Legend Biotech Corporation (LEGN) 2026 Q2 法說會逐字稿

Good day, everyone, and thank you for standing by. Welcome to Legend Biotech second-quarter 2026 earnings call. (Operator Instructions) Please be advised that today's conference is being recorded.

各位好，感謝各位稍候。歡迎參加傳奇生物科技 2026 年第二季財報電話會議。(接線員指示) 請注意，今天的會議將被錄音。

Now it's my pleasure to hand the conference to Caroline Paul, Director of Investor Relations. Please go ahead.

現在我很榮幸將會議交給投資人關係總監 Caroline Paul。請開始。

Good morning. This is Caroline Paul, Director of Investor Relations at Legend Biotech. Thank you for joining our conference call today to review our second-quarter 2026 performance. Prior to this call, we issued a press release announcing our financial results for the quarter, which can be found on the Legend Biotech Investor Relations website.

各位早安。我是傳奇生物科技投資人關係總監 Caroline Paul。感謝各位參加今天的電話會議，一同回顧我們 2026 年第二季的表現。在本次電話會議之前，我們已發布新聞稿公布本季財務結果，可於傳奇生物科技投資人關係網站查閱。

Joining me on today's call are Alan Bash, the company's Interim Chief Executive Officer, and Carlos Santos, the company's Chief Financial Officer. Following the prepared remarks, we will open up the call for Q&A. We also have our Interim Head of R&D, Yuhong Qiu, joining the Q&A session.

今天與我一同參與電話會議的有公司臨時執行長 Alan Bash，以及公司財務長 Carlos Santos。在事先準備的發言之後，我們將開放問答。我們的臨時研發主管 Yuhong Qiu 也將參與問答環節。

During today's call, we will be making forward-looking statements, which are subject to risks and uncertainties that may cause our actual results to differ materially from those expressed or implied herein. These forward-looking statements are discussed in greater detail in our SEC filings, which we encourage you to read and can be found under the Investors section of our company website.

在今天的電話會議中，我們將作出前瞻性陳述；此類陳述受風險與不確定性影響，可能導致實際結果與本文明示或暗示者有重大差異。這些前瞻性陳述在我們向美國證券交易委員會（SEC）提交的文件中有更詳細的討論；我們鼓勵各位閱讀，並可於公司網站的投資人專區查閱。

In addition, adjusted net income or loss is a non-IFRS metric. This non-IFRS financial measure is in addition to and not a substitute for or superior to measures of financial performance prepared in accordance with IFRS. There are a number of limitations related to the use of these non-IFRS financial measures versus their closest IFRS equivalents.

此外，調整後淨利或淨損為非 IFRS 指標。此非 IFRS 財務衡量指標是對依 IFRS 編製之財務績效衡量的補充，並非替代，也不優於 IFRS 衡量。相較於最接近的 IFRS 對應指標，使用這些非 IFRS 財務衡量指標存在若干限制。

However, we believe that providing information concerning adjusted net income or loss and adjusted net income or loss per share enhances an investor's understanding of our financial performance. Our press release includes IFRS to non-IFRS reconciliations for these measures.

然而，我們相信提供有關調整後淨利或淨損，以及調整後每股淨利或淨損的資訊，有助於投資人更了解我們的財務表現。我們的新聞稿包含這些指標由 IFRS 轉換至非 IFRS 的調節表。

With that, I will now turn the call over to Alan.

接下來，我將把電話會議交給 Alan。

Thank you, Caroline, and good morning, everyone. I want to start by briefly addressing the leadership transition announced last month. As you all know, Dr. Ying Huang stepped down as Chief Executive Officer and Member of the Board, and the Board appointed me to serve as Interim Chief Executive Officer. On behalf of the Board and all our employees, I want to thank Ying for his leadership over many years and his many contributions to Legend Biotech.

謝謝你，Caroline，各位早安。我想先簡要談談上個月宣布的領導階層交接。如各位所知，黃穎博士已卸任執行長及董事會成員，董事會並任命我擔任臨時執行長。我謹代表董事會與全體員工，感謝穎多年來的領導，以及他對傳奇生物科技的諸多貢獻。

We want to be very clear, this is a leadership transition, not a strategy transition. Our priorities remain unchanged. We remain focused on three main objectives: maximizing CARVYKTI, advancing our next-generation pipeline and strengthening our execution on all fronts. My commitment is to provide continuity, transparency and disciplined execution, working closely with Carlos, our senior R&D team, the Board and the broader leadership team to maintain momentum across the business.

我們希望非常清楚地說明：這是領導階層的交接，而非策略的轉變。我們的優先事項維持不變。我們仍聚焦三大目標：最大化 CARVYKTI、推進我們的下一代產品線，並在各方面強化執行力。我的承諾是提供延續性、透明度與紀律性的執行；我將與 Carlos、我們的資深研發團隊、董事會以及更廣泛的領導團隊緊密合作，維持公司各項業務的動能。

We are operating from a strong foundation with continued CARVYKTI momentum, meaningful progress across our in vivo CAR-T platform and as you are about to see from the Q2 results, the financial flexibility to continue investing in growth, innovation and long-term value creation. Notably, during the second quarter, we generated adjusted net income of $63 million. And we believe we will maintain adjusted net income profitability for the second half of 2026.

我們立足於穩固的基礎之上：CARVYKTI 動能持續、我們的體內（in vivo）CAR-T 平台取得實質進展；而且如各位即將從第二季結果所見，我們具備財務彈性，可持續投資於成長、創新與長期價值創造。值得注意的是，第二季我們創造了 6,300 萬美元的調整後淨利。我們相信在 2026 年下半年仍將維持調整後淨利的獲利能力。

Now let's turn to our second-quarter highlights. We had a strong second quarter at Legend as CARVYKTI continues to expand globally, maintaining its market leadership in CAR-T. Additionally, we recently presented compelling early efficacy and safety data from our in vivo CAR-T platform and plan to provide meaningful updates to these programs at future medical conferences.

接下來談談第二季重點。傳奇在第二季表現強勁，CARVYKTI 持續在全球擴張，並維持其在 CAR-T 領域的市場領導地位。此外，我們近期公布了體內 CAR-T 平台令人信服的早期療效與安全性數據，並計畫在未來的醫學會議上提供這些計畫的重要更新。

During the quarter, CARVYKTI delivered worldwide net trade sales of approximately $657 million, representing 50% year-over-year growth driven by strong demand globally and increasing adoption in earlier lines of therapy. In the United States, sales increased 32% year over year, while ex US sales grew 128% year over year.

本季 CARVYKTI 全球淨貿易銷售額約為 6.57 億美元，年增 50%，主要受全球強勁需求以及在較早治療線別中採用率提升所帶動。在美國，銷售額年增 32%；美國以外市場銷售額年增 128%。

Beyond commercial execution, we continue to advance our innovative next-generation cell therapy pipeline, particularly in our in vivo CAR-T platform as highlighted by our participation at the ASCO Annual Meeting and the European Hematology Association Congress. We will turn to these updates in just a moment.

除商業執行之外，我們也持續推進創新的下一代細胞治療產品線，尤其是體內 CAR-T 平台；這可從我們參與 ASCO 年會與歐洲血液學協會（EHA）大會的成果看出。我們稍後將就這些更新進一步說明。

Finally, we strengthened our balance sheet through the successful completion of a public equity offering, resulting in approximately $212 million of net proceeds and a cash position of approximately $965 million at the end of the second quarter.

最後，我們成功完成公開增資發行，強化了資產負債表，淨募資約 2.12 億美元，並使第二季末現金部位約為 9.65 億美元。

Drilling deeper on CARVYKTI second-quarter performance, CARVYKTI global net trade sales increased 50% year over year to $657 million, delivering strong global sequential growth of 10% compared to the first quarter. In the United States, quarter-over-quarter growth of 9% was primarily driven by accelerating adoption in earlier lines of therapy.

