Genmab A/S (GMAB) 2025 Q3 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. During this telephone conference, you may be presented with forward-looking statements that include words such as beliefs, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects.

大家好，歡迎參加 Genmab 2025 年上半年財務業績電話會議。再次提醒，本次電話會議正在錄音。在本次電話會議期間，您可能會看到一些前瞻性陳述，其中包含諸如“信念”、“預期”、“計劃”或“期望”之類的詞語。實際結果可能與預期有重大差異，例如，由於開發案延期或失敗等原因。

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

Genmab 沒有義務更新有關未來的聲明，也沒有義務確認與實際結果相關的此類聲明，除非法律要求這樣做。另請注意，Genmab 可能會根據您在投資者關係拓展活動中提供的資訊保留您的個人數據，以便向您提供 Genmab 的最新動態。請造訪我們的網站以了解更多關於Genmab及其隱私權政策的資訊。

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

現在，我想把會議交給今天的第一位發言人，Jan van de Winkel。請繼續。

Hello and welcome to our financial results call for the first 9 months of 2025. With me today is our Chief Financial Officer, Anthony Pagano, our Chief Commercial Officer, Brad Bailey, and the Chief Medical Officer, Dr. Judith Kaur. For the Q&A, we will be joined by our Chief Development Officer, Juri Klimovsky.

大家好，歡迎參加我們2025年前9個月的財務業績電話會議。今天陪同我的有財務長安東尼·帕加諾、首席商務官布拉德·貝利和首席醫療官朱迪思·考爾博士。在問答環節，我們將邀請首席發展長 Juri Klimovsky 出席。

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

如前所述，我們將發表一些前瞻性聲明，請注意這一點。在今天的演講中，我們將提及一些我們正在進行策略合作開發的產品，這張投影片正是對這些合作關係的認可。

As we near the end of 2025, I would like to remind you of the commitments that we made at the beginning of the year. We said that we would accelerate the development of a 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. I'm pleased to say that we are following through on these commitments, supporting our continued growth.

2025 年即將結束，我想提醒大家我們在年初所做的承諾。我們曾表示，我們將加快開發具有重大影響的後期研發管線，我們將最大限度地發揮已商業化藥物的潛力，並且我們將實現我們的資本配置優先事項。我很高興地告訴大家，我們正在履行這些承諾，這將有助於我們持續發展。

Over the past 9 months, our total revenue grew by 21%, fueled by increased recurring revenue, and we have invested fully aligned with the capital allocation priorities. Importantly, we have grown operating profit by 52%, even while making these strategic investments. We ended the first 9 months with around $3.4 billion in cash.

過去 9 個月，在經常性收入增加的推動下，我們的總收入增加了 21%，我們的投資完全符合資本配置優先事項。重要的是，即使在進行這些策略性投資的同時，我們的營業利潤也成長了 52%。在前9個月結束時，我們擁有約34億美元的現金。

Our strong financial foundation has given us the flexibility for continued growth and expansion through investment in high-impact late-stage programs. Epcoritamab and Renoir have both progressed rapidly over the course of this year with extremely encouraging data.

我們雄厚的財務基礎使我們能夠靈活地透過投資高影響力後期專案來實現持續成長和擴張。今年以來，Epcoritamab 和 Renoir 都取得了快速進展，並獲得了非常令人鼓舞的數據。

And for Renoir, we have initiated additional Phase 3 clinical trials. As part of our disciplined investment into the highest potential programs, together with BioNTech, we have agreed that the current data in frontline head and neck cancer for GEN1042 did not meet our high bar for continued development.

對於雷諾阿，我們已經啟動了額外的 3 期臨床試驗。作為我們對最具潛力項目進行嚴謹投資的一部分，我們與 BioNTech 一致認為，GEN1042 目前在頭頸癌一線治療方面的數據尚未達到我們繼續開發的高標準。

As part of our capital allocation priorities was our promise to explore focused M&A opportunities. We have delivered on this commitment with a potentially transformative proposed acquisition of Mediar Therapeutics.

作為我們資本配置優先事項的一部分，我們承諾探索有針對性的併購機會。我們已履行了這項承諾，提出了一項可能具有變革意義的對 Mediar Therapeutics 的收購方案。

So let's briefly review the highlights; The proposed acquisition of Mediar is an exceptional opportunity that advances our evolution into a global biotech leader.

那麼讓我們簡要回顧一下重點；擬議收購 Mediar 是一個絕佳的機會，它將推動我們發展成為全球生物技術領導者。

It accelerates our shift towards a 100% owned model, expands and diversifies our revenue, and brings us closer to achieving our 2030 vision to improve the lives of patients.

它加速了我們向 100% 自有模式的轉變，擴大並多元化了我們的收入，使我們更接近實現 2030 年改善患者生活的願景。

It is proposed to receive epcoritamab into our already compelling portfolio. High-potential assets like epcoritamab, which has received two breakthrough therapy designations, are truly rare. The totality of data we have seen for epcoritamab underscores its potential as a best-in-class bispecific across head and neck cancer indications, as well as in other EGFR-expressing tumors. And with data anticipated in 2026 from one or both of the ongoing Phase 3 trials, we expect data will also be first-in-class, with an initial launch expected in 2027.

建議將epcoritamab納入我們已有的極具競爭力的產品組合中。像 epcoritamab 這樣具有高潛力的資產（已獲得兩種突破性療法認定）實屬罕見。我們所看到的所有關於 epcoritamab 的數據都凸顯了其作為頭頸癌適應症以及其他 EGFR 表達腫瘤中一流雙特異性抗體的潛力。預計在 2026 年，正在進行的 3 期臨床試驗中的一項或兩項將公佈數據，我們預計這些數據也將是同類首創，並預計在 2027 年首次推出。

We are confident that our expertise and leadership in antibody-based innovation, as well as our swift and broad clinical development of both epcoritamab and Renoir, demonstrate our ability to fully realize epcoritamab's potential.

我們相信，憑藉我們在抗體創新方面的專業知識和領導地位，以及我們對 epcoritamab 和 Renoir 的迅速而廣泛的臨床開發，我們有能力充分發揮 epcoritamab 的潛力。

We also see real promise for it to join epcoritamab and Renoir as multi-billion-dollar programs. We expect to close the acquisition by early in the first quarter of 2026, subject to the satisfaction of customary closing conditions.

我們也看到它很有可能像 epcoritamab 和 Renoir 一樣，成為數十億美元的項目。我們預計 2026 年第一季初完成此收購，但需滿足慣例成交條件。

Combined with disciplined capital allocation, strong financial foundation, and proven commercial execution, this transaction sets us up for durable long-term growth into the next decades.

結合嚴格的資本配置、雄厚的財務基礎和成熟的商業執行力，這項交易將為我們未來幾十年的可持續長期成長奠定基礎。

Now, let's go to some of the recent advancements for late-stage programs, beginning with epcoritamab. We eagerly await the potential approval in second-line follicular lymphoma later this month. In addition to the unprecedented Phase 2 second-line follicular lymphoma data we discussed during our second-quarter call, recently, we announced updated results for epcoritamab in the outpatient setting.

現在，讓我們來看看後期專案的一些最新進展，首先是epcoritamab。我們熱切期待本月稍後該藥物在二線治療濾泡性淋巴瘤方面獲得批准。除了我們在第二季度電話會議上討論的前所未有的 2 期二線濾泡性淋巴瘤數據外，最近，我們還公佈了 epcoritamab 在門診治療中的最新結果。

This data evaluated the feasibility of treating and monitoring patients with relapsed or refractory diffuse large B-cell lymphoma in this setting. Data from both the Phase 3 second-line and outpatient studies are included in more than 20 ASH abstracts that have been accepted for presentation at this year's meeting.

此數據評估了在此情況下治療和監測復發或難治性瀰漫性大B細胞淋巴瘤患者的可行性。來自 3 期二線研究和門診研究的數據包含在 20 多篇已被接受在今年會議上發表的 ASH 摘要中。

Excitingly, the second-line follicular lymphoma data will be one of seven oral presentations for epcoritamab at ASH. These abstracts highlight advances that expand epcoritamab's clinical profile, supporting use in earlier lines of therapy and across additional B-cell malignancies.

令人興奮的是，二線濾泡性淋巴瘤數據將是 epcoritamab 在 ASH 大會上進行的七項口頭報告之一。這些摘要重點介紹了擴大 epcoritamab 臨床應用範圍的進展，支持在早期治療方案和更多 B 細胞惡性腫瘤中使用。

So now let's turn to Renoir. Last month at ESMO, we presented an update of the data for single-agent Renoir in patients with advanced endometrial cancer.

現在讓我們來看看雷諾瓦。上個月在 ESMO 會議上，我們發表了單藥 Renoir 治療晚期子宮內膜癌患者的最新數據。

Today, Judith will provide a brief overview of this data, which further supports the encouraging results that we showed at ASCO.

