Genmab A/S (GMAB) 2026 Q1 法說會逐字稿

Hello, and welcome to the Genmab first-quarter 2026 financial results conference call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as beliefs, anticipates, plans, or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects.

您好，歡迎參加 Genmab 2026 年第一季財務業績電話會議。提醒各位，本次電話會議將被錄音。在本次電話會議中，您可能會聽到前瞻性陳述，其中包含例如「相信」、「預期」、「計畫」或「期望」等字眼。實際結果可能會有重大差異，例如因開發專案延遲或未能成功所致。

Genmab is not under any obligation to update statements regarding the future, nor to confirm such statements in relation to actual results, unless this is required by law. Please also note that Genmab may hold your personal data as indicated by you as a part of our investor relations outreach activities, in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy.

除非法律要求，Genmab 無義務更新任何關於未來的陳述，亦無義務就實際結果確認該等陳述。另請注意，作為我們投資人關係外聯活動的一部分，Genmab 可能會依您所提供之資訊持有您的個人資料，以便未來持續向您更新 Genmab 的相關資訊。更多關於 Genmab 與我們的隱私權政策資訊，請參閱本公司網站。

I would now like to hand the conference over to our first speaker today, Jan van der Winkle. Please go ahead.

接下來我想把會議交給今天的第一位講者 Jan van der Winkle。請開始。

Hello, and welcome to our financial results call for the first quarter of 2026. With me today is our Chief Financial Officer, Anthony Pagano; and our Chief Commercial Officer, Brad Bailey. For the Q&A, we will be joined by our Chief Medical Officer, Tai Yamadi; and our Chief Development Officer, Judith Klimovsky. As noted, we will be making forward-looking statements, so please keep that in mind.

您好，歡迎參加我們 2026 年第一季財務業績電話會議。今天與我一同出席的有財務長 Anthony Pagano，以及商務長 Brad Bailey。在問答環節，我們的醫務長 Tai Yamadi 與研發長 Judith Klimovsky 也將加入。如先前所述，我們將發表前瞻性陳述，請各位留意。

Let's move to the first quarter highlights. In Q1 2026, we continue to deliver strong financial performance and make focused progress against our strategic priorities. We grew total revenue by 25%, reflecting continued momentum across our portfolio. And importantly, we continue to invest with discipline, in our medicines, in our pipeline, and in our future growth, fully aligned with our capital allocation priorities. Even with these strategic investments, we grew operating profits.

我們先看第一季重點。在 2026 年第一季，我們持續交出強勁的財務表現，並針對策略優先事項取得聚焦的進展。我們的總營收成長 25%，反映我們產品組合持續的動能。更重要的是，我們持續以紀律性方式投資於我們的藥物、研發管線與未來成長，並與我們的資本配置優先順序完全一致。即使進行這些策略性投資，我們的營業利益仍然成長。

The quarter was also marked by progress in our mission to bring innovative medicines to patients. There are a few highlights I would like to mention. (inaudible) continued to build positive momentum. We were very pleased to see the hospitalization recommendations were moved from the turn-line plus relapsed or refractory diffuse large B-cell lymphoma label, and we are on track with the integration of Merus.

本季也標誌著我們在「將創新藥物帶給病患」使命上的進展。我想提幾個重點。（聽不清）持續建立正向動能。我們非常高興看到住院建議已自 turn-line plus 復發或難治性瀰漫性大 B 細胞淋巴瘤（DLBCL）標籤中移除，且我們正按計畫推進 Merus 的整合。

And we are approaching this with the same focus and discipline that we brought to profound bio. Finally, the breadth, depth, and potential of RINA-S continues to increase. The data we presented at SGO in April further support the promise of RINA-S, including in combination with the standard of care therapy such as bevacizumab.

我們以與對待 Profound Bio 相同的專注與紀律來推進此事。最後，RINA-S 的廣度、深度與潛力持續提升。我們於 4 月在 SGO 發表的數據進一步支持 RINA-S 的前景，包括與標準治療（例如 bevacizumab）合併使用。

We are also making significant progress with our development plan, as you can see on the next slide. We anticipate starting two new Phase 3 trials for RINA-S in the coming months, underscoring our commitment to a comprehensive development plan across ovarian and endometrial cancers. These include a Phase 3 chemo replacement trial in platinum-sensitive ovarian cancer and the first frontline trial for RINA-S in endometrial cancer, as we continue to explore new opportunities for RINA-S outside gynecological oncology with a Phase 2 trial seeking with a Phase 2 signal-seeking basket trial in advanced gastrointestinal cancers.

我們的開發計畫也取得顯著進展，如下一張投影片所示。我們預期在未來幾個月啟動兩項新的 RINA-S 第三期試驗，凸顯我們致力於在卵巢癌與子宮內膜癌領域推動全面性的開發計畫。這些試驗包括：在鉑敏感性卵巢癌中的第 3 期化療替代試驗，以及 RINA-S 在子宮內膜癌中的首個一線試驗；同時，我們也將透過一項第 2 期訊號探索（signal-seeking）的籃式試驗，在晚期胃腸道癌中探索 RINA-S 於婦科腫瘤學以外的新機會。

Finally, I am pleased to share an update on the ongoing Phase 3 trial in Second Line PSOC Platinum-resistant ovarian cancer on the next slide. Because recruitment has been much faster than expected, the Phase 3 RAINFOL-02 trial has now completed enrollment. This important milestone brings forward the pivotal Phase 3 data for RINA-S and platinum-resistant cancer into 2026.

最後，我很高興在下一張投影片分享正在進行中的第 3 期試驗更新：第二線 PSOC 鉑抗性卵巢癌。由於招募速度遠快於預期，第 3 期 RAINFOL-02 試驗現已完成收案。這一重要里程碑使 RINA-S 在鉑抗性癌症中的關鍵性第 3 期數據時程提前至 2026 年。

This reflects strong investigator engagement, the significant unmet medical needs in this indication, and the strength of our execution on one of our highest-priority late-stage programs. So we can now look forward to two datasets in the second half of this year for RINA-S in platinum-resistant ovarian cancer.

這反映了研究者的高度投入、此適應症顯著的未滿足醫療需求，以及我們在最優先的後期開發專案之一上的強大執行力。因此，我們現在可期待今年下半年取得兩組 RINA-S 於鉑抗性卵巢癌的數據。

And the opportunity for broader global regulatory filings earlier than anticipated. For both (inaudible) and at EPKINLY, we are maintaining our guidance on the timing of data, as you see here. So the key takeaway is that 2026 continues to be a very catalyst-rich year for Genmab, with readouts that have the potential to support important launches in 2027 to bring our antibody medicines to many more patients.

並有機會比原先預期更早進行更廣泛的全球法規申請。對於（聽不清）以及 EPKINLY，我們仍維持對數據時程的指引，如此處所示。因此，關鍵重點是：2026 年對 Genmab 而言仍是充滿催化劑的一年，相關讀出結果有望支持 2027 年的重要上市，讓我們的抗體藥物惠及更多病患。

With that, I'm very pleased to hand you over to Brad for a review of the recent commercial performance for EPKINLY and TIVDAK. Brad?

接下來，我很高興把時間交給 Brad，請他回顧 EPKINLY 與 TIVDAK 近期的商業表現。Brad？

Thanks, Jan. Our proprietary portfolio is off to a strong start here in 2026. Sales for the quarter totaled $176 million, representing 43% growth compared to Q1 last year. Momentum for TIVDAK and EPKINLY reflects effective execution by our teams in the new and established markets to expand utilization, accelerate uptake and ultimately reach more patients. This performance, combined with our work this year to advance our portfolio and expand our footprint to reach patients in more markets, positions us well to deliver on our growth ambitions in 2026 and beyond.

謝謝你，Jan。我們的自有產品組合在 2026 年開局表現強勁。本季銷售額合計 1.76 億美元，較去年第一季成長 43%。TIVDAK 與 EPKINLY 的動能反映我們團隊在新市場與既有市場的有效執行，擴大使用、加速採用，最終觸及更多病患。這樣的表現，加上我們今年推進產品組合並擴大市場覆蓋以觸及更多市場病患的工作，使我們具備良好條件，在 2026 年及未來實現成長目標。

In the quarter, EPKINLY continued to gain notable traction as the only bispecific approved in DOBCL and FL indications. Looking globally, EPKINLY grew 52% year-over-year, reaching $137 million in sales. In the US, EPKINLY continued to expand across both academic and community settings, and this growth reinforces EPKINLY's value as a single bispecific option in lymphoma indications, which is resonating well with hospitals and health systems.

