Genmab A/S (GMAB) 2024 Q4 法說會逐字稿

Hello, and welcome to the Genmab full year 2024 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 believes, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed on successful development projects. 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.

您好，歡迎參加 Genmab 2024 年全年財務業績電話會議。提醒一下，本次電話會議正在錄音。在此次電話會議中，您可能會看到前瞻性陳述，其中包括相信、預期、計劃或期望等字眼。實際結果可能存在重大差異，例如由於成功的開發專案延遲而導致。Genmab 沒有義務更新有關未來的聲明，也沒有義務確認與實際結果有關的聲明，除非法律要求。

Please also note that Genmab may hold your personal data as indicated by you as 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.

另請注意，Genmab 可能會根據您所表明的個人資料作為我們投資者關係外展活動的一部分保存，以便向您更新 Genmab 的最新情況。請參閱我們的網站以獲取有關 Genmab 和我們的隱私權政策的更多資訊。

I would now like to hand the conference over to your first speaker today, Jan van de Winkel. Please go ahead.

現在，我想將會議交給今天的第一位演講者 Jan van de Winkel。請繼續。

Hello, and welcome to Genmab's conference call to discuss our financial results for the period ending December 31, 2024. With me today to present these results is our CFO, Anthony Pagano; and our Chief Commercial Officer, Brad Bailey. For the Q&A, we will be joined by our Chief Medical Officer, Tahi Ahmadi; and our Chief Development Officer, Judith Klimovsky.

您好，歡迎參加 Genmab 的電話會議，討論截至 2024 年 12 月 31 日的財務表現。今天與我一起介紹這些結果的是我們的財務長 Anthony Pagano；以及我們的首席商務官布拉德貝利。在問答環節，我們的首席醫療官 Tahi Ahmadi 將出席；以及我們的首席開發長 J​​udith Klimovsky。

As already said, we will be making forward-looking statements, so please keep that in mind as we go through this call. During today's presentation, we will reference products being developed under some of our strategic collaborations, and this slide acknowledges those relationships.

正如我們已經說過的，我們將做出前瞻性陳述，因此請在我們進行本次電話會議時牢記這一點。在今天的演講中，我們將提及在我們的一些策略合作下正在開發的產品，這張投影片也承認了這些關係。

2024 was marked by significant milestones towards our mission to deliver innovative medicines to patients. We made strategic investments to both accelerate the development of late-stage programs with the potential to generate meaningful revenue by the end of the decade and to maximizing the success of our commercialized medicines.

2024 年是我們向患者提供創新藥物的使命的重要里程碑。我們進行了策略性投資，既加速了後期專案的開發，有可能在十年末產生可觀的收入，又最大限度地提高了我們商業化藥物的成功率。

So we delivered on our capital allocation priorities in 2024. And as Anthony will describe later, we will do so again in 2025. Overall, our financial performance in 2024 was exceptionally strong. And we have further solidified our foundation for sustainable future success.

因此，我們在 2024 年實現了資本配置重點。正如安東尼稍後會描述的，我們將在 2025 年再次這樣做。整體而言，我們 2024 年的財務表現異常強勁。我們進一步鞏固了未來可持續成功的基礎。

Let's take a look at this in more detail. 2024 was a year of strong execution and disciplined investments, driving 31% total revenue growth, fueled by the success of our eight commercialized medicines, including EPKINLY and Tivdak Our investments are fully aligned with our strategic priorities, supporting key late-stage pipeline programs and commercial expansion, allowing us to grow operating profit by an impressive 26%, demonstrating the strength of our business. Despite significant investments, including the $1.8 billion acquisition of ProfoundBio and a $500 million share buyback, we ended the year with nearly $3 billion in cash, reinforcing our financial strength.

讓我們更詳細地看一下這一點。 2024 年是執行力強、投資嚴謹的一年，推動總收入增長 31%，這得益於我們八種商業化藥物（包括 EPKINLY 和 Tivdak）的成功。儘管我們進行了大量投資，包括斥資 18 億美元收購 ProfoundBio 和斥資 5 億美元回購股票，但我們到年底仍持有近 30 億美元現金，增強了我們的財務實力。

This exceptionally strong financial position gives us the flexibility to continue investing in innovation deliver -- while delivering long-term value to shareholders. Taken together, our financial results for 2024 exemplify our ability to deliver strong revenue growth while simultaneously advancing high-potential programs.

這種異常強勁的財務狀況使我們能夠靈活地繼續投資於創新交付，同時為股東帶來長期價值。總的來說，我們 2024 年的財務表現證明了我們在推進高潛力專案的同時實現強勁收入成長的能力。

Now let's take -- let's look forward, starting with our pipeline. We currently have 12 products or product candidates in 30 clinical trials either ongoing or recruiting. This includes 7 Phase III trials between EPKINLY, Rina-S and acasunlimab. And based on the strong emerging data, we expect more to come. Because these three programs are poised to drive significant revenue growth for Genmab by the end of this decade. We have prioritized investments for 2025 and purposely reallocated our R&D dollars to these programs.

現在讓我們—展望未來，從我們的管道開始。目前，我們有 12 種產品或候選產品，正在進行或正在招募 30 項臨床試驗。其中包括 EPKINLY、Rina-S 和 acasunlimab 之間的 7 項 III 期試驗。根據強勁的新興數據，我們預計未來還會有更多數據。因為這三個項目將在本世紀末為 Genmab 帶來顯著的收入成長。我們已經確定了2025年的投資重點，並特意將我們的研發資金重新分配給這些項目。

Now let's take a deeper look at why we are confident in their significant potential. Starting with EPKINLY. Together with AbbVie, we continue to advance an ambitious clinical development program for epcoritamab across B-cell malignancies, including frontline studies in diffuse large B-cell lymphoma and follicular lymphoma. Three of five ongoing Phase III studies have been fully recruited well ahead of schedule.

現在讓我們深入了解我們為何對它們的巨大潛力充滿信心。從 EPKINLY 開始。我們與 AbbVie 攜手，繼續推進 epcoritamab 針對 B 細胞惡性腫瘤的雄心勃勃的臨床開發計劃，包括針對瀰漫性大 B 細胞淋巴瘤和濾泡性淋巴瘤的前沿研究。正在進行的五項 III 期研究中有三項已提前完成招募。

And in addition to confirmatory data based on accelerated enrollment we now anticipate three potentially significant pivotal readouts by the end of 2026, second line plus follicular lymphoma, frontline diffuse large B-cell lymphoma and in second line plus diffuse large B-cell lymphoma for transplant ineligible patients.

除了基於加速招募的確認數據外，我們現在預計到 2026 年底將有三個具有潛在重要意義的關鍵讀數，即二線加濾泡性淋巴瘤、一線瀰漫性大 B 細胞淋巴瘤以及針對不適合移植患者的二線加瀰漫性大 B 細胞淋巴瘤。

If successful, this could lead to significant market expansion, especially as frontline diffuse large B-cell lymphoma represents the single largest indication. As you can see, see this on the next slide, where we summarize the significant market opportunity for EPKINLY. We have successfully obtained multiple regulatory approvals for EPKINLY, making this therapy accessible to a broader patient population. And thanks to our exceptionally strong performance in key markets like the US and Japan, we are confident in our ability to expand that EPKINLY's reach even further.

如果成功的話，這將導致市場大幅擴張，特別是因為第一線治療瀰漫性大B細胞淋巴瘤是最大的單一適應症。正如您所看到的，請在下一張投影片中查看，我們在此總結了 EPKINLY 的重要市場機會。我們已成功獲得 EPKINLY 的多項監管部門批准，使更廣泛的患者群體能夠使用這種療法。而且由於我們在美國和日本等主要市場表現異常強勁，我們有信心進一步擴大 EPKINLY 的影響力。

In fact, our commitment to advancing EPKINLY across multiple indications in B-cell cancers underscores its potential as a best-in-class treatment with a peak sales opportunity exceeding $3 billion.

事實上，我們致力於推進 EPKINLY 在 B 細胞癌症的多種適應症治療，這凸顯了它作為一流治療方法的潛力，高峰銷售額可能超過 30 億美元。

Let's now turn to Rina-S. As we have shared previously, we have now initiated the first Phase III trial for Rina-S in second line plus platinum-resistant ovarian cancer. This trial is designed to address all comers regardless of folate receptor alpha expression, expanding its potential reach to a broader patient population. We intend to present meaningful follow-up data from the expansion cohort with PROC early in the first half of 2025.

現在我們來談談Rina-S。正如我們之前所分享的，我們現在已經啟動了 Rina-S 在二線加鉑耐藥卵巢癌中的首階段 III 期試驗。該試驗旨在解決所有人的問題，無論葉酸受體α的表達如何，從而擴大其對更廣泛患者群體的潛在影響。我們打算在 2025 年初與 PROC 一起提供擴展隊列的有意義的後續數據。

Additionally, we are actively generating combination data to inform next steps in platinum-sensitive ovarian cancer. Beyond development in ovarian cancer, we are also planning to present data in endometrial cancer in the first half of this year. And based on the strong signals we are seeing, we plan to start a Phase III study in second-line plus endometrial cancer by the end of the year.

此外，我們正在積極產生組合數據，為鉑敏感型卵巢癌的下一步治療提供資訊。除了卵巢癌的進展外，我們還計劃在今年上半年公佈子宮內膜癌的數據。根據我們看到的強烈訊號，我們計劃在今年年底前啟動二線以上子宮內膜癌的 III 期研究。

All this adds up to a significant market opportunity for Rina-S, which you can see on the next slide. Rina-S' differentiated profile has the potential to address a broader patient population than is served by current standard of care, including low to medium folate receptor alpha expression targeting about 85% of the platinum-resistant ovarian patient population.

所有這些都為 Rina-S 帶來了巨大的市場機會，您可以在下一張投影片中看到。Rina-S 的差異化特性有可能滿足比目前標準治療更廣泛的患者群體，包括針對約 85% 鉑類抗藥性卵巢患者群體的低至中等葉酸受體 α 表達。

We are exceptionally well positioned to maximize the potential of Rina-S, given our proven clinical development capabilities track record of acceleration and our experience in the gyn-onc space with Tivdak. based on the exceptionally strong execution of the team post acquisition, we remain on track to bring Rina-S to patients by 2027. And -- with its best-in-class profile expected to achieve peak sales exceeding $2 billion. And with the 2 Phase IIIs we plan to have underway by year's end, we are well on track to putting in place the building blocks to achieve this target.

鑑於我們經過驗證的臨床開發能力、加速記錄以及我們在婦科腫瘤領域的經驗，我們完全有能力最大限度地發揮 Rina-S 的潛力。基於收購後團隊異常強勁的執行力，我們仍預計在 2027 年之前將 Rina-S 帶給患者。並且——憑藉其一流的產品性能，預計高峰銷售額將超過 20 億美元。我們計劃在年底前啟動第三階段的兩個項目，這將使我們在實現這一目標的過程中獲得良好的基礎。

Finally, let's take a look at the market opportunity for acasunlimab. In 2024, Genmab took full control of the acasunlimab program, providing us with a remarkable opportunity to fully own and advance this promising assets. Non-driver mutated second-line non-small cell lung cancer continue to be an area of significant needs. Given the worsening of performance status as patients progress, through lines of therapy, physicians are interested in more tolerable chemo-free regimens.