進一步深入 CARVYKTI 第二季表現，CARVYKTI 全球淨貿易銷售額年增 50% 至 6.57 億美元，較第一季呈現 10% 的強勁全球季增。在美國，季增 9% 主要由於在較早治療線別的採用加速所帶動。

We continue to increase the usage in second and third lines, up from the 41% we discussed last quarter. We have also been expanding treatment access with more than 150 authorized treatment centers, of which approximately 40% are community hospitals.

我們持續提升在第二線與第三線治療中的使用占比，高於我們上季討論的 41%。我們也持續擴大治療可近性，已超過 150 家授權治療中心，其中約 40% 為社區醫院。

Outside the United States, quarter-over-quarter growth of 13% was primarily driven by continued launch uptake across 19 markets and expansion of the activated treatment site network. We recently launched CARVYKTI in Ireland, further expanding availability to 348 global treatment sites, reflecting continued geographic expansion with our partner J&J.

在美國以外市場，季增 13% 主要由於在 19 個市場的上市導入持續升溫，以及已啟用治療據點網絡的擴張所帶動。我們近期在愛爾蘭推出 CARVYKTI，進一步將可用性擴展至全球 348 個治療據點，反映我們與合作夥伴 J&J 持續推動的地域擴張。

Across geographies, we continue to see encouraging trends in both market penetration and earlier-line utilization. These dynamics support our belief that CARVYKTI remains a durable growth opportunity.

在各地區，我們持續看到市場滲透率與較早治療線別使用方面的正向趨勢。這些動態支持我們的看法：CARVYKTI 仍是一項具持久性的成長機會。

Turning to our recent clinical data, we shared encouraging updates across both our solid tumor and multiple myeloma programs at ASCO this year. LB2102 is our DLL3-targeted CAR-T therapy being evaluated in small-cell lung cancer and large-cell neuroendocrine carcinoma.

談到近期臨床數據，我們今年在 ASCO 分享了涵蓋實體腫瘤與多發性骨髓瘤計畫的令人鼓舞更新。LB2102 是我們以 DLL3 為標的的 CAR-T 療法，正在小細胞肺癌與大細胞神經內分泌癌中進行評估。

LB2102 demonstrated a manageable safety profile and encouraging clinical activity in a heavily pre-treated patient population. Higher dose levels achieved an objective response rate of 28.6% and a disease control rate of 78.6% with durable responses observed.

LB2102 在高度既往治療的病人族群中展現出可管理的安全性特徵，以及令人鼓舞的臨床活性。較高劑量組達到 28.6% 的客觀反應率，以及 78.6% 的疾病控制率，且觀察到持久反應。

Solid tumors remain difficult to treat with limited therapeutic options, so this is an encouraging sign. As a reminder, we have an exclusive global licensing agreement with Novartis to develop and commercialize LB2102 and other DLL3-targeting CAR-T therapies discovered by Legend.

實體腫瘤仍然難以治療，且治療選項有限，因此這是一個令人鼓舞的訊號。提醒各位，我們與諾華（Novartis）簽有全球獨家授權協議，以開發並商業化 LB2102 以及其他由傳奇發現、以 DLL3 為標的的 CAR-T 療法。

We also reported additional CARTITUDE program data supporting the durable efficacy and consistent safety profile of CARVYKTI in multiple myeloma. These data included sustained, progression-free, and overall survival benefits across cytogenetic risk groups, along with a low incidence of immune effector cell-associated enterocolitis.

我們也公布了 CARTITUDE 計畫的更多數據，支持 CARVYKTI 在多發性骨髓瘤中的持久療效與一致的安全性特徵。這些數據顯示，在不同細胞遺傳風險族群中均具有持續的無進展生存期與總生存期獲益，同時免疫效應細胞相關腸結腸炎的發生率偏低。

Notably, in the CARTITUDE-4 subgroup analysis, patients who responded to bridging therapy demonstrated 30-month overall survival rates exceeding 85% with no of IEC-associated Parkinsonism. Taken together, these presentations further reinforce both the strength of the CARVYKTI clinical profile and the breadth of our innovation pipeline.

值得注意的是，在 CARTITUDE-4 的亞組分析中，對橋接治療有反應的患者，其 30 個月總生存率超過 85%，且未出現 IEC 相關帕金森症。綜合而言，這些發表進一步強化了 CARVYKTI 臨床特徵的優勢，以及我們創新研發管線的廣度。

The most notable recent pipeline update was our Phase 1 LB2501 study with data presented at the European Hematology Association Congress in June. LB2501 is a CD19/CD20 dual-targeting in vivo CAR-T therapy for the treatment of relapsed-refractory non-Hodgkin's lymphoma.

近期管線更新中最受矚目的是我們的第 1 期 LB2501 研究，其數據已於 6 月在歐洲血液學協會（EHA）年會上發表。LB2501 是一種 CD19/CD20 雙靶點的體內（in vivo）CAR-T 療法，用於治療復發／難治性非霍奇金氏淋巴瘤。

The new results were the first human data with our in vivo platform and from an ongoing dose escalation Phase 1 study. The data presented at EHA included 12 patients with six patients in each of the two dose cohorts as part of an investigator-initiated trial conducted in China.

這些新結果是我們體內平台的首次人體數據，並來自一項正在進行的第 1 期劑量遞增研究。在 EHA 發表的數據包含 12 名患者，兩個劑量隊列各 6 名，屬於在中國進行的研究者發起試驗的一部分。

We had compelling results at dose level two, achieving a 100% objective response rate and an 83.3% complete response rate across the six patients with diffuse large B-cell lymphoma, mantle cell lymphoma, and follicular lymphoma. We also observed impressive in vivo CAR-T cell persistence in peripheral blood with cells detectable up to 116 days based on these early results.

在第二劑量水平，我們取得了令人信服的結果：在 6 名瀰漫性大 B 細胞淋巴瘤、套細胞淋巴瘤與濾泡性淋巴瘤患者中，客觀緩解率達 100%，完全緩解率達 83.3%。基於這些早期結果，我們也觀察到體內 CAR-T 細胞在周邊血中的持續性表現亮眼，最長可檢測至 116 天。

From a safety perspective, LB2501 was well tolerated with no dose-limiting toxicities, no serious adverse events, and no deaths reported. We anticipate filing a US IND for LB2501 by the end of the year to initiate a US-based clinical program in NHL and plan to report additional data from the China study in due course.

從安全性角度來看，LB2501 耐受性良好，未出現劑量限制性毒性、未報告嚴重不良事件，亦無死亡案例。我們預期在年底前為 LB2501 提交美國 IND，以啟動在美國針對 NHL 的臨床計畫，並計畫在適當時點公布中國研究的更多數據。

These results represent an important milestone for our entire in vivo CAR-T platform, which has broad applicability and includes other candidates with other targets in additional indications and supports our continued investment and development of candidates using our in vivo platform.

這些結果是我們整體體內 CAR-T 平台的重要里程碑；該平台具廣泛適用性，亦涵蓋其他靶點與更多適應症的候選項目，並支持我們持續投入與開發採用體內平台的候選療法。

Beyond LB2501, we continue to advance a broad and diversified pipeline spanning autologous, allogeneic, and in vivo cell therapies. As it relates to CARVYKTI, multiple frontline multiple myeloma studies remain ongoing, including CARTITUDE-5, CARTITUDE-6, as well as others, which could potentially expand our market opportunity into the first-line setting.