今天，Judith 將簡要概述這些數據，這些數據進一步支持了我們在 ASCO 上展示的令人鼓舞的結果。

This progress reflects our vision to accelerate our innovative late-stage pipeline and shows additional momentum behind the possibilities of Renoir.

這項進展反映了我們加速推動創新後期研發管線的願景，也展現了 Renoir 計畫未來發展潛力的進一步成長動能。

Our confidence in the potential of Renoir in endometrial cancer is reinforced by the breakthrough therapy designation granted by the US FDA.

美國FDA授予Renoir突破性療法認定，這更加堅定了我們對Renoir在子宮內膜癌治療中潛力的信心。

As a reminder, this indicates that the FDA considers us to have the potential to significantly improve patient outcomes compared with existing therapies.

再次提醒，這表明 FDA 認為我們有可能比現有療法顯著改善患者的治療效果。

The data we have seen and the recognition from the FDA both support our development plans for Renoir, and I am pleased to tell you that we have initiated the Phase 3 trial in endometrial cancer. So our rapid development of Renoir continues. We are also preparing for potential commercialization.

我們看到的數據以及 FDA 的認可都支持我們對 Renoir 的開發計劃，我很高興地告訴大家，我們已經啟動了子宮內膜癌的 3 期試驗。因此，我們對雷諾瓦的快速開發仍在繼續。我們也在為可能的商業化做準備。

Tivdak is now available for prescribing in Germany, our first European market, and the foundation that we are building in the European oncology community with Tivdak will set us up for future success with Renoir.

Tivdak 現已在我們的第一個歐洲市場德國上市，我們憑藉 Tivdak 在歐洲腫瘤學界建立的基礎，將為我們未來在 Renoir 方面取得成功奠定基礎。

Now over to Tahi and the updated Rina-S data from ESMO.

現在讓我們來看看 Tahi 和 ESMO 提供的最新 Rina-S 數據。

Thank you Jan. At ASCO, we presented the first results for single-agent Renoir in patients with advanced endometrial cancer from the ongoing Phase 1/2 RAINBOW-1 study. And at ESMO, just a few weeks ago, we provided an update on that data with four additional months of follow-up.

謝謝 Jan。在 ASCO 會議上，我們發表了正在進行的 1/2 期 RAINBOW-1 研究中，單藥 Renoir 治療晚期子宮內膜癌患者的首批結果。就在幾週前的 ESMO 會議上，我們提供了該數據的最新信息，並增加了四個月的隨訪數據。

What we saw was that, at a median follow-up of around a year, Renoir at 100 mg per meter squared showed deep and durable responses regardless of FOLRα expression.

我們發現，在大約一年的中位數追蹤期內，每平方公尺 100 毫克的 Renoir 顯示出深度和持久的反應，而與 FOLRα 表達無關。

Disease control rate at that dose continued to be at 100%, and ORR remained at 50%, including two complete responders, and with 7 out of the 11 confirmed responses still ongoing at the data cutoff. This compares to the standard of chemotherapy, which delivers approximately 15% ORR and limited durability, roughly around six months.

該劑量下的疾病控制率持續維持在 100%，客觀緩解率維持在 50%，其中包括 2 例完全緩解，在數據截止時，11 例已確認的緩解中有 7 例仍在持續。相較之下，標準的化療的客觀緩解率約為 15%，療效持續時間有限，大約只有六個月。

In addition to the durable efficacy, Renoir continues to have a manageable safety profile. There are still no signals of ocular toxicity, interstitial lung disease, or neuropathy across the entire program.

除了持久的療效外，雷諾瓦還具有良好的安全性。整個計畫中仍未出現眼部毒性、間質性肺病或神經病變的跡象。

So in summary, the data we have seen for Renoir, both in endometrial cancer and the data we've presented on lung, reinforce our conviction that Renoir is best-in-class ADC. It combines efficacy, safety, and durability across the entire spectrum of FOLRα expression.

綜上所述，我們看到的 Renoir 在子宮內膜癌方面的數據以及我們提出的肺癌數據都強化了我們的信念，即 Renoir 是同類最佳的 ADC。它兼具功效、安全性和持久性，涵蓋了 FOLRα 表現的整個範圍。

And we are maximizing its potential with an accelerated and extremely comprehensive development plan that now includes three ongoing Phase 3s, if you follow today's disclosure on clinicaltrials.gov, and two Phase 3s intended for potential registration on the accelerated approval pathway in the United States one in platinum-resistant ovarian cancer and one in second-line endometrial cancer. Separately, we are also generating data beyond ovarian cancer with a signal-seeking Phase 2 trial in non-small cell lung cancer.

我們正在透過一項加速且極其全面的開發計劃最大限度地發揮其潛力，該計劃目前包括三個正在進行的 3 期臨床試驗（如果您關註今天在 clinicaltrials.gov 上的披露），以及兩個旨在通過加速審批途徑在美國註冊的 3 期臨床試驗，一個用於治療鉑耐藥性卵巢癌，另一個用於治療二線子宮內膜癌。此外，我們也在非小細胞肺癌領域進行訊號探索性第 2 期試驗，以產生卵巢癌以外的數據。

And now over to Brad for a review of the recent commercial performance for EPKINLY and Tivdak.

現在請 Brad 為大家回顧 EPKINLY 和 Tivdak 最近的商業表現。

Yes. Thank you, Tahi. Q3 marked another strong quarter for our proprietary portfolio. Our commercialized medicines are contributing positively to our overall revenue growth, driven by the strong performance in our established markets as well as now the early success in new markets. This gives us further confidence in our growth potential as we advance our portfolio and prepare to bring our medicines to even more patients around the world.

是的。謝謝你，塔希。第三季度，我們的自有投資組合再次表現強勁。我們已上市的藥品對我們的整體收入成長做出了積極貢獻，這得益於我們在成熟市場的強勁表現以及目前在新市場的初步成功。這讓我們對自身的成長潛力更有信心，因為我們正在推進產品組合，並準備將我們的藥品帶給世界各地更多的患者。

Take a closer look now at performance overall.

現在讓我們更仔細地看一下整體性能。

EPKINLY Tivdak sales through the third quarter of 2025 were up 54% year-over-year. This accounted for 25% of our total revenue growth. And as we've said before, we expect our proprietary portfolio to increasingly contribute to our overall revenue growth over time. During the quarter, we continue to scale our operations across markets in a disciplined fashion, accelerate the adoption of our medicines and meet patients' needs. And as you just heard from Jan, the proposed (inaudible) transaction provides us with the unique potential to double down on our shift to a 100% owned model and maximize our long-term growth.

截至 2025 年第三季度，EPKINLY Tivdak 的銷售額年增 54%。這占我們總收入成長的 25%。正如我們之前所說，我們預計隨著時間的推移，我們的專有產品組合將對我們的整體收入成長做出越來越大的貢獻。本季度，我們將繼續以嚴謹的方式擴大在各市場的營運規模，加速藥品的推廣應用，滿足患者的需求。正如 Jan 剛才所說，擬議的（聽不清楚）交易為我們提供了獨特的潛力，可以加倍努力實現向 100% 所有權模式的轉變，並最大限度地提高我們的長期增長。

With pembro, Rina-S, acasunlimab and potentially petosemtamab, we have the pieces in place to deliver several multibillion-dollar opportunities in the coming years.

憑藉帕博利珠單抗、Rina-S、acasunlimab 以及可能還有 petosemtamab，我們已經具備了在未來幾年內創造多個數十億美元商機的條件。

Let's turn now to our EPKINLY's performance. EPKINLY posted $333 million through Q3, which represents a 64% year-over-year increase. We're highly encouraged by EPKINLY performance and steady growth globally as the clear leader in the third-line setting across diffuse large B-cell lymphoma and follicular lymphoma. In the U.S., performance continues to demonstrate the value of EPKINLY as the only dual indication option in DLBCL and FL. We're seeing increases in adoption across sites of care and new patient starts.

現在讓我們來看看EPKINLY的表現。EPKINLY 第三季營收達 3.33 億美元，年增 64%。EPKINLY 在全球表現出色，穩定成長，在瀰漫性大 B 細胞淋巴瘤和濾泡性淋巴瘤的三線治療領域處於領先地位，這令我們倍感鼓舞。在美國，EPKINLY 的療效持續證明其價值，因為它是唯一一種同時適用於 DLBCL 和 FL 的雙重適應症選擇。我們看到各個醫療機構的採用率和新患者的就診量都在增加。

Reinforcing both the clinical and operational differentiation that EPKINLY brings to the market dedications further growing utilization within order and accounts and expanding more broadly into the community setting.