最後，讓我們來看看acasunlimab的市場機會。2024 年，Genmab 完全控制了 acasunlimab 項目，為我們提供了一個絕佳的機會來完全擁有和推進這一有前景的資產。非驅動突變的二線非小細胞肺癌仍然是一個具有重大需求的領域。由於隨著患者病情進展，透過各種療法，體能狀態會惡化，因此醫生對更容易耐受的無化療方案很感興趣。

Yet that many novel treatments failing in Phase III trials, docetaxel continues to be the current standard of care. By identifying potential synergies of IO therapies, we have the potential to unlock clinical benefits that were not possible with monotherapy alone.

儘管許多新療法在 III 期試驗中失敗，多西他賽仍然是目前的標準治療方法。透過確定IO療法的潛在協同作用，我們有可能獲得單一療法無法實現的臨床益處。

So there is meaningful opportunity for novel treatments like acasunlimab in the second-line plus setting to provide not just improved response rates, but durability of response. And we are progressing a strategic development program to explore acasunlimab's full potential across solid tumors.

因此，在二線治療中，acasunlimab 等新型治療方法具有重大機遇，不僅可以提高緩解率，還可以提高緩解的持久性。我們正在推動一項策略發展計劃，以探索 acasunlimab 在實體腫瘤中的全部潛力。

So in summary, in 2025, we will be in execution mode. We will continue to deliver on our financial commitments through focused investments in our high priority late-stage and commercial programs. Because the investment in these areas today -- that will position us well at the end of the decade.

總而言之，到 2025 年，我們將處於執行模式。我們將繼續透過專注於投資於高優先級的後期和商業項目來履行我們的財務承諾。因為今天在這些領域的投資將使我們在下一個十年處於有利地位。

I will now hand over the presentation to Brad, who will provide you with a review of the recent performance for Tivdak and EPKINLY, both of which have seen growth in 2024. Brad, the floor is yours.

現在，我將演講交給布拉德，他將為您回顧 Tivdak 和 EPKINLY 的近期表現，這兩家公司在 2024 年都實現了成長。布拉德，現在你來發言。

Thank you, Jan. Over the course of 2024, our commercialization teams executed effectively to bring EPKINLY and Tivdak to an increasing number of patients around the world. Overall, EPKINLY and Tivdak ended the year in a strong position, demonstrating the strength of our commercialization strategy and the performance of our field teams.

謝謝你，Jan。總體而言，EPKINLY 和 Tivdak 在年底取得了強勁的成績，證明了我們商業化策略的實力和現場團隊的表現。

We also achieved critical milestones, including two new regulatory approvals in the US and continued our work to rapidly progress our development program to fuel our future growth. Through these efforts, our commercialized medicines contributed 29% of our revenue growth for the year. Moving to highlights from our commercialized portfolio. we achieved meaningful milestones with both medicines that contributed to their overall growth.

我們還實現了關鍵的里程碑，包括在美國獲得兩項新的監管批准，並繼續努力快速推進我們的發展計劃，以推動我們未來的成長。透過這些努力，我們的商業化藥品為我們全年的收入成長貢獻了29%。轉向我們商業化產品組合的亮點。我們在這兩種藥物上都取得了有意義的里程碑，促進了它們的整體成長。

Over the past three months, Tivdak and EPKINLY have collectively received three new or updated NCCN guidelines designations First, in December, Tivdak monotherapy was upgraded from category 2A to Category 1 designation for the treatment of recurrent or metastatic cervical cancer, further validating its clinical benefit for these patients. Tivdak, in combination with pembrolizumab was also added as a Category 2B designation for patients with PDL1-positive disease.

在過去三個月中，Tivdak 和 EPKINLY 共同獲得了三項新的或更新的 NCCN 指南指定：首先，在 12 月，Tivdak 單藥療法從 2A 類升級為 1 類，用於治療復發性或轉移性子宮頸癌，進一步驗證了其對這些患者的臨床益處。Tivdak 與 pembrolizumab 的合併用藥也被添加為 PDL1 陽性疾病患者的 2B 類治療方案。

And earlier this month, of EPKINLY, in combination with GemOx received a Category 2A designation for the treatment of diffuse large B-cell lymphoma in the relapsed refractory setting. This is especially notable as we look to bring the potential of EPKINLY into earlier lines of therapy in the future. Lastly, for EPKINLY at ASH, we presented a three-year long-term data from our EPCORE NHL-1 study which evaluated EPKINLY in patients with third line or later relapsed or refractory DLBCL.

本月初，EPKINLY 與 GemOx 的聯合療法獲得了 2A 類認定，用於治療復發難治性瀰漫大 B 細胞淋巴瘤。當我們期待在未來將 EPKINLY 的潛力帶入早期治療領域時，這一點尤其值得注意。最後，對於 ASH 的 EPKINLY，我們展示了 EPCORE NHL-1 研究的三年長期數據，該研究評估了 EPKINLY 對三線或後期復發或難治性 DLBCL 患者的作用。

These data showed that over half of patients who achieved a complete response in the trial maintain the response for more than three years with no new safety signals identified. These results represent the longest duration of CRs reported by a bispecific in this setting, further reinforcing EPKINLY's clinically differentiated profile and potential to deliver deep durable responses.

這些數據表明，在試驗中獲得完全緩解的患者中，超過一半的患者維持緩解三年以上，且未發現新的安全訊號。這些結果代表了雙特異性抗體在此環境下報告的最長 CR 持續時間，進一步強化了 EPKINLY 的臨床差異化特性和提供深度持久反應的潛力。

Now let's turn to performance, beginning with EPKINLY. EPKINLY continues to perform exceptionally well since its initial launch in 2023. We -- it closed 2024 in a position of strength, achieving $78 million in sales in the quarter and $281 million in sales for the year. This growth was driven primarily by sales in the United States and Japan.

現在讓我們來談談性能，從 EPKINLY 開始。EPKINLY 自 2023 年首次推出以來一直表現優異。我們 -- 公司在 2024 年結束時保持強勁勢頭，本季實現銷售額 7800 萬美元，全年銷售額實現 2.81 億美元。這一增長主要得益於美國和日本的銷售。

In the US, EPKINLY remains the first and only bispecific approved with a dual indication in third line plus DLBCL and follicular lymphoma. Throughout 2024, we continue to see sustained uptake across sites of care driven by targeted field execution and the successful FL launch in June. Since the FL launch, we have observed accelerated growth and positive physician feedback highlighting the value of EPKINLY's dual indication, it's uniquely differentiated clinical profile and seamless administration. Moving forward, we will continue to focus on accelerating adoption across broad sites of care.

在美國，EPKINLY 是第一個也是唯一一個獲準用於第三線及 DLBCL 和濾泡性淋巴瘤雙重適應症的雙特異性藥物。在整個 2024 年，我們將繼續看到在有針對性的現場執行和 6 月成功推出 FL 的推動下，各個護理站點的持續應用。自 FL 推出以來，我們觀察到加速​​的成長和積極的醫生回饋，凸顯了 EPKINLY 的雙重適應症的價值、其獨特的差異化臨床特徵和無縫管理。展望未來，我們將繼續致力於加速廣泛護理站點的採用。

In Japan, EPKINLY is the only approved CD3, CD20 bispecific and third line plus relapsed or refractory large B-cell lymphoma, and we continue to see strong, stable performance, largely driven by field execution and account activation. We are well positioned to build on this leadership position in Japan with the anticipated approval for third-line plus relapsed or refractory follicular lymphoma in early 2025.

在日本，EPKINLY 是唯一獲準的 CD3、CD20 雙特異性和三線加復發或難治性大 B 細胞淋巴瘤藥物，我們繼續看到強勁、穩定的表現，這主要得益於現場執行和帳戶激活。我們已做好準備，鞏固在日本的領導地位，預計 2025 年初該藥物將獲得日本政府對第三線及復發或難治性濾泡性淋巴瘤治療的批准。

With this indication, EPKINLY will become the first and only bispecific approved in Japan with a dual indication in LBCL and FL. In the rest of the world, we're seeing increased utilization of EPKINLY our partner, AbbVie, and achieved approvals in more than 50 countries worldwide by the end of 2024. We look forward to this trajectory continuing in 2025 and beyond.

憑藉此適應症，EPKINLY 將成為日本第一個也是唯一一個同時在 LBCL 和 FL 中具有雙重適應症的雙特異性藥物。在世界其他地區，我們看到合作夥伴 AbbVie 對 EPKINLY 的使用率不斷增加，到 2024 年底，該藥物已在全球 50 多個國家獲得批准。我們期待這一軌跡在 2025 年及以後繼續延續。

Looking ahead, our teams remain focused on driving adoption in priority markets, while accelerating our robust development program to establish EPKINLY as the core therapy in B-cell lymphomas, including in earlier lines of therapy. As we continue to target areas of high unmet need, our commercialization teams remain focused on creating optimal customer experiences through the disciplined execution of our targeted go-to-market strategy that has consistently driven our success to date.

展望未來，我們的團隊將繼續專注於推動優先市場的應用，同時加快我們強勁的發展計劃，將 EPKINLY 確立為 B 細胞淋巴瘤的核心療法，包括早期療法。隨著我們繼續瞄準尚未滿足的巨大需求領域，我們的商業化團隊始終專注於透過嚴格執行我們有針對性的行銷策略來創造最佳客戶體驗，而這項策略始終推動著我們迄今為止的成功。

Turning now to Tivdak. As the only ADC with a proven survival benefit in advanced cervical cancer, Tivdak has continued to achieve solid growth since its launch in 2021 and is regarded by physicians as the global standard of care and the clear answer in second line plus recurrent or metastatic cervical cancer. Tivdak produced $131 million in sales during the year including $38 million in the fourth quarter, driven by depth and breadth of ordering accounts.

現在轉向蒂夫達克。作為唯一一款在晚期子宮頸癌中被證實具有生存獲益的 ADC，Tivdak 自 2021 年上市以來持續穩健成長，被醫生視為全球治療標準和第二線及復發或轉移性子宮頸癌的明確答案。由於訂購帳戶的深度和廣度，Tivdak 全年銷售額達到 1.31 億美元，其中第四季銷售額為 3,800 萬美元。

With strong utilization rates in this setting, we anticipate modest growth in the US in 2025. We -- looking ahead, we see opportunities to expand the potential of Tivdak in advanced cervical cancer to new markets where patients' needs remain high. We expect approval in Japan early this year where Genmab will lead full commercialization responsibilities and in Europe later this year following a positive CHMP opinion issued in January.

