有更多 CIDP 達到峰值。那麼，我們是否應該參考去年的分階段實施情況，以了解今年的分階段實施情況呢？

Okay. Thank you, James. I think you asked three questions. So let me take them one by one. First one is on most favored nations.

好的。謝謝你，詹姆斯。我認為你問了三個問題。因此，讓我逐一介紹。第一個是關於最惠國的問題。

We have been very disciplined and aim to keep a less price in all our markets within a narrow band. For example, we have the launch of VYVGART in Germany, where less price was set very close to the US list price. Prices evolve, of course, over time due to foreign exchange, labor expansion and so forth. But that said, we have done a good job in keeping the list prices in all our priority markets in a narrow band.

我們一直非常自律，目標是將所有市場的價格保持在較小的範圍內。例如，我們在德國推出了VYVGART，其價格非常接近美國的價格。當然，價格會隨著時間的推移而變化，原因是外匯、勞動力擴張等因素。但話雖如此，我們在將所有重點市場的標價保持在一個狹窄的區間內方面做得很好。

On your second question, the PFS pricing have been set in all our priorities. So I think that's done. Your third question, I think, in terms of Q2, I think it goes back to what Karen has said that PFS is an expansion strategy, which will create -- which will give us more prescribers and more patients. But yes, gross to net will also increase quarter over quarter as the product mix between medical and pharmacy changes.

關於您的第二個問題，PFS 定價已在我們的所有優先事項中確定。所以我認為已經完成了。您的第三個問題，就第二季而言，我認為它可以追溯到 Karen 所說的 PFS 是一種擴張策略，它將創造 - 這將為我們提供更多的處方者和更多的患者。但是，隨著醫療和藥局產品組合的變化，毛利與淨利之比也將逐季增加。

I'm just going to add, in terms of the rebound effect that you mentioned, I wouldn't think about it like that, would zoom out. And what you can see when you look quarter over quarter since the beginning of the launch of VYVGART. When you take a line through it, it's relatively consistent growth quarter over quarter.

我只是想補充一點，就您提到的反彈效應而言，我不會那樣想，會縮小範圍。從 VYVGART 推出以來，逐季回顧一下，你會看到什麼。當你畫一條線時，你會發現它每季都呈現相對穩定的成長。

So we don't look at the ups and downs each quarter, but rather I'd encourage you to take that line through it and look at the long-term trajectory. And we're confident that, that consistent growth will continue over the long term.

因此，我們不會關注每季的起伏，而是鼓勵您沿著這條線看長期軌跡。我們相信，這種持續的成長態勢將長期持續下去。

Derek Archila, Wells Fargo.

德里克·阿奇拉，富國銀行。

Just wanted to see, given the ADVANCE-NEXT publication and the data set there, are you assuming increasing number of treatment cycles in MG patients as part of your growth calculation to offset the Part D exposure?

只是想看看，鑑於 ADVANCE-NEXT 出版物和其中的數據集，您是否假設 MG 患者的治療週期數增加作為增長計算的一部分，以抵消 D 部分的風險？

Thanks, Eric. Thanks for the question. If you look at the material consumption between that next or cyclical dosing, actually, net-net, you end up using the same amount of material. So we do not believe this is going to materially impact the dosing of VYVGART. I think what is really important that next is that now we have taken the individualization, the end.

謝謝，埃里克。謝謝你的提問。如果您查看下一次或週期性劑量之間的材料消耗，實際上，淨值最終會使用相同數量的材料。因此我們認為這不會對 VYVGART 的劑量產生實質影響。我認為接下來真正重要的是，現在我們已經實現了個人化，也就是終點。

Now each patient can dose the drug the way it should be dosed from cyclical to continuous dosing. So now we can offer the full spectrum. We are very proud of the data at AAN. I think we showed impressive efficacy data from that next with a 56% MSC, spick-and-span safety profile, and real nice Scotian over 126 weeks of use. Thank you for your question.

現在，每個病人都可以按照應有的方式服用藥物，從週期性服用變為連續服用。所以現在我們可以提供全方位的服務。我們對 AAN 的數據感到非常自豪。我認為我們在接下來展示的功效數據令人印象深刻，使用 126 週後，MSC 達到 56%，安全性一塵不染，而且 Scotian 效果非常好。感謝您的提問。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Maybe, Karen, just a question for you on CIDP. If given a chance can you give us a little bit of a sense how many patients did you have during the quarter or finished during the quarter.

也許，Karen，我只是想問你一個關於 CIDP 的問題。如果有機會，您能否告訴我們您在本季度接待了多少名患者或完成了多少例治療？

And then related to that, at AAN, there was a publication, right, that looked at safety in CIDP and you had just over 1,300. I think it was 1,316. -- real world on VYVGART at that point. Can you triangulate that maybe to gain your commercial patient numbers on CIDP.

與此相關的是，在 AAN，有一份出版物，對吧，研究了 CIDP 中的安全性，其中有 1,300 多個。我認為是 1,316。 ——當時 VYVGART 上的真實世界。您能否透過三角測量來獲取 CIDP 上的商業患者數量。

Yes. Thank you for the question. We're not updating that number at this moment. What we'll do in the style of what we've done for other launches is update the number as we hit different milestones. But what I would say, again, just zooming out is we have had consistent patient adds quarter over quarter and consistent prescriber growth in CIDP.