本季，EPKINLY 作為唯一在 DOBCL 與 FL 適應症獲批的雙特異性抗體，持續獲得顯著的市場牽引力。從全球來看，EPKINLY 年增 52%，銷售額達 1.37 億美元。在美國，EPKINLY 持續在學術與社區醫療場域擴張；此成長進一步強化 EPKINLY 作為淋巴瘤適應症中單一雙特異性選項的價值主張，並在醫院與醫療體系中引起良好共鳴。

The recent approval of fixed duration of EPKINLY plus R-squared in second-line FL has been a growth driver for the brand and contributed positively to EPKINLY's growth in the quarter. The recent approval in the quarter, we're seeing physicians increasingly use this chemo-free combination in academic and community sites, supported by unprecedented data demonstrating powerful efficacy and proven safety with seamless subcutaneous administration.

近期 EPKINLY 加上 R-squared 於第二線 FL 的固定療程（fixed duration）獲批，成為品牌成長的驅動因素，並對本季 EPKINLY 的成長帶來正面貢獻。隨著本季的近期核准，我們看到醫師在學術與社區院所愈來愈多採用此無化療（chemo-free）合併療法；其背後有前所未有的數據支持，展現強勁療效與已證實的安全性，並可透過無縫的皮下注射給藥。

Looking ahead, we expect adoption in the community to continue to expand across both FL and DOBCL, bringing up KINLY -based therapies closer to where patients live. And in March, the FDA revised the label for EPKINLY in third line plus DOBCL to remove the recommendation for 24-hour hospitalization following the first full dose.

展望未來，我們預期社區端的採用將持續在 FL 與 DOBCL 兩個適應症擴大，讓以 KINLY 為基礎的治療更貼近病患居住地。此外在 3 月，FDA 修訂 EPKINLY 於第三線以上 DOBCL 的標籤，移除首次完整劑量後需住院 24 小時的建議。

Now the label advises physicians to assess whether outpatient monitoring for hospitalization is appropriate following the first full dose. We do expect this will further broaden use in the community and in the outpatient setting. Beyond the US, performance remains strong. In Japan, EPKINLY continues to stand out as the only bispecific approved in both Third Line Plus LBCL and FL with continued year-over-year growth. The FL launch is building positively on the brand success in large B-cell lymphoma, supported by strong field execution and ongoing site activation.

目前標籤建議醫師評估在首次完整劑量後，是否適合採用門診監測而非住院。我們預期這將進一步擴大在社區端與門診場域的使用。在美國以外，表現仍然強勁。在日本，EPKINLY 持續以唯一同時在第三線以上 LBCL 與 FL 獲批的雙特異性抗體脫穎而出，並維持年對年成長。FL 的上市正建立在大 B 細胞淋巴瘤領域的品牌成功之上，並受惠於強勁的前線執行與持續的院所啟用。

In other markets, through our partner AbbVie, EPKINLY continues to grow with approvals in more than 65 countries, which most have dual indications. For the remainder of 2026, we're focused on maximizing our first-mover advantage in second-line FL in the US, while preparing for expected approvals in this setting in Europe and Japan later this year and in early lines of DLBCL in the future.

在其他市場，透過我們的合作夥伴 AbbVie，EPKINLY 持續成長，已在超過 65 個國家獲得核准，其中多數具有雙適應症。在 2026 年剩餘期間，我們將聚焦於在美國第二線 FL 最大化我們的先行者優勢，同時為今年稍晚在歐洲與日本預期於此治療線別的核准做準備，並為未來在更早期治療線別的 DLBCL 做準備。

As we look ahead, our priority is to accelerate development, including in combination and across early lines of therapy to continue to build on the already strong clinical data demonstrating EPKINLY's versatility and ultimately establish EPKINLY as the core therapy in B-cell malignancies.

展望未來，我們的優先事項是加速開發，包括在聯合療法以及更早期治療線別的拓展，以持續建立在已相當強勁的臨床數據之上，這些數據證明了 EPKINLY 的多樣適用性，並最終將 EPKINLY 確立為 B 細胞惡性腫瘤的核心治療。

Turning now to TIVDAK, which is the global standard of care in recurrent or metastatic cervical cancer. TIVDAK grew 18% year over year, reaching $39 million in sales in the quarter. This reflects both the significant need for therapies that have improved survival for women with advanced cervical cancer and our ability to effectively scale commercialization across markets.

接著談到 TIVDAK，它是復發或轉移性子宮頸癌的全球標準治療。TIVDAK 年增 18%，本季銷售額達 3,900 萬美元。這反映了針對晚期子宮頸癌女性、能改善存活的治療方案之重大需求，以及我們在各市場有效擴大商業化規模的能力。

In the US, the brand delivered steady performance and continues to lead the market, a position that has held since launch nearly five years ago. Outside the US, we're seeing encouraging progress in newer launch markets.

在美國，該品牌表現穩健並持續領先市場，自近五年前上市以來一直維持此一地位。在美國以外，我們在較新的上市市場看到令人鼓舞的進展。

In both Japan and Europe, where we lead commercialization directly, growth is being driven by strong field execution and expanding site activation. We also made meaningful progress expanding patient access this quarter. In the UK, TIVDAK launched in February through private prescribing and payer channels, and we're actively engaging NICE and SMC to secure broader availability.

在日本與歐洲兩地（我們直接主導商業化），成長主要由強而有力的前線執行與擴大醫療機構啟用所帶動。本季我們也在擴大病患可近性方面取得實質進展。在英國，TIVDAK 於 2 月透過自費處方與支付方通路上市，我們正積極與 NICE 與 SMC 互動，以爭取更廣泛的可及性。

At the same time, building upon our work in the UK and our established presence in Germany, we're actively preparing for additional launches, with infrastructure and teams being established across key European markets, including France, Italy, and Spain.

同時，在延續我們於英國的工作以及在德國既有布局的基礎上，我們正積極準備更多上市，並在法國、義大利與西班牙等關鍵歐洲市場建立基礎設施與團隊。

Given the significant unmet need in advanced cervical cancer, we look forward to the impact TIVDAK can make for more patients as additional markets gain approval and reimbursement. And more broadly, we're building a strong, scalable presence in gynecologic oncology with a meaningful opportunity to expand our impact overtime, particularly with RINA-S in the future.

鑑於晚期子宮頸癌仍存在顯著未被滿足的醫療需求，隨著更多市場取得核准與給付，我們期待 TIVDAK 能為更多病患帶來影響。更廣泛而言，我們正在婦科腫瘤領域建立強健且可擴展的布局，並具備可觀機會隨時間擴大影響力，尤其是未來的 RINA-S。

To wrap up, our Q1 performance positions us well to sustain momentum in 2026. With continued performance and expanding portfolio, we're well-positioned to successfully evolve our business and grow through the decade, supported by the strength of our science, including three potential blockbuster assets with EPKINLY, RINA-S and Petosemtamab and our proven ability to scale commercialization and successfully launch in markets where we can drive the greatest impact for patients.

總結而言，我們第一季的表現使我們在 2026 年能夠維持動能。在持續的業績表現與產品組合擴張之下，我們具備良好條件，得以成功推動業務演進並在本十年持續成長；這得益於我們科學實力的支撐，包括 EPKINLY、RINA-S 與 Petosemtamab 三項潛在重磅資產，以及我們已被驗證的能力：在能為病患帶來最大影響的市場中擴大商業化規模並成功上市。

Overall, we're very pleased with the start to the year and expect 2026 to be another strong year for Genmab.

整體而言，我們對今年的良好開局感到非常滿意，並預期 2026 年將是 Genmab 另一個強勁的一年。

With that, I'll turn it over to Anthony to walk through the financials.

接下來，我把時間交給 Anthony 來說明財務表現。

Thanks, Brad. Before diving into the numbers, as we highlighted last quarter, please note that these results and guidance in our remarks exclude the impact of acquisition-related expenses, including amortization. The reconciliation to our reported results is included in the appendix.

謝謝，Brad。在深入數字之前，如同我們上季所強調，請注意我們在發言中所提及的這些結果與財測指引不包含併購相關費用的影響，包括攤銷。與我們已揭露之財報結果的調節表列於附錄。

In Q1 2026, we delivered growth driven by sustained revenues and the solid market performance of our portfolio. Revenue grew by 25%, driven by strong royalties from Darzalex and Kesimpta. And importantly, this growth was also driven by product sales from our own medicines, especially EPKINLY, continuing to diversify our revenue base.

在 2026 年第一季，我們在持續性營收與產品組合穩健的市場表現帶動下實現成長。營收成長 25%，主要由 Darzalex 與 Kesimpta 的強勁權利金所驅動。更重要的是，這項成長也來自我們自有藥品的產品銷售，尤其是 EPKINLY，持續推動我們的營收來源多元化。

Our investments remained fully in line with our capital allocation priorities, including significant investments for EPKINLY, RINA-S, and Petosemtamab. And we made these important investments while growing operating profit by 23%.