在此環境下，利用率強勁，我們預計 2025 年美國將適度成長。展望未來，我們看到了將 Tivdak 在晚期子宮頸癌治療中的潛力擴展到患者需求仍然很高的新市場的機會。我們預計該藥物將在今年年初在日本獲得批准，屆時 Genmab 將負責全部商業化工作；繼 1 月 CHMP 給予積極意見後，該藥物將在今年稍後在歐洲獲得批准。

Importantly, the anticipated launch in Europe provides a catalyst to enter the next phase of our commercialization strategy as we expand our work to new markets. As of January 1, Genmab and Pfizer have agreed to transition full commercialization responsibilities for Tivdak in second line plus recurrent or metastatic cervical cancer to Genmab for all countries outside the US and China, where Pfizer will continue to partner with Genmab and ZiLab, respectively.

重要的是，預計在歐洲推出的產品將為我們在將工作拓展到新市場時進入商業化策略的下一階段提供催化劑。自 1 月 1 日起，Genmab 和輝瑞已同意將 Tivdak 在二線及復發性或轉移性子宮頸癌治療中的全部商業化責任轉交給 Genmab，用於美國和中國以外的所有國家，輝瑞將繼續分別與 Genmab 和 ZiLab 合作。

We're pleased with the terms of this updated agreement as it optimally positions us to expand our commercialization capabilities first to Europe in a strategic and financially disciplined manner, just as we have successfully done in the US and Japan to date. We're confident that with this approach, we can optimize the launch opportunity for Tivdak and also build a strong foundation for the potential launches of Rina-S and acasunlimab in the future.

我們對這份更新後的協議的條款感到滿意，因為它使我們能夠以戰略性和財務紀律的方式首先將我們的商業化能力擴展到歐洲，就像我們迄今為止在美國和日本成功做到的那樣。我們相信，透過這種方法，我們可以優化 Tivdak 的發布機會，並為未來 Rina-S 和 acasunlimab 的潛在發布奠定堅實的基礎。

We are extremely pleased by the performance of our commercialized brands in 2024, validating our strategic approach and investments to date. As we look toward 2025 and beyond, our focus remains on building upon the strong foundation we've established in the US and Japan to capture more value from our commercialized medicines, increasing utilization of EPKINLY and Tivdak across regions and strategically entering new markets to prepare for the launches of our wholly owned medicines to reach even more patients in the future.

我們對 2024 年商業化品牌的表現感到非常滿意，這驗證了我們迄今為止的策略方針和投資。展望 2025 年及以後，我們的重點仍然是鞏固我們在美國和日本已經建立的堅實基礎，從我們的商業化藥品中獲取更多價值，提高 EPKINLY 和 Tivdak 在各地區的利用率，並戰略性地進入新市場，為推出我們全資擁有的藥品做好準備，以便將來惠及更多的患者。

With that, I'll hand the call to Anthony to provide more perspective on our financials.

說完這些，我會把電話交給安東尼，讓他提供更多關於我們財務狀況的觀點。

Thanks, Brad. We continue to strengthen our foundation throughout the year. We delivered on our goal of multiple successful regulatory approvals and launches for EPKINLY. And we're pleased with how these launches are progressing.

謝謝，布拉德。我們全年都在不斷鞏固我們的基礎。我們實現了 EPKINLY 成功獲得多項監管部門批准和發布的目標。我們對這些發布的進展感到非常滿意。

We've also significantly enhanced our long-term growth potential with the addition of Rina-S to our late-stage pipeline as part of the acquisition of ProfoundBio. And as we'll see, our financials remain exceptionally strong. We achieved 31% total revenue growth. And importantly, we grew our recurring revenues by 35%. And -- this was driven by strong royalties from DARZALEX and Kesimpta and from product sales from EPKINLY and Tivdak.

作為收購 ProfoundBio 的一部分，我們將 Rina-S 添加到我們的後期產品線中，從而顯著增強了我們的長期成長潛力。正如我們所見，我們的財務狀況依然強勁。我們實現了31%的總收入成長。重要的是，我們的經常性收入成長了 35%。這是由於 DARZALEX 和 Kesimpta 的強勁特許權使用費以及 EPKINLY 和 Tivdak 的產品銷售推動的。

This growth reflects sustained recurring revenue expansion and robust execution across markets. We can see that the investments we made in building out our commercialization teams and capabilities are paying off. And this sets us up well as we prepare for potential expansion into earlier lines for EPKINLY and the potential launch of Rina-S in 2027.

這一成長反映了持續的經常性收入擴張和跨市場強勁的執行力。我們可以看到，我們在建立商業化團隊和能力方面所做的投資正在獲得回報。這為我們做好了準備，可以為 EPKINLY 的早期產品線擴展以及 2027 年推出 Rina-S 做好準備。

Stepping back and looking at our revenues. What really stands out for me is the improving quality of our revenue profile. In 2024, recurring revenues rose to represent 91% of total revenue, and that's compared to 88% in 2023.

退一步來看看我們的收入。對我來說真正引人注目的是我們收入狀況的品質不斷提高。2024 年，經常性收入將佔總收入的 91%，而 2023 年則為 88%。

Finally, looking at DARZALEX specifically. Overall, net sales grew by almost 20%. That's net sales of nearly $11.7 billion for the year, which translates to almost DKK14 billion in royalty revenue. This growth was driven by continued share gains and strong performance in the frontline setting.

最後，具體看一下 DARZALEX。總體而言，淨銷售額成長了近20%。這意味著全年淨銷售額接近 117 億美元，相當於特許權使用費收入近 140 億丹麥克朗。這一成長主要得益於市場份額的持續成長和第一線業務的強勁表現。

Turning to our investments where we continue to take a disciplined approach. Total operating expenses in 2024 were DKK13.8 billion. As you can see, the majority of the investment, over 70% was driven by R&D, reflecting our focus on late-stage priority programs at EPKINLY, Rina-S and acasunlimab. Our investment in SG&A was focused to put us in a strong position for key market launches in the US and Japan.

談到我們的投資，我們將繼續採取嚴謹的態度。2024 年總營運費用為 138 億丹麥克朗。如您所見，大部分投資（超過 70%）來自研發，這反映了我們對 EPKINLY、Rina-S 和 acasunlimab 的後期優先項目的關注。我們對銷售、一般及行政開支的投資主要是為了讓我們在美國和日本等關鍵市場的開拓中佔有有利地位。

So if we step back and think about our investment levels for 2024, we overdelivered on our financial commitments made at the time of the ProfoundBio acquisition. This was achieved through the balance of disciplined investing in line with our capital allocation framework and a continued and increased focus on productivity and prioritization efforts. And in a minute, you're going to see how this has been effectively carried through to 2025.

因此，如果我們退一步思考一下我們 2024 年的投資水平，我們超額履行了收購 ProfoundBio 時所做的財務承諾。這是透過根據我們的資本配置框架進行有紀律的投資以及持續和更加關註生產力和優先排序工作而實現的。一會兒您就會看到這個目標如何有效地延續到 2025 年。

Pulling this all together, our operating profit for 2024 grew 26%. So we delivered exceptionally strong profitability while investing to advance those programs with the highest potential for long-term growth.

綜合考慮所有這些，我們 2024 年的營業利潤增長了 26%。因此，我們在投資推進那些具有最高長期成長潛力的專案的同時，實現了異常強勁的獲利能力。

Then moving on to tax. As you can see in the appendix of this presentation, we have tax expense of around $1.3 billion, which equates to an effective tax rate of 14.4%. The -- the decrease compared to last year's rate of 22.8% was primarily due to our ability to recognize deferred tax assets that were not previously recognized.

然後討論稅收。正如您在本簡報的附錄中所看到的，我們的稅費約為 13 億美元，相當於有效稅率 14.4%。與去年同期的 22.8% 相比，這一下降主要是由於我們能夠確認以前未確認的遞延所得稅資產。

Moving forward, we anticipate that our effective tax rate should be closer to the Danish statutory rate of 22%. Taken together, our net profit amounts to nearly DKK7.8 billion. So as you can see, continued strong underlying financial performance.

展望未來，我們預期我們的有效稅率應該更接近丹麥22%的法定稅率。總的來說，我們的淨利達到近78億丹麥克朗。正如您所看到的，基礎財務表現持續強勁。

With that, let's move to our 2025 financial guidance. To start, the guidance we're providing today is in dollars. That's because as of January 1, our functional currency changed from Krone to dollars due to the growing number and significance of our US dollar-denominated transactions. For comparison, we've converted our 2024 results from Krone to dollars using an exchange rate of $6.89, representing the average rate during the year.

有了這些，我們來制定 2025 年的財務指導。首先，我們今天提供的指導是以美元計算的。這是因為，由於以美元計價的交易數量和重要性不斷增長，自 1 月 1 日起，我們的功能貨幣從克朗變為美元。為了進行比較，我們使用 6.89 美元的匯率（代表全年平均匯率）將 2024 年的結果從克朗轉換為美元。

With that background, now let's take a look at our 2025 guidance. We expect our revenue to be in the range of around $3.3 billion to $3.7 billion, delivering robust growth of 12% at the midpoint. And this is despite our nonrecurring revenue decreasing by more than $100 million. So it's our recurring revenues from royalty medicines and revenues from EPKINLY and Tivdak that's driving our anticipated growth in 2025.

有了這些背景知識，現在讓我們來看看我們的 2025 年指導方針。我們預計我們的營收將在 33 億美元至 37 億美元之間，中間值實現 12% 的強勁成長。儘管我們的非經常性收入減少了 1 億多美元，但情況仍然如此。因此，來自特許藥品的經常性收入以及來自 EPKINLY 和 Tivdak 的收入將推動我們 2025 年的預期成長。

For operating expenses, as I highlighted for you at Q3 last year, expectations were in a reasonable place. For 2025, we expect to be in a range of around $2.1 billion to $2.2 billion. So as you can see, we not only delivered but over delivered on the commitment we made at Q3. We -- this reflects our disciplined approach to investments as well as rigorous portfolio prioritization.

對於營運費用，正如我在去年第三季向您強調的那樣，預期是合理的。到 2025 年，我們預計該數字將在 21 億美元至 22 億美元之間。因此，正如您所看到的，我們不僅兌現了在第三季度做出的承諾，而且超額兌現了。我們——這反映了我們對投資的嚴謹態度以及嚴格的投資組合優先順序。

Putting all this together, we're planning for operating profit in a range between $895 million to nearly $1.4 billion, with the midpoint of guidance amounting to more than $1.1 billion of operating profit, and year-over-year growth of 16%.

綜合考慮所有這些因素，我們計劃實現營業利潤在 8.95 億美元至近 14 億美元之間，預期中間值為營業利潤超過 11 億美元，同比增長 16%。

Now let's take a look at the components of our guidance. Building on the exceptional growth in 2024, we expect recurring revenues to grow 18% in 2025 driven by DARZALEX and Kesimpta, and this increasingly includes contributions from EPKINLY and Tivdak. Taken together, these two products contribute 34% of our total projected revenue growth. This really highlights the continually improving quality of our revenue profile. Notably, our recurring revenue represents 95% of our total projected revenue in 2025.

現在讓我們來看看我們的指導的組成部分。基於 2024 年的卓越成長，我們預計在 DARZALEX 和 Kesimpta 的推動下，2025 年經常性收入將成長 18%，並且其中越來越多地包括來自 EPKINLY 和 Tivdak 的貢獻。總的來說，這兩種產品貢獻了我們預期總收入成長的34%。這確實凸顯了我們的收入狀況品質的不斷提高。值得注意的是，我們的經常性收入佔 2025 年預計總收入的 95%。

I -- looking beyond 2025, for EPKINLY, we anticipate three potentially significant pivotal readouts by the end of 2026, including frontline and second-line DLBCL and and second-line FL that could support regulatory filings and subsequently, additional meaningful revenue growth.