除 LB2501 之外，我們持續推進涵蓋自體、同種異體與體內細胞治療的廣泛且多元化研發管線。就 CARVYKTI 而言，多項前線多發性骨髓瘤研究仍在進行中，包括 CARTITUDE-5、CARTITUDE-6 以及其他研究，這些研究有望將我們的市場機會擴展至一線治療。

Across our autologous portfolio, we continue to develop therapies targeting Claudin 18.2, DLL3, GPRC5D, and dual target approaches for multiple myeloma. We are also advancing several off-the-shelf CAR-T programs, ranging from allogeneic programs for autoimmune disease and B-cell malignancies, as well as additional in vivo CAR-T candidates beyond LB2501, which I just described for its impressive first human data in a Phase 1 trial at EHA.

在自體產品組合方面，我們持續開發靶向 Claudin 18.2、DLL3、GPRC5D 的療法，以及用於多發性骨髓瘤的雙靶點策略。我們也在推進多項現成型（off-the-shelf）CAR-T 計畫，涵蓋用於自體免疫疾病與 B 細胞惡性腫瘤的同種異體計畫，以及除 LB2501 之外的其他體內 CAR-T 候選項目；我剛才已說明 LB2501 在 EHA 第 1 期試驗中令人印象深刻的首次人體數據。

Overall, we believe this portfolio reflects a balanced approach to innovation across the different modalities of CAR-T while leveraging our expertise in cell therapy development and manufacturing. Looking ahead, we believe Legend is well positioned for sustainable long-term growth.

整體而言，我們認為此產品組合反映了在不同 CAR-T 模態間採取平衡的創新策略，同時運用我們在細胞治療研發與製造方面的專業能力。展望未來，我們相信 Legend 已具備實現可持續長期成長的良好定位。

We continue to advance our pipeline and are working towards an IND submission for LB2501 by the end of the year. We ended the period with approximately $965 million in cash, cash equivalents and time deposits. And commercially, CARVYKTI remains a leading franchise in multiple myeloma and continues to demonstrate strong global momentum, expanding into new markets on a regular.

我們持續推進研發管線，並朝著在年底前提交 LB2501 的 IND 邁進。期末我們持有約 9.65 億美元的現金、約當現金與定期存款。在商業化方面，CARVYKTI 仍是多發性骨髓瘤領域的領先產品線，並持續展現強勁的全球動能，定期拓展至新市場。

We also continue to believe CARVYKTI has a peak annual sales potential exceeding $5 billion and we are making meaningful steps to reach that goal. Supported by a durable commercial business, a deep pipeline and a focus on execution, we remain committed to achieving company-wide profitability in 2026.

我們也持續相信 CARVYKTI 的年度峰值銷售潛力可超過 50 億美元，且我們正採取具實質意義的步驟以達成該目標。在穩健且具持久性的商業業務、深厚的研發管線與對執行力的專注支持下，我們仍致力於在 2026 年實現公司整體獲利。

And with that, I will turn over the call to Carlos.

接下來，我把電話會議交給 Carlos。

Thank you, Alan. This quarter's financial results continue to demonstrate the operating leverage inherent in our business model. Revenue has scaled at a CAGR of 74% since the second quarter of 2023, supported by growing demand for CARVYKTI and continued commercial execution.

謝謝你，Alan。本季財務結果持續展現我們商業模式中固有的營運槓桿。在 CARVYKTI 需求成長與持續的商業化執行支持下，自 2023 年第二季以來，營收以 74% 的年複合成長率（CAGR）擴張。

At the same time, operating margins have improved significantly from negative 142% in the second quarter of 2023 to a positive 15% in the second quarter of 2026. This now marks a major milestone objective for Legend as the first quarter of company-wide profitability on both an IFRS and an adjusted basis.

同時，營業利益率也顯著改善，從 2023 年第二季的負 142% 提升至 2026 年第二季的正 15%。這也標誌著 Legend 的一項重大里程碑：在 IFRS 與調整後口徑下，公司首次實現整體獲利的季度。

Going forward, we will continue to focus on adjusted net income as the metric for sustained profitability. While we remain focused on investing in the future growth of Legend, we are doing so with increasing discipline and operating efficiency.

展望未來，我們將持續以調整後淨利作為衡量可持續獲利能力的指標。在我們仍專注於投資 Legend 未來成長的同時，也將以更高的紀律與營運效率來推進。

Turning to our quarterly financial performance, total revenue increased 52% year over year, driven by continued CARVYKTI demand and commercial expansion. Given the recent increases in international sales, we wanted to note that we are using Legend's foreign exchange rates for CARVYKTI collaboration revenue, which we also plan to use going forward.

就本季財務表現而言，總營收年增 52%，主要由持續的 CARVYKTI 需求與商業化擴張所帶動。鑑於近期國際銷售增加，我們想特別說明：我們在 CARVYKTI 合作收入上採用 Legend 的外匯匯率，且未來也計畫持續採用。

Each quarter, Legend receives the collaboration revenue through a profit split analysis in US dollars as constant currency. From an accounting perspective, the revenue is then converted to the appropriate functional currency using Legend's foreign exchange rates, which may differ from our partners.

每一季，Legend 透過以美元作為固定幣別（constant currency）的利潤分成分析來取得合作收入。在會計處理上，該收入再使用 Legend 的外匯匯率換算為相應的功能性貨幣，而該匯率可能與我們合作夥伴所採用者不同。

While we expect the differences each quarter to be small over the near term, we wanted to specifically call it out this quarter as international sales are becoming an increasing percentage of the overall revenue. And in any given quarter, an increase in international revenue and/or a significant movement in foreign exchange rates between the euro and the US dollar could result in additional divergence between the revenues reported by our collaboration partner and the revenue that Legend reports.

雖然我們預期短期內各季差異不大，但由於國際銷售正逐步成為整體營收中更高的占比，因此本季特別提出說明。在任何一個季度，國際收入增加和／或歐元兌美元匯率出現顯著波動，都可能導致我們合作夥伴所報告的收入與 Legend 所報告的收入之間出現更大的差異。

As we look at collaboration revenue growth for the remainder of the year, we wanted to offer some thoughts on quarterly progression in Q3 and Q4. As we have been consistently saying, we are pleased with the steady increasing rate of CARVYKTI penetration into the second to the fourth lines of treatment, which is our focus and has now grown to be over 70% of our volume.

在評估今年剩餘期間的合作收入成長時，我們想就第三季與第四季的季度走勢提供一些看法。如同我們一再強調的，我們對 CARVYKTI 在第二線至第四線治療中的滲透率穩步提升感到滿意；這是我們的重點方向，目前已成長至占我們用量的 70% 以上。

With the increasing penetration into earlier lines has also come increasing usage in the outpatient setting. And with a higher percentage of outpatient volume contributing to the revenue mix comes a different set of gross margin dynamics.

隨著在更早期治療線別的滲透率提高，門診使用也隨之增加。而當門診用量在營收組合中的占比提高時，毛利率的動態也會有所不同。

Additionally, we expect to see an increase in Q4 revenue from an extra selling week in this calendar year and greater international expansion compared to Q3. Despite these fluctuations, we remain confident in our adjusted net income profitability projections for both Q3 and Q4.

此外，我們預期第四季營收將因本曆年多出一個銷售週，以及相較第三季更大的國際擴張而增加。儘管存在這些波動，我們仍對第三季與第四季的調整後淨利獲利預測保持信心。

Moving down the income statement, gross margin on net product sales grew 1% year over year, improving to 58%, which was an improvement of 17% compared with 41% for the first quarter of 2026, which as you may recall, was artificially low primarily due to one-time costs associated with manufacturing expansion, which we unwound in the second quarter, adding additional one-time favorability of a few percentage points to our Q2 gross margin.

