Genmab A/S (GMAB) 2023 Q3 法說會逐字稿

Hello, and welcome to Genmab's Third Quarter 2023 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 or unsuccessful development projects.

您好，歡迎參加 Genmab 2023 年第三季財務業績電話會議。謹此提醒，本次電話會議正在錄音中。在本次電話會議期間，您可能會收到前瞻性陳述，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，由於開發專案延遲或不成功。

Genmab is not under any obligation to update statements regarding the future nor to confirm such statements in relation to actual results, unless it is required by law. 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.

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相關的此類聲明，除非法律要求。另請注意，作為我們投資者關係外展活動的一部分，Genmab 可能會根據您的指示保存您的個人數據，以便今後為您提供有關 Genmab 的最新資訊。請造訪我們的網站，以了解有關 Genmab 的更多資訊以及我們的隱私權政策。

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發言人 Jan van de Winkel。請繼續。

Hello, and welcome to Genmab's conference call to discuss our financial results for the period ending September 30, 2023. With me today to present these results is our CFO, Anthony Pagano. For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky; our Chief Operating Officer, Anthony Mancini; and our Chief Medical Officer, Tahi Ahmadi.

您好，歡迎參加 Genmab 的電話會議，討論我們截至 2023 年 9 月 30 日的財務業績。今天與我一起介紹這些業績的是我們的首席財務官 Anthony Pagano。我們的首席開發長 J​​udith Klimovsky 將參加問答環節；我們的營運長安東尼·曼奇尼；以及我們的首席醫療官 Tahi Ahmadi。

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. This slide acknowledges those relationships.

正如已經說過的，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。在今天的演示中，我們將參考我們的一些策略合作下正在開發的產品。這張投影片承認了這些關係。

Genmab's strong foundation is built on our consistent track record of success. As we near the end of the year, it's a good time to reflect on how far we have come as a company, even in the last 12 months. We continue to expand our pipeline with new INDs and new product candidates in the clinic. We also matured our pipeline with new clinical trials and positive data readouts.

Genmab 的堅實基礎建立在我們一貫的成功記錄之上。接近年底，是時候反思我們公司在過去 12 個月中所取得的成就。我們繼續透過新的 IND 和臨床新候選產品擴大我們的產品線。我們還透過新的臨床試驗和積極的數據讀數使我們的管道更加成熟。

And very excitingly, there are now 8 approved medicines that are followed by our innovations, half of which were created with our proprietary DuoBody technology. Epcoritamab, which we are codeveloping with AbbVie, is also our first medicine to be approved for patients and territories outside the U.S.

非常令人興奮的是，現在有 8 種批准的藥物是我們的創新產品，其中一半是用我們專有的 DuoBody 技術創造的。我們與艾伯維 (AbbVie) 共同開發的 Epcoritamab 也是我們第一個被批准用於美國以外患者和地區的藥物。

These advances are possible because we have a dedicated and unstoppable team at Genmab, an international team that has grown to enable us to continue to evolve into a leading integrated biotech innovation powerhouse.

這些進步之所以成為可能，是因為 Genmab 擁有一支敬業且勢不可擋的團隊，這是一支不斷成長的國際團隊，使我們能夠繼續發展成為領先的綜合生物技術創新強國。

Let's now turn to recent key company events. September was an exciting month for epcoritamab as we and AbbVie received approvals in both Japan as EPKINLY and in Europe as TEPKINLY. Like the approval in the U.S. earlier in the year, these approvals were important milestones, both for our patients in need and for Genmab as a company.

現在讓我們來看看最近的公司重大事件。 9 月對 epcoritamab 來說是令人興奮的一個月，因為我們和艾伯維在日本獲得了 EPKINLY 的批准，在歐洲獲得了 TEPKINLY 的批准。與今年稍早在美國的批准一樣，這些批准對於我們有需要的患者和 Genmab 公司來說都是重要的里程碑。

The approval in Japan is especially significant as we at Genmab are the commercial lead for EPKINLY there. We began growing our presence in Japan in 2019. So we would be ready for just such an opportunity. So we are very pleased to be launching our own product there, especially as EPKINLY as the first and only bispecific antibody approved in Japan to treat adults with certain types of relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy.

在日本的批准尤其重要，因為我們 Genmab 是 EPKINLY 在日本的商業領導者。我們在 2019 年開始擴大在日本的業務。因此，我們已經為這樣的機會做好了準備。因此，我們很高興在那裡推出我們自己的產品，特別是EPKINLY 作為日本批准的第一個也是唯一一個雙特異性抗體，用於治療經過2 線或以上全身治療後患有某些類型的複發或困難治性大B 細胞淋巴瘤的成人。

And we are excited to note that in addition to the U.S., Japan and Europe, epcoritamab has now been approved in Canada and the U.K. I'm also happy to announce that once again, the broad potential of epcoritamab to become a core therapy for B-cell malignancies will be on display at this year's prestigious ASH Conference at the end of -- at the beginning of December.

我們很高興地註意到，除了美國、日本和歐洲之外，epcoritamab 現已在加拿大和英國獲得批准。我也很高興地再次宣布，epcoritamab 具有成為 B 型乳腺癌核心療法的廣泛潛力。- 細胞惡性腫瘤將於12 月初在今年著名的ASH 會議上展出。

We have had 15 total abstracts accepted for presentation at ASH, 2 of which are oral presentations. Of the accepted abstracts, 4 will be initial disclosures of clinical data for epcoritamab, including an oral presentation of data from the EPCORE NHL-5 trial of epcoritamab in combination with lenalidomide as treatment for patients with relapsed or refractory diffused large cell -- B-cell lymphoma.

我們總共有 15 篇摘要被接受在 ASH 上演講，其中 2 篇是口頭演講。在已接受的摘要中，4 份將是 epcoritamab 臨床數據的初步披露，包括 epcoritamab 聯合來那度胺治療復發或難治性瀰漫性大細胞患者的 EPCORE NHL-5 試驗數據的口頭介紹 - B-細胞淋巴瘤。

This data is further support for EPCORE's combinability and highlights its potential to move into earlier lines of therapy.

這些數據進一步支持了 EPCORE 的組合性，並強調了其進入早期治療系列的潛力。

HexaBody-CD38 will also be recognized at ASH with a poster presentation on preliminary results from the expansion cohort at the recommended Phase II dose of the ongoing Phase I/II trial. We are actively enrolling in the head-to-head portion of the trial. We are very encouraged by what we are seeing. And as we said previously, we anticipate the head-to-head data in 2024.

HexaBody-CD38 也將在 ASH 上獲得認可，並以海報展示形式展示正在進行的 I/II 期試驗的建議 II 期劑量的擴展隊列的初步結果。我們正在積極參與試驗的面對面部分。我們對所看到的感到非常鼓舞。正如我們之前所說，我們預計 2024 年將出現面對面的數據。

If we look beyond our own pipeline and include all abstracts involving products that are powered by Genmab's innovations, there are nearly 200 total abstracts accepted for presentation at this year's ASH meeting, 36 of them oral presentations.

如果我們超越自己的管道，將涉及 Genmab 創新產品的所有摘要納入其中，那麼今年 ASH 會議上將接受近 200 份摘要，其中 36 份為口頭報告。

Now I want to turn to some additional exciting updates on the progress of our maturing proprietary antibody product pipeline.

現在我想談談我們成熟的專有抗體產品管道的一些額外令人興奮的進展。

First, GEN1046. It has cleared the high bar that we set. We are very pleased to share that we are now engaging with health authorities to determine next steps. Previously, we shared data from an expansion cohort of patients with non-small cell lung cancer, who failed prior checkpoint inhibitors. We saw encouraging single-agent activity, but responses are not durable.

首先，GEN1046。它已經超越了我們設定的高標準。我們非常高興地告訴大家，我們現在正在與衛生當局合作，以確定下一步。先前，我們分享了一組非小細胞肺癌患者的數據，這些患者先前的檢查點抑制劑都無效。我們看到令人鼓舞的單一代理活動，但反應並不持久。

Based on clinical and strong preclinical data that showed that the combination of GEN1046 plus checkpoint inhibitors resulted in improved efficacy, we embarked on a scientific question, how to most optimally engage 4-1BB activation with checkpoint inhibition?

基於臨床和強有力的臨床前數據表明 GEN1046 與檢查點抑制劑的組合可提高療效，我們開始提出一個科學問題，即如何最有效地將 4-1BB 活化與檢查點抑制結合？

The Phase II study of GEN1046 in combination with pembrolizumab in patients with PD-L1-positive non-small cell lung cancer, who failed standard-of-care therapy with an immune checkpoint inhibitor, address this question. And emerging data from this study has provided us a clear answer. So far, the data from this study indicates that we can combine these two mechanisms and that this leads to improved efficacy.

GEN1046 合併派姆單抗治療 PD-L1 陽性非小細胞肺癌患者（免疫檢查點抑制劑標準治療失敗）的 II 期研究解決了這個問題。這項研究的新數據為我們提供了明確的答案。到目前為止，這項研究的數據顯示我們可以將這兩種機制結合起來，從而提高療效。

Based on this, we believe there is a clear path forward, and we are engaging with health authorities to determine next steps. We look forward to sharing the relevant clinical data at a medical conference in the first half of 2024. As a reminder, we are developing GEN1046 with BioNTech.

基於此，我們相信有一條明確的前進道路，我們正在與衛生當局合作以確定下一步。我們期待在 2024 年上半年的醫學會議上分享相關臨床數據。提醒一下，我們正在與 BioNTech 一起開發 GEN1046。

Moving to TIVDAK. We were very pleased that we, along with our partner, Seagen, presented the late-breaking results from the innovaTV 301 trial of tisotumab vedotin in recurrence or metastatic cervical cancer during the presidential symposium of the Asthma Congress in Madrid in October. This follows the announcement by us and Seagen in September that the trial met its primary endpoint of overall survival.

搬到蒂夫達克。我們非常高興與我們的合作夥伴 Seagen 在 10 月馬德里氣喘大會主席研討會上展示了 tisotumab vedotin 治療復發或轉移性子宮頸癌的 innovaTV 301 試驗的最新結果。此前，我們和 Seagen 在 9 月宣布該試驗達到了整體存活期的主要終點。

As a reminder, the results of this trial are intended to serve as both the pivotal confirmatory trial for TIVDAK's accelerated approval in the U.S. as well as to support global regulatory applications. Likewise, TIVDAK has also cleared the high bar that we set. We are optimistic about the data we have seen in head and neck cancer post standard of care. Here, we will actively engage with health authorities on next steps in this indication.