展望 2025 年以後，對於 EPKINLY，我們預計到 2026 年底將出現三個可能具有重要意義的關鍵讀數，包括一線和二線 DLBCL 以及二線 FL，這可以支持監管備案，並隨後實現額外的有意義的收入增長。

Finally, coming back to DARZALEX, we anticipate that DARZALEX sales will continue to ramp up and be in the range of $12.6 million to $13.4 billion.

最後，回到 DARZALEX，我們預計 DARZALEX 的銷售額將繼續上升，介於 1,260 萬美元至 134 億美元之間。

Turning now to OpEx. We've purposely reallocated our R&D investments in 2025 and are focused on advancing our high-impact late-stage programs, EPKINLY, Rina-S and acasunlimab. So here, we are prioritizing late-stage assets with strong commercial potential while also applying a balanced approach to our investments in our early pipeline. As a result, our investment in these late-stage programs increases from 45% of total R&D spending in 2024 to more than 55% or 55% in 2025.

現在來談談 OpEx。我們特意在 2025 年重新分配了我們的研發投資，並專注於推進我們具有高影響力的後期專案 EPKINLY、Rina-S 和 acasunlimab。因此，我們優先考慮具有強大商業潛力的後期資產，同時對早期管道的投資採取平衡的方式。因此，我們對這些後期項目的投資將從 2024 年佔總研發支出的 45% 增加到 2025 年的 55% 以上或 55%。

Our sales and marketing investments are focused on launch readiness in key markets, most notably for Rina-S with a disciplined approach that balances growth and efficiency. These investments are aligned to drive both immediate launches and long-term revenue.

我們的銷售和行銷投資集中在主要市場的發布準備，尤其是針對 Rina-S，採用平衡成長和效率的嚴謹方法。這些投資旨在推動即時發布和長期收入。

For G&A, I am pleased to note that spend is broadly flat between 2024 and 2025. And -- and here, our G&A capabilities are increasingly at scale, so we expect minimal growth. If you add it all together, you can see the power of our growing recurring revenues and underlying profitability.

對於 G&A，我很高興地註意到 2024 年至 2025 年期間支出基本上持平。而且 — 而且在這裡，我們的 G&A 能力規模不斷擴大，因此我們預計成長幅度將很小。如果將所有這些加在一起，您就可以看到我們不斷增長的經常性收入和潛在盈利能力的強大力量。

In 2025, we'll make significant investments in late-stage R&D and launch preparations. At the same time, we plan to deliver 16% operating profit growth at the midpoint. This reflects our ability to scale efficiently and control costs, supporting both near-term launches and long-term value creation. So when you look at our 2025 guidance as well as our 2024 results, you can see that we continue to deliver on our financial commitments.

2025年，我們將對後期研發和發布準備進行大量投資。同時，我們計劃實現中期16%的營業利潤成長。這反映了我們有效擴大規模和控製成本的能力，既支持近期發布，也支持長期價值創造。因此，當您查看我們的 2025 年指引以及 2024 年業績時，您會發現我們將繼續履行我們的財務承諾。

Having covered our results for 2024 and our guidance for 2025, and -- let me outline our capital allocation strategy aimed at fueling revenue growth by the end of the decade and enhancing shareholder value. First, we will continue to invest and accelerating the development of our high-impact late-stage programs at EPKINLY, Rina-S and acasunlimab with investment into Phase III clinical trials. We will also continue to maximize the success of our commercialized medicines, because it's our investment in these programs now that will potentially generate meaningful revenue for us by the end of the decade.

我已經介紹了我們 2024 年的業績和 2025 年的指引，以下讓我概述一下我們的資本配置策略，該策略旨在推動本世紀末的收入成長並提高股東價值。首先，我們將繼續投資並加速開發 EPKINLY、Rina-S 和 acasunlimab 等具有高影響力的後期項目，並投入 III 期臨床試驗。我們也將繼續最大限度地提高我們商業化藥物的成功率，因為我們現在對這些項目的投資將有可能在十年末為我們帶來可觀的收入。

Second, we will continue to seek out business development and M&A opportunities that fit within our core focus areas. As you know, we executed on our acquisition of ProfoundBio last year. Here, I'd like to highlight how quickly and successfully we were able to integrate ProfoundBio into our business as evidenced by our ability to progress Rina-S so significantly. We not only brought forward the start of the first Phase III trial for Rina-S, but today, we announced a second Phase III trial in an additional indication.

其次，我們將繼續尋找符合我們核心重點領域的業務發展和併購機會。如您所知，我們去年完成了對 ProfoundBio 的收購。在這裡，我想強調我們能夠多麼迅速且成功地將 ProfoundBio 融入到我們的業務中，這一點從我們顯著推進 Rina-S 的能力中可見一斑。我們不僅提前開始了 Rina-S 的第一階段 III 期試驗，而且今天我們還宣布了針對另一項適應症的第二階段 III 期試驗。

Now having built out our development and commercialization capabilities, we're well positioned to continue to consider both mid- to late-stage development and commercial stage product opportunities.

現在，我們已經具備了開發和商業化能力，可以繼續考慮中後期開發和商業階段的產品機會。

And finally, today, we're announcing our plan to repurchase an additional approximate 1.9 million shares, which is equivalent to around $370 million at our current stock price. This underscores our confidence in Genmab's future and our commitment to delivering value to our shareholders, both in the short and long term.

最後，今天，我們宣布回購額外約 190 萬股股票的計劃，以當前股價計算，相當於約 3.7 億美元。這凸顯了我們對 Genmab 未來的信心以及我們致力於在短期和長期內為股東創造價值的承諾。

In summary, our performance in 2024 underscores our ability to deliver exceptional revenue growth, advanced key pipeline assets and maintain strong profitability through disciplined execution. Looking ahead to 2025, we are building on this momentum by further prioritizing our investments and expanding market opportunities, positioning us for sustained growth and long-term value creation for our shareholders.

總而言之，我們在 2024 年的表現凸顯了我們透過嚴格的執行來實現卓越收入成長、先進的關鍵管道資產和維持強勁獲利能力的能力。展望2025年，我們將在此基礎上進一步優先考慮投資、擴大市場機會，實現持續成長並為股東創造長期價值。

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

關於這一點，我將把你交還給 Jan。

Thank you, Anthony. Let's move on to our final slides. Now with this strong foundation supporting us, we are looking ahead to an energizing 2025. Starting with HexaBody CD38, we submitted the data package to J&J, and we anticipate a decision from them no later than the first quarter of this year.

謝謝你，安東尼。讓我們繼續觀看最後一張投影片。如今，有了這個堅實的基礎，我們展望充滿活力的2025年。從 HexaBody CD38 開始，我們向強生公司提交了資料包，預計他們最遲會在今年第一季做出決定。

At that time, we will press release the decision and includes top line clinical data. Regardless of J&J's decision, Genmab's strategic priorities in 2025 and beyond remain unchanged. Looking beyond these events, this year, we are anticipating additional regulatory decisions for both at EPKINLY and Tivdak including the potential approval of Tivdak in Europe following a positive opinion from the CHMP in January.

屆時，我們將發布該決定，並附上最重要的臨床數據。無論強生公司做出何種決定，Genmab 在 2025 年及以後的策略重點保持不變。除了這些事件之外，今年我們預計 EPKINLY 和 Tivdak 還將收到更多監管決定，包括 1 月 CHMP 給予正面意見後，Tivdak 可能會獲得歐洲批准。

For both acasunlimab and Rina-S, we anticipate presenting additional supportive clinical data and both have the potential to move into broader indications with new clinical trials. And we will continue to actively look for opportunities to grow our pipeline, both organically and inorganically, positioning us for sustained growth and long-term value creation for our shareholders.

對於 acasunlimab 和 Rina-S，我們期待提供更多支持性臨床數據，並且兩者都有潛力透過新的臨床試驗進入更廣泛的適應症。我們將繼續積極尋找機會透過有機和無機的方式擴大我們的產品線，實現持續成長並為股東創造長期價值。

In summary, in 2024, we further solidified our already very strong foundation and delivered on our commitments. And in 2025, we will continue our laser-sharp focus on an investment in our late-stage product pipeline and commercial execution. That ends our formal presentation.

總而言之，2024年，我們進一步鞏固了原本就非常強大的基礎，並兌現了我們的承諾。2025 年，我們將繼續專注於投資後期產品線和商業執行。我們的正式演講到此結束。

Operator, please open the call for questions.

接線員，請打開電話詢問問題。

(Operator instructions)

（操作員指令）

Jonathan Chang, Leerink.

Jonathan Chang，Leerink。

Can you discuss your reasons for confidence in the endometrial cancer opportunity for Rina-S and for committing to a Phase III second line plus endometrial cancer study by year-end.

您能否討論一下對 Rina-S 子宮內膜癌治療機會充滿信心的原因，以及承諾在年底前進行 III 期二線以上子宮內膜癌研究的原因。

Thanks, Jonathan, for the question. I will let Tahi dive into this. Tahi can you talk about the endometrial cancer data and the commitment to go into a Phase III.

謝謝喬納森提出這個問題。我會讓 Tahi 深入研究這個問題。Tahi，您能談談子宮內膜癌數據和進入第三階段的承諾嗎？

Sure. Jonathan, thank you for the question. I think you heard from Jan earlier that we will present data in endometrial so we have the data. It's been submitted, and then will be publicly available. in the end of this first half.

當然。喬納森，謝謝你的提問。我想您之前從 Jan 那裡聽說過，我們將展示子宮內膜數據，所以我們有數據。它已提交，然後將公開。在上半場結束時。

That data in our mind, is highly competitive. It is the most robust efficacy signal that is currently being generated in that new population that you described patients with endometrial cancer who at chemotherapy and checkpoint inhibition. And so we are very excited about that data. We think it's going to be a robust data. It will be very well appreciated by investigators and investors win it is public, and that's driving our excitement to move forward aggressively with the Phase III.

在我們看來，這些數據具有很強的競爭力。這是目前在您所描述的接受化療和檢查點抑制的子宮內膜癌患者新族群中產生的最強的療效訊號。因此我們對這些數據感到非常興奮。我們認為這將是一份可靠的數據。一旦該藥物公開，研究人員和投資者將非常感激，這也促使我們積極推動第三階段的試驗。

Michael Schmidt, Guggenheim Partners.

古根漢合夥人公司的麥可‧施密特。

This is Paul on for Michael. Just for EPCORE and the DLBCL landscape, there's a competing CD25 specific that could potentially have combo data approved this year for the transplant in eligible second-line plus setting. What do you have to show to be competitive here for EPCORE monotherapy? And can you provide any updates on the status of your efforts there with GemOx?