是的。謝謝你的提問。目前我們不會更新該數字。我們將按照對其他發布所採取的方式，在達到不同的里程碑時更新數字。但我想再次強調的是，從規模來看，我們的患者數量逐季穩定增加，CIDP 的處方數量也持續增加。

We've also seen consistency in where the patients are coming from. And what I mean by that is 85% to 90% of the patients continue to be switched from IVIG or subcutaneous IG to VYVGART. And that's exactly in line with where we thought we would be at this moment in launch and with the 12,000 pan.

我們也發現患者來源地具有一致性。我的意思是，85% 到 90% 的患者繼續從 IVIG 或皮下 IG 轉換為 VYVGART。這與我們當時在發布會上以及 12,000 個平底鍋時所想的完全一致。

So we think we have a long way to go in terms of our growth. We're just at the start of the growth trajectory with the CIDP launch. And certainly, PFS will be a strong driver of that continued expansion as we continue to launch PFS through the year.

因此我們認為我們的成長還有很長的路要走。隨著 CIDP 的推出，我們才剛開始步入成長軌道。當然，隨著我們全年繼續推出 PFS，PFS 將成為持續擴張的強大推動力。

Victor Floch, BNP Paribas.

法國巴黎銀行的維克多‧弗洛赫。

Great. So I was just -- I mean, obviously, there's been a lot of focus on the price implication of the PFS ramp-up as a product. But at the same time, I think it -- if you could share with us your expectation in terms of incremental volume attached to the PFS opportunity. I mean I think you've notably said that you were basically not following a conversion strategy.

偉大的。所以我只是——我的意思是，顯然，人們非常關注 PFS 升級作為一種產品對價格的影響。但同時，我認為——如果您可以與我們分享您對 PFS 機會的增量方面的預期。我的意思是，我認為您明確表示過，您基本上沒有遵循轉換策略。

So I mean we're looking to add patients. So I mean, I think we tend to look at the pain right now. We tend to look at the implication on the price. But I mean, what are your expectations in terms of volume growth tied to the PFS?

所以我的意思是我們正在尋求增加病人。所以我的意思是，我認為我們現在傾向於關注痛苦。我們傾向於關注其對價格的影響。但我的意思是，您對與 PFS 相關的銷售成長有何期望？

And my follow-up is very much close to the first one. It's about the seronegative Phase 3 trial. I mean a lot of -- I mean, investors have been pointing pretty light news flow over the -- for the next part of the year. I mean there is the Phase 3 interactive and maybe for some of them is seen as a given.

我的後續行動與第一個行動非常接近。這是關於血清陰性的第三階段試驗。我的意思是，很多投資人都指出，今年下半年的新聞流相當少。我的意思是，存在第三階段的互動，也許對他們中的一些人來說，這被視為理所當然。

But I mean, it would be nice if you could share your views on the opportunity in terms of incremental volume and potentially sales there because, obviously, it's not nothing to grow the addressable opportunity from 80% to 100% of patients, even though I agree that I mean it's fair to say that the risk is pretty low. But yes, any comment on the volume would be super helpful.

但我的意思是，如果您能分享您對增量數量和潛在銷售機會的看法，那就太好了，因為顯然，將可尋址機會從 80% 增加到 100% 的患者並不是一件容易的事，儘管我同意，公平地說風險相當低。但是是的，任何關於音量的評論都會非常有幫助。

Yes. Thanks for the question. I'll take the first one, and I think Tim will take the second. So I would say, we're confident about PFS driving significant volume growth both for MG and CIDP. I would say we got the optimal label, and I would like to say it's huge congratulations to the team.

是的。謝謝你的提問。我會選擇第一個，我認為提姆會選擇第二個。所以我想說，我們相信 PFS 將推動 MG 和 CIDP 的銷售大幅成長。我想說我們獲得了最佳標籤，我想向團隊表示熱烈祝賀。

I mean when you look at 20 to 30 second injection time, no specific monitoring or training requirements, these are all features, but the benefit that we -- and we hear from patients are that they are completely free from the office. We hear that they're excited. You heard in the script that patients are describing this as a game changer in terms of managing their MG and CIDP.

我的意思是，當您看到 20 到 30 秒的注射時間時，沒有特定的監測或培訓要求，這些都是特點，但我們從患者那裡聽到的好處是，他們完全不需要去辦公室。我們聽說他們很興奮。您在腳本中聽到過，患者將此描述為管理 MG 和 CIDP 方面的遊戲規則改變者。

So as you said, this is a market expansion opportunity for us. What we're seeing in the early data is that 50% of the PFS prescription new to VYVGART patients. So they're not converted rather they're overall new to VYVGART, and that's exactly in line with this market expansion strategy.

正如您所說，這對我們來說是一個市場擴張的機會。我們在早期數據中看到，50% 的 PFS 處方是針對 VYVGART 患者的。所以他們並不是已經轉變了，而是對 VYVGART 完全陌生，這完全符合這個市場擴張策略。

So if you zoom out, what we're looking to do in both MG and CIDP is bringing new innovation and patient-centric innovation to the market and we're seeing this exactly in PFS. And that's what's going to drive long-term growth trajectory for both of those indications. And then maybe further seronegative and the news flow, Tim, do you make that?