沿著損益表往下看，淨產品銷售的毛利率年增1%，提升至58%；相較於2026年第一季的41%，改善了17個百分點。各位可能還記得，2026年第一季的毛利率偏低主要是因製造擴產相關的一次性成本所致；我們在第二季將其回轉，並為第二季毛利率額外帶來數個百分點的一次性正面影響。

Going forward, gross margin on net product sales will be more reflective of volume as we continue to expect improvements over time by leveraging our investments in manufacturing to scale and increasing utilization across all nodes. However. It is important to realize that there is still likely to be quarter-to-quarter variability in gross margin, and we expect Q3 gross margin on net product sales to be in the lower 50% range with a rebound into the mid-50% range anticipated for Q4.

展望未來，淨產品銷售的毛利率將更能反映出銷量表現；我們仍預期，隨著持續運用我們在製造端的投資以擴大規模，並提升各節點的產能利用率，毛利率將隨時間推移而改善。然而。需要注意的是，毛利率仍可能出現季度間波動；我們預期第三季淨產品銷售毛利率將落在50%出頭的區間，而第四季預計回升至50%中段。

Total operating expenses increased only 7% year over year, reflecting our continued focus on disciplined investment and operating leverage. Research and development expenses decreased 2% year over year as the costs from the later stage BCMA frontline clinical studies roll off. This will be partially offset by increased spending in our in vivo assets as they move into Phase 1 and later studies.

總營業費用年增僅7%，反映我們持續聚焦於有紀律的投資與營運槓桿。研發費用年減2%，因後期BCMA前線臨床研究的相關成本逐步退場。這將部分被我們in vivo資產隨著推進至第一期及後續研究而增加的支出所抵銷。

Selling, general, and administrative expenses increased 19%, primarily driven by investments supporting sustained leadership in BCMA CAR-T markets. As a result, operating margin improved to a positive 15% compared with negative 9% in the second quarter of 2025.

銷售、一般及行政費用增加19%，主要由支持我們在BCMA CAR-T市場持續領先地位的投資所帶動。因此，營業利益率改善至正15%，相較於2025年第二季的負9%。

Regarding taxes, we had an income tax expense of $22.3 million during the second quarter compared to an income tax expense of approximately $600,000 for the same quarter last year. The year-over-year increase was primarily driven by an increase in taxable income across our US, Belgium and PRC entities.

關於稅負，我們在第二季認列所得稅費用2,230萬美元，而去年同期的所得稅費用約為60萬美元。年增主要是由於我們在美國、比利時及中國（PRC）實體的應稅所得增加所致。

As we have now achieved company-wide profitability on a quarterly basis for the first time, I wanted to provide more detail on our tax rate and the effect of various tax jurisdictions as you develop your longer-term financial models. We are in the process of negotiating a unilateral advance pricing agreement with the Chinese tax authorities as part of our proactive tax governance strategy.

由於我們如今首次在公司整體層面達成按季度計算的獲利，我想在各位建立較長期的財務模型時，提供更多關於我們稅率以及不同稅務管轄區影響的細節。作為我們主動式稅務治理策略的一部分，我們正與中國稅務機關洽談單邊預先訂價協議（unilateral advance pricing agreement）。

Although a formal agreement has not yet been formally executed, we have now reflected the expected impact of the agreement as a component of income tax expense in our Q2 numbers. We expect to report income tax in each quarter that we are profitable, and although we are not yet at a point that we can provide more precise guidance, we anticipate a tax rate in the high-20% range over the next several quarters.

雖然正式協議尚未正式簽署，但我們已在第二季數字中，將該協議的預期影響反映為所得稅費用的一部分。我們預期在每個獲利的季度都會申報所得稅；儘管目前尚未能提供更精確的指引，但我們預估未來數個季度的稅率將落在接近30%（高20%區間）。

In addition, although quarterly adjusted net income may vary from quarter to quarter over the near term, primarily driven by some expected fluctuations in gross margins I mentioned earlier, we are increasingly confident in the long-term durability of our profitability profile.

此外，雖然短期內季度調整後淨利可能會因季度而異，主要受我先前提到的毛利率預期波動所驅動，但我們對於長期獲利能力輪廓的持久性愈發有信心。

With adjusted net income of $63 million in Q2, we feel comfortable in maintaining our projection for adjusted net income profitability on an adjusted basis in 2026. On a non-IFRS basis, this represents $0.16 per diluted share compared with adjusted net income of $10 million or $0.03 per diluted share in the same period last year.

第二季調整後淨利為6,300萬美元，我們有信心維持對2026年在調整後基礎上達成調整後淨利獲利的預測。以非IFRS基礎計算，稀釋後每股為0.16美元；相較去年同期調整後淨利1,000萬美元或稀釋後每股0.03美元。

Turning to our balance sheet, which remains a significant strategic asset. As of June 30, 2026, we held approximately $965 million in cash, cash equivalents, and time deposits and have no long-term debt. The equity offering in June contributed meaningfully to this strong cash position, allowing for additional flexibility to fund our pipeline programs and pay down our loan to Johnson & Johnson under the terms of our agreement.

接著談資產負債表，這仍是重要的策略性資產。截至2026年6月30日，我們持有約9.65億美元的現金、約當現金與定期存款，且沒有長期負債。6月的股權發行對這項強勁的現金部位有顯著貢獻，使我們在資金運用上更具彈性，可用於支持研發管線計畫，並依協議條款償還對強生（Johnson & Johnson）的貸款。

Our investment priorities have remained consistent, and our strategy has not changed. We remain committed to delivering sustainable profitability on adjusted net income while still advancing our in vivo CAR-T pipeline and making modest capital investments to support manufacturing capacity expansion.

我們的投資優先順序一直保持一致，策略也沒有改變。我們仍致力於在維持推進in vivo CAR-T研發管線的同時，實現以調整後淨利衡量的可持續獲利，並進行適度的資本投資以支持製造產能擴張。

Our key objectives include, first, continued quarter-over-quarter CARVYKTI growth through 2026 with a growing portion of our business coming from second to fourth line patients. Second, adjusted net income profitability for the second half of 2026.

我們的關鍵目標包括：第一，2026年持續實現CARVYKTI逐季成長，且業務中來自第二線至第四線患者的占比提升。第二，2026年下半年達成調整後淨利獲利。

Third, an IND submission for LB2501 in Q4. And lastly, presenting additional in vivo data at future medical conferences. We believe our strong financial position provides the flexibility needed to execute on all of these priorities.

第三，於第四季提交LB2501的IND申請。最後，在未來的醫學會議上發表更多in vivo數據。我們相信，強勁的財務狀況提供了執行上述所有優先事項所需的彈性。

Let me end in the same way that Alan started this call. This is a period of leadership transition and not strategy transition. Our Q2 financial results support this, and you can expect that this leadership team will continue to deliver on the clear objectives that we just laid out and to provide transparency for the investment community as we move into the second half of 2026.

我想用與Alan開場相同的方式作結。這是一段領導層交接的時期，而非策略轉變的時期。我們第二季的財務結果也支持這一點；各位可以預期，這個領導團隊將持續達成我們剛才提出的明確目標，並在邁入2026年下半年之際，為投資社群提供透明資訊。

With that, I will turn the call back to the operator to open the line for questions.

接下來，我把電話交回給接線員，開放提問。

(Operator Instructions) Eric Schmidt, Cantor.

(接線員指示) Eric Schmidt，Cantor。

Congrats on achieving the milestone of profitability. My question is on the in vivo CAR-T side and the BCMA program in particular. I think Alan mentioned you work on a variety of different targets, so I assume that's still one of them. Can you provide for us kind of an update on your strategy with your partner J&J and when we may hear something in addition on BCMA?