這是保羅，代替麥可。僅就 EPCORE 和 DLBCL 領域而言，存在一種競爭性 CD25 特異性，其組合數據可能在今年獲得批准，可用於符合條件的二線加治療環境中的移植。您必須展示什麼才能在 EPCORE 單一療法領域具有競爭力？您能否提供與 GemOx 合作的最新進展？

And as a follow-up, how are physicians currently thinking about the potential to sequence multiple CD25 specifics for DLBCL?

作為後續研究，醫師目前如何看待 DLBCL 進行多個 CD25 特異性定序的可能性？

Thanks very much, Paul, for the questions. I'll let Tahi address those for epcoritamab. Tahi?

非常感謝保羅提出這些問題。我會讓 Tahi 解決 epcoritamab 的問題。塔希？

So the second line the first part, of course, we just really a couple of days ago, got the good news that the NCCN has included our data with GemOx and EPCORE in second-line patients who are ineligible for transplant with a Type 2A recommendation. So that's very exciting.

因此，第二行，第一部分，當然，我們幾天前就得到了好消息，NCCN 已將我們的數據與 GemOx 和 EPCORE 一起納入了不適合接受 2A 型建議移植的二線患者中。這非常令人興奮。

And then there's, of course, the Phase III ongoing in combination with lenalidomide. So from our end, we kind of like capture both opportunities, the debulking with chemotherapy for in conjunction with the CD3, CD20 bispecific GMO strategy as well as the more outpatient-oriented oral medication plus a subcutaneous administration enhancing T cell function strategy, and these two things are going to play out.

當然，還有與來那度胺合併進行的 III 期臨床試驗。因此，從我們的角度來看，我們有點像是抓住了這兩個機會，即聯合化療進行減瘤治療與 CD3、CD20 雙特異性轉基因策略以及更面向門診的口服藥物加皮下給藥增強 T 細胞功能策略，這兩件事都會發揮作用。

I think as we have said many, many times, the opportunity in the relapse refractory setting for the diffuse large B-cell is really in expanding access to this novel mechanism. And we think that from the whole target product profile for subcutaneous administration, the fact that it is the only one that is to prove in both indications, it is extremely well positioned to enter the community space and provide access to patients in those settings.

我認為，正如我們多次說過的那樣，復發難治性瀰漫大 B 細胞疾病的機會實際上在於擴大獲得這種新機制的途徑。我們認為，從皮下給藥的整個目標產品概況來看，由於它是唯一一款在兩種適應症中都得到證實的產品，因此它非常適合進入社區空間並為這些環境中的患者提供治療。

Asthika Goonewardene, Truist.

Asthika Goonewardene，Truist。

Just very quick to follow up on EPKINLY, $281 million in the first full year of launch is very commendable. Just want to jump into the market dynamics in the second half. I wanted to see if there was something funky about Q4, given that it was kind of flat on Q3, if there's anything unusual you'd point to?

讓我們來快速跟進 EPKINLY，推出後的第一年就獲得 2.81 億美元的收入，這是非常值得稱讚的。只是想了解下半年的市場動態。我想看看 Q4 是否有一些奇怪的事情，考慮到 Q4 與 Q3 相比比較平淡，您是否能指出什麼不尋常的地方？

And then if I can ask, on acasunlimab, I like that you're putting peak sales number here for the key pipeline assets, over 136,000 potential treatable patients with acasunlimab the $1 billion in peak sales teams a little bit light compared to the others that you provided. Can you tell us a little bit about what goes into as mentioned, is that something to do with the longer treatment interval for six weeks versus three weeks? Or is there something else that you're anticipating with acasunlimab.

然後我可以問一下，關於 acasunlimab，我喜歡您在這裡列出關鍵管道資產的峰值銷售數字，超過 136,000 名潛在可治療患者，acasunlimab 的 10 億美元峰值銷售團隊與您提供的其他團隊相比有點輕。您能否向我們稍微介紹一下上述情況，這是否與六週而不是三週的較長治療間隔有關？或者您對 acasunlimab 還有其他期待嗎？

Thanks, Asthika, for the questions. I will ask Brad to comment on the first two and then maybe Judith can step in also on the estimate for acasunlimab Brad, why don't you start with EPCORE.

感謝 Asthika 提出這個問題。我會請布拉德對前兩個發表評論，然後也許朱迪思也可以介入 acasunlimab 的估算，布拉德，你為什麼不從 EPCORE 開始呢。

Thank you very much for the question. And we remain very confident actually in the core markets with US and Japan with EPKINLY's performance with the growth that we're seeing there. We did have a onetime accounting adjustment for sales in Europe. France specifically that impacted the Q4 number specifically.Otherwise, again, feel very confident with our growth trajectory at this point.

非常感謝您的提問。事實上，我們對美國和日本等核心市場仍然非常有信心，因為 EPKINLY 在這些市場表現出色，並且持續成長。我們確實針對歐洲的銷售進行了一次性會計調整。法國對第四季的數據產生了特別大的影響。

Then maybe the market size for acasunlimab, as we estimated at around $1 billion for 136,000 patients. Do you want to add anything to that, Brad?

那麼可能是 acasunlimab 的市場規模，我們估計 136,000 名患者的市場規模約為 10 億美元。布拉德，你還有什麼要補充嗎？

Yeah. No, for ACA, certainly a competitive space that we see, particularly in this Post-I/O setting a significant opportunity, as you showed on your slide earlier. And -- but nothing really further to comment on that from a size perspective at this point.

是的。不，對於 ACA 來說，我們看到的肯定是一個競爭空間，特別是在這個後 I/O 環境中，這是一個重大機遇，正如您之前的幻燈片中所展示的那樣。並且 — — 但從規模角度來看，目前還沒有進一步的評論。

All right. Thanks, Brad. Judith, any color from the clinical side on acasunlimab and the estimated markets?

好的。謝謝，布拉德。朱迪思，您對 acasunlimab 的臨床方面和預計的市場有何看法？

Yeah. The only thing to add is, as you know, we preselect for PD-L1 positive. So this came into account on the assessment of the market opportunity.

是的。唯一需要補充的是，如您所知，我們預先選擇 PD-L1 陽性。因此，在評估市場機會時要考慮到這一點。

Yifeng Liu, HSBC.

劉逸峰，匯豐銀行。

Maybe I have one follow-up on acasunlimab. So in 2095 the Phase II data update, what are we expecting to see in the data in the presentation? And then what sort of roughly the timing of that presentation?

也許我對 acasunlimab 有一個後續行動。那麼在 2095 年第二階段的資料更新中，我們期望在簡報中看到什麼資料？那麼，這次演講的大致時間是怎麼樣的呢？

And secondly, on EPKINLY second line and transplant eligible. So you've launched a DLBCL 4 trial last year. And could you maybe talk a little bit about the proposition for that setting against the DLBCL 1?

其次，EPKINLY 第二線符合移植條件。你們去年啟動了 DLBCL 4 試驗。您能否稍微談談針對 DLBCL 1 的建議？

Thanks for both questions. Judith why don't you talk a bit more about the acasunlimab data, which we are very excited about to present this year and a bit more on timing. And then Tahi can address the epcoritamab question in the second line plus DLBCL setting after that. Judith?

感謝您提出這兩個問題。朱迪思，為什麼不多談談 acasunlimab 的數據呢？然後 Tahi 可以在第二行解決 epcoritamab 問題以及之後的 DLBCL 設定。朱迪思？

Yes. So thank you for the question. As you know, we presented the first couple of Meyer's curve on overall survival last year at ASCO we saw very interesting durability. elevate the curves were not with enough maturity or with more maturity, we expect to stay the same stream and this is what we will present later this year. So basically, durability of the time to event endpoint, mainly or –

是的。感謝您的提問。如你所知，我們去年在 ASCO 上展示了第一對整體存活率的 Meyer 曲線，我們看到了非常有趣的耐久性。提升曲線不夠成熟或更成熟，我們希望保持相同的流程，這就是我們在今年稍後將要展示的。因此，基本上，事件終點的時間持久性，主要或â

Thanks, Judith, Tahi maybe a comment on the second line plus question for EPCORE.

謝謝，朱迪思，Tahi 也許對第二行有一個評論，並對 EPCORE 提出一個問題。

Yeah, thank you. And maybe I use as an opportunity to more broadly lay out our diffuse such B cell strategy as it relates to a EPKINLY So initial launch, as you know, as a single agent in third line plus going really well. Then the next extension of data was in combination getting data in our hands and providing confidence to physicians and patients that this is a safe and an efficient way of administering this new mechanism. The GemOx data now recognized with 2A classification by the NCCN, meaning this is something that in the judgment of the NCCN is providing benefits to patients. And then we have this Phase III that is ongoing with lenalidomide. These are complementary in our minds and give a opportunity of choices for investigators to treat their patients respected of the need either somebody who needs more debulking or maybe somebody is a little bit more frail.

是的，謝謝。也許我會藉此機會更廣泛地闡述我們與 EPKINLY 相關的瀰漫性 B 細胞策略，因此首次推出時，如您所知，作為第三線單一藥物，進展非常順利。然後，數據的下一個擴展是結合我們手中的數據，並讓醫生和患者相信這是一種安全有效的管理新機制的方法。GemOx 數據現在被 NCCN 認定為 2A 類，這意味著 NCCN 認為這是對患者有益的。目前我們正在進行來那度胺的 III 期研究。我們認為，這些都是互補的，並為研究人員提供了一個選擇的機會，讓他們能夠根據患者的需要來治療他們，無論是需要更多減瘤手術的人，還是身體稍微虛弱的人。

Really, the main focus is actually frontline. This is -- I think we spoke about this, and we also put this on the slide. The study is fully culled to anticipate the readout in 2026. And a lot of the data that we're generating now is in anticipation of that data set and to really supplement a very robust complementary data set in frontline such that when this indication hopefully is going to be that positive, we'll have, again, a very complementary data set to provide physicians with all opportunities to treat their patients. That's essentially broadly the strategy.

確實，主要焦點實際上是前線。這是——我想我們討論過這個問題，我們也把它放在了幻燈片上。該研究已全面完成，預計 2026 年的讀數將會出現。我們現在產生的大量數據都是為了預期該數據集而產生的，並且真正補充了前線非常強大的互補數據集，以便當這個指徵有望變得如此積極時，我們將再次擁有一個非常互補的數據集，為醫生提供治療患者的所有機會。這基本上就是總體策略。

And this is why also in the second line, we have a chemo and a non-chemo combination strategy, if that makes sense.

這就是為什麼在第二線，我們採用化療和非化療聯合策略，如果這有意義的話。

Thanks, Tahi. I think it's very clear. Let's move on to the next question.

謝謝，Tahi。我認為這是非常清楚的。我們繼續討論下一個問題。

Xian Deng, UBS.

瑞銀（UBS）的鄧賢（Xian Deng）。

Just one on time, please. Just wondering, you mentioned the frontline DLBCL trial could be -- could have readout by the end of 2026. Just wondering if you have a readout by end of 2026, do you think you will have two year or three year follow-up at that time -- and that time -- that follow-up time frame, do you think that's actually enough to allow FDA to give a decision without being out for longer follow-up just considering the previous precedent?