EPKINLY 為市場帶來了臨床和營運方面的差異化優勢，進一步增強了其在訂單和帳戶中的應用，並更廣泛地擴展到社區環境。

As we prepare to enter earlier lines of therapy with the anticipated launch in second-line FL later this year, we'll build on this positive momentum to bring up EPKINLY to even more patients. Now looking in Japan, we're seeing an encouraging start at EPKINLY's launch in third line plus follicular lymphoma. Our teams are building on the traction we've seen in large B-cell lymphoma and continue to drive account activation while also preparing for future potential launches. To that end, today, we filed a supplemental JNDA for EPKINLY in second-line FL. Marking another important milestone to potentially bring up EPKINLY to earlier lines of therapy in this priority market.

隨著我們準備進入更早的治療階段，預計今年稍後將在二線 FL 中推出，我們將利用這一積極勢頭，將 EPKINLY 帶給更多患者。現在來看看日本，EPKINLY 在三線及以上濾泡性淋巴瘤治療中的上市取得了令人鼓舞的開端。我們的團隊正在鞏固我們在大B細胞淋巴瘤領域取得的進展，並繼續推動帳戶激活，同時也在為未來潛在的產品發布做準備。為此，今天我們提交了 EPKINLY 在佛羅裡達州二線治療的補充 JNDA。這標誌著EPKINLY預計在這個重點市場中進入更早期的治療階段，又邁出了重要的一步。

Across all other markets through our partner, AbbVie, we saw solid sales EPKINLY in the quarter as an increasing number of countries gain access to reimbursement and so rapid uptake.

在其他所有市場，透過我們的合作夥伴艾伯維，我們看到本季 EPKINLY 的銷售額穩步增長，因為越來越多的國家獲得了報銷資格，因此市場迅速接受。

Globally, EPKINLY has received the most regulatory approvals for a bispecific in DLBCL and FL with approvals in more than 65 countries worldwide, including more than 50 countries now with the dual indication. As we look ahead to the remainder of the year and into 2026, we're focused on increasing utilization across sites of care and deliver epti patients in earlier disease settings where we may have the opportunity to transform outcomes. With its strong performance to date and accelerating development program, we're confident in EPKINLY's growth potential to reach peak sales of more than $3 billion in the future.

在全球範圍內，EPKINLY 已獲得針對 DLBCL 和 FL 的雙特異性抗體最多的監管批准，在全球 65 多個國家/地區獲得批准，其中 50 多個國家/地區目前已批准其雙重適應症。展望今年剩餘時間以及 2026 年，我們將專注於提高各個護理場所的利用率，並在疾病早期階段為 epti 患者提供服務，以便我們有機會改變治療結果。憑藉迄今為止的強勁表現和加速發展計劃，我們對EPKINLY的成長潛力充滿信心，相信其未來銷售額高峰將超過30億美元。

Now let's look at TIVDAK. TIVDAK is well recognized as the global standard of care in recurrent or metastatic cervical cancer. Our year-to-date sales for TIVDAK totaled $120 million with performance in both new and established markets highlighting the clear need for women with advanced solvable cancer across geographies. In the U.S., we continue to see strong, stable performance across sites of care. And in Japan, we saw continued early launch success, further reinforcing the patient need the strength of our launch strategy and impactful execution by our field teams.

現在我們來看看TIVDAK。TIVDAK 被公認為復發性或轉移性子宮頸癌的全球標準治療方案。今年迄今為止，TIVDAK 的銷售額總計達 1.2 億美元，在新興市場和成熟市場均取得了顯著業績，凸顯了各地患有晚期可治愈癌症的女性對該產品有明確的需求。在美國，我們看到各個醫療機構都持續保持強勁、穩定的表現。在日本，我們看到了早期上市的持續成功，這進一步印證了患者對我們上市策略的重視以及我們現場團隊的有效執行。

Broadening our reach across markets in September, TIVDAK officially launched in Germany. This marks the first medicine we've launched in Europe independently. We've seen encouraging early uptake in Germany, providing positive momentum as we look ahead to expand to additional countries. With our focus on TIVDAK, we've made important progress establishing our operations to support our current and future portfolio in Europe. The strong foundation will ensure we are equipped to broaden our impact with the gynecologic cancer community and deliver our medicines to more patients around the world.

9 月，TIVDAK 正式進軍德國市場，進一步拓展了我們在各個市場的業務。這是我們首次在歐洲獨立推出的藥品。我們在德國已經看到了令人鼓舞的早期市場反響，這為我們未來拓展到其他國家提供了積極的動力。我們專注於 TIVDAK，在建立營運體係以支援我們在歐洲的現有和未來業務方面取得了重要進展。堅實的基礎將確保我們有能力擴大在婦科癌症領域的影響力，並將我們的藥物帶給世界各地更多的患者。

The work we've done to transform our business has positioned us well now for sustained growth and profitability. We remain focused on expanding the utilization of our medicines and bring them to as many patients as possible. The proposed acquisition of Merus and the potential addition of petosemtamab could strengthen the opportunities ahead for our proprietary portfolio of antibody-based medicines. We look forward to closing out the fiscal year with continued strong performance. And with that, I'll hand the call over to Anthony to discuss our financials.

我們為轉型業務所做的工作，使我們現在能夠實現持續成長和獲利。我們將繼續致力於擴大藥品的使用範圍，讓盡可能多的患者都能使用我們的藥品。擬議收購 Merus 以及潛在地加入 petosemtamab，可能會增強我們專有的抗體藥物組合未來的發展機會。我們期待以持續強勁的業績為本財年畫下圓滿的句點。接下來，我將把電話交給安東尼，讓他來討論我們的財務狀況。

Thanks, Brad. We continue to deliver solid revenue growth throughout the first 9 months of 2025, driven by sustained recurring revenues and the solid market performance of our products. We've also strengthened our long-term growth potential as we continue to generate encouraging clinical data for both epritumab and Rina-S. And our financials remain strong. We grew total revenues by 21% with recurring revenue up 26%.

謝謝你，布拉德。在持續的經常性收入和我們產品良好的市場表現的推動下，我們在 2025 年前 9 個月繼續保持穩健的收入成長。隨著我們不斷獲得 epritumab 和 Rina-S 的令人鼓舞的臨床數據，我們也增強了我們的長期成長潛力。我們的財務狀況依然穩健。總收入成長了 21%，經常性收入成長了 26%。

This was driven by royalties from DARZALEX and Kesimpta. And importantly, this growth was also supported by product sales from EPKINLY and TIVDAK, which together represented 25% of our total revenue growth.

這主要得益於DARZALEX和Kesimpta的版稅收入。更重要的是，EPKINLY 和 TIVDAK 的產品銷售也支持了這一成長，這兩家公司合計占我們總收入成長的 25%。

Looking at DARZALEX. We continue to see extremely strong growth. Overall, net sales grew by nearly 22%. That's $10.4 billion for the first 9 months of the year, which translates to over $1.7 billion in royalty revenue for us. This growth was driven by continued share gains and solid performance in the frontline setting.

正在查看DARZALEX。我們持續看到強勁的成長勢頭。總體而言，淨銷售額成長了近 22%。今年前 9 個月的收入為 104 億美元，這意味著我們獲得了超過 17 億美元的特許權使用費收入。這一增長得益於市場份額的持續提升和一線市場的穩健表現。

So you can see that the quality of our revenue profile continues to improve. In fact, in the first 9 months of this year, recurring revenues represented 96% of our revenues, and that's up from 92% in the same period of last year, a clear sign of increasing visibility and durability of our revenues. What's really clear is that the investments we've made in building out our commercialization teams and capabilities are paying off.

由此可見，我們的收入結構品質持續提升。事實上，今年前 9 個月，經常性收入占我們總收入的 96%，高於去年同期的 92%，這清楚地表明我們收入的可見性和可持續性正在不斷提高。顯而易見的是，我們在建立商業化團隊和能力方面所做的投資正在發揮作用。

This sets us up well as we prepare for potential expansion into earlier lines for EPKINLY including second-line FL and the anticipated launch of arenas and contingent on the successful close of the transaction, the launch of (inaudible). And we continue to take a disciplined approach to these investments. Total OpEx in the first 9 months of 2025 was slightly less than $1.5 billion, up over the same period last year, excluding the impact of the Profound Bio acquisition. And we're managing our investments strategically. Prioritizing our high-impact Phase III programs and focused investments in our commercialization capabilities.

這為我們做好準備，以便未來EPKINLY能夠拓展到更早的生產線，包括二線FL以及預期的競技場館的推出。如果交易成功完成，則競技場館的推出也將提上日程。（聽不清楚）我們將繼續採取嚴謹的投資方式。2025 年前 9 個月的總營運支出略低於 15 億美元，比去年同期有所成長，不包括 Profound Bio 收購的影響。我們正在進行策略性投資管理。優先推進高影響力的 III 期項目，並專注於我們的商業化能力。

Our operational discipline contributed to our operating profit growth of an impressive 52% in the first 9 months of the year. So here, you can see that we're really continuing to deliver on our commitments.