恭喜達成獲利這個里程碑。我的問題是關於in vivo CAR-T，特別是BCMA計畫。我想Alan提到你們在多種不同標的上進行研發，所以我假設BCMA仍是其中之一。你們能否向我們更新一下與合作夥伴J&J的策略，以及我們何時可能會聽到更多關於BCMA的進一步消息？

Thanks, Eric, for the question. Yes, previously we had said that BCMA CAR-T programs were subject to the terms of Legend Biotech's collaboration agreement with J&J and previously, we could not say more. We can now share an update that Legend will be conducting an investigator-initiated clinical study in China evaluating LB2505, which is an investigational BCMA-targeted in vivo CAR-T therapy for multiple myeloma.

謝謝你，Eric，提問。是的，先前我們曾表示，BCMA CAR-T計畫受Legend Biotech與J&J之合作協議條款所約束，因此之前我們無法多談。現在我們可以分享最新進展：Legend將在中國進行一項研究者發起的臨床研究，評估LB2505；LB2505是一項以BCMA為標的、用於多發性骨髓瘤的研究中in vivo CAR-T療法。

This program is subject to the terms of Legend Biotech's collaboration agreement with J&J. So we're not able to share additional details at this time, but we do look forward to providing updates on LB2505 when appropriate.

該計畫受Legend Biotech與J&J之合作協議條款所約束。因此目前我們無法分享更多細節，但在適當時機，我們也期待就LB2505提供更新。

Terence Flynn, Morgan Stanley.

Terence Flynn，Morgan Stanley。

This is Chris on for Terrence, and thanks for taking our question. On LB2501, can you remind us of what the minimum duration of response you think is needed to be confident in the durability of a complete response? And is ASH a reasonable expectation for when you could release the updated Phase 1 data?

我是代Terrence提問的Chris，謝謝你們回答我們的問題。關於LB2501，你們能否提醒我們：你們認為需要多長的最短反應持續時間，才能對完全緩解（CR）的持久性有信心？另外，ASH是否是你們可能發布更新第一期數據的合理時間點？

Yeah, previously at the EHA conference, we had shared durability as long as 120 days. We would be targeting ultimately to be able to share data at the six-month CR rate and we will be able to provide updates at future medical conferences in terms of the LB2501 program.

是的，先前在EHA會議上，我們曾分享過持久性可長達120天。我們最終的目標是能夠分享六個月CR率的數據；我們也會在未來的醫學會議上，就LB2501計畫提供更新。

Jon Miller, Evercore ISI.

Jon Miller，Evercore ISI。

Hello, this is [Huenye] on for Jon. I would like to touch on the recent announcement for the MonumenTAL-6 top-line data where we saw a hazard ratio of 0.11%. This seems like physicians are gradually getting comfortable with anticipating and managing the talks in the study, and there were also some kind of commentary that the (multiple speakers) --

您好，我是代替 Jon 的 [Huenye]。我想談一下近期公布的 MonumenTAL-6 頂線數據，我們看到危險比為 0.11%。這看起來像是醫師正逐漸更能適應在研究中預期並管理相關的討論，而且也有一些評論提到(多位講者) --

I'm sorry.

抱歉。

Hello? Yeah, can you hear me?

喂？對，你聽得到我嗎？

Your line isn't coming in as clearly. If you could just repeat the question, please.

你的線路聽起來不太清楚。可以請你把問題再重複一次嗎？

Yeah. So I'd like to ask a question on the recent announcement for the MonumenTAL-6 top-line data. So it seems like physicians are gradually getting comfortable with managing and anticipating the talks in the study.

好的。我想就近期公布的 MonumenTAL-6 頂線數據問一個問題。看起來醫師正逐漸更能適應在研究中管理並預期相關的討論。

And then there are also some commentary that the combo might be perfectly sequenced for later line usage. So I'd like to ask what kind of feedback have you been hearing from physicians on your end in terms of managing the talks and the sequencing of that relative to CARVYKTI?

另外也有一些評論認為，這個聯合療法可能非常適合在後線治療中進行序列安排。因此我想問，從你們這邊聽到醫師對於管理這些討論，以及相對於 CARVYKTI 的治療序列安排，有哪些回饋？

Thanks for the question. So yes, the MonumenTAL study was looking at the combination of tec and tal. And as J&J has shared publicly, they intend for that combination to be primarily used in later lines, as you point out.

謝謝你的問題。是的，MonumenTAL 研究是在評估 tec 與 tal 的聯合使用。正如 J&J 已公開分享的，他們打算讓這個組合主要用於後線治療，如你所指出。

I think more generally, as we've seen the bispecific data and indications emerge, we've been very focused on educating physicians and patients on the key points of differentiation of CARVYKTI relative to other options in myeloma, in particular other BCMA options.

更廣泛來說，隨著雙特異性抗體的數據與適應症逐步出現，我們一直非常專注於教育醫師與病患，說明 CARVYKTI 相較於骨髓瘤其他選項、特別是其他 BCMA 選項的關鍵差異點。

Of course, one is that -- one and done, right, versus continuous therapy. That's a very important driver of patient preference, of quality of life and of the opportunity for a long-term treatment-free interval and a long-term remission.

當然，其中一點是——一次完成（one and done），對吧，而不是持續治療。這是驅動病患偏好、生活品質，以及獲得長期無治療間隔與長期緩解機會的一個非常重要因素。

The second thing that we've been really emphasizing relative to the landscape is that the data really suggests that earlier is better with CAR-T. You get better efficacy, better safety and improved manufacturing when you get CAR-T earlier.

第二點，我們相對於整體競爭格局一直強調的是，數據確實顯示 CAR-T 越早使用越好。越早使用 CAR-T，可獲得更好的療效、更好的安全性，以及更佳的製造表現。

And really, where the conversation has gone is not really about CARVYKTI versus bispecifics; it's really about the sequencing. And I think if you hear KOLs and the feedback we've been getting from KOLs, the storyline is really about the optimal sequencing and the data both in the real world as well as additional studies. Or if you look at the biology, it really does point to the fact that patients will benefit if they can get to CAR-T first before other options in BCMA.

而且實際上，討論的焦點已不太是 CARVYKTI 對上雙特異性抗體；而是治療序列安排。我認為如果你聽 KOL 的看法以及我們從 KOL 收到的回饋，主軸其實是最佳序列安排，以及真實世界數據與更多研究的結果。或者從生物學角度來看，也確實指向一個事實：如果病患能在其他 BCMA 選項之前先接受 CAR-T，將會受益。

Leonid Timashev, RBC.

Leonid Timashev，RBC。

I just want to clarify some of the comments on the gross margin. Can you maybe just elaborate on why having more outpatients is going to change the gross margin dynamics?

我想釐清一下你們對毛利率的一些評論。你能否再多說明一下，為什麼門診病患比例提高會改變毛利率的動態？

And then looking ahead, I think in the past, you've talked about aiming for large molecule-like cost of goods. Is that still the plan here? Any sense of when you might achieve that with some of these modest CapEx spend plans?

另外展望未來，我記得你們過去談到目標是把銷貨成本做到接近大分子藥物的水準。這仍然是目前的計畫嗎？在這些相對溫和的資本支出（CapEx）規劃下，你們大概何時可能達成？

Yes, thanks for the question. All we would say at this point is that as outpatient grows -- and outpatient is starting to become about approximately 60% of our overall mix, it does come with various dynamics, which could potentially impact gross margin. So that's all we're able to say at this point on that. But let me turn it to Carlos to your second question.