我們的投資仍完全符合資本配置優先順序，包括對 EPKINLY、RINA-S 與 Petosemtamab 的重大投資。在進行這些重要投資的同時，我們的營業利益也成長了 23%。

Moving to tax. As you can see in the appendix of this presentation, we have tax expense of around $21 million, which equates to an effective tax rate of 28.9%. And here, I do want to pause for a moment and note that we are currently evaluating the integration of Marist operations from a tax perspective. So our effective tax rate may experience some volatility as integration activities progress. However we do anticipate that this is going to normalize within the next 12 to 18 months. Overall, the first quarter of 2026 demonstrates the continued strength and quality of Genmab's underlying financial performance.

接著談稅務。如各位在本簡報附錄所見，我們的所得稅費用約為 2,100 萬美元，對應的有效稅率為 28.9%。在此我想稍作停留並說明，我們目前正從稅務角度評估 Marist 營運的整合。因此，隨著整合活動推進，我們的有效稅率可能會出現一定波動。不過，我們預期這將在未來 12 至 18 個月內趨於正常化。整體而言，2026 年第一季展現了 Genmab 基礎財務表現持續的強度與品質。

With that, let's move to our 2026 financial guidance. We remain on track to achieve our existing financial guidance with revenue growth that enables strategic investment, supporting long-term value creation. After midpoint, we expect 14% total revenue growth, driven by continued momentum in at EPKINLY and our royalty portfolio, further enhancing revenue quality. For operating expenses, we expect to be in a range of around $2.7 billion to $2.9 billion.

接下來我們看 2026 年財務指引。我們仍按計畫達成既有財務指引，透過營收成長支持策略性投資，進而支撐長期價值創造。以中位數來看，我們預期總營收成長 14%，主要由 EPKINLY 的持續動能與我們的權利金產品組合所帶動，進一步提升營收品質。在營業費用方面，我們預期約落在 27 億至 29 億美元的區間。

Reflecting planned investments to advance late-stage development for Petosemtamab and RINA-S, as well as launch readiness activities to support multiple potential product launches. And even with the strategic step-up, our guidance delivers on our commitment to maintain substantial profitability in 2026.

此反映了為推進 Petosemtamab 與 RINA-S 的後期開發所規劃的投資，以及支援多項潛在產品上市的上市準備活動。即使在策略性加碼之下，我們的指引仍兌現我們在 2026 年維持可觀獲利能力的承諾。

In summary, our performance in the first quarter of 2026 underscores our ability to deliver revenue growth, advance key pipeline assets and maintain strong profitability through disciplined execution. Looking ahead to the rest of 2026, we will continue to build on our momentum through disciplined prioritization of our investments, continued operating discipline and expansion of market opportunities. This positions us for sustained growth and long-term value creation.

總結來說，2026 年第一季的表現凸顯我們透過嚴謹執行來實現營收成長、推進關鍵研發管線資產並維持強勁獲利能力的能力。展望 2026 年剩餘期間，我們將透過對投資的嚴謹優先排序、持續的營運紀律以及市場機會的擴張，持續累積動能。這使我們具備持續成長與長期價值創造的有利位置。

And on that note, I'm going to hand you back over to Jan.

基於此，我將把時間交回給 Jan。

Thank you, Anthony. Let's move on to our final slides. In the first quarter of 2026, our financial performance reinforced the strength of our foundation and the durability of our growth trajectory. That strength supports a disciplined capital allocation strategy focused on the areas with the greatest potential to create long-term value, accelerating our late-stage pipeline, maximizing the success of our commercialized medicines, and ensuring strong launch readiness for future opportunities.

謝謝你，Anthony。我們來看最後幾張投影片。在 2026 年第一季，我們的財務表現再次印證了我們基礎的穩健以及成長軌跡的韌性。這樣的強度支撐一項嚴謹的資本配置策略，聚焦於最有潛力創造長期價值的領域：加速我們的後期研發管線、最大化已商業化藥品的成功，以及確保未來機會的強健上市準備。

And as we further move into 2026, we also remain focused on integrating Merus . So that we can capture the full value of Petosemtamab. Lastly, we remain committed to deleveraging, targeting gross leverage below 3 times by the end of 2027 while maintaining balance sheet strength and flexibility.

隨著我們進一步邁入 2026 年，我們也仍專注於整合 Merus。以便我們能充分掌握 Petosemtamab 的全部價值。最後，我們仍致力於去槓桿化，目標是在 2027 年底前將總槓桿降至 3 倍以下，同時維持資產負債表的強度與彈性。

Taken together, Genmab is very well positioned. We have a growing and increasingly diversified revenue base, a powerful late-stage pipeline, and multiple capitalists ahead. And our focus remains clear to translate our antibody science and development expertise into meaningful breakthroughs for patients and sustainable long-term value for shareholders. So that ends our formal presentation. Thank you for listening.

綜合而言，Genmab 的定位非常有利。我們擁有持續成長且日益多元化的營收基礎、強大的後期研發管線，以及多項未來催化劑。我們的重點依然明確：將我們在抗體科學與開發方面的專長轉化為對病患具有意義的突破，以及為股東帶來可持續的長期價值。以上為我們的正式簡報內容。感謝各位聆聽。

Operator, please open the call now for questions.

接線員，請現在開放提問。

(Operator Instructions)

(接線員指示)

Jonathan Chang.

Jonathan Chang。

Hi, guys. Thanks for taking my question. On the frontline Petosemtamab head and neck cancer study, it looks like the size of the study has been increased. Can you discuss the rationale behind any changes to the study and implications of those changes? Thank you.

嗨，各位。謝謝讓我提問。關於一線治療的 Petosemtamab 頭頸癌研究，看起來研究規模已經增加。能否談談研究設計變更背後的理由，以及這些變更的影響？謝謝。

Thanks, Jonathan, for the question. Tahi, why don't you take the first question by Jonathan?

謝謝你，Jonathan，提出問題。Tahi，要不要你先回答 Jonathan 的第一個問題？

Yeah, thank you, Jan and thank you, Jonathan. Yes, also indeed. We increased the size of the frontline study. I think we had in the past indicated that there were thoughts that we had as it relates to the studies that we wanted to ensure that they have the highest probability of success. The details, I don't think, are the ones that we want to discuss in a public space.

好的，謝謝你，Jan，也謝謝你，Jonathan。是的，確實如此。我們提高了一線研究的規模。我想我們過去也提過，針對這些研究我們有一些想法，目的是確保它們具備最高的成功機率。至於細節，我想我們不希望在公開場合討論。

But these trials are being increased based on our insight that we generated during the diligence to ensure that they have the highest probability to our standards. We do not have any anticipation that these changes have any impact on the timelines and steadfast. With our guidance, that one or both of the picture studies will read out this year and will provide data this year.

不過，基於我們在盡職調查期間所產生的洞見，為了確保試驗符合我們的標準並具備最高成功機率，因此擴大了這些試驗。我們不預期這些變更會對時程造成任何影響，時程仍將維持不變。依照我們的指引，其中一項或兩項關鍵研究將在今年讀出，並於今年提供數據。

Thanks, Tahi. Let's move on to the next question.

謝謝你，Tahi。我們進入下一個問題。

Zain Ebrahim, JPMorgan.

Zain Ebrahim，摩根大通。

Thanks a lot. I've got two questions, Zain Abraham, JP Morgan.

非常感謝。我有兩個問題，我是 Zain Abraham，摩根大通。

First question is just a follow-up on the previous one. And it's helpful that you just said you don't expect the increased size of the first line trial to impact the timing. But just to understand in more detail why that is, given that you're increasing the trial from 500 patients to 700, so have you already completed enrollment of the initial patient population that you're looking to enroll, and how is enrollment progressing, I suppose, and I guess tied to that, whether the increase is for HPV negative to patients, that would be helpful to understand as well.

第一個問題是延續前一題。你剛才提到不預期一線試驗擴大規模會影響時程，這點很有幫助。但我想更深入了解原因：你們把試驗從 500 名病人增加到 700 名，所以你們是否已完成原先目標族群的收案？收案進度目前如何？另外，這次增加是否是針對 HPV 陰性病人？也希望能說明。

Second question is just on EPKINLY first-line deal with CL. You've guided for the readout this year and haven't narrowed out further. So is that the final analysis, or are we still waiting on the interim?

第二個問題是關於 EPKINLY 與 CL 的一線合作案。你們指引今年會有讀出，但尚未進一步縮小範圍。所以那會是最終分析，還是我們仍在等待期中分析？

Thanks, Zain, for the questions. I think, Tahi, you can have a board of the results with the next question, and then the first line trial.

謝謝你，Zain，提出問題。我想，Tahi，你可以把結果與下一個問題一起回答，然後再談一線試驗。

Yeah, Zain, I'm sorry, I will have to repeat what I just said, which is, yes, we increased the study from 500 to 700. This was indeed to ensure that this trial has the appropriate data that we need for our probability of success, how we feel about the program and what we understand about the program, and this will not impact the timelines and what patient populations it does impact on the timing or the status of a call.

