Genmab A/S (GMAB) 2025 Q4 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

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

    大家好,歡迎參加 Genmab 2025 年全年財務業績電話會議。再次提醒,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 on successful development projects. Genmab is not under any obligation to update statements regarding the future nor to confirm such statements in relation to actual results, unless this is required by law.

    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“相信”、“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,由於成功的開發案延期所致。除非法律另有規定,否則 Genmab 沒有義務更新有關未來的聲明,也沒有義務確認此類聲明與實際結果的關係。

  • Please also note Genmab may hold your personal data as indicated by you as part of our Investor Relations outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy.

    另請注意,Genmab 可能會根據您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 your first speaker today, Jan van de Winkel. Please go ahead.

    現在我謹將會議交給今天的第一位發言人,揚‧范德溫克爾。請繼續。

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Hello, and welcome to our financial results call for 2025. With me today is our Chief Financial Officer, Anthony Pagano; and our Chief Commercial Officer, Brad Bailey. For the Q&A, we will be joined by our Chief Medical Officer, Tahi Ahmadi; and our Chief Development Officer, Judith Klimovsky. As noted, we will be making forward-looking statements, so please keep that in mind.

    大家好,歡迎參加我們2025年財務業績電話會議。今天陪同我的是我們的財務長安東尼·帕加諾;以及我們的首席商務官布拉德·貝利。在問答環節,我們將邀請首席醫療官 Tahi Ahmadi 和首席發展官 Judith Klimovsky 出席。如前所述,我們將發表一些前瞻性聲明,請注意這一點。

  • As we reflect on 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 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.

    展望 2025 年,我想提醒大家我們在年初所做的承諾。我們曾表示,我們將加速開發具有重大影響的後期研發管線,最大限度地發揮已商業化藥物的潛力,並實現我們的資本配置優先事項。

  • I'm pleased to say that we have delivered on these commitments. And we began 2026 with a diversified high-quality revenue base and a late-stage portfolio that can drive sustainable growth well into the -- 2030s.

    我很高興地說,我們已經履行了這些承諾。2026 年伊始,我們擁有多元化的高品質收入基礎和後期投資組合,這可以推動可持續成長直至 2030 年代。

  • In 2025, we grew total revenue by 19%, fueled by both our royalty portfolio and sales from our own medicines. And we also invested fully aligned with our capital allocation priorities. Importantly, we have also grown operating profit, even while making these strategic investments. 2025 was marked by some significant milestones in our mission to deliver innovative medicines to patients.

    2025 年,我們的總收入成長了 19%,這得益於我們的特許權使用費組合和我們自有藥品的銷售。而且,我們的投資也完全符合我們的資本配置優先事項。重要的是,即便在進行這些策略投資的同時,我們的營業利潤也實現了成長。 2025年,我們在為患者提供創新藥物的使命中取得了一些重要的里程碑式進展。

  • Highlights include positive momentum for EPKINLY as it continues to demonstrate the potential to become a core therapy in B-cell format, its FDA approval in second-line follicular lymphoma in combination with our squares as well as the unprecedented data in this indication are key milestones.

    亮點包括 EPKINLY 的積極發展勢頭,它繼續展現出成為 B 細胞療法核心的潛力;其與我們的方塊聯合用於二線濾泡性淋巴瘤的 FDA 批准,以及該適應症中前所未有的數據,都是重要的里程碑。

  • Taken together, these move treatment into earlier lines of therapy and expand our impact for people living with follicular lymphoma. We also built on our commitment to the Genmab community. In addition to the availability of TIVDEK in both Japan and Europe, we expanded the development of Rina-S, ending the year with three Phase 3 trials across POC endometrial cancer and PSOC.

    綜合來看,這些措施將治療提前到早期治療階段,並擴大了我們對濾泡性淋巴瘤患者的影響。我們也進一步鞏固了對 Genmab 社區的承諾。除了 TIVDEK 在日本和歐洲上市外,我們還擴大了 Rina-S 的開發,並在年底完成了三個針對 POC 子宮內膜癌和 PSOC 的 3 期試驗。

  • Finally, a pivotal step in our journey to sustainable diversified growth was our acquisition of Merus, which enhanced our late-stage portfolio with petosemtamab. Petosemtamab -- with petosemtamab joining up EPKINLY and Rina-S, we have a strong pipeline of late-stage assets that will provide us with multiple value-creating catalysts in 2026 and in the future.