需要提醒的是，該試驗的結果旨在作為 TIVDAK 在美國加速批准的關鍵驗證性試驗，並支持全球監管申請。同樣，TIVDAK 也突破了我們設定的高標準。我們對標準護理後頭頸癌的數據感到樂觀。在這裡，我們將積極與衛生當局就這一適應症的後續步驟進行接觸。

Moving to GEN1042. We are also codeveloping with BioNTech, and we remain very encouraged by the clinical efficacy data that we are seeing across several tumor types. We are currently taking the learnings from GEN1046 on how we can optimally dose and schedule GEN1042. We need more time to do this, so we now anticipate that we will have the data we need to determine next steps for this program in the coming months.

轉向 GEN1042。我們也與 BioNTech 共同開發，我們對多種腫瘤類型的臨床療效數據感到非常鼓舞。我們目前正在從 GEN1046 中吸取經驗教訓，以了解如何最佳劑量和安排 GEN1042。我們需要更多的時間來完成這項工作，因此我們現在預計我們將獲得所需的數據，以便在未來幾個月內確定該計劃的後續步驟。

Looking at some of our earlier-stage programs, I have a brief update on GEN1047, our DuoBody CD3B7H4. We have now completed dose escalation in the Phase I/II trial and have transitioned to dose expansion. This is an important step in progressing our CD3-based bispecific platform in solid tumors.

看看我們的一些早期項目，我對 GEN1047（我們的 DuoBody CD3B7H4）有一個簡短的更新。我們現已完成 I/II 期試驗的劑量遞增，並已過渡到劑量擴大。這是我們基於 CD3 的雙特異性平台在實體腫瘤領域取得進展的重要一步。

Then, GEN3017, our DuoBody-CD3xCD30, a program that we announced last quarter, has now started recruitment for our first-in-human clinical trial. We're also very pleased to announce another IND submission for 2023, GEN1059, our DuoBody-EpCAMx4-1BB. The first preclinical disclosure for this program, which will further leverage our knowledge of 4-1BB, also took place at ESMO in October in Madrid.

然後，GEN3017，我們的 DuoBody-CD3xCD30，我們上季度宣布的一個項目，現已開始招募我們的首次人體臨床試驗。我們也非常高興地宣布 2023 年提交的另一項 IND 申請，即 GEN1059，即我們的 DuoBody-EpCAMx4-1BB。該計劃的首次臨床前披露也於 10 月在馬德里的 ESMO 進行，這將進一步利用我們對 4-1BB 的知識。

This bispecific antibody, which we are codeveloping with BioNTech, has potential in solid tumors. We anticipate that GEN1059 will enter the clinic in 2024.

我們與 BioNTech 共同開發的這種雙特異性抗體在實體腫瘤方面具有潛力。我們預計GEN1059將於2024年進入臨床。

Finally, as we work to progress these new and existing programs, we have also made the decision to seize development of GEN3009, our DuoHexaBody-CD37. This decision was made following its strategic evaluation of the program within the context of our entire portfolio and was not based on any safety or regulatory concerns.

最後，在我們努力推進這些新專案和現有專案的同時，我們也決定抓緊開發 GEN3009，也就是我們的 DuoHexaBody-CD37。這項決定是在我們整個投資組合的背景下對該計劃進行戰略評估後做出的，並非基於任何安全或監管問題。

Our goal of transforming the lives of patients is always at the center of our decisions, and we look forward to continuing to create and develop truly differentiated antibody products. The power of our innovation is reflected in programs that apply our DuoBody technology. 2 of these products are Janssen's TALVEY and RYBREVANT.

改變患者生活的目標始終是我們決策的核心，我們期待繼續創造和開發真正差異化的抗體產品。我們的創新力量體現在應用 DuoBody 技術的專案中。其中 2 種產品是楊森的 TALVEY 和 RYBREVANT。

In August, TALVEY was approved in both the U.S. and Europe for relapsed or refractory multiple myeloma, making it the fourth approved DuoBody-based bispecific antibody. Also in August, Janssen submitted an sBLA for RYBREVANT, followed by a type 2 extension to the EMA in October. Both of these submissions are based on the confirmatory Phase III [PAPILLON] study.

8 月，TALVEY 在美國和歐洲獲得批准用於治療復發或難治性多發性骨髓瘤，使其成為第四個獲得批准的基於 DuoBody 的雙特異性抗體。同樣在 8 月，楊森提交了 RYBREVANT 的 sBLA，隨後在 10 月向 EMA 提交了 2 類擴展。這兩項提交均基於驗證性 III 期 [PAPILLON] 研究。

So overall, you can see plenty of progress across our business, with lots to be excited about as we look forward. And that's a good note on which to hand over to Anthony Pagano, and he will take you through our financials. Anthony, the floor is yours.

總的來說，您可以看到我們的業務取得了很大的進展，並且有很多值得我們期待的事情。這是一個很好的說明，可以交給安東尼·帕加諾，他將帶您了解我們的財務狀況。安東尼，地板是你的。

Great. Thanks, Jan. We continue to strengthen our foundation over the first 9 months of the year. Of course, top of mind for everyone are the multiple regulatory approvals for EPKINLY. And as we'll see, our financials continue to be strong.

偉大的。謝謝 Jan。今年前 9 個月我們將繼續加強我們的基礎。當然，每個人最關心的是 EPKINLY 獲得的多項監管批准。正如我們將看到的，我們的財務狀況持續強勁。

Recurring revenues grew by 22% on a reported basis and impressively, 30% on an operational basis. This was principally driven by strong royalties from DARZALEX, along with significant growth from our other 7 approved medicines.

根據報告，經常性收入成長了 22%，而營運收入則成長了 30%，令人印象深刻。這主要是由 DARZALEX 的強勁特許權使用費以及我們其他 7 種批准藥物的顯著增長所推動的。

Our solid balance sheet, growing recurring revenues and significant underlying profitability allow us to continue to invest in our business and our pipeline in a very focused and disciplined way. And an important part of this has been to continue to build the team and capabilities we need to succeed. So let's look at those revenues in a bit more detail.

我們穩健的資產負債表、不斷增長的經常性收入和顯著的潛在盈利能力使我們能夠繼續以非常專注和嚴格的方式投資於我們的業務和管道。其中一個重要部分是繼續建立我們成功所需的團隊和能力。讓我們更詳細地看看這些收入。

We continued to see strong performance for DARZALEX during the first 9 months of the year. As you can see in the chart, overall, net sales grew by 22%. That's net sales of nearly $7.2 billion, which translates to over DKK 8 billion in royalty revenue. This growth was driven by continued share gains and strong performance in the frontline setting.

今年前 9 個月，我們繼續看到 DARZALEX 的強勁表​​現。正如您在圖表中看到的那樣，總體而言，淨銷售額增長了 22%。淨銷售額接近 72 億美元，相當於特許權使用費收入超過 80 億丹麥克朗。這一成長是由持續的份額成長和一線環境的強勁業績所推動的。

So DARZALEX remains a key driver of our revenue. We grew total revenue to almost DKK 11.8 billion in the first 9 months of the year. And as I've already highlighted, that included a 22% increase in our recurring revenue. And to be clear, that's on a reported basis. Excluding some FX headwinds, recurring revenues grew by 30% on an operational basis. Last year's results make for a somewhat tough comparator as we saw pretty significant FX tailwinds, particularly for our royalty revenue.

因此，DARZALEX 仍然是我們收入的主要驅動力。今年前 9 個月，我們的總收入成長至近 118 億丹麥克朗。正如我已經強調過的，這包括我們的經常性收入成長了 22%。需要明確的是，這是根據報告得出的。排除一些外匯不利因素，經常性收入在營運基礎上成長了 30%。去年的業績有點難以比較，因為我們看到了相當大的外匯順風，尤其是我們的特許權使用費收入。

As a reminder, under our DARZALEX agreement, for purposes of calculating our royalties, sales outside the United States are translated to U.S. dollars at a specified annual hedged foreign exchange rate. Operational growth in the first 9 months of this year continued to be strong, driven by higher DARZALEX royalties as well as royalties from our other products, and this really illustrates the power of our recurring revenue.

提醒一下，根據我們的 DARZALEX 協議，為了計算我們的特許權使用費，美國境外的銷售額按指定的年度對沖外匯匯率換算為美元。在 DARZALEX 特許權使用費以及我們其他產品特許權使用費增加的推動下，今年前 9 個月的營運成長繼續強勁，這真正說明了我們經常性收入的力量。

We also recognized the first full quarter of sales for EPKINLY in [Q3]. And we're very pleased with how the launch is progressing so far, with around $22 million in net sales for the quarter and $28 million year-to-date. Overall, our strong recurring revenue growth enables continued highly focused investment, as you can see on the next slide.

我們也確認了 EPKINLY 在[第三季]的第一個完整季度的銷售額。我們對迄今為止的發布進度感到非常滿意，本季淨銷售額約為 2,200 萬美元，年初至今淨銷售額為 2,800 萬美元。總體而言，我們強勁的經常性收入成長使我們能夠持續進行高度集中的投資，正如您在下一張幻燈片中看到的那樣。

Back in February, we were very clear that we would continue to invest to capture the opportunities we see in front of us. And that's exactly what we've done with total OpEx up 42% in the first 9 months of the year. At that time back in February, I outlined our top 4 investment priorities. First, securing a successful EPKINLY launch by investing in our 2 key markets, the United States and Japan.

早在二月份，我們就非常明確，我們將繼續投資以抓住我們面前的機會。這正是我們所做的，今年前 9 個月的總營運支出成長了 42%。早在二月的時候，我概述了我們的四大投資重點。首先，透過投資美國和日本這兩個關鍵市場，確保 EPKINLY 的成功推出。

Second, continuing to advance our pipeline. Here, the lion's share of our investment is being directed to our most advanced programs, including EPKINLY, TIVDAK, 1046 and 1042, which are all exciting opportunities for us.

二是繼續推進管道建設。在這裡，我們的大部分投資都投向了我們最先進的項目，包括 EPKINLY、TIVDAK、1046 和 1042，這些對我們來說都是令人興奮的機會。

Third, investing in our world-class discovery engine, including focused investments to expand our therapeutic focus to include I&I. And fourth, foundational investments in enabling functions to achieve required scale. As you can see, our investments continue to be fully in line with these priorities. And as always, we continue to focus on long-term value creation.