因此，如果放大來看，我們希望在 MG 和 CIDP 中做的是將新的創新和以患者為中心的創新推向市場，而我們在 PFS 中看到了這一點。這也正是推動這兩種疾病長期成長軌跡的因素。然後也許會進一步出現血清陰性和新聞流，提姆，你是這麼說的嗎？

Yes. I think Victor, you're right, calling out the news flow for this year, which I think is strong with Phase 3 readouts and three Phase 2 readouts this company is in a strong position from flow point of view. So the Phase 3 read out in seronegative myasthenia, the Phase 2 in lupus nephritis for efgartigimod, the Phase 2 in delayed graft function for EMPA and then the Phase 2 proof of concept in CMS 19.

是的。我認為維克多，你是對的，說出今年的新聞流，我認為第三階段讀數和第三階段讀數的強勁表現，從流量的角度來看，這家公司處於強勢地位。因此，血清陰性肌無力的 3 期結果顯示，efgartigimod 的狼瘡性腎炎 2 期結果顯示，EMPA 的移植功能延遲 2 期結果顯示，CMS 19 的 2 期概念驗證結果顯示。

Specifically on seronegative MG, I think we are very excited about the opportunity in front of us. You have to think about 15% of the overall MG patient population, which falls in the seronegative basket. We do know from Japan that we have seronegative on label that VYVGART is offering the same benefit risk profile to seronegative patients as it does to the acetylcholine receptor antibody patients. So very strong performance.

具體來說，對於血清陰性 MG，我認為我們對眼前的機會感到非常興奮。你必須考慮到佔 MG 患者總數 15% 的患者屬於血清陰性族群。我們確實從日本了解到，我們的標籤上有血清陰性，VYVGART 為血清陰性患者提供的益處風險概況與乙醯膽鹼受體抗體患者相同。表現非常強勁。

Now it's all about the experiments. We have been learning and triangulating with the FDA on the endpoint for the SLIM trial. We think it's a solid clinical trial, and we feel strong about the opportunity in front of us. Let me end by calling out our excitement of ocular MG, which I think is equally in size and unmet medical needs. So opportunity would be equal in Ocular MG in seronegative MG.

現在一切都與實驗有關。我們一直在與 FDA 一起學習和討論 SLIM 試驗的終點。我們認為這是一個可靠的臨床試驗，我們對眼前的機會充滿信心。最後，我想表達我們對眼部重症肌無力的興奮之情，我認為該疾病的規模和未滿足的醫療需求同樣巨大。因此，血清陰性重症肌無力患者罹患眼部重症肌無力的機會是均等的。

(Operator Instructions) Tom Smith, Leerink Partners.

（操作員指示）Tom Smith，Leerink Partners。

This is Nat Charoensook on for Tom Smith. So following the approval of pre-filled syringe, what's your expectation on the split among uses of the three representations of VYVGART including VYVGART Hytrulo and pre-filled syringe in GMG and CIDP? And similarly, how do you expect the payer mix to evolve following the.

我是 Nat Charoensook，為 Tom Smith 主持節目。那麼，在預充式註射器核准之後，您對VYVGART Hytrulo和預充式註射器等VYVGART三種劑型在GMG和CIDP中的用途劃分有何期待？同樣，您預計付款人組合將如何演變？

Thanks for the question. So what we're seeing already with the launch of Hytrulo, is it the majority of growth in patients, in new patients for MG and CIDP is coming from Hytrulo. That was even with the butterfly execution, and we expect that, that will continue and even accelerate with prefilled syringe.

謝謝你的提問。因此，隨著 Hytrulo 的推出，我們已經看到，患者數量的增長，MG 和 CIDP 的新患者數量大部分都來自 Hytrulo。即使採用蝴蝶注射器，情況也是如此，我們預計，隨著預充式註射器的推出，這種情況將繼續下去，甚至會加速。

Again, we're hearing from the market that people are really excited that it really is a game changer having prefilled syringe for self-injection available for patients. So we think that will be growing portion of the market.

再次，我們從市場聽說，人們真的很高興，這確實是一個改變遊戲規則的事件，為患者提供自我注射的預充式註射器。因此我們認為這將會是不斷增長的市場份額。

Karl, do you want to take the question around the payer mix. I mean, I know we've shared in the past on 50-50 commercial Medicare, and I don't think we get that to change significantly.

卡爾，你想回答有關付款人組合的問題嗎？我的意思是，我知道我們過去在商業醫療保險方面已經達成了 50-50 的分成，我認為我們不會讓這種局面發生重大改變。

Yes. No. I mean, I think that is what it is today, and I'm not expecting changes. We'll keep give you updated if it does.

是的。不。我的意思是，我認為這就是今天的情況，我並不期待改變。如果有的話，我們會及時向您通報最新情況。

Akash Tewari, Jefferies.

Akash Tewari，傑富瑞。

This is Amy on for Akash. So one, is your fill finish and better considered being transformative? And if needed, how quickly could you move that into the US.

我是 Amy，為 Akash 服務。那麼，你的填充是否完成了並且更好地被認為是變革性的？如果需要的話，你能多快將其運往美國？

And then just seronegative on MFN. What mitigation measures could you potentially employ? Could you price your PFS differently ex US. It's a different product code? And would you consider pulling some of the other formulations?

然後 MFN 血清呈現陰性。您可以採取哪些緩解措施？您的 PFS 在美國以外地區的價格可以有所不同嗎？這是不同的產品代碼嗎？您是否會考慮採用一些其他的配方？

Thanks, Amy, for two questions. The first one, in terms of substantial transformation, I would use the drug substance manufacturing as your guide here and the drug substance manufacturing, of course, is taking place on US territory.