好的，Zain，抱歉，我只能重申我剛才說的：是的，我們把研究從 500 增加到 700。這確實是為了確保該試驗能產出我們所需、足以支持成功機率的適當數據，符合我們對該計畫的信心以及我們對該計畫的理解；而這不會影響時程，也不會影響其所涵蓋的病人族群對時程或目前狀態的影響。

I hope you will appreciate that in the context of a very competitive landscape, we are trying to be a little bit more disciplined on what we're sharing, when we're sharing it. So two things. It will not change the timelines of what we have guided before, and we continue to stay with the statement that one or both of these studies will read out this year.

我希望你能理解，在一個競爭非常激烈的環境下，我們會更有紀律地決定分享什麼、以及何時分享。所以有兩點：它不會改變我們先前所給出的時程指引，我們也持續維持「其中一項或兩項研究將在今年讀出」的說法。

As it relates to the future such (inaudible), again, I think we have also been very disciplined, and I will try to be continuously disciplined today. We've got it at the front end, the future such (inaudible) will read out this year, and we have not commented on interim or final or any of these questions. But we stay with the statement that the (inaudible) self-study will have a readout this year.

至於未來的（聽不清），同樣地，我想我們也一直很有紀律，我今天也會持續保持這樣的紀律。我們已在前面提到，未來的（聽不清）將在今年讀出，而我們並未評論是期中或最終分析或其他這類問題。但我們仍維持（聽不清）這項自我研究將在今年讀出的說法。

Thanks, Zain. Let's move on.

謝謝你，Zain。我們繼續。

James Gordon, Barclays.

James Gordon，巴克萊。

Hello, James Gordon, Barclays. Thanks for taking the question. Two quick ones. One was reading the (inaudible). So there's O1 and O2 coming in H2 this year. So just wanted to confirm, with the two trials reporting so closely together, so Phase 2 and Phase 3, would you definitely report them as separate results, and if the Phase 2 is positive, you'll file it and not wait for the phase three, or have you discussed that plan with FDA, or might they say we've been so close together, let's see both?

你好，我是 James Gordon，巴克萊。謝謝讓我提問。兩個簡短問題。第一個是我在閱讀（聽不清）。所以今年下半年會有 O1 和 O2 的結果。我想確認一下：兩個試驗（第二期與第三期）讀出時間非常接近，你們會確定分開公布結果嗎？如果第二期結果正面，你們會先遞交申請而不等第三期嗎？你們是否已與 FDA 討論過這個計畫？或者 FDA 可能會說兩者時間太接近，想同時看兩個結果？

And the other one was just more generally that we've seen more data from B7H4 ADCs in gynecological cancers. How do you think that stacks up versus ADCs? This is where a few people go for this approach. Is it a different target?

另一個問題是更一般性的：我們看到在婦科癌症中，B7H4 ADC 有更多數據出來。你認為相較於 ADC（原文如此），表現如何？有一些人採用這種策略。這是不同的標的嗎？

Thanks, James, for the questions. I will ask Judith to address both the Phase 2 and Phase 3 POC trials, and then the B7H4 versus [folate] receptor alpha ADCs.

謝謝你，James，提出問題。我會請 Judith 回答第二期與第三期的 POC 試驗，以及 B7H4 相較於 [葉酸] 受體 alpha ADC 的問題。

Yeah, thank you for the question. So, for the first part, as we highlighted, the Phase 3 accrued ahead of projections, that means that we will have these two data sets this year. Given the change in landscape in PoC, the potential for the Phase 3 submission and approval becomes more relevant, and this is the plan, so we stay behind our guidance that (inaudible) will be launched in PoC in 2027.

好的，謝謝你的問題。第一部分，如同我們強調的，第三期收案進度超前原先預估，這表示我們今年會拿到兩組數據。鑑於 POC 的環境變化，第三期遞交申請與獲批的可能性變得更為重要，而這就是我們的計畫；因此我們維持先前的指引，即（聽不清）將於 2027 年在 POC 推出。

With these two data sets at support, but the main data set for filing the Phase 3 that will allow for global submissions, part one.

這兩組數據將提供支持，但用於申報的主要數據集會是第三期，並可支持全球遞交申請；以上是第一部分。

With regard to the competitive landscape, of course, we are very aware of the B7H4, the two in investigation, the [GLAXA and PUTISAM]. As we said several times, we know that this is a hyper-competitive space. We stand behind the strength of the data of RINA in terms of efficacy, safety, durability of the efficacy, and a clinical development plan and speak to market. So more competitors makes it, more competitive, but doesn't preclude the fact that we it could be not just first in class, but best in class, given the data so far.

至於競爭態勢，當然我們非常清楚 B7H4 的情況，目前有兩個正在研究中的項目，[GLAXA 和 PUTISAM]。如同我們多次提到，這是一個競爭極度激烈的領域。我們對 RINA 的數據優勢仍有信心，包括療效、安全性、療效持久性，以及臨床開發計畫與商業化策略。因此，競爭者增加會讓競爭更激烈，但不會排除我們不僅可能成為同類首創（first-in-class），也可能依據目前數據成為同類最佳（best-in-class）的可能性。

Thanks, thank you. So, it comes down to effective execution, James, and we moved in basically two years from zero Phase 3 to now five Phase 3 with the news of today.

謝謝，謝謝。所以，James，關鍵在於有效的執行；而我們基本上在兩年內，從零個第三期推進到現在五個第三期，這也是今天消息所反映的。

Xian Deng, UBS.

Xian Deng，瑞銀。

Hi, Xian, UBS.

你好，我是 Xian，瑞銀。

Thank you for taking my question. So I got a few at EPKINLY frontline BCL trials, please. Just wondering, even, the typical PFF curve tend to pretty much, almost start to plateau after, let's say, 18 months or so in a typical, let's say, frontline BLPCL trial like Polarix. Just purely, hypothetically, right, it doesn't have to be, anything to do with that team lead, just purely from a statistical point of view, do you expect a big change in hazard ratio when during the last 25% of events, just assuming sort of a typical, let's say, frontline BLPCL trial, PFF curve, that's the first question.

感謝讓我提問。我有幾個關於 EPKINLY 一線 BCL 試驗的問題。我想請教的是，在典型的一線 BLPCL 試驗（例如 Polarix）中，PFF 曲線通常在大約 18 個月左右就會幾乎開始進入平台期。純粹假設性地說（不一定與該試驗團隊領導有任何關係），僅從統計角度來看，在最後 25% 的事件期間，您是否預期風險比（hazard ratio）會出現很大的變化？這是在假設一個典型的一線 BLPCL 試驗 PFF 曲線的前提下。這是第一個問題。

And the second one is kind of, also on that one is your study is capped at 30% of IPI Stage 2 patients. So just wondering if you could give any colors on whether, you've reached this number or your IPI-2 patients is actually below this. I'm just wondering what impact could they have in terms of powering and timing for the primary endpoint. Thank you.

第二個問題也與此相關：你們的研究對 IPI 第 2 期患者的比例上限設定為 30%。想請問能否提供一些資訊，說明是否已達到這個比例，或是 IPI-2 患者實際上低於此上限。我想了解他們可能會對主要終點的統計把握度（power）與讀出時間（timing）造成什麼影響。謝謝。

Thank you. Xian. I was always teach never to answer hypothetical questions, but we'll see if we'll test out the Tahi is willing to do that. Then, moving to the second part, Tahi over to you.

謝謝。Xian。我一直被教導不要回答假設性問題，但我們看看是否要測試一下 Tahi 是否願意這麼做。接著進入第二部分，Tahi 交給你。

Yes, yeah, thank you. So, yeah, so what I can say is you're absolutely right. (inaudible) front line studies tend to [plateau] on month 18 to 20, and I think that's my only comment on that question. I'm particularly speculating what I expect. I don't think it's helpful because I actually don't know how these curves are going to behave on this trial until we see the data.

是的，謝謝。我能說的是，你說得完全正確。（聽不清）一線研究的曲線往往在第 18 到 20 個月左右進入[平台期]，我對這個問題的評論大概就到這裡。我不會特別去推測我預期會如何。我認為那沒有幫助，因為在我們看到數據之前，我其實不知道這些曲線在本試驗中會如何表現。

The cap is also correct. There's a 30% cap. Again, I don't think it's appropriate at this point to talk about what the actual demographics of the study are. The only other point that I think is important to understand, the primary endpoint is actually IPI-3 to 5 passes certain statistics, and then it will read out 2 to 5. And so I think these are my comments on the questions. Thank you.