請準時到達一次。只是想知道，您提到一線 DLBCL 試驗可能在 2026 年底前完成。只是想知道，如果您在 2026 年底之前有數據，您是否認為屆時將有兩年或三年的跟踪——並且那個時間——那個跟踪時間框架，您是否認為這實際上足以讓 FDA 做出決定，而不必考慮到以前的先例而進行更長時間的跟踪？

Thanks, Xian, for the question. Very exciting one, so I'll let Tahi address that. Tahi?

謝謝 Xian 提出這個問題。非常令人興奮，所以我讓 Tahi 來解決這個問題。塔希？

Yes, sure. I mean so first things first, the study was fully good in summer of last year. And so then there is an event-driven endpoint, PFS, that is the accepted endpoint. And the population in the study is 2 IPI or higher, but there's also a subgroup analysis for 3 IPI and higher. These events play out, and we anticipate they play out in 2026.

是的，當然。我的意思是，首先，去年夏天的研究進展非常順利。因此有一個事件驅動的端點 PFS，即接受的端點。研究中涉及的族群 IPI 為 2 或更高，但也有針對 IPI 為 3 或更高的亞組分析。這些事件將會展開，我們預期它們將在 2026 年展開。

That would mean that the study would meet its statistical defined primary endpoint.

這意味著該研究將達到其統計學定義的主要終點。

I think what you're referring to is the challenge that the FDA had with a lack of over survival benefit initially as it relates to the POLARIX study. And so obviously, it will be whatever the data will be, but based on the Phase II data set that we have generated a pretty robust Phase II data set, we are quite optimistic actually that the signal in the experimental arm will be significantly stronger than the one I was seen in POLARIX. And so we don't anticipate that it's going to be an issue for us.

我認為您所指的是 FDA 在 POLARIX 研究方面最初面臨的挑戰，即缺乏過度生存益處。因此顯然，數據將是任意的，但基於第二階段數據集，我們已經生成了一個相當強大的第二階段數據集，我們實際上非常樂觀地認為實驗組中的信號將比我在 POLARIX 中看到的信號強得多。因此我們預計這不會為我們帶來問題。

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

謝謝，Tahi，我們繼續下一個問題。

Yaron Werber, TD Securities.

道明證券的 Yaron Werber。

Great. So maybe just, Tahi, just a follow-up. The -- should we assume that the second line follicular and second-line DLBCL, that data by year-end '26, is that filable, assuming positive as well, so you can follow both first and second line? Or do you need more data from second line?

偉大的。所以也許只是，Tahi，只是一個後續行動。我們是否應該假設第二線濾泡性和第二線 DLBCL，到 26 年底的資料是可歸檔的，也假設為陽性，那麼您可以追蹤第一線和第二線嗎？或者您需要來自第二行的更多數據？

And then just secondly, on Tivdak. So it sounds like from now on, you're going to be the lead commercialization party and you will book sales in the US, Europe and Japan? And how do we model that? Like how do we -- is there a royalty, I assume, back to Pfizer? And congrats on getting that.

其次，關於蒂夫達克 (Tivdak)。所以聽起來從現在開始，您將成為主要的商業化方，並將在美國、歐洲和日本進行銷售？那我們要怎麼建模呢？例如，我們如何——我猜，輝瑞公司會獲得特許權使用費嗎？恭喜您獲得該獎項。

Thanks, Yaron, for the question. So, Tahi, you can address the question on the very exciting developments with epcoritamab and then Brad why don't you explain the exact contract on Tivdak and commercialization to Yaron after Tahi. Tahi?

謝謝 Yaron 提出這個問題。因此，Tahi，您可以回答有關 epcoritamab 非常令人興奮的發展的問題，然後 Brad，為什麼不向 Yaron 解釋一下 Tahi 之後有關 Tivdak 和商業化的具體合約。塔希？

We, just to clarify what Jan also said at the beginning in his prepared remarks, there are three of the five ongoing Phase IIIs that are fully accrued and awaiting a readout based on events, say, in third line, diffuse large B-cell in second-line follicular lymphoma, which is in combination with R2 and in frontline diffuse large B-cell and we were talking about the frontline diffuse large B cell study that finished a call last year and where we anticipate a readout by events earlier than it was initially prognosticated and that's also true for the second-line follicular lymphoma Phase III, which also accrued significantly faster than is projected and thus because it's event-driven studies, we anticipate a readout earlier than initially projected. .

我們只是為了澄清 Jan 在一開始的準備好的發言中所說的內容，在五個正在進行的 III 期研究中，有三個已經完全累積並等待根據事件得出的讀數，比如，在第三線、二線濾泡性淋巴瘤中的瀰漫性大 B 細胞，與 R2 聯合使用以及在一線瀰漫性大 B 細胞中，我們正在談論去年結束電話預計的要快得多，因此由於它是事件驅動的研究，我們預計讀數將早於最初的預測。。

Thanks, Tahi. And then maybe move on to Brad for the exact commercial formulation of the contract for Tivdak. Brad?

謝謝，Tahi。然後也許會去找布拉德來制定 Tivdak 合約的具體商業表述。布拉德？

Yeah. Just -- thank you. And again, we are excited about the opportunity as it provides us the opportunity to expand our commercialization footprint. But the terms of the agreement, as mentioned earlier, remain that US and China are as is where Pfizer is actually still lead party in both of those areas as we're still promoting here in the US.

是的。只是--謝謝你。我們再次對這個機會感到非常興奮，因為它為我們提供了擴大商業化足跡的機會。但如前所述，協議條款仍然是美國和中國之間的協議，輝瑞實際上仍然是這兩個領域的主導方，我們仍然在美國進行推廣。

and in Europe. -- and rest of world, including Japan, we will be the lead party at that point, and there will be a low double-digit royalties involved as per the contract that we've already set up. But it's -- just as a reminder, US and China remain the same.

以及歐洲。 ——而在包括日本在內的世界其他地區，我們將是主導方，並且根據我們已經簽訂的合同，我們將收取低兩位數的版稅。但需要提醒的是，美國和中國保持不變。

Thanks, Brad. Very clear. Thanks, Yaron, for the questions. Let's move on to the next question.

謝謝，布拉德。非常清楚。謝謝 Yaron 提出的問題。我們繼續討論下一個問題。

Matthew Phipps, William Blair.

馬修菲普斯、威廉布萊爾。

Are you guys able to disclose if you're going to use a folate receptor alpha expression cutoff for the endometrial cancer Phase III?

你們能否透露是否將使用葉酸受體 α 表現截止值來治療子宮內膜癌 III 期？

And then on EPKINLY, given, I don't know, maybe half a year of launch, maybe a little more on that in follicular lymphoma at this point. Do you see any broader utilization in follicular, given no need for hospitalization. Just wondering if that is helping get into community settings and if you think that will be a continuing trend?

然後關於 EPKINLY，考慮到，我不知道，可能已經推出半年了，目前可能在濾泡性淋巴瘤方面還有更多進展。由於不需要住院治療，您是否認為毛囊治療有更廣泛的用途？只是想知道這是否有助於融入社區環境，以及您是否認為這會是一種持續的趨勢？

Thanks, Matt, for the questions. And I think Tahi you can address both folate receptor alpha question for endometrial and then also the EPCORE question.

謝謝馬特提出的問題。我認為 Tahi 您可以同時解答子宮內膜葉酸受體 α 問題以及 EPCORE 問題。

All right. First things first. So this question has come up a couple of times, so I'll try to be very clear. So firstly folate receptor alpha is a validated target in ovarian in PROC essentially all patients have some degree of folate receptor alpha expression.

好的。首先要做的事。這個問題已經出現過幾次了，所以我會盡力解釋清楚。因此，首先，葉酸受體 α 是 PROC 中卵巢的一個經過驗證的目標，基本上所有患者都具有一定程度的葉酸受體 α 表現。

Second, and this is partially related to the antibody that is the component of Rina-S and the internalization rate and partially related to the linker and the stability that comes to the hydrophilic linker, the profile of Rina-S is that it has generated and we have the data on degree also in the ASO presentation already disclosed, but there's obviously more data that we have in today that we're not able to disclose yet has generated robust data across the entire spectrum of folate receptor alpha expression, including patients who are by the technicality of the assay called negative.

其次，這部分與作為 Rina-S 成分的抗體和內化率有關，部分與連接子和親水性連接子的穩定性有關，Rina-S 的概況是它已經生成，我們在 ASO 演示中也已經披露了有關程度的數據，但顯然我們今天還有更多數據無法披露，但已經在整個葉酸受體 α 表達範圍內生成了可靠的數據，包括根據技術的陰性患者。

And I spoke to that before, this is to be also a function of the sensitivity. So to be clear, our strategy in the Phase II and our strategy in the Phase III is to not select folate receptor alpha expression. Now we do stratify in the Phase III by the various cutoffs, which is [125%] and 75%, and that's just good purpose.

我之前說過，這也是敏感度的功能。因此需要明確的是，我們在第二階段和第三階段的策略是不選擇葉酸受體 α 表現。現在，我們確實根據不同的截止值（即 [125％] 和 75％）在第三階段進行分層，這是一個很好的目的。

And EPKINLY, sorry. On EPKINLY, the question was whether the lack of hospitalization is going to help us expand into areas outside of the larger academic institutions. And I think that is certainly a general part of our strategy with piney, and that's my understanding is also playing out already that the utilization of EPKINLY in follicular lymphoma is helping us to get access into institutions that originally were not open to using EPKINLY in the diffuse large B-cell setting, and that's also how the community is getting more comfortable and that leads also to the discussion on our active efforts to remove hospitalization from the diffuse large B-cell label, but I would actually ask Brad to maybe add from his point of view to this.

還有 EPKINLY，抱歉。在 EPKINLY 上，問題是缺乏住院治療是否會幫助我們擴展到大型學術機構以外的地區。我認為這當然是我們與 Piney 合作的總體策略的一部分，而且據我了解，EPKINLY 在濾泡性淋巴瘤中的應用正在幫助我們進入最初不願意在瀰漫大 B 細胞環境中使用 EPKINLY 的機構，這也是社區變得更加舒適的方式，這也引發了關於我們積極努力將住院治療從實際上瀰漫大 B 細胞標籤中去除的 Brad，但我想補充的請補充

Brad. Do you want to comment on this

布拉德。你想對此發表評論嗎

Yeah. Thanks, Tahi. I agree with what you said. I think it's just another validation of physicians reported a really strong response to our favorable clinical profile, the dual indication as well as the positive label without hospitalization that's required or not required in FL.

是的。謝謝，Tahi。我同意你的說法。我認為這只是對醫生報告的強烈反應的另一種驗證，這些反應包括我們良好的臨床特徵、雙重指徵以及無需住院治療的陽性標籤，而這在 FL 中是必需的或不需要的。

So we do feel confident that this FL approval has and will continue to help us deliver innovative bispecifics across multiple histologies, that -- across broad and diverse sites of care as well. So it's just reinforcing that from the physician standpoint.