是的，謝謝你的問題。我們目前只能說，隨著門診占比提升——而門診目前開始約占我們整體組合的 60%——確實會帶來各種動態，可能影響毛利率。關於這點我們目前只能說到這裡。不過你的第二個問題我交給 Carlos 回答。

Yes, so Leonid, in terms of the path for gross margin, we are still expecting our cost of goods sold to decline over time. We have to get to a certain level of volume to keep up the consistency, but once all of our nodes are at a steady state, our gross margins will be in line with what we believe is industry standards of around 75% and we actually have we see a clear path to 75% over time.

好的，Leonid，關於毛利率的路徑，我們仍預期銷貨成本會隨時間下降。我們需要達到一定的量能水準以維持一致性，但一旦我們所有節點都進入穩態，我們的毛利率將與我們認為的產業標準一致，約在 75% 左右，而且我們確實看到隨時間推進達到 75% 的清晰路徑。

Jessica Fye, JPMorgan.

Jessica Fye，摩根大通（JPMorgan）。

I had two kind of on the financial side. First, can you just expand a little bit on the comments you made about how to think about the revenue cadence in 3Q and 4Q?

我有兩個偏財務面的問題。第一，你能否再多展開一下你提到的，如何看待第三季與第四季的營收節奏？

And second, can you just recap the motivation behind the recent equity raise, given that the company is still very committed to achieving profitability this year?

第二，鑑於公司仍非常致力於在今年達成獲利，你能否回顧一下近期增發股權募資背後的動機？

Let me start with talking about the raise. The follow-on was an opportunistic equity raise following the strong in vivo data that we presented at EHA. This additional capital really gives us greater flexibility to accelerate the development of LB2501 and our broader in vivo platform.

我先談募資。這次增發是在我們於 EHA 發表強勁的體內（in vivo）數據之後，所進行的一次機會型股權募資。這筆額外資金確實讓我們在加速 LB2501 與更廣泛的體內平台開發方面，擁有更大的彈性。

This really allows us to be able to take our in vivo platform further in the development process and this will provide us better BD optionality down the road. We continue to be confident in our profitability goals, and we will be in a stronger position to fund our R&D efforts following the loan repayment to J&J now that we have completed this raise.

這也讓我們能把體內平台推進到更後段的開發流程，並在未來為我們提供更好的商務開發（BD）選擇性。我們對獲利目標仍有信心，而且在完成這次募資後，隨著我們現在已償還對 J&J 的貸款，我們將處於更有利的位置來資助研發投入。

And related to your first question, as we heard earlier in the call from Carlos, we are indicating a global growth on a sequential basis across the balance of the two quarters in the second half of 2026.

至於你的第一個問題，正如稍早 Carlos 在電話會議中提到的，我們指引在 2026 年下半年剩餘兩個季度，全球業務將以季對季（sequential）基礎持續成長。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Congrats on moving towards the IND with in vivo in China. I thought maybe -- it's just a two-part question on the tax rate in China, that would be applied, it sounds like, to the global profits from now on. Is that actually going to be a cash payment or is that an accounting tax rate?

恭喜你們在中國推進體內（in vivo）項目朝 IND 邁進。我有一個關於中國稅率的兩段式問題：聽起來這個稅率從現在起會適用於全球利潤。那這實際上會是現金支付，還是僅是會計上的稅率？

And then secondly, just to answer -- your answer to Jessica's question on the raise, and you said that the payment after the payment to J&J, can you just clarify, is that relating to historical CapEx and how big that is? Thank you.

第二點，回到你對 Jessica 關於募資問題的回答，你提到在支付給 J&J 之後的付款；你能否釐清一下，這是否與歷史資本支出（CapEx）有關、規模大概是多少？謝謝。

Sorry, Yaron, could you repeat your second question?

抱歉，Yaron，你可以把第二個問題再說一次嗎？

I think you mentioned that there was a -- I might have misunderstood, a payment to J&J when you were talking about the financing. So I just wanted to make sure, is there any historical sort of sale balance sheet cleanup that you need to do as part of CapEx or did you never actually borrow capital from J&J for building manufacturing facilities that are still outstanding?

我想你在談融資時提到有一筆——可能是我誤解了——要支付給 J&J 的款項。所以我想確認一下：是否有任何與歷史資本支出相關、需要處理的資產負債表清理事項？或者你們其實從未向 J&J 借款來興建製造設施，因此也沒有任何尚未償還的款項？

Yeah, so let me start there. So as part of our collaboration agreement, there was a loan of around $300 million and that accrued interest over time. That became a current liability this year. So we have been paying down both principal and interest on that loan this year, and it's a combination of cash repayments to J&J as well as recoupment of profits from our collaboration. We expect to fully settle that liability this year.

是的，那我就從這裡開始。作為我們合作協議的一部分，當時有一筆約3億美元的貸款，並且隨時間累積利息。這在今年成為一項流動負債。因此我們今年一直在償還該筆貸款的本金與利息，方式包括向J&J支付現金償還，以及從我們合作中的利潤回收（recoupment）。我們預期今年將完全清償該項負債。

So with regards to the tax provision, we have reflected the expected impact of an agreement based on the information we have today as a component of our income tax expense in Q2. So this provision not only includes the China portion, but also profitability that's realized in other legal entities for Legend.

關於所得稅提列（tax provision），我們已根據目前掌握的資訊，將一項協議的預期影響反映為第二季所得稅費用的一部分。因此，這項提列不僅包含中國部分，也包含Legend在其他法律實體中實現的獲利。

Kostas Biliouris, Oppenheimer.

Kostas Biliouris，Oppenheimer。

Maybe a couple of quick questions, one on the CEO search. We are wondering whether the Board search is focused on a commercial operator for the CARVYKTI ramp or perhaps a platform CEO for the in vivo CAR-T development?

我這邊可能有兩個簡短問題，第一個關於CEO的尋覓。我們想了解董事會的搜尋重點，是偏向能推動CARVYKTI放量（ramp）的商業營運型人才，還是偏向能帶領體內（in vivo）CAR-T研發的平台型CEO？

And the second question is on the in vivo CAR-T development and commercialization. You already touched a little bit on the BCMA, but we are wondering how are you thinking about perhaps the lead program in NHL? Are you thinking to develop these by yourself or are you still looking for a partnership there? What is the latest status?

第二個問題是關於體內CAR-T的研發與商業化。你們已經稍微提到BCMA，但我們想了解你們如何看待例如在NHL的領先（lead）專案？你們打算自行開發，還是仍在尋找合作夥伴？最新進展如何？

Thanks, Kostas. Yeah, so as we previously announced, the Board has initiated a search, is conducting a thorough process for the full-time permanent CEO position. And I don't think the Board wants to put an artificial deadline on that process.

謝謝你，Kostas。是的，如同我們先前公告，董事會已啟動搜尋，並正就全職永久CEO職位進行一個全面的遴選流程。我認為董事會不希望為這個流程設定一個人為的截止期限。

They're also looking holistically and looking at various qualities that would provide for the best long-term leader given the stage of the growth of the company. So I don't think there's anything specific that they wanted to share at this point about that.

他們也會以更整體的角度來看，評估多項特質，以便在公司成長階段下找到最適合的長期領導者。因此我認為目前他們沒有任何特定內容想在此時分享。

As it relates to your second question, as we mentioned on the call here, we are excited to say that we will be moving toward an IND with 2501 in the second half of 2026 and our intention is to be able to conduct that Phase 1 ourselves. We have the capabilities and we obviously have the financial flexibility and the resources to do that.

至於你的第二個問題，如同我們在本次電話會議中提到的，我們很高興地表示，我們將在2026年下半年推進2501走向IND，我們的意圖是能夠自行執行該項第一期試驗。我們具備相關能力，且顯然也有財務彈性與資源來完成。

We continue to remain open to various options around partnership, long term, across the in vivo platform. We obviously made the announcement this morning with 2505 moving forward in multiple myeloma and BCMA, and we'll continue to assess all of our options to maximize the value, both in terms of maintaining economics, but also ensuring speed and scale to maximize the opportunity with in vivo.

我們仍對體內平台在長期上各種合作選項保持開放。我們今天早上也已公告2505將在多發性骨髓瘤與BCMA方向推進；我們會持續評估所有選項以最大化價值，既包括維持經濟利益（economics），也包括確保速度與規模，以在體內領域把握並最大化機會。

Etzer Darout, Barclays.

Etzer Darout，Barclays。

This is Luke on for Etzer. Real quick on the J&J partnership, how does that impact your in vivo development in immune disease? Does that change what you're able to pursue? And then maybe can you like highlight any differences between your in vivo CAR-T platform and Sail?

我是代Etzer提問的Luke。很快問一下關於與J&J的合作，這會如何影響你們在免疫疾病上的體內研發？這是否改變你們能夠推進的方向？另外，你能否重點說明你們的體內CAR-T平台與Sail之間的差異？

Sure, so yeah, the announcement that we're making today is around BCMA CAR-T in multiple myeloma, that's the aspect of the program that is subject to the agreement with J&J. So at this point now, Legend will look and step back and assess our options for autoimmune disease.

當然。是的，我們今天的公告是關於多發性骨髓瘤中的BCMA CAR-T；這部分專案是受與J&J協議所涵蓋的。因此在目前這個時間點，Legend將會回頭檢視並重新評估我們在自體免疫疾病方面的選項。

We remain very interested in autoimmune disease with multiple targets. We obviously have been looking at potentially BCMA, potentially CD19/CD20 and other targets in autoimmune and we think in vivo can play a meaningful role there.

我們仍然對自體免疫疾病非常有興趣，且有多個標的。我們顯然一直在評估例如BCMA、可能的CD19/CD20以及其他自體免疫標的，我們認為體內方式在其中可以扮演有意義的角色。

As it relates to the J&J deal that you mentioned with Sail. I'll remind you that Sail has a preclinical platform around circular mRNA and LNP, and so that's very different from our program, which is LV-based, and we've also already shown clinical data in a very meaningful market, which is non-Hodgkin's lymphoma.

至於你提到J&J與Sail的交易。我提醒一下，Sail的臨床前平台是圍繞環狀mRNA（circular mRNA）與LNP，因此這與我們的專案非常不同；我們的專案是以LV為基礎（LV-based），而且我們已在一個非常重要的市場——非霍奇金氏淋巴瘤——展示了臨床數據。

So I think these are two very different opportunities. I think it speaks to the excitement across the industry in in vivo. Many large pharma companies are looking at multiple platforms and we're very excited about the platform that we have to offer.

所以我認為這是兩個非常不同的機會。我想這也反映出整個產業對體內（in vivo）的興奮與期待。許多大型製藥公司正在評估多種平台，而我們也對我們能提供的平台感到非常振奮。

Edward Tenthoff, Piper Sandler.

Edward Tenthoff，Piper Sandler。

Thanks for the updates on the in vivo side and all the great progress with CARVYKTI. My question has to do with the rest of the pipeline, sort of the allogeneic approaches. It really sounds like the focus is in vivo going forward.

感謝你們在體內方面的更新，以及CARVYKTI的所有重大進展。我的問題與其餘產品線有關，也就是同種異體（allogeneic）策略。聽起來未來的重點確實會放在體內。

So should we be expecting updates on either some of the other autologous CAR-Ts, or some of the allogeneic CAR-Ts in the next year or so? Can you give us a sense for when to expect those updates?

那麼我們是否應該預期在未來一年左右，會看到其他一些自體（autologous）CAR-T或某些同種異體CAR-T的更新？你能否讓我們了解大概何時可以期待這些更新？

Let me turn this over to Yuhong to answer your question.

我把這個問題交給Yuhong來回答。

So the in vivo platform and allogeneic platform each have its strength. We prioritize in vivo, but we still believe that allogeneic has a place. We previously provided our G39D program in ASH last year, and we continue to provide additional updates in future conferences on that program.

體內平台與同種異體平台各有其優勢。我們會優先推進體內，但我們仍相信同種異體也有其定位。我們先前在去年ASH上提供了G39D專案的資訊，並且會在未來的會議上持續就該專案提供更多更新。

(Operator Instructions) Mitchell Kapoor, HC Wainwright.

（接線員指示）Mitchell Kapoor，HC Wainwright。

This is Ahmed on from Mitchell. Congrats on the strong quarter. Just a couple of questions from us. One on how much CARVYKTI's current 2L to 4L mix is in 2L and 3L versus fourth line and how has that shifted QoQ? And if (inaudible) cell launches and fourth line, what portion of CARVYKTI's current business would face direct overlap at launch?

我是代Mitchell提問的Ahmed。恭喜本季表現強勁。我們這邊有兩個問題。第一個是CARVYKTI目前在二線到四線（2L到4L）的組合中，二線與三線相對於四線各占多少？相較上一季（QoQ）有何變化？另外，如果（聽不清）細胞療法在四線上市，CARVYKTI目前業務中有多少比例在上市時會面臨直接重疊的競爭？

And the second one. I was wondering with CARVYKTI showing clinical proof of concept and LB2102 validating DLL3 CAR activity in small cell lung cancer, how are you thinking about extending the in vivo platform into solid tumors? And would DLL3 be the logical target and would that fall within the Novartis agreement?

第二個問題是，我想請教，隨著CARVYKTI展現臨床概念驗證（proof of concept），以及LB2102在小細胞肺癌中驗證DLL3 CAR活性，你們如何思考將體內平台延伸到實體腫瘤？DLL3會是合理的標的嗎？而且這是否會落在與諾華（Novartis）的協議範圍內？

Let me answer your second question first and just say that we're looking across a range of potential solid tumor targets. Solid tumor, obviously, has its own unique characteristics, and I think there are challenges that we and other companies are continuing to try to solve with in vivo in solid tumor.

我先回答你的第二個問題：我們正在評估一系列潛在的實體腫瘤標的。實體腫瘤顯然有其獨特特性，我認為在實體腫瘤中以體內方式推進，仍存在一些我們與其他公司持續努力解決的挑戰。

So more to come on that one. We do think that the DLL3 auto CAR-T data set was meaningful. And as you know, we have a partnership with Novartis where we will be having Novartis take the asset forward into full clinical development.

所以這方面後續還會有更多進展。我們確實認為 DLL3 自體 CAR-T 的資料集具有重要意義。而且如各位所知，我們與諾華（Novartis）有合作夥伴關係，諾華將推動該資產進入完整的臨床開發。

As it relates to your question about line of therapy, yes, you did hear us share an update today that our 2L through 4L now comprises 70% -- in fact, over 70% of our mix in the US. And that's exciting because that means that we are making significant progress in getting CARVYKTI to be used earlier in the treatment paradigm.

就您關於治療線別（line of therapy）的問題而言，是的，您今天確實聽到我們分享最新進展：我們在美國的 2L 到 4L 目前已占 70%——事實上超過 70% 的組合。這令人振奮，因為這代表我們在推動 CARVYKTI 更早納入治療範式方面取得了顯著進展。

And as you mentioned, where (inaudible) cell will be potentially indicated in later lines, depending, of course, on what label they do receive, our foothold in second through fourth line, I think, provides a meaningful opportunity for CARVYKTI going forward.

而如您所提到的，（聽不清）細胞療法可能會在較後線別獲得適應症，當然取決於其最終獲得的標籤；我們在第二線到第四線的立足點，我認為為 CARVYKTI 未來帶來了相當可觀的機會。

Last quarter, we did break down and share an insight that within the 2L and 3L specifically, that that represented 41% of the overall mix, and we did that because we wanted to share a point-in-time reference to the fact that we've made significant growth and significant progress in early lines, specifically 2L and 3L.