    最後,我們實現永續多元化成長的關鍵一步是收購了 Merus,這為我們後期產品組合增添了 petosemtamab。Petosemtamab——隨著 petosemtamab 與 EPKINLY 和 Rina-S 的加入,我們擁有強大的後期資產管線,這將為我們在 2026 年及以後提供多個創造價值的催化劑。

  • Now let's take a look at the strength of these three programs on the next slide. With our five combined breakthrough therapy designations, these three programs have multibillion dollar potential and they firmly underpin our long-term growth. EPKINLY is clearly the only bispecific antibody with a dual indication across B-cell malignancies in the US, Europe and Japan. And following unprecedented data, EPKINLY + R2 is well positioned to become a best-in-class option in second line plus follicular lymphoma.

    現在讓我們在下一張投影片中看看這三個項目的優勢。憑藉我們五項突破性療法認定,這三個項目具有數十億美元的潛力,並為我們的長期成長奠定了堅實的基礎。顯然,EPKINLY 是唯一一種在美國、歐洲和日本均具有 B 細胞惡性腫瘤雙重適應症的雙特異性抗體。根據前所未有的數據,EPKINLY + R2 有望成為第二線及以上濾泡性淋巴瘤治療的最佳選擇。

  • Rina-S, is a follicular receptor alpha-targeted ADC designed to broadly -- to broaden eligibility beyond high expressors. Based on current expression distributions, this could expand the addressable pork population by as much as 3 times versus approved medicines that are restricted to high folate receptor alpha expression.

    Rina-S 是一種針對卵泡受體 α 的抗體藥物偶聯物 (ADC),旨在廣泛擴大適用範圍,使更多患者(包括高表達者)也能接受治療。根據目前的表達分佈情況,與僅限於高葉酸受體α表達的已批准藥物相比,這可能會使可治療的豬群數量增加多達3倍。

  • And finally, item a potentially transformative each of our LGL5 bispecific antibody with compelling data in both first line and later line recurrence and metastatic head and neck cancer. As a reminder, in the first-line setting, petosemtamab in combination with pembro achieved a 60% response rate, and that is more than 3 times higher than the 19% that has been observed at the standard of care.

    最後,我們展示了一種可能具有變革意義的 LGL5 雙特異性抗體,該抗體在頭頸癌的一線治療和後續治療中均有令人信服的數據,包括復發和轉移性治療。提醒一下,在第一線治療中,petosemtamab 與 pembro 聯合使用可達到 60% 的應答率,比標準治療觀察到的 19% 的應答率高出 3 倍以上。

  • 2026 will be a defining year for all three of these programs as we will see on the next slide. We expect up to six potential potentially registrational data readouts that could set the stage for multiple important product launches and line extensions in 2027.

    2026 年對於這三個項目來說都將是具有決定性意義的一年,我們將在下一張幻燈片中看到這一點。我們預計 2027 年將有多達 6 項潛在的註冊資料公佈,這可能為多項重要產品的上市和產品線擴展奠定基礎。

  • In the second half of the year, we expect Phase 2 data for Rina-S and platinum-resistant ovarian cancer. We also anticipate that one of both Phase 3 trials for petosemtamab in first and second line or third-line head and neck cancer will deliver top line data in the second half. And while we anticipate around 25,000 potential patients for later lines of therapy in first-line head and neck cancer, this increases to an additional 41,000 patients.

    今年下半年,我們預計將公佈 Rina-S 治療鉑類抗藥性卵巢癌的 II 期臨床試驗數據。我們也預計,petosemtamab 在一線、二線或三線頭頸癌治療中的兩項 3 期試驗之一將在下半年公佈主要數據。雖然我們預計一線頭頸癌後續治療的潛在患者約為 25,000 人,但這一數字將增加到 41,000 人。

  • For EPKINLY, we anticipate data from two Phase 3 trials in diffuse large B-cell lymphoma. The indication with the largest addressable patient population around 70,000 people is, of course, frontline diffuse last B-cell lymphoma, and we are looking forward to data in this indication in combination with our shop this year. We are also looking forward to data in the first half of the year and second line plus diffuse large B-cell lymphoma in combination with lenalidomide.

    對於 EPKINLY,我們期待獲得兩個瀰漫性大 B 細胞淋巴瘤 3 期試驗的數據。當然,目前針對的患者群體最大的適應症(約 7 萬人)是一線瀰漫性晚期 B 細胞淋巴瘤,我們期待今年能獲得該適應症與本產品聯合治療的數據。我們也期待今年上半年的數據,以及來那度胺合併治療瀰漫性大B細胞淋巴瘤的二線治療效果。

  • Now as you are aware, in general, we announced top line results from the Phase 3 EPCORE-DLBCL1 trial of a EPKINLY monotherapy. The results showed an improvement in progression-free survival as well as improvements in complete response rate, duration of response and time to next treatment. And in fact, this is the first Phase 3 study to demonstrate an improvement in progression-free survival and patients that relapsed or refractory diffuse large B-cell lymphoma, who are treated with the CD3/CD20 T cell engaging bispecific monotherapy.

    如您所知,我們已發表了 EPKINLY 單藥療法 3 期 EPCORE-DLBCL1 試驗的主要結果。結果顯示,無惡化存活期有所改善,完全緩解率、緩解持續時間和下次治療時間也有所改善。事實上,這是第一個證明 CD3/CD20 T 細胞活化雙特異性單一療法可改善復發或難治性瀰漫性大 B 細胞淋巴瘤患者的無惡化存活期的 3 期研究。

  • Overall survival did not reach statistical significance and further analysis of the data is ongoing. Including the potential impact of a variety of factors, including COVID-19 and the increasing availability of novel anti-lymphoma therapies. The full trial results will be submitted for presentation at a future medical meeting, and we will engage with global regulatory authorities on next steps.

    整體存活率未達統計學意義,數據仍在進一步分析中。包括各種因素的潛在影響,例如 COVID-19 疫情以及新型抗淋巴瘤療法的日益普及。完整的試驗結果將提交給未來的醫學會議進行展示,我們將與全球監管機構就下一步措施進行磋商。

  • The monotherapy results do not change our expectations for our other Phase 3 trials. And we are very confident that these studies continue to have the potential to move EPKINLY earlier in the treatment paradigm and significantly increase its addressable population from approximately 27,000 and patients today to almost 150,000 patients by early in the next decade. The data presented across at EPKINLY, Rina-S and petosemtamab in 2025, strengthened our conviction in these programs.

    單藥治療的結果不會改變我們對其他 3 期試驗的預期。我們非常有信心,這些研究將繼續有可能使 EPKINLY 更早進入治療模式,並顯著增加其可治療人群,從目前的約 27,000 名患者增加到下一個十年初的近 150,000 名患者。2025 年 EPKINLY、Rina-S 和 petosemtamab 公佈的數據增強了我們對這些項目的信心。

  • Now in 2026, it is the meaningful registrational readouts that will be the -- that allow us to potentially bring these antibodies to patients in 2027.

    現在到了 2026 年,真正有意義的註冊結果將使我們能夠在 2027 年將這些抗體帶給患者。

  • I'm pleased to now hand you over to Brad for a review of the recent commercial performance for EPKINLY and TIVDAK.

    現在我很高興將麥克風交給布拉德,讓他來回顧一下EPKINLY和TIVDAK最近的商業表現。

  • Brad Bailey - Executive Vice President and Chief Commercial Officer

    Brad Bailey - Executive Vice President and Chief Commercial Officer

  • Thanks, Jan. 2025 marked another successful year for our commercialization team. We maintained leading positions for our proprietary brands globally, and we made important progress evolving into a wholly owned model fueling our long-term growth engine.

    謝謝,2025年1月標誌著我們商業化團隊又一個成功的一年。我們維持了旗下自有品牌在全球的領先地位,並在向全資擁有模式轉型方面取得了重要進展,從而推動了我們的長期成長。

  • In the past year, we successfully executed four key launches across our portfolio, two of which were led entirely by Genmab, demonstrated the strength of the commercialization model we've built in the US, Japan and now in Europe.

    在過去一年中,我們成功地在我們產品組合中完成了四項關鍵產品的上市,其中兩項完全由 Genmab 主導,這證明了我們在美國、日本以及現在在歐洲建立的商業化模式的強大實力。

  • We expanded our footprint to three additional markets, opening business operations in Germany, the UK and France, and we delivered on our commitment to bringing our antibody-based medicines to patients in area of high need.

    我們將業務拓展到另外三個市場,在德國、英國和法國開展業務,並履行了將我們的抗體藥物帶給急需地區患者的承諾。

  • To this end, TIVDAK became the first ADC approved in recurrent or metastatic cervical cancer in the EU, UK, and Japan, providing a much-needed option for patients whose disease progresses after initial therapy. And where outcomes have historically been poor. Additionally, when its approval in the US -- with the approval in the US in relapsed or refractory follicular lymphoma, EPKINLY became the first bispecific antibody approved in any form of non-Hodgkin's lymphoma in the second line setting and the first bispecific combination therapy approved in the lymphoma space.

    為此,TIVDAK 成為歐盟、英國和日本首個獲準用於治療復發性或轉移性子宮頸癌的抗體藥物偶聯物 (ADC),為初始治療後病情進展的患者提供了急需的選擇。以及歷史上結果較差的地區。此外,EPKINLY 在美國獲準用於治療復發或難治性濾泡性淋巴瘤後,成為首個獲準用於任何形式的非何杰金氏淋巴瘤二線治療的雙特異性抗體,也是首個獲準用於淋巴瘤治療的雙特異性聯合療法。

  • These milestones represent progress for patients, and they set the foundation for our growth trajectory in gynecologic cancers, along with Rina-S in the future and further into B cell malignancies. Through our efforts in 2025, sales of our proprietary analytic totaled $632 million. This is up 54% year-over-year and accounting for approximately 28% of our total revenue growth.

    這些里程碑代表著患者的進步,也為我們未來在婦科癌症領域的發展軌跡奠定了基礎,未來也將與 Rina-S 一起,進一步拓展到 B 細胞惡性腫瘤領域。透過我們的努力,到 2025 年,我們專有分析產品的銷售額總計達到 6.32 億美元。這比去年同期成長了 54%,約占我們總營收成長的 28%。

  • We expect this growth trajectory to continue in 2026 and grounded in the strong foundation we've built as we deliver our own medicines to an increasing number of patients around the world.

    我們預計這一成長勢頭將在 2026 年繼續保持,並建立在我們為世界各地越來越多的患者提供自有藥物的強大基礎上。

  • Now let's take a closer look at EPKINLY. We closed out 2025 with solid performance, achieving $468 million in sales for the year, which represents a 67% year-over-year increase. This performance was driven by continued growth for the brand across geographies and as the first and only bispecific with approved dual location in diffuse large B cell lymphoma and FL in Europe, Japan and US.

    現在讓我們仔細看看EPKINLY。2025 年我們取得了穩健的業績,全年銷售額達到 4.68 億美元,年增 67%。這一業績得益於品牌在各個地區的持續成長,並且是歐洲、日本和美國首個也是唯一一個獲準用於治療瀰漫性大B細胞淋巴瘤和濾泡性淋巴瘤的雙特異性抗體。

  • In fact, EPKINLY closed 2025 with regulatory approvals in more than 65 countries, nearly all of which feature the dual indication. We continue to be encouraged by EPKINLY's strong momentum and the positive feedback we hear from physicians across geographies regarding kidney's differentiated clinical profile, powerful efficacy and proven safety and the value of having a single dual indication option across DLBCL and FL.

    事實上,EPKINLY 在 2025 年底獲得了 65 多個國家的監管批准,幾乎所有國家都批准了其雙重適應症。我們持續受到 EPKINLY 強勁勢頭的鼓舞,並聽到來自世界各地醫生的積極反饋,他們稱讚腎臟藥物具有差異化的臨床特徵、強大的療效和已證實的安全性,以及在 DLBCL 和 FL 中擁有單一雙重適應症選擇的價值。

  • In the US, this momentum has translated to continued growth for EPKINLY across sites of care with an acceleration in new sites ordering including in the community and the majority of health systems now ordering from multiple sites.

    在美國,這種勢頭轉化為 EPKINLY 在各個醫療場所的持續增長,新場所的訂購量加速增長,包括社區,現在大多數醫療系統都從多個場所訂購。

  • As expected, following the launch of EPKINLY in second-line FL in November, we're seeing increased uptake suggesting that this approval will be a growth driver for the brand.

    正如預期的那樣,繼 11 月 EPKINLY 在二線 FL 上市後,我們看到其使用率有所提高,這表明此次批准將成為該品牌的成長動力。

  • In Japan, we continue to see EPKINLY's launch in third line plus FL build on the brand's success in large B-cell lymphoma. This is driven in large part by EPKINLY's dual indication differentiation and execution by our FL teams to activate sites.

    在日本,我們繼續看到 EPKINLY 在三線治療和 FL 領域的推出,鞏固了品牌在大 B 細胞淋巴瘤領域的成功。這主要得益於 EPKINLY 的雙重適應症差異化以及我們 FL 團隊活化站點的執行。

  • Across all other markets, we continue to increase our presence through our partner AbbVie and its global footprint. We closed out the year with yet another quarter of solid sales rep EPKINLY in these markets as we continue to see rapid uptake in countries gaining access and reimbursement.

    在其他所有市場,我們將繼續透過合作夥伴艾伯維及其全球佈局來擴大我們的市場份額。我們以EPKINLY在這些市場又一個季度穩健的銷售業績結束了這一年,因為我們繼續看到在獲得准入和報銷的國家中,EPKINLY的普及速度很快。

  • Looking ahead, 2026 will be a pivotal year for EPKINLY as we advance our position in early lines of therapy and anticipate key data readouts supporting EPKINLY's versatility and status as the core therapy in B-cell malignancies.

    展望未來,2026 年將是 EPKINLY 的關鍵一年,我們將推進我們在早期治療領域的地位,並期待關鍵數據公佈,以支持 EPKINLY 的多功能性及其作為 B 細胞惡性腫瘤核心療法的地位。

  • Our focus is on delivering EPKINLY to as many patients as possible, particularly in early lines of therapy where we see the market opportunity and critically where we may have the opportunity to truly transform the trajectory of these diseases for patients.

    我們的重點是盡可能為患者提供 EPKINLY,尤其是在早期治療領域,我們看到了市場機會,更重要的是,我們有機會真正改變這些疾病患者的治療軌跡。

  • To that end, we're maximizing our first-mover advantage in second-line FL in the US, and we expect to build on this opportunity across markets with anticipated approvals in this setting in Europe and Japan later this year.

    為此,我們正在最大限度地發揮我們在美國二線 FL 治療領域的先發優勢,並期望在今年晚些時候隨著歐洲和日本在該領域的預期批准,在其他市場擴大這一機會。

  • With this traction in earlier lines of FL, we're looking towards key readouts in 2026 in first- and second-line DLBCL with fixed duration of kidney combination therapies to further strengthen EPKINLY's position in DLBCL. Together with a robust development program for EPKINLY and strong execution by our teams, we see a clear opportunity for EPKINLY to achieve blockbuster status over the next few years.

    憑藉在 FL 早期治療中取得的進展,我們期待在 2026 年獲得一線和二線 DLBCL 固定療程聯合治療的關鍵結果,以進一步鞏固 EPKINLY 在 DLBCL 領域的地位。憑藉 EPKINLY 強大的開發計劃和我們團隊的強力執行,我們看到 EPKINLY 在未來幾年內有明顯的機會成為爆款產品。

  • Moving now to TIVDAK. TIVDAK continues to be recognized as the global standard of care in recurrent or metastatic cervical cancer. In 2025, TIVDAK generated $164 million in sales representing a 26% year-over-year increase. TIVDAK continues to perform well across both new and established markets highlighting the clear need for treatments that improve survival for women with advanced cervical cancer across geographies.

    現在轉到TIVDAK。TIVDAK 療法持續被公認為復發性或轉移性子宮頸癌的全球標準治療方案。2025 年,TIVDAK 的銷售額達到 1.64 億美元,年增 26%。TIVDAK 在新興市場和成熟市場均持續表現良好,這凸顯了各地對能夠提高晚期子宮頸癌女性存活率的治療方法的迫切需求。

  • In the US, notably, TIVDAK posted its fourth consecutive year-over-year growth underscoring its continued market leadership. This strong, stable performance continues to be driven by the depth and breadth of sites of care using TIVDAK .

    值得注意的是,TIVDAK 在美國連續第四年實現同比成長,凸顯了其持續的市場領導地位。這一強勁穩定的業績持續得益於使用TIVDAK的醫療機制的深度和廣度。。

  • In Japan, TIVDAK demonstrated another strong quarter of continued performance, underscoring the traction it's gaining in the second-line setting and the high patient need in recurrent and metastatic cervical cancer in the country. This trend continued in Europe where the launch in Germany continues to be off to an encouraging start with strong consistent uptake and positive physician feedback.

    在日本,TIVDAK 又展現了強勁的季度持續表現,凸顯了其在二線治療領域的進展,以及該國復發性和轉移性子宮頸癌患者的高需求。這一趨勢在歐洲也得以延續,在德國的上市取得了令人鼓舞的開局,獲得了強勁而持續的市場認可和積極的醫生反饋。

  • As the first medicine we've launched in Europe independently, our efforts in recent months have demonstrated our ability to strategically build infrastructure and scale in new markets. We received MHRA approval in December in the UK and are now working towards reimbursement to bring TIVDAK to more patients as soon as possible.

    作為我們在歐洲獨立推出的第一款藥品,我們近幾個月的努力已經證明我們有能力在新市場策略性地建立基礎設施並擴大規模。我們於去年 12 月獲得了英國藥品和保健產品監管署 (MHRA) 的批准,現在正努力爭取報銷,以便盡快讓更多患者使用 TIVDAK。

  • As we look ahead of the new fiscal year, we have the foundation in place to continue this momentum and bring TIVDAK to additional markets. Infrastructure and operations are well underway in new markets with our team is executing in preparation for exciting launches on the horizon. We expect to see continued positive performance across markets as we strengthen and scale our presence and broaden our impact within the gynecologic cancer community.

    展望新的財政年度,我們已經奠定了基礎,可以繼續保持這種勢頭,並將 TIVDAK 推向更多市場。在新市場,基礎設施和營運工作正在順利進行,我們的團隊正在積極籌備,為即將到來的令人興奮的產品發布做好準備。我們預計隨著我們在婦科癌症領域不斷加強和擴大業務規模,並擴大我們的影響力,我們將在各個市場持續取得積極業績。

  • Wrapping up, 2025 was a critical year in our company's evolution. We built on our proven launch expertise and scientific strength and achieved key milestones to solidify our commercialization model and business operations that will unlock our ability to deliver on the significant growth opportunities ahead of us.

    綜上所述,2025 年是我們公司發展歷程中的關鍵一年。我們憑藉自身成熟的產品上市經驗和科學實力,實現了關鍵里程碑,鞏固了我們的商業化模式和業務運營,這將釋放我們抓住未來重大成長機會的能力。

  • Our proven ability to evolve our model in the US and Japan, coupled with the early traction we are seeing in Europe gives us the confidence that we have the pieces in place today to drive future growth and expansion.

    我們在美國和日本已經證明了我們有能力不斷改進我們的模式,再加上我們在歐洲看到的早期進展,讓我們有信心,我們現在已經擁有了推動未來成長和擴張的條件。

  • With this strong foundation, 2026 is shaping up to be another meaningful year for Genmab. We will grow the impact of our proprietary portfolio, expand our footprint and strapped our capabilities as we look towards entering new and larger market opportunities and delivering on the blockbuster presential of EPKINLY, Rina-S and petosemtamab in the coming years.

    憑藉這一堅實的基礎,2026 年對於 Genmab 來說有望成為另一個意義非凡的年份。我們將擴大我們專有產品組合的影響力,擴大我們的業務範圍,並增強我們的能力,以期進入新的、更大的市場機遇,並在未來幾年內實現 EPKINLY、Rina-S 和 petosemtamab 的重磅上市。

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

    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。

  • Anthony Pagano - Chief Financial Officer, Executive Vice President

    Anthony Pagano - Chief Financial Officer, Executive Vice President

  • Thanks, Brad. 2025 was a year of strong execution for Genmab with solid revenue growth, expanding profitability and disciplined investment. Looking ahead, our 2026 guidance reflects the same framework we outlined at Q3 and at the time of the Merus acquisition. And it also reflects our continued commitment to funding growth while maintaining substantial profitability.

    謝謝,布拉德。 2025年對於Genmab來說是執行力強勁的一年,實現了穩健的收入成長、獲利能力的提升和審慎的投資。展望未來,我們 2026 年的業績指引與我們在第三季和收購 Merus 時概述的框架相同。這也反映了我們持續致力於在保持可觀獲利能力的同時,為成長提供資金支持的承諾。

  • Now before diving into the numbers, please note at the results and guidance I will review exclude the impact of acquisition-related expenses, