Genmab A/S (GMAB) 2024 Q3 法說會逐字稿

Hello, and welcome to Genmab's financial results conference call for the first nine months of 2024 As a reminder, this conference call is being recorded.

您好，歡迎參加 Genmab 2024 年前 9 個月的財務業績電話會議。

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 all in 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.

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、計劃或期望等詞語。實際結果可能存在重大差異，例如，由於成功的開發專案全部延遲。 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。

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 Denmark going forward. Please refer to our website for more information on a and our privacy policy.

另請注意，作為我們投資者關係外展活動的一部分，Genmab 可能會保存您所指定的個人數據，以便為您提供有關丹麥的最新資訊。請造訪我們的網站，以了解有關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發言人 Jan van de Winkel。請繼續。

Hello, and welcome to Genmab's conference call to discuss the company's financial results for the period ending September 30, 2024.

您好，歡迎參加 Genmab 的電話會議，討論公司截至 2024 年 9 月 30 日的財務表現。

With me today to present these results is our CFO, Anthony Pagano. And we will also welcome our new Chief Commercial Officer, Brad Bailey. For the Q&A, we will also be joined by our Chief Medical Officer, Tahi Ahmadi; and our Chief Development Officer, Judith Klimovsky. Let's move to slide 2.

今天與我一起介紹這些結果的是我們的財務長安東尼·帕加諾。我們也將歡迎新任首席商務官布拉德貝利 (Brad Bailey)。我們的首席醫療官 Tahi Ahmadi 也將參加問答環節；以及我們的首席開發長 J​​udith Klimovsky。讓我們轉到投影片 2。

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.

正如已經說過的，我們將做出前瞻性陳述。因此，在我們進行此次電話會議時，請記住這一點。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。

This slide acknowledges those relationships. At Genmab, we have a history of consistent and exceptional success, eight products either created by Genmab or via our technology are currently approved and making a difference in the lives of patients.

這張投影片承認了這些關係。在 Genmab，我們擁有持續且卓越的成功歷史，由 Genmab 或透過我們的技術開發的八種產品目前已獲得批准，並正在改變患者的生活。

Of all approved bispecific antibodies, two of them were created using our DuoBody technology. This success allows us to continue our focus on transforming our business in a strategic and step-wise manner. With an eye into the future and how we can best serve patients to our innovative antibody medicines.

在所有核准的雙特異性抗體中，其中兩種是使用我們的 DuoBody 技術創建的。這一成功使我們能夠繼續專注於以策略性和逐步的方式實現業務轉型。著眼於未來以及我們如何能夠最好地為患者提供我們的創新抗體藥物。

At the beginning of 2024, EPKINLY was the key focus of our late-stage development. Nine months later, we now have two wholly owned late-stage assets, Rina-S and acasunlimab. Recent events showcase how we are prioritizing the development of these programs.

2024年初，EPKINLY是我們後期開發的重點。九個月後，我們現在有兩個全資的後期資產，Rina-S 和 acasunlimab。最近發生的事件展示了我們如何優先考慮這些計劃的開發。

Starting with EPKINLY, we believe that our validated DuoBody technology has given it a best-in-class profile. We are extremely pleased with the launch, especially in Japan, where we have a significant head start over other therapies and, at present, EPKINLY is the only approved CD3, CD20 base bispecific. In fact, since launch, we have consistently outperformed our closest competitors globally.

從 EPKINLY 開始，我們相信經過驗證的 DuoBody 技術已賦予其一流的配置。我們對這款產品的上市感到非常高興，特別是在日本，我們在日本比其他療法具有顯著的領先優勢，目前 EPKINLY 是唯一獲得批准的 CD3、CD20 鹼基雙特異性藥物。事實上，自推出以來，我們的表現一直優於全球最接近的競爭對手。

In August, the EPKINLY received its second approval in Europe. That makes it the first and only subcutaneous bispecific antibody approved in both the European Union and the US to treat both relapsed/refractory follicular lymphoma and relapsed/refractory diffuse large B-cell lymphoma. This demonstrates the potential of epcoritamab to provide a convenient single treatment option across multiple B-cell malignancies.

8月，EPKINLY在歐洲獲得第二次批准。這使其成為第一個也是唯一一個在歐盟和美國批准用於治療復發/難治性濾泡性淋巴瘤和復發/難治性瀰漫性大 B 細胞淋巴瘤的皮下雙特異性抗體。這證明了 epcoritamab 為多種 B 細胞惡性腫瘤提供便捷的單一治療選擇的潛力。

We received additional support for the potential of EPKINLY in September with the FDA granting a second breakthrough therapy designation for EPKINLY in relapsed/refractory follicular lymphoma, this time in combination with rituximab and lenalidomide. With five Phase 3 clinical trials ongoing and more than 20 abstracts accepted at this year's S meeting, including four oral presentations, we and our partner, AbbVie remain committed to exploring the development of epcoritamab as a potential core therapy across B-cell malignancies.

9 月份，我們獲得了對EPKINLY 潛力的額外支持，FDA 授予EPKINLY 治療復發/難治性濾泡性淋巴瘤的第二個突破性療法稱號，這次是與利妥昔單抗和來那度胺聯合用藥。隨著五項3 期臨床試驗正在進行中，並在今年的S 會議上接受了20 多份摘要，其中包括四份口頭報告，我們和我們的合作夥伴艾伯維(AbbVie) 仍然致力於探索epcoritamab的開發，作為跨B 細胞惡性腫瘤的潛在核心療法。

As demonstrated through the breadth of data presentations this year across forms of lymphoma and lines of therapy. We have also seen recent progress with Rina-S and acasunlimab, our two wholly owned programs with the potential to be best-in-class therapies. Both of these programs have now moved toward late-stage development with the recent listing of Phase 3 trials on clinicaltrials.gov.

正如今年各種淋巴瘤形式和治療方案的廣泛數據展示所證明的那樣。我們還看到了 Rina-S 和 acasunlimab 的最新進展，這兩個項目是我們全資擁有的項目，有潛力成為一流的療法。隨著最近在 ClinicalTrials.gov 上列出 3 期試驗，這兩個項目現已進入後期開發。

We presented promising dose expansion data in ovarian cancer for Rina-S at ESMO, and we also presented PK/PD data at the World Conference on Lung Cancer for acasunlimab that is supportive of our every six-week dosing schedule. We continuously evaluate our clinical pipeline to ensure we are prioritizing our resources in the best and most effective way possible.

我們在 ESMO 上展示了 Rina-S 在卵巢癌方面有希望的劑量擴展數據，我們也在世界肺癌會議上展示了 acasunlimab 的 PK/PD 數據，這支持了我們每六週的給藥方案。我們不斷評估我們的臨床管道，以確保我們以盡可能最好、最有效的方式優先考慮我們的資源。

After careful consideration, we have decided to terminate the early-stage clinical programs, GEN1047, GEN3017 and Gen1056 and we will no longer start Phase 3 development for Tivdak and second line plus head and neck cancer. What should be clear is that our strategic prioritization means we are very focused on maximizing the potential of our Phase 3 programs, EPKINLY, Rina-S and acasunlimab.

經過慎重考慮，我們決定終止早期臨床計畫GEN1047、GEN3017和Gen1056，我們將不再啟動Tivdak和二線+頭頸癌的3期開發。應該明確的是，我們的策略優先順序意味著我們非常專注於最大限度地發揮我們的 3 期專案 EPKINLY、Rina-S 和 acasunlimab 的潛力。

The number of patients who may benefit from medicines powered by our innovation continues to expand. In September, Amgen's TEPEZZA was approved in Japan, making it the first and only treatment for active thyroid eye disease in the country.

受益於我們創新藥物的患者數量持續增加。 9月，安進的TEPEZZA在日本獲得批准，成為全國第一個也是唯一一個治療活動性甲狀腺眼疾的藥物。

J&J achieved multiple approvals for RYBREVANT across the US, Europe and Japan. And J&J have also expanded DARZALEX FASPRO indications with additional approvals and a regulatory submission. These developments highlight significant advancements in products that fuel our growing recurring revenues.

強生 (J&J) 的 RYBREVANT 在美國、歐洲和日本獲得多項批准。強生還透過額外的批准和監管提交擴大了 DARZALEX FASPRO 的適應症。這些發展凸顯了產品的重大進步，推動了我們不斷成長的經常性收入。

With that we will now provide you with a review of the recent performance for EPKINLY and Tivdak, both of which have consistent quarter-over-quarter growth. Brad, the floor is yours.

現在，我們將向您回顧 EPKINLY 和 Tivdak 的近期業績，這兩家公司都實現了持續的季度環比成長。布拉德，地板是你的。

Thank you, Yang. I'm delighted to be joining my first earnings call as Chief Commercial Officer.

謝謝你，楊。我很高興能夠作為首席商務官參加我的第一次財報電話會議。

And over the past several years, we've had a clear focus on building our commercialization capabilities at Genmab. To date, we've been very pleased by the strong performance of our launches in the US and Japan, powered by this strategic investment at work, and this quarter is no different.

在過去的幾年裡，我們明確地關注 Genmab 的商業化能力建構。到目前為止，在這項策略性投資的推動下，我們在美國和日本推出的產品取得了強勁表現，我們對此感到非常高興，本季也不例外。

Specifically, during the third quarter, our commercialization teams executed effectively to deliver our own medicines of EPKINLY and Tivdak to even more patients worldwide. EPKINLY, which is the first and only bispecific approved for both relapsed refractory third line plus diffuse large B-cell lymphoma and third line plus follicular lymphoma, closed Q3 with strong performance, reporting 17% growth in the quarter, million in net sales globally and year-to-date sales of $203 million.

具體來說，在第三季度，我們的商業化團隊有效執行，將我們自己的 EPKINLY 和 Tivdak 藥物交付給全球更多患者。 EPKINLY 是第一個也是唯一一個被批准用於治療復發難治性三線+瀰漫性大B 細胞淋巴瘤和三線+濾泡性淋巴瘤的雙特異性藥物，第三季度業績強勁，報告本季增長17%，全球淨銷售額為100 萬美元，年初至今銷售額達 2.03 億美元。

Overall, we've continued to see robust uptake across key accounts, strong field execution and positive responses from physicians and patients. What we're seeing in the field is validating EPKINLY's differentiated profile. Most importantly, patients are benefiting from its efficacy, manageable safety and the seamless experience of subcutaneous administration.

總體而言，我們繼續看到關鍵客戶的強勁採用、強大的現場執行力以及醫生和患者的積極回應。我們在現場看到的是驗證 EPKINLY 的差異化設定檔。最重要的是，患者受益於其功效、可控的安全性和皮下給藥的無縫體驗。

In the US, EPKINLY continues to assert in-class leadership through competitive differentiation and targeted activation with rapid uptake and adoption by key accounts, including a meaningful acceleration following the FL approval. We attribute this performance to three key factors.

在美國，EPKINLY 透過競爭差異化和有針對性的激活，以及關鍵客戶的快速吸收和採用，包括在 FL 批准後的有意義的加速，繼續保持一流的領導地位。我們將這種表現歸因於三個關鍵因素。

First and foremost is EPKINLY's clinically differentiated profile, which addresses a high unmet need across histologies. We've heard positive feedback from physicians regarding the long-term follow-up data presented at ASCO, underscoring the durability of powerful responses with EPKINLY in third line plus DLBCL. And as John mentioned, we look forward to building upon this with continued follow-up at ASH in December.

首先也是最重要的是 EPKINLY 的臨床差異化概況，它解決了跨組織學方面未滿足的高度需求。我們聽到了醫生對 ASCO 上提供的長期追蹤數據的正面回饋，強調了 EPKINLY 在三線加 DLBCL 中的強大反應的持久性。正如 John 所提到的，我們期待在此基礎上在 12 月的 ASH 上繼續跟進。

Second is broad US market accessibility across payers, institutional formularies and diverse sites of care. Third is the highly effective and well coordinated execution across our field-based commercialization teams to deliver optimal customer experiences. As we look ahead, brand execution will focus on accelerating the adoption and tailoring their approach to account needs.

其次是美國市場對支付者、機構處方集和不同護理場所的廣泛准入。第三是我們的現場商業化團隊有效率且協調一致的執行，以提供最佳的客戶體驗。展望未來，品牌執行將專注於加速採用並根據客戶需求量身定制方法。

Moving on to Japan. We continue to be pleased with EPKINLY's performance with growth largely driven through strong field execution and the broadening types of accounts is activated. As we move to Q4, we will continue to focus on account openings to assure a broad range and become familiar with EPKINLY ahead of a potential approval in FL. In Europe and rest of world, through our partner AbbVie, we also saw strong growth in the third quarter.

繼續前往日本。我們仍然對 EPKINLY 的表現感到滿意，其成長主要是透過強大的現場執行力推動的，並且啟動了擴大的帳戶類型。隨著進入第四季度，我們將繼續專注於開戶，以確保廣泛的範圍，並在佛羅裡達州可能獲得批准之前熟悉 EPKINLY。在歐洲和世界其他地區，透過我們的合作夥伴艾伯維，我們在第三季也看到了強勁的成長。

Turning to Tivdak. Tivdak continues to demonstrate strong performance with the 12th consecutive quarter of demand growth and $32 million in sales. The increase in demand is largely driven by the strength and breadth of accounts using Tivdak.

轉向蒂夫達克。 Tivdak 持續展現強勁的業績，需求連續第 12 個季度成長，銷售額達到 3,200 萬美元。需求的成長主要是由使用 Tivdak 的帳戶的實力和廣度所推動的。

Tivdak provides unprecedented efficacy where previous options have typically offered low response rates and poor outcomes and its strong performance with solid year-over-year growth builds a strong foundation to deliver future success in the gyn-onc space. We continue to receive positive feedback from physicians around the results from the innovaTV 301 confirmatory trial which demonstrated an overall survival benefit for Tivdak, with most stating that these data establish Tivdak as the clear standard of care in second line plus recurrent or metastatic cervical cancer globally.

Tivdak 提供了前所未有的功效，而先前的選擇通常反應率低且結果不佳，其強勁的業績和穩健的同比增長為婦科領域未來的成功奠定了堅實的基礎。我們繼續收到醫生對 innovaTV 301 驗證性試驗結果的正面回饋，該試驗證明 Tivdak 具有整體生存獲益，大多數人表示這些數據使 Tivdak 成為全球二線加復發性或轉移性子宮頸癌的明確護理標準。

As we move ahead, we're focused on capturing more value from our owned commercialized medicines, which represented 35% of Genmab's overall revenue growth this year. Our foundational investments in our commercialization capabilities are fueling our success and will enable us to scale functions across the business to support our long-term growth. We're building on our momentum and expect a successful year-end conclusion.

隨著我們的前進，我們專注於從我們擁有的商業化藥物中獲取更多價值，這些藥物佔 Genmab 今年整體收入成長的 35%。我們對商業化能力的基礎投資正在推動我們的成功，並使我們能夠擴展整個業務的功能，以支持我們的長期成長。我們正在鞏固我們的勢頭，並期望在年底取得圓滿成功。

With that, I'll pass it over to Anthony to provide more perspective on our third quarter financials.

接下來，我會將其轉交給安東尼，以提供有關我們第三季度財務狀況的更多觀點。

Thanks, Brad. We continue to strengthen our foundation throughout the first nine months of 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。今年前九個月，我們將繼續鞏固我們的基礎。我們實現了 EPKINLY 多次成功獲得監管部門批准和發布的目標，我們對這些發布的進度感到滿意。

We've also significantly enhanced our long-term growth potential with the acquisition of Profound Bio. And as we'll see, our financials remain strong. Recurring revenues grew by 37%. This was principally driven by strong royalties from DARZALEX, Kesimpta and other approved medicines as well as strong performance for -- at EPKINLY and Tivdak.

透過收購 Profound Bio，我們也顯著增強了我們的長期成長潛力。正如我們將看到的，我們的財務狀況仍然強勁。經常性收入成長了 37%。這主要是由於 DARZALEX、Kesimpta 和其他批准藥物的強勁特許權使用費以及 EPKINLY 和 Tivdak 的強勁業績推動的。

Our solid balance sheet growing recurring revenues and significant underlying profitability allow us to strategically prioritize our investment, especially in our Phase 3 programs at EPKINLY, Rina-S and acasunlimab.

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策略性地優先考慮我們的投資，特別是在我們的 EPKINLY、Rina-S 和 acasunlimab 的第 3 階段項目中。

Now let's take a look at those revenues in a bit more detail. We grew total revenue to over DKK15 billion in the first nine months of the year. And as I've already highlighted, that included a 37% increase in our recurring revenue. This strong growth was driven by higher DARZALEX and Kesimpta royalties as well as royalties from other products.

現在讓我們更詳細地看看這些收入。今年前 9 個月，我們的總收入成長至超過 150 億丹麥克朗。正如我已經強調過的，我們的經常性收入成長了 37%。這一強勁增長是由 DARZALEX 和 Kesimpta 特許權使用費以及其他產品特許權使用費增加所推動的。

Looking at DARZALEX specifically. Overall, net sales grew by 19%. That's net sales of nearly $8.6 billion, which translates to almost DKK10 billion in royalty revenue. This growth was driven by continued share gains and strong performance in the frontline setting. And as Brad noted, we're pleased with how EPKINLY and Tivdak are performing with consistent growth quarter-over-quarter.

具體看DARZALEX。總體而言，淨銷售額成長了 19%。淨銷售額接近 86 億美元，相當於特許權使用費收入近 100 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。正如 Brad 指出的那樣，我們對 EPKINLY 和 Tivdak 的季度環比持續增長的表現感到滿意。

Now what we're most excited about is that we can see the investments we've made in building out our commercialization teams and capabilities to secure the EPKINLY launch are paying off. And this is reflected in our in-class leadership and the strength of our launch in Japan.

現在，我們最興奮的是，我們可以看到我們在建立商業化團隊和能力以確保 EPKINLY 發布方面所做的投資正在獲得回報。這反映在我們一流的領導力和我們在日本的推出實力上。

Taken together, these two products contributed 35% of our total revenue growth in the first nine months. This really illustrates the power of our recurring revenue. And overall, this strong recurring revenue growth enables our continued focused investment in our priorities, as you can see on the next slide.

總的來說，這兩種產品為我們前 9 個月的總收入成長貢獻了 35%。這確實說明了我們經常性收入的力量。總的來說，這種強勁的經常性收入成長使我們能夠繼續集中投資於我們的優先事項，正如您在下一張幻燈片中看到的那樣。

We continue to take a disciplined approach to our investments with a focus on portfolio prioritization and being efficient. Total operating expenses including ProfoundBio acquisition and integration-related charges were approximately DKK9.9 billion.

我們繼續對投資採取嚴格的方法，重點關注投資組合的優先順序和效率。包括 ProfoundBio 收購和整合相關費用在內的總營運費用約為 99 億丹麥克朗。

As you can see, the majority of the investment or 74% in -- was driven by R&D, and this compares to 71% in the prior year. As you'd expect, given everything we've said about prioritization, we've accelerated investment into advancing our Phase 3 programs at EPKINLY, Rina-S and acasunlimab. SG&A growth moderated up only 8% year-over-year reflecting our focus on driving SG&A efficiency.

正如您所看到的，大部分投資（即 74%）是由研發驅動的，而去年這一比例為 71%。正如您所期望的，考慮到我們就優先順序所說的一切，我們已經加快了對 EPKINLY、Rina-S 和 acasunlimab 的 3 期項目的投資。 SG&A 成長年比僅放緩 8%，反映出我們專注於提高 SG&A 效率。

Now let's take a look at our financials as a whole. Here, you can see our summary P&L. Revenue came in at over DKK15 billion. That's up 29% on last year.

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。收入超過 150 億丹麥克朗。比去年增長了 29%。

Here, I want to highlight the improving quality of our revenue profile. In 2024, recurring revenues represented 92% of total revenue compared to 86% over the same period last year. Total OpEx was around DKK9.9 billion, up 23%. And even with that increased investment, we're still delivering over DKK4.5 billion of operating profit, and that's up more than 27%.

在這裡，我想強調我們收入狀況的品質不斷提高。 2024 年，經常性收入佔總收入的 92%，而去年同期為 86%。總營運支出約 99 億丹麥克朗，成長 23%。即使增加了投資，我們仍能實現超過 45 億丹麥克朗的營業利潤，增幅超過 27%。

Moving to our net financial items. Here, we have a net gain of DKK1 billion. This was driven by net foreign exchange rate gain as well as by an increase in interest income. Then we have tax expense of around DKK1.6 billion, which equates to an effective tax rate of 28.1%.

轉向我們的淨金融項目。在這裡，我們的淨收益為 10 億丹麥克朗。這是由外匯淨匯率收益以及利息收入增加所推動的。那麼我們的稅收支出約為 16 億丹麥克朗，相當於 28.1% 的有效稅率。

And here, as I did last quarter, we continue to evaluate the integration of ProfoundBio operations from a tax perspective. So our effective tax rate may experience some volatility as activities progress.

在這裡，正如我上個季度所做的那樣，我們繼續從稅務角度評估 ProfoundBio 業務的整合。因此，隨著活動的進展，我們的有效稅率可能會出現一些波動。

We anticipate this will normalize within the next 12 to 18 months. And that brings us to our net profit of almost DKK4 billion. So as you can see, continued strong underlying financial performance.

我們預計這種情況將在未來 12 至 18 個月內恢復正常。這為我們帶來了近 40 億丹麥克朗的淨利。正如您所看到的，基本財務表現持續強勁。

Now let's take a look at our guidance. Here, based on strong performance in the first nine months, I'm pleased to say that we've been able to narrow our guidance range with our revenue growth outpacing this year's growth and investment.

現在讓我們來看看我們的指導。在此，基於前九個月的強勁表現，我很高興地說，我們已經能夠縮小我們的指導範圍，因為我們的收入成長超過了今年的成長和投資。

We are raising the lower end of our revenue range, and this increase is driven by higher royalty revenues from DARZALEX. As a result, we now anticipate revenue in the range of DKK21.1 million to DKK21.7 billion, which is a growth of 30% at the midpoint. Importantly, we continue to anticipate strong growth for our own medicines with around DKK1.4 billion of growth from EPKINLY and Tivdak.

我們正在提高收入範圍的下限，這一增長是由 DARZALEX 更高的特許權收入推動的。因此，我們現在預計營收在 2,110 萬丹麥克朗至 217 億丹麥克朗之間，中間值成長 30%。重要的是，我們繼續預計我們自己的藥品將出現強勁增長，EPKINLY 和 Tivdak 的增長約為 14 億丹麥克朗。

Turning now to our operating expenses. Here, we've lowered the upper end of our OpEx range, anticipating DKK13.7 billion to DKK14 billion, excluding acquisition and integration-related charges. This reflects our disciplined approach to investments as well as rigorous portfolio prioritization.

現在談談我們的營運費用。在這裡，我們降低了營運支出範圍的上限，預計為 137 億丹麥克朗至 140 億丹麥克朗，不包括收購和整合相關費用。這反映了我們嚴謹的投資方法以及嚴格的投資組合優先順序。

So as you can see, we continue to deliver on our guidance and prioritization commitments. Taken together, we are generating significant underlying profitability. We're on track to deliver another year of substantial operating profit of between DKK6.2 billion to DKK7.1 billion, excluding acquisition and integration costs. At the midpoint, this represents growth of 25% compared to last year.

正如您所看到的，我們將繼續履行我們的指導和優先順序承諾。總的來說，我們正在創造可觀的潛在獲利能力。我們預計在新的一年實現 62 億至 71 億丹麥克朗的可觀營業利潤（不包括收購和整合成本）。與去年相比，中間值成長了 25%。

So in summary, we continue to focus on our priorities while consistently delivering on our financial commitments. Now having covered 2024, let's look ahead a bit to 2025. While guidance will be given in February next year, we are committed to investment in Phase 3 trials for EPKINLY, Rina-S and acasunlimab. Now as I stand here today, consensus expectations for our investment in 2025 appear to be in a reasonable place, capturing our investment priorities.

總而言之，我們將繼續專注於我們的優先事項，同時始終如一地履行我們的財務承諾。現在已經涵蓋了 2024 年，讓我們展望一下 2025 年。當我今天站在這裡時，我們對 2025 年投資的共識預期似乎處於合理位置，抓住了我們的投資重​​點。

Now let me wrap up and provide a few closing remarks. In summary, we are advancing our late-stage product portfolio from one to three products while achieving our financial goals through strategically prioritizing our investments. This focused approach enables us to realize our vision and to capitalize on the significant growth opportunities ahead.

現在讓我總結一下並提供一些結束語。總而言之，我們正在將後期產品組合從一種產品推進到三種產品，同時透過策略性地確定投資優先順序來實現我們的財務目標。這種專注的方法使我們能夠實現我們的願景並利用未來的重大成長機會。

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

說到這裡，我要把你交還給簡。

Thank you, Anthony. Let's move now to our final slide. We are very pleased with the progress we have made towards our 2024 goals. Additional approvals have enabled us to expand the reach of EPKINLY and Tivdak.

謝謝你，安東尼。現在讓我們來看最後一張投影片。我們對實現 2024 年目標所取得的進展感到非常高興。其他批准使我們能夠擴大 EPKINLY 和 Tivdak 的覆蓋範圍。

We've strategically advanced our proprietary product portfolio, including the Phase 3 trials for Rina-S and acasunlimab. And in addition to Rina-S, the acquisition of ProfoundBio gave us next-generation ADC platforms. All of this advanced our evolution into an integrated biotech innovation powerhouse.

我們策略性地推進了我們的專有產品組合，包括 Rina-S 和 acasunlimab 的 3 期試驗。除了 Rina-S 之外，收購 ProfoundBio 也為我們提供了下一代 ADC 平台。所有這些都推動我們發展成為綜合生物技術創新強國。

Finally, for HexaBody CD38, we are in the process of preparing data submissions to J&J. The data package is scheduled to be submitted by the end of December, the opt-in period of 60 days is expected to start in the beginning of January, which means we anticipate a decision from J&J no later than the first quarter of 2025.

最後，對於 HexaBody CD38，我們正在準備向強生提交資料。數據包計劃於 12 月底提交，60 天的選擇期預計從 1 月初開始，這意味著我們預計強生不遲於 2025 年第一季做出決定。

We will inform the market via press release when J&J has made their decision. This release will include relevant top line clinical data. To support the integrity of J&J's review process, we will not disclose the information before the official release.

當強生做出決定時，我們將透過新聞稿告知市場。此版本將包括相關的一線臨床數據。為了支持強生審核流程的完整性，我們不會在正式發布之前披露這些資訊。

Before we move to Q&A, I'm pleased to announce that we will hold our annual R&D updates and our data review event on December 11. To ensure the event is accessible to as many people as possible, this year's presentations will once again be fully virtual. Details will be available on our website, and we look forward to a lively event.

在我們進行問答之前，我很高興地宣布，我們將於 12 月 11 日舉行年度研發更新和資料審核活動。詳細資訊將在我們的網站上公佈，我們期待一場熱鬧的活動。

That ends our formal presentation. Operator, please open the call for questions now.

我們的正式演講到此結束。接線員，請立即撥打電話提問。

(Operator Instructions) Jonathan Chang.

（操作員說明）Jonathan Chang。

First question, just a clarification on the HexaBody CD38. Did you say that the top line data will be disclosed in the press release when J&J makes a potential opt-in decision or the data package submission press release?

第一個問題，只是對 HexaBody CD38 的澄清。您是否說過，當強生做出潛在的選擇加入決定或資料包提交新聞稿時，將在新聞稿中揭露頂線資料？

And then second question, on Rina-S, can you discuss the rationale behind not having an FR alpha expression requirement in the Phase 3. What's the mechanistic rationale for Rina-S as working at low or no FR-alpha expressing patients?

然後是第二個問題，關於Rina-S，您能否討論一下在第3 階段沒有FR α 表達要求背後的基本原理。是什麼？

Thanks, Jonathan, for the question. For the HexaBody CD38 top line data, we will announce that once J&J has made the opt-in decision. So we already know the opt-in decision and then we will release the data, the key data, the key clinical data, Jonathan.

謝謝喬納森提出的問題。對於 HexaBody CD38 的頂線數據，一旦強生做出選擇加入的決定，我們將宣布。所以我們已經知道選擇加入的決定，然後我們將發布數據，關鍵數據，關鍵臨床數據，喬納森。

So not at the date of submission, but when the opt-in decision is coming in. Then for Rina-S, I propose to move this question to Judith and Judith can give you further color on the folate receptor alpha expression levels requirements. Judith?

因此，不是在提交之日，而是在做出選擇加入決定時。朱迪思？

Yes. So the data presented at ESMO, we showed activity regardless of the expression, 75% cut off or above, which is the approved cut off for another folate receptor in the market. In addition, there is a footnote that says that we have seen activity in patients that had folate-receptor below 25%. So because of the data that we have described the decision was not to preselect for folate receptor alpha expression.

是的。因此，在 ESMO 上提供的數據顯示，無論表達如何，我們都顯示出 75% 截止值或以上的活性，這是市場上另一種葉酸受體批准的截止值。此外，還有一個腳註說我們已經在葉酸受體低於 25% 的患者中發現了活性。因此，根據我們描述的數據，決定不預先選擇葉酸受體α表現。

Michael Schmidt.

邁克爾·施密特。

This is Paul on for Michael. Maybe just a follow-up on Rina-S. So for the Phase 3 study, the clinical trials listing doesn't seem to have [simply one] geography yet. So can you talk about how you plan to limit perhaps patients who have been treated with mirvetuximab maybe based on your site distribution?

這是保羅替補邁克爾。也許只是 Rina-S 的後續。因此，對於 3 期研究，臨床試驗清單似乎還沒有[僅一個]地理位置。那麼您能否談談您計劃如何根據您的站點分佈來限制接受米維妥昔單抗治療的患者？

And then my second question is just on Tivdak and what factored into your decision to discontinue the planned Phase 3 given your enthusiasm earlier this year? And does that have any impact on how you be able the potential in other solid tumors?

我的第二個問題是關於 Tivdak 的，考慮到您今年早些時候的熱情，是什麼因素導致您決定停止計劃中的第三階段？這對您在其他實體瘤中發揮潛力有什麼影響？

Thanks, Paul, for the questions. I think Judith can actually start with both questions, and maybe Tahi can step in also on the Rina-S. Judith?

謝謝保羅提出的問題。我認為 Judith 實際上可以從這兩個問題開始，也許 Tahi 也可以介入 Rina-S。朱迪思？

Yes. So for Tivdak as Anthony and Jan alluded it's a strategic decision based on the prioritization of our pipeline and taking into consideration totality of the data, external and internal. But basically a strategic decision based on prioritization of our pipeline.

是的。因此，對於 Tivdak 來說，正如 Anthony 和 Jan 所提到的，這是一個基於我們管道優先順序並考慮外部和內部資料整體的策略決策。但基本上是基於我們管道優先順序的策略決策。

And for Rina-S, I will start by saying that the approval of mirvetuximab is this rolling. So of course, in some countries where mirvetuximab is not approved, it's not needed, and it's not standard of care. And on those countries where it is approved, it's become standard of care, and we have this into consideration for the Phase 3.

對於 Rina-S，我首先要說的是，mirvetuximab 的批准正在滾動。因此，當然，在一些米韋妥昔單抗未獲批准的國家，不需要它，也不是標準護理。在那些獲得批准的國家，它已成為護理標準，我們在第三階段考慮了這一點。

Thanks, Judith. I don't know, Tahi, you want to add anything to that? Or this is okay?

謝謝，朱迪思。我不知道，Tahi，你想補充什麼嗎？或者這樣可以嗎？

While I was just going to add something related to the prior question, that is like the phenomenon that ADCs or the top of payloads exhibit efficacy in low or ultra low expressing tumors is not necessarily restricted to Rina-S as a function. And there's still to be a function of the linker stability in the payload and the ability to actually detect -- accurately detect the expression of a given target.

雖然我只是想補充一些與前一個問題相關的內容，但這就像 ADC 或有效負載頂部在低表達或超低表達腫瘤中表現出功效的現像不一定僅限於 Rina-S 作為功能。並且仍然需要有效負載中連結器的穩定性以及實際檢測的能力——準確地檢測給定目標的表達。

So as Judith was saying, we have efficacy in low and negative, that is also a function of how you determine low negative folate receptor alpha positive ovarian cancer. And I was just pointing out that this is not a new phenomenon..

正如朱迪思所說，我們對低陰性和陰性的卵巢癌具有療效，這也是您如何確定低陰性葉酸受體α陽性卵巢癌的功能。我只是指出這不是一個新現象..

Sam Abraham.

山姆·亞伯拉罕.

Sam Abraham, JPMorgan. Just for me, please. So my first question is on GEN1042. So when can we expect to hear from you in terms of next steps before GEN1042? And is the decision to prioritize Tivdak in head and neck related to your potential plans for GEN1042?

薩姆·亞伯拉罕，摩根大通。只為我，請。我的第一個問題是關於 GEN1042 的。那麼，在 GEN1042 之前，我們什麼時候可以收到您關於後續步驟的訊息呢？將 Tivdak 優先用於頭部和頸部的決定與您的 GEN1042 潛在計劃有關嗎？

And then my second question was just on HexaBody CD38 in terms of -- it's quite helpful in the time line that you gave us. But just how should we think about the potential safety profile in the head-to-head trial given the safety signal we saw last year based on the baseline recruitment (inaudible) the patients you recruited, do you think that the lower risk of any cardiovascular signal coming through in that head-to-head trial?

然後我的第二個問題是關於 HexaBody CD38 的——它在您給我們的時間線上非常有幫助。但是，考慮到我們去年根據基線招募（聽不清楚）招募的患者看到的安全訊號，我們應該如何考慮頭對頭試驗中的潛在安全性，您是否認為任何心血管疾病的風險越低？次面對面的試驗中發出訊號了嗎？

Thanks for the questions. I think I can help both of them myself. Over 1042, we are still collecting more data. And in the next months, we aim to take a decision on next steps.

感謝您的提問。我想我自己可以幫助他們兩個。超過 1042，我們仍在收集更多數據。在接下來的幾個月裡，我們的目標是就後續步驟做出決定。

So we will be in the coming months, and we have collected all that data, different doses and dose frequency. We'll make a decision on next step for 1042 bispecific program.

因此，我們將在未來幾個月內收集所有數據、不同劑量和劑量頻率。我們將就 1042 雙特異性計畫的下一步做出決定。

Then for HexaBody CD38, the data will be released at the time that J&J will have announced or have made their opt-in decision. So we are not going to discuss any other data at this moment.

然後，對於 HexaBody CD38，數據將在強生宣布或做出選擇加入決定時發布。所以我們現在不打算討論任何其他數據。

We'll just wait until the decision has been taken also to ensure there is no buyers in the decision process and there is an optimal way for them to take the decision. But we're very pleased having very close now to all of the data. And you will hear from that in due time.

我們將等到做出決定，同時確保沒有買家參與決策過程，並且有一個最佳方式讓他們做出決定。但我們很高興現在已經非常接近所有數據。你會在適當的時候收到訊息。

Suzanne van Voorthuizen.

蘇珊娜·範·福特赫伊曾。

First question in relation to up EPKINLY and the commercial traction. Can you frame which indications or treatment settings geographies or other segments that you're looking at, you expect to be potential major drivers from here in the forthcoming years?

第一個問題與 EPKINLY 和商業吸引力有關。您能否列出您正在關注的適應症或治療環境、地理位置或其他細分市場，您預計它們將成為未來幾年的潛在主要驅動因素？

And remind us how you think about the peak potential of the drug. And then a tiny follow-up on HexaBody CD38, very helpful guidance there. But did you also comment on the time line for the update that you have referred to, should we still continue to expect something this year?

並提醒我們您如何看待該藥物的峰值潛力。然後是 HexaBody CD38 的一個小後續內容，這是非常有幫助的指導。但您是否也對您提到的更新時間表發表了評論，我們今年是否還應該繼續期待一些事情？

Thanks, Suzanne, for the questions. And the first one, I will definitely turn over to Brad and then see whether I can add further perspective after Brad has given you his input on the commercial potential and we have to expect that.

謝謝蘇珊娜提出的問題。第一個，我肯定會轉向布拉德，然後在布拉德向您提供有關商業潛力的意見後看看我是否可以添加進一步的觀點，我們必須對此有所期待。

For HexaBody CD38, we will actually plan to present the data in Q1 Suzanne. Brad, maybe you can answer the question on EPKINLY commercial potential and the geographies, countries, et cetera.

對於 HexaBody CD38，我們實際上計劃在第一季 Suzanne 中提供數據。 Brad，也許你可以回答有關 EPKINLY 商業潛力以及地理位置、國家等的問題。

You still connected, sir.

您仍然保持聯繫，先生。

Brad?

布拉德？

Shall I unmute the line from my side, if it's possible?

如果可以的話，我可以從我這邊取消線路靜音嗎？

Yes. Please do. maybe a technical problem. Otherwise, I will.

是的。請這樣做。也許是一個技術問題。否則，我會的。

He is now unmuted.

他現在已取消靜音。

All right, Brad?

好吧，布拉德？

Thank you, operator. I apologies. The unable to get the mute off. So thank you for the question.

謝謝你，接線生。我很抱歉。無法取消靜音。謝謝你的提問。

And yes, from EPKINLY perspective, obviously, extremely pleased with the work that's been done from a US and Japan perspective and driving over 90% of the revenues at this point in time, certainly rest of world with EPKINLY. We're now in a position as we're expanding from third line plus DLBCL with potential new approvals in FL as well and most recently in Europe and then expected early next year in Japan.

是的，從EPKINLY 的角度來看，顯然，我們對從美國和日本的角度所做的工作非常滿意，並且在此時推動了超過90% 的收入，當然也透過EPKINLY 推動了世界其他地區的收入。我們現在的處境是，我們正在從三線加上 DLBCL 進行擴展，並可能在佛羅裡達州獲得新的批准，最近在歐洲，然後預計明年初在日本獲得批准。

So we still see the two major drivers in US and Japan were certainly our partner AbbVie as we are in these later lines of therapy that are certainly modest in patient numbers at this point. But certainly, as we continue along the development plan moving into earlier lines of therapy as well as combinations where we see the value to be increased at that point in time. So thank you.

因此，我們仍然看到美國和日本的兩個主要推動者肯定是我們的合作夥伴艾伯維（AbbVie），因為我們處於這些較晚的治療領域，目前患者數量肯定不多。但當然，隨著我們繼續沿著開發計劃進入早期的治療路線以及組合，我們看到當時的價值會增加。所以謝謝你。

Thanks, Brad, for that color. Hopefully, that helps Suzanne.

謝謝布拉德，給我這種顏色。希望這對蘇珊娜有幫助。

Xian Deng

鄧賢

Thank you very much. Two, please. The first one is on 2025 catalyst. I mean I understand this is probably a bit too early to give full details for next year's catalysts. But just wondering, on high level, do you think we could expect the acasunlimab clinical data follow-up next year but we'll also see more clinical data on Rina-S to have these combo. That's the first question.

非常感謝。請兩位。第一個是 2025 年催化劑。我的意思是，我知道現在提供明年催化劑的完整細節可能還為時過早。但只是想知道，在高水平上，您認為我們是否可以期待明年 acasunlimab 的臨床數據隨訪，但我們還將看到更多關於 Rina-S 的臨床數據來擁有這些組合。這是第一個問題。

And the second one is on test and the cost related to that. So just wondering, given now you will not progress with the Phase 3 trial -- just wondering how much in terms of R&D savings do you expect to come from that? Or the other way of asking this is could you remind us roughly how big the size of the trial in relationship to the other Phase 3 ?

第二個正在測試以及與之相關的成本。所以只是想知道，鑑於現在您將無法進行第三階段試驗 - 只是想知道您預計從中可以節省多少研發費用？或者問這個問題的另一種方式是，您能否提醒我們，與其他第 3 階段相比，該試驗的規模大致有多大？

Thanks, Xian, for the questions. And definitely, next year, we will inform you on Catalysts early next year when we give guidance for the year, Xian. But definitely for acasunlimab, we expect further data on the lung cancer setting for sure.

謝謝西安的提問。當然，明年，當我們給出今年的指導時，西安，我們會在明年初向您通報催化劑的情況。但對於 acasunlimab 來說，我們肯定期待有關肺癌設定的進一步數據。

And for Rina-S there will surely be data, both updated data, I think, for the ovarian carcinoma, but also other tumors. So there will definitely be data, and we will let you know early next year what the catalysts are and the approximate timing.

對於 Rina-S 肯定會有數據，我認為，既有卵巢癌的更新數據，也有其他腫瘤的數據。所以肯定會有數據，我們會在明年初讓你知道催化劑是什麼以及大概的時間。

And then maybe Anthony Pagano can give you a bit of color on the Phase 3 trial costs for Tivdak as we anticipated them originally. Anthony?

然後，也許 Anthony Pagano 可以為您提供有關 Tivdak 第三階段試驗成本的一些信息，正如我們最初預期的那樣。安東尼？

Yes. And I can comment on the investment profile a bit and then any additional color either Tahi or Judith going to provide -- we can do after I provide my comments. I think the net here is that we're really focused on prioritizing our portfolio.

是的。我可以對投資概況發表一些評論，然後塔希或朱迪思將提供任何額外的顏色——我們可以在我提供評論後進行。我認為，我們真正關注的是我們的投資組合的優先順序。

You heard from Jan today that we've taken four decisions, three on earlier-stage programs and one on a later stage program, the Tivdak program you just noted. This is done with an eye towards really prioritizing our other Phase 3 programs, including at EPKINLY, Rina-S and acasunlimab.

今天你從 Jan 那裡聽說，我們已經做出了四項決定，其中三項是關於早期計劃的，一項是關於後期計劃的，即你剛才提到的 Tivdak 計劃。這樣做的目的是真正優先考慮我們的其他 3 期項目，包括 EPKINLY、Rina-S 和 acasunlimab。

And what I'd leave you with here are two thoughts. This prioritization is something we take very, very seriously, and we'll continue to do. And then the impact of that is reflected in the revised 2024 OpEx guidance as well as -- and it's probably worth repeating, the comments that I made as it relates to 2025. So again, looking ahead of 2025.

我想留給你們的是兩個想法。我們非常非常重視這種優先順序，並將繼續這樣做。然後，其影響會反映在修訂後的 2024 年營運支出指南中，以及我發表的與 2025 年相關的評論，這可能值得重複。

Again, I'll provide guidance in February -- we're committed to investment in Phase 3 trials for EPKINLY, Rina-S and acasunlimab. Again, as I stand here today, consensus expectations for our investment in 2025 and -- appear to be in a reasonable place, again, capturing those investment priorities that I just highlighted.

我將再次在 2 月提供指導——我們致力於投資 EPKINLY、Rina-S 和 acasunlimab 的 3 期試驗。當我今天站在這裡時，我們對 2025 年投資的共識預期似乎處於合理的位置，再次體現了我剛才強調的那些投資優先事項。

So I'm not really in a position to break out the specifics, again, other than just to highlight for you, really, our laser-sharp focus on directing the lion's share of our capital in terms of R&D investment to these, particularly the growth to these Phase 3 programs that I just mentioned. Judith, anything you want to highlight regarding -- I think you haven't said already on the Tivdak program?

因此，我真的無法再次透露具體細節，除了向您強調，實際上，我們非常專注於將研發投資方面的大部分資本用於這些領域，特別是我剛才提到的這些第三階段計劃的增長。 Judith，您有什麼想強調的嗎？

No, no, no. I mean you said it is a strategic decision and there at that time when the decision was made, we were in the planning stage, so the Phase 2 was not fully designed and costed it was the privatization of the portfolio that led to the decision.

不，不，不。我的意思是，你說這是一個策略決策，當時做出決定時，我們正處於規劃階段，所以第二階段還沒有完全設計和計算成本，是投資組合的私有化導致了這個決定。

Yaron Werber.

亞龍·韋伯.

Great. I just have essentially a follow-up on GEN1042 on the CD40x4-1BB. So it sounds like your -- the way I'm reading you correctly, is you're still doing some work on dosing in combination with standard of care in first line.

偉大的。我基本上只是在 CD40x4-1BB 上對 GEN1042 進行了後續操作。所以聽起來你的——我正確理解你的方式是，你仍在結合第一線的護理標準做一些劑量工作。

If I remember correctly, it was head and neck and then you had several other opportunities coming behind like non-small cell pancreatic and melanoma and the data is going to be next year. Like are we -- are you thinking that you're moving to Phase 3 and you'll give us an update on the trial design? Or what should we expect next year?

如果我沒記錯的話，那是頭部和頸部，然後還有其他幾個機會落後，例如非小細胞胰腺癌和黑色素瘤，數據將在明年公佈。就像我們一樣——您是否認為您正在進入第三階段，並且您會給我們有關試驗設計的最新資訊？或者明年我們該期待什麼？

Thanks for the question. On GEN1042, we are still collecting data in form like settings in four different cancers. And we believe that we have all the data in hand in the coming months to make a decision on next steps and we'll let you know at that time.

謝謝你的提問。在 GEN1042 上，我們仍在收集四種不同癌症的設定形式的數據。我們相信，我們在未來幾個月內掌握了所有數據，可以對下一步行動做出決定，屆時我們會通知您。

Asthika Goonewardene.

阿斯提卡·古內瓦德內。

I have a quick one on HexaBody C38. Is the data package that you will -- final data packages will send to J&J going to include any of the preclinical data that you explored in autoimmune diseases?

我有一個關於 HexaBody C38 的快速版本。您將發送給強生的最終數據包是否將包含您在自體免疫疾病中探索的任何臨床前數據？

And then on Rina-S, Judith, you mentioned the presentation at ESMO, how that had an indication that patients with FR alpha less than 25% had clinical activity. Can you tell us if you actually saw clinical responses in those patients? That's my question.

然後在 Rina-S 上，Judith，您提到了 ESMO 的演講，其中表明 FR α 低於 25% 的患者俱有臨床活性。您能告訴我們您是否確實看到了這些患者的臨床反應嗎？這就是我的問題。

Thanks, Asthika , for the questions. And Judith can definitely take the second one on Rina-S. But for the HexaBody CD38, the data package will be the clinical head-to-head data, Asthika, in multiple myeloma, which we'll share with J&J in December. And Judith, maybe you can speak a bit about the Rina-S data.

謝謝阿斯提卡提出的問題。而茱蒂絲（Judith）絕對可以在麗娜-S（Rina-S）上獲得第二名。但對於 HexaBody CD38，資料包將是多發性骨髓瘤的臨床頭對頭資料 Asthika，我們將在 12 月與強生公司分享。 Judith，也許你可以談談 Rina-S 的數據。

Yes. And Asthika, again, I would you to the slide that was presented at the oral presentation at ESMO that shows the waterfall plot with 75% above and below. And a footnote that says we saw responses as well in patients below 25%. And we can refer you to the slide number on that oral presentation. So yes, we saw responses.

是的。 Asthika，再次，我想請您看一下 ESMO 口頭演講中展示的幻燈片，該幻燈片顯示了 75% 上下的瀑布圖。還有一個腳註說我們在低於 25% 的患者中也看到了反應。我們可以向您推薦該口頭簡報的投影片編號。所以是的，我們看到了回應。

Yifeng Liu.

劉逸風.

I've got one for Rina-S, and obviously, we talked about the FR alpha expression level. And do you see that -- my question is, do you see that adaptable into other tumor indication in the sense that you see responses or signals or early signals that the response across different level of FR alpha expression levels? And how should we think about the opportunities there?

我有一個 Rina-S 的，顯然，我們討論了 FR α 表達量。你是否看到了這一點——我的問題是，你是否認為它可以適應其他腫瘤適應症，因為你看到了不同水平的 FR α 表達水平的反應或信號或早期信號？我們該如何看待那裡的機會？

Thanks, Yifeng for the questions. Why don't you ask Tahi to start and then maybe Judith you can add when you have a few things to angles to add. Tahi?

謝謝一鋒的提問。為什麼不讓塔希開始，然後當你需要添加一些角度的東西時，也許朱迪思可以添加。塔希？

Well, I mean, without getting too specific, I mean, there obviously is already in the protocol data being generated in -- and I think this is clearly publicly disclosed in endometrial as well as in the subset of non-small cell lung cancer, the is not for folate receptor alpha positive.

嗯，我的意思是，不用太具體，我的意思是，顯然已經在生成的協議數據中——而且我認為這在子宮內膜癌以及非小細胞肺癌子集中已明確公開，不適用於葉酸受體α陽性。

And there might be opportunity that we be able to show some of this data, but we're not going to commit to the time when we're going to show that data when we have the data in our head. So we're collecting this data as we speak. And when we still on (inaudible) folate alpha-expressing tumors that are quite obvious that are already being interrogated as we speak.

我們可能有機會展示其中一些數據，但當我們腦子裡有數據時，我們不會承諾何時展示這些數據。因此，我們正在收集這些數據。當我們仍在研究（聽不清楚）表達葉酸α的腫瘤時，這些腫瘤是非常明顯的，就在我們說話的時候，它們已經被審問了。

Matt Phipps.

馬特·菲普斯。

Just one quick follow-up on the Tivdak decision. Are you still planning to evaluate Tivdak plus KEYTRUDA in the frontline head and neck setting -- and then is this part of just a maybe broader shift to incorporate some of the next-gen ADC components from ProfoundBio into programs going forward. Any additional ProfoundBio assets that we should be looking for?

這只是 Tivdak 決定的一個快速後續行動。您是否仍計劃在前線頭頸部環境中評估 Tivdak 加上 KEYTRUDA？我們還應該尋找其他 ProfoundBio 資產嗎？

So let me -- thanks, Matt, for the questions. Let me ask Judith to comment on the Tivdak question, and then I can tell ProfoundBio. We have now two other programs in the clinic as we speak. And the third one beyond Rina-S which will go to the clinic bispecific HuMax-EGFr ADC program.

所以讓我——謝謝馬特提出的問題。讓我請 Judith 對 Tivdak 問題發表評論，然後我可以告訴 ProfoundBio。就在我們說話的時候，我們診所現在還有另外兩個項目。 Rina-S 以外的第三個產品將進入臨床雙特異性 HuMax-EGFr ADC 計畫。

We are very, very keen on actually moving forward all of these ADC programs. And then at some point, we may actually also begin to combine some of the immune activator programs like the acasunlimab program with ADCs because we think it makes perfect sense conceptually start combining those. But we are very excited about the pipeline maps.

我們非常非常熱衷於實際推進所有這些 ADC 專案。然後在某個時候，我們實際上也可能開始將一些免疫活化劑計畫（例如 acasunlimab 計畫）與 ADC 結合起來，因為我們認為從概念上講，開始將這些計畫結合起來是非常有意義的。但我們對管道圖感到非常興奮。

We will see a very rapid progress, I think, of the pipeline in the coming time. But in the coming year, we will definitely focus a lot on the late-stage clinical development, Phase 2 program for a number of antibodies. But let me ask Judith to give color on the KEYTRUDA combinations in front line.

我認為，在未來的時間裡，我們將看到管道的快速進展。但在未來一年，我們肯定會專注於多種抗體的後期臨床開發、二期計畫。但讓我請 Judith 為前線的 KEYTRUDA 組合提供色彩。

So as you know, I mean, the (inaudible) run by Pfizer is ongoing and has a cohort that is exploring [EV] in combination with pembro in the first-line setting. So you are correct. The cohort is ongoing.

如你所知，我的意思是，輝瑞 (Pfizer) 運營的（聽不清）正在進行中，並且有一批人正在一線環境中探索 [EV] 與 pembro 的結合。所以你是對的。該隊列正在進行中。

Alistair Campbell.

阿利斯泰爾·坎貝爾。

Just a quick follow-up on the Rina-S trial. Just to be clear, are you going to be testing for folate receptor expression at this line? And could that be a predefined a predefined analysis of the value? Or is this going to be an all-comers trial.

只是 Rina-S 試驗的快速後續。需要澄清的是，您是否要測試該細胞系的葉酸受體表現？這可能是預先定義的價值分析嗎？或者這將是一場全民審判。

And then just move your recent collaboration with Revitope. So wondering if you discuss what's attractive to that technology. What do you think that could offer this different from your own capabilities and bispecifics.

然後就可以轉移您最近與 Revitope 的合作。所以想知道您是否討論了該技術的吸引力。您認為這可以提供與您自己的能力和雙特異性不同的什麼。

Thanks for the questions. The first one on the Rina-S trial, I think a straightforward. Judith can address that. And maybe, Tahi you can address the second one.

感謝您的提問。 Rina-S 試驗的第一個，我認為很簡單。朱迪思可以解決這個問題。也許，塔希，你可以解決第二個問題。

Yes. So for the first one, I will -- so we are not -- the study is not preselecting for folate receptor expression. So this is a direct answer. Of course, we are assessing folate receptor expression in every patient, but it's not used to preselect.

是的。因此，對於第一個，我會——所以我們不會——該研究不會預先選擇葉酸受體表達。所以這是一個直接的答案。當然，我們正在評估每位患者的葉酸受體表達，但它不用於預選。

Thanks, Judith. And then maybe Tahi the newer deal with the new technologies.

謝謝，朱迪思。然後也許塔希（Tahi）是新技術的新處理者。

Well, generally speaking, we always are looking at outside technologies that complement and enhance our internal capabilities. This is a deal to complement discovery efforts that we're working on to understand how we can expand the opportunity space for T-cell reduction, particularly, but not only use but particularly also to the solid oncology space where it has, for the most part, been challenging to come up with concepts that are able to replicate the success of T-cell reduction in the heme space, particularly in myeloma lymphoma.

嗯，一般來說，我們總是在尋找外部技術來補充和增強我們的內部能力。這是一項補充發現工作的協議，我們正在努力了解如何擴大 T 細胞減少的機會空間，特別是，但不僅是使用，而且特別是在實體腫瘤學領域，對於大多數人來說，在某種在程度上，提出能夠複製血紅素空間中T 細胞減少成功的概念一直是一項挑戰，特別是在骨髓瘤淋巴瘤中。

So this is just another component for us to expand our research opportunities, and it works really well nicely with our [CD3] program that we have internally.

因此，這只是我們擴大研究機會的另一個組成部分，它與我們內部的 [CD3] 專案配合得非常好。

It's actually very complementary, not competitive it or do body technology. We believe that this will actually widen the space where we can actually use T-cell engagers.

它實際上是非常互補的，而不是競爭它或做車身技術。我們相信，這實際上會拓寬我們實際使用 T 細胞接合器的空間。

Vikram Purohit.

維克拉姆·普羅希特。

So we had two, one on the pipeline discontinuations, one on the EPKINLY. So apologies if you mentioned this and we missed it, but the discontinuations you mentioned, are they part of a broader pipeline review? And as a result, can we expect more deprioritization from the earlier-stage efforts you have underway in the coming quarters?

所以我們有兩個問題，一個是關於管線中斷，一個是關於 EPKINLY。因此，如果您提到這一點而我們錯過了，我們深表歉意，但是您提到的中斷是更廣泛的管道審查的一部分嗎？因此，我們是否可以預期您在未來幾季正在進行的早期階段工作會被更多地取消優先級？

And then secondly, on EPKINLY, was just curious to get your sense on how the profile of patients with DLBCL that you've been treating has been evolving over the past couple of months as the launch has progressed?

其次，在 EPKINLY 上，我只是想了解一下，隨著發布的進展，您一直在治療的 DLBCL 患者的情況在過去幾個月中發生了怎樣的變化？

Thanks for the questions. So let me address the first one. We have actually now really reprioritized our pipeline. And we actually have no stop progression of the 1047, 3017 and 1056 programs because these programs simply didn't meet the high bar we have set internally for really having a truly differentiated therapeutic candidates.

感謝您的提問。那麼讓我談談第一個問題。事實上，我們現在已經重新確定了管道的優先順序。事實上，我們 1047、3017 和 1056 計畫的進展一直沒有停止，因為這些計畫根本沒有達到我們內部設定的真正擁有真正差異化候選治療藥物的高標準。

So yes, we have now, I think, gone through a lot of pipeline reprioritization. In the future, you will again see both new programs added to the pipeline. We recently, for example, added a DuoBody (inaudible) DL4 bispecific program with fantastic preclinical data that's called GEN1057 to the pipeline. It started recruiting patients in September.

所以，是的，我認為我們現在已經經歷了許多管道的優先調整。將來，您將再次看到這兩個新程式添加到管道中。例如，我們最近在管道中添加了一個 DuoBody（聽不清楚）DL4 雙特異性程序，該程序具有出色的臨床前數據，稱為 GEN1057。它於九月開始招募病患。

And there will be others starting soon, like the HuMax-EGFr ADC program, which is coming from the ProfoundBio acquisition. And we will also potentially close other programs based on data, but this is the pipeline repatriation for now. It is actually very rigorous.

還有其他項目很快就會啟動，例如 HuMax-EGFr ADC 項目，該項目來自 ProfoundBio 收購。我們也可能會根據數據關閉其他程序，但這只是目前的管道遣返。其實是非常嚴謹的。

And we actually intend to focus more and more on the winners and expand the breadth of the (inaudible) in the future. Then for EPKINLY the profile of patients and maybe Brad is the best person to start, and then maybe Thai can add further perspective. Brad?

實際上，我們打算在未來越來越多地關注獲勝者並擴大（聽不清楚）的廣度。然後對於 EPKINLY 患者的概況，也許 Brad 是最好的入手者，然後 Thai 可能會添加更多的觀點。布拉德？

Yes. Thanks, Thai -- Thanks, Jan. Thanks for the question. And we certainly continue to hear from HCPs regarding the types of patients about their positive clinical experiences across both DLBCL and now FL, certainly further validating our differentiated profile in the subcu administration as well and the ease of administration.

是的。謝謝，泰國人——謝謝，簡。我們當然會繼續從 HCP 那裡聽到關於患者類型的關於 DLBCL 和現在的 FL 的積極臨床經驗，這當然進一步驗證了我們在 subcu 給藥方面的差異化特徵以及給藥的簡便性。

But past the initial phase of the launch period, we're now hearing that the types of patients are evolving into the true and so multiple later lines of therapy into the true third-line plus setting in DLBCL. And with FL, it's a little too early to accurately assess any type of unique patients at this point but continue to hear favorable responses from our providers.

但經過啟動期的初始階段，我們現在聽說患者類型正在演變成真正的、多種後續療法，進入 DLBCL 真正的三線+環境。對於 FL，目前準確評估任何類型的獨特患者還為時過早，但我們會繼續聽到我們的提供者的積極回應。

Thanks, Brad. Tahi, do you want to add anything to that? .

謝謝，布拉德。塔希，你想補充什麼嗎？ 。

Well, I mean, I would just say generally saying, I think that is a continuous evidence that the initial hypothesis around EPKINLY epcoritamab, that the subcutaneous administration from a patient convenience point of view, but also from a safety point of view, would play out well and would expand access to this modality for patients, I think it's fair to say that this is playing out.

嗯，我的意思是，我只是籠統地說，我認為這是一個持續的證據，表明圍繞 EPKINLY epcoritamab 的最初假設，即從患者便利的角度以及安全的角度來看，皮下給藥將發揮作用如果進展順利，並將擴大患者使用這種模式的機會，我認為可以公平地說，這正在發揮作用。

Thank, Thai,. And what I can also say is that we are seeing really, really good data in broader and broader patient populations also in clinical trials, (inaudible). I can tell you that also the CLL data has been selected for the (inaudible) program on December 8, as one of the very few programs with epcoritamab.

謝謝，泰語，。我還可以說的是，我們在越來越廣泛的患者群體以及臨床試驗中看到了非常非常好的數據（聽不清楚）。我可以告訴您，CLL 數據也已被選用於 12 月 8 日的（聽不清楚）計劃，作為極少數使用 epcoritamab 的計劃之一。

So we also see some very good data in CLL. And then when you look at the overall presentations at ASH, you can look at the abstracts for now, we see actually a better and better profile suggesting that epcoritamab is clearly a best-in-class -- having a best-in-class profile and different B-cell cancer.

所以我們在CLL中也看到了一些非常好的數據。然後，當您查看 ASH 上的整體演示時，您現在可以查看摘要，我們實際上看到了越來越好的概況，表明 epcoritamab 顯然是一流的 - 擁有一流的概況和不同的B細胞癌。

So we are very excited about potentially we're going to grow and maximize the potential of epcoritamab program together with our partner AbbVie over the coming time. So more to come in early December at ASH and -- and also, I think one of the highlights is on December 8 in the (inaudible) program, which will feature amongst other programs, epcoritamab treatment of patients with CLL.

因此，我們對未來與我們的合作夥伴艾伯維 (AbbVie) 一起發展並最大限度地發揮 epcoritamab 項目的潛力感到非常興奮。因此，12 月初的 ASH 將會有更多活動，而且，我認為亮點之一是 12 月 8 日的（聽不清楚）計劃，該計劃將在其他計劃中重點介紹對 CLL 患者的 epcoritamab 治療。

Etzer Darout.

埃澤·達魯特.

Just given the portfolio review, just wondered if you had any updated thoughts on to the platform in autoimmune disease, given what we're hearing about CD38 and 40 in development, just your overall thoughts given your platform, antibody platform and some of the enthusiasm around some of these mechanisms in autoimmune.

剛剛進行了投資組合審查，只是想知道您是否對該平台在自身免疫性疾病方面有任何最新的想法，考慮到我們所聽到的有關正在開發的CD38 和40 的信息，考慮到您的平台、抗體平台和一些熱情，您的整體想法圍繞著自身免疫中的一些機制。

So for the questions. And I will start here and then Tahi you don't hesitate to step in then with more perspective. We still have a very active number of programs in preclinical development as an autoimmune indications, either with ourselves or with ourselves in combination with argenx, where we are working on a number of programs in the autoimmune area, also using our next-generation antibody technology platforms.

所以對於問題。我將從這裡開始，然後塔希，你會毫不猶豫地以更多的視角介入。我們仍然有許多非常活躍的臨床前開發項目作為自體免疫適應症，無論是我們自己還是我們自己與 argenx 聯合，我們正在自身免疫領域開展許多項目，也使用我們的下一代抗體技術平台。

And of course, the risk potential to potentially move also with ADC technologies towards auto immune. And we definitely have a number of preclinical scenarios we're working on, but they are not yet ready for clinical introduction.

當然，ADC 技術也可能帶來自動免疫的潛在風險。我們確實正在研究許多臨床前方案，但它們尚未準備好投入臨床。

So the majority of the work at Genmab over the coming years will still be in cancer where we have our dominant focus, but we are clearly very interested in exploring innovative ways to move towards autoimmune with the T cell engager program potentially ADCs on our next-generation antibody technologies.

因此，未來幾年Genmab 的大部分工作仍將集中在癌症領域，這是我們的主要關注點，但我們顯然非常有興趣探索創新方法，利用T 細胞接合器計劃，在我們的下一個項目中使用潛在的ADC 來實現自體免疫。

And this year, we will also see the clinical validation of the HexaBody program HexaBody CD38 approach, but that is right now in multiple myeloma. But that I think has also a potential in autoimmune type settings. But more to comment in the future. Tahi, do you want to add anything to that?

今年，我們還將看到 HexaBody 計劃 HexaBody CD38 方法的臨床驗證，但目前正在多發性骨髓瘤中。但我認為這在自體免疫類型設定中也有潛力。但未來會有更多評論。塔希，你想補充什麼嗎？

I think you summarized it very well. I think,

我覺得你總結得很好。我認為，

All right, it's. So thanks to for the questions and more to come in the future. Yes. Thank you very much, operator.

好吧，是這樣。感謝您提出的問題以及未來更多的問題。是的。非常感謝您，接線生。

So thank you all for calling in today to discuss Genmab financial results for the first nine months of 2024. If you have any additional questions, please reach out to our Investor Relations team. We hope that you all stay safe and keep optimistic, and we very much look forward to speaking with you all again soon.

因此，感謝大家今天致電討論 Genmab 2024 年前 9 個月的財務表現。我們希望大家保持安全並保持樂觀，我們非常期待很快能再次與大家交談。

Thank you. This concludes today's conference call. Thanks for participating. You may now disconnect.

謝謝。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。