第三，投資於我們世界一流的發現引擎，包括集中投資以擴大我們的治療重點，將 I&I 納入其中。第四，對使職能能達到所需規模的基礎性投資。正如您所看到的，我們的投資繼續完全符合這些優先事項。一如既往，我們繼續關注長期價值創造。

So with that, let's now take a look at our financials as a whole. Here, you can see our summary P&L. Revenue came in at close to DKK 11.8 billion. That's up 26% on last year. As mentioned, that's negatively impacted by FX headwinds. Total expenses were around DKK 8 billion, with 71% being R&D and 29% SG&A. And even with the increased investment and significant FX headwinds, we're still delivering around DKK 3.7 billion of operating profit.

因此，現在讓我們來看看我們的整體財務狀況。在這裡，您可以看到我們的損益表摘要。收入接近 118 億丹麥克朗。比去年增長了 26%。如前所述，這受到外匯逆風的負面影響。總支出約 80 億丹麥克朗，其中 71% 用於研發，29% 用於銷售、一般管理費用。即使投資增加並面臨巨大的外匯阻力，我們仍能實現約 37 億丹麥克朗的營業利潤。

Moving now to our net financial items. Here, we have a gain of over [DKK 1 billion] so far in 2023. This is driven by an increase in interest income due to higher effective interest rates as well as the strengthening of U.S. dollar against the Danish kroner in the first 9 months of the year. Then we have tax expense of about DKK 1 billion, which equates to an effective tax rate of 21.2%. And that brings us to our net profit of over DKK 3.7 billion. So as you can see, continued strong underlying financial performance.

現在轉向我們的淨財務項目。到目前為止，2023 年我們的收益已超過 [10 億丹麥克朗]。這是由於實際利率上升導致利息收入增加以及前 9 個月美元兌丹麥克朗走強推動的今年的。那麼我們的稅收支出約為 10 億丹麥克朗，相當於有效稅率為 21.2%。這使我們的淨利潤超過 37 億丹麥克朗。正如您所看到的，基本財務表現持續強勁。

With that, let's take a minute to revisit our robust financial framework. First off, our revenue profile on the left. With the approval of EPKINLY in May and TALVEY in August, there are now 8 products on the market that are generating recurring revenues for us, and we expect significant cash inflows for the years to come.

接下來，讓我們花一點時間重新檢視一下我們穩健的財務架構。首先，左邊是我們的收入概況。隨著 EPKINLY 於 5 月獲得批准，TALVEY 於 8 月獲得批准，目前市場上已有 8 種產品為我們帶來經常性收入，我們預計未來幾年將有大量現金流入。

Moving to the right. We remain focused on our investments as we evolve our organization for continued success. At the top of the list is accelerating and expanding EPCORE. But that's just one of the exciting opportunities that provide us with a compelling rationale for increasing our investment. As we've told you before, if we want to seize these meaningful opportunities, we've got to invest, and that's exactly what we're doing.

向右移動。在我們不斷發展我們的組織以取得持續成功的同時，我們仍然專注於我們的投資。首要任務是加速和擴展 EPCORE。但這只是令人興奮的機會之一，它為我們增加投資提供了令人信服的理由。正如我們之前告訴過您的，如果我們想抓住這些有意義的機會，我們就必須進行投資，而這正是我們正在做的事情。

So with that background, let's take a look at our guidance. As you can see, we are adjusting our 2023 financial guidance. In summary, we are lifting the bottom end of our revenue and OpEx ranges. This is due to current year-to-date performance and the strong U.S. dollar. This, of course, has the effect of tightening the ranges across the board.

有了這樣的背景，讓我們來看看我們的指導。如您所見，我們正在調整 2023 年財務指引。總之，我們正在提高收入和營運支出範圍的下限。這是由於今年迄今的表現和美元走強。當然，這具有全面收緊範圍的效果。

We now expect our revenue to be in a range of DKK 15.9 billion to DKK 16.5 billion. One of the drivers of this increase is higher DARZALEX royalties. So we've increased our guidance here to DKK 11.3 billion to DKK 11.5 billion.

我們現在預計收入將在 159 億丹麥克朗至 165 億丹麥克朗之間。這一成長的驅動因素之一是 DARZALEX 特許權使用費的增加。因此，我們將此處的指導價值提高至 113 億丹麥克朗至 115 億丹麥克朗。

Turning to our investments. As always, we remain focused on executing against our strategy and key priorities and at the same time, creating long-term value. So we're investing to capture the significant growth opportunities in front of us.

轉向我們的投資。一如既往，我們仍然專注於執行我們的策略和關鍵優先事項，同時創造長期價值。因此，我們正在投資以抓住我們面前的重大成長機會。

And here, we're increasing the bottom end of our OpEx guidance to a range of DKK 10.6 billion to DKK 10.9 billion. This is primarily related to increased and accelerated investment in epcoritamab clinical trials and the progression of other pipeline products, including 1046 and TIVDAK.

在這裡，我們將營運支出指引的下限提高到 106 億丹麥克朗至 109 億丹麥克朗的範圍。這主要與 epcoritamab 臨床試驗投資的增加和加速以及其他管道產品（包括 1046 和 TIVDAK）的進展有關。

Putting all this together, we're on track to deliver another year of substantial operating profit in a range of DKK 4.8 billion to nearly DKK 5.8 billion.

綜上所述，我們預計在新的一年實現 48 億丹麥克朗至近 58 億丹麥克朗的可觀營業利潤。

As a reminder, note that these projections are based on an assumed U.S. dollar-Danish kroner exchange rate of 6.8. And finally, to give you a bit more color on FX, every 10 basis point move in the exchange rate relative to our guidance rate is worth around DKK 80 million in operating income for the balance of the year.

請注意，這些預測是基於假設的美元兌丹麥克朗匯率為 6.8 計算的。最後，為了讓您對外匯有更多的了解，相對於我們的指導匯率，匯率每變動 10 個基點，就相當於今年剩餘時間的營業收入約為 8,000 萬丹麥克朗。

Now before I wrap up, I do want to take a moment to zoom out a bit and take a look at the very high quality of our revenue profile and the power of our discovery engine. We believe this powerful combination sets us up very well for the long term.

現在，在結束之前，我確實想花點時間稍微縮小一下範圍，看看我們的收入狀況的高品質以及我們發現引擎的強大功能。我們相信，這種強大的結合為我們的長期發展奠定了良好的基礎。

First, let's think about the 8 approved medicines you can see in the box in the top right-hand side of the page that are powered by our innovation and technology and that are currently generating significant revenues for us.

首先，讓我們考慮一下您可以在頁面右上角的框中看到的 8 種批准藥物，這些藥物由我們的創新和技術提供動力，目前正在為我們帶來可觀的收入。

The top 3 are already blockbusters. The remaining 5 all have meaningful growth profiles and have the potential to become blockbusters. I can say this with confidence because we have the clinical development plans, and with our partners, we're investing to make this happen.

前三名已經是重磅炸彈。其餘 5 個都具有有意義的成長概況，並且有潛力成為重磅炸彈。我可以充滿信心地說這一點，因為我們有臨床開發計劃，並且與我們的合作夥伴一起，我們正在投資以實現這一目標。

The 6 royalty-generating products are marketed by pharma and biotech powerhouses, J&J, Novartis and Amgen. And our 2 proprietary products are co-marketed with AbbVie and Seagen, and moving forward, we anticipate Pfizer. So we're confident we will realize their potential.

這 6 種特許權使用費產品由製藥和生物技術巨頭強生 (J&J)、諾華 (Novartis) 和安進 (Amgen) 銷售。我們的 2 種專有產品與艾伯維 (AbbVie) 和 Seagen 聯合銷售，展望未來，我們預計輝瑞 (Pfizer)。因此，我們有信心能夠發揮他們的潛力。

Now let me turn to the power of our discovery engine. Of around the [40] programs we've moved into the clinic, 8 are already approved and 19 are currently in active clinical development. That's a pretty strong hit rate, and it's no accident. We understood very early on the competitive advantage that our deep antibody science and focused discovery engine could provide.

現在讓我談談我們的發現引擎的力量。在我們已進入臨床的大約 [40] 個項目中，8 個已獲得批准，19 個目前正在積極的臨床開發中。這是一個相當高的命中率，這並非偶然。我們很早就了解我們深厚的抗體科學和專注的發現引擎可以提供的競爭優勢。

So we've invested more in discovery to increase the number and quality of our product candidates. This includes investment into our proprietary technology platforms. We believe that these diverse tech platforms are key to our success. They allow us to select the most appropriate modality from our [toolbox] to tackle a specific disease target. We have 4 proprietary tech platforms, including DuoBody and HexaBody, and we also have access to a suite of other technologies through our partners.

因此，我們在發現方面投入了更多資金，以提高候選產品的數量和品質。這包括對我們專有技術平台的投資。我們相信這些多樣化的技術平台是我們成功的關鍵。它們使我們能夠從我們的[工具箱]中選擇最合適的方式來應對特定的疾病目標。我們擁有 4 個專有技術平台，包括 DuoBody 和 HexaBody，並且我們還可以透過合作夥伴獲得一套其他技術。

This unique position allows us to bring only the products with the best potential through to development. It's our deep insight into antibodies and our proprietary platforms that have helped us discover, build or design the 8 products that are currently approved. If all 8 currently approved products were wholly owned by Genmab, we would have the potential to generate estimated revenue here in 2023 of over $14 billion.

這種獨特的地位使我們能夠只開發具有最佳潛力的產品。正是我們對抗體的深入洞察和我們的專有平台幫助我們發現、建造或設計了目前獲得批准的 8 種產品。如果目前批准的所有 8 個產品均由 Genmab 全資擁有，我們將有可能在 2023 年產生超過 140 億美元的預計收入。

As we move forward to a model in the future where we have 100% ownership of our products, we believe we can continue this track record of success and further solidify our position as an innovative biotech powerhouse.

隨著我們未來邁向我們擁有 100% 產品所有權的模式，我們相信我們能夠繼續保持這一成功記錄，並進一步鞏固我們作為創新生物技術巨頭的地位。

Now to really wrap up, let me provide a few closing remarks. In summary, we've had a solid first 9 months of 2023. We've created growing recurring revenue streams, including now 2 of our own products on the market, and that gives us a strong backbone of significant underlying profitability. And we're investing those revenues in a highly focused way to realize our vision and to capitalize on the very significant growth opportunities in front of us.

現在，讓我做一些總結發言。總而言之，我們在2023 年的前9 個月表現強勁。我們創造了不斷增長的經常性收入流，包括現在市場上的2 種我們自己的產品，這為我們提供了顯著的潛在盈利能力的強大支柱。我們正在以高度集中的方式投資這些收入，以實現我們的願景並利用我們面前的非常重要的成長機會。

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

關於這一點，我要把你交還給簡。

Thanks, Anthony. We continue to work towards our goal for the year and are especially excited about the multiple approvals for epcoritamab, the positive data for tisotumab vedotin and for the next steps in the development of our earlier-stage product pipeline.

