Zai Lab Ltd (ZLAB) 2025 Q1 法說會逐字稿

Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab's first quarter 2025 financial results conference call. (Operator Instructions) As a reminder, today's call is being recorded.

女士們、先生們，大家好。感謝您的支持，歡迎參加再鼎醫藥 2025 年第一季財務業績電話會議。（操作員指示）提醒一下，今天的通話正在被錄音。

It is now my pleasure to turn the floor over to Christine Chiou, Senior Vice President of Investor Relations. Please go ahead.

現在我很高興將發言權交給投資者關係高級副總裁 Christine Chiou。請繼續。

Thank you, operator. Hello, and welcome, everyone. Today's earnings call will be led by Dr. Samantha Du, Zai Lab's Founder, CEO and Chairperson. She will be joined by Josh Smiley, President and Chief Operating Officer; Dr. Rafael Amado, President and Head of Global Research and Development; and Dr. Yajing Chen, Chief Financial Officer. Jonathan Wang, our Chief Business Officer, will also be available to answer questions during the Q&A portion of the call.

謝謝您，接線生。大家好，歡迎大家。今天的收益電話會議將由再鼎醫藥創辦人、執行長兼董事長杜嘉班納博士主持。與她一同出席的還有總裁兼營運長 Josh Smiley、總裁兼全球研發主管 Rafael Amado 博士以及財務長 Yajing Chen 博士。我們的商務長 Jonathan Wang 也將在電話會議的問答環節回答問題。

As a reminder, during today's call, we will be making certain forward-looking statements based on our current expectations. These statements are subject to numerous risks and uncertainties that may cause actual results to differ materially from what we expect due to a variety of factors, including those discussed in our SEC filings. We will also refer to adjusted loss from operations, which is a non-GAAP financial measure. Please refer to our earnings release furnished with the SEC on May 8, 2025, for additional information on this non-GAAP financial measure.

提醒一下，在今天的電話會議中，我們將根據我們目前的預期做出某些前瞻性的陳述。這些聲明受到許多風險和不確定性的影響，這些風險和不確定性可能導致實際結果與我們的預期有重大差異，這是由於各種因素造成的，包括我們向美國證券交易委員會提交的文件中討論的因素。我們也會參考調整後的營業虧損，這是一項非公認會計準則財務指標。有關此非 GAAP 財務指標的更多信息，請參閱我們於 2025 年 5 月 8 日向美國證券交易委員會 (SEC) 提交的收益報告。

At this time, it is my pleasure to turn the call over to Dr. Samantha Du.

現在，我很高興將電話轉給 Samantha Du 博士。

Thank you, Christine. Good morning and good evening, everyone. Thank you for joining us today. We entered 2025 with a conviction that this will be a pivotal year for Zai Lab, a year where strong execution, disciplined growth and the scientific innovation would begin to shape our long-term trajectory. Let me be clear, our conviction in the strength of our business fundamentals and strategic direction remains strong. As we close out the first quarter, we're reaffirming our full year revenue guidance of between $560 million to $590 million. We anticipate accelerating sales growth in the next three quarters, which will translate into significant operating leverage and keep us on track to achieve profitability by Q4 of this year.

謝謝你，克里斯汀。大家早安，晚上好。感謝您今天加入我們。進入 2025 年，我們堅信這將是再鼎醫藥的關鍵一年，強勁的執行力、穩健的成長和科學創新將開始塑造我們的長期發展軌跡。我要明確指出的是，我們對我們的業務基礎和策略方向的實力依然堅信不疑。在第一季結束之際，我們重申全年營收預期為 5.6 億至 5.9 億美元。我們預計未來三個季度的銷售成長將加速，這將轉化為顯著的經營槓桿，並使我們預計在今年第四季實現盈利。

Before I turn the call over to Josh to discuss our Q1 performance, I want to share my excitement for the road ahead. Zai Lab has a differentiated and highly potential portfolio, including multiple regional first or best-in-class assets that are poised to deliver significant long-term value. This includes a pipeline of product opportunities like VYVGART and povetacicept as well as other potential blockbusters like bemarituzumab in gastric cancer, KarXT in schizophrenia and TTFields in pancreatic cancer.

在我將電話轉給喬希討論我們第一季的業績之前，我想分享一下我對未來道路的興奮之情。再鼎醫藥擁有差異化且極具潛力的投資組合，其中包括多個區域首創或一流的資產，這些資產有望帶來巨大的長期價值。其中包括 VYVGART 和 povetacicept 等產品機會以及其他潛在的重磅炸彈，如治療胃癌的 bemarituzumab、治療精神分裂症的 KarXT 和治療胰腺癌的 TTFields。

We are confident in delivering our 2025 revenue targets and surpassing $2 billion by 2028, with the strong momentum carrying well into the 2030s. Our original business is already commercially profitable with a clear growth runway, and we will continue to add new assets with discipline and focus.

我們有信心實現 2025 年的收入目標，到 2028 年收入超過 20 億美元，並且強勁的發展勢頭將持續到 2030 年代。我們原有的業務已經實現商業盈利，並擁有清晰的成長軌跡，我們將繼續有紀律、有重點地增加新資產。

At the same time, we have made bold investments to accelerate our global R&D pipeline. Our lead global asset, ZL-1310, is a potential first and best-in-class DLL3 ADC. We'll present updated Phase I data in small cell lung cancer at ASCO in June and outline our broader development strategy across multiple indications, including a registrational trial that positions us for a potential FDA approval in 2027, a milestone that would elevate our position on the global stage.

同時，我們也進行了大膽投資，以加速我們的全球研發進程。我們的主要全球資產 ZL-1310 是潛在的首款和同類最佳的 DLL3 ADC。我們將於 6 月在 ASCO 上展示小細胞肺癌 I 期更新數據，並概述我們針對多種適應症的更廣泛的發展策略，包括一項註冊試驗，該試驗預計將在 2027 年獲得 FDA 批准，這是一個將提升我們在全球舞台上地位的里程碑。

Beyond 1310, we're advancing our next wave of innovation. ZL-6201, our novel LRRC15 ADC for solid tumors, and ZL-1503, a first-in-class IL-13/IL-31 bispecific for atopic dermatitis are both expected to enter the clinic this year, further expanding our global oncology immunology pipeline. Looking ahead, we see clear drivers of margin expansion, increased scale with VYVGART, efficient new launches that leverage our existing infrastructure, manufacturing localization and the ramp-up of high-value global assets. These efforts are building Zai Lab into a profitable, high-growth business with global impact. We're just getting started, and I look forward to updating you on our progress throughout the year.

超越 1310，我們正在推動下一波創新。我們的新型 LRRC15 實體瘤 ADC ZL-6201 和首創的 IL-13/IL-31 雙特異性抗體藥物 ZL-1503 預計均將於今年進入臨床階段，進一步擴大我們的全球腫瘤免疫學產品線。展望未來，我們看到了利潤率擴張的明顯驅動力、VYVGART 規模的擴大、利用現有基礎設施的高效新產品的推出、製造本地化以及高價值全球資產的提升。這些努力正在將再鼎醫藥打造成為一家具有全球影響力、獲利能力強、高成長的企業。我們才剛開始，我期待著向您通報我們全年的進展。

Now I'll turn the call over to Josh. Josh?

現在我將把電話轉給喬希。喬希？

Thank you, Samantha, and good morning and good evening to everyone. Let's start with Vivar.

謝謝你，薩曼莎，大家早安，晚上好。讓我們從 Vivar 開始。

Following the exceptional to 2024, we expect another strong year in 2025 with Vivart's sales growth expected to outpace total revenue growth driven by increased patient demand, improved treatment continuity, and expanded access.

在 2024 年取得優異成績後，我們預計 2025 年將再次呈現強勁成長勢頭，在患者需求增加、治療連續性改善和治療管道擴大的推動下，Vivart 的銷售額增長預計將超過總收入增長。

First quarter sales reflected seasonal trends with Chinese New Year driving a temporary decline in patients in January and February. As an IV treatment for a chronic disease, Vivar is more susceptible to this type of seasonality.

第一季的銷售額反映了季節性趨勢，由於中國新年導致 1 月和 2 月患者數量暫時下降。作為一種治療慢性病的靜脈注射療法，Vivar 更容易受到這種季節性的影響。

That said, patient volumes rebounded in March and April, and we anticipate a return to strong sequential growth throughout the rest of the year.

儘管如此，3 月和 4 月患者數量有所反彈，我們預計今年剩餘時間內患者數量將恢復強勁的連續成長。

Inventory dynamics also influenced quarterly sales growth. In preparation for the launch of Vivar Hrulo, we had some inventory build in Q4. The timing of these movements had a notable impact on reported sales growth.

庫存動態也影響了季度銷售成長。為了準備推出 Vivar Hrulo，我們在第四季建立了一些庫存。這些措施的時機對報告的銷售成長產生了顯著影響。

Looking ahead, we are seeing early positive results from our ongoing strategic initiatives to extend treatment duration.