因此，我們確實有信心，這項 FL 批准已經並將繼續幫助我們在多種組織學以及廣泛而多樣的護理場所提供創新的雙特異性藥物。因此，從醫生的角度來看，這只是強化了這一點。

Thanks, Brad. I'm add to top it off. As a reminder, there's no requirement for any hospitalization in any of the ongoing Phase III trials. So I think that should clarify that. Let's move to the next question.

謝謝，布拉德。我補充一下。提醒一下，正在進行的任何 III 期試驗都不需要住院。所以我認為這應該可以澄清這一點。我們來討論下一個問題。

Qize Ding Redburn Atlantic

齊澤丁 Redburn Atlantic

Just one quick question on the Rina-S because you just mentioned about your clinical development plan in ovarian cancer, endometrial cancer. I'm just wondering -- what is your clinical development plan for other solid tumor indications such as lung and breast.

關於 Rina-S，我只想問一個簡單的問題，因為您剛才提到了您在卵巢癌、子宮內膜癌方面的臨床發展計劃。我只是想知道——您針對肺癌和乳癌等其他實體腫瘤適應症的臨床開發計劃是什麼。

Very good question, Qize, and we will let Tahi comment on that, Tahi excitement all on other tumors.

非常好的問題，Qize，我們讓 Tahi 對此進行評論，Tahi 對所有其他腫瘤都感到興奮。

Yeah. So, there is, indeed, as you were alluding to folate receptor alpha expression in non-month lung cancer, particularly in patients who have EGFR mutation but not only restricted to that and in triple negative breast. And we already spoke about that there will be activities in that range. We already have a cohort in non-small cell lung cancer with patients who have EGFR mutations in second line open and are enrolling patients in their cohort.

是的。因此，正如您所暗示的，在非月經肺癌中確實存在葉酸受體 α 的表達，特別是在 EGFR 突變患者中，但不僅限於此，還存在於三陰性乳癌中。我們已經討論過將開展這方面的活動。我們已經有一個非小細胞肺癌隊列，其中患者在二線開放性治療中出現 EGFR 突變，並且正在招募患者。

And so hopefully, we'll get validation of what we all believe, which is that this -- this asset will also have efficacy in these two indications, and then we're going to inform you about the next steps quite timely. .

因此，希望我們能夠驗證我們所相信的，即這種資產也將對這兩種適應症有效，然後我們將及時通知您下一步的行動。。

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

感謝 Tahi、感謝 Qize 提出這個問題。我們繼續討論下一個問題。

Justin Smith, Bernstein.

賈斯汀·史密斯，伯恩斯坦。

I've got two. First one, just on Dara, if you wanted to possibly share any thoughts about the potential impact from the potential relaunch of Blenrep this year?

我有兩個。首先，關於 Dara，您是否想分享一下對今年重新推出 Blenrep 可能帶來的影響的看法？

And then the second one, just on the buyback, I'm sorry if I'm thinking about things the wrong way. But just trying to understand why you've announced that now I'm not waiting until after the HexaBody decision from J&J? Just -- is it a case of interesting assets out there? Or just any thoughts on why the buyback timing now?

然後第二個問題，關於回購，如果我的想法錯誤，我很抱歉。但我只是想知道為什麼你現在宣布我不等到強生公司的 HexaBody 決定之後？只是——這是一個有趣的資產案例嗎？或者您對為什麼選擇現在回購有什麼想法？

Thanks, Justin, for the question. So I think the dara question is definitely more a question for J&J because they are developing daratumumab. But anyway I will ask Tahi to give his perspective because he's an expert in multiple myeloma maybe you can say some general things there on the landscape Tahi.

謝謝賈斯汀提問。因此，我認為 dara 問題肯定是強生公司的問題，因為他們正在開發 daratumumab。但無論如何，我會請 Tahi 給他的觀點，因為他是多發性骨髓瘤的專家，也許你可以就 Tahi 的情況說一些一般性的事情。

And then Anthony, I can absolutely give you more rationale and thinking behind the buyback which we just announced today, Justin. Tahi, maybe some further color on Blenrep and the landscape in multiple myeloma.

然後安東尼，賈斯汀，我絕對可以給你提供我們今天剛剛宣布的回購背後的更多理由和想法。Tahi，也許可以進一步了解 Blenrep 和多發性骨髓瘤的情況。

Yeah. I will hesitate to comment and so on another company's assets. So broadly speaking, it's always good for patients that there are a lot of opportunities. And I think we should leave it at that.

是的。我會猶豫是否對其他公司的資產進行評論等等。因此從廣義上講，擁有很多機會對患者來說總是有益的。我認為我們就此打住。

All right. I agree with that. So as J&J is the feedback, Justin. And then for Anthony, maybe a more rationale on the buyback right now?

好的。我同意這一點。正如強生公司的回饋，賈斯汀。那麼對安東尼來說，現在回購可能更合理嗎？

Yeah, happy to give you a little bit more context here. Look, our capital allocation priorities are super clear and are aligned with fueling revenue growth and enhancing shareholder value. . Our first priorities I highlighted is really accelerating the development of our late-stage pipeline and maximizing the success of our commercialized medicines, as I highlighted.

是的，很高興在這裡為您提供更多背景資訊。你看，我們的資本配置優先事項非常明確，並且與促進收入成長和提高股東價值一致。。我強調的首要任務是真正加速我們後期產品線的開發，並最大限度地提高我們商業化藥物的成功率。

Second priority is pursuing focused BD and M&A. And after we evaluate these opportunities from these first two priorities, we can consider our third priority, which your question is about, which is return of capital. As a reminder, here in 2024, we executed an approximate $500 million buyback of 1.8 million shares. And for 2025, having carefully considered this, looking at all factors, we announced today our plans to buy back an additional 1.9 million shares. And we really think this strikes the right balance fueling the revenue growth and enhancing shareholder value.

第二個優先事項是追求有針對性的 BD 和 M&A。在我們評估了前兩個優先事項中的這些機會之後，我們可以考慮第三個優先事項，也就是您的問題，即資本回報。提醒一下，2024 年，我們執行了約 5 億美元的回購計劃，回購了 180 萬股股票。對於 2025 年，經過仔細考慮並考慮所有因素後，我們今天宣布了額外回購 190 萬股的計畫。我們確實認為這在促進收入成長和提高股東價值方面達到了正確的平衡。

So I think this is the appropriate time to really outline for all of our stakeholders, our shareholders, our capital allocation framework and priorities. And I think we stepped through that in a fair amount of detail and very clearly outline these priorities and also demonstrated how we've executed against that framework in 2024, and -- and how we're set up very well to continue to execute against that in 2025.

因此，我認為現在是向我們的所有利害關係人、股東真正概述我們的資本配置框架和優先事項的適當時機。我認為我們已經非常詳細地介紹了這一點，非常清楚地概述了這些優先事項，同時也展示了我們如何在 2024 年執行該框架，以及我們如何在 2025 年繼續執行該框架。

Thanks, Anthony. I think it's crystal clear. Thanks, Justin, for the questions. Let's move on to the next analyst.

謝謝，安東尼。我認為它非常清楚。謝謝賈斯汀的提問。讓我們繼續討論下一位分析師。

Vikram Purohit, Morgan Stanley.

摩根士丹利的維克拉姆·普羅希特（Vikram Purohit）。

Great. We had one on BD as a follow-up to the last question and then one on guidance. So on BD, I mean, given you noted 2025 is a heavy execution year for the pipeline. I just wanted to see how strong of the priority external BD and M&A could be for the year? And if you decided to go that route, what is the profile of the assets you'd find most interesting and attractive to kind of bring into the pipeline where it stands now?

偉大的。我們對 BD 進行了一次提問，作為上一個問題的跟進，然後又提出了一次關於指導的問題。所以關於 BD，我的意思是，鑑於你指出 2025 年是管道執行最為繁重的一年。我只是想看看今年的優先外部 BD 和 M&A 有多強？如果您決定走這條路，您認為最有趣和最有吸引力的資產狀況是怎樣的，可以納入目前的管道？

And then secondly, on guidance. I was just wondering if you could provide a bit more color about what the drivers are for the bookends for the revenue, gross profit and OpEx guidance that you outlined for the year.

其次，關於指導。我只是想知道您是否可以提供更多詳細信息，說明您概述的今年收入、毛利和營運支出指導的驅動因素。

Thanks, Vikram, for the questions. Let me address the BD one, and then Anthony can do the guidance question. So the BD is very, very important to us, Vikram we want to organically and inorganically strengthen the pipeline, accelerated. What we will do focus on antibody-based medicine because that is our field of expertise.

謝謝維克拉姆 (Vikram) 的提問。讓我先解決 BD 問題，然後 Anthony 可以回答指導問題。因此，BD 對我們來說非常非常重要，Vikram，我們希望透過有機和無機的方式加強管道，加速發展。我們將重點關注抗體藥物，因為這是我們的專業領域。

We did it very well last year with ProfoundBio. I can tell you that we did this not this acquisition in record time and actually run into the Chief Medical Officer of a very large pharma and the Head of Oncology of a very large biotech, we all know. We said what basically congratulations on the ProfoundBio deal and we just snapped the way in front of our face because we are simply much quicker than other companies.

去年我們與 ProfoundBio 合作非常成功。我可以告訴你，我們以創紀錄的速度完成了這項收購，實際上我們還遇到了一家大型製藥公司的首席醫療官和一家大型生物技術公司的腫瘤學負責人，我們都知道。我們基本上對 ProfoundBio 的交易表示祝賀，我們只是在我們面前拍了拍，因為我們比其他公司快得多。

And what we are looking for Vikram is antibody-based medicines, which are totally differentiated. We can use our expertise in this field for over 25 years now to really zoom into the right opportunities, and that should be Phase III products or Phase III-ready programs ideally for Genmab. And that is to complement our own pipeline. We're also filling our own pipeline.

而我們為維克拉姆尋找的是基於抗體的藥物，這是完全差異化的。我們可以利用我們在該領域超過 25 年的專業知識來真正挖掘正確的機會，而對於 Genmab 來說，理想的應該是 III 期產品或 III 期就緒專案。這是為了補充我們自己的管道。我們也在充實自己的管道。

We are bringing more and more new molecules in the pipeline ourselves from our own platforms. We have several platforms, now ADC platforms, which are responsible for 50% of our pipeline right now, then we have -- sorry, 40% of our pipeline and the 50% is about bispecifics at this moment and the rest is HexaBody. So we have molecules from our own pipeline, but we also look very actively at companies having interesting assets, which we can then accelerate like we did for Rina-S as we described today in the call.

我們正在透過自己的平台，將越來越多的新分子引入研發管線。我們有幾個平台，現在是 ADC 平台，它們占我們目前產品線的 50%，然後我們有 — — 抱歉，我們產品線的 40%，目前 50% 是關於雙特異性抗體，剩下的是 HexaBody。因此，我們擁有來自自己管道的分子，但我們也積極地關注擁有有趣資產的公司，然後我們可以加速這些資產的發展，就像我們今天在電話會議上描述的那樣，我們為 Rina-S 所做的那樣。

I mean, within the year of the acquisition already announced in two Phase III or potentially others to come. in other tumors. I think it's really long -- it's fitting very well with our expertise as a developer of differentiated antibody medicines. I think I believe it with that, Vikram. So we will have to see how effectively we can execute, but we are looking at multiple opportunities as we speak.

我的意思是，在收購一年內，已經宣布了兩個第三階段或可能的其他階段。在其他腫瘤中。我認為它真的很長——它非常符合我們作為差異化抗體藥物開發人員的專業知識。我想我相信這一點，維克拉姆。因此，我們必須看看我們能有多有效地執行，但我們正在尋找多種機會。

So we are very busy with that. And let's now move to Anthony to give a bit more color on the guidance.

所以我們非常忙於此事。現在讓我們請安東尼對這項指導做出更詳細的說明。

Yeah. Vikram, I think the starting point I would really just highlight for you to really kind of frame this out. And hopefully, this is super clear for both 2024 and 2025. From my perspective, we absolutely delivered on our financial commitments. If we zoom in on 2025 and just look at the -- really the quality of the guidance we put forward, total revenue growth -- all my comments will be at the midpoint, total revenue growth at 12%, recurring revenue growth of 18%, we had $100 million plus nonrecurring revenue headwind looking at the improving quality of our revenue profile, recurring revenue is now at 95%.

是的。維克拉姆，我想我真正想強調的出發點是讓你真正闡明這一點。希望這一點在 2024 年和 2025 年都能非常清晰。從我的角度來看，我們完全履行了我們的財務承諾。如果我們將目光聚焦到 2025 年，只看我們提出的指導質量，總收入增長，我所有的評論都將放在中間點，總收入增長率為 12%，經常性收入增長率為 18%，我們有 1 億美元以上的非經常性收入逆風，從我們收入狀況質量的提高來看，經常性收入現在為 95%。

If we look at then the performance EPKINLY and Tivdak, we can really see the investments we've made -- really focused investments we've made over the last couple of years and building out our commercialization capabilities really paying off.

如果我們看看 EPKINLY 和 Tivdak 的表現，我們就能真正看到我們所做的投資——過去幾年我們真正集中的投資以及建立我們的商業化能力確實獲得了回報。

You can look at the net product sales, collaboration revenue line where we see growth for that line really driven by, again, EPKINLY and Tivdak, primarily at EPKINLY, to be clear, projected growth of around 39%, nearly 40% at the midpoint. So it gives you a sense of the quality of the revenue profile.

您可以查看淨產品銷售額、協作收入線，我們發現該線的成長真正受到 EPKINLY 和 Tivdak 的推動，主要是在 EPKINLY，明確地說，預計成長率約為 39%，中間值接近 40%。因此它可以讓您了解收入狀況的品質。

Of course, a big driver of our revenue continues to be DARZALEX and here, we provided our range of $12.6 billion to $13.4 billion, $13 billion at the midpoint. So I would say this is probably the primary driver here of the revenue guidance range.

當然，我們收入的主要驅動力仍然是 DARZALEX，我們給出的範圍是 126 億美元到 134 億美元，中間值為 130 億美元。所以我想說這可能是收入指導範圍的主要驅動因素。

In terms of our investments, again, we've really delivered on our commitments here really purposefully reallocating our investments to the late-stage pipeline and really investing in a smart way in sales and marketing to really deliver on today's launches, but to continue to build that foundation and platform for upcoming future launches and again, delivering on our commitments.

就我們的投資而言，我們確實履行了我們的承諾，有目的地將我們的投資重​​新分配到後期渠道，並以明智的方式投資於銷售和營銷，以真正實現今天的發布，但繼續為即將到來的未來發布構建基礎和平台，再次履行我們的承諾。

In terms of the OpEx range around $2.1 billion to $2.2 billion, this is really driven by the three investment priorities and where these exactly will land and let us do with the expansion and acceleration of EPCORE clinical development with the 5 Phase III trials ongoing and expansion of EPCORE in our key markets.

就營運支出 (OpEx) 範圍而言，約為 21 億美元至 22 億美元，這實際上是由三個投資重點驅動的，這些重點將具體落到哪裡，讓我們能夠擴大和加速 EPCORE 臨床開發，正在進行的 5 個 III 期試驗以及 EPCORE 在我們主要市場的擴張。

Then we have Rina-S with the start of Phase III and second line plus endometrial cancer as well as the overall trajectory of the Phase III trial in PROC. And of course, we have the ongoing work with GEN1046, or (technical difficulty) with the Phase III -- Phase II start in another indication and also progressing the Phase III, Vikram.

然後我們有了 Rina-S，開始了 III 期和二線治療加子宮內膜癌，以及 PROC 的 III 期試驗的總體軌跡。當然，我們正在進行 GEN1046 的研發工作，或者說（技術難題）第三階段——第二階段在另一個適應症中開始，並且第三階段 Vikram 的研發也在推進中。

So it's really going to be these three programs, I would say, that are largely driving the variability in OpEx. Again, if we sort of if I finished my comments where I started, really, we continue to deliver on our financial commitments very strong recurring revenue growth and seeing that come through to the bottom line in terms of the 16% operating profit growth at the midpoint. We're projecting -- or more than $1.1 billion.

所以我想說，這三個項目實際上是營運支出變化的主要動力。再說一遍，如果我能從我們開始的地方結束我的評論，那麼我們確實會繼續履行我們的財務承諾，實現非常強勁的經常性收入增長，並且看到這一增長轉化為中期 16% 的營業利潤增長。我們預計該數字將超過 11 億美元。

All right. Thanks, Vikram, for the questions. Let's move on to the next one.

好的。謝謝維克拉姆 (Vikram) 的提問。我們繼續下一個吧。

Rajan Sharma, Goldman Sachs.

高盛的拉詹夏爾馬 (Rajan Sharma)。

So I was just wondering if we could get an update on GEN1042, I know this slide said that there's going to be a decision in 2025. but it's obviously been a decision that's been pending for some time. So just interested in understanding what you're still trying to establish here. And if we could just get a little bit more clarity on the timing? Is that likely to be first half or second half of the year?

所以我只是想知道我們是否可以獲得有關 GEN1042 的最新消息，我知道這張投影片上說將在 2025 年做出決定。所以只是想了解您在這裡仍試圖建立什麼。我們是否可以更清楚地了解一下時間安排？這可能是上半年還是下半年？

And just one for Anthony on clarification on the guidance. Is there anything assumed in guidance for 1042 development?

只想問一下安東尼關於該指導意見的澄清。1042 開髮指南中有什麼假設嗎？

And then a very quick one to wrap up. You previously talked about potential developments in immunology and inflammatory disease either through your own internal pipeline or through external sources. Could you just kind of talk to your latest thoughts there and appetite both from an internal and external perspective.

然後很快結束。您之前透過自己的內部管道或外部資源談到了免疫學和發炎疾病領域的潛在發展。您能否從內在和外在的角度談談您最近的想法和胃口？

Thanks, Rajan for the questions. So I will ask Judith to comment on the timing for 1042. And Anthony, for the what is the plans for 1042 in development.

感謝拉詹提出的問題。因此我會請 Judith 對 1042 的時間安排作出評論。安東尼，1042 的開發計畫是什麼？

Let me start with the I&I question. What we already said, right, John, is that EPKINLY, we believe, is an excellent candidate for development also in select I&I indications, and we are in discussions now with AbbVie to actually plan and discuss next steps for EPKINLY. We think it's an excellent molecule, which will likely work really, really well. in the I&I area, but we also have collaboration with Argenx, which is preclinical. and a number of internal 100% owned program for Genmab.

讓我先從 I&I 問題開始。對的，約翰，我們已經說過了，我們相信 EPKINLY 也是在選擇性 I&I 適應症中開發的絕佳候選藥物，我們現在正在與 AbbVie 進行討論，以實際規劃和討論 EPKINLY 的下一步行動。我們認為它是一種優秀的分子，很可能會發揮非常非常好的作用。在I&I領域，但我們也與Argenx進行了臨床前合作。以及一些 Genmab 內部 100% 擁有的項目。

So we continue to be very focused on creating next-generation differentiated antibody-based medicine candidates for I&I. And then we will update you once we are closer to the clinic. But the most advanced candidate is EPKINLY.

因此，我們將繼續致力於為 I&I 創造下一代差異化抗體候選藥物。一旦我們接近診所，我們將向您更新最新情況。但最先進的候選人是EPKINLY。

Then let's move on to Judith to speak a bit about timing for 1042. Judith?

然後我們請朱迪思談談 1042 的時間安排。朱迪思？

Yeah. So as we put in the slide by 2025, I cannot be more precise at this point becausedurability is key for IO and we need to assess durability in first line and then undergo the prioritization within our own pipeline and head and neck externally is moving as well, and we will come with all these data sets more likely by the second half of the year.

是的。因此，正如我們在幻燈片中提到的2025年，我現在無法更精確地描述這一點，因為耐用性是IO的關鍵，我們需要在第一線評估耐用性，然後在我們自己的管道內進行優先排序，並且頭部和頸部的外部也在移動，我們將更有可能在今年下半年獲得所有這些數據集。

Thanks, Judith. And then Anthony, what is in the budget of the guidance for 2025 for 1042.

謝謝，朱迪思。那麼安東尼，2025 年 1042 的指導預算是多少。

Yeah. Well, look, Rajan, thanks, and good to hear from you. I think as we sort of think about 1042 has the, of course, the ongoing work that Judith has just alluded to. And I'd say the future work was really just not really material one way or the other this year. That's primarily based and is a function of timing.

是的。好吧，拉詹，謝謝，很高興收到你的來信。我認為，正如我們所想的，1042 當然還有 Judith 剛才提到的正在進行的工作。我想說，無論今年的未來工作如何，都不是真正重要的。這主要基於時間並且是時間的函數。

Then finally, to top it off, Rajan, I can tell you that not only lead, but also a part of Biotech is very excited about what we have seen up to now withy 1042. We need more data, as Judith already alluded to. But we also think there was a great potential for combining 1042 with different ADCs and other concepts which both companies are working on.

最後，最重要的是，拉詹，我可以告訴你，不僅是領導，而且生物技術的一部分也對我們迄今為止在 1042 中看到的情況感到非常興奮。正如 Judith 已經提到的，我們需要更多數據。但我們也認為，將 1042 與兩家公司正在研究的不同 ADC 和其他概念結合具有巨大的潛力。

So I think exciting times we will need a bit more data to get more -- a better feeling for durability, but a high level of excitement.

因此我認為激動人心的時刻，我們將需要更多的數據來獲得更多——對耐用性的更好的感覺，但興奮程度更高。

All right. Operator, this was the last question. So thank you all for calling in today to discuss Genmab's financial results for 2024. If you have additional questions please reach out to our Investor Relations team. They are ready to answer your questions.

好的。接線員，這是最後一個問題。感謝大家今天來電討論 Genmab 2024 年的財務表現。如果您還有其他問題，請聯絡我們的投資者關係團隊。他們已準備好回答您的問題。

And then we hope that you all stay safe, keep optimistic, and we very much look forward to speaking with you all again soon.

我們希望大家保持安全，保持樂觀，我們非常期待很快能再次與大家交談。

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。感謝您的參與。現在你們都可以斷開連結了。祝你今天過得愉快。