關於上限，你說得也沒錯。確實有 30% 的上限。同樣地，我認為在這個時間點談論研究的實際人口學分布並不恰當。我認為另一個需要理解的重要點是：主要終點其實是針對 IPI 3 到 5 的人群達到特定統計條件後，接著才會讀出 2 到 5 的結果。以上是我對問題的回應。謝謝。

Thank you.

謝謝。

Yes, absolutely. Thank you. On to the next one, operator.

是的，完全同意。謝謝。請接下一位，接線員。

Rajan Sharma, Goldman Sachs.

Rajan Sharma，高盛。

Hi, thanks for taking a question. So first one on EPKINLY, just kind of following on the theme there, but what do you think is sort of the relevant benchmark for EPCORE DLBCL-4? That's the second line trial, just in the context of the competitive landscape and some of the potential advantages that EPKINLY has.

嗨，謝謝讓我提問。第一個問題關於 EPKINLY，延續剛才的主題，你認為 EPCORE DLBCL-4 的相關對標基準（benchmark）應該是什麼？那是一個二線試驗，想在競爭格局以及 EPKINLY 可能具備的一些優勢背景下請教。

And then secondly, just on the new (inaudible) trial that you announced, RAINFOL-8, is that likely to be a catered combination trial. Thanks.

第二個問題，關於你們宣布的新（聽不清）試驗 RAINFOL-8，它是否可能是一個量身打造的聯合用藥試驗？謝謝。

Thanks, Rajan for the questions. Tahi, why don't you take the first one, and then Judith maybe you can go into the new RINA-S trial, one of the new RINA-S trials.

謝謝你，Rajan，提出這些問題。Tahi，你先回答第一個，然後 Judith 也許可以談談新的 RINA-S 試驗，也就是其中一個新的 RINA-S 試驗。

Yes, so this is a question about the second line, if you search visa. And so I think there's a couple of things to be said about the 1 to 8 study. First, it is again a randomization against GemOx. So in the end, that's what the study is going to be compared, and everything else is going to cost study comparison. They're obviously a little bit problematic.

好的，這個問題是關於二線，如果你搜尋 visa（原文如此）。我認為關於 1 到 8 研究，有幾點可以說明。第一，它同樣是與 GemOx 進行隨機對照。因此最終，研究的比較對象就是 GemOx，而其他所有比較都會變成跨研究比較。而跨研究比較顯然會有些問題。

But what is the excitement on our end for this particular regimen is that this is a regimen comprised of an oral medication and a subcutaneous administration that hopefully will show positive data and meaningful positive data for patients. And then also comes with a safety profile that is tolerable and differentiated from maybe the chemotherapy combinations with GemOx, but also improved in efficacy means of immunotherapy.

但我們對這個特定方案感到興奮之處在於：這是一個由口服藥物加上皮下注射給藥所組成的方案，我們希望它能呈現正向且對患者具有臨床意義的正向數據。此外，它也具備可耐受的安全性特徵，並且可能相較於 GemOx 的化療聯合方案有所差異化，同時在免疫治療的療效層面有所提升。

And it's really perfectly suited for the outpatient setting or the community setting. And that's what this trial was intended to do, to generate a regimen that is patient-friendly with increased CR rates that then is appropriate and suitable for the community setting, and so we'll see what the data is, but that's the intent of the trial.

而且它非常適合門診環境或社區醫療場域。這正是本試驗的目的：建立一個對患者友善、CR 率更高、並且適合且可在社區場域使用的治療方案；至於數據如何我們拭目以待，但這就是試驗設計的初衷。

Thanks, Tahi, and then maybe Judith on the combination for RINA.

謝謝，Tahi。接著請 Judith 談談 RINA 的聯合用藥。

Okay, the question, can you repeat the question? The combination with did you ask? Oh, yeah, the data that we present. The okay, so we, in terms of combination, the combination with [VEV] was presented at HGO, and if you can appreciate, if you are there, the safety was very well tolerated.

好的，你的問題是什麼？可以再重複一次嗎？你問的是與什麼的聯合？喔，是的，我們所呈現的數據。好的，關於聯合用藥，與 [VEV] 的聯合已在 HGO 上報告；如果你當時在場，你會看到其安全性耐受性非常好。

The study was meant only for safety, but in terms of efficacy, we are very pleased with the median number of cycles of 10. And even the fact that 15 of the patients were refractory, 85% of the patients got more than six cycles. So this is VEV.

該研究原本僅旨在評估安全性，但就療效而言，我們對中位治療週期數達到 10 個週期感到非常滿意。甚至在其中 15 位患者為難治（refractory）的情況下，仍有 85% 的患者接受了超過六個週期。這就是 VEV。

In terms of Pembro, we have two cohorts ongoing in different settings and we will communicate the data and when the data is a little bit mature and enrolled, so it's actively enrolling.

至於 Pembro，我們在不同情境下有兩個隊列正在進行中；待數據更成熟且入組更完整時，我們會對外溝通數據，目前仍在積極入組。

Thanks, Judith. I think that answers your questions, Rajan. Let's move on to the next question.

謝謝，Judith。我想這回答了你的問題，Rajan。我們進入下一個問題。

Michael Schmidt, Guggenheim Partners.

Michael Schmidt，Guggenheim Partners。

Hey, thanks for taking my questions. I had another one on EPCORE DLBCL-2. Maybe just in terms of the enrollment of the study, Tahi, could you just comment on how enrollment has been relative to your expectations when starting the trial?

嗨，謝謝讓我提問。我還有一個關於 EPCORE DLBCL-2 的問題。也許就研究入組而言，Tahi，你能否評論一下，入組速度相對於你們啟動試驗時的預期如何？

And secondly, I know in the Phase 2 study, you've evaluated, I believe, a continuous treatment paradigm versus the fixed duration treatment in the Phase 3 study. And can you speak to your confidence level that the fixed duration paradigm can replicate the Phase 2 data? Thanks.

第二個問題，我知道在二期研究中，你們評估了我相信是連續治療模式，相對於三期研究中的固定療程治療。你能談談你對固定療程模式能夠複製二期數據的信心程度嗎？謝謝。

Thanks, Michael. Tahi.

謝謝，Michael。Tahi。

Yeah, generally speaking, I think, true for one to eight, which is the second line of research trials, as for the frontline research research trials, that these trials accrued significantly faster than they were initially projected. I think that's a statement that we've made multiple times.

是的，概括來說，我認為無論是 1 到 8（也就是二線研究試驗），還是一線研究試驗，這些試驗的入組速度都明顯快於最初的預測。我想這是我們多次提到過的一點。

As it relates to the original Phase 2 data in frontline where we continued echoing a more therapy after ARCH drop for the full year, and the design of the trial, the Phase 3 trial, where it's ARCH for six cycles, plus (inaudible), followed by two more therapy cycles of (inaudible).

至於一線原始二期數據，我們在 ARCH 之後持續給予更多治療，總共達到一整年；而三期試驗的設計則是 ARCH 六個週期，加上（聽不清），之後再追加兩個治療週期的（聽不清）。

When we started to generate this data, gosh, in 2020, we were going for the maximum possible exposure if you wanted to ask to be generated the data and had the opportunity to see this and also discuss with health authority became very clear partially also because of the data that was presented by (inaudible) and MID negativity that you don't actually need to expose these patients to continue therapy. Keep in mind a significant portion of these patients are cured already with our (inaudible).

當我們開始產生這些資料時，天啊，在2020年，我們的目標是盡可能達到最大的暴露量——如果你希望要求產生資料，並且有機會看到這些資料、也能與衛生主管機關討論——那麼就變得非常清楚，部分也因為（聽不清）所呈現的資料以及MID陰性，你其實不需要讓這些病人持續治療而繼續暴露於治療之下。請記住，這些病人中有相當一部分已經透過我們的（聽不清）治癒了。

And so that's why we ended up with the design. We feel extremely confident that, the, if you will, shorten observation of EPKINLY, as you framed it, doesn't have any impact on the ability of this combination regimen to achieve CR and even MID negativity at really very high rates as they have been in the public domain and shared.

因此這就是我們最後採用這個設計的原因。我們非常有信心，你所說的EPKINLY較短的觀察期（如你所表述）不會影響這個合併療法達到CR、甚至以非常高的比例達到MID陰性的能力；這些結果已在公開領域中披露並分享。

And we have a reason, as I've discussed many times, to be confident because we've seen it's not a number of EPKINLY that the Phase 3 trials tends to mimic the original Phase 2 data just because the mechanism is very predictable for EPKINLY. Thank you.

而且我們有理由——正如我多次討論過的——保持信心，因為我們看到，對於EPKINLY而言，第三期試驗的結果往往會重現原始第二期資料，這並不是因為EPKINLY的數量，而是因為其作用機轉非常可預測。謝謝。

Thanks, Tahi. Thanks, Michael.

謝謝，Tahi。謝謝，Michael。

Benjamin Jackson, Jefferies.