展望未來，我們正在進行的延長治療時間的策略性舉措正在看到早期的積極成果。

In addition, the first expert recommendations for the clinical application of FCRN antagonists in the treatment of GMG were published in February and a similar update to the national GMG treatment guidelines is expected later this year. Together these developments provide additional momentum for continued sequential growth and an acceleration in the second half of this year.

此外，第一份關於臨床應用 FCRN 拮抗劑治療 GMG 的專家建議已於 2 月發布，預計今年稍後全國 GMG 治療指南也將進行類似的更新。這些發展共同為今年下半年持續的連續成長和加速提供了額外的動力。

We're also preparing for the upcoming NRDL cycle, targeting IV renewal for GMG and initial listing of the SC formulation, both of which would take effect on January 1st, 2026.

我們也正在為即將到來的國家健保目錄週期做準備，目標是續簽GMG的靜脈注射劑型和首次列出SC製劑，這兩項措施都將於2026年1月1日生效。

Now let me turn to our broader commercial portfolio.

現在讓我來談談我們更廣泛的商業組合。

All other products, including Zadua and Nuzira, delivered sequential growth supported by NRDL Access. We also saw early contributions from Montyro and Zachdoro. In particular, Zakdoro is showing strong initial demand. Physician feedback has been highly positive, citing Zachdoro's rapid efficacy and favorable safety profile in treating crab infections. A serious unmet need in China, where an estimated 300,000 ainobacter cases occur annually with limited treatment options and poor outcomes.

包括 Zadua 和 Nuzira 在內的所有其他產品均在國家醫療保健目錄的支持下實現了連續增長。我們還看到了 Montyro 和 Zachdoro 的早期貢獻。尤其是 Zakdoro，其初始需求強勁。醫生的回饋非常積極，稱讚 Zachdoro 在治療蟹感染方面具有快速療效和良好的安全性。中國有嚴重的未滿足需求，每年約有 30 萬例嗜酸桿菌感染病例，但治療選擇有限且療效不佳。

Turning to our financial position, we continue to strengthen efficiency and operating leverage. For the first quarter of 2025, operating loss improved by 20% to $56.3 million and by 25% to $37.1 million on an adjusted basis, keeping us firmly on track to reach profitability in the fourth quarter.

談到我們的財務狀況，我們繼續加強效率和經營槓桿。2025 年第一季度，營業虧損改善 20% 至 5,630 萬美元，調整後營業虧損改善 25% 至 3,710 萬美元，使我們堅定地走在第四季度實現盈利的軌道上。

Looking ahead, we have a robust set of late stage opportunities to drive substantial growth. three regulatory reviews are currently underway, including CAXC for schizophrenia and TIAC for cervical cancer, and we anticipate at least three additional submissions this year, including beertuzumab for gastric cancer, TT Fields for pancreatic cancer, and Vivart's prefilled syringe for GMG and CIDP.

展望未來，我們擁有一系列強勁的後期發展機遇，可推動大幅成長。目前有三項監管審查正在進行中，包括用於治療精神分裂症的 CAXC 和用於治療子宮頸癌的 TIAC，我們預計今年至少還會有三項新藥提交，包括用於治療胃癌的 beertuzumab、用於治療胰腺癌的 TT Fields 以及用於治療 GMG 和 CIDP 的 Vivart 預充式註射器。

We expect to optimize our commercial footprint by leveraging our existing commercial infrastructure to efficiently support future launches. For example, deploying our Zijea team to support TIDA and our Kinlock team for Beatuszumab.

我們希望利用現有的商業基礎設施來優化我們的商業足跡，從而有效地支援未來的發布。例如，部署我們的 Zijea 團隊來支援 TIDA，部署我們的 Kinlock 團隊來支援 Beatuszumab。

For targeted opportunities like Car XT, we can effectively reach over 85% of the market with a focused team of approximately 150 sales representatives.

對於像 Car XT 這樣的目標機會，我們可以透過大約 150 名銷售代表組成的專注團隊有效地覆蓋超過 85% 的市場。

In parallel, we are advancing further operational efficiencies as Vivar scales, and as we localize manufacturing for key products to more cost effectively support our regional portfolio. These efforts are central to our strategy for achieving profitability alongside long-term revenue growth.

同時，隨著 Vivar 規模的擴大以及關鍵產品製造的在地化，我們正在進一步提高營運效率，以更具成本效益地支援我們的區域產品組合。這些努力對於我們實現盈利和長期收入成長的策略至關重要。

With a fast growing greater China business, a deep, deepening global pipeline, and disciplined financial execution, we are well positioned to deliver substantial value for our shareholders in 2025 and beyond.

憑藉快速成長的大中華區業務、不斷深化的全球管道以及嚴格的財務執行，我們已做好準備，在 2025 年及以後為股東創造豐厚的價值。

And with that, I'll pass the call over to Rafael to discuss the great progress within our pipeline.

說完這些，我將把電話轉給拉斐爾，討論我們管道內的巨大進展。

Thank you, Josh. I'll start by highlighting the key progress updates in our global pipeline since our last earnings call, along with our next steps. Starting with ZL-1310, our potential first and best-in-class DLL3 ADC for small cell lung cancer. Last year, we shared promising preliminary monotherapy results from the Phase I dose escalation cohort, demonstrating antitumor responses in the majority of patients with extensive stage small cell lung cancer, including in brain lesions with good tolerability. We completed enrollment in the dose escalation monotherapy cohort.'

謝謝你，喬希。首先，我將重點介紹自上次收益電話會議以來我們全球管道中的關鍵進展更新以及我們的後續步驟。從 ZL-1310 開始，這是我們針對小細胞肺癌的潛在首個也是同類最佳的 DLL3 ADC。去年，我們分享了 I 期劑量遞增隊列中令人鼓舞的初步單一療法結果，顯示大多數廣泛期小細胞肺癌患者（包括腦病變患者）均表現出抗腫瘤反應，且耐受性良好。我們完成了劑量遞增單一療法隊列的招募。 ’

Enrollment in the ongoing monotherapy dose optimization cohort is progressing rapidly, and we look forward to presenting updated data from both cohorts of the global Phase I study at the ASCO meeting in June this year. We're also pleased with ongoing regulatory discussions with the FDA, and we are on track to initiate a pivotal study in small cell lung cancer later this year, positioning us for a potential accelerated approval in 2027. We're also assessing potential combinations in the first-line setting, and we expect to provide data in the second half of this year.

正在進行的單藥治療劑量優化隊列的招募正在快速進展，我們期待在今年 6 月的 ASCO 會議上展示全球 I 期研究兩個隊列的最新數據。我們也對與 FDA 正在進行的監管討論感到高興，並且我們預計在今年稍後啟動小細胞肺癌的關鍵研究，這為我們在 2027 年獲得加速批准做好準備。我們也正在評估第一線治療中的潛在組合，預計今年下半年將提供數據。

As DLL3 is also highly expressed in other neuroendocrine tumors, we're exploring its therapeutic potential beyond small cell lung cancer. A global Phase I/II study was initiated in April to explore ZL-1310 in this indication.

由於 DLL3 在其他神經內分泌腫瘤中也高度表達，我們正在探索其在小細胞肺癌以外的治療潛力。一項全球 I/II 期研究已於 4 月啟動，旨在探索 ZL-1310 的適應症。

Next, on our other global oncology assets. At the American Association for Cancer Research meeting, we presented new data for two of our internally developed oncology therapies, ZL-6201 and ZL-1222. ZL-6201 is a novel ADC with an internally developed high affinity and specificity for LRRC15 antibody and next-generation payload linker. LRRC15 is an attractive target for cancer therapy due to its over expression in multiple solid tumors such as sarcoma, glioblastoma and melanoma as well as its expression in fibroblasts in the tumor microenvironment of multiple tumors such as breast, lung and colorectal cancer.

接下來，談談我們的其他全球腫瘤學資產。在美國癌症研究協會會議上，我們展示了我們內部開發的兩種腫瘤療法 ZL-6201 和 ZL-1222 的新數據。ZL-6201 是一種新型 ADC，具有內部開發的對 LRRC15 抗體和下一代有效載荷接頭的高親和力和特異性。LRRC15 是一個有吸引力的癌症治療靶點，因為它在肉瘤、膠質母細胞瘤和黑色素瘤等多種實體瘤中過度表達，並且在乳腺癌、肺癌和結直腸癌等多種腫瘤的腫瘤微環境中的成纖維細胞中表達。

The payload linker system releases the payload by cleavage both extracellularly in the tumor microenvironment and intracellularly within the cellular lysosomes once the antibody is internalized. We are advancing ZL-6201 into a global Phase I study this year. ZL-1222 is a PD-1 targeted next-generation IL-12 immunocytokine designed to leverage the antitumor potential of IL-12 while lowering the associated systemic toxicity. The IL-12 mutant is engineered to remain in a less potent state, reducing systemic IL-12 induced toxicity.

