Genmab A/S (GMAB) 2025 Q2 法說會逐字稿

Hello, and welcome to the Genmab first half 2025 financial results conference call. As a reminder, this conference call is being recorded.

您好，歡迎您參加 Genmab 2025 年上半年財務業績電話會議。提醒一下，本次電話會議正在錄音。

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.

在本次電話會議中，您可能會看到前瞻性陳述，其中包括相信、預期、計劃或期望等字眼。實際結果可能會存在重大差異，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 the actual results unless this is required by law. Please 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.

除非法律要求，否則 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聲明。請注意，Genmab 可能會根據您所指出的個人資料作為我們投資者關係外展活動的一部分來保存，以便向您更新 Genmab 的未來動態。請參閱我們的網站以獲取有關 Genmab 和我們的隱私權政策的更多資訊。

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

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

Hello, and welcome to our financial results for the first half of 2025. With me today is our Chief Financial Officer, Anthony Pagano; our Chief Commercial Officer, Brad Bailey; and our Chief Medical Officer, Tahi Ahmadi. And for the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky.

您好，歡迎查看我們 2025 年上半年的財務表現。今天和我一起的有我們的財務長安東尼·帕加諾 (Anthony Pagano)、我們的首席商務官布拉德·貝利 (Brad Bailey) 和我們的首席醫療官塔希·艾哈邁迪 (Tahi Ahmadi)。我們的首席開發長 Judith Klimovsky 將參與問答環節。

As we have already said, we will be making forward-looking statements. So please keep that in mind during the call. During today's presentation, we will reference products being developed under some of our strategic collaborations. This slide acknowledges those relationships.

正如我們已經說過的，我們將做出前瞻性的陳述。因此請在通話過程中記住這一點。在今天的演示中，我們將參考一些戰略合作下正在開發的產品。這張投影片承認了這些關係。

I would like to start with a reminder of our commitments for 2025. In February, we said that we would accelerate the development of our high-impact late-stage pipeline, that we would maximize the potential of our commercialized medicines and that we would deliver on our capital allocation priorities, supporting our continued growth and long-term value creation.

首先我想回顧一下我們對 2025 年的承諾。今年 2 月，我們表示將加速開發具有高影響力的後期研發管線，最大限度地發揮已商業化藥品的潛力，並履行資本配置優先事項，支持我們的持續成長和長期價值創造。

Let's review how we have delivered on these commitments in the first half. Over the past six months, our total revenue grew by 19%, fueled by increased recurring revenue. And we have invested fully in line with our capital allocation priorities, focusing on our high-impact programs. More on that in a moment. Importantly, we have grown operating profit by 56%, even while making these strategic investments.

讓我們回顧一下上半年我們是如何履行這些承諾的。在過去的六個月中，由於經常性收入的增加，我們的總收入增加了 19%。我們完全按照資本配置優先順序進行投資，並專注於那些具有高影響力的項目。稍後將對此進行詳細介紹。重要的是，即使在進行這些策略性投資的同時，我們的營業利潤仍成長了 56%。

In addition, in June, we completed share buyback, underscoring both our confidence in Genmab's future and our commitment to delivering value to our shareholders. We ended the first half with around $3 billion in cash. And that not only reinforces the strength of our financial foundation, but importantly, it gives us the flexibility for continued growth and expansion.

此外，我們在 6 月完成了股票回購，這突顯了我們對 Genmab 未來的信心以及我們為股東創造價值的承諾。截至上半年，我們的現金餘額約為 30 億美元。這不僅增強了我們的財務基礎，更重要的是，它為我們持續成長和擴張提供了靈活性。

Now let's turn to some of the recent advancements for our late-stage programs as well as a reminder of the overall potential. epcoritamab, rinatabart and acasunlimab are all poised to drive significant revenue growth for Genmab by the end of this decade.

現在，讓我們來看看我們後期專案的一些最新進展，以及整體潛力的回顧。 epcoritamab、rinatabart 和 acasunlimab 都有望在本世紀末為 Genmab 帶來顯著的收入成長。

And all three programs made progress towards this potential over the past few months. Excitingly for EPKINLY in May, we submitted an sBLA to the FDA for epcoritamab in second-line follicular lymphoma in combination with rituximab and lenalidomide or R-square based on a statistical and clinically significant improvement in overall response rates.

過去幾個月來，這三個項目都朝著這項潛力取得了進展。令人興奮的是，EPKINLY 在 5 月向 FDA 提交了一份 sBLA，申請將 epcoritamab 與利妥昔單抗和來那度胺或 R 平方聯合用於二線濾泡性淋巴瘤治療，其依據是總體反應率在統計和臨床上顯著的改善。

In July, the FDA accepted this BLA for priority review with a target action date of November 30, 2025. If approved, epcoritamab plus R-squared has the potential to be the first bispecific antibody combination regimen available as a second-line treatment option for patients with relapsed or refractory follicular lymphoma.

7 月，FDA 接受了該 BLA 的優先審查，目標行動日期為 2025 年 11 月 30 日。如果獲得批准，epcoritamab 加 R-squared 有可能成為第一個可作為復發或難治性濾泡性淋巴瘤患者二線治療選擇的雙特異性抗體組合方案。

Even more excitingly, today, we announced that the EPCORE FL-1 study met its dual endpoints of progression-free survival and overall response rate in a preplanned interim analysis. These unprecedented positive results will be the basis for global regulatory submissions. And Tahi will share some of the details of this promising data with you in just a moment.

更令人興奮的是，今天，我們宣布 EPCORE FL-1 研究在預先規劃的中期分析中達到了無惡化存活期和整體反應率的雙重終點。這些前所未有的正面成果將成為全球監管提交的基礎。Tahi 稍後將與您分享這些有希望的數據的一些細節。

These important Phase 3 results support our goal to move EPKINLY into earlier lines of therapy in order to benefit more cancer patients. Also supporting this goal in recent months, we and AbbVie have presented data highlighting the depth, breadth and strength of the comprehensive epcoritamab development program. This includes 14 abstracts at EHA, including 2 oral presentations and 28 abstracts, including 1 oral at iCML.

這些重要的 3 期結果支持了我們的目標，即將 EPKINLY 轉移到早期治療領域，以造福更多癌症患者。近幾個月來，我們和 AbbVie 也支持這一目標，並提供了數據，強調了綜合 epcoritamab 開發計劃的深度、廣度和實力。其中包括在 EHA 發表的 14 篇摘要（包括 2 篇口頭報告）和在 iCML 上發表的 28 篇摘要（包括 1 篇口頭報告）。

So EPKINLY, with its rapid clinical development and over 40 active clinical trials remains positioned to become the core therapy in B-cell lymphomas with anticipated peak sales exceeding $3 billion. Turning to Rina-S. The first disclosure for single-agent Rina-S in patients with advanced endometrial cancer from a dose expansion cohort of the Phase 1/2 RAINFOL-01 study was unveiled at ASCO.

因此，EPKINLY 憑藉其快速的臨床開發和超過 40 項活躍的臨床試驗，仍有望成為 B 細胞淋巴瘤的核心療法，預計高峰銷售額將超過 30 億美元。轉向 Rina-S。在 ASCO 上首次揭露了 1/2 期 RAINFOL-01 研究劑量擴展隊列中單藥 Rina-S 治療晚期子宮內膜癌患者的療效。

Today, Tahi will provide a brief reminder of this exciting data. During our post-ASCO event, we also announced our plans to broaden the reach of Rina-S, and we anticipate that we will have 3 Phase 3 trials underway by the end of the year.

今天，Tahi 將簡要回顧這些令人興奮的數據。在 ASCO 會後活動中，我們還宣布了擴大 Rina-S 覆蓋範圍的計劃，預計到今年年底將進行 3 個 3 期試驗。

In addition to our ongoing trial in platinum-resistant ovarian cancer, we plan to initiate a Phase 3 in endometrial cancer and a Phase 3 trial in platinum-sensitive ovarian cancer. Beyond gynecologic cancers, we also announced our intent to begin a Phase 2 trial in non-small cell lung cancer. So you can see our track record of being able to accelerate the clinical development of key programs continues.

除了我們正在進行的鉑金抗藥性卵巢癌試驗外，我們還計劃啟動子宮內膜癌的 3 期試驗和鉑敏感型卵巢癌的 3 期試驗。除了婦科癌症之外，我們也宣布了開始非小細胞肺癌二期試驗的意圖。因此，您可以看到我們能夠加速關鍵項目臨床開發的記錄仍在繼續。

Based on this exceptionally strong execution, we remain on track to bring Rina-S to ovarian cancer patients in 2027. And given its best-in-class profile, we expect to achieve peak sales in ovarian and endometrial cancers exceeding $2 billion.

基於這項異常強大的執行力，我們仍有望在 2027 年將 Rina-S 帶給卵巢癌患者。鑑於其一流的性能，我們預計卵巢癌和子宮內膜癌的銷售額高峰將超過 20 億美元。

We're also launching a Phase 2 study for acasunlimab as we evaluate its potential in advanced melanoma. And we continue to look forward to additional data for this program in non-small cell lung cancer in the second half of the year.

我們也啟動了 acasunlimab 的 2 期研究，以評估其在治療晚期黑色素瘤方面的潛力。我們繼續期待今年下半年獲得該計畫在非小細胞肺癌方面的更多數據。

Now over to Tahi, who will provide a brief review of our recent company announcement on epcoritamab followed by an overview of the promising Rina-S data from ASCO. Tahi, the floor is yours.

現在請 Tahi 簡要回顧我們公司最近發布的有關 epcoritamab 的公告，然後概述來自 ASCO 的有希望的 Rina-S 數據。Tahi，現在請你發言。

Thank you, Jan. And we are, of course, extremely pleased to announce today the result the Phase 3 EPCORE FL-1 which met its primary endpoints of overall response rate and progression-based survival, demonstrating statistically significant and remarkably clinical data and differences in both endpoints reducing the risk of disease progression or death by 79%.

謝謝，Jan。當然，我們今天非常高興地宣布，第三階段 EPCORE FL-1 的結果達到了其主要終點，即總體反應率和基於進展的生存期，顯示出統計學上顯著且顯著的臨床數據和兩個終點的差異，將疾病進展或死亡的風險降低了 79%。

In other words, a hazard ratio of 0.21. These results, which were derived from a pre-planned interim analysis will be submitted for presentation at the [CS] ASH meeting, and they will serve as the basis for global regulatory submissions.

換句話說，風險比為0.21。這些結果來自預先計劃的中期分析，將提交給[CS] ASH會議進行展示，並作為全球監管提交的基礎。

Now here, I would like to note that the supplemental BLA submission that Jan mentioned earlier with the FDA was actually based on data from an earlier interim analysis in the beginning of this year. These results also demonstrated comparable consistent statistically significant improvements in ORR and PFS and the details you can see on this slide.

現在，我想指出的是，Jan 之前提到的向 FDA 提交的補充 BLA 實際上是基於今年年初早期中期分析的數據。這些結果還表明 ORR 和 PFS 具有可比較的、一致的、統計上顯著的改善，您可以在此投影片上看到詳細資訊。

For both internal uses, the safety profile of epcoritamab in combination with R-square was consistent with the known safety profile of the individual regimens and no new safety signals have been observed. Patients with relapsed and refractory follicular lymphoma to have therapeutic options available.

對於兩種內部用途，epcoritamab 與 R 平方聯合使用的安全性與各個方案的已知安全性一致，並且沒有觀察到新的安全訊號。為復發性和難治性濾泡性淋巴瘤患者提供治療選擇。

However, responses become progressively shorter and less doable with each subsequent line of therapy, and this is accompanied by an increased list of transformation into large cell -- into aggressive large cell lymphoma.

然而，隨著後續治療的進行，治療反應變得越來越短，越來越不可行，並且伴隨著向大細胞——侵襲性大細胞淋巴瘤的轉化清單的增加。

What the data we shared today for epcoritamab highlights is the potential to completely transform and disrupt this current treatment paradigm. And it's also reflected in the collaboration with the FDA as we were able to accelerate submission in the United States.

我們今天分享的 epcoritamab 數據凸顯了其徹底改變和顛覆當前治療模式的潛力。這也反映在與 FDA 的合作中，因為我們能夠加快在美國提交申請的速度。

Both the recent sBLA submission and these data, which will support the planned global regulator submissions as mentioned bring us closer to being able to offer EPKINLY to patients in need of innovative therapies earlier in their treatment journey where they can have a much larger impact.

最近的 sBLA 提交和這些數據都將支持上述計劃中的全球監管機構提交，使我們更接近能夠為治療早期需要創新療法的患者提供 EPKINLY，從而產生更大的影響。

Now let's move on to the recent Rina-S data that was shared at ASCO. Previously, we discussed the medical need for patients with ovarian cancer. There also continues to be a significant unmet medical need for the treatment of women with endometrial cancer. At ASCO, we presented the first results for single agent Rina-S in women with advanced endometrial cancer from the dose expansion cohort, two of the ongoing Phase 1/2 RAINFOL-01 study.

現在讓我們來看看最近在 ASCO 上分享的 Rina-S 數據。之前，我們討論了卵巢癌患者的醫療需求。對於子宮內膜癌患者的治療，仍然存在著巨大的未滿足的醫療需求。在 ASCO 上，我們展示了劑量擴展隊列中單藥 Rina-S 治療晚期子宮內膜癌女性的首批結果，該隊列是正在進行的 1/2 期 RAINFOL-01 研究的兩個研究組。

This cohort includes 64 patients with heavily pre-treated endometrial cancer who were randomized one-to-one to receive either wins at Rina-S 100 milligram per meter square or Rina-S at 120-milligram per meter square.

該隊列包括 64 名已接受大量治療的子宮內膜癌患者，他們以一對一隨機分配接受每平方公尺 100 毫克的 Rina-S 治療或每平方公尺 120 毫克的 Rina-S 治療。

In the efficacy value of patients confirmed ORR was 50%, including two complete responses with Rina-S 100-milligram per meter square and the disease control rate at that dose was 100%. Antitumor activity was observed regardless of exploratory folate receptor alpha expression levels.

在療效值方面，確診患者的ORR為50%，其中兩例使用Rina-S 100毫克/平方公尺治療的完全緩解患者，該劑量下的疾病控制率為100%。無論探索性葉酸受體 α 表現量為何，均觀察到抗腫瘤活性。

In addition to a superior response rate treated with Rina-S at 100 milligrams per meter square led to the deeper more meaning tumor size full reductions. At the time of the data cut off for the presentation, the median duration of response was not yet reached. And with a median follow-up of 7.7 months, 8 of the 11 confirmed responses were still following.

除了優異的反應率外，以每平方公尺 100 毫克的 Rina-S 進行治療還可以導致更深、更有意義的腫瘤尺寸完全減少。在演示數據截止時，尚未達到響應的中位數持續時間。經過平均 7.7 個月的隨訪，11 個已確認的應答中有 8 個仍在繼續。

In short in the (inaudible) responses with Rina-S were observed early with the medium time to response of six weeks for both groups, that is the fact at the first response assessment. Rina-S also had a manageable safety also had a manageable safety profile consistent with previous reports. And the safety profile was partly similar between the two dose levels. The most common treatment emergent TEAEs were cytopenias and Grade 1 and 2 gastrointestinal events.

簡而言之，在（聽不清楚）中，早期就觀察到了 Rina-S 的反應，兩組的中位數反應時間均為六週，這是第一次反應評估的事實。Rina-S 還具有可控的安全性，並且具有與先前的報告一致的可控的安全性。兩種劑量水平的安全性部分相似。最常見的治療中出現的 TEAE 是血球減少症和 1 級和 2 級胃腸道事件。

Notably, there were no signals of ocular toxicity, interstitial lung disease or neuropathy observed in these reported patient cohorts, and the data we've now seen in both ovarian and especially endometrial cancer, which is known to actually have a much lower expression of folate receptor alpha support the important hypothesis that Rina-S has potentially works irrespective of the level for the folate receptor alpha expression.

值得注意的是，在這些報告的患者群體中沒有觀察到眼部毒性、間質性肺病或神經病變的信號，我們現在在卵巢癌和特別是子宮內膜癌中看到的數據（已知其葉酸受體 α 的表達實際上要低得多）支持重要的假設，即 Rina-S 可能無論葉酸受體 α 表達水平如何都有效。

And as folate-receptor offer is expressed across a broad range of solid tumors. This, of course, presents an opportunity to broaden the potential across a diverse area of tumor types, opening multiple avenues for therapeutic expansion.

且葉酸受體在多種實體腫瘤中都有表現。當然，這為拓寬不同類型腫瘤的潛力提供了機會，為治療擴展開闢了多種途徑。

So our ambition is to expand both within gynecological cancers across lines and move Rina-S into the earlier lines as fast and efficient as possible. But also beyond targeting additional solid tumors such as in the first step, non-small cell lung cancer.

因此，我們的目標是擴大婦科癌症的治療範圍，並盡可能快速有效地將 Rina-S 推廣到早期治療領域。但除了第一步針對其他實體腫瘤（例如非小細胞肺癌）之外。

To that end, a proof-of-concept Phase 2 study is in the plan to start dosing patients in the fourth quarter of this year. And as Jan mentioned, we are accelerating and expanding the development of Rina-S into additional trials, which already announced 3 Phase 3s to dose the first patient in 2025, one of them already, while ongoing.

為此，計劃進行概念驗證第二階段研究，並於今年第四季開始對患者進行給藥。正如 Jan 所提到的，我們正在加速和擴展 Rina-S 的開發，以進行更多試驗，我們已經宣布了 3 個 3 期臨床試驗，將於 2025 年為第一位患者進行給藥，其中一位已經在進行中。

And now I hand it over to Brad for a review of the solid recent commercial performance for EPKINLY and TIVDAK.

現在我把責任交給布拉德，讓他對 EPKINLY 和 TIVDAK 近期的出色商業表現進行評論。

Thanks, Tahi. We delivered strong performance across our commercial business in the first half of 2025. This is driven by our innovative antibody science, our proven launch capabilities and execution by our field teams.

謝謝，Tahi。2025 年上半年，我們的商業業務表現強勁。這是由我們創新的抗體科學、我們經過驗證的發布能力以及我們現場團隊的執行力所推動的。

We've maintained leading positions for our commercialized brands and have achieved critical milestones that will support our long-term growth. This performance enforces the solid foundation we've built that we strategically scale our operations accelerate adoption of our medicines and positively impact treatment paradigms for patients around the world.

我們保持了商業化品牌的領先地位，並取得了支持我們長期成長的關鍵里程碑。這項業績鞏固了我們所建立的堅實基礎，即我們策略性地擴大我們的業務規模，加速我們藥物的採用，並對全球患者的治療模式產生積極影響。

Overall, sales EPKINLY and TIVDAK in the first half of 2025 were up 60% year over year. This accounted for 31% of our total revenue growth, and we expect to see our commercialized medicines increasingly contribute to our overall revenue growth over time.

整體而言，2025 年上半年 EPKINLY 和 TIVDAK 的銷售額年增 60%。這占我們總收入成長的31%，我們預計隨著時間的推移，我們的商業化藥品將對我們的整體收入成長做出越來越大的貢獻。

In the second quarter, we achieved significant milestones for EPKINLY and TIVDAK that will be an important catalyst for our future growth. Following regulatory approvals for TIVDAK in Japan and Europe last quarter, we've now entered into the next phase of our commercialization strategy focused on long-term value creation through our wholly owned launches. We also made important progress on our work to reach more patients and deliver on EPKINLY growth potential.

在第二季度，我們為 EPKINLY 和 TIVDAK 取得了重要的里程碑，這將成為我們未來成長的重要催化劑。繼上個季度日本和歐洲監管部門批准 TIVDAK 之後，我們現已進入商業化策略的下一階段，重點是透過全資上市創造長期價值。我們也在接觸更多患者和發揮 EPKINLY 成長潛力的工作中取得了重要進展。

As Jan noted, we presented data at ASCO, EHA and iCML that together emphasized the strength of the EPKINLY clinical development program across histology’s and treatment studies. And importantly, as we announced earlier today, we've exported our work to move EPKINLY in earlier lines of therapy with the launch in second-line follicular lymphoma expected later this year.

正如 Jan 所指出的，我們在 ASCO、EHA 和 iCML 上展示的數據共同強調了 EPKINLY 臨床開發計劃在組織學和治療研究中的優勢。重要的是，正如我們今天早些時候宣布的那樣，我們已將我們的研究成果輸出到 EPKINLY 的早期治療領域，預計將於今年稍後推出二線濾泡性淋巴瘤治療。

Turning now to EPKINLY's first half performance. EPKINLY posted $211 million in global sales. This is a 74% year over year increase. We're highly encouraged by EPKINLY's performance and steady growth across geographies to date as we work to bring up EPKINLY to as many appropriate patients as possible.

現在來談談 EPKINLY 的上半場表現。EPKINLY 全球銷售額達 2.11 億美元。與去年同期相比，成長了 74%。我們對 EPKINLY 迄今為止在各個地區的表現和穩定成長感到非常鼓舞，我們致力於將 EPKINLY 推廣給盡可能多的合適患者。

Performance in the US continues to demonstrate the value of EPKINLY as an off-the-shelf dual indication option for both DLBCL and FL as we're seeing accelerating adoption across sites of care and increases in new patient starts.

美國的表現繼續證明了 EPKINLY 作為 DLBCL 和 FL 的現成雙重適應症選項的價值，因為我們看到各個護理站點的採用速度加快以及新患者數量的增加。

As we continue executing on our launches and prepare to enter earlier lines of therapy, we remain focused on increasing adoption and rapidly identifying patients, particularly in the community setting where most patients seek treatment.

隨著我們繼續執行發布計劃並準備進入早期治療領域，我們仍然專注於提高採用率並快速識別患者，特別是在大多數患者尋求治療的社區環境中。

In Japan, EPKINLY launched in third line plus follicular lymphoma in May. The launch is off to an encouraging start, building on the uptake we've seen in large B-cell lymphoma and also driven by the national and field level activities and account activation.

在日本，EPKINLY 於五月上市，用於治療第三線及以上濾泡性淋巴瘤。此次發布有一個令人鼓舞的開端，建立在我們在大型 B 細胞淋巴瘤中看到的吸收基礎上，同時也受到國家和現場級活動和帳戶激活的推動。

Across all other markets through our partner, AbbVie, we've always seen solid growth for EPKINLY and TEPKINLY. This is driven by an increasing number of countries gaining excess and reimbursement, along with the rapid uptake by physicians following remember visitations. Globally, EPKINLY has received the most regulatory approvals for a bispecific in DLBCL and FL with approvals in more than 60 countries worldwide.

透過我們的合作夥伴 AbbVie 在所有其他市場中，我們始終看到 EPKINLY 和 TEPKINLY 的穩健成長。這是由於越來越多的國家獲得了超額和報銷，以及醫生在記憶訪問後迅速接受這項政策。在全球範圍內，EPKINLY 已獲得 DLBCL 和 FL 雙特異性藥物最多的監管批准，全球已有 60 多個國家批准。

This includes nearly 50 countries with approvals in both indications. Today, EPKINLY is uniquely positioned as the only bispecific approved as an off-the-shelf dual indication option in DLBCL and FL. With encouraging utilization across markets, consistently positive feedback from physicians type EPKINLY profile, and our progress moving into earlier lines of therapy, we're confident that we have the commercial and clinical foundation in place for EPKINLY to become to therapy across B-cell lymphomas.

其中包括近 50 個國家已批准這兩種適應症。如今，EPKINLY 具有獨特的優勢，是唯一獲準用於治療 DLBCL 和 FL 的現成雙重適應症的雙特異性藥物。隨著各個市場令人鼓舞的利用率、來自醫生對 EPKINLY 概況的持續積極反饋以及我們在早期治療領域取得的進展，我們相信我們已經為 EPKINLY 成為 B 細胞淋巴瘤治療藥物奠定了商業和臨床基礎。

Moving now to TIVDAK. TIVDAK has proven to be a significant advancement for women with recurrent or metastatic cervical cancer in the US It has changed the treatment paradigm serving as a model -- a new standard of care around the world.

現在移至 TIVDAK。事實證明，TIVDAK 對美國復發性或轉移性子宮頸癌患者來說是一項重大進步，它改變了治療模式，成為一種典範——一種全球新的治療標準。

In the first half of this year, we built on this progress to bring TIVDAK to more women and deliver on our commitment to contribute to the gynecologic cancer community in a meaningful way. Global sales for TIVDAK in the first half of 2025 totaled $78 million. This is up 30% compared to the same time last year.

今年上半年，我們在此基礎上將 TIVDAK 推廣給更多女性，並履行了為婦科癌症社區做出有意義的貢獻的承諾。2025 年上半年 TIVDAK 的全球銷售額總計 7,800 萬美元。與去年同期相比，成長了 30%。

Of note, commercial sales now reflect our launch TIVDAK in May. This was the first medicine launched independently by Genmab and we're seeing encouraging uptake. In the US, performance continues to be strong and stable across sites of care. And in Europe, we've made important progress establishing our infrastructure operations to support commercial markets in the region.

值得注意的是，商業銷售現在反映了我們 5 月推出的 TIVDAK。這是 Genmab 獨立推出的第一款藥物，我們看到了令人鼓舞的市場認可。在美國，各醫療機構的表現持續保持強勁穩定。在歐洲，我們在建立基礎設施營運以支援該地區的商業市場方面取得了重要進展。

Our teams are ready to launch TIVDAK with the first launch anticipated in Germany soon. Other countries are expected to follow based on regulatory and reimbursement time lines. This progress marks a strong entrance into the next phase of our commercialization strategy as we lock our medicines independently enter new markets and broaden our impact for patients in the gynecologic cancer community.

我們的團隊已準備好發射 TIVDAK，預計很快將在德國進行首次發射。預計其他國家也將根據監管和報銷時間表採取類似措施。這項進展標誌著我們強勢進入商業化策略的下一階段，我們將獨立鎖定我們的藥物進入新市場，並擴大我們對婦科癌症患者的影響。

So with continued solid performance of our commercialized medicines, and proven launch execution, we're confident in our path for growth. We believe we have the right pieces in place to drive long-term value creating and maximize our opportunities ahead prep EPKINLY and our emerging not portfolio.

因此，憑藉我們商業化藥品的持續穩健表現和經過驗證的上市執行力，我們對我們的成長道路充滿信心。我們相信，我們已經具備了正確的條件來推動長期價值創造，並最大限度地利用我們為 EPKINLY 和新興投資組合所準備的機會。

As we continue executing in the next phase of our commercialization strategy, we're focused on expanding utilization of our medicines and bringing them to as many patients as possible around the world. The work we've done to transform our commercialization business and accelerating our pipeline is paying off. As we've agreed through this new and exciting chapter for Genmab, we look forward to all that is to come for TIVDAK and EPKINLY in the back half of the year.

隨著我們繼續執行商業化策略的下一階段，我們專注於擴大我們藥品的利用範圍，並將其帶給世界各地盡可能多的患者。我們為轉變商業化業務和加速產品線所做的工作正在取得成效。正如我們在 Genmab 這一激動人心的新篇章中所達成的共識一樣，我們期待 TIVDAK 和 EPKINLY 在下半年取得的一切進展。

With that, I'll hand the call over to Anthony to discuss our financials.

說完這些，我會把電話交給安東尼來討論我們的財務狀況。

Thanks, Brad. In the first half of 2025, we delivered solid revenue growth, driven by sustained recurrent revenues and the solid market performance of our products. We've also significantly enhanced our long-term growth potential as we continue to gather promising clinical data for both epcoritamab and Rina-S.

謝謝，布拉德。2025 年上半年，在持續的經常性收入和產品穩健的市場表現的推動下，我們實現了穩健的收入成長。隨著我們繼續收集 epcoritamab 和 Rina-S 的有希望的臨床數據，我們的長期成長潛力也顯著增強。

And as we're going to see our financials remain strong. We achieved 19% total revenue growth and 27% recurring revenue growth. This was driven by very strong royalties from DARZALEX and Kesimpta. And importantly, this growth was also driven by product sales from EPKINLY and TIVDAK, which together represented around 31% of our total revenue growth.

我們將看到我們的財務狀況依然強勁。我們實現了總收入成長 19% 和經常性收入成長 27%。這是由 DARZALEX 和 Kesimpta 的豐厚特許權使用費所推動的。重要的是，這一成長也受到 EPKINLY 和 TIVDAK 產品銷售的推動，這兩個品牌的銷售量合計占我們總收入成長的 31% 左右。

Looking at DARZALEX. We continue to see strong growth. Overall, net sales grew by nearly 22%, that's $6.8 billion for the first half of the year, which translates to $1 billion in royalty revenue for us. This growth was driven by continued share gains and strong performance in the front line setting.

看著 DARZALEX。我們繼續看到強勁的成長。總體而言，今年上半年淨銷售額成長了近 22%，達到 68 億美元，這意味著我們的特許權使用費收入為 10 億美元。這一成長是由持續的市場份額成長和一線市場的強勁表現所推動的。

So you can see that the quality of our revenue profile continues to improve. In fact, in the first half of this year, recurring revenues represented 97% of our total revenue and that compares favorably to 90% in the first half of last year. Stepping back, what's really clear is that the investments we've made in building out our commercialization teams and capabilities are paying off.

所以你可以看到我們的收入狀況品質持續改善。事實上，今年上半年，經常性收入占我們總收入的 97%，與去年上半年的 90% 相比有所提高。回顧過去，真正清楚的是，我們在建立商業化團隊和能力方面所做的投資正在獲得回報。

And this sets us up well as we prepare for potential expansion into earlier lines for EPKINLY including second-line FL and the potential launch of Rina-S in 2027. And we continue to take a disciplined approach to these investments.

這為我們做好了準備，以便將 EPKINLY 擴展到早期產品線，包括二線 FL 以及 2027 年可能推出的 Rina-S。我們將繼續對這些投資採取嚴謹的態度。

Total OpEx in the first half of 2025 were slightly less than $1 billion, up 6% over the first half of last year, and that excludes the impact of the ProfoundBio acquisition. And we're managing our investments strategically prioritizing our high-impact Phase 3 programs and focused investments in our commercialization capabilities.

2025 年上半年的總營運支出略低於 10 億美元，比去年上半年成長 6%，這還不包括收購 ProfoundBio 的影響。我們正在策略性地管理我們的投資，優先考慮具有高影響力的第三階段計劃，並專注於投資於我們的商業化能力。

Our operational discipline contributed to our operating profit growth of an impressive 56% in the first half. So here, you can see that we're really continuing to deliver on our commitments.

我們的營運紀律促使我們上半年的營業利潤成長了 56%。所以在這裡，你可以看到我們確實在繼續履行我們的承諾。

Next, looking at our net financial items. Here, we have a net gain of $119 million. Then moving on to tax. We have tax expense of $136 million, which equates to an effective tax rate of about 20%. Taken together, our net profit amounts to $531 million. So as you can see, continued strong underlying financial performance. With that, let's move to our 2025 financial guidance.

接下來，看看我們的淨財務項目。這樣，我們的淨收益為 1.19 億美元。然後討論稅收。我們的稅費為 1.36 億美元，相當於實際稅率約為 20%。總體而言，我們的淨利潤達到 5.31 億美元。因此，正如您所看到的，基礎財務表現持續強勁。有了這些，我們來看看 2025 年的財務指引。

Here, I'm pleased to note that we're improving our guidance based on projected higher revenues and operating profit even as we continue to expand the development of our late-stage programs. We now expect our revenue to be in the range of around $3.5 billion to $3.7 billion, delivering a robust 15% growth at the midpoint. And that compares to 12% growth under our previous guidance.

在這裡，我很高興地註意到，即使我們繼續擴大後期專案的開發，我們也正在根據預期的更高收入和營業利潤來改善我們的指導。我們現在預計我們的營收將在 35 億美元至 37 億美元之間，中間值將實現 15% 的強勁成長。相比之下，我們先前的指導成長率為 12%。

We're increasing the midpoint of our total revenue guidance by $100 million. This is driven by the strong performance of DARZALEX and positive EPKINLY momentum and partially offset by a slight impact from lower TEPEZZA royalties and milestone revenue. So we now anticipate that our recurring revenues for the year will grow 22%, and that compares to 18% under our previous guidance.

我們將總收入預期的中點提高了 1 億美元。這是由 DARZALEX 的強勁表現和 EPKINLY 的積極勢頭推動的，但部分被 TEPEZZA 特許權使用費和里程碑收入降低的輕微影響所抵消。因此，我們現在預計今年的經常性收入將成長 22%，而我們先前的預期是成長 18%。

For OpEx, due to our continued focused and disciplined approach to our investments, we still expect to be in a range of around $2.1 billion to $2.2 billion. Putting this all together, we're planning for operating profit in a range between around $1.1 billion to $1.4 billion, with the midpoint of guidance amounting to over $1.2 billion of operating profit and strong year over year growth of 26%.

對於營運支出，由於我們繼續採取專注且嚴謹的投資方式，我們仍預計其規模將在 21 億美元至 22 億美元之間。綜合以上所有因素，我們計劃實現營業利潤在 11 億美元至 14 億美元之間，預計中間值為營業利潤超過 12 億美元，年增 26%。

Our improved guidance highlights our continued strategic discipline, targeted investments and operational efficiency, all while advancing our pipeline.

我們改進的指導凸顯了我們持續的策略紀律、有針對性的投資和營運效率，同時推進我們的產品線。

Now finally, to give you just a bit of color on FX. Here, every 10 point move in the exchange rate relative to our guidance rate for the dollar to kroner of [7.2] is worth around $5 million in operating profit or loss at the midpoint.

最後，讓我們來稍微介紹一下 FX。在這裡，相對於我們對美元兌瑞典克朗 [7.2] 的指導匯率，匯率每變動 10 個點，中間價就會造成約 500 萬美元的營業利潤或損失。

In summary, our performance in the first half of 2025 underscores our ability to deliver solid, high-quality revenue growth, advanced key pipeline assets and maintain strong profitability through disciplined execution.

總而言之，我們在 2025 年上半年的業績凸顯了我們透過嚴格的執行實現穩健、高品質的收入成長、先進的關鍵管道資產和保持強勁盈利能力的能力。

Looking ahead to the second half of 2025, we will continue to build on this momentum by further prioritizing our investments and expanding market opportunities. Now we are, of course, continuing to monitor the geopolitical situation and the potential impact on our business.

展望 2025 年下半年，我們將繼續保持這一勢頭，進一步優先考慮投資並擴大市場機會。當然，現在我們正在繼續關注地緣政治局勢及其對我們業務的潛在影響。

At this stage, we do not anticipate a significant impact on our 2025 financial guidance. What's important to note is our very strong financial foundation, sustained profitability and disciplined capital allocation strategy really enable us to position Genmab for growth and expansion as well as create value for shareholders, and patients.

現階段，我們預計這不會對我們的 2025 年財務指引產生重大影響。值得注意的是，我們非常強大的財務基礎、持續的獲利能力和嚴謹的資本配置策略真正使我們能夠為 Genmab 的成長和擴張做好準備，並為股東和患者創造價值。

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

關於這一點，我將把您的發言權交還給 Jan。

Thank you, Anthony. Let's move on to our final slide. So we have strengthened the foundations of our business in the first half of 2025. We have expanded the reach of both EPKINLY and TIVDAK to more patients and we anticipate even further growth for EPKINLY before the end of the year.

謝謝你，安東尼。讓我們繼續看最後一張投影片。因此，我們在 2025 年上半年加強了業務基礎。我們已將 EPKINLY 和 TIVDAK 的覆蓋範圍擴大到更多患者，我們預計 EPKINLY 在今年年底前將進一步成長。

For Rina-S, we have presented additional support of clinical data showing its potential beyond ovarian cancer, and we are prepared to maximize that potential with additional Phase 3 clinical trials. As we continue to anticipate further acasunlimab data this year.

對於 Rina-S，我們提供了額外的臨床數據支持，顯示其在治療卵巢癌以外的疾病方面的潛力，並且我們準備透過額外的 3 期臨床試驗來最大限度地發揮其潛力。我們將繼續期待今年的更多 acasunlimab 數據。

In addition to these priorities, we will continue to actively look for opportunities to grow our pipeline both organically and inorganically, positioning us for sustainable long-term growth and value creation. In summary, in the first half of 2025 our solid financial performance, including our own products at EPKINLY and TIVDAK, reinforced the strength of our financial foundation.

除了這些優先事項之外，我們還將繼續積極尋找機會，透過有機和無機的方式擴大我們的產品線，為可持續的長期成長和價值創造做好準備。總而言之，2025 年上半年我們穩健的財務業績，包括我們在 EPKINLY 和 TIVDAK 的自有產品，增強了我們財務基礎的實力。

This strong foundation is coupled with a disciplined capital allocation strategy that prioritizes investment in our hype impacts Phase 3 programs allowing us to unleash the full potential of our late-stage pipeline while maximizing the success of our commercialized medicines, together with our demonstrated track record of execution, we are set up for long-term success and continued outperformance through 2030 and beyond.

這個堅實基礎與嚴格的資本配置策略相結合，該策略優先投資於我們備受矚目的第三階段項目，使我們能夠充分發揮後期產品線的潛力，同時最大限度地提高商業化藥物的成功率，再加上我們已證明的執行記錄，我們已為長期成功和在 2030 年及以後的持續優異表現做好了準備。

That answer formal presentation. Thank you for listening. Operator, please open the call for questions.

該答案正式提出。謝謝您的聆聽。接線員，請打開電話詢問。

(Operator Instructions)

（操作員指示）

Jonathan Chang, Leerink.

Jonathan Chang，Leerink。

Hi guys, thanks for taking my questions and congrats on the positive Phase 3 EPCORE FL-1 results. What is your latest thinking on the positioning of EPCORE versus other C20 bispecific in the competitive landscape, both in terms of clinical development and your commercial experience. Thank you.

大家好，感謝你們回答我的問題，並祝賀第三階段 EPCORE FL-1 取得正面成果。您對 EPCORE 與其他 C20 雙特異性抗體在競爭格局中的定位有何最新看法，包括臨床開發和商業經驗。謝謝。

Thank you, Jonathan, for the question. Excellent question. I'm going to hand it over to Tahi first, and then Brad will certainly add to that. Tahi, why don't you start?

謝謝喬納森提出的問題。非常好的問題。我將首先把它交給 Tahi，然後 Brad 肯定會補充。塔希，你為什麼不開始呢？

Yes, Jonathan, thank you for the question. As it relates to the position, I think we feel -- we've been saying this for very comfortable where we are. We have a very broad and aggressive development plan. This is the first Phase 3 read out now for EPKINLY, but there are more to come in the next six to nine months. You just look at the breadth of the development and also the core as well as the times when these studies were initiated.

是的，喬納森，謝謝你的提問。就職位而言，我認為我們感覺——我們對目前的情況感到非常滿意。我們有一個非常廣泛和積極的發展計劃。這是 EPKINLY 目前發布的第 3 階段報告，但未來六到九個月還會有更多報告。您只需看看發展的廣度和核心以及這些研究開始的時間。

I think we have a head start now in second line particular formal for sure, even we expect 1.5 years later. We announced that our frontline [diffuser] include a year ahead of initial projections. So we are very anxiously awaiting those results coming. And we announced that we expect them to come in '26, Phase 3 in both the monotherapy as well as in combination with lenalidomide are also results we're also were looking forward.

我認為我們現在在第二線特別是正式領域已經處於領先地位，即使我們預計一年半後也是如此。我們宣布，我們的前線[擴散器]比最初的預測提前了一年。因此，我們非常焦急地等待結果。我們宣布，預計這些藥物將在 26 年上市，單一療法以及與來那度胺聯合治療的第三階段試驗結果也是我們預期的。

The frontline -- the frontline for the (inaudible) study is going extremely well. And so from a positioning, from a data generation point of view, we feel very strong and utilization, I think Brad can also talk about this the fact that we very early on to generate data that was informing physicians in the outpatient setting, how to utilize EPKINLY is also paying off quite well and then for the more to come on that end as well as it relates to how the market was probably should hand this over to Brad.

前線－（聽不清楚）研究的前線進展非常順利。因此，從定位、從數據生成的角度來看，我們感覺非常強大和利用率，我認為布拉德也可以談談這個事實，我們很早就生成了數據，為門診醫生提供信息，如何利用 EPKINLY 也獲得了相當好的回報，然後在這方面還有更多的發展，以及它與市場如何將其交給布拉德的關係。

But broadly speaking, we feel that we have the most broadest, most ambitious program in the bispecific space and we've also been consistently showing that we're executing successfully on these studies, and that's equally important, not only on the clinical execution but also on the regulatory execution if you look at some of the competitiveness.

但從廣義上講，我們認為我們在雙特異性領域擁有最廣泛、最雄心勃勃的計劃，而且我們也一直在表明我們在這些研究中執行得很成功，這同樣重要，不僅在臨床執行方面，而且在監管執行方面，如果你看一下競爭力的話。

Yeah, Jonathan, thanks for the question and just kind of building on what Tahi said, we're certainly encouraged by our current leading sales position globally and then also being the off-the-shelf dual indication bispecific, just receiving tremendous feedback from our physicians and customers.

是的，喬納森，謝謝你的提問，基於塔希所說的，我們目前在全球的領先銷售地位確實讓我們感到鼓舞，而且作為現成的雙重適應症雙特異性藥物，我們從醫生和客戶那裡得到了大量反饋。

And now as we've said all along, starting to move into earlier lines of therapy with larger markets, it's proving beneficial, as I mentioned, with the 60-plus countries where we're approved, within a dual indication. And certainly, this most recent FL data can continue to help us expand into the community where we've seen accelerating uptake already. So it has been a differentiator around the marketplace.

現在，正如我們一直所說的那樣，開始進入更大市場的早期治療領域，事實證明，這是有益的，正如我所提到的那樣，我們在 60 多個國家/地區獲得了批准，並且具有雙重適應症。當然，最新的 FL 數據可以繼續幫助我們擴展到我們已經看到加速發展的社區。因此它已經成為了市場上的一個差異化因素。

Got it. Thanks for taking the question.

知道了。感謝您回答這個問題。

Thanks. And to top it off, Jonathan, we just submitted close to 30 abstracts on (inaudible) for ASH. So there will be a lot of data, hopefully, at the end of the year. Let me, let us move to the second -- to the next question operator.

謝謝。最重要的是，喬納森，我們剛剛向 ASH 提交了近 30 篇（聽不清楚）摘要。因此，希望到今年年底會有大量數據。讓我們進入第二個問題——下一個問題操作員。

Asthika Goonewardene, Truist.

Asthika Goonewardene，Truist。

Hi guys, thanks for taking my question. So there is a lot of chaos at the FDA right now or calamity, what do you want to fall it? As we think about some of the regulatory filings you have coming up, I want to -- so I have a two part question on that.

大家好，感謝你們回答我的問題。那麼，FDA 現在有很多混亂或災難，您希望如何解決它？當我們考慮您即將提交的一些監管文件時，我想 - 因此我對此有兩個部分的問題。

One, how confident do you feel that you can file RAINFOL-01 Part C, which is a single-arm cohort. How confident you intimate accelerator approval? And then secondly, is there any risk of pushback from the FDA on EPCORE FL-1 to wait until OS is more mature? Thanks.

首先，您對提交 RAINFOL-01 C 部分（單臂隊列）有多大信心。您對加速器批准有多大信心？其次，FDA 是否會延後 EPCORE FL-1 的上市，以等待 OS 更成熟？謝謝。

Thanks, Asthika, for the questions. I will ask Judith to start off with the RAINFOL study and then maybe you can also take the FL-1 study units.

謝謝 Asthika 提出的問題。我會讓 Judith 從 RAINFOL 學習開始，然後你也許可以參加 FL-1 學習單元。

Yeah. Thank you again, and thank you Ashtika. So I'll start with RAINFOL, the accelerated approval of course, predicated on strong on ORR and duration of response. At this moment, we don't have any reason to believe that the FDA will have any prospect provided the data supports, and we are aligned with the regulations in terms of the Phase 3 well underway. So at this moment, we don't have perceive any risk on that.

是的。再次感謝您，也謝謝 Ashtika。因此，我將從 RAINFOL 開始，當然，這是加速批准，以強大的 ORR 和回應持續時間為前提。目前，我們沒有任何理由相信 FDA 會在數據支持的情況下給出任何前景，並且我們與正在進行的第三階段的規定保持一致。因此目前我們還沒有察覺到任何風險。

And as we committed launch in 2027, we reinforced our commitment to the launch early in 2027. And with regard EPCORE FL-01, as you know, that indication got BTD in September 2024. So we are engaging with the FDA in a very active and positive manner. So when as we announced publicly today without the sBLA was accepted with the PDUFA date in November. This -- so we feel very confident that we have a path forward with ahead of us.

當我們承諾在 2027 年發射時，我們加強了在 2027 年初發射的承諾。關於 EPCORE FL-01，如您所知，該指示將於 2024 年 9 月獲得 BTD。因此，我們正以非常積極和正面的方式與 FDA 合作。因此，正如我們今天公開宣布的那樣，沒有 sBLA 的申請已被接受，而 PDUFA 的日期是 11 月。因此，我們非常有信心，我們前面有一條前進的道路。

Thank you, Judith. Thanks Ashtika for the question.

謝謝你，朱迪絲。感謝 Ashtika 提出的問題。

Rajan Sharma, Goldman Sachs.

高盛的拉詹·夏爾馬。

Hi, thanks for taking the question. Firstly, on EPKINLY, so assuming you get the approval in November. Could you just outline your initial launch strategy? Is there a specific patient group that you might be targeting? Or -- and how should we think about revenue contribution in '25 and '26? And then just on the label there, do you expect that there will be no requirement for hospitalization.

你好，謝謝你回答這個問題。首先，在 EPKINLY 上，假設您在 11 月獲得批准。您能否概述一下您最初的發布策略？您的目標患者群是否是特定的？或者—我們該如何看待 25 年和 26 年的收入貢獻？那麼，就標籤而言，您是否認為不需要住院治療？

And then second question was just on the pipeline. I noticed that the HexaBody-OX40 or GEN1055 has been discontinued in solid tumors. Could you just talk to the rationale here? And I think that's the second HexaBody asset now that's not being progressed this year. So it would be great to just hear your confidence in that platform. And could that OX40 asset be used in immunology potentially? Thank you.

第二個問題是關於管道的。我注意到 HexaBody-OX40 或 GEN1055 已停止用於治療實體腫瘤。您能談談這裡的理由嗎？我認為這是今年第二個沒有進展的 HexaBody 資產。因此，我很高興聽到您對該平台的信心。OX40 資產是否可能用於免疫學？謝謝。

Thanks, Rajan, for the questions. I'll ask first Brad to comment on the EPKINLY questions. And Tahi, you can probably speak a bit more on HexaBody-OX40. What I can tell you before they start, Rajan we are very excited about the HexaBody platform. We're actually bringing a new one into the clinic. We hope between now and the end of the year.

謝謝 Rajan 提出的問題。我首先請布拉德對 EPKINLY 問題發表評論。Tahi，您可以再多談談 HexaBody-OX40。在他們開始之前我可以告訴你，Rajan，我們對 HexaBody 平台感到非常興奮。我們實際上正在將一種新產品引入診所。我們希望從現在到年底。

So we are certainly very confident in the platform, but we also are rigorous in prioritizing our portfolio, focusing more on late-stage programs and that requires tough decisions. But I want to give you some further color there. But Brad, why don't you start on EPKINLY and the launch strategy for (inaudible)

因此，我們對該平台非常有信心，但我們也嚴格確定投資組合的優先順序，並且更專注於後期項目，這需要做出艱難的決定。但我想給你進一步說明一下。但是布拉德，為什麼不開始討論 EPKINLY 和它的發布策略呢？（聽不清楚）

Thank you for the question. And I think as we've stated for quite some time, larger opportunity is in these earlier lines of therapy. And we're certainly pleased with the potential EPKINLY to pave the way in this indication specifically in second-line FL.

謝謝你的提問。我認為，正如我們長期以來所說的那樣，這些早期的治療方法中蘊藏著更大的機會。我們非常高興 EPKINLY 有潛力為這一適應症，特別是在二線 FL 中鋪平道路。

And in the US, as we've discussed, FL as a really important opportunity as we expand into the community, where we've already seen accelerating uptake and see this as a meaningful opportunity for patients, but also for the brand on moving forward.

正如我們所討論的，在美國，FL 是我們向社區擴張的一個非常重要的機會，我們已經看到了其加速普及，並將其視為對患者和品牌未來發展的有意義的機會。

Thanks so much, Brad.

非常感謝，布拉德。

I'll take the question on OX40. Well, the first thing I would say is like just to correct the impression the tax amortization as it is used for this particular target and also how it was used for CD27 in order to increase outside inside signaling by improving clustering, that hypothesis definitely help through.

我將在 OX40 上回答這個問題。好吧，我想說的第一件事就是糾正人們對稅收攤銷的印象，因為它用於這個特定的目標，以及它如何用於 CD27，以通過改善聚類來增加外部內部信號，這個假設肯定有幫助。

So the HexaBody-OX40 program did show all the things that we were anticipating and we're hoping for both in terms of a much, much stronger signal in terms of the biology, but also in terms of overcoming the bell shape curve, the decision to discontinue as Jan was already indicating, was primarily on the fact that -- it's a profile not really differentiated from some of the other assets that we have.

因此，HexaBody-OX40 計畫確實展示了我們所預期的一切，我們希望它不僅在生物學方面發出更強的信號，而且在克服鐘形曲線方面也能如此，正如 Jan 已經指出的那樣，決定停止該項目主要是因為——它與我們擁有的其他一些資產並沒有什麼區別。

And from a development path vis-a-vis other opportunities that exist is really not as promising as some of the other opportunities. So we're investing still been hearing for one of us, our resources or money where we can see the most return on our investment. So that was the OX40 question.

從發展路徑來看，現有的其他機會確實不如其他一些機會那麼有前景。因此，我們在投資時仍然會聽取我們的意見，我們的資源或資金在哪裡可以獲得最大的投資回報。這就是 OX40 問題。

Maybe I'll take the labeling question that we owe you. The lymphoma label already does not include any hospitalization. That's true for monotherapy, for the lymphoma, follicular and third line, and that's also going to be true in combination with elsewhere.

也許我會回答我們欠你的標籤問題。淋巴瘤標籤已經不包括任何住院治療。這對於單一療法、淋巴瘤、濾泡性療法和三線療法都是如此，與其他療法合併使用也是如此。

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

謝謝，Tahi。我們繼續討論下一個問題。

Yaron Werber, TD Securities.

道明證券的 Yaron Werber。

Hi, congrats on the quarter and thanks for your question. This is Jen on for Yaron. Now that follicular lymphoma is really a growing part of the conversation with EPKINLY, how are you thinking about the EPKINLY's opportunity and differentiation versus [lysumio] specifically? Thanks so much.

您好，恭喜本季取得佳績，感謝您的提問。這是 Jen 為 Yaron 表演的。現在，濾泡性淋巴瘤已成為 EPKINLY 討論中越來越重要的部分，您如何看待 EPKINLY 與 [lysumio] 相比的機會和差異化？非常感謝。

Thank you very much for the question. I am handing it over to you, Tahi.

非常感謝您的提問。我把它交給你了，塔希。

Well, I mean, thank you for the question. First things first. Well, we have a positive Phase 3 in second line and they don't yet have reported the results. I think they have publicly said that they expect the results are coming by the end of the year. So that's the first differentiation.

嗯，我的意思是，謝謝你的提問。首先要做的事情。嗯，我們在第二線的第三階段取得了積極的成果，但他們還沒有報告結果。我認為他們已經公開表示，預計結果將在年底前公佈。這是第一個區別。

We will have a significant head start. And I think that has played out well for us. In terms of the signal consistently, although maybe not as dramatic EPKINLY has shown better efficacy higher or higher CR rates both in food lymphoma and then definitely also the issue of B-cell.

我們將取得顯著的領先優勢。我認為這對我們來說是件好事。就訊號而言，儘管可能不那麼引人注目，但 EPKINLY 始終表現出更好的療效，無論是在食物淋巴瘤還是 B 細胞問題中，CR 率都更高。

So it seems more efficacious of the two bispecific, subcutaneous administration has been an advantage for us and [Russia] plan to bridge towards that, but not yet. So that's another differentiation that currently is playing out.

因此，兩種雙特異性抗體中皮下注射似乎更有效，這對我們來說是一個優勢，而俄羅斯也計劃朝著這個方向發展，但目前還沒有。這是目前正在發生的另一個區別。

And I think in terms of safety, with the subsequent optimization, our CRS rates are as low as they are with (inaudible) so broadly speaking, we feel are now very, very good about our position. I don't know if Brad has anything to say to that.

我認為就安全性而言，透過後續的優化，我們的 CRS 利率會與（聽不清楚）一樣低，所以從廣義上講，我們感覺現在我們的地位非常非常好。我不知道布拉德對此有何看法。

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

謝謝，Tahi。這就足夠了。我們繼續討論下一個問題。

Michael Schmidt, Guggenheim Partners.

古根漢合夥公司的麥可‧施密特。

Oh, hey, thanks for taking my questions. I had another one on Rina-S and specifically around your plans for development outside ovarian cancer. You did talk about this new Phase 2 study in non-small cell lung cancer. And just wondering if you could expand upon that opportunity. Do you have any data in how Phase 1 is and how is the supporting this? And what do we know about the full of the alpha expression in lung cancer? Thanks so much.

哦，嘿，感謝您回答我的問題。我還有另一封關於 Rina-S 的郵件，特別是關於您在卵巢癌以外的領域發展的計劃。您確實談到了非小細胞肺癌的這項新的 2 期研究。我只是想知道您是否可以擴大這個機會。您是否有關於第一階段進展如何以及其支持情況的數據？那麼，我們對肺癌中 α 表現的全部了解有多少呢？非常感謝。

Thanks, Michael, for the question. I'm going to hand it over to Tahi and he can give you an excellent rationale Michael.

謝謝邁克爾提出這個問題。我將把它交給 Tahi，他可以給你一個很好的理由，Michael。

All right. Thank you for the question and I'll start at the beginning. So yes, I think the way we have been talking about this is as we have increasingly learned that Rina-S is able to generate efficacy even in patients who have lower levels of folate receptor alpha expression. That, of course, then raises interest in disease areas of folate receptor alpha is expressed by the lower levels. And so that was what I was mentioning and referring to.

好的。感謝您的提問，我從頭開始。所以是的，我認為我們一直在談論這個問題，因為我們越來越了解到 Rina-S 甚至能夠對葉酸受體 α 表達水平較低的患者產生療效。當然，這引起了人們對葉酸受體 α 的疾病領域的興趣，該領域由較低水平表達。這就是我所提到和提及的。

EGFR-mutated non-small cell lung cancer. So that's the indication we are looking at as the next step is one that slightly different adenocarcinoma and non-small cell lung cancer is known to have folate receptor alpha expression really broadly, but not as high as it is, for example, in ovarian, but somewhat similar to endometrial actually.

EGFR突變的非小細胞肺癌。因此，這就是我們正在研究的下一步跡象，即略有不同的腺癌和非小細胞肺癌已知具有非常廣泛的葉酸受體 α 表達，但不如卵巢癌那麼高，但實際上與子宮內膜癌有些相似。

EGFR-mutated non-small lung cancer does actually have an increase in fleet alpha expression. So this is the first case study for us to then explore additional solid tumor indications, not the last, but the first in a sequence that is very much driven by clinical data and scientific rationale.

EGFR 突變的非小細胞肺癌確實存在 Fleet Alpha 表現的增加。因此，這是我們探索其他實體腫瘤適應症的第一個案例研究，這不是最後一個，而是一系列由臨床數據和科學原理驅動的研究中的第一個。

We do have, as you were pointing to already a small cohort that is very well involved now. For its size, initially meant to just generate some safety data. And so we do have some signals, and they are continue to be encouraging. So we continue to generate that data.

正如您所指出的，我們確實已經有一小部分人參與其中。就其規模而言，最初目的只是為了產生一些安全資料。因此，我們確實有一些信號，而且它們繼續令人鼓舞。因此我們繼續產生這些數據。

But the intent of this study is really to give us now a dedicated vehicle with multiple different arms so that we can really strategically explore the opportunity for Rina-S initially and EGFR muted but not restricted necessary to EGFR-muted non-small-cell lung cancer. So very excited about that study and so we're going to be very much looking forward to the data the study will generate.

但這項研究的目的實際上是為我們現在提供一種具有多種不同分支的專用載體，以便我們能夠真正從戰略上探索 Rina-S 最初的機會以及 EGFR 沉默但不局限於 EGFR 沉默的非小細胞肺癌的必要性。我們對這項研究感到非常興奮，因此我們非常期待這項研究將產生的數據。

Thanks, Tahi. Thanks, Michael.

謝謝，Tahi。謝謝，麥可。

Matt Phipps, William Blair.

馬特菲普斯、威廉布萊爾。

Thanks for taking my question. Congrats on the strong, of course, all one data. Maybe a question -- you mentioned the broad development plan with epcoritamab being a strength. I was wondering what you think about ADC combinations. And do you see a role for those longer term in lymphoma? Maybe how you will continue to explore those? And then quickly, acasunlimab and melanoma. will that use the same Q6 dosing or do you need to explore additional dosing regimens in melanoma? Thank you.

感謝您回答我的問題。恭喜強大，當然，全是一數據。也許有一個問題——您提到了廣泛的發展計劃，其中 epcoritamab 是一個優勢。我想知道您對 ADC 組合的看法。您認為這些藥物對長期治療淋巴瘤有作用嗎？也許您將如何繼續探索這些？然後很快，acasunlimab 和黑色素瘤。這會使用相同的 Q6 劑量嗎，還是您需要探索黑色素瘤中的其他給藥方案？謝謝。

Thanks, Matthew. I can take the second question. Acasunlimab, we will stick with this every six-week dosing because we think it's optimal for that that compound. We don't need to do a further dose frequency combinations, we believe. And I'll let Judith add to that if there are any further things to add. But Tahi, why don't you start with the [APCO] development plans in the context of ADC combinations.

謝謝，馬修。我可以回答第二個問題。Acasunlimab，我們將堅持每六週給藥一次，因為我們認為這是該化合物的最佳劑量。我們認為，我們不需要進行進一步的劑量頻率組合。如果還有其他內容需要補充，我會讓 Judith 補充。但是 Tahi，為什麼不從 ADC 組合背景下的 [APCO] 發展計劃開始呢？

Yeah. Thank you for the question. And maybe the way I start what I laid out was the regulatory strategy that was following a very clear outline strategy, which we actually really talked about five years ago, that we were going to enter a monotherapy in the relapsed refractory second and very rapidly moved down the lines with into frontline, both in follicular lymphoma and these studies to read out. And so that was the development plan.

是的。謝謝你的提問。也許我開始闡述的方式是遵循非常清晰的概要策略的監管策略，我們實際上在五年前就討論過這個策略，我們將在復發難治性第二階段進入單一療法，然後非常迅速地進入一線治療，無論是在濾泡性淋巴瘤還是這些研究中。這就是開發計劃。

Once we had the development plan, we would then focus on complementary data that would drive or inform how physicians can use the drug in different settings in combination with ADCs is a very interesting one in that regard in that place.

一旦我們有了開發計劃，我們就會專注於補充數據，這些數據將推動或告知醫生如何在不同環境下與 ADC 結合使用該藥物，在這方面這是一個非常有趣的例子。

Jan already mentioned that there's a lot of data generation up to a little bit more than 30 abstracts are being submitted to ASH. There's actually an IST that's going to open up in commission with Lonca, which is I think where you're heading towards to. There are other ADCs that are coming [mark us one] on where there are discussions ongoing.

Jan 已經提到，有大量資料生成，多達 30 篇摘要提交給 ASH。實際上，有一個 IST 即將與 Lonca 合作開放，我認為這就是您要去的地方。還有其他 ADC 即將到來 [標記我們一個]，目前正在進行討論。

And so I think ADCs very well will have a role in diffuse success as well if they are able to improve the outcomes. I do think that with increasing data, what is our ambition? What is also becoming a reality is that bispecific in particular, EPKINLY are going to become a backbone of these novel combinations in the future.

因此，我認為如果 ADC 能夠改善結果，那麼它們也將在擴散成功中發揮重要作用。我確實認為，隨著數據的增加，我們的目標是什麼？同樣正在成為現實的是，特別是雙特異性抗體，EPKINLY 將成為未來這些新型組合的支柱。

Thanks, Tahi. Especially combinability seems to be really, really good with epcoritamab. We can combine it with literally all different -- all types of different agents, Matthew. And I think that may be a big advantage of the bispecific format like the one we use for epcoritamab. Judith, you want to add anything more to the acasunlimab FX dosing question.

謝謝，Tahi。尤其是與 epcoritamab 的結合性似乎真的非常好。我們可以將它與所有不同類型的代理結合起來，馬修。我認為這可能是雙特異性形式的一大優勢，就像我們用於 epcoritamab 的形式一樣。朱迪思，您還想對 acasunlimab FX 劑量問題補充什麼嗎？

No, thank you. As you said, we explore every six weeks because it shows the best in terms of efficacy and safety.

不，謝謝。正如您所說，我們每六週進行一次探索，因為這樣在功效和安全性方面表現最佳。

Thanks, Judith. I think that's it. Matthew, thank you very much for the questions.

謝謝，朱迪思。我想就是這樣了。馬修，非常感謝您的提問。

Qize Ding, Redburn Atlantic.

丁啟澤，Redburn Atlantic 公司。

Oh, hi. Thanks for taking my question. I just have one follow-up question on the Rina-S in non-small-lung cancer. Is the Phase 2 trial going to test Rina-S patients in the first line or second line setting of the non-small cell lung cancer or all come. And just a quick follow-up. Is the arena as going to be taxed as a monotherapy or in combination with other checkpoint inhibitor. Thank you.

噢，你好。感謝您回答我的問題。我只有一個關於 Rina-S 在非小細胞肺癌治療中的後續問題。階段 2 試驗是否會測試 Rina-S 在非小細胞肺癌第一線或二線治療的患者，還是所有患者都參與？這只是一次快速的跟進。該領域是否會作為單一療法或與其他檢查點抑制劑聯合徵稅。謝謝。

Thank you for the question. Tahi, can you address this one?

謝謝你的提問。Tahi，你能解決這個問題嗎？

Yes. I will try to address it, although I do think we are now entering into spaces where we have to be careful because it's a competitive finance we may not necessarily want to show our hands as we are moving into this field. This study, as I mentioned, is intended to give us the optionality to interrogate Rina-S both in monotherapy and as well as in combination.

是的。我會盡力解決這個問題，但我確實認為我們現在進入了一個必須小心謹慎的領域，因為這是一個競爭激烈的金融領域，我們在進入這個領域時可能不一定想亮出自己的底牌。正如我所提到的，這項研究旨在讓我們能夠選擇在單一療法和聯合療法中對 Rina-S 進行研究。

And if you look a little bit on how our philosophy is in drug development as it played out in EPKINLY or in Rina-S, in ovarian and endometrial, then I think you can get an idea of how study is going to be set up without going into the details of what combinations we're going to test in which line of therapy. But clearly, it is going to interrogate more in combination therapy.

如果您稍微了解一下我們在藥物開發中的理念，就像它在 EPKINLY 或 Rina-S、卵巢和子宮內膜中發揮作用一樣，那麼我想您就可以了解如何進行研究，而無需了解我們將在哪種療法中測試哪些組合的細節。但顯然，它將在聯合治療方面進行更多的探討。

Thanks, Tahi. Very clear. So this was the last question, operator?

謝謝，Tahi。非常清楚。那麼這是最後一個問題嗎，接線生？

Yes. This is the last question showing. So I hand back to you for closing remarks.

是的。這是顯示的最後一個問題。因此，我把話題交還給你們，請你們做最後的總結發言。

So thank you for calling in today. If you have additional questions, please reach out to our Investor Relations team, and we very much look forward to speaking with you again soon.

非常感謝您今天的來電。如果您還有其他問題，請聯絡我們的投資者關係團隊，我們非常期待很快再次與您交談。

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

今天的電話會議到此結束。感謝大家的參與。現在您可以斷開線路了。謝謝。