上一季我們確實拆解並分享了一項洞見：在 2L 與 3L 這兩個線別中，該部分占整體組合的 41%。

And we said at the time and we maintain today, we don't intend to provide that update on every single quarter. Really, it is an opportunity to share that we are growing in second and third line. It continues to be the fastest-growing part of our business. And we're excited with the fact that we do continue both from a clinical standpoint and a commercial execution standpoint to focus on the early-line opportunities.

我們當時也說過，且今天仍維持相同立場：我們不打算每一季都提供這項更新。這主要是個機會，讓大家了解我們在第二線與第三線正在成長。這仍然是我們業務中成長最快的部分。我們也很振奮，因為無論從臨床角度或商業執行角度，我們都持續聚焦於早線治療的機會。

Ash Verma, UBS.

Ash Verma，瑞銀（UBS）。

Congrats on the progress here. So maybe just the first one, can you talk about the potential impact on CARVYKTI from J&J's growing body of clinical data in this MonumenTAL-6 data that for Tecvayli, Talvey showed hazard ratio of 0.11% on PFS in second to fifth line patients. So just help us understand -- I know you're growing a lot in second to third line, but just if competition catches up to that?

恭喜你們在這裡取得的進展。那我先問第一個：能否談談 J&J 在 MonumenTAL-6 這些日益累積的臨床資料，對 CARVYKTI 可能造成的影響？在 Tecvayli、Talvey 的資料中，於第二到第五線患者的 PFS 顯示風險比為 0.11%。請協助我們理解——我知道你們在第二到第三線成長很快——但如果競爭對手追趕到那個區段，會怎麼看？

And then secondly, you commented on the sequential global sales growth. But can you confirm that if it applies to the US sales growth as well going into 3Q and 4Q?

第二，你們提到全球銷售額的連續（逐季）成長。但能否確認，這是否也同樣適用於美國銷售額在進入第三季與第四季時的成長？

At this point, and again, we stay very close to our partner J&J here on this, so we wanted to just maintain the comment that we had previously, which is around global sequential growth quarter on quarter. But to answer your first question on the bispecifics, again, I pointed this out earlier, but I think it's important to emphasize the bispecifics do have, I think, very compelling data, but they offer a very different value proposition for patients.

目前，且再次強調，我們在這方面與合作夥伴 J&J 保持非常緊密的溝通，因此我們希望維持先前的說法，也就是全球逐季（quarter-on-quarter）的連續成長。至於您第一個關於雙特異性抗體（bispecifics）問題的回答，我之前也提過，但我認為值得強調：雙特異性抗體確實有非常具吸引力的數據，但它們為患者提供的是非常不同的價值主張。

And what we're focused on is the fact that -- and jointly with J&J, and J&J has reiterated the fact that CARVYKTI, even on their recent earnings call, that CARVYKTI has the potential to be a $5 billion-plus peak sales asset and we very much are in lockstep with them on that. Both J&J and Legend are committed to the fact that CARVYKTI provides a very unique value proposition to patients, to physicians and to the market.

我們所聚焦的是——並且與 J&J 共同聚焦——J&J 也在其近期財報電話會議上再次重申：CARVYKTI 具有成為峰值銷售額超過 50 億美元資產的潛力，我們在這點上與他們高度一致。J&J 與 Legend 都致力於強調：CARVYKTI 對患者、醫師以及市場提供了非常獨特的價值主張。

One and done versus continuous therapy, the opportunity for a long-term remission and really meeting the definition of cure as defined by the IMWG guidelines, really, we have a potential for cure here based on the CARTITUDE-1 long-term five-year data.

一次治療即可完成（one and done）相對於持續治療（continuous therapy），其機會在於達成長期緩解，並真正符合 IMWG 指南所定義的治癒（cure）標準；根據 CARTITUDE-1 的五年長期數據，我們在此確實具備治癒的潛力。

We look forward to presenting updates in earlier lines over the next year or so. And we do believe that this one-and-done opportunity with long-term remissions and the potential for cure is what patients and physicians ultimately want.

我們期待在未來一年左右，於更早線別公布更新資料。我們也相信，這種一次治療、可帶來長期緩解並具治癒潛力的機會，正是患者與醫師最終所追求的。

And I would also add to your question, which is, I mentioned it earlier, there's really been a very robust conversation now at all the medical conferences and all the follow-up conferences about sequencing. And I think the real-world evidence that was presented at ASCO, whether it's the Germany registry or whether it's the Mountain West US registry from TriNetX or whether it's other data sets.

另外補充回應您的問題：如我先前提到的，現在在所有醫學會議以及後續會議上，關於治療序列（sequencing）的討論都非常熱烈。而在 ASCO 發表的真實世界證據（real-world evidence），無論是德國登錄資料，或是來自 TriNetX 的美國 Mountain West 登錄資料，或其他資料集。

Institution-specific real-world data suggests that when patients get CAR-T first, they have prolonged survival, they have better outcomes, and you have less opportunity for antigen escape or antigen mutation. So you really have an opportunity to get CAR-T first, and that's really where the KOLs are on this topic.

各機構特定的真實世界資料顯示，當患者先接受 CAR-T，他們的存活期更長、結局更好，且抗原逃逸或抗原突變的機會更少。因此，確實存在讓患者優先使用 CAR-T 的機會，而這也正是此議題上 KOL（關鍵意見領袖）的主流看法。

Sean McCutcheon, Raymond James.

Sean McCutcheon，Raymond James。

And speaking to the earlier line, with the iberdomide PDUFA coming up in about a week on the MRD negativity results, how does this inform your calculus on potential for filing on MRD for CARTITUDE-6 and accelerating the time-to-market for CARVYKTI and the frontline transplant eligible population? Thanks.

談到更早線別，iberdomide 的 PDUFA 大約一週後就要到了，且與 MRD 陰性結果相關；這如何影響你們對於在 CARTITUDE-6 以 MRD 進行申報的評估，以及加速 CARVYKTI 在一線、可接受移植族群上市時程的考量？謝謝。

Let me ask Yuhong to comment about MRD as an endpoint.

我請 Yuhong 來評論一下 MRD 作為終點（endpoint）的議題。

Thank you. With the advancement of frontline therapies for multiple myeloma patients, the median PFS gets longer and longer, which is very good news for patients. But for the development of newer therapies, some of those patients still relapse. So MRD become a necessary surrogate in order for those effective therapies to reach patients earlier.

謝謝。隨著多發性骨髓瘤患者一線治療的進步，中位無惡化存活期（PFS）越來越長，這對患者而言是非常好的消息。但在更新療法的開發上，仍有部分患者會復發。因此，MRD 成為必要的替代指標（surrogate），以便讓這些有效療法能更早惠及患者。

Although in the MRD ODAC, the correlation analysis does not include any of the CAR-T data sets. We continue to work with FDA on the possibility of using MRD as a surrogate for registration purpose for the CAR-T therapy. So CAR-6 will continue on this effort.

儘管在 MRD 的 ODAC 中，相關性分析並未納入任何 CAR-T 的資料集。我們仍持續與 FDA 合作，探討將 MRD 作為 CAR-T 療法註冊（registration）用途之替代指標的可能性。因此 CAR-6 將持續推進這項工作。

Thank you, and as I see no further questions in the queue, I will conclude the Q&A session and conference for today. We want to thank everyone for participating, and you may now disconnect.

謝謝。由於我看到隊列中已無其他問題，我將結束今天的問答環節與會議。感謝各位參與，現在您可以斷線。