一旦抗體被內化，有效載荷連接系統就會透過在腫瘤微環境中的細胞外和細胞溶酶體內的細胞內裂解來釋放有效載荷。我們今年正在將 ZL-6201 推進到全球 I 期研究。ZL-1222 是一種針對 PD-1 的下一代 IL-12 免疫細胞因子，旨在利用 IL-12 的抗腫瘤潛力，同時降低相關的全身毒性。IL-12 突變體經過設計後可維持效力較低的狀態，進而降低系統性 IL-12 誘導的毒性。

A [CIF]-mediated signaling process is initiated when ZL-1222 binds to PD-1. Findings from its preclinical studies demonstrate potent antitumor activity in both anti-PD-1 sensitive and resistant tumor models with improved systemic safety. These results suggest a potential role in patients who are unresponsive or resistant to current immuno-oncology therapies.

當 ZL-1222 與 PD-1 結合時，[CIF] 介導的訊號傳導過程就開始了。其臨床前研究結果表明，該藥物在抗 PD-1 敏感和抗性腫瘤模型中均具有強大的抗腫瘤活性，並具有提高的系統性安全性。這些結果表明，對於對目前免疫腫瘤療法無反應或有抵抗力的患者，它可能具有一定的作用。

We also expect to advance ZL-1503, an IL-13/IL-31 bispecific antibody for atopic dermatitis into Phase I development this year, and we'll present a progress update in June. We are committed to expanding our global pipeline and progressing at least one global product to IND submission stage every year.

我們也預計今年將 ZL-1503（一種用於治療異位性皮膚炎的 IL-13/IL-31 雙特異性抗體）推進到 I 期開發階段，並將在 6 月公佈進展更新。我們致力於擴大我們的全球產品線，每年至少有一款全球產品進入 IND 提交階段。

Now moving on to our key late-stage regional programs and starting with immunology. Our partner, argenx, announced in April that the US FDA approved VYVGART Hytrulo prefilled syringe, or PFS, for self-injection in generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. It is the third administration option, providing additional flexibility and convenience for patients, and we're planning a CMC submission in China later this year.

現在我們來談談我們的關鍵後期區域項目，從免疫學開始。我們的合作夥伴 argenx 於 4 月宣布，美國 FDA 批准 VYVGART Hytrulo 預充式註射器（PFS）用於全身性重症肌無力和慢性發炎性脫髓鞘性多發性神經病變的自我注射。這是第三種給藥選擇，為患者提供額外的靈活性和便利性，我們計劃今年稍後在中國提交 CMC 申請。

We continue to explore the potential of efgartigimod to treat other IgG-mediated autoimmune indications, including thyroid eye disease, myositis, seronegative gMG, ocular MG and lupus nephritis. In 2025, we expect top line results from the global Phase III study in seronegative gMG and the Phase II of lupus nephritis.

我們繼續探索 efgartigimod 治療其他 IgG 介導的自體免疫疾病的潛力，包括甲狀腺眼疾、肌肉炎、血清陰性 gMG、眼部 MG 和狼瘡性腎炎。2025 年，我們預期血清陰性 gMG 全球 III 期研究和狼瘡性腎炎 II 期研究將達到最佳結果。

In January this year, we strengthened our regional immunology franchise with a pipeline in a product opportunity with povetacicept, a novel dual B-cell activating factor, or BAFF, and a proliferation-inducing ligand or APRIL antagonist. We're leveraging our regional expertise and established footprint with efgartigimod to accelerate its development in renal diseases, namely IgAN and primary membranous nephropathy.

今年 1 月，我們透過 povetacicept（一種新型雙 B 細胞活化因子或 BAFF）和增殖誘導配體或 APRIL 拮抗劑的產品機會，加強了我們在區域免疫學領域的特許經營權。我們正在利用我們在區域方面的專業知識和在 efgartigimod 方面的既有經驗來加速其在腎臟疾病（即 IgAN 和原發性膜性腎病）方面的發展。

China has already joined the global Phase III RAINIER trial in IgAN and enrollment of the interim analysis cohort has completed. Our partner, Vertex, will conduct an interim analysis once this cohort reaches 36 weeks of treatment with the potential to file for accelerated approval in the US in the first half of 2026. We also plan to join the global pivotal Phase II/III study in PMN this year. There are no approved therapies targeting the underlying cause of the disease, and current treatments rely on immunosuppressants or anti-CD20 monoclonal antibodies, which are associated with infection and myelosuppression. In addition, a subset of these patients experiences progressive kidney function impairment despite available therapies.

中國已加入IgAN全球III期RAINIER試驗，並已完成中期分析隊列的招募。一旦該組患者達到 36 週的治療，我們的合作夥伴 Vertex 將進行中期分析，並有可能在 2026 年上半年在美國申請加速批准。我們也計劃今年加入PMN的全球關鍵II/III期研究。目前尚無針對該疾病根本原因的核准療法，目前的治療依賴免疫抑制劑或抗 CD20 單株抗體，而這些藥物與感染和骨髓抑制有關。此外，儘管有治療方法，但其中一部分患者的腎功能仍會逐漸受損。

In neuroscience, KarXT for schizophrenia is under review by China's NMPA since the acceptance of the NDA earlier this year, and we are awaiting the data readout from the global Phase III ADAPT-2 study in Alzheimer's disease psychosis later this year.

在神經科學領域，用於治療精神分裂症的 KarXT 自今年稍早接受 NDA 以來一直在接受中國國家藥品監督管理局的審查，我們正在等待今年稍後針對阿茲海默症精神病的全球 III 期 ADAPT-2 研究的數據讀數。

In oncology, for bemarituzumab, our first-in-class FGFR2b targeting therapy for gastric cancer, we expect the data readout from the global Phase III FORTITUDE-101 study in the second quarter of this year. Gastric cancer poses a significant threat in China with over 350,000 new cases each year and a 5-year survival rate of less than 10% in advanced stages. There are currently no approved therapies specifically targeting FGFR2b over expression in gastric cancer, and we look forward to bringing this potentially transformative therapy to patients as quickly as possible.

在腫瘤學領域，對於我們針對胃癌的首創 FGFR2b 標靶療法 bemarituzumab，我們預計今年第二季獲得全球 III 期 FORTITUDE-101 研究的數據。胃癌在中國是嚴重的威脅，每年新發病例超過35萬，晚期胃癌患者5年存活率不足10%。目前尚無專門針對胃癌中 FGFR2b 過度表現的核准療法，我們期待盡快為患者帶來這種具有變革意義的療法。

We continue to make great progress across our global pipeline, and we will continue to enrich it and execute existing programs with speed and precision. I look forward to sharing further updates in the coming quarters.

我們的全球產品線持續取得巨大進展，我們將繼續豐富它並快速、精確地執行現有專案。我期待在接下來的幾個季度分享更多更新。

And now Yajing will give an overview of our financial results. Yajing?

現在雅靜將概述我們的財務表現。雅靜？

Thank you, Rafael. Now I will discuss highlights from our first quarter 2025 financial results compared to the prior year period. Total revenue grew 22% year-over-year to $106.5 million in the first quarter, driven by increased sales for VYVGART, ZEJULA and NUZYRA. Our base business remains strong, and we began to see early contributions from our newly launched products.

謝謝你，拉斐爾。現在，我將討論我們 2025 年第一季財務業績與去年同期相比的亮點。第一季總營收年增 22% 至 1.065 億美元，這得益於 VYVGART、ZEJULA 和 NUZYRA 銷售額的成長。我們的基礎業務依然強勁，我們開始看到新推出的產品帶來的早期貢獻。

Our focus on financial discipline and efficiency efforts was also reflected on the expense side. R&D and SG&A as a percentage of revenue declined significantly year-over-year. R&D expenses for the first quarter increased 11% year-over-year due to upfront fees totaling $20 million for our license and collaboration agreements. Other R&D expenses decreased as a result of resource prioritization and efficiency efforts. SG&A expenses for the first quarter decreased 8% year-over-year, mainly due to strategic resource allocation and efficiency improvements.

我們對財務紀律和效率努力的關注也體現在支出方面。研發和銷售、一般及行政費用佔收入的百分比較去年同期大幅下降。由於我們的授權和合作協議的預付費用總計 2,000 萬美元，第一季的研發費用年增 11%。由於資源優先和效率努力，其他研發費用減少。第一季銷售、一般及行政費用較去年同期下降8%，主要得益於策略資源分配及效率提升。

As a result of operating leverage we are building into our business, our loss from operations decreased 20% for the first quarter to $56.3 million. When you adjust our loss from operations to exclude certain noncash items, specifically depreciation, amortization and share-based compensation, we had adjusted loss from operations of $37.1 million in the first quarter, reflecting year-over-year improvement of 25%. Based on our operating plan and our anticipated revenue growth, we expect to achieve profitability on an adjusted basis by the fourth quarter of this year.

由於我們在業務中建立了經營槓桿，第一季我們的營業虧損減少了 20%，至 5,630 萬美元。當我們調整我們的營業虧損以排除某些非現金項目（特別是折舊、攤提和股權激勵）時，我們第一季的調整後營業虧損為 3,710 萬美元，年成長 25%。根據我們的營運計劃和預期的收入成長，我們預計今年第四季將實現調整後的利潤。

Looking ahead, we expect to deliver quarter-over-quarter total revenue growth in 2025 with a meaningful acceleration anticipated in the later part of the year. We remain confident in reaffirming our full year 2025 total revenue guidance in the range of $560 million to $590 million. This revenue forecast reflects strong growth for the VYVGART franchise, continued growth from our base business, including NUZYRA and ZEJULA and contributions from our newly launched products, including AUGTYRO and XACDURO. We are in a strong financial position, ending the quarter with a cash position of $857.3 million.