今年前 9 個月，我們嚴格的營運紀律使我們的營業利潤實現了令人矚目的 52% 的成長。所以，由此可見，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 $142 million. Then moving on to tax. We have a tax expense of $217 million, which equates to an effective tax rate of 18.9%. Taken together, our net profit amounts to $932 million.

接下來，我們來看看我們的淨財務項目。這樣一來，我們淨賺了 1.42 億美元。接下來談談稅收。我們的稅收支出為 2.17 億美元，相當於實際稅率為 18.9%。合計，我們的淨利潤為 9.32 億美元。

So as you can see, continued strong underlying financial performance. With that, let's move to our 2025 financial guidance. We remain on track to achieve our existing financial guidance with projected double-digit revenue and double-digit profit growth. We 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 it's our recurring revenues from royalty medicines and from EPKINLY and TIVDAK that's been driving that growth in 2025.

如您所見，財務基本面持續強勁。接下來，讓我們來看看2025年的財務預測。我們仍有望實現現有的財務目標，預計營收和利潤將實現兩位數成長。我們預計營收將在 35 億美元至 37 億美元之間，中位數計算可實現 15% 的強勁成長。2025 年，推動我們成長的主要是來自特許權使用費藥品以及 EPKINLY 和 TIVDAK 的經常性收入。

In total for the year, we expect our recurring revenues to grow by 22%. For operating expenses, 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 all this together, we're planning for operating profit in a range between around $1.1 billion to $1.4 billion, with the midpoint of our guidance amounting to over $1.2 billion of operating profit and strong year-over-year growth of 26%. Our guidance highlights our continued strategic discipline, targeted investments and operational efficiency, all while advancing our pipeline and enhancing shareholder value. Now to give you just a bit more color on FX, every 10-point move in the exchange rate relative to our guidance rate of the U.S.

我們預計全年經常性收入將成長 22%。營運費用方面，由於我們持續採取專注且嚴謹的投資方式，我們預計仍將在 21 億美元至 22 億美元之間。綜合以上因素，我們預計營業利潤將在 11 億美元至 14 億美元之間，其中值超過 12 億美元，年增 26%。我們的指導方針強調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並提高股東價值。現在，為了讓您對外匯市場有更深入的了解，匯率相對於我們設定的美國指導匯率每變動 10 個點，就會產生以下影響：

dollar to the Danish kroner of 7.20 is worth just around $1 million in operating profit or loss at the midpoint. Now finally, before I conclude, I would like to take a minute to look ahead to 2026.

美元兌丹麥克朗匯率為 7.20，以中間價計算，相當於約 100 萬美元的營業利潤或虧損。最後，在結束之前，我想花一分鐘時間展望一下 2026 年。

While, of course, our guidance will be given in February next year, as I stand here today, 2026 consensus expectation for Genmab stand-alone investments appear to be in a reasonable place, capturing our investment priorities. And as I take a look at consensus expectations for Merus investments, they also appear to be in a reasonable place. Importantly, we remain confident that Genmab will deliver significant profitability in 2026 and meaningful EBITDA growth in 2027. Our performance in the first 9 months of 2025 underscores our ability to produce solid high-quality revenue growth. advanced key pipeline assets, deliver on our capital allocation commitments with the proposed acquisition of Merus and maintain strong profitability through disciplined execution.

當然，我們的指導方針將在明年二月公佈，但就目前而言，Genmab 2026 年獨立投資的普遍預期似乎處於合理水平，符合我們的投資重​​點。當我查看市場對 Merus 投資的普遍預期時，發現它們也處於合理的水平。重要的是，我們仍然相信 Genmab 將在 2026 年實現顯著盈利，並在 2027 年實現有意義的 EBITDA 成長。我們在 2025 年前 9 個月的業績凸顯了我們實現穩健、高品質收入成長的能力，推進了關鍵管道資產的開發，透過擬議收購 Merus 履行了我們的資本配置承諾，並透過嚴謹的執行保持了強勁的盈利能力。

So in summary, our very strong financial foundation, sustained profitability and disciplined capital allocation strategy positions Genmab for growth, creating value for both shareholders and for patients. And on that note, I'm going to hand the call back over to Jan.

總而言之，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使 Genmab 能夠實現成長，為股東和患者創造價值。說到這裡，我要把電話交還給 Jan。

Thank you, Anthony. Let's move on to our final slide. We have strengthened the foundations of our business in the first 9 months of 2025. We have expanded the reach of both up EPKINLY and TIVDAK to more patients. For Rina-S, we have presented additional support of clinical data showing its potential beyond ovarian cancer, and we are prepared to accelerate and maximize the potential with additional Phase III clinical trials.

謝謝你，安東尼。我們來看最後一張投影片。在 2025 年的前 9 個月裡，我們鞏固了業務的基礎。我們已將 EPKINLY 和 TIVDAK 的適用範圍擴大到更多患者。對於 Rina-S，我們提供了更多臨床數據支持，證明其在卵巢癌以外的治療潛力，我們準備透過更多 III 期臨床試驗來加速和最大限度地發揮其潛力。

And we continue to anticipate further acasunlimab data this year, and they will be presented at ESMO I-O in December in London.

我們繼續期待今年能獲得更多 acasunlimab 數據，這些數據將於 12 月在倫敦舉行的 ESMO I-O 會議上公佈。

Beyond our commitments, to our existing pipeline priorities, we further delivered on our capital allocation strategy with the proposed acquisition of Merus. An extraordinary opportunity that will advance our evolution into a global biotech leader and position us for sustainable long-term growth and value creation. Before we move to the Q&A, I'm pleased to announce that we will hold our annual R&D updates and a data review, on December 11 and to ensure that this event is accessible to as many people as possible, this year's presentation will once again be fully virtual Details will be available on our website, and we look forward to a lively event. That ends our formal presentation. Thank you for listening.

除了我們對現有專案優先事項的承諾之外，我們還透過擬議收購 Merus 進一步實現了我們的資本配置策略。這是一個絕佳的機會，它將推動我們發展成為全球生物技術領域的領導者，並為可持續的長期成長和價值創造奠定基礎。在進入問答環節之前，我很高興地宣布，我們將於12月11日舉行年度研發進度報告和資料回顧會議。為了確保盡可能多的人能夠參與這項活動，今年的匯報會議將再次完全以線上形式進行。詳情請訪問我們的網站，我們期待著一場精彩的活動。我們的正式報告到此結束。謝謝聆聽。

Operator, please open the call for questions.

接線員，請開啟提問環節。

(Operator Instructions)

（操作說明）

Jonathan Chang, Leerink.

Jonathan Chang，Leerink。

Hi guys, thanks for taking my question.

大家好，感謝你們回答我的問題。

Now coming out of ESMO, there's been a lot of discussion around the competitive landscape of Peto and Rina-S. What are your latest thoughts on how these drugs are positioned in the competitive landscape. And what gives you confidence in the potential for these 2 programs to be key drivers of growth. Thank you.

ESMO 結束後，圍繞著 Peto 和 Rina-S 的競爭格局展開了許多討論。您對這些藥物在競爭格局中的定位有何最新看法？您為何對這兩個項目有信心成為成長的關鍵驅動力？謝謝。

Thanks, Jonathan. Very good question. So let me ask Tahi to start off, giving you our thinking on the positioning of Peto as the best and first-in-class molecule and the same for Rina-S, and I'm sure that Judith will then also add to that. Tahi, why don't you get going?

謝謝你，喬納森。問得好。那麼，就請 Tahi 先發言，談談我們對 Peto 定位為最佳和同類首創分子的看法，Rina-S 也是如此，我相信 Judith 也會補充說明。塔希，你為什麼不走？

Thank you, Jonathan, for the question. And so let me start this. There was really nothing that in any shape or form was surprised us. Our conviction in Peto and Rina-S being the best and first-in-class asset in the respective indications of head and neck and (inaudible) has not changed. Peto, if you look at totality of data, Jan said this in the prepared remarks in our mind, has all the attributes of the best-in-class second-generation EGFR bispecific.

謝謝你的提問，喬納森。那麼，就讓我開始吧。沒有任何事情以任何形式讓我們感到驚訝。我們對 Peto 和 Rina-S 是頭頸部和（聽不清楚）各自適應症中最佳和一流資產的信念沒有改變。Peto，如果你看一下所有數據，正如 Jan 在準備好的演講稿中所說，在我們看來，它具備一流第二代 EGFR 雙特異性抗體的所有屬性。

They are to Phase IIIs already ongoing in head neck and second line, the Monotype has and in combination with pembro in frontline, where it has BTD.So it's also on track to be the first in class, nothing really changed on that. As it relates to Rina, there's, of course, a couple of fully receptor alpha ADCs in development by AZ and (inaudible), again. This is not news. We are, generally speaking, operating in a very competitive landscape.