謝謝艾米，我問了兩個問題。第一個，就實質轉變而言，我將以藥物物質製造作為指導，當然，藥物物質製造是在美國領土上進行的。

Secondly, Karl already explained that I think we're in a strong position from an MFM point of view because we have shown the discipline in the way we have been maintaining -- setting and maintaining price in a narrow band globally in our key markets.

其次，卡爾已經解釋過，我認為從 MFM 的角度來看，我們處於有利地位，因為我們已經展示了我們一直維持的紀律——在我們的主要市場在全球範圍內將價格設定在狹窄的區間內並維持在一個狹窄的區間內。

So stay away from speculation. I think we have strong cards to navigate whatever the future will bring us on these two fronts.

因此，不要進行猜測。我認為，無論未來在這兩個方面發生什麼，我們都擁有強大的實力來應對。

Charles Pitman, Barclays.

巴克萊銀行的查爾斯·皮特曼。

Just a question on Part B, Part D movements. If you could just give us a little bit more insight on what the actual price differential is between a Part B and Part D patient over 1Q. I think that would be very helpful. And then just following on from that, thinking about the future split patients, I mean, I think you highlighted PFS is expected to be increasing proportion going forward.

這只是關於 B 部分、D 部分動作的一個問題。如果您能向我們詳細介紹 1Q 期間 B 部分和 D 部分患者之間的實際價格差異。我認為那將會非常有幫助。然後，接著考慮未來的分組患者，我的意思是，我認為您強調的 PFS 預計未來的比例會增加。

But given you've already been seeing these Part B patients move to Part D in the $2,000 co-pay, related to the redesign? Like how do you expect IV to grow from here? Or should we expect -- like what's the future split of the three administrations?

但考慮到您已經看到這些 B 部分患者轉入 D 部分，共同支付 2,000 美元，這與重新設計有關嗎？您認為 IV 今後將如何發展？或者我們應該期待──三個政府未來的分工如何？

Thank you. I mean, at a high level, the difference between the net price for a Part B and Part D would be the 20% incremental rebate which we have to pay and the Part D for Delta of the CMS patients who aren't catastrophic. So that's at a high level difference between the two.

謝謝。我的意思是，從高層次來看，B 部分和 D 部分的淨價之間的差額是我們必須支付的 20% 增量回扣，以及非災難性的 CMS 患者的 Delta 的 D 部分。這就是兩者之間高層次的差異。

In terms of the presentations going forward, remember, we said that in the US, we think IV will always continue to be important for the US market. Think of a buy and bill customers, physician preference and so forth.

就未來的演示而言，請記住，我們說過，在美國，我們認為 IV 對美國市場始終具有重要意義。考慮一下購買和帳單客戶、醫生偏好等等。

But over time, from where we are today and today, we already have a minority, but we already have do have Part D patients over time, but mix will increase and you're going to see a greater proportion of the patients in Part D.

但隨著時間的推移，從我們現在的情況來看，我們已經有少數，但隨著時間的推移，我們已經有 D 部分患者，但混合會增加，你會看到 D 部分患者的比例更大。

Myles Minter, William Blair.

邁爾斯·明特、威廉·布萊爾。

Just on you've got Hytrulo, I think those patients switch patients. Can you just comment on the incidence of CIDP disease worsening when you make that switch? Just wondering if you have any real-world data. I think someone has presented it.

就你得到的海特魯羅而言，我認為那些病人會換病人。您能否評論一下在進行這種轉變時 CIDP 疾病惡化的發生率？只是想知道您是否有任何真實世界的數據。我認為有人已經提出過它。

Yes. Thanks, Myles, for the question. So -- and I referred to the great conversation we had with Dr. Karam in the panel conversation during AAN.

是的。謝謝 Myles 提出的問題。所以 — — 我提到了我們在 AAN 期間的小組討論中與 Karam 博士進行的精彩對話。

The first thing you need to know in CIDP is that whatever switch you consider to do, be it from steroids to immunoglobulin or vice versa of the VYVGART, there's always an expectation and the possibility that the patient will relapse. So this is a fact you also see that in the IV IG subcu IG switch studies.

在 CIDP 中您需要知道的第一件事是，無論您考慮進行何種轉換，無論是從類固醇到免疫球蛋白還是從 VYVGART 到免疫球蛋白，總是存在患者復發的預期和可能性。因此，這也是您在 IV IG subcu IG 開關研究中看到的事實。

I think the symptom worsening, which we have seen in the context of the trial is perfectly in line with those historical studies. And in the real world, that it's a relatively small phenomenon, we see low single digits reporting on CIDP worsening. So the vast majority of our physicians are doing it the right way.

我認為我們在試驗中看到的症狀惡化與那些歷史研究完全一致。而在現實世界中，這是一個相對較小的現象，我們看到有關 CIDP 惡化的報告僅為個位數。所以我們的絕大多數醫生都採取了正確的方法。

It seems like switching to VYVGART one week after the last dose of IVIg is a recipe for success, but we're trying to document that in our Phase 1 and where we really try to collect evidence on how to switch best. So it is a non phenomenon in CIDP, and it looks like we are navigating that quite well.

看起來在最後一劑 IVIg 一周後改用 VYVGART 是成功的秘訣，但我們正試圖在第一階段記錄這一點，並真正嘗試收集有關如何最佳轉換的證據。因此這在 CIDP 中並不是一種現象，而且看起來我們正在很好地應對這一問題。

Suzanne van Voorthuizen, Kempen.