展望未來，我們預計 2025 年總收入將實現環比成長，並預計在今年下半年將顯著加速。我們仍然有信心重申我們對 2025 年全年總收入的預期，即 5.6 億美元至 5.9 億美元。此收入預測反映了 VYVGART 特許經營的強勁成長、我們基礎業務（包括 NUZYRA 和 ZEJULA）的持續成長以及我們新推出的產品（包括 AUGTYRO 和 XACDURO）的貢獻。我們的財務狀況良好，本季末的現金狀況為 8.573 億美元。

And with that, I would now like to turn the call back over to the operator to open up the line for questions. Operator?

現在，我想將電話轉回給接線生，以便大家能夠提問。操作員？

(Operator Instructions)

（操作員指示）

Michael Yee from Jefferies.

傑富瑞 (Jefferies) 的 Michael Yee。

Thank you. Good morning. Congrats on the results and the outlook for the year. We had two questions. First, just on VYVGART, maybe the team could add a little bit more color. Obviously, the number was sequentially down and would be eye-opening. But can you just maybe describe was a lot of the sequential change inventory changes or just seasonality of purchasing? And is your confidence in the guidance based specifically on your awareness of what's going on in April and into May?

謝謝。早安.恭喜今年取得的成果和前景。我們有兩個問題。首先，僅在 VYVGART 上，也許團隊可以添加更多一點顏色。顯然，這個數字是連續下降的，而且令人大開眼界。但是您能否描述一下庫存變化的連續變化還是僅僅是採購的季節性變化？您對指導的信心是否具體基於您對 4 月和 5 月情況的了解？

And then the second question is a strategic question, maybe for Samantha. Obviously, you're seeking to become more of a global company. Are you seeking to bring in more Chinese assets to be wholly owned this year? And how should we think about some more deals in terms of a wholly owned pipeline?

第二個問題是一個戰略問題，也許對薩曼莎來說是這樣。顯然，你們正在尋求成為一家全球化公司。今年您是否尋求引入更多中國資產進行全資收購？我們應該如何考慮更多全資管道交易？

Thank you.

謝謝。

Mike, it's Josh. I'll start with VYVGART and then hand it over to Samantha to make some comments on your second question. First on VYVGART, I would say, as you heard in the call and in our press release, we're reiterating our total sales guidance for the year, $560 million to $590 million. That implies a growth rate in the mid to high 40s depending on the range. And we are also reiterating that we expect VYVGART itself to grow faster than the overall sales growth.

麥克，我是喬希。我先從 VYVGART 開始，然後交給 Samantha 對您的第二個問題發表一些評論。首先關於 VYVGART，我想說，正如您在電話會議和新聞稿中聽到的那樣，我們重申今年的總銷售預期，即 5.6 億美元至 5.9 億美元。這意味著成長率將在 40% 左右，具體取決於範圍。我們也重申，我們預計 VYVGART 本身的成長速度將快於整體銷售的成長速度。

So I think if you look at Q1, to your question, we did see seasonality in January and February and I think patient utilization. Of course, we -- all products experience this to some degree in China given Chinese New Year, IV products particularly. If you think about VYVGART, it requires, when you're in a cycle, a weekly trip to the hospital for an infusion. And as probably anticipated, we saw some of those visits being delayed. We saw a good recovery of patient volumes and utilization in March and really a really strong April. I think if we look at our April patient utilization and patient numbers, it's our highest ever and at least 10% better than anything we've seen to date.

因此，我認為，如果您看一下第一季的問題，我們確實看到了一月和二月的季節性，我認為是患者利用率。當然，在中國，由於農曆新年的緣故，所有產品都會在一定程度上經歷這種情況，尤其是 IV 產品。如果您考慮 VYVGART，它要求您在週期內每週去醫院輸液一次。正如我們所預料的那樣，我們發現一些訪問被推遲了。我們看到 3 月份患者數量和利用率恢復良好，4 月份的情況也非常強勁。我認為，如果我們看一下四月份的患者利用率和患者人數，這是我們有史以來的最高水平，並且比我們迄今為止看到的任何情況都要好至少 10%。

So we're quite confident about the progress for the year for VYVGART. And I think the utilization piece was an issue in January and February and not totally unexpected given what we know about China. Hopefully, in future years, this will be less of an issue as we have products like -- or formulations like subcu and the prefilled syringe, which wouldn't require hospital visits per se.

因此，我們對 VYVGART 今年的進展充滿信心。我認為利用率問題是一月和二月的一個問題，考慮到我們對中國的了解，這並不完全出乎意料。希望在未來幾年，這將不再是一個問題，因為我們有類似的產品或配方，如皮下注射和預充式註射器，這些產品本身不需要去醫院。

We did have some inventory moves as well as you asked. As you remember from Q4, we got approval for Hytrulo last year. We did ship Hytrulo to get it into the channel. And until we get NRDL listing, which we're pursuing for 2026, we're going to see limited usage there. So there was some inventory move there. But again, I'd say we're quite confident about the outlook for the year for VYVGART to see really good progress in terms of new patients, patient duration, and we're seeing that in April and May, as you suggested.

正如您所要求的，我們確實進行了一些庫存移動。正如您在第四季度記得的那樣，我們去年獲得了 Hytrulo 的批准。我們確實運送了 Hytrulo 並將其送入渠道。在我們爭取在 2026 年將其列入國家健保目錄之前，其使用量將受到限制。因此那裡有一些庫存變動。但我再次強調，我們對 VYVGART 今年的前景非常有信心，在新增患者數量和患者持續時間方面將取得非常好的進展，正如您所說，我們將在 4 月和 5 月看到這一點。

For your question about overall -- how we're thinking about the strategy and company, I'll ask Samantha to make some comments.

對於您關於整體的問題——我們如何看待策略和公司，我會請薩曼莎發表一些評論。

As you know, we are a company focused on not only China regional rights, but also for global rights. We have a very strong BD team, which has a strong coverage in China as well as in the rest of the world. So if we -- but of course, we have a very high bar. But if we see anything we think have high potential to have a differentiated products, we will definitely go for it.

如您所知，我們是一家不僅關注中國地區版權，還關注全球版權的公司。我們擁有一支非常強大的 BD 團隊，其業務覆蓋範圍涵蓋中國以及世界其他地區。所以如果我們——當然，我們的標準很高。但如果我們發現任何具有很大潛力成為差異化產品的東西，我們肯定會嘗試。

Louise Chen from Scotiabank

豐業銀行的 Louise Chen

So I wanted to ask you a few questions here. First of all, are you comfortable with where consensus is today for VYVGART and then for the fiscal year revenues? And then also wanted to ask you on Bema-101 study, we would have expected to see something here. Has there been any delay or anything to read into this?

所以我想在這裡問你幾個問題。首先，您對 VYVGART 以及財政年度收入的當前共識感到滿意嗎？然後也想問您關於 Bema-101 研究的問題，我們希望在這裡看到一些東西。有沒有任何延遲或任何需要解讀的地方？

Thank you.

謝謝。

Louise, it's Josh. I'll do the first piece and then Rafael can talk about bema. I think first, as it relates to overall consensus, as I mentioned, we're reaffirming $560 million to $590 million for the year. We feel good about that range. And we're not giving specific product level guidance. But I think if you look at VYVGART, I think the consensus is sort of in line with what I mentioned in the last question, which is VYVGART sales for the full year growing at faster than the overall implied business rate. So I think that puts us in range with what I see for consensus now. And again, we're off to a really good last couple of months start for the second quarter and feel good about the progress for VYVGART and for the business overall.

路易絲，我是喬希。我會做第一部分，然後拉斐爾可以談論 bema。我認為首先，因為它與整體共識有關，正如我所提到的，我們重申今年的撥款為 5.6 億至 5.9 億美元。我們對這個範圍感到滿意。我們沒有提供具體的產品等級指導。但我認為，如果你看看 VYVGART，我認為共識與我在上一個問題中提到的一致，即 VYVGART 全年銷售額的成長速度快於整體隱含的業務率。所以我認為這使我們達到了我現在所看到的共識範圍。再次，我們第二季最後幾個月的開局非常好，對 VYVGART 和整體業務的進展感到滿意。

Rafael, you could talk about bema, please?

拉斐爾，你能談談 bema 嗎？

Sure. So bema for the FORTITUDE-101 study, which is the chemotherapy plus/minus bema in FGFR2b expressing tumors, the data is expected in the second quarter of this year. I would not really read anything into whether or not it has been released yet or not. It's an interim analysis, and we're pretty excited both about the design of the study and also the potential for this drug to really impact the lives of patients with these tumors with this alteration, particularly based on the results of the Phase II study, which was quite large compared to what we've been seeing with nivolumab and Claudin and some of the other products that have been added to gastric cancer. So I would just say stay tuned, and I'm confident that we will get this data in the second quarter.

當然。因此，對於 FORTITUDE-101 研究（即針對 FGFR2b 表達腫瘤的化療加/減 bema）而言，預計數據將在今年第二季公佈。我不會真正解讀它是否已經發布。這是一項中期分析，我們對研究的設計以及這種藥物透過這種改變真正影響這些腫瘤患者生活的潛力感到非常興奮，特別是基於第二階段研究的結果，與我們在 nivolumab 和 Claudin 以及其他一些用於治療胃癌的產品相比，這項研究的規模相當大。所以我只想說請繼續關注，我相信我們將在第二季獲得這些數據。

Jonathan Chang from Leerink Partners.

Leerink Partners 的 Jonathan Chang。

Hi, good morning. This is Yen-Der Li on for Jonathan Chang. So I have two questions. The first one, can you provide some color on how recent change in the FDA and also maybe tariff might impact Zai Lab going forward? And how do you estimate these risks in the current financial guidance?

嗨，早安。我是 Yen-Der Li，取代 Jonathan Chang 發言。我有兩個問題。第一個問題，您能否介紹一下 FDA 最近的變化以及關稅可能對 Zai Lab 的未來產生什麼影響？您如何在目前的財務指導中評估這些風險？

Thank you.

謝謝。

I'll start with the tariff piece and then ask Rafael to make some comments on FDA. And then, Samantha, if you have anything at the end you want to add, please do. But I think first on tariffs, we don't see any impact to our business today or anticipated in the future.

我將從關稅問題開始，然後請拉斐爾對 FDA 發表一些評論。然後，薩曼莎，如果你最後還有什麼想補充的，請補充。但我認為首先就關稅而言，我們認為它不會對我們目前的業務產生任何影響，也不會對未來產生任何影響。

Obviously, tariffs are sort of a fluid situation. But if you look at where we sell product today in China, we have local rights to manufacture product. Any of our regional deals we can manufacture in China. We do that, for example, with ZEJULA and are in the process for our big new launches like bema and KarXT to bring that manufacturing locally.

顯然，關稅是一種不穩定的情況。但如果你看看我們今天在中國的產品銷售地點，我們擁有在當地生產產品的權利。我們的任何區域交易都可以在中國進行。例如，我們透過 ZEJULA 實現了這一目標，並且正在為 bema 和 KarXT 等大型新產品的推出實施本地製造。

Other products today that we don't make locally like VYVGART are sourced out of Europe and Asia, not out of the US So we really anticipate no impact on tariffs today for our revenue base as we think about going forward and products like DLL3, which we anticipate launching in the US in 2027, we'll manufacture that locally from a commercial perspective. So we won't be exposed to tariffs coming into the US there either.

目前，其他我們不在當地生產的產品（如 VYVGART）來自歐洲和亞洲，而不是美國。因此，我們確實預計今天的關稅不會對我們的收入基礎產生影響，因為我們考慮未來發展，而像 DLL3 這樣的產品（我們預計將於 2027 年在美國推出）將從商業角度在當地生產。因此我們也不會受到進入美國的關稅影響。

Rafael, if you want to make some comments about recent FDA interactions?

拉斐爾，您想對最近與 FDA 的互動發表一些評論嗎？

Yes. Very briefly, I would say that most of our products are -- we interact with CEDAR at FDA. We recently had interactions with FDA on 1310. We really saw no difference based on my experience of developing drugs with regards to the nature of those interactions. Of course, this is a macro question of how FDA will evolve in the future with the new commissioner and as they appoint heads of both CEDAR and CEDAR, but we will have to see how that shapes up. But so far, we -- in our products, have seen really no impact with regards to their advice and the way that we've been able to interact with them and including time lines.

是的。簡而言之，我想說我們的大多數產品都是——我們與 FDA 的 CEDAR 互動。我們最近就 1310 與 FDA 進行了互動。根據我開發藥物的經驗，我們確實沒有發現這些交互作用的性質有任何區別。當然，這是一個宏觀問題，即隨著新局長上任以及他們任命 CEDAR 和 CEDAR 負責人，FDA 未來將如何發展，但我們必須觀察其發展。但到目前為止，我們在我們的產品中，並沒有看到他們的建議以及我們與他們互動的方式（包括時間表）產生任何影響。

Understood. Very helpful. And my second question is about on the study design.

明白了。非常有幫助。我的第二個問題是關於研究設計。

There was a silence at least for me. Can you please repeat the question?

至少對我來說，一片寂靜。您能重複一下這個問題嗎？

Yes, sorry, I'm asking like could you share your thoughts on the pivotal trial design for ZL-1310 in small cell lung cancer? And also, can you share how far you are in reaching the agreement with the FDA for the study design?

是的，抱歉，我想問的是，您能否分享一下您對 ZL-1310 在小細胞肺癌中的關鍵試驗設計的看法？另外，您能否分享一下您與 FDA 就研究設計達成協議的進展？

Thank you.

謝謝。

Thank you for the question. Yes. So our interactions with FDA have been very productive. We obviously have generated a lot of monotherapy data. The current plan is to launch a randomized pivotal trial for registration. We think and have reasons to believe that the accelerated approval pathway remains open, and that can be achieved in a randomized trial by comparing response rates -- and then the final post-approval commitment will be within the same study, looking at overall survival. So the study will be powered for overall survival and response rate will be an interim analysis for accelerated approval. So that's our current plan, and we plan to start that study this year as soon as we have the dose.

謝謝你的提問。是的。因此我們與 FDA 的互動非常有成效。我們顯然已經產生了大量單一療法數據。目前的計劃是啟動一項隨機關鍵試驗以供註冊。我們認為並且有理由相信加速審批途徑仍然開放，並且可以通過比較響應率在隨機試驗中實現 - 然後最終的批准後承諾將在同一研究中進行，以觀察總體生存率。因此，該研究將以總體存活率和反應率為重點，作為加速核准的中期分析。這就是我們目前的計劃，我們計劃今年一有劑量就開始研究。

And that's it. Thank you so much.

就是這樣。太感謝了。

Li Watsek from Cantor.

來自 Cantor 的 Li Watsek。

Maybe a couple here. Just wondering on VYVGART, can you talk a little bit about the competitive landscape of gMG in China, given there are some other therapies that might get approval in the near term, how do you see the sort of competitive dynamics playing out in the near and longer term?

也許這裡有一對夫婦。我只是在 VYVGART 上想知道，您能否談談中國 gMG 的競爭格局，考慮到其他一些療法可能會在短期內獲得批准，您如何看待短期和長期的競爭動態？

And the second question is on the BD efforts. Just given the uncertainty of tariffs and geopolitical tensions, what are you seeing in terms of big pharma's appetite to out-licensing the commercial rights in China? And just in general, anything from the macro side have shifted your thinking around in-licensing?

第二個問題是關於 BD 工作。鑑於關稅和地緣政治緊張局勢的不確定性，您認為大型製藥公司對在中國授權商業權利的興趣如何？總的來說，宏觀方面的任何因素是否改變了您對許可的看法？

Thanks, Lee. It's Josh. I'll do VYVGART and ask Jonathan to make some comments on business development. I think on VYVGART, first, I'd just remind everybody, there's -- it's a very big opportunity in China for gMG, about 170,000 patients. And while we're really happy with where we are today, we still have less than 10% of patients who are getting a newer biologic therapy. So in one sense, I think having more newer agents approved and in the market is going to be good for everyone, and it will be good for VYVGART as we continue to educate physicians and get them to adopt the new and best therapies.

謝謝，李。我是喬希。我會做 VYVGART 並請喬納森對業務發展發表一些評論。我認為在 VYVGART 上，首先我想提醒大家，中國對 gMG 來說是一個巨大的機會，大約有 17 萬名患者。儘管我們對目前的狀況非常滿意，但仍然只有不到 10% 的患者接受了較新的生物療法。因此從某種意義上說，我認為有更多新藥物獲得批准並進入市場對每個人都有好處，而且對 VYVGART 也有好處，因為我們會繼續教育醫生並讓他們採用新的最佳療法。

I think then as we compare where we are with VYVGART to other recent approvals or anticipated approvals, we love the position we're in. We've got a comprehensive data set. I think if you look at the results around activities of daily living or getting back to sort of as much normalcy as possible. Our data is strong, compelling and I think stacks up well against any of the FcRns or other newer agents that are either approved or headed towards approval. We obviously have this year as the only newer agent on NRDL, and we'll continue to build our experience and expertise there.

我認為，當我們將 VYVGART 的現狀與其他近期批准或預期批准進行比較時，我們會喜歡我們所處的位置。我們有一套全面的數據集。我認為，如果你觀察日常生活活動的結果或盡可能恢復正常狀態。我們的數據強大、令人信服，我認為與任何已批准或即將批准的 FcRns 或其他較新的藥物相比，我們的數據具有良好的競爭力。顯然，我們是今年國家醫保目錄上唯一一家新加入的代理商，我們將繼續在那裡累積經驗和專業知識。

But I think longer term, between efficacy, and I think if you look at safety across the FcRns and other agents, again, we feel very good about where we are from that perspective. So we welcome new approvals. And again, I think it's going to be good for patients and good for treating physicians to have options and to have more education in the market. And it doesn't change our view in terms of how we see progress this year. As I've said, we're quite excited about what we're seeing today in the market with VYVGART.

但我認為從長期來看，在療效方面，如果你看一下 FcRn 和其他藥物的安全性，那麼從這個角度來看，我們對目前的狀況感到非常滿意。因此我們歡迎新的批准。而且，我認為這對患者和治療醫生都有好處，讓他們有更多選擇，並在市場上接受更多教育。這並沒有改變我們對今年進展的看法。正如我所說，我們對 VYVGART 目前在市場上的表現感到非常興奮。

Of course, we have a series of new indications coming as well that will help, I think, bolster our competitiveness versus anticipated new approvals. We'll -- of course, we have CIDP. We've got new formulations coming that we'll be pursuing for NRDL. And over the course of the next few years, we'll have more supplemental indications for MG. We also anticipate other indications, including things like thyroid eye disease, where we're running trials in conjunction with argenx today. So I think the future is very bright for VYVGART and for patients in China with gMG.

當然，我們也即將迎來一系列新跡象，我認為這將有助於增強我們相對於預期新批准的競爭力。我們——當然，我們有 CIDP。我們即將推出新配方，並將其納入國家健保目錄。在接下來的幾年裡，我們將對 MG 有更多的補充適應症。我們也預期其他適應症，包括甲狀腺眼疾等，我們今天正在與 argenx 聯合進行試驗。所以我認為VYVGART和中國gMG患者的前景都非常光明。

Jonathan, if you want to address the business development question?

喬納森，您想討論業務發展議題嗎？

Sure. Thanks, Josh, and thanks for the question. On the BD sort of impact from the geopolitical situation, I think the first is that so far, there has been no suggestions, no sort of regulatory prohibition from the administration with regards to any licensing transactions between life sciences companies. So, so far, I think it's business as usual. We have been doing deals earlier this year as well. So we continue to evaluate deals. In fact, sometimes I think volatility creates opportunities.

當然。謝謝，喬希，謝謝你的提問。關於地緣政治局勢對 BD 的影響，我認為首先是到目前為止，政府尚未針對生命科學公司之間的任何許可交易提出任何建議，也沒有任何監管禁令。所以，到目前為止，我認為一切都正常。我們今年早些時候也一直在做交易。因此我們繼續評估交易。事實上，有時我認為波動會創造機會。

Multinational companies are increasingly looking to China for innovation and looking to China also for commercial opportunities. There has been a lot of visits, increasing number of visits by multinational business development heads as well as CEOs. Just today, actually, Samantha and myself met several multinational CEOs here. So we expect to continue to do deals in this environment. And obviously, as Samantha earlier said, I think the bar is always very high for us. Quality is the most important. But I don't think the current situation will prohibit us certainly not from doing any deals.

跨國公司越來越多地向中國尋求創新，也向中國尋求商業機會。來訪次數很多，跨國公司業務發展主管和執行長的來訪次數不斷增加。事實上，就在今天，薩曼莎和我在這裡會見了幾位跨國公司的執行長。因此，我們希望在這種環境下繼續開展交易。顯然，正如薩曼莎之前所說，我認為我們的標準一直很高。品質最重要。但我不認為目前的情況會阻止我們進行任何交易。

Thank you.

謝謝。

Great, thanks guys.

太好了，謝謝大家。

Yigal Nochomovitz from Citi.

花旗銀行的 Yigal Nochomovitz。

I have one for Josh and two for Rafael. Josh, just could you outline the scenarios with regard to how the ERL will help with negotiation of the price for VYVGART. I'm just curious, is there some sort of a cap in terms of how much you can get negotiated down? Or is there a floor? And is this going to apply to both IV and subcu pricing terms?

我為喬希準備了一個，為拉斐爾準備了兩個。喬希，你能否概述一下 ERL 將如何幫助談判 VYVGART 價格的情況。我只是好奇，對於你能協商的降價幅度，是否有某種上限？或者說有底線嗎？這是否適用於 IV 和 subcu 定價條款？

And then for Rafael, with the FORTITUDE-101 and FORTITUDE-102, I'm just curious how you're thinking about the competitive dynamics and whether the Jazz trial with zanidatamab chemo and the BeiGene PD-1 impacts your thinking about the competitive landscape or maybe not so much considering you're focused on FGFR2b patients?

然後對於 Rafael，對於 FORTITUDE-101 和 FORTITUDE-102，我只是好奇您如何看待競爭動態，以及 Jazz 對 zanidatamab 化療和 BeiGene PD-1 的試驗是否影響了您對競爭格局的看法，或者可能不會有太大影響，因為您專注於 FGFR2b 患者？

And then last question, with regard to the ADCs, the DLL3 and the LLRC15, just curious about the antibody engineering there and whether you've tuned these antibodies to cleave mainly intracellularly or if there's also extracellular cleavage.

最後一個問題，關於 ADC、DLL3 和 LLRC15，我只是好奇那裡的抗體工程，以及您是否調整了這些抗體以主要在細胞內切割，或者是否也有細胞外切割。

Thank you.

謝謝。

We've got Jonathan on the phone. Jonathan leads our pricing work in China. So I'll ask him to comment on the NRDL process for VYVGART for 2026, and then we can pass it on to Rafael.

我們和喬納森通了電話。喬納森負責我們在中國的定價工作。因此，我會請他對 2026 年 VYVGART 的 NRDL 流程發表評論，然後我們可以將其轉交給拉斐爾。

Sure. Yigal, I think for VYVGART, we have two formulations, first of all. Each of these formulations, the subcu and IV will be treated as different products. So we have a lot of flexibility when it comes to pricing. Of course, the NRDL negotiation will happen potentially earlier this year as well. So as they do this, sort of the time line brought forward. So they also look at the sales from last year in quarter 1 this year. But we expect potential modest discounts to the price, obviously, subject to negotiations. Too early to comment on the precise pricing, but we would expect probably some discount there.

當然。Yigal，我認為對於 VYVGART，首先我們有兩種表述。每種配方、皮下注射和靜脈注射都將被視為不同的產品。因此，我們在定價方面具有很大的彈性。當然，國家健保目錄談判也有可能在今年稍早進行。因此，當他們這樣做時，時間線就提前了。因此，他們也會查看今年第一季的去年銷售額。但我們預期價格可能會有適度的折扣，顯然，這取決於談判結果。現在評論確切的價格還為時過早，但我們預計可能會有一些折扣。

Yes, I'll take the R&D question. So yes, there is some competition in gastric cancer. It is generally for HER2-negative disease. We still have yet to see what effect these new products will have. Clearly, they've been promising in other settings. Because this is specific for an alteration that is present in about one-third of patients, and we're looking at least 10% expression. So these are patients where their tumors is driven by this oncogene and we are silencing this oncogene. We feel pretty positive about it.

是的，我將回答研發問題。所以是的，胃癌治療確實存在一些競爭。它通常用於治療 HER2 陰性疾病。我們還沒有看到這些新產品會產生什麼效果。顯然，它們在其他環境中也表現出色。因為這是針對大約三分之一的患者中存在的變化而言的，並且我們正在觀察至少 10% 的表達。所以這些患者的腫瘤是由這種致癌基因所驅動的，而我們正在抑制這種致癌基因。我們對此感到十分樂觀。

And our second study also includes a PD-1 inhibitor, as you know, nivolumab. So we will have to see what happens with the competition, but we think these studies are pretty well designed and they're targeted to the alteration that the disease manifests.

我們的第二項研究還包括一種 PD-1 抑制劑，即您所知的 nivolumab。因此，我們必須觀察競爭對手的表現，但我們認為這些研究設計得非常好，並且針對的是疾病所表現出的改變。

With regards to the antibodies, DLL3 was engineered to have picomolar activity, and I think that's bearing out in some of the -- what we're seeing in the clinic. And LRRC15 is internally developed, and they both are conjugated with a system whereby there's a release of the payload after internalization of the intact molecule as well as cleavage in the extracellular matrix.

關於抗體，DLL3 被設計為具有皮摩爾活性，我認為這在我們在臨床上看到的一些情況中得到了證實。LRRC15 是在內部開發的，它們都與一個系統結合，透過該系統，在完整分子內化以及在細胞外基質中裂解後釋放有效載荷。

So that's why with LRRC15, we're excited about the fact that the target may just be a flag and whether it's in the tumor or it's in the malignant fibroblast, there will still be a strong bystander effect. So we don't see a really high levels at all of the payload in circulation, but it is in the tumor microenvironment, and I think it's due to the second-generation payload linker system.

所以這就是為什麼對於 LRRC15，我們感到興奮，因為目標可能只是一個標誌，無論它是在腫瘤中還是在惡性成纖維細胞中，仍然會有強烈的旁觀者效應。因此，我們根本沒有看到循環中有效載荷的真正高水平，但它存在於腫瘤微環境中，我認為這是由於第二代有效載荷連接系統造成的。

Thank you.

謝謝。

Anupam Ram from JPMorgan.

摩根大通的 Anupam Ram。

Quick one for me. Just what's going to be the size and scope of the 1310 ASCO update? And what would you have us focus in on the data at ASCO?

對我來說很快。1310 ASCO 更新的規模和範圍到底是多少？您希望我們關注 ASCO 的哪些資料？

So the 1310 data that we presented was with 25 patients. There were 19 patients eligible for efficacy. So that was dose escalation. Since that presentation, we've completed the dose escalation with a few more patients. And every patient has had an opportunity to have a confirmatory scan. So we will have the complete data set for dose escalation.

因此，我們呈現的 1310 則數據來自 25 名患者。有 19 名患者符合療效標準。這就是劑量增加。自那次演示以來，我們已對更多患者完成了劑量遞增。每位患者都有機會接受確認掃描。因此我們將擁有劑量遞增的完整資料集。

And then the other data set that will be new will be the dose optimization. And I think there, it will be really a focus on which dose or doses are looking most promising to be included as the dose in the pivotal trial in the Phase III study. In terms of numbers, we will -- as I said, we had a few more patients than at ENA in the dose escalation and we should have another 50 patients or so in the dose optimization.

然後，另一個新的數據集將是劑量優化。我認為，真正關注的重點將是哪種劑量或哪種劑量最有希望被納入第三階段研究的關鍵試驗劑量。就數量而言，正如我所說，我們在劑量遞增方面比 ENA 多了一些患者，在劑量優化方面我們應該還會有另外 50 名左右的患者。

So I think the focus for me would be what is the dose that has the broader therapeutic benefit as we have been marching on the dose optimization with the knowledge that we've accrued rapidly and that the follow-up is not going to be very long, but at least we'll have responses and we will have durability of response in the earlier patients that we enroll.

因此，我認為我關注的重點是具有更廣泛治療益處的劑量，因為我們一直在進行劑量優化，我們已經快速積累了知識，並且後續過程不會很長，但至少我們會有反應，並且我們將在我們招募的早期患者中具有持久的反應。

Thanks so much for taking.

非常感謝您接受。

Jack Lin from Morgan Stanley

摩根士丹利的 Jack Lin

I just have two quick ones. First, I was wondering, this is a very big SG&A improvement. I was wondering if you guys will be able to kind of share more in terms of what kind of initiatives were taken this quarter specifically to help reduce the SG&A to this degree? And how much we'll be able to continue leveraging on for the following quarters? How many of these are actually, I guess, onetime thing? Yes, that if you help us kind of break down how this was achieved?

我只有兩個簡短的問題。首先，我想知道，這是一個非常大的銷售、一般和行政費用改進。我想知道你們是否能夠分享更多關於本季採取了哪些具體舉措來幫助將銷售、一般和行政費用降低到這種程度的信息？在接下來的幾個季度中，我們還能夠繼續利用多少槓桿？我猜其中有多少實際上是一次性的事情？是的，您能幫我們分析一下這是如何實現的嗎？

And the second one is just kind of on where we stand as far as CTF. I see that the pancreatic cancer data is going to present at the ASCO as well. And just kind of wondering what -- where our focus is that right now, kind of how our strategy is going moving forward?

第二個問題是關於我們在 CTF 的立場。我看到胰腺癌數據也將在 ASCO 上展示。我只是有點想知道──我們現在的重點是什麼，我們的策略又將如何向前發展？

Thank you.

謝謝。

Thanks for the question. On the financial results and SG&A specifically, I think if you look at our Q1, I think it's representative of what you should expect through the year. Obviously, we have ups and downs as it relates to marketing programs. But our fixed resource base to support the products that we have today and to prepare for launches for the big things coming like COVEMTI and Bemarituzumab are pretty stable.

謝謝你的提問。具體來說，就財務業績和銷售、一般及行政費用而言，我認為如果你看一下我們的第一季業績，它代表了你對全年業績的預期。顯然，我們在行銷計劃方面有起有落。但是，我們用於支援現有產品和為即將推出的 COVEMTI 和 Bemarituzumab 等重大產品做準備的固定資源基礎相當穩定。

So I think this year, SG&A should be modest, very modest growth versus last year. And I think we're happy with where we've started the year from a cost base and from a profitability perspective. As Yajing mentioned, if you look at our adjusted net loss, basically taking out noncash charges. We were at a $37 million loss. That includes though $20 million of R&D -- I mean, upfront payments for the two new assets we brought in, in Q1. So if you take that out, we're at about a $17 million loss.

因此我認為今年銷售、一般及行政開支與去年相比應該會溫和成長，成長幅度非常小。我認為，從成本基礎和獲利能力的角度來看，我們對今年的開局感到滿意。正如雅靜所提到的，如果你看一下我們的調整後淨虧損，基本上就扣除了非現金費用。我們損失了 3700 萬美元。其中包括 2000 萬美元的研發費用——我的意思是，我們在第一季引進的兩項新資產的預付款。所以如果去掉這個數字，我們的損失大約是 1700 萬美元。

And as we've mentioned, we see sales accelerating through the year. And I think as they do on a relatively fixed SG&A base and R&D, which should be pretty stable as well. We feel quite confident about our ability to achieve profitability this year. So SG&A is rightsizing the organization for optimizing the launches and products that we have today. And we've taken a lot of actions in the last few years to try to get to that point. So that's why we have a lot of confidence in profitability later this year and expanding operating margins as we get into the 2026 to 2028 time frame.

正如我們所提到的，我們看到今年的銷售額正在加速成長。我認為，由於他們的銷售、一般及行政費用基礎和研發費用相對固定，因此也應該相當穩定。我們對今年實現獲利的能力充滿信心。因此，銷售、一般和行政管理部門正在調整組織規模，以優化我們目前的產品發布和產品。過去幾年我們採取了許多行動來努力實現這一目標。因此，我們對今年稍後的獲利能力以及 2026 年至 2028 年期間營業利潤率的提高充滿信心。

Rafael, you can address the second part of the question.

拉斐爾，你可以回答問題的第二部分。

Yes. So with regards to the TTF, as you correctly said, there will be an oral presentation on the PANOVA -3 study, which is in locally advanced pancreatic cancer. So these are inoperable patients that don't have metastatic disease, and it was announced that it was positive for overall survival, which is a really important outcome given that this is a very difficult and unmet need in that there hasn't been any intervention that have improved survival in this setting.

是的。因此，關於 TTF，正如您正確指出的那樣，將會有一個關於 PANOVA -3 研究的口頭報告，該研究針對局部晚期胰腺癌。因此，這些都是沒有轉移性疾病的無法手術的患者，並且宣布總體生存率呈陽性，這是一個非常重要的結果，因為這是一個非常困難且未滿足的需求，因為還沒有任何干預措施可以改善這種情況下生存率。

So we plan to file this year with our partner, Novocure. We've started the regulatory discussions in China, and we think that we are well on our way to do this. With regards to LUNAR, we've deprioritized this given the fact that PANOVA three is really an important indication for us. And I think together with gastric cancer as well as GIST, it really positions us well in the GI setting in China with really transformational products. So I think this is really our plan this year, and we're working very well with Novocure to ensure that this submission can go into this year.

因此，我們計劃今年與我們的合作夥伴 Novocure 一起提交申請。我們已經開始在中國進行監管討論，我們認為我們正在順利地進行這項工作。至於 LUNAR，我們已經降低了它的優先級，因為 PANOVA 3 對我們來說確實是一個重要的指標。我認為，結合胃癌和胃腸道間質瘤，我們能夠憑藉真正具有變革性的產品，在中國的胃腸道領域中佔據有利地位。所以我認為這確實是我們今年的計劃，我們正在與 Novocure 進行良好的合作，以確保這份提交能夠在今年完成。

Thank you

謝謝

Rebecca Liang from Bernstein

伯恩斯坦的 Rebecca Liang

My first question is on R&D. So it seems that you've highlighted quite a few in-house developed assets. Are you shifting the strategy from more in-licensing to more in-house focus? And if so, are we expecting to see more in-house develop assets to enter into the clinical phase in the coming years? And if so, could you provide some guidance as to the pace of such assets?

我的第一個問題是關於研發的。因此看起來您已經強調了相當多的內部開發資產。您是否正在將策略從更多的內部授權轉向更多的內部關注？如果是這樣，我們是否預計未來幾年將有更多內部開發資產進入臨床階段？如果是的話，您能否就此類資產的步伐提供一些指導？

And my second question is on the topic of the FDA changes recently. There's been a new appointment of CER Head as well as the job cuts from FDA. So how do you expect these to impact on the approval process, for example, the upcoming talks regarding DL3 and the whole accelerated track that you mentioned?

我的第二個問題是關於 FDA 最近的變化。CER 負責人有新任命，同時 FDA 也進行了裁員。那麼您預計這些會對審批過程產生什麼影響，例如即將舉行的有關 DL3 和您提到的整個加速軌道的談判？

Thank you.

謝謝。

Thanks for the question. It's Josh. First, I think we're really excited about the progress of the internal pipeline. So we'll give Rafael a chance to talk about that. I think you should expect us to continue to be balanced as we move forward, looking at both really good internal assets as well as opportunities to bring in best-in-class products for both the globe and for China over the coming years.

謝謝你的提問。我是喬希。首先，我認為我們對內部管道的進展感到非常興奮。因此我們會給拉斐爾一個機會來談論這個問題。我認為，我們應該繼續保持平衡，既要專注於真正優質的內部資產，也要關注未來幾年為全球和中國帶來一流產品的機會。

But I think with that introduction, Rafael, why don't you talk a little bit about the internal pipeline and then the FDA question.

但是我認為，拉斐爾，在介紹完之後，為什麼不先談內部管道，然後再談一談 FDA 的問題呢？

Yes. So with regards to the new agents that we will bring forward in development, I think it will be a blend of internally discovered products as well as BD products, and it will match our strategy. So for instance, in oncology, we will focus on ADCs and in immuno-oncology with improved checkpoint inhibitors as well as in the future T-cell engagers. So relatively sort of confined area where we have these agents already made or in development, we will utilize them and where we find high-quality products, then we will utilize our BD capabilities to do this.

是的。因此，關於我們將在開發中提出的新藥物，我認為它將是內部發現的產品和 BD 產品的混合，並且它將符合我們的策略。例如，在腫瘤學中，我們將專注於 ADC，在免疫腫瘤學中，我們將重點放在改進的檢查點抑制劑以及未來的 T 細胞接合劑上。因此，在相對有限的領域中，我們已經製造或正在開發這些藥劑，我們將利用它們，並在找到高品質產品的地方，利用我們的 BD 能力來做到這一點。

So as I said, our goal is to have one IND, whether it's internally sourced or externally sourced every year. This year, we plan to have two LRRC15 or 6201 and 1503, which is IL13-31 for atopic dermatitis. And so it just so happened that these two are internally discovered, but that doesn't necessarily mean that, that will be the exclusive pattern going forward.

正如我所說，我們的目標是每年有一個 IND，無論是內部來源還是外部來源。今年我們計畫有兩個LRRC15，分別是6201和1503，也就是針對異位性皮膚炎的IL13-31。碰巧的是，這兩個都是內部發現的，但這並不一定意味著，這將是未來的唯一模式。

So with regards to FDA, I made some comments before about the experience that we've had so far. And of course, it's early as FDA begins to reshape itself with new leaders coming in. Again, we deal with Cedar, where we yet had to see the appointment there. We see, yes, there's been some comments about accelerated approval. But I think the comments were made more in the context of accelerated approvals based on single arms. So there's not that I've heard of any -- there's not been any comments about accelerated approval in the context of randomized trials.

關於 FDA，我之前對我們迄今為止的經驗發表了一些評論。當然，隨著新領導人的加入，FDA 開始重塑自我，現在還為時過早。再次，我們與 Cedar 打交道，我們還必須在那裡看到任命。我們看到，是的，有一些關於加速審批的評論。但我認為這些評論更多的是在基於單一武器的加速審批的背景下發表的。所以我沒有聽說過——沒有任何關於在隨機試驗背景下加速批准的評論。

And I think in our case with 1310, that shouldn't be the case since our pathway forward for accelerated approval will be an interim analysis on a randomized study against standard of care. So that's all I have to say for now because it's still early in the reshaping of the agency, and we will have to see, how, if it does evolve, how it evolves. But as I said, so far, we have seen no changes with regards to our history of developing drugs in the past.

我認為，就 1310 而言，情況不應該如此，因為我們獲得加速批准的途徑將是對針對護理標準的隨機研究進行中期分析。我現在要說的就這些，因為該機構的重塑還處於早期階段，如果它確實發展的話，我們將拭目以待，看看它將如何發展。但正如我所說，到目前為止，我們還沒有看到過去開發藥物的歷史有任何變化。

from Linhai Zhao from Goldman Sachs.

來自高盛的趙林海。

This is Ling Hai from Goldman. My question is on KarXT, particularly regarding the recent top line is on the Phase III ARISE trial. What would be the read across the China market? I know that Zai Lab is not participating.

我是高盛的凌海。我的問題是關於 KarXT 的，特別是關於第三階段 ARISE 試驗的最新進展。整個中國市場將會如何解讀？我知道 Zai Lab 沒有參加。

Rafael, why don't you go ahead on that?

拉斐爾，你為什麼不繼續做下去？

Yes. So ARISE was a study where KarXT was used as an adjunctive therapy to standard therapy in schizophrenia. It didn't meet the primary endpoint. But with regards to the indication of schizophrenia in China, it really has no impact. Our regulatory submission was based on a study that mimic the EMERGENT studies, and it was positive in all endpoints. More than 80% of patients with schizophrenia in China are treated with single agent. And clearly, there was -- there are some clear advantages of this product with regards to toxicity over the classical antipsychotics.

是的。因此，ARISE 是一項研究，其中 KarXT 被用作精神分裂症標準療法的輔助療法。它沒有達到主要終點。但對於中國的精神分裂症的指徵來說，這確實沒有什麼影響。我們的監管提交是基於一項模仿 EMERGENT 研究的研究，並且在所有終點都取得了積極成果。國人80%以上的精神分裂症患者採用單一藥物治療。顯然，該產品在毒性方面比傳統抗精神病藥物具有一些明顯的優勢。

So the patients that require adjuvant therapy are difficult-to-treat patients, and this is not a practice that occurs in China. So no impact with regards to that. And likewise, we see no impact with regards to ADP, where obviously, those patients were not included in the ARISE study, and we're just awaiting the results of ADEPT-2 in the second half of this year where we participated together with Karuna BMS.

所以需要輔助治療的病人都是難治性病人，而在中國，這種情況是不存在的。因此這不會造成影響。同樣，我們沒有看到對 ADP 有任何影響，顯然，這些患者沒有被納入 ARISE 研究，我們只是在等待今年下半年與 Karuna BMS 共同參與的 ADEPT-2 的結果。

Great. A quick follow-up on that would be, since you mentioned that majority of schizophrenia patients in China are primarily treated with a single agent. So if that's the case, what's your perspective based on the communications with the KOLs in China? What would be the potential treatment position for KarXT? Do you see it be used as an initial usage for patients when they were at the initial acute stage or more possibly used as a longer-term maintenance stage while the patients are having better control on the positive symptoms while they are trying to get more prepared when getting back to their normal life?

偉大的。既然您提到中國大多數精神分裂症患者主要採用單一藥物治療，那麼我們可以快速跟進。那麼如果是這樣的話，根據與中國 KOL 的溝通，您有何看法？KarXT 的潛在治療地位是什麼？您是否認為它可以作為患者在初期急性期的初始用途，或者更可能用作長期維持階段，當患者對陽性症狀有更好的控制時，他們試圖在恢復正常生活時做好更多的準備？

Yes. I mean my impression is that this is an agent that will be used in novel in patients with schizophrenia. I think the differences with regards to toxicity are really stark in favor of this drug. It's also a drug that has the potential to be effective in multiple other indications. And so we will see other indications coming through as PMS develops this drug, and we will partner with them on other indications. But with regards to schizophrenia, we think that this is kind of a sort of a quantum leap with regards to the side effects, including tardive dyskinesia and all the metabolic side effects that we're seeing with the classical antipsychotics.

是的。我的意思是，我的印像是，這是一種將在小說中用於治療精神分裂症患者的藥物。我認為這種藥物在毒性方面的差異確實非常明顯。它也是一種有可能在多種其他適應症上有效的藥物。因此，隨著 PMS 開發這種藥物，我們將看到其他適應症的出現，我們將與他們合作研究其他適應症。但就精神分裂症而言，我們認為這在副作用方面是一種量子飛躍，包括遲發性運動障礙和我們在傳統抗精神病藥物中看到的所有代謝副作用。

So -- our impression is that this will be used de novo. And there's really data that goes now beyond 52 weeks showing that this safety profile really is maintained over the long term. So therefore, the logical conclusion is that it should become the treatment of choice.

所以——我們的印像是，這將被重新使用。現在確實有超過 52 週的數據顯示這種安全性確實可以長期維持。因此，合理的結論是它應該成為首選治療方法。

Got it, thanks for the very comprehensive answers. That concludes my question.

明白了，感謝您非常全面的回答。我的問題到此結束。

Thank you for the question. There are no more questions on the line. I'd like to hand the call back to management for closing.

謝謝你的提問。線路上沒有其他問題。我想將電話交還給管理層以結束通話。

Thank you, operator. I want to thank everyone for taking the time to join us on the call today. We appreciate your support. We look forward to updating you again after the second quarter of 2025. Operator, you may now disconnect this call.

謝謝您，接線生。我要感謝大家今天抽出時間來參加我們的電話會議。感謝您的支持。我們期待在 2025 年第二季之後再次向您更新資訊。接線員，您現在可以掛斷此通話了。

That concludes today's conference call. Thank you all for participating. You may now disconnect the lines.

今天的電話會議到此結束。感謝大家的參與。現在您可以斷開線路。