Benjamin Jackson，Jefferies。

Brilliant. Thank you for the question. I guess just another one thinking about sequencing of drugs through the lines of therapies in the DLBCL. We've heard from some docs that probably is a very strong salvage option. So when you're speaking to physicians, are you hearing that there is a preference for biospecifics up front just naturally because of the order that those drugs can come in? So any thoughts that could be a tailwind that would be useful? Thank you.

太棒了。謝謝你的提問。我想再問一個，關於在DLBCL不同治療線別中藥物的序列安排。我們聽一些醫師說，這可能是一個非常強的挽救治療選項。所以當你們與醫師交流時，你們是否聽到對雙特異性抗體在前線優先使用的偏好——只是因為這些藥物能夠介入的順序使然？所以你們是否認為這可能是一個有利因素（tailwind）並且會有幫助？謝謝。

Thanks, Ben, for the question. Tahi, this one is again for you.

謝謝你，Ben，這個問題。Tahi，這題又是給你的。

Well, I think, yeah, I'll try to answer Benjamin and maybe Brad has had something he may have something to do. But from the way I think about this, at least, I think this is also how physicians that we work with and always engage, think about this, needed a sequencing of drugs, generally speaking, as a function of efficacy and safety.

嗯，我想，是的，我會試著回答Benjamin，也許Brad也有一些補充，他可能也想說幾句。但就我對這件事的看法——我想這也大致是我們合作並持續互動的醫師們的思考方式——藥物的序列安排，一般而言，是依據療效與安全性來決定。

And in particular, in the future, we said frontline, where (inaudible) a decent amount of patients. I think the anticipation just has to be that, this trial, that the trial that leads out is going to generate data that is going to have a significant impact on the outcomes for patients. And if it does, then that will need some natural adoption because the obvious goal in [diffuser] is to avoid the relapse of factory setting where things become, generally speaking, a little bit harder to manage.

特別是未來我們所說的前線治療，（聽不清）涵蓋相當多的病人。我認為合理的預期必須是：這項試驗——也就是最先讀出的那個試驗——將產生對病人結局有重大影響的資料。如果確實如此，那麼就會需要自然的採用，因為在[diffuser]中顯而易見的目標，是避免復發的「工廠設定」情境，因為一旦走到那一步，整體而言會更難管理。

Thanks, Tahi. Brad, do you want to add anything to this, to sequencing of the medicines?

謝謝，Tahi。Brad，你想就藥物序列安排再補充什麼嗎？

I think maybe the only thing to add, Tahi said it well, is we do hear from physicians that, and we've said quite a while all along that the value of bispecifics are certainly in earlier lines of therapy where patients are actually treated closer to their home. We're starting to see this really come to fruition with the advent of the second-line FL launch just late last year, and that's been a key growth driver.

我想可能唯一要補充的是，Tahi已經說得很好：我們確實聽到醫師表示——而且我們一直以來也說了很久——雙特異性抗體的價值，確實在較早的治療線別更能體現，因為病人實際上能在離家更近的地方接受治療。隨著去年年底第二線FL上市，我們開始看到這點真正落地實現，而這也成為一個關鍵的成長驅動因素。

The feedback from physicians, hospitals, and hospitals and health systems has been extremely positive with not only the unprecedented data as Tahi referenced, but also the convenience and being able to realize the value closer to the patient's home.

來自醫師、醫院，以及醫院與醫療體系的回饋都非常正面，不僅因為Tahi所提到的前所未有的資料，也因為其便利性，以及能夠在更接近病人住家的地方實現其價值。

Thanks. Thanks, Brad. And then we are super excited about the potential to see both the four line and the second line, the future lymphoma data. Pretty soon, for Tisotumab or upgrade them up, so exciting times.

謝謝。謝謝，Brad。另外，我們也對於有機會看到第四線與第二線、未來的淋巴瘤資料感到非常興奮。很快就會有，對於Tisotumab或把它們往上提升，所以是令人振奮的時刻。

Charlie Haywood, Bank of America.

Charlie Haywood，美國銀行（Bank of America）。

Hi, Charlie Haywood, Bank of America.

你好，我是Charlie Haywood，美國銀行。

Thanks for taking the question. I have two, please. First is on your PTO Phase 2 OS rates. Just wondered if you've taken a two-year OS cut and any directional comment on how that OS curve has trended relative to the first 12-month data that we've seen? Would it be fair to think of similar trajectory to what you've seen at year one or could you actually see similar to what your competitor saw with faster first 12-month curve decline and then stabilize more thereafter? And then will that date be presented anytime?

謝謝讓我提問。我有兩個問題。第一個是關於你們PTO第二期的OS（總生存）率。想請問你們是否已經做了兩年OS的截點（cut），以及能否方向性地評論一下，這條OS曲線相對於我們看到的前12個月資料，走勢如何？我們是否可以認為其軌跡與第一年的表現相近，還是你們可能會看到類似競品的情況：前12個月曲線下降較快，之後才更趨於穩定？另外，那些資料會在近期任何時點發表嗎？

And then second one is just on RINA-S in second-line endometrial, could you just remind us on timelines of that data and then frame your excitement in that op relative to the more imminent second-line PRoC setting, I think potential smaller patient number there, but possibly higher unmet need given lack of limited ADC presence to date? Thank you.

第二個問題是關於RINA-S在第二線子宮內膜癌，能否請你們再提醒我們該資料的時間線，並且相對於更迫近的第二線PRoC情境，幫我們框定你們對這個機會的興奮程度？我想那邊病人數可能較少，但由於迄今ADC的存在有限，未滿足需求可能更高。謝謝。

Thanks, Charlie, for the questions. Tahi, why don't you take the first one on Peto, and then Judith can handle the question on Rena, and then I need to cancel second line?

謝謝你，Charlie，這些問題。Tahi，你先回答第一個關於Peto的問題，然後Judith可以處理Rena的問題，然後我需要取消第二線？

So, if I understood your question correctly, you were asking if we are intending to update the Phase 2 data set for Peto in second line or in front line?

所以，如果我正確理解你的問題，你是在問我們是否打算更新Peto在第二線或前線的第二期資料集？

In front line, yes, front line.

前線，是的，前線。

I mean, we'll probably at some point going to update that curfew presented in the data, but I think the more meaning we got is going to be the actual study. So, we said one or two of them will read out this year, and so that's probably the more meaningful data set and relevant to the brand and to the company.

我的意思是，我們可能在某個時間點會更新那個先前呈現的資料曲線，但我認為更有意義的會是實際的研究結果。因此我們說過，今年會有一到兩項讀出，所以那可能是更有意義、也更與品牌及公司相關的資料集。

Thanks, Tahi. And then, Judith, maybe that there's something more on the timeline for [stack online], the plus and RINA.

謝謝，Tahi。然後，Judith，或許你可以再多談一些[stack online]、plus以及RINA的時間線？

Yeah, no, thank you for the question. And as the Phase 3 is actively enrolling. We haven't guided the method community about the readout. But what I can say is the activation and enrollment is going very well. To add just something to add to Tahi's first question on the first line Petosemtamab combination.

好的，謝謝你的提問。第三期目前正在積極收案中。我們尚未向醫學界提供讀出時間的指引。但我能說的是，啟動與收案進展非常順利。另外也補充一點，回到Tahi剛才第一個問題、關於第一線Petosemtamab合併療法。

I think that it's very apparent what we already presented with 17 months follow-up, which is not negligible. And at this time point, around 30% were censored and alive. And this gives you a kind of magnitude of duration. And as Tahi alluded, now we are fixated on the Phase 3, which are much more relevant. But I think that the data presented at ASCO is a very good representation of the durability of the effect.

我認為，我們已經呈現的17個月追蹤結果非常明顯，而這並不是可以忽略的追蹤期。在這個時間點，大約30%被截尾（censored）且仍存活。這讓你大致了解其持續時間的量級。而如Tahi所提到的，我們現在更聚焦在第三期，因為那更具相關性。但我認為在ASCO所呈現的資料，對於療效持久性是一個非常好的代表。

Thanks. Thanks, Charlie, for the questions. Let's move on to the next question.

謝謝。謝謝你，Charlie，提出問題。我們進入下一個問題。

Eva Forter, Wells Fargo.

Eva Forter，富國銀行（Wells Fargo）。

Hi, team. Thanks for taking our question. A quick one from us. On Peto as it relates to CRC development. How should we be thinking about timing for any announcements for this tumor type, and are you exploring other mechanisms that would make sense to combine with beyond chemo? Thanks.

嗨，各位團隊成員。謝謝讓我們提問。我們這邊一個簡短的問題。關於Peto在CRC（結直腸癌）開發上的進展。對於這個腫瘤類型的任何公告時點，我們應該如何看待？另外，除了化療之外，你們是否也在探索其他適合搭配合併治療的機制？謝謝。

Thanks, Eva, for the question. I think probably Tahi can handle this CRC updates for Peto in the second-half.