蘇珊娜·範·沃特赫伊森，肯彭。

This is Suzanne from Kempen. Could you please elaborate a bit more on how you look at empa relative to VYVGART in CIDP given the pivotal trial for empa different than what you did for VYVGART. Can you share how are you thinking about the positioning of each product and comment how the commercial opportunity looks like for each molecule in this indication, perhaps relative to each other.

我是來自肯彭的蘇珊娜。鑑於 empa 的關鍵試驗與您對 VYVGART 所做的不同，您能否詳細說明您如何看待 CIDP 中 empa 相對於 VYVGART 的看法。您能否分享一下您對每種產品的定位有何看法，並評論一下這種適應症中每種分子的商業機會如何（也許是相互關聯的）。

Thanks, Susan. So CIDP is a heterogeneous disease. I think the trial, which was the biggest and the highest quality trial ever done in the CIDP space is clearly demonstrating that pathogenic IgGs drive disease at least in about 70%, 75% of the patients.

謝謝，蘇珊。因此CIDP是一種異質性疾病。我認為這項試驗是 CIDP 領域有史以來規模最大、品質最高的試驗，它清楚地表明致病性 IgG 至少會導致約 70% 至 75% 的患者患病。

The question is then why do the other patients not respond. There is a suspicion that complement is in play through pathogenic IgM antibodies. And we have pretty strong translational data in hand for EMPA in CIDP.

那麼問題是為什麼其他患者沒有反應。人們懷疑補體透過致病性 IgM 抗體發揮作用。我們手中有可供 EMPA 在 CIDP 中使用的相當強大的轉換資料。

Now we do not want to niche EMPA into refractory setting only we really want to give this great molecule, the fullest chance of success in the CIDP setting. So that's why we have designed the clinical trial, you all see and let the data speak, I think this is a significant market, a significant opportunity which can harbor multiple innovative molecules to optimally address the patient needs. So let the data speak now. Thank you for the question.

現在我們不想將 EMPA 局限於難治性治療領域，我們只是想讓這種偉大的分子在 CIDP 環境中獲得最大的成功機會。這就是我們設計臨床試驗的原因，大家看看，讓數據說話，我認為這是一個重要的市場，一個重要的機會，它可以容納多種創新分子，以最佳地滿足患者的需求。所以現在就讓數據來說話吧。謝謝你的提問。

Yatin Suneja, Guggenheim.

古根漢美術館的亞廷·蘇內賈（Yatin Suneja）。

Question is on the GMG side. Could you just talk about the relative penetration the targeted patient population you have achieved. Also, I think in the past, you have said that at least in myasthenia gravis , you are consistently seeing $40 million to $50 million worth of quarter-over-quarter growth.

問題出在 GMG 方面。您能否談談您所實現的目標患者群的相對滲透率？此外，我認為您過去曾說過，至少在重症肌無力方面，您一直看到價值 4000 萬至 5000 萬美元的季度環比增長。

Is that the same -- is that what you are seeing now? And how should we think about the growth just purely in the GMG? And any impact of some competition, whether it's the CD90 or anything else that you might be seeing a complement?

這和你現在看到的一樣嗎？那麼我們該如何看待 GMG 的純粹成長呢？某些競爭會產生什麼影響，無論是 CD90 還是其他您可能看到的補充？

Yes. Thanks for the question. Always appreciate being able to talk about MG growth, 13 quarters into launch and the fact that we're still delivering that consistent cadence of quarter-over-quarter growth. And to your question, I would say it is -- we are seeing consistent penetration into the earlier line. I mentioned that before.

是的。謝謝你的提問。我很高興能夠談論 MG 的成長，在推出 13 個季度後，我們仍然保持著逐季成長的節奏。對於您的問題，我想說是的——我們看到了對早期生產線的持續滲透。我之前提到過這一點。

More than 60% of our patients are coming from earlier lines. And what we're seeing as part of that is that the share of the market treated by biologics is growing substantially, and VYVGART is leading growth. We have the number one market share. We're growing that number one all of our major markets.

我們超過 60% 的患者來自早期階段。我們看到，生物製劑的市佔率正在大幅成長，而 VYVGART 正引領著這一成長。我們的市佔率位居第一。我們在所有主要市場都實現了第一。

I would say, at the early stages in terms of penetration, we updated the TAM to 60,000. You'll recall last year, and with that, I think you can see that we're on the -- in the early stages of the growth curve for MG, even though we're 13 quarters into the launch.

我想說，在滲透的早期階段，我們將 TAM 更新為 60,000。您會記得去年，我想您會發現我們正處於 MG 成長曲線的早期階段，儘管我們已經推出了 13 個季度。

And what we can -- what you can expect and what we expect is consistent and continued growth in whether you look at new patient starts, at prescriber growth, all the metrics that you mentioned, which is revenue growth when you take a line through it since I think we've been delivering that consistent growth on average since launch, and we expect that to continue. Tim, did you have something to add?

而我們能夠期待的以及我們所期待的是持續的穩定增長，無論是新病人數量、處方量增長，還是您提到的所有指標，從收入增長來看，我認為自推出以來我們平均一直保持著穩定增長，我們預計這種增長趨勢將持續下去。提姆，你還有什麼要補充的嗎？

Yes, Karen. And you can please see that we have broken out of the refractory patient population, right? What it takes to really move first line and lead in the first line is the clean safety profile, which we have demonstrated for the drug. Remember what we said in the prepared remarks, no black box, no need for vaccination, no lapse, no monitoring.

是的，凱倫。你看得出來我們已經擺脫了難治性患者群體，對嗎？真正推動一線治療並在一線處於領先地位的是清晰的安全性，我們已經證明了該藥物的安全性。記住我們在準備好的發言中說過的話，沒有黑盒子，不需要接種疫苗，沒有失誤，不需要監測。

That's a very powerful profile to go front line as a biological. And what we see, right, Karen, is that about 60% of the new patients coming on drug comes straight from the orals. And that is where the growth opportunity is in front of us, and we think PFS will continue to fuel that.

作為一名生物軍人，這是一個非常強大的前線人物。我們看到的是，凱倫，大約 60% 的新患者直接透過口服藥物就診。這就是我們面前的成長機會，我們認為 PFS 將繼續推動這個成長機會。

Andy Chen, Wolfe Research.

安迪‧陳 (Andy Chen)，沃爾夫研究公司 (Wolfe Research)。

And back to the topic of most favored nation. So Karl, I understand that you talked about a narrow band. And just wondering if that narrow band is it's less than the 20% discount that you will have to pay on Part D or is it more than the 20%. Just curious if there's a way for you to push your patients to the Part D to minimize exposure just because Part D price cut is less likely than a Part B price cut if most favored nation comes to play.

回到最惠國的話題。卡爾，我知道你談到了窄帶。我只是想知道這個窄帶是否低於您在 D 部分支付的 20% 折扣，還是高於 20%。只是好奇，您是否有辦法讓您的患者購買 D 部分以盡量減少風險，因為如果實行最惠國政策，D 部分降價的可能性小於 B 部分降價的可能性。

Andy, I think I don't want to talk about percentages, but I think the reference to most favored nations here are list prices. And I think in less prices we are in the narrow price band. And I think we shouldn't -- I don't want to speculate on where below and it's still in concept phase. So what -- so for now, I think I'll stop there. But maybe, Tim, you want to add something?

安迪，我想我不想談論百分比，但我認為這裡提到的最惠國是標價。我認為，在較低的價格下，我們的價格區間很窄。我認為我們不應該——我不想猜測下面的情況，它仍處於概念階段。那麼——所以現在，我想我就此打住。但是，提姆，也許你想補充一些內容？

Yes, we're not in the business of pushing patients into certain directions. I will be trying to offer is the broadest product of possible to satisfy the needs of the different patient segments. So I think what you guys are seeing is a strong appetite of patients to move into self-administration at home or product administration at home.

是的，我們的工作不是將患者推向某些方向。我將盡力提供最廣泛的產品以滿足不同患者群體的需求。所以我認為你們看到的是患者對在家中進行自我管理或在家中進行產品管理有著強烈的渴望。

That's why this acceleration under Medicare Part D is coming that, guys, this is the force you need in order to spectacularly grow your market. So following the patient demand, satisfying the demand is the best way for growth going forward. And I think you basically see a signal here that patients are eagerly awaiting the PFS.

這就是為什麼醫療保險 D 部分會加速發展，夥計們，這是你們實現市場大幅成長所需的力量。因此，遵循患者需求並滿足需求是未來成長的最佳方式。我認為您基本上看到了一個信號，即患者正熱切地等待 PFS。

David Nierengarten, Wedbush Securities.

大衛‧尼倫加滕 (David Nierengarten)，韋德布希證券公司 (Wedbush Securities)。

I have one question is, are the dynamics as you see patients getting treated with ocular MG currently? Are those dynamics different from generalized MG and how that might affect your commercialization plans and duration of treatment, things like that in that potential expansion?

我有一個問題，您看到目前接受眼部 MG 治療的患者情況如何？這些動態與普遍性的 MG 有何不同？這將如何影響您的商業化計劃和治療持續時間，以及潛在擴展中的其他事項？

Yes, we don't want to see you, right? I mean your question is valuable to us. Ocular MG, high unmet medical needs, which we overlooked in the beginning when we were approaching the MG market. It's very debilitating to have ocular MG. There's no ability to work on the screen, drive a car, the social stigma associated with the symptoms, et cetera.

是啊，我們不想見到你，對吧？我的意思是您的問題對我們很有價值。眼部重症肌無力有很高的未滿足醫療需求，我們在進入重症肌無力市場時就忽略了這一點。患有眼部重症肌無力會讓人非常虛弱。無法在螢幕上工作、駕駛汽車，還會遭受與症狀相關的社會恥辱等等。

So the truth is that today, the toolbox to treat these patients is more limited. You would typically see that these patients are being treated with mestinon and a high dose of corticosteroids. We know what the detrimental effects are of high-dose corticosteroids used chronically. And we really on a campaign of steroid tapering. We have a strategic alliance with Steritas.

所以事實是，今天治療這些患者的工具更加有限。您通常會看到這些患者接受美斯汀和高劑量皮質類固醇治療。我們知道長期使用高劑量皮質類固醇的有害影響。我們確實在進行減少類固醇使用的運動。我們與 Steritas 建立了策略聯盟。

We think the moment is ripe to actually offer these patients a real alternative with the benefit risk profile of VYVGART. So high unmet need, very limited treatment toolbox and an opportunity to disrupt that treatment paradigm.

我們認為現在時機已經成熟，可以為這些患者提供具有 VYVGART 效益風險特徵的真正替代方案。未滿足的需求很高，治療工具非常有限，並且有機會打破這種治療模式。

Gavin Clark-Gartner, Evercore ISI.