謝謝，安東尼。我們將繼續努力實現今年的目標，尤其對 epcoritamab 的多項批准、tisotumab vedotin 的積極數據以及我們早期產品管道開發的後續步驟感到特別興奮。

I'm also pleased to announce that we will hold our annual R&D Update and ASH Data Review event on December 12. To ensure the event is accessible to as many people as possible, this year's presentation will be fully virtual. Details are available on our website, and we look forward to a lively event.

我還很高興地宣布，我們將於 12 月 12 日舉行年度研發更新和 ASH 數據審查活動。為了確保盡可能多的人能夠參加該活動，今年的演示將完全虛擬進行。詳情請造訪我們的網站，我們期待一場熱鬧的活動。

So that ends our presentation of Genmab's financial results for the first 9 months of 2023. Operator, please open the call for questions.

我們對 Genmab 2023 年前 9 個月財務表現的介紹到此結束。營運商，請開啟提問環節。

(Operator Instructions) We will now take the first question, coming from the line of Vikram Purohit from Morgan Stanley.

（操作員說明）我們現在將回答第一個問題，來自摩根士丹利的 Vikram Purohit。

Great. We had two. First, on GEN3014. So as you mentioned, there were some clinical data that was recently featured for this program through abstracts that were posted for ASH. And we were wondering, what you think are some of the appropriate benchmarks to compare against here on both efficacy and safety to really frame these initial results?

偉大的。我們有兩個。首先，在GEN3014上。正如您所提到的，最近透過 ASH 發布的摘要介紹了該計畫的一些臨床數據。我們想知道，您認為在有效性和安全性方面可以與此處進行比較的一些適當基準是什麼，以真正建立這些初步結果？

And secondly, just to clarify for the R&D update you'll be hosting alongside ASH, should we expect to see any updates for GEN1042 or GEN1046 at this event?

其次，為了澄清您將與 ASH 一起主持的研發更新，我們是否應該期望在本次活動中看到 GEN1042 或 GEN1046 的任何更新？

Thanks, Vikram, for the questions. I will hand over the first one to Tahi. He can give you further perspective on the benchmarks, which you need to think about for the HexaBody-CD38 program. And then the question on 1042 and 1046, to give a bit more color, I will hand it over to Judith. So let's start with Tahi for the GEN3014. Tahi?

謝謝維克拉姆提出的問題。我會把第一個交給塔希。他可以為您提供有關基準的進一步視角，您需要考慮 HexaBody-CD38 程式。然後關於1042和1046的問題，為了提供更多的色彩，我將把它交給Judith。讓我們從 GEN3014 的 Tahi 開始。塔希？

Yes. Thank you for the question. So yes, in principle, of course, for daratumumab, a benchmark would be the 501 study the [SIRIUS] study and then also for the subcutaneous administration, the COLUMBA study. And it gives you a range of efficacy of somewhere between 30% to 40%, with 19% data that can follow up a little bit more about 90% of the patients having VGPR better.

是的。感謝你的提問。所以，是的，原則上，當然，對於 daratumumab，基準將是 501 研究 [SIRIUS] 研究，然後也是皮下給藥的 COLUMBA 研究。它為您提供了 30% 到 40% 之間的療效範圍，其中 19% 的數據可以對 90% 的 VGPR 患者進行更好的追蹤。

But it's also important to understand that this data was generated in a setting with completely different treatment paradigms. And presumably, the data in today's world with patients that are more heavily treated with other mechanisms, may look differently, probably less favorable. That's why there is a head-to-head randomized data set that we are generating.

但同樣重要的是要了解這些數據是在完全不同的治療範式的環境中產生的。據推測，當今世界接受其他機制更嚴格治療的患者的數據可能看起來有所不同，可能不太有利。這就是為什麼我們正在產生一個頭對頭隨機資料集。

But broadly speaking, that's the efficacy benchmark. And I think it's important as you think about comparison from an efficacy point of view, not only the [ORR], but also the depth of response is going to be very important and certainly for us, as we look at the data that we have on our hand.

但從廣義上講，這就是功效基準。我認為當你從功效的角度考慮比較時，這很重要，不僅是 [ORR]，而且響應的深度也將非常重要，當然對我們來說，當我們查看我們擁有的數據時在我們手上。

The same with safety. And I think the safety data issue, of course, is like small data sets in a different environment. There are some factors that are different in today's world. For example, one of the patients that had a great (inaudible) was a patient with COVID that was certainly not a virus existing at the time when the reference data sets were generated from 8 years ago. So again, there, I would say the comparison will come from the randomized asset, which is why we're doing randomized study.

安全方面也是如此。當然，我認為安全資料問題就像不同環境中的小資料集。當今世界有一些不同的因素。例如，其中一位病情嚴重（聽不清楚）的患者是一名新冠肺炎患者，而 8 年前產生參考資料集時，該患者肯定不是存在的病毒。因此，我想說，比較將來自隨機資產，這就是我們正在進行隨機研究的原因。

Thanks, Tahi. And maybe over to Judith, maybe a bit more color on 1042 and 1046, Judith, at ASH?

謝謝，塔希。也許交給 Judith，也許在 ASH 的 1042 和 1046 上有更多的顏色，Judith？

Yes. Thank you, Jan. So as you alluded, Jan, for 1046, we look forward to share the data of [study 04] in a scientific congress that will -- and we are looking for opportunities within the first quarter, second quarter next year. So this is where the data -- the actual data will be presented.

是的。謝謝你，Jan。正如你所提到的，Jan，對於 1046，我們期待在科學大會上分享[研究 04] 的數據，我們正在尋找明年第一季和第二季的機會。這就是數據——實際數據將被呈現的地方。

We expect at ASH to give a little bit more color directionally, where we are going. But as was discussed several times at [03/03/2021], we presented interesting data of responders in non-small cell lung cancer after failing the current standard of care, which encompass chemo and immunotherapy. Responses were always not durable.

我們希望 ASH 能為我們前進的方向提供更多的色彩。但正如 [03/03/2021] 多次討論的那樣，我們在未達到當前護理標準（包括化療和免疫治療）後，提供了非小細胞肺癌應答者的有趣數據。反應總是不持久。

Interestingly enough, when we analyzed the clinical data, we saw that this responders were concentrated in the period 1 positive. And we also saw that these responders who are mostly the patients that received a checkpoint inhibitor in the last 8 months.

有趣的是，當我們分析臨床數據時，我們發現這些反應者集中在第一階段的陽性反應。我們也看到，這些反應者大多是過去 8 個月內接受過檢查點抑制劑的患者。

Based on those data points and the strong preclinical synergy between pembro and 1046, we designed the 04 study, which those results allow us to discuss in future meetings with health authorities next steps. So we will see where we are, but we've directionally plan to present a little bit more color. This is 1046.

基於這些數據點以及 pembro 和 1046 之間強大的臨床前協同作用，我們設計了 04 研究，這些結果使我們能夠在未來與衛生當局的會議中討論下一步措施。所以我們會看看我們的處境，但我們有針對性地計劃呈現更多一點的色彩。這是 1046。

1042, we are very encouraged. And what we continue to see, not just aligned with the 4 responders that we presented in head and neck, but in other tumor types. We're also getting the learnings from 1046 in order to understand better how to dose and [schedule] 4-1BB engagement.

1042，我們很受鼓舞。我們繼續看到的情況，不僅與我們在頭頸部展示的 4 種反應者一致，而且與其他腫瘤類型一致。我們也從 1046 中汲取經驗教訓，以便更好地了解如何劑量和[安排] 4-1BB 參與。

So we may give more color, but we need to understand where we are to see to what degree. And it will be more directionally because we usually present data in a scientific forum before we share with investors and analysts, but we will do our best to directionally give more color.

所以我們可能會給予更多的色彩，但我們需要了解我們所處的位置，才能看到什麼程度。而且會更有方向性，因為我們通常會在科學論壇上展示數據，然後再與投資者和分析師分享，但我們會盡力定向地賦予更多色彩。

Thanks, Judith. Vikram, as you can hear, we are literally [steaming] about all these 3 programs. So we're very excited, and I think we'll use the coming months to further position the molecules for next steps. And more to come from Genmab in the coming months, for sure.

謝謝，朱迪思。 Vikram，正如您所聽到的，我們確實對這 3 個項目感到[興奮]。所以我們非常興奮，我想我們將在接下來的幾個月中進一步定位分子以進行下一步。當然，未來幾個月 Genmab 還會推出更多產品。

We will now take the next question from the line of Jonathan Chang from Leerink.

現在我們將回答來自 Leerink 的 Jonathan Chang 的下一個問題。

First question, can you discuss the progress made with the early EPKINLY launch? What gives you confidence that EPKINLY can become the market leader in the CD20xCD3 class? And then second question on GEN1046, what could a path forward in post-IO lung cancer look like? And can you discuss the opportunity for this program in endometrial cancer?

第一個問題，您能談談 EPKINLY 早期發布所取得的進展嗎？是什麼讓您有信心 EPKINLY 能成為 CD20xCD3 等級的市場領導者？然後是關於 GEN1046 的第二個問題，IO 後肺癌的前進道路會是什麼樣子？您能討論一下這個項目在子宮內膜癌中的機會嗎？

Thanks, Jonathan, two excellent questions. The first one, I will hand over to Anthony Mancini, who will be delighted to speak about the EPKINLY launch and next steps. And then 1046, maybe Judith can give a bit more color on both checkpoint inhibitor lung cancer landscape and the way to develop a -- potentially develop the molecule. Anthony Mancini?

謝謝喬納森，兩個很好的問題。第一個問題，我將交給 Anthony Mancini，他將很高興談論 EPKINLY 的發布和後續步驟。第 1046 章安東尼曼奇尼？

Thanks, Jan, and thanks, Jonathan, for the question. As was covered earlier, we're seeing a really healthy uptake of EPKINLY and really strong execution of our launch plans in the first quarter. And we're also highly encouraged by the launch momentum and the overall positive feedback that we're getting from our customers that are using EPKINLY in the third line plus DLBCL setting.

謝謝簡，謝謝喬納森提出的問題。正如之前所述，我們看到 EPKINLY 得到了非常健康的採用，並且我們在第一季的發布計劃得到了非常強有力的執行。我們也對發布動能以及從在第三線和 DLBCL 設定中使用 EPKINLY 的客戶那裡得到的整體正面回饋感到非常鼓舞。

Our go-to-market approach really look to leverage our first-mover advantage. And the strong early uptake really is driven by a couple of factors that I think give me confidence that we can continue that through the life cycle: First, the solid execution and focus on key accounts and on key customers from our field-based teams, across medical affairs, across the sales team, across our alliance with AbbVie and, of course, the market access team. And that really has yielded strong customer engagement and EPKINLY early uptake. And it's also resulted in rapid access.

我們的進入市場方法確實希望利用我們的先發優勢。早期的強勁採用確實是由幾個因素推動的，我認為這些因素讓我相信我們可以在整個生命週期中繼續這樣做：首先，我們的現場團隊對關鍵客戶和關鍵客戶的堅定執行和關注，跨醫療事務、跨銷售團隊、跨越我們與艾伯維的聯盟，當然還有市場進入團隊。這確實帶來了強大的客戶參與度和 EPKINLY 的早期採用。這也帶來了快速訪問。

So what we're seeing, Jonathan, is 99% of covered medical lives in the United States with functional access to EPKINLY, which is very encouraging. It's also very clear that there's a high unmet need in later-line DLBCL. And EPKINLY is really filling the void, enabling an off-the-shelf access to T cell engaging innovation across diverse sites of care.

喬納森，我們看到美國 99% 的受保醫療生命都可以使用 EPKINLY，這是非常令人鼓舞的。很明顯，後期 DLBCL 的需求有很大未被滿足。 EPKINLY 確實填補了這一空白，使跨不同護理場所能夠獲得現成的 T 細胞參與創新。

We feel very good about being the first FDA-approved T cell-engaging bispecific antibody for the treatment of patients with third-line DLBCL, but we really understand it's an important starting point to build from to help EPKINLY become the core therapy across B-cell malignancies. So overall, we're highly encouraged by the early response in the market to EPKINLY. And so far, uptake has gone better than expected.

我們對成為 FDA 批准的第一個用於治療三線 DLBCL 患者的 T 細胞接合雙特異性抗體感到非常高興，但我們真正理解這是一個重要的起點，可以幫助 EPKINLY 成為 B 領域的核心療法。細胞惡性腫瘤。總的來說，市場對 EPKINLY 的早期反應讓我們深受鼓舞。到目前為止，使用情況比預期好。

Thanks very much, Anthony. And Jonathan, we intend to actually give further color on the complete development plan this year potentially at the post-ASH event. So we will talk more about how to further build the market and the landscape for use of EPKINLY in the coming years.

非常感謝，安東尼。喬納森（Jonathan），我們實際上打算在 ASH 後的活動中進一步闡述今年的完整開發計劃。因此，我們將更深入討論如何在未來幾年進一步打造 EPKINLY 的使用市場和格局。

Now let's move to Judith for giving a bit more color on the importance of the post checkpoint inhibitor lung cancer market because we feel that, that's a very strongly growing market with a need for new medicines. Judith?

現在讓我們轉向朱迪思，她對檢查點後抑制劑肺癌市場的重要性進行了更多的闡述，因為我們認為，這是一個成長非常強勁的市場，需要新的藥物。朱迪思？

Yes. So as we all know, with checkpoint inhibitors moving to the first line, a single agent, if patients have PD-L1 above 50% or in combination with chemo for patients with lower expression of PD-L1, there is a huge unmet medical need for patients that failing pembro checkpoint inhibitors and chemo, where the standard of care, unfortunately, is [Taxotere] that derives an ORR. Let's say, benchmark vary, but from 12% to 17%, 18%, 20% at the most and with [variable] prognosis, and this segment is growing.

是的。所以眾所周知，隨著檢查點抑制劑走向一線，單藥如果患者PD-L1超過50%或者聯合化療治療PD-L1表達較低的患者，存在巨大的未滿足的醫療需求對於pembro 檢查點抑製劑和化療失敗的患者，不幸的是，護理標準是[Taxotere]，它會產生ORR。比方說，基準有所不同，但從 12% 到 17%、18%、最多 20%，且預測[可變]，而且這一細分市場正在成長。

As you know, more and more patients received first-line combinatory treatment [or even] sequential. And it is in this very setting where we conducted the randomized 04 study, assessing 2 different [schedules] and even 1046 as a single agent, which gives us a strong foundation for a potential Phase III in this very setting.

如您所知，越來越多的患者接受第一線聯合治療[甚至]序貫治療。正是在這種情況下，我們進行了隨機04 研究，評估了2 個不同的[時間表]，甚至評估了1046 個單一藥物，這為我們在這種情況下進行潛在的III 期研究奠定了堅實的基礎。

So we are encouraged about the data, about the methodical follow of the science, and this is where we are engaging with health authorities in coming weeks to define better. And we will share more as we define better those plans.

因此，我們對這些數據、對科學的有條不紊的遵循感到鼓舞，這就是我們在未來幾週內與衛生當局合作以更好地定義的地方。當我們更好地制定這些計劃時，我們將分享更多資訊。

Thanks, Judith. So more to come in the coming weeks and months, Jonathan, for sure.

謝謝，朱迪思。喬納森，接下來的幾週和幾個月肯定會有更多的事情發生。

We will now take the next question from the line of Michael Schmidt from Guggenheim Partners.

現在我們將回答來自古根漢合夥人公司的邁克爾·施密特的下一個問題。

This is Paul on for Michael. First one is on the pivotal data for EPCORE in follicular lymphoma at ASH. How are you thinking about the opportunity and differentiation from [lymphoma], based on the emerging clinical profile and your conversations with physicians? How much do you think that the evolving duration of response will possibly factor into how the two drugs are positioned?

這是保羅替補邁克爾。第一個是 ASH 上 EPCORE 治療濾泡性淋巴瘤的關鍵數據。根據新出現的臨床概況以及您與醫生的對話，您如何看待[淋巴瘤]的機會和差異？您認為不斷變化的反應持續時間可能會在多大程度上影響這兩種藥物的定位？

And then my second question is sort of building off the prior one on GEN1046. Can you sort of just talk a little bit about your decision to initiate that Phase II study for endometrial cancer, whether that was driven by emerging data in Phase I or perhaps the non-small cell lung cancer combo trial?

我的第二個問題是在 GEN1046 上的前一個問題的基礎上提出的。您能否簡單談談您啟動子宮內膜癌 II 期研究的決定，無論是由 I 期新數據驅動還是非小細胞肺癌組合試驗？

Thanks, Paul. The first question, I think, can be handled by Tahi. And then the second one, maybe Judith, you can talk a bit about endometrial on the start of that trial and why we are so excited there. Tahi?

謝謝，保羅。我認為第一個問題可以由塔希來解決。然後第二個，也許是朱迪思，你可以在試驗開始時談談子宮內膜，以及為什麼我們對此如此興奮。塔希？

Yes. Thank you for the question. So as it relates to the data in follicular lymphoma, there's obviously some public release of our data top lines, but you will see more data.

是的。感謝你的提問。因此，由於它與濾泡性淋巴瘤的數據相關，顯然我們的數據頂線有一些公開發布，但您會看到更多數據。

And I think, here, the most important part will be to pay attention to the optimized schedule that will be presented at ASH and then the safety profile of EPCORE in the optimized setting, which will, I think, very clearly show that EPCORE has a profile both on efficacy but also from a safety profile that is extremely competitive with best-in-class safety and best-in-class efficacy, even in follicular lymphoma.

我認為，在這裡，最重要的部分是專注於將在 ASH 上展示的優化時間表，然後是優化設定中 EPCORE 的安全概況，我認為這將非常清楚地表明 EPCORE 不僅在療效方面，而且在安全性方面也具有極高的競爭力，即使在濾泡性淋巴瘤中，該藥物也具有一流的安全性和一流的療效。

Duration of response is a tricky one. To some degree, it's a question of follow-up. Obviously, mosunetuzumab has significantly longer follow-up in EPCORE because they started about 3 years before us. And so that is also reflected in the duration of response. And then there's other parts that are kind of like compounders to some degree. The [Omicron] base certainly played a role in that.

回應的持續時間是一個棘手的問題。從某種程度上來說，這是一個後續的問題。顯然，mosunetuzumab 在 EPCORE 中的追蹤時間明顯更長，因為他們比我們早大約 3 年開始。這也反映在回應的持續時間上。還有其他部分在某種程度上有點像複合機。 [Omicron] 基地無疑在其中發揮了作用。

But even with that, I think there will be some data in the future and continuously showing that patients who are -- and that's basically the truism about this mechanism. Patients who achieved a deep response, particularly as CR, are staying very, very long in their CR.

但即便如此，我認為未來還會有一些數據並不斷顯示患者是——這基本上是關於這種機制的不言而喻的道理。獲得深度緩解（尤其是達到 CR）的患者的 CR 狀態會持續非常非常長的時間。

And in some cases, we will oversee if that is actually reflection of a big word in cancer cure because we have patients now who are approximating 5 years in CR. So broadly speaking on EPCORE, I would say, pay attention to the disclosure of data where we'll share at ASH and also the updated data and the optimization data set.

在某些情況下，我們會監督這是否真的反映了癌症治癒中的一個重要詞，因為我們現在有患者的 CR 時間大約為 5 年。因此，從廣義上講，我想說，在 EPCORE 上，請注意我們將在 ASH 上共享的資料的揭露，以及更新的資料和最佳化資料集。

Thanks, Tahi. Let's move to GEN1046, Judith, and then maybe talk a bit about rationale for endometrial cancel, why did we start that study, et cetera.

謝謝，塔希。 Judith，讓我們轉向 GEN1046，然後也許談談子宮內膜取消的基本原理，我們為什麼開始這項研究，等等。

Thank you so much. So we started studying endometrial because it's a tumor type where 4-1BB is constitutively overexpressed and is a setting to test a hypothesis difference from what we have done in 04, which I already alluded to. So this is the reason to target endometrial cancer.

太感謝了。因此，我們開始研究子宮內膜，因為它是一種 4-1BB 組成性過度表達的腫瘤類型，並且是檢驗與我們在 04 中所做的假設差異的環境，我已經提到過這一點。這就是子宮內膜癌的原因。

Now we understand that endometrial cancer is not a single disease. You have the [MSL] high and MSL low. We are gathering data as we speak. And based on the data, we plan to daggle this different subtypes and go from there. And so it's very preliminary to say what is the path forward because we are gathering data in this Phase II program to understand the data and where there could be a path forward.

現在我們知道子宮內膜癌不是一種單一的疾病。您有 [MSL] 高和 MSL 低。我們正在收集數據。根據這些數據，我們計劃混合這些不同的子類型並從那裡開始。因此，現在說前進的道路是什麼是非常初步的，因為我們正在第二階段計劃中收集數據，以了解數據以及可能的前進道路。

As another point to flag is endometrial cancer in the Phase I, we saw long, durable responses with 1046 as a single agent, which, again, [prompted] us to investigate a more. So again, we expect to have this data in coming months to allow us to make decisions.

另一個值得注意的點是 I 期子宮內膜癌，我們看到 1046 作為單一藥物產生了長期、持久的反應，這再次[促使]我們進行更多研究。因此，我們希望在未來幾個月內獲得這些數據，以便我們做出決策。

Excellent, Judith. Thank you very much. Thanks, Paul, for the questions.

太棒了，朱迪思。非常感謝。謝謝保羅提出的問題。

We will now take the next question from the line of Etzer Darout from BMO.

現在我們將回答來自 BMO 的 Etzer Darout 的下一個問題。

The first one on sort of GEN1046 again. You have data next year sort of at a medical meeting. Just how are you thinking about sort of the target relative to other IO agents that we've seen now being combined with PD-1 like what we're seeing sort of from the TIGIT class? Just how you see the PD-L1 4-1BB mechanism relative to that?

第一個又是 GEN1046。明年的醫學會議你會得到數據。您如何看待相對於我們現在看到的與 PD-1 結合的其他 IO 代理的目標，就像我們從 TIGIT 類別中看到的那樣？您如何看待與之相關的 PD-L1 4-1BB 機制？

And then maybe quickly on HexaBody-CD38. Just if you could sort of remind us sort of the opt-in rights for J&J with respect to that program, just so we could think a little bit about more or less when that could be triggered potentially by J&J?

然後也許很快就會在 HexaBody-CD38 上出現。您是否可以提醒我們強生公司對該計劃的選擇權，以便我們或多或少地思考強生公司何時可能觸發該計劃？

Thanks, Etzer, for the questions. The first one, I will hand over to Judith to talk a bit about 4-1BB targeting versus TIGIT and other immune checkpoint targets. And I can take the HexaBody-CD38 question myself. Judith, why don't you go ahead?

謝謝埃澤提出的問題。第一個，我將請 Judith 談談 4-1BB 標靶與 TIGIT 和其他免疫檢查點靶點的比較。我可以自己回答 HexaBody-CD38 問題。朱迪絲，為什麼不繼續呢？

Yes. So I first tried to say that there is no precedent of IO as a single agent-provided responses in patients that failed checkpoint inhibition, PD-1 inhibitors. So if you think about the RA of TIGIT or other targets, the response rate in patients that failed checkpoint inhibitor is [zero] or in a handful. So we -- for PD-L1 4-1BB, we showed in the first cohort that there were responses.

是的。所以我首先想說的是，IO 作為單一藥物對檢查點抑制（PD-1 抑制劑）失敗的患者提供反應是沒有先例的。因此，如果您考慮 TIGIT 或其他標靶的 RA，檢查點抑制劑失敗的患者的緩解率為零或極少數。因此，對於 PD-L1 4-1BB，我們在第一組中顯示出有反應。

And we -- there was 17%, and we enrolled all comers. Then we presented in [CTC '21] when we segmented this population based on the PD-L1 presence. Their response rate was higher, albeit not durable. However, we had this preclinical data that showed this synergy additivity with pembro. And this is what [prompted] us to do the [offer].

我們—有 17%，我們招收了所有參與者。然後我們在 [CTC '21] 中介紹了我們根據 PD-L1 的存在對該群體進行了細分。他們的回應率較高，但並不持久。然而，我們的臨床前數據顯示了與 pembro 的這種協同加和性。這就是[促使]我們做出[報價]的原因。

So to reinforce the fact that IO single-agent activity post-IO, it's almost unheard of. But we saw it with 1046 to overcome the durability and strengthened signal, the right next step to combine with pembro as the next step, and this is what we have done, which results are emerging, and we will share.

因此，為了強調 IO 單代理活動在 IO 之後的事實，這幾乎是聞所未聞的。但我們看到它與 1046 一起克服了耐用性並增強了信號，正確的下一步是與 pembro 結合作為下一步，這就是我們所做的，結果正在出現，我們將分享。

So there is no precedent of IO in a post-IO. The TIGITs are all going to first line in PD-L1 high. This is where the data show that there is a stronger activity. So even in the hypothetical case that TIGIT go to the first line, it won't change the huge unmet medical need in a post-IO for non-small cell lung cancer in particular.

所以沒有後IO中IO的先例。 TIGIT 都將進入 PD-L1 高點的第一線。這是數據顯示活動更為強勁的地方。因此，即使在 TIGIT 進入第一線的假設情況下，它也不會改變 IO 後尤其是非小細胞肺癌的巨大未滿足的醫療需求。

Thank you, Judith. I think that's very clear. Let me take the HexaBody-CD38 opt-in rights for J&J.

謝謝你，朱迪絲。我認為這非常清楚。讓我來談談 J&J 的 HexaBody-CD38 選擇加入權。

They have the right to take a decision, yes or no, for opting in. So after we give them the data from the dose escalation, the dose expansion data, which we already have, and the head-to-head data against the subcu data, which we are gathering very rapidly. We believe that we'll have the head-to-head data next year and then basically hand over that data package to J&J. And then they have only a very limited time to say yes or no.

他們有權做出選擇是或否的決定。因此，在我們向他們提供我們已經擁有的劑量遞增數據、劑量擴展數據以及針對 subcu 的頭對頭數據之後，我們正在非常迅速地收集數據。我們相信明年我們將獲得面對面的數據，然後基本上將數據包移交給強生。然後他們只有非常有限的時間說“是”或“不是”。

And the opt-in, they want to develop -- commit to develop that molecule in any indication they want to, but I think multiple myeloma is now the number one, I think, indication for HexaBody-CD38, definitely, with the new data now from the expansion cohort.

他們想要開發——致力於開發他們想要的任何適應症的分子，但我認為多發性骨髓瘤現在是 HexaBody-CD38 的第一適應症，毫無疑問，根據新的數據現在來自擴展隊列。

And then we will get a $150 million upfront payment, and they pay for all, and we get straight 20% royalty rather than a 12% to 20% royalty until some point in 2031, where we go from 13% to 20% in the tiered fashion. So next year will be an important year because then we will hand over the head-to-head data package on top of the dose escalation and the dose expansion cohort data, which we already have in our hands.

然後我們將獲得1.5 億美元的預付款，他們支付全部費用，我們直接獲得20% 的特許權使用費，而不是12% 到20% 的特許權使用費，直到2031 年的某個時候，我們的特許權使用費將從13% 升至20%。分層時尚。因此，明年將是重要的一年，因為那時我們將在我們已經掌握的劑量遞增和劑量擴展隊列數據之上移交頭對頭數據包。

And keep following the data at ASH, which we will present on a poster, will be updated data from the abstract. So please watch out for that. And Tahi already gave you some color on what to look for versus years ago, daratumumab monotherapy data.

繼續關注 ASH 的數據，我們將在海報上展示這些數據，這些數據將是摘要中的更新數據。所以請注意這一點。 Tahi 已經為您提供了一些關於與多年前相比需要尋找什麼的顏色，達雷妥尤單抗單藥治療數據。

But you can hear from the enthusiasm of the team here that we are really -- we can't wait till we're in San Diego and can present that data because we believe it's very, very encouraging. I think we should probably leave it to that upsell for the time being.

但你可以從這裡團隊的熱情中聽到，我們真的——我們迫不及待地想在聖地亞哥展示這些數據，因為我們相信這非常非常令人鼓舞。我認為我們應該暫時將其留給追加銷售。

We will now take the next question from the line of Sachin Jain from Bank of America.

現在我們將回答美國銀行 Sachin Jain 提出的下一個問題。

Just more follow-ons on the same topics, if I may. So firstly, Tahi, on the CD38 [Grade 5] events, thank you for clarifying one of the 2 was COVID. Was that the respiratory event? And any color on the patient characteristics with [CV] event, just to get some color as to whether that was treatment related or not, in your mind? And then just a follow-on on the [Grade 5s] . The abstract was obviously a May cutoff. Have you seen any Grade 5 events since that May cutoff? So that's on the CD38.

如果可以的話，我只是針對同一主題提供更多後續內容。首先，Tahi，關於 CD38 [5 級] 事件，感謝您澄清 2 個事件之一是新冠病毒。那是呼吸系統事件嗎？在您看來，[CV] 事件對患者特徵的任何顏色，只是為了了解這是否與治療有關？然後是 [Grade 5s] 的後續。摘要顯然是五月的截止日期。自 5 月截止以來，您看過任何 5 級活動嗎？這就是 CD38 上的內容。

Second topic is the 1046. You said more color at ASH. Just to clarify, will you've met with the regulators by then? So could you confirm your Phase III program at the ASH event? And then a follow-on on your clear efficacy comment, do I infer that as a response rate above the 20% of [Taxotere] you referenced? And any color on the duration of response you're seeing ?

第二個主題是 1046。您在 ASH 上提到了更多顏色。澄清一下，到那時您會與監管機構會面嗎？那麼您能在 ASH 活動上確認您的 III 期專案嗎？然後，根據您明確的功效評論，我是否可以推斷，反應率高於您提到的 [Taxotere] 的 20%？您看到的回應持續時間有什麼顏色嗎？

Thanks, Sachin. Let's see what my colleagues are willing to give you this information. Tahi can definitely comment further on the [Grade 5] events for HexaBody-CD38, and I will ask Judith to think carefully about how to answer the question on 1046 and the ASH data as it relates to clarity on a potential Phase III trial as well as the bar for responses. Tahi, maybe you can start

謝謝，薩欽。讓我們看看我的同事願意向您提供哪些資訊。 Tahi 絕對可以進一步評論 HexaBody-CD38 的 [5 級] 事件，我會請 Judith 仔細考慮如何回答有關 1046 和 ASH 數據的問題，因為它也關係到潛在的 III 期試驗的清晰度作為響應欄。塔希，也許你可以開始

Yes. So as I said, I think earlier, right, there's one patient was a patient who postulated to COVID and the other one was cardiac event. Neither of the two events were, in our judgment and the judgment of the investigators or in the judgment of the [DMC] related to that -- sorry, (inaudible) in these studies.

是的。正如我所說，我認為早些時候，有一名患者被認為患有新冠肺炎，另一名患者則患有心臟事件。根據我們的判斷和研究人員的判斷或 [DMC] 的判斷，這兩個事件都與這些研究中的事件無關 - 抱歉，（聽不清楚）。

And if you look at the (inaudible) study that I referenced earlier, you'll see there is roughly like a 7%-ish rate of Grade 5 events on these trials of patients passing away of all kinds of business, not always related to drug.

And if you look at the (inaudible) study that I referenced earlier, you'll see there is roughly like a 7%-ish rate of Grade 5 events on these trials of patients passing away of all kinds of business, not always related to藥物.

So at this point, we don't really have, in the assessment of the DMC , safety signal with small patients that in any way or shape or form seems to deviate for what is known for the class of CD38 antibodies. I hope that answers it.

因此，在這一點上，在 DMC 評估中，我們並沒有真正獲得小型患者的安全訊號，這些訊號以任何方式或形狀或形式似乎偏離了已知的 CD38 抗體類別。我希望這能回答這個問題。

Thanks, Tahi. And then, Judith, on 1046 and ASH potential updates there or further clarity on the program.

謝謝，塔希。然後，朱迪思，關於 1046 和 ASH 的潛在更新或對該計劃的進一步澄清。

Yes. So thank you for the question. I think that we will try directionally to give more color. Just to share the design, we expect to have more certainty on that, and this usually happens after discussions with health authorities. So we will give as much as we can, predicated on where we stand in the process.

是的。謝謝你的提問。我認為我們會定向嘗試賦予更多色彩。只是為了分享設計，我們希望對此有更多的確定性，這通常是在與衛生當局討論後發生的。因此，我們將根據我們在過程中的立場，盡可能多地提供幫助。

As related to the benchmark, I alluded to the multiple data sets in this setting that unfortunately, failed and failed because they haven't done or they didn't do this rigorous scientific approach question-by-question to connect the dots and have the best potential hypothesis.

與基準相關，我提到了這種情況下的多個數據集，不幸的是，這些數據集都失敗了，因為他們沒有這樣做，或者他們沒有逐個問題地採用這種嚴格的科學方法來連接點並獲得最佳潛在假設。

And this allow us to wait a little bit to have not only ORR but duration, which is critical because time to event is the right endpoint in a Phase III setting. So I mean, I want to reinforce that we will share as much as we can, whenever we can. The commitment is there, but we are bound to when these meetings will happen.

這讓我們可以等待一段時間，不僅可以得到 ORR，還可以得到持續時間，這一點至關重要，因為事件發生時間是 III 期設定中的正確終點。所以我的意思是，我想強調，只要有可能，我們都會盡可能地分享。承諾已經存在，但我們必須遵守這些會議何時舉行。

Thanks, Judith, and thanks, Sachin, for the questions.

謝謝朱迪思，也謝謝薩欽提出的問題。

We will now take the next question from the line of Kaveri Pohlman from BTIG.

現在我們將回答來自 BTIG 的 Kaveri Pohlman 的下一個問題。

My first question is for GEN3014. Can you provide any insight into your expectations for its efficacy in CD38 pretreated patients, given that previous studies have shown that these patients develop resistance via overexpression of complement inhibitory proteins?

我的第一個問題是針對 GEN3014 的。鑑於先前的研究顯示這些患者透過補體抑制蛋白的過度表現而產生抗藥性，您能否對它在 CD38 預處理患者中的療效有何期望？

And my second question is for EPKINLY. Can you provide any color on your plans for follicular lymphoma and any timelines around that? Also, for EPKINLY in DLBCL, especially from the safety standpoint, are you planning to have some real-world data collected that could further differentiate it from its competitors?

我的第二個問題是針對 EPKINLY 的。您能否提供有關濾泡性淋巴瘤治療計劃的任何資訊以及相關的時間表？另外，對於 DLBCL 中的 EPKINLY，特別是從安全角度來看，您是否計劃收集一些真實世界的數據，以進一步將其與競爭對手區分開來？

Thanks, Kaveri, for the questions. I think I will hand both over to Tahi. Before Tahi starts, I already stated in an earlier comment that we will intend to actually describe the compound development plan for EPKINLY in more detail -- or, epcoritamab, I should say, in more detail at the post-ASH update. But Tahi, maybe you can give us a bit more color on the efficacy -- or the potential efficacy in CD38 pretreated patients.

謝謝卡維裡提出的問題。我想我會把兩者都交給塔希。在 Tahi 開始之前，我已經在先前的評論中指出，我們將打算更詳細地實際描述 EPKINLY 的化合物開發計劃 - 或者，我應該說，epcoritamab，在 ASH 後更新中更詳細地描述。但是 Tahi，也許你可以給我們更多關於療效的信息，或者對 CD38 預處理患者的潛在療效。

Yes. Thank you, and you're absolutely right, right? And there was a subgroup analysis worked on the combined data set for SIRIUS and 501 study that actually looked at the impact of -- in those cases, there are tumor treatment on the CD38 expression, which actually gets kind of shredded off the surface, so to speak, to the process called [thrombocytosis] and then the upregulation of complement inhibitory proteins, and that's absolutely correct.

是的。謝謝你，你說得完全正確，對吧？對 SIRIUS 和 501 研究的組合數據集進行了亞組分析，實際上研究了在這些情況下，腫瘤治療對 CD38 表達的影響，實際上 CD38 表達被從表面上撕碎了，所以可以說，這個過程稱為[血小板增多]，然後是補體抑制蛋白的上調，這是絕對正確的。

And so this is why the study that we're conducting is actually in CD38-naive patients, with the head-to-head comparison against subcu. We have had some signals of efficacy in daratumumab-exposed patients. And the dose escalation, there were 2 patients who had a response.

這就是為什麼我們正在進行的研究實際上是在未接觸過 CD38 的患者中進行的，並與 subcu 進行了頭對頭的比較。我們在達雷妥尤單抗暴露患者中獲得了一些療效訊號。隨著劑量的增加，有 2 名患者出現了反應。

But broadly speaking, that's not where we're focusing right now because the focus is, right now, as in the original agreement with Janssen, to generate data that allows us and Janssen, frankly, to elucidate whether the single point mutation that is underlying hexamerization, really has the impact that we have preclinically seen and that we believe to be seeing in the clinical data so far.

但從廣義上講，這不是我們現在關注的重點，因為現在的重點是，正如與楊森最初的協議一樣，生成數據，使我們和楊森坦率地說，能夠闡明潛在的單點突變是否存在六聚化確實具有我們在臨床前看到的影響，我們相信迄今為止在臨床數據中也看到了這種影響。

And then sorry, the second part of the question was about positioning of EPCORE in follicular lymphoma. So yes, to some degree, there is already a Phase III in combination with LEN in the second line, and we have talked about that we are actively working with AbbVie on plans on a frontline study. So there will be some news to come in the near future. That is in fully follicular lymphoma.

抱歉，問題的第二部分是關於 EPCORE 在濾泡性淋巴瘤中的定位。所以，是的，在某種程度上，二線療法中已經有與 LEN 聯合的 III 期臨床研究，我們已經談到，我們正在積極與艾伯維合作制定一線研究計劃。所以在不久的將來會有一些消息傳來。那就是完全濾泡性淋巴瘤。

And then in the B-cell lymphoma, there are multiple [viable] data sets attempted to generate data, both to show also the impact of epcoritamab in comparison to [CAR-Ts], right, and driving on the point that actually this modality that this bispecific antibody, the accessibility of it, the ease of the administration and the safety of it compare quite favorably to [CAR-T] therapies in the real-world data. I hope that answered the question.

然後，在B 細胞淋巴瘤中，有多個[可行] 數據集試圖產生數據，兩者都顯示了epcoritamab 與[CAR-T] 相比的影響，正確的，並且推動了實際上這種模式的發展在現實世界的數據中，這種雙特異性抗體的可及性、給藥的簡單性和安全性與 [CAR-T] 療法相比相當有利。我希望這回答了問題。

Thanks, Tahi. I think that was a good question, Kaveri. Thank you very much for the questions.

謝謝，塔希。我認為這是一個很好的問題，卡維裡。非常感謝您的提問。

We will now take the next question from the line of Michael Novod from Nordea.

現在我們將回答 Nordea 的 Michael Novod 的下一個問題。

Just a few follow-up questions, especially to timing. If we take GEN1042 first, I just need to understand. So I think Judith said some directional guidance also on 1042. When do you expect to sort of have more clear data on 1042 and also for some of the potentially larger indications? I think we all had expected it would be around till ESMO, IO. But is that also sort of, then, later in 2024?

只是一些後續問題，特別是關於時間的問題。如果我們先拿GEN1042，我只需要理解。所以我認為朱迪思也對 1042 說了一些方向性指導。您預計什麼時候能獲得有關 1042 以及一些潛在更大跡象的更清晰的數據？我想我們都預料到它會一直存在到 ESMO、IO。但這也是 2024 年晚些時候嗎？

And to HexaBody-CD38, there was a question earlier on relating to the J&J potential opt-in. Timing-wise, is it most realistic that you need to complete the head-to-head, which says October '24 on clinicaltrials.gov? Or could that happen sort of midway in that trial also? Maybe just to clarify.

對於 HexaBody-CD38，早期有一個關於強生潛在選擇加入的問題。從時間角度來看，您需要完成面對面的比較是否最現實，臨床試驗網站上顯示「10 月 24 日」？或者這種情況也可能發生在試驗的中間嗎？也許只是為了澄清。

Thanks, Michael, for the question. So I will hand over to Judith for 1042 to give you a bit further drilling for the timing, when do we have the data in hand. We believe that in some of the tumors, we actually have the data in the coming months, if not sooner. But Judith can give you a bit further color, Michael.

謝謝邁克爾提出這個問題。因此，我將把 1042 的任務交給 Judith，讓您進一步了解時間安排，我們何時掌握數據。我們相信，對於某些腫瘤，我們實際上會在未來幾個月（甚至更早）獲得數據。但茱蒂絲可以給你更多的色彩，麥可。

Then for HexaBody-CD38 timing of the potential opt-in for J&J, I mean, they have the right to wait for all of the data from the head-to-head cohorts, Michael. I don't know whether they need to, to make a long story short, because we think the data is shaping up very nicely, as you can see from the expansion cohorts, but it's up to them. So it's very difficult to actually give you an estimate of when J&J would like to obtain because it's basically in their corner.

然後，對於強生公司潛在選擇加入的 HexaBody-CD38 時機，我的意思是，他們有權等待來自頭對頭隊列的所有數據，Michael。長話短說，我不知道他們是否需要這樣做，因為我們認為數據的發展非常好，正如您從擴展隊列中看到的那樣，但這取決於他們。因此，實際上很難估計強生公司希望何時獲得，因為這基本上是他們的專利。

But the full head-to-head data will likely come in the second half of '24, not before. But there will be a lot of data already by that time in the first half. Whether that's an [opt] is up to J&J. But maybe I can hand over the 1042 timing question and some of the tumor cohorts to Judith. Judith?

但完整的面對面數據可能會在 24 年下半年而不是之前公佈。但到了上半年，已經有很多數據了。這是否是[選擇]取決於強生公司。但也許我可以將 1042 時序問題和一些腫瘤隊列交給 Judith。朱迪思？

Yes. So as you know, Michael, we are collecting data to assess the hypothesis that a checkpoint inhibition pembro adds to 1042, and this is further potentiated by the addition of chemotherapy and the creation of immunogenic cell [death]. This is the basic hypothesis that guided us to collect to address in different tumor types. Among them, head and neck and non-small cell lung cancer, squamous and non-squamous mainly. This hypothesis is the same.

是的。如你所知，邁克爾，我們正在收集數據來評估這樣的假設：檢查點抑制 pembro 添加到 1042，並且通過添加化療和產生免疫原性細胞 [死亡] 進一步加強了這一點。這是指導我們收集以解決不同腫瘤類型的基本假設。其中，頭頸癌和非小細胞肺癌以鱗狀和非鱗狀為主。這個假設是一樣的。

So the data sets are complementary from one each other. So the goal is to have a kind of a good number of patients with some level of durability for more than one cohort because this will make the data stronger.

因此，這些數據集是相互補充的。因此，我們的目標是讓大量患者在多個隊列中具有一定程度的持久性，因為這將使數據更強大。

So this is why there is no firm congress to when we are presenting. But I can tell you that enrollment is going very well. So it will be in 2024, depends on when the abstract is close to submission and the data we have in hand to decide the venue. So I cannot provide you a firm date at this point.

所以這就是為什麼我們在演講時沒有堅定的大會。但我可以告訴你，招生進展順利。所以將於 2024 年舉行，具體取決於摘要何時接近提交以及我們現有的數據來決定地點。因此，我目前無法向您提供確定的日期。

Thanks, Judith.

謝謝，朱迪思。

We will now take the last question from the line of Emily Field from Barclays.

現在我們將回答來自巴克萊銀行艾米麗·菲爾德的最後一個問題。

Great. I will ask a quick financial question. I believe that for OpEx going into 2024, I think consensus is modeling about half the growth rate of OpEx for 2023. Obviously, it's going to be off of a larger base for next year. But maybe, Anthony, if you have any comments on just how we should think about modeling OpEx going to 2024 before you officially guide for it?

偉大的。我會問一個簡單的財務問題。我認為，對於進入 2024 年的營運支出，我認為共識是對 2023 年營運支出成長率的一半進行建模。顯然，明年的基礎將會更大。但也許，安東尼，在您正式指導之前，您對我們應該如何考慮對 2024 年營運支出進行建模有什麼意見嗎？

Thanks, Emily, for the question. And Anthony will be delighted, Anthony Pagano, to answer a question on finances. So Anthony, floor is yours.

謝謝艾米麗提出這個問題。安東尼帕加諾，安東尼會很高興回答有關財務的問題。安東尼，請發言。

Yes, thanks, Emily. Thanks, Jan. Yes, you're right, Emily, of course, we'll, at the appropriate time and end of the year, take the time to really contextualize our overall guidance, including our investment levels.

是的，謝謝，艾米麗。謝謝，Jan。是的，你是對的，艾米麗，當然，我們會在適當的時間和年底，花時間真正結合我們的整體指導，包括我們的投資水平。

I can summarize for you now, though, really what our message has been consistently throughout 2023 about how we should think about our overall OpEx levels, moving forward. So I'll take the next minute or 2 to summarize that.

不過，我現在可以為您總結一下，我們在 2023 年始終傳達的訊息是，我們應該如何考慮未來的整體營運支出水準。因此，我將花一兩分鐘的時間來總結一下。

As always, given our strong position, we're going to continue to invest in the significant growth opportunities in a focused and disciplined way. It's something that we do take very, very seriously. As I think about that investment profile moving forward, particularly as it relates to, let's say, call it, the transition from 2023 to next year in the midterm, there are three drivers here now, particularly as it relates to R&D.

像往常一樣，鑑於我們的強勢地位，我們將繼續以專注和嚴格的方式投資於重大成長機會。我們確實非常非常認真地對待這件事。當我考慮未來的投資狀況時，特別是與從 2023 年到明年中期的過渡有關時，現在有三個驅動因素，特別是與研發有關。

First, EPCORE R&D is still in growth mode, so I fully expect EPCORE investment to go up as we add new Phase III trials over the coming years. And here, it's really important to remember that this is grounded in our conviction of EPCORE's potential to help a large number of people living with cancer and of course, will continue to be data-driven. And here, I mean looking at the clinical data and the landscape and also resourcing and sizing our investment accordingly, given this potential very meaningful opportunity.

首先，EPCORE 研發仍處於成長模式，因此我完全預計，隨著我們在未來幾年增加新的 III 期試驗，EPCORE 投資將會增加。在這裡，重要的是要記住，這是基於我們相信 EPCORE 有潛力幫助大量癌症患者，當然，這將繼續由數據驅動。在這裡，我的意思是考慮臨床數據和情況，並相應地分配資源和調整我們的投資規模，因為這是一個潛在的非常有意義的機會。

Second, again, still thinking about R&D, and this is kind of the swing factor, which additional programs will transition to later-stage development? As a reminder, you heard a lot about this today, we're doing some significant, let's call it, Phase II work for both CD40/4-1BB and PD-L1/4-1BB during the course of 2023. And as just announced, the emerging data from 1046 leads us to believe there is a path forward here in terms of late-stage development.

其次，仍在考慮研發，這是一種搖擺因素，哪些額外的項目將過渡到後期開發？提醒一下，您今天聽到了很多相關內容，我們正在 2023 年期間針對 CD40/4-1BB 和 PD-L1/4-1BB 進行一些重要的（我們稱之為）第二階段工作。宣布後，1046 的新數據讓我們相信，在後期開發方面有一條前進的道路。

Also for TIVDAK, based on what you've heard today, we also believe that there's a path forward here, particularly in terms of expanded development into head and neck, which also, we think, warrants further late-stage development. Now with that, hopefully, we'll come larger revenue opportunities in the medium term.

同樣地對於 TIVDAK，根據您今天所聽到的情況，我們也相信這裡有一條前進的道路，特別是在擴大開發到頭部和頸部方面，我們認為這也需要進一步的後期開發。現在，希望我們能在中期內獲得更大的收入機會。

Sticking with R&D and the third factor, we're going to continue to invest to maximize the value of our current tech platforms. And here, we're going to continue to invest to generate the next wave of IND candidates as well as progress some of our early-stage pipeline. And Jan shared with you some of the exciting progress there. So that takes care of R&D.

堅持研發和第三個因素，我們將繼續投資，以最大限度地發揮我們目前技術平台的價值。在這裡，我們將繼續投資以產生下一波 IND 候選藥物，並推進我們的一些早期管道。 Jan 與您分享了一些令人興奮的進展。這樣就可以解決研發問題了。

Now let's talk about SG&A and starting on the G&A side. Here, we are starting to increasingly approach scale, based on our existing footprint. So growth here is already starting to moderate, and we expect it to further moderate here as we transition from Q4 '23 into 2024.

現在讓我們談談 SG&A，並從 G&A 方面開始。在這裡，我們開始根據現有的足跡逐步擴大規模。因此，這裡的成長已經開始放緩，我們預計隨著我們從 23 年第 4 季過渡到 2024 年，這裡的成長將進一步放緩。

Now if we think about the S part of SG&A., as it relates to EPCORE, there's a couple of things that you should all be thinking about as you start to model for 2024 and beyond. First, for the U.S., to be clear, the 2023 P&L reflects nearly a full year of costs for the initial indication. There will be some annualization impact next year, but that's going to be more on the moderate side.

現在，如果我們考慮 SG&A 的 S 部分，因為它與 EPCORE 相關，那麼當您開始為 2024 年及以後建模時，您應該考慮一些事情。首先，對於美國來說，需要明確的是，2023 年損益表反映了初步跡象的近一整年的成本。明年將會有一些年化影響，但影響會比較溫和。

And here, as we potentially build out the EPCORE label over time, of course, there's going to be some incremental investments. However, we will be able to leverage existing investments in many cases.

在這裡，隨著時間的推移，我們可能會建立 EPCORE 標籤，當然，將會有一些增量投資。然而，在許多情況下，我們將能夠利用現有投資。

Now shifting to our other priority market. In terms of Japan, the same for what I just went through; for the United States, also applies. However, everything is just pushed out a bit, based on the potential approval date that we've now seen with epcoritamab in Japan, is coming at a much later point in the year. So the incremental impact in 2024 will be higher.

現在轉向我們的另一個優先市場。就日本而言，我剛剛經歷的也是如此；對美國來說，也適用。然而，一切都被推遲了一點，根據我們現在在日本看到的 epcoritamab 的潛在批准日期，將在今年晚些時候到來。所以2024年的增量影響會更大。

So maybe just to wrap up the comments on our investment levels, so everything I just covered, of course, is directional in nature. As always, we're going to continue to be very focused and very disciplined in our approach, and we're going to continue to take a detailed bottom-up approach and make sure that we're putting the appropriate amount of resource into our most important priorities.

因此，也許只是為了總結對我們投資水平的評論，所以我剛才涵蓋的所有內容當然都是方向性的。一如既往，我們將繼續在我們的方法中非常專注和嚴格，我們將繼續採取詳細的自下而上的方法，並確保我們將適當數量的資源投入到我們的工作中。最重要的優先事項。

And certainly look forward in February in conjunction with our full-year results we're really sharing what our investment priorities will look like for 2024. But what we heard today, hopefully, was conveyed a lot of excitement across our entire pipeline.

當然，展望 2 月份，結合我們的全年業績，我們確實會分享 2024 年的投資重點。但希望我們今天聽到的消息在我們的整個管道中傳達了很多興奮。

Thanks, Anthony. Thanks, Emily, for the financial question.

謝謝，安東尼。謝謝艾米麗提出財務問題。

I would now like to turn the conference back to Jan van de Winkel for closing remarks.

現在我想請揚范德溫克爾（Jan van de Winkel）致閉幕詞。

So thank you for calling in today to discuss Genmab's financial results for the first 9 months of 2023. If you have additional questions, please reach out to our Investor Relations team. We hope that you all stay safe, keep optimistic and remain healthy. And we very much look forward to speaking with you all again soon.

感謝您今天致電討論 Genmab 2023 年前 9 個月的財務表現。如果您還有其他問題，請聯絡我們的投資者關係團隊。我們希望大家保持安全、保持樂觀、保持健康。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 disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。