謝謝你，Eva，提出問題。我想大概由Tahi來說明下半年Peto在CRC方面的更新。

Yeah, so look, we've answered this question a couple of times. We obviously have looked at the CRC data. We have generated more CRC data. We liked what we saw early on in the diligence. We continue to like what we see. And we will update you a little bit closer to, similar to what we did with RINA, when these studies then go into the public domain on our next steps. So there will be more to come at some point.

是的，你看，我們已經回答過這個問題幾次了。我們當然已經看過CRC的數據。我們也產生了更多CRC數據。在早期盡職調查時，我們喜歡我們看到的結果。我們現在仍然喜歡我們看到的結果。而我們會在更接近的時間點向各位更新，類似我們對RINA所做的方式，當這些研究進入公開領域時，我們會說明下一步。所以之後某個時間點還會有更多資訊。

As it relates to combination with other mechanisms there's a number of interesting things that are happening in this space in the subset of patients and obviously we are aware of that and there is a good rationale to combine with Peto and so more to come on that end as well.

至於與其他機制的合併治療，在這個患者子群中，這個領域有許多有趣的進展；我們顯然也了解這些情況，而且與Peto合併有很好的理據，因此這方面後續也會有更多消息。

Thanks Tahi. So we keep the guards closed to our chest Eva because it's very exciting area and also a very competitive area. So we want to be first and hopefully best here.

謝謝，Tahi。Eva，我們會把細節先保留在心裡，因為這是一個非常令人興奮、同時也非常競爭的領域。所以我們希望能在這裡搶先一步，並且希望做到最好。

Got it. Thanks.

了解。謝謝。

Matthew Phipps, William Blair.

Matthew Phipps，William Blair。

Hello. Thanks for taking my question. I'm going to harp on the enrollment as well. There are some rumors on whether or not the increase of 200 patients would focus exclusively on HV negative patients. So maybe just remind us on your thought on the breakdown of patients by that baseline characteristic. And then, has the number of patients needed to conduct the ORR analysis changed, or is this really just patients for the OS analysis? Thank you.

你好。謝謝讓我提問。我也想再追問一下入組（收案）情況。有一些傳聞說增加的200名患者是否會專注於HV陰性患者。所以也許請你們再提醒我們，對於依該基線特徵的患者分布，你們的想法是什麼。另外，進行ORR（客觀緩解率）分析所需的患者數是否有改變？還是這次增加主要是為了OS（總生存期）分析？謝謝。

Thanks, Matt. For the questions. Tahi, can you address both of these questions and get some perspective?

謝謝你，Matt。謝謝你的問題。Tahi，你能否回應這兩個問題並提供一些觀點？

Matt, I'm going to have to answer your questions. Good question. I will not go into the specifics. I will stick with the line that I used before that the increase in the end of the study was intended to increase the overall probability of success of the study as we see it based on what we understood in the diligence. These were decisions made already back then and that we continue to understand about Pito. And that none of the things that we're doing right now has any impact on the timelines for the readouts that we anticipate.

Matt，我得來回答你的問題。好問題。我不會進入具體細節。我會沿用我先前的說法：在研究末期增加樣本量，是為了提高我們所看到的、基於盡職調查所理解的研究整體成功機率。這些決策在當時就已經做出，而我們也持續加深對Pito的理解。而且我們目前所做的任何事情，都不會影響我們預期的讀出時間表。

Thanks, Tahi. Thanks, Matt, for the questions.

謝謝，Tahi。謝謝你，Matt，提出問題。

Yaron Werber, TD Securities.

Yaron Werber，TD Securities。

Great, thank you so much. Tahi, I'm just going to maybe ask another question on the Liger program, maybe a little bit broader. Do you plan on filing with both studies or would you file presumably on second line potentially first and then front line and when you do release the data by year end?

很好，非常感謝。Tahi，我想再問一個關於Liger計畫的問題，可能更宏觀一些。你們計畫用兩項研究一起申報，還是可能會先以二線申報、之後再到一線？以及你們在年底前釋出數據時，會怎麼做？

Do you think it's going to be, let's assume it's going to be in second line first because you're not continuing to, you're not over enrolling that study. Would you have kind of, at least the interim OS and would it even be mature OS at that time? Thank you.

假設會先從二線開始，因為你們沒有繼續對那項研究超額入組。那麼到時候你們是否會有某種程度的OS期中數據？甚至那時OS會成熟嗎？謝謝。

Thanks, Yaron. Tahi, that's another sharp one.

謝謝你，Yaron。Tahi，這又是一個很犀利的問題。

Very good question. Unfortunately, my answer will be the same as I did before. Right now, all we got and. have been consistently guiding that we indeed expect one or more of these studies to read out this year. And I don't want to comment on which one, first or second, to get all these permutations that may exist.

非常好的問題。不幸的是，我的回答會和之前一樣。目前我們所掌握的，以及我們一直以來對外一致的指引是：我們確實預期今年會有一項或多項研究讀出。我不想評論是哪一項先、是一線或二線，或是所有可能存在的各種排列組合。

Thanks, Tahi. So more to come later, Jan.

謝謝，Tahi。所以之後還會有更多資訊，Jan。

(Operator Instructions)

（接線員指示）

Suzanne Van Werhuizen, Kempen & Company.

Suzanne Van Werhuizen，Kempen & Company。

Hi, team. This is Romy on for Suzanna. One on at EPKINLY. So looking ahead to the phase three readouts in first line, we recently did a survey which found that doctors are projecting at EPKINLY even before seeing this data to be the most dominant first line option. I just want to know your thoughts on what you see as the most important features of EPKINLY specifically that drives this enthusiasm. Thank you.

嗨，各位團隊成員。我是Romy，代Suzanna提問。有一題關於EPKINLY。展望一線治療的三期讀出，我們最近做了一項調查，發現醫師即使在看到這些數據之前，也預期EPKINLY會成為最具主導地位的一線選項。我想請教你們的看法：你們認為EPKINLY最重要、最能驅動這股熱情的特點是什麼？謝謝。

Thanks very much for referring to that very nice survey. We like the data, of course, and I will ask Tahi to sum up basically what the key parameters are here for why EPKINLY is so advantageous in the first-line setting according to the survey.

非常感謝你提到那份很棒的調查。我們當然喜歡這些數據；我會請Tahi總結一下，根據該調查，為什麼EPKINLY在一線治療情境下如此具優勢的關鍵參數是什麼。

Yeah, so I mean, this is like, if you step back, this is also something that we talked about from the very beginning when we engaged on the development program with that the [C3C20] mechanism of action of EPKINLY is a unique and very powerful single agent mechanism that comes with a safety profile that predominantly is infusion related actions and then otherwise it's extremely well tolerated.

是的，我的意思是，如果你退一步看，這也是我們從一開始在推動該開發計畫時就談到的：EPKINLY的[C3C20]作用機制是一種獨特且非常強力的單藥機制；其安全性特徵主要是輸注相關反應，除此之外整體耐受性非常好。

And because of subcutaneous administration, also convenience administration, that makes it easy for the patient and also for the providers. And so if you start combining EPKINLY and (inaudible) with chemotherapy, we've already seen this in all kinds of Phase 2 studies or Phase 3 studies, that tends to be a mechanism that is very well combined with chemotherapy and at least additive.

而且因為是皮下注射給藥，也帶來給藥便利性，對患者以及醫療提供者都更容易。因此當你把EPKINLY和（聽不清）與化療合併時，我們已經在各種二期或三期研究中看到，這種機制與化療的合併效果通常很好，至少是加成的。

And so that's, I think, what's driving the enthusiasm of the frontline in terms of what the expectations are on data. And then what drives EPKINLY specifically, of course, is then the observation that A, in very high likelihood, will be the first study to read out in frontline (inaudible) significant time advantage. And B, it is the one that comes with a subcutaneous administration.

所以我認為，這就是推動大家對一線治療熱情的原因之一，也就是對數據的期待。而驅動EPKINLY本身的因素，當然還包括：A，它很有可能會是第一個在一線（聽不清）讀出的研究，因此具有顯著的時間優勢。以及B，它是採皮下注射給藥的方案。

And as Brad was saying earlier, in frontline diffusage B cell, the vast majority of these patients. I actually treated in the community setting. And so the fact that there is now a potential readout on a drug that is available for these patients, for these physicians and these patients in this particular setting, particularly in the US Healthcare system, that is labeled, it's the only one that is labeled without restrictions on where it can be provided to the patients. I think that is what's driving the entire enthusiasm on that particular study, and I think why we had, I don't know, six or seven questions from you guys on this study.