Gavin Clark-Gartner，Evercore ISI。

Apologies, but it's one more on that price question. For the prefilled syringe, what are your current assumptions for the payer contracts that will include VBA moving forward specifically wondering on the CIDP side. I'm wondering if this could offset the gross to net a little bit.

抱歉，關於價格我還有一個問題。對於預充式註射器，您目前對包括 VBA 在內的付款人合約的假設是什麼？特別是在 CIDP 方面。我想知道這是否可以稍微抵消總額和淨額。

Yes. So maybe just to start before I hand it over to Karl. To take a step back and run everyone that our strategy with VYVGART is to provide as broader access as possible to patients. And certainly that we don't want them to be choosing between product presentation based price. We want them to have access and be able to choose the product presentation that fits into their lines.

是的。所以也許只是在我把它交給卡爾之前開始。退一步來說，我們與 VYVGART 合作的策略是為患者提供盡可能更廣泛的治療機會。當然，我們不希望他們根據產品展示和價格來做出選擇。我們希望他們能夠選擇適合他們產品線的產品展示方式。

So that's the strategy that we're pursuing. And what we've seen, whether it through the the CIDP launch and what we expect with the PFS launch is that our market access team, our experts are getting really good access in place quickly for patients. And we expect that will be the same and the agreements will be signed quickly to get that access in place for prefilled syringe. But Karl, did you have anything else to add on the details.

這就是我們正在推行的策略。我們看到，無論是透過 CIDP 的推出，還是透過 PFS 的推出，我們的市場准入團隊和專家都在為患者快速提供良好的准入管道。我們期望情況會一樣，協議將很快簽署，以實現預充式註射器的使用。但卡爾，你還有其他細節可以補充嗎？

I mean Karen, I think the only thing I will say is that generally, VBAs are less important in the pharmacy channel than the medical channel. So I think we'll leave it at that and we'll let's negotiate the contracts during the next few weeks.

我的意思是，凱倫，我認為我唯一要說的是，一般來說，VBA 在藥房管道中的重要性不如在醫療管道中那麼重要。所以我認為我們就到此為止吧，我們將在接下來的幾週內協商合約事宜。

Samantha Semenkow, Citi.

Samantha Semenkow 的花旗銀行。

Another one on CIDP. I'm wondering how has the discontinuation rate in CIDP trended? Are you still seeing physicians giving the majority of patients a 12-week trial? Or has that trended down as they gain more experience with VYVGART in this population.

另一個是關於 CIDP 的。我想知道 CIDP 的停藥率趨勢如何？您是否仍看到醫生為大多數患者提供 12 週的試用期？或者隨著他們在這個人群中獲得更多使用 VYVGART 的經驗，這一趨勢已經下降。

Yes. Thanks for the question. So in terms of CIDP, we are still seeing that doctors are giving that 12-week trial. And what we've seen as the launch of -- is that there has been a little bit of an uptick in discontinuation more towards we'd expect based on the ADHERE trial, but there is still a significant gap.

是的。謝謝你的提問。因此就 CIDP 而言，我們仍然看到醫生正在進行為期 12 週的試驗。隨著試驗的開展，我們看到停藥率略有上升，這更符合我們根據 ADHERE 試驗所預期的水平，但仍有很大差距。

And I would say we're below that discontinuation rate. So what we're seeing is patients starting on VYVGART, having a positive experience and staying on VYVGART

我想說我們的停產率低於這個水平。因此，我們看到患者開始使用 VYVGART 後，獲得了積極的體驗並繼續使用 VYVGART

Leland Gershell, Oppenheimer.

利蘭·格謝爾，奧本海默。

Great. Just two from us if we can. Just with respect to the upcoming data from the SWITCH study from -- I see the VYVGART in CIDP. Just given the dynamics there and the positive launch. Just wondering how critical do you see those data for physicians to effect a switch in their patients.

偉大的。如果可以的話，我們就兩個。僅就 SWITCH 研究即將得出的數據而言——我在 CIDP 中看到了 VYVGART。只是考慮到那裡的動態和積極的啟動。只是想知道您認為這些數據對於醫生改變患者治療方式有多重要。

I also want to ask with respect to 119 later this year, we'll see the POC data in CMS, few clinical end points being looked at. Just wondering if you have any threshold in mind when you look at those data were taking that program forward in CMS.

我還想問一下關於今年稍後的 119，我們將在 CMS 中看到 POC 數據，其中很少關注臨床終點。只是想知道當您查看這些數據時，是否有任何閾值在考慮在 CMS 中推進該程序。

Yes. Thank you for the two questions. So the significance of the IVIG switch study is very simple. I think the ADHERE trial was a very ambitious trial, but there is only so that you can answer in one clinical trial. So we addressed this is an Ig-driven disease, we addressed the magnitude of the effects you can show across the board in CIDP patients, but we did not really study in detail the switch dynamic.

是的。謝謝你的兩個問題。因此 IVIG 開關研究的意義非常簡單。我認為 ADHERE 試驗是一項非常雄心勃勃的試驗，但只有在一次臨床試驗中才能回答這個問題。因此，我們認為這是一種由免疫球蛋白驅動的疾病，我們討論了 CIDP 患者中可能出現的各種影響的程度，但我們並沒有真正詳細研究這種轉換動態。

Remember, patients had to worsen so they could demonstrate active disease before they came on trial. That is a bit of an artificial experimental setting. The Phase 4 trial is now investigating a practical question, how do you really switch in IVIg or CIG patients to VYVGART, a simple trial design.

請記住，患者病情必須惡化，以便在接受試驗之前能夠證明疾病處於活動狀態。這有點像是人為的實驗設定。階段 4 試驗目前正在研究一個實際問題，即如何真正讓 IVIg 或 CIG 患者轉換為 VYVGART，這是一種簡單的試驗設計。

It's a Phase 4, and it's meant to give some practical handle to creating physicians on how to do the switch. So I think it's an important data point.

這是第四階段，旨在為醫生提供一些關於如何進行轉換的實際指導。所以我認為這是一個重要的數據點。

With regards to 119 molecule, which is very close to my heart, congenital myasthenic syndrome, what we learn about these patients in the natural history study is that they actually look very much like the autoimmune myasthenic patients. There is a very strong aspect to that disease.

關於我非常關心的 119 分子，即先天性肌無力症，我們在自然史研究中了解到這些患者實際上看起來非常像自體免疫性肌無力患者。這種疾病具有非常嚴重的症狀。

Limb-girdle is really weakness of the shoulders, weakness of the hips. And therefore, we're really testing a menu of endpoints that just testing which ones are really, truly capturing the nature of the disease, the classical ADL and QMG measures are in there. And we know what the clinical thresholds are for clinical relevance.

肢帶症其實是指肩膀無力、臀部無力。因此，我們實際上正在測試一系列端點，只是測試哪些端點真正捕捉到了疾病的本質，經典的 ADL 和 QMG 測量就在其中。我們知道臨床相關性的臨床閾值是多少。

So we will be looking to that lens at our patients, and we will inform you, of course, when we have the data in hand. Thank you for the question.

因此，我們將從這個角度觀察我們的患者，當然，當我們掌握數據時，我們會通知您。謝謝你的提問。

Joel Beatty, Baird.

喬爾·比蒂，貝爾德。

Just a longer term, I know the PFS rollout is just taking place. But have you started turning your attention a little bit now to firming up time lines and strategy regarding the auto-injector?

從長遠來看，我知道 PFS 的推出才剛剛開始。但是，您現在是否已經開始將注意力轉向確定自動注射器的時間表和策略？

Yes. Thanks for the question. I appreciate zooming out and looking over the long term. And yes, our team is consistently working on the -- not just autoinjector but how we can innovate for patients overall. In terms of the auto-injector, we continue with that development.

是的。謝謝你的提問。我很欣賞縮小視野並放眼長遠。是的，我們的團隊一直在努力工作——不僅僅是自動注射器，還包括如何為患者提供全面的創新。在自動注射器方面，我們將繼續進行這項開發。

And the latest update we have provided is that we're moving it into being able to understand how to produce it at larger capacity. So everything is on track, and we look forward being able to bring continued innovation to patients in the future.

我們提供的最新更新是，我們正在將其轉變為能夠了解如何以更大的容量生產它。所以一切都在按計畫進行，我們期待未來能為患者帶來持續的創新。

Xian Deng, UBS.

鄧賢，瑞銀。

So really, thank you for the comment on European and US have very similar list price. But just wondering, could you give us some color on the difference in terms of the net price, please?

所以真的感謝您對歐洲和美國的標價非常相似的評論。但我只是想知道，您能否跟我們講一下淨價方面的差異？

I'm asking in relationship to how should we think about the commercial opportunity for PFS in Europe because on one hand, Europe does have this lack of IV infrastructure compared to the US. But then on the other hand, probably, we have probably less net price. So how should we think about that, please?

我問的是，我們應該如何看待 PFS 在歐洲的商業機會，因為一方面，與美國相比，歐洲確實缺乏 IV 基礎設施。但另一方面，我們的淨價可能會更低。那我們應該如何考慮這個問題呢？

Yes. Thanks for the question. And maybe not with I'll reinforce something that Karl has said. In terms of our ex US expansion, we've taken a very disciplined approach to ensure financial sustainability as we provide access to patients around the world with VYVGART.

是的。謝謝你的提問。也許我不會重申卡爾所說的話。就我們在美國以外的擴張而言，我們採取了非常嚴謹的方法來確保財務可持續性，因為我們透過 VYVGART 為世界各地的患者提供治療服務。

So I think we're very well positioned in terms of our net price from that perspective. And you're exactly right. We see the PFS opportunity as a big opportunity ex US because of the hospital dynamics that you mentioned. We've already seen the first patient dosed in Germany.

因此，從這個角度來看，我認為我們的淨價處於非常有利的地位。你說得完全正確。由於您提到的醫院動態，我們認為 PFS 機會是美國以外的一個巨大機會。我們已經看到德國第一位患者接受了藥物治療。

We saw with the Hytrulo butterfly execution is a very fast conversion in Europe, in particular, of patients from IV to the Butterfly execution of Hytrulo. And we think that will accelerate with PFS and ultimately help to accelerate and continue our growth in rest of world or outside of the US in the future.

我們看到，在歐洲，海特魯羅蝴蝶式處決的轉換速度非常快，特別是從靜脈注射處決到海特魯羅蝴蝶式處決的患者。我們認為這將加速 PFS 的發展，並最終幫助我們在未來加速並繼續在世界其他地區或美國以外的成長。

So we're really excited about the opportunity for PFS, not just in US but around the globe with launches coming. Thanks for the question.

因此，我們對 PFS 的機會感到非常興奮，不僅在美國，而且在全球範圍內即將推出。謝謝你的提問。

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

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。