它們已經進入第三階段，目前正處於頭部、頸部和二線階段。 Monotype 已經與 Pembro 合作，在一線階段使用 BTD 技術。因此，它也有望成為同類產品中的佼佼者，這一點並沒有改變。至於 Rina，當然，AZ 和（聽不清楚）又在開發幾種完全受體 α 抗體藥物偶聯物。這並非新聞。總的來說，我們身處在一個競爭非常激烈的環境中。

None of the data in any way, shape or form are changing our assumption that Rina-S based on the data in Pro and endometrial both in response and long-term follow-up and durability and long-term safety has the profile to be best-in-class. I mentioned this in my comments, there are now 2 Phase IIs that are ongoing for some time. And we expect to launch at least one of these indications '27 and 3 Phase IIIs that are actively involving. So I think we have a good position here also to be the first class (inaudible) space, and we're expanding already into other indications. So in totality, we feel very comfortable about the profile of the assets.

沒有任何數據以任何方式、形式或途徑改變我們的假設，即基於Pro和子宮內膜數據，Rina-S在反應、長期追蹤、持久性和長期安全性方面都具有同類最佳的潛力。我在評論中提到過，目前有兩個第二階段項目正在進行一段時間了。我們預計至少會推出其中一項適應症“27”，並且目前正在積極進行 3 項 III 期臨床試驗。所以我認為我們在這裡也處於有利地位，可以成為一流（聽不清楚）的空間，而且我們已經在擴展到其他適應症領域。綜上所述，我們對這些資產的狀況感到非常滿意。

We feel extremely comfortable over where we are positioned in the competitive landscape, and we feel very confident in our ability to accelerate the development of petro once we are having control of this asset, hopefully and on VNAND, so there's more to come on both of these assets.

我們對自身在競爭格局中的地位感到非常滿意，並且對一旦掌控該資產（希望如此，也希望能夠掌控 VNAND）後加速石油開發的能力充滿信心，因此這兩個資產都還有更多發展空間。

That's probably all that to say at this point.

目前大概就說這麼多吧。

Thanks, T. Judy, do you want to add anything to Dan?

謝謝，T. Judy，你還有什麼要補充的嗎？

I know, beautifully said. Nothing to add.

我知道，說得真好。沒什麼要補充的。

Thank you. All right, thanks, Jonathan for the question. Let's go to the next question.

謝謝。好的，謝謝喬納森的提問。我們來看下一個問題。

Michael Schmidt, Guggenheim Partners.

麥可‧施密特，古根漢合夥公司。

Hey, thanks for taking my questions and congrats on all the progress. I had a question on EPKINLY I was just wondering if you could comment on the commercial dynamics. I'm just curious in terms of sales, what are you seeing in terms of use in the approved indications between follicular and DLBCL. And then how should we think about the near-term growth opportunity in second line follicular in the U.S. and Japan in your markets?

嘿，謝謝你回答我的問題，也恭喜你取得的所有進展。我有一個關於EPKINLY的問題，想請您談談其商業動態。我只是好奇銷售方面，在已批准的適應症中，濾泡性淋巴瘤和瀰漫性大B細胞淋巴瘤的使用情況有何不同。那麼，我們該如何看待貴公司在美國和日本市場二線卵泡刺激素療法的近期成長機會呢？

What is the magnitude of that near-term growth opportunity? Thanks so much.

近期成長機會的規模有多大？非常感謝。

Thanks, Michael, for the questions. And I think these are perfect questions for Brad to handle. Brad?

謝謝邁克爾提出的問題。我覺得這些問題非常適合由布萊德來回答。布拉德？

Thank you for the question. We actually are extremely encouraged and pleased with our progress to date in the performance. We don't actually split out by indication, and that's actually part of the benefit, and we're hearing from customers and planning around their feedback that the dual indication from an operationalization perspective is extremely beneficial along with the seamless subcu administration. And as we move into the earlier lines of therapy, I see this as a tremendous opportunity to bring treatment close to where patients live and see this as an opportunity, again, moving forward with where we are. So I'm extremely encouraged with our performance to date.

謝謝你的提問。事實上，我們對目前為止的演出進展感到非常鼓舞和滿意。我們其實並沒有依照適應症來劃分，而這其實是優勢之一。我們從客戶那裡了解到，根據他們的回饋，從營運角度來看，雙重適應症以及無縫的子帳戶管理是非常有益的。隨著我們進入早期治療階段，我認為這是一個巨大的機會，可以將治療帶到患者居住地點附近，這也是一個機會，讓我們能夠繼續向前邁進。因此，我對我們迄今為止的表現感到非常鼓舞。

And as we know the value is in earlier lines of therapy, and I look forward to seeing that success in the future as well.

我們知道，治療的價值在於早期治療，我期待未來也能看到這種成功。

Thanks, Brad. Do you want to say a bit about the size of the market in second line of follicular lymphoma.

謝謝你，布拉德。您能否談談濾泡性淋巴瘤二線治療的市場規模？

Yes. The second line follicular lymphoma previously stated, we really feel the value of these medicines are much broader and much greater in the earlier lines, approximately 9,000 patients in second line FL and it's really our first step into this larger opportunity. And so we would expect that this enabling treatment in earlier lines will open up additional opportunities for us in the not-too-distant future as well.

是的。對於二線濾泡性淋巴瘤，正如之前所述，我們確實認為這些藥物的價值在早期治療中更為廣泛和巨大，大約有 9,000 名二線濾泡性淋巴瘤患者，這確實是我們邁向更大機遇的第一步。因此，我們預計，這種在早期治療中取得的突破性進展，將在不久的將來為我們帶來更多機會。

Thanks, Brad. Thanks, Michael, for the question.

謝謝你，布拉德。謝謝你的提問，麥可。

Xian Deng, UBS.

鄧賢，瑞銀。

Hi, thank you very much. Thank you for taking my question. Sorry, if I may just stay on key a bit. I wonder if I could maybe push a little bit more on sort of the near-term performance given I mean in this quarter, we did see kind of a miss EPKINLY. Just wondering if there's anything you would flag in terms of this quarter's performance. And also just wondering for second follicular lymphoma. Just wondering how should we think about the launch trajectory?

您好，非常感謝。感謝您回答我的問題。抱歉，請容許我稍微保持一下音準。我想知道我是否可以稍微強調一下近期業績，因為我的意思是，在本季度，我們確實看到了 EPKINLY 的業績未達預期。想問您對本季的業績有什麼需要特別指出的地方嗎？另外，我還想知道是否有第二原發性濾泡性淋巴瘤。我想知道我們應該如何考慮發射軌跡？

Do you think this is actually going to be a bit more gradual given I don't know, follicular lymphoma. Is that mainly community setting? Or do you think this actually will be a pretty fast uptake? Thank you very much.

你認為考慮到濾泡性淋巴瘤，這種情況實際上會進展得更慢一些嗎？主要是指社區環境嗎？或者你認為這實際上會很快被接受？非常感謝。

Thanks, Xian, for the questions. I'm going to hand them over to Brad. Brad, please comment.

謝謝Xian的提問。我要把它們交給布拉德。布拉德，請發表意見。

Yes. We're actually seeing right now the observed consistent and continued uptake across sites of care in the U.S., and we do see to your latter part of the question that second line allows this acceleration in the community setting where FL patients are actually treated as you stated. And we do see that as a consistent uptake over time as we continue to get operationalization, if you will, bispecifics in the community setting. And as it relates to the performance, we're extremely encouraged by what we're seeing year-to-date with the performance. Both in the U.S. as well as Japan and through our partner AbbVie globally.

是的。我們現在確實看到，美國各地的醫療機構都在持續不斷地接受治療，而且正如您所說，對於您問題的後半部分，我們也看到了第二線治療在社區環境中加速普及，FL 患者正是在那裡接受治療的。而且我們看到，隨著我們在社區環境中不斷實現雙特異性抗體的運作，這種趨勢會隨著時間的推移而持續增長。至於業績方面，我們對今年迄今的業績表現感到非常鼓舞。無論是在美國、日本，或是透過我們的全球合作夥伴艾伯維公司。

And again, feel like as we said all along, the earlier lines of therapy or where the value of kidney will be and the second line FL is really that first step taking us into this next phase. So hopefully, that answers your question.

再次強調，就像我們一直以來所說的那樣，早期治療方案或腎臟的價值所在，以及二線治療方案FL實際上是帶領我們進入下一階段的第一步。希望這能解答你的疑問。

Thanks, Brad. And definitely, Xian, we definitely hope to move forward to frontline and second-line diffuse labs for also very rapidly from here. with readouts hopefully soon of the Phase III trial. So we're very encouraged by EPKINLY and really look forward to a very, very good future there. Let us move to the next question. Let us move to the next, question.