而且如Brad先前所說，在一線瀰漫性B細胞（淋巴瘤）中，這些患者的絕大多數。其實是在社區醫療環境中接受治療。因此，現在有機會讀出一款可在此情境下提供給這些患者的藥物，對這些醫師與患者而言——特別是在美國醫療體系中——它的標籤核准是不受提供地點限制、可在任何地方給藥的唯一一個，我認為這正是推動大家對這項研究整體熱情的原因；也就是為什麼你們對這項研究問了，我不知道，六到七個問題。

Great, thank you.

很好，謝謝。

Thanks, Tahi, for the answer. Let's move on to the next question.

謝謝你，Tahi，提供的回答。我們進入下一個問題。

Victor Floch, BNP Paris.

Victor Floch，法國巴黎銀行（BNP Paribas）。

Thanks for taking my question. Just one on EPKINLY. So, I mean, Kenya has reported a decent Q1 performance. I was just wondering whether this is driven by the recent label change in the US. So, I mean, I was just wondering if you select a material at least in the academic setting and whether you can comment on the key orders that you need to clear to further drive penetration in this setting. Thank you very much.

謝謝讓我提問。我只有一個關於 EPKINLY 的問題。所以，我的意思是，Kenya 在第一季表現不錯。我只是想知道，這是否是由於美國近期的標籤變更所帶動。所以，我的意思是，我也想知道你們是否至少在學術醫療體系中看到明顯的採用，並且你們是否能評論為了進一步推動在此場域的滲透率，需要克服的關鍵障礙。非常感謝。

Absolutely, Victor. So good question. So perhaps you can handle both of these, Brad?

當然可以，Victor。這是個好問題。Brad，也許你可以一併回答這兩點？

No, I think, first of all, thanks for the question. And the strong start to the year is certainly evident by the profile being appreciated by physicians as well as health systems, primarily being looked at as the only bispecific of the (inaudible) indication. And the proven efficacy piece is certainly extremely important, as well as the subcutaneous administrations, which is what, Tahi had mentioned well.

不，我想首先，謝謝你的提問。而今年強勁的開局，確實反映在醫師以及醫療體系對其產品特性的認可上；主要是因為它被視為（聽不清）適應症中唯一的雙特異性抗體。而已證實的療效當然極其重要，另外還有皮下注射給藥，這點 Tahi 也提得很好。

Now, as it relates to the moving forward into earlier areas, the ability to, again, have all of these. The ingredients in place, moving quickly into earlier lines, featuring accommodations as well as fixed-dose options is extremely important, but then also, as you mentioned, as it relates to the performance of second-line FL, we're seeing as a key part of this driver performance.

接著，關於往更早期治療線推進，再次強調，具備所有這些條件。各項要素到位、能快速推進到更早期治療線，並提供便利性以及固定劑量選項，這非常重要；同時，如你所提到的，就二線 FL 的表現而言，我們看到這是帶動表現的關鍵因素之一。

And then the hospital removal of the potential hospitalization update has been very well received. And again, looking to improve just additional barriers to be able to treat patients closer to where they live in the ways that you're seeing with this extremely important profile from an efficacy, safety, and deep durable responses along with subcutaneous administration.

此外，醫院端移除可能需要住院的更新要求，獲得了非常正面的回饋。同樣地，我們希望進一步降低其他障礙，使患者能在更接近居住地的地方接受治療；而你所看到的這個產品特性在療效、安全性，以及深度且持久的反應，再加上皮下注射給藥方面，都極其重要。

Thanks, Brad, for the question.

謝謝，Brad，回答這個問題。

Kalpit Patel, Wolfe Research.

Kalpit Patel，Wolfe Research。

Yeah, hey, thanks for taking the question. For EPKINLY, the EPCORE DLBCL-2 trial in frontline setting, what PFS hazard ratio do you think you need to be clinically meaningful, especially given the context behind POLERIC study? And then do you also need to show an OS benefit to potentially drive a more meaningful commercial uptake in the first time?

是的，嗨，謝謝讓我提問。關於 EPKINLY，在一線治療場域的 EPCORE DLBCL-2 試驗，你認為需要達到什麼樣的 PFS 風險比（hazard ratio）才具有臨床意義，特別是在 POLERIC 研究的背景之下？另外，你們是否也需要顯示 OS 的獲益，才能在一線治療中推動更有意義的商業採用？

Thanks for the questions. Tahi, you can address both of these.

謝謝你的問題。Tahi，你可以一併回答這兩點。

Yeah, so this question, unlike what hazard ratio we are expecting has to come up a lot essentially, it doesn't make sense to speculate. What we've said is that based on the public data that is available in Phase 2. Yes, of course, and you heard this in the other question earlier, expectation and enthusiasm of what the possible readout of that study. So, Phase 3 have in the past on a EPKINLY tended to mimic close Phase 2 data, as I said, because it's a mechanism of action, it's very predictable.

好的，所以這個問題——我們預期的風險比是多少——其實經常被問到，但本質上推測並沒有意義。我們所說的是，基於第二期公開可得的數據。是的，當然，而且你在前一個問題也聽到了，大家對該研究可能的讀出結果抱有期待與熱情。因此，過去 EPKINLY 的第三期結果往往與第二期數據相當接近，如我所說，因為其作用機轉非常可預測。

And so, we're excitingly as you are awaiting the readout and, of course, are very enthusiastic of how positive this trial could be, but we will see what it is when we have it. As it really relates to OS now, we all know from the ODAC that the FDA will approve frontline diffusage regimens even without OS benefits.

所以，我們和你一樣非常期待讀出結果，當然也對這項試驗可能有多正面感到非常振奮，但最終仍要等到拿到數據才知道。至於 OS，我們都從 ODAC 了解到，即使沒有 OS 獲益，FDA 也會核准一線瀰漫性（聽不清）治療方案。

I said in the past, the ability of showing (inaudible) benefit, of course, is becoming a little bit more challenging, the diffuse of research in general because of the increasing availability of very effective salvage therapies for particularly the (inaudible) patients. But, in fact, they have access to cards and the bispecifics that are also now penetrating second line and are already very much available in third line.

我過去也說過，顯示（聽不清）獲益的能力，當然變得更具挑戰性；整體瀰漫性（聽不清）研究也是如此，因為特別是（聽不清）患者可使用的非常有效的救援治療越來越多。但事實上，他們可以使用 CAR-T，以及雙特異性抗體；這些療法現在也正在滲透到二線，且在三線已經非常普遍可得。

Having said all of that, it's also a function of the effects that you have from PFS, meaning the larger the PFS has a ratio benefit becomes the larger the opportunity to show an less benefit. That's kind of like partly speaking how we think about it.

話雖如此，這也取決於你在 PFS 上看到的效果；也就是說，PFS 的風險比獲益越大，顯示 OS 獲益的機會就越大。這大致上就是我們思考的方式之一。

Thanks, Tahi. Let's move on to the next question.

謝謝你，Tahi。我們進入下一個問題。

(inaudible) Morgan Stanley.

（聽不清），Morgan Stanley。

Yeah. Hi thanks for squeezing us in here. Just a follow-up on the Peto trial upsizing. Have you said whether that upsizing will occur at already enrolled centers in the trial? Will you be adding any investigation sites? I'm just curious if you are, if any other eGFR bispecifics might be being studied at those sites and what reception might be. Thanks.

是的。嗨，謝謝把我們也安排進來。我想追問一下 Peto 試驗擴大樣本數的事。你們是否已說明這次擴大會發生在試驗中已經納入的中心？你們會新增任何研究中心嗎？我只是好奇，如果你們會新增，那些中心是否也在研究其他 eGFR 雙特異性抗體，以及可能的接受度如何。謝謝。

Thanks, (inaudible), for the question. Tahi, can you address the recruitment and the setting for the Peto trial?

謝謝你，（聽不清），提出問題。Tahi，你能說明一下 Peto 試驗的招募情況與試驗場域嗎？

Yes, what I will answer, [Judah], is that this amendment that increases the end had no impact on additional sites or a need for additional sites, but it's enrolling extremely well, so that's why it won't have an impact on anything.

可以，我要回答的是，[Judah]，這項提高終點的修訂不會影響是否需要新增中心或增加中心；而且目前招募進展非常順利，所以不會對任何事情造成影響。

Thanks, Tahi. That's, I think, addresses the last question of today. So thank you all for calling in today. And if you have any additional questions, please reach out to the Investor Relations team of Genmab. We very much look forward to speaking with all of you soon in this super exciting year for the company. Thank you.

謝謝你，Tahi。我想這也回答了今天最後一個問題。因此，感謝各位今天來電參與。如果還有其他問題，請聯繫 Genmab 的投資人關係團隊。我們非常期待在這個對公司而言極其令人振奮的一年中，很快再與各位交流。謝謝。

This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.

今天的電話會議到此結束。感謝各位參與。各位現在可以掛線。祝各位有美好的一天。