謝謝你，布拉德。當然，西安，我們非常希望能夠迅速推進一線和二線彌散性實驗室的研究，並有望很快獲得第三期臨床試驗的結果。因此，我們對EPKINLY的發展感到非常鼓舞，並真誠地期待在那裡擁有非常美好的未來。讓我們來看下一個問題。讓我們進入下一個問題。

Qize Ding, Rothschild.

丁啟澤，羅斯柴爾德。

Hi, thanks for taking my question. One, if I may. So can you elaborate a little bit more on your decision to terminate the clinical development of 1042 in first-line anti cancer. And also, what is the implication to the future development of this drug in first-line lung cancer and first-line melanoma?

您好，感謝您回答我的問題。第一個問題，如果可以的話。那麼，您能否再詳細解釋一下您終止 1042 作為一線抗癌藥物的臨床開發的決定？此外，這對該藥物未來在肺癌一線治療和黑色素瘤第一線治療的應用有何影響？

Thank you.

謝謝。

Thanks, Qize, for the question. I think I can start there and then maybe Judith can step in there. So what we determined together with our part of Biotech basically the data of 142 in combination with chemo and pembro, and frontline head and neck cancer didn't meet the high bar we set internally internally for continued development. So we stopped the development there. And that's where I want to leave at that.

謝謝Qize的提問。我覺得我可以先從那裡開始，然後也許茱蒂絲可以接手。因此，我們和我們生物技術部門共同確定，142 與化療和帕博利珠單抗聯合用於一線頭頸癌治療的數據，並未達到我們內部為繼續研發設定的高標準。所以我們就停止了那裡的開發。我就說到這裡吧。

Judith, do you want to add anything there?

朱迪思，你還有什麼要補充的嗎？

Yes. No, just to add that this was the most relevant data set and the initial proof of concept. And based on that, we decided to stop the development in combination with pembro and chemo.

是的。不，我只是想補充一點，這是最相關的資料集，也是最初的概念驗證。基於此，我們決定停止將帕博利珠單抗和化療合併用於該療法。

Thanks. Thanks, Qize for the question.

謝謝。謝謝Qize的提問。

Rajan Sharma, Goldman Sachs.

Rajan Sharma，高盛集團。

Hi, thanks for, taking my question. Just wanted to get your thoughts that had the Apine PDUFA in November, there's obviously been a bit more of a focus seemingly on U.S. representation in clinical trials. So I just wanted to get your confidence into that potential approval. And if you could just confirm the efficacy in the ATCO FL1 trial is consistent across both U.S. and non-U.S patients. Thank you.

您好，謝謝您回答我的問題。只是想聽聽您對 11 月 Apine PDUFA 的看法，顯然，臨床試驗中美國代表性的問題似乎得到了更多關注。所以我只是想增強你對這項潛在批准的信心。如果您能確認 ATCO FL1 試驗的療效在美國患者和非美國患者中是否一致，那就太好了。謝謝。

Thanks, Raj, for the question. Tahi, can you get some color on the U.S., non-U.S.

謝謝Raj的提問。Tahi，你能提供一些關於美國和非美國情況的資訊嗎？

Yes. I mean, basically, the way I'm going to respond to that without getting into the minutia of the data is that there's absolutely nothing at this point that would indicate that it will not be approved in the next few weeks or days. in United States.

是的。我的意思是，基本上，我不會深入探討數據的細節，我的回應是，目前沒有任何跡象表明它不會在未來幾週或幾天內獲得批准。在美國。

All right. I think. So we're highly confident, Rajan. So let's wait and see the coming weeks. Thank you.

好的。我認為。所以我們非常有信心，拉詹。所以讓我們拭目以待，看看接下來的幾週會發生什麼。謝謝。

Yaron Werber, TD Securities.

Yaron Werber，TD證券。

Great, thanks so much. Anthony, I got a couple of questions for you more about 2026 and then 27%. So you mentioned for next year, the numbers -- the stand-alone OpEx for Merus and Genmab are reasonable. For Merus, they're sort of in the 450 range in terms of OpEx, let's call it, 450, maybe some you're going to have as high as 500. I think we were imagining there's going to be some synergies as you bring that company in. And I know you're not -- you can't give guidance, but can you give us any -- a little bit of a sense, are we thinking about this correctly?

太好了，非常感謝。安東尼，我還有幾個問題想問你，關於 2026 年和 27% 的情況。所以你提到了明年的數據——Merus 和 Genmab 的獨立營運支出是合理的。對 Merus 來說，他們的營運成本大概在 450 左右，我們姑且稱之為 450，有些可能高達 500。我認為我們當時設想，引入這家公司後會產生一些協同效應。我知道你無法提供指導，但你能給我們一點感覺嗎？我們思考這個問題的方式是否正確？

And then secondly, when you're talking about significant profitability next year, there could be as much as like $430 million change between interest income net to noninterest expense net because of the debt liability. So we're thinking about that correctly because it would impact profitability next year. Thank you.

其次，談到明年的顯著獲利能力時，由於債務負債，淨利息收入與淨非利息支出之間可能會有高達 4.3 億美元的變化。所以，我們這樣想是對的，因為這會影響明年的獲利能力。謝謝。

Thanks, Jan, for the questions. Anthony, I think it's good that you also got a chance to answer some questions here.

謝謝Jan提出的問題。安東尼，我覺得你也有機會在這裡回答一些問題，這很好。

Thanks. So I can really start off by thinking as you all know, I know would appreciate we have a very disciplined and focused approach to our investments we've outlined for the market starting the overall capital allocation framework, a very clear framework of where and how we're going to invest on the one hand and as we do that in the most prioritized and productive manner as possible. That's how we were able to deliver on our 2024 actual financial results and also what our overall guide was for 2025 and where the year-to-date performance is. Moving forward, that same approach in terms of very clear investment priorities remains as well as that approach to being super focused and disciplined. Now to reiterate what I said is I kind of look at overall stand-alone consensus for Genmab, that is in a reasonable place.

謝謝。所以，首先我想說的是，正如大家所知，我知道大家會很欣賞我們對投資採取非常嚴謹和專注的態度，我們已經為市場製定了整體資本配置框架，一個非常清晰的框架，一方面規定了我們將在哪里以及如何投資，另一方面，我們以盡可能優先和高效的方式進行投資。正因如此，我們才能實現 2024 年的實際財務業績，以及我們對 2025 年的整體指導和今年迄今的業績表現。展望未來，我們將繼續秉持同樣的理念，即非常明確的投資重點，以及高度專注和自律。現在重申我剛才說的，我認為 Genmab 的整體獨立共識處於一個合理的水平。

Likewise, for Merus here, I'm looking at the consensus number is in a reasonable place. We also have to appreciate where we are at in the overall process here as it relates to being on track to closing the transaction in early Q1 2026. Today, I thought it was important to provide that market -- the market the commentary similar to it did last year, but I think the overall investments are in a reasonable place. Of course, we will look for opportunities to prioritize, to remain disciplined and ultimately, we'll provide our guidance when we get to February of 2026. Now my comment as it relates to significant profitability, just to be super clear here, I am referring to EBIT.

同樣，對於 Merus 來說，我認為共識數字處於合理範圍內。我們也必須了解我們目前在整個過程中所處的位置，因為這關係到能否在 2026 年第一季初完成交易。今天，我認為有必要對市場進行一番評論——與去年類似的市場評論，但我認為整體投資處於合理水平。當然，我們會尋找機會來確定優先事項，保持自律，最終，到 2026 年 2 月，我們將提供指導。現在，關於獲利能力，我先明確一點，我指的是息稅前利潤（EBIT）。

So I'm referring to our EBIT figure, our operating profit consistent with historical practice, we are guiding on the EBIT line. So overall, if I think you sort of step back, we think about the overall setup here, what you should expect here on is continued investment in line with our capital allocation framework, lots of focus and discipline by the team and continue to deliver on our overall commitments, both operationally and financially.

所以我指的是我們的息稅前利潤（EBIT）數據，我們的營業利潤與歷史慣例一致，我們以息稅前利潤（EBIT）為指導。總的來說，如果我們退後一步，從整體來看，我們應該期待的是，我們將按照資本配置框架繼續投資，團隊將保持高度專注和自律，並繼續履行我們在營運和財務方面的所有承諾。

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

謝謝你，安東尼。我們來看下一個問題。

Asthika Goonewardene, Truist.

Asthika Goonewardene，Truist。

Hey guys, thanks for taking my questions. I want to also say congrats on all the growth that you guys have shown this quarter is impressive. Jan, when the Merus acquisition was announced, you mentioned that head-neck cancer was the main driving factor for that your interest there. And you said you'll talk a little bit more about colorectal when that data is presented. To get at in CRC at the Triple meeting was, I would say, perhaps a little better than what even Bill telegraphed. So how do you view that colorectal opportunity?

各位好，感謝你們回答我的問題。我還要祝賀你們本季取得的所有成長，這令人印象深刻。Jan，在宣布收購 Merus 時，你提到頭頸癌是你對該公司感興趣的主要驅動因素。您說過，等相關數據公佈後，您會再詳細談談大腸癌的問題。我認為，在三方會議上從 CRC 那裡得到的結果，可能比比爾預想的還要好。那麼，您如何看待結直腸手術這個機會？

And then importantly, that as well as a net, do you feel that you need a subcutaneous formulation to be competitive with their emerging competition from Rina. Thanks.

還有一點很重要，除了網之外，你是否覺得你需要皮下製劑才能與 Rina 等新興競爭對手競爭？謝謝。

Thanks very much for the questions. And we said about the fall was primarily determined by head-neck and we want to expand head and neck epcoritamab, as you know, into locally advanced and potentially other settings fairly soon. And we would say that the data, the early data in colorectal cancer is very exciting, but very early data. And we believe that the risk potential in other each of our positive tumors also outside of head and neck, but there's simply no or limited data there. I will ask Tahi to maybe give a bit more color there on our thinking.

非常感謝大家的提問。我們之前說過，跌幅主要取決於頭頸部，正如您所知，我們希望將頭頸部 epcoritamab 的治療範圍擴大到局部晚期，並可能很快擴展到其他領域。我們認為，大腸直腸癌的早期數據非常令人振奮，但畢竟是早期數據。我們認為，在其他部位，除了頭部和頸部以外，其他部位的陽性腫瘤也存在風險，但這方面的數據要么沒有，要么非常有限。我會請塔希再詳細解釋我們的想法。

Yes. Thank you, Ashtika, thank you for always the hard questions. So I try to manage this. I think as Jan said, early data, limited data, encouraging and we should leave it at that until we have control of the asset, and it's really used to speak about the data. But I think that's kind of the top line.

是的。謝謝你，阿什蒂卡，謝謝你總是提出這麼有挑戰性的問題。所以我盡量想辦法解決這個問題。我認為正如 Jan 所說，早期數據、有限的數據令人鼓舞，我們應該就此打住，直到我們控制了資產，而且它實際上只是用來討論數據的。但我認為這算是最重要的一點。

And broadly speaking, I think we even talked about this in the prepared remarks when we announced the acquisition. We do think of Peto as a best-in-class second-generation EGFR spispecific, and that obviously includes also opportunities outside of head and neck.

總的來說，我認為我們在宣布收購時的準備好的發言稿中也談到了這一點。我們認為 Peto 是同類最佳的第二代 EGFR spi 特異性藥物，這顯然也包括頭頸部以外的治療機會。

But the focus is where it is right now. 2 Phase IIIs ongoing in head and neck. And there we have a significant head start over any form of competition. Subcutaneous administration is something that we are very familiar with that we have some deep understanding in prior past. And it's obviously something that we are looking at as part of a life cycle management, but our focus right now is execution on the studies that are already ongoing.

但目前的重點仍然在這裡。2項針對頭頸部的III期臨床試驗正在進行中。這樣一來，我們就比任何形式的競爭都擁有顯著的優勢。皮下注射是我們非常熟悉的一種給藥方式，我們過去在這方面已經有了相當深入的了解。顯然，這是我們在生命週期管理中正在考慮的問題之一，但我們現在的重點是執行已經在進行的研究。

And then we can talk more about what Genmab is going to plan in due time.

然後我們可以進一步討論 Genmab 在適當的時候將要製定的計劃。

Thanks, TahI. So confirming that the subcu development is an integral part of our strategy for Peto, but more to come after the finalization of the transaction. Let's move on to the next question, operator.

謝謝，TahI。因此，可以確定子帳戶開發是我們 Peto 策略的重要組成部分，但交易完成後會有更多消息公佈。接下來我們來看下一個問題，操作員。

Matthew Phipps, William Baird.

馬修·菲普斯，威廉·貝爾德。

Hi, thanks for taking my question. I've had a lot of investor interest recently on the first-line DLBCL trial with EPKINLY reading out next year. I'm wondering if you can give us any sense of where you think that's a first half or second half readout. And then what level of PFS benefit do you think you need to really outcompete the PVR CHP regimen that has gained some traction there. Thanks.

您好，感謝您回答我的問題。最近，許多投資者對第一線 DLBCL 試驗很感興趣，EPKINLY 將於明年公佈結果。我想知道您能否大致判斷一下，您認為這是上半場還是下半場的讀數。那麼，您認為需要達到怎樣的 PFS 獲益水準才能真正超越目前已獲得一定關注度的 PVR CHP 方案？謝謝。

Thanks, Matthew, for the question. Tahi, can you give a bit of color on the frontline, the Fuse label trial and the potential need for the type of data to give us an angle, a differentiated angle of other therapies.

謝謝馬修的提問。Tahi，可以稍微介紹一下前線情況、Fuse 標籤試驗以及可能需要這類數據來為我們提供與其他療法不同的角度嗎？

Well, thank you, Jan. I think we have guided that we expect the readout to happen in 2026, and we should probably leave it at this now. It's obviously an event-driven study, and we will update in the appropriate setting when we have a little bit more clarity. But clearly, the study was more or less fully accrued in the summer of last year. So as it relates to what it has to do in order to be competitive in the competitive landscape vis-a-vis put I don't know -- I don't think it makes sense to go into some kind of like discussion about how that ratio and what it has to show.

好的，謝謝你，Jan。我認為我們已經預計在 2026 年公佈結果，現在我們應該就此打住。這顯然是一項事件驅動型研究，當我們對情況有更清晰的了解時，我們會在適當的時候更新研究結果。但很顯然，這項研究的數據基本上是在去年夏天收集完畢的。所以，就其在競爭環境中保持競爭力所需採取的措施而言，我不知道——我認為討論這個比例及其所代表的意義是沒有意義的。

I think we are very confident that if the study -- when the study reads out, then there will be a significant improvement over the standard of care.

我認為我們非常有信心，如果這項研究——當研究結果出來的時候——那麼治療效果將比標準治療有顯著提高。

And in that regard, also significantly differentiated from the POLIVY data, the POLARIX study. That is partially underwritten by the data that's going to be represented now with a longer follow-up at ASH, where you have a Phase II data set that in these high-risk patients shows a incredible high CR rates with an incredible high durability and on -- what we've seen over and over again is that these very robust Phase II studies that we win and then the data we generated on them more or less one-to-one translates into the Phase III. And so we anticipate the same to be true for the frontline diffuse BIS study.

在這方面，POLARIX 研究也與 POLIVY 數據有顯著差異。這部分得益於即將在 ASH 會議上公佈的更長時間的隨訪數據，其中包含了 II 期臨床試驗的數據集，該數據集顯示，在這些高危患者中，CR 率非常高，療效持久性也非常高——我們一次又一次地看到，我們贏得的這些非常可靠的 II 期臨床試驗，以及我們從中獲得的數據，幾乎可以一一轉化為 III 期臨床試驗的結果。因此，我們預計一線瀰漫性 BIS 研究也會如此。

Thanks, Tahi. So in addition to efficacy, I also think about the convenience of the subcu dosing and the safety pattern may be very different from other combination therapies metro. So we are very excited about the potential to see the readout, hopefully, soon from the frontline DLBCL, potential game changer we feel for EPKINLY. Let's move to the next question.

謝謝你，塔希。所以除了療效之外，我還考慮了皮下給藥的便利性，而且其安全性模式可能與其他聯合療法（如甲硝唑）截然不同。因此，我們非常興奮地期待著能盡快看到來自前線 DLBCL 的讀數，我們認為這可能會改變 EPKINLY 的治療模式。我們來看下一個問題。

Let's move to the next question.

我們來看下一個問題。

Victor Floch, BNP Paribas.

Victor Floch，法國巴黎銀行。

Yes, thank you so much for taking my question.

是的，非常感謝您回答我的問題。

Maybe just a keeping question on data readout timing. So taken for the comments on the first-line DLBCL. But you used to have an anticipated readout column on the Slide 7. So I just wanted to ask you whether you can confirm that all the Phase III trials that are on that slide. on the timings are consistent with what we -- what you've discussed last time for the second quarter update.

或許可以留存一個關於資料讀取時序的問題。以上評論僅供參考，針對第一線瀰漫性大B細胞淋巴瘤（DLBCL）。但你以前在第 7 張投影片上有一個預期結果欄。所以我想問一下，您是否可以確認投影片上列出的所有三期臨床試驗的時間安排是否與我們上次在第二季更新中討論的內容一致。

Thanks so much.

非常感謝。

Tahi, cna you comments on the timing there?

Tahi，你對那個時間點有什麼看法嗎？

Nothing has changed.

一切都沒有改變。

So we have confirmed the signal.Thanks. Let's move to the next one.

我們已經確認了訊號。謝謝。我們繼續處理下一個訊號。

Thanks. Let's move to the next one.

謝謝。我們來看下一個。

Zain Ebrahim, JPMorgan.

Zain Ebrahim，摩根大通。

Hi everyone, thanks for taking my question. Got one clarification question for just on the OpEx for '26 in terms of when you say both the time alone investments from Mediar and for Genmab, reasonable pace, I think is how you characterized it. Does that include the potential for indication expansion that you outlined for locally advanced head and neck for Peto and maybe other indications that we might hear about more in Q1 was my first question. And the second question is just on -- can you remind us of the filing strategy for Renoir next year? I know you just said everything is on track. But in terms of recruitment, how that's progressing for the Phase III and when we can expect to see more duration of response data from the Phase II trial. Thanks a lot.

大家好，感謝大家回答我的問題。關於 2026 年的營運支出，我有一個需要澄清的問題。您提到 Mediar 和 Genmab 的時間投入，以及合理的進度，我認為您是這樣描述的。我的第一個問題是：這是否包括您概述的局部晚期頭頸部疾病的適應症擴展潛力，以及我們可能在第一季聽到的更多其他適應症？第二個問題就到這裡—您能提醒我們雷諾阿明年的報案策略嗎？我知道你剛才說過一切都在照計畫進行。但就招募而言，III 期試驗的進展如何？我們何時才能看到 II 期試驗中更多持續時間反應數據？多謝。

Thanks, Zain, for the questions. I will leave the first one to Anthony, of course, to give you further clarity there. The second one I can take for RIAs filing strategy. The initial filing will likely be based on the Phase II potentially registrational trial for platinum-resistant ovarian cancer. That trial is completely recruited and also in parallel to Phase III is recruiting very rapidly.

謝謝Zain提出的問題。當然，第一個問題就交給安東尼回答，讓他進一步闡明。第二個我可以考慮用於RIA申報策略的方案。初步申請很可能基於鉑金抗藥性卵巢癌的 II 期潛在註冊試驗。該試驗已完成全部受試者招募，同時，第三階段試驗也快速招募受試者。

So we are fully on track there to have a readout next year potentially a filing and an approval, hopefully, in '27. Anthony, can you give a bit more color on the inclusion of the locally advanced head and neck for the GEN MOP trials as projected for 2026.

因此，我們完全有信心在明年公佈結果，並預計在 2027 年提交申請並獲得批准。Anthony，你能否更詳細地介紹一下預計於 2026 年進行的 GEN MOP 試驗中納入本地先進的頭部和頸部的情況？

So yes, the short answer is yes. So I think about, again, just reiterating, as we think looking about forward to 2026, it was important to condition the market thinking about overall investment levels, again, to reiterate, expect as I look at consensus today for both Genmab stand-alone as well as Merus, look to be in a reasonable place, also reflective of our investment priorities. Of course, we're going to provide ultimately our guidance to the market in February of 26%. But to put a finer point on it, Zain, yes.

所以，簡而言之，答案是肯定的。因此，我想再次重申，當我們展望 2026 年時，重要的是要引導市場思考整體投資水準。再次重申，就我目前對 Genmab 獨立營運和 Merus 的共識來看，它們似乎都處於合理的位置，這也反映了我們的投資重​​點。當然，我們最終會在2月向市場提供26%的業績指引。但更準確地說，Zain，是的。

As I say today does include what we think about it from an overall portfolio development, including your specific question around inclusion of investment in the locally advanced.

正如我今天所說，這包括我們從整體投資組合發展的角度對此進行思考，包括您關於將投資納入本地先進技術的具體問題。

Thanks, Anthony. So thanks, Zain, for the questions. Let's move on to the next one.

謝謝你，安東尼。謝謝Zain提出的問題。我們來看下一個。

Charlie Haywood, Bank of America.

查理·海伍德，美國銀行。

Hi Charlie Hay with Bank of America. Thanks for taking the questions. First one was on just how to look -- how you're looking at the first-line head and neck cancer landscape, specifically, I guess, the option to have a triplet versus a doublet strategy. How you think those segments of the markets differ versus the KEYTRUDA mono or combo arms that you have as part trials? And then the second one being in Rina-S endometrial data I think optically looked like better responses in the file receptor greater than 25% and a bigger delta than you've seen in PROCs, I guess, confidence in efficacy across broad flareceptor alpha expresses. Thank you.

您好，查理·海，來自美國銀行。謝謝您回答問題。第一個問題是如何看待——你如何看待一線頭頸癌治療現狀，具體來說，我想，是三聯療法與雙聯療法的選擇。您認為這些細分市場與您正在進行試驗的 KEYTRUDA 單藥或合併用藥方案有何不同？然後，第二個例子是 Rina-S 子宮內膜數據，我認為從光學上看，文件受體的反應比 25% 以上更好，而且 delta 比你在 PROC 中看到的更大，我想，這增強了對廣泛 flareceptor alpha 表達的療效的信心。謝謝。

Thanks, Charlie, for the question. Tahi, can you start and then Judith maybe you can step in there. The first start with the form line had a cancer landscape.

謝謝你的提問，查理。Tahi，你先開始，然後Judith，也許你可以接替她。最初以表格形式呈現的是癌症景觀。

The way I would answer your question is that, broadly speaking, in the current landscape, as you were alluding to, there is a pembro mono strategy and then a pembro chemo strategy and at times physicians make that choice based on maybe a slightly higher response rate for the chemo pembro combination in a faster time to response, and that's had a lot to do with location of the tumor and the size of the tumor. That all becomes essentially irrelevant if the data in the Phase II with Petro and pembro is essentially double twice the report response rate for chemo. Pembro because at that point, you basically have a higher to response rate without the significant toxicities of chemotherapy and these patients don't necessarily tolerate chemotherapy too well.

我的回答是，總的來說，在目前的治療環境下，正如你所提到的，存在帕博利珠單抗單藥治療策略和帕博利珠單抗合併化療策略。有時，醫生會根據帕博利珠單抗合併化療可能略高的反應率和更快的起效時間來做出選擇，而這與腫瘤的位置和大小有很大關係。如果在二期臨床試驗中，Petro 和 pembro 聯合用藥的療效數據是化療報告療效的兩倍，那麼上述所有因素基本上都變得無關緊要了。帕博利珠單抗（Pembro）之所以被採用，是因為在那種情況下，它能帶來更高的反應率，而不會產生化療的顯著毒性，而且這些患者不一定能很好地耐受化療。

So this is what we like about the profile of pet, in particular, also in the data and people in the combination provides an opportunity where you have a high response rate, a rapid time to response without any of the quite significant toxicities that go along with combination chemotherapy in this patient setting. That's the head and neck story. On the EC and the Rina-S the endometrial cancer, I mean the nuances here and there it's not that we have ever said that fully receptor alpha expression is irrelevant to the response? That's not the case. What we said is that Rina has a profile that allows us to generate meaningful responses across the entire spectrum of 4 receptor alpha expression and that does not require a biomarker selection.

這就是我們喜歡寵物（pet）的特點，尤其是在數據和人群方面，這種聯合療法提供了一個機會，可以實現高反應率、快速起效，而不會像聯合化療那樣給患者帶來相當大的毒性。這就是頭部和頸部的情況。關於 EC 和 Rina-S 子宮內膜癌，我的意思是，這裡那裡的一些細微差別，並不是說我們曾經說過受體 α 的完全表達與反應無關？事實並非如此。我們所說的是，Rina 具有能夠讓我們在整個 4 受體 α 表達範圍內產生有意義的反應的特性，並且不需要生物標記選擇。

And that's a strategy that has allowed us to go into these indications in the mitral generally considered to be a lower folateceptor alpha-expressing tumors than Prog. And it's also what is underwriting the confidence in going to other indications such as, for example, EGFR non-small cell lung cancer. And so this is one the differentiating aspects of Rina-S as that it was able to generate meaningful and stable real response rates across the entire spectrum. That doesn't mean that the higher don't even have higher responses that just means that even at the low end, the responses are meaningful and durable.

正是這種策略使我們能夠進入這些適應症，二尖瓣通常被認為比 Prog 低表達葉酸受體 α 的腫瘤。這也為進一步研究其他適應症（例如 EGFR 非小細胞肺癌）提供了信心。因此，Rina-S 的一個顯著特徵是，它能夠在整個頻譜範圍內產生有意義且穩定的真實響應率。這並不意味著高收入者就沒有更高的收入水平，而只是意味著即使在低收入者中，他們的反應也是有意義且持久的。

Thanks, Jan.

謝謝你，簡。

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

謝謝你，查理。我們來看下一個問題。

Next question, please.

下一個問題。

There are no further questions at this time. I would now like to turn the conference back to Jan van de Winkel for closing remarks.

目前沒有其他問題了。現在我謹將會議交還給 Jan van de Winkel，請他作閉幕致詞。

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

感謝您今天來電。如果您還有其他疑問，請聯絡我們的投資者關係團隊。我們非常期待盡快再次與各位交流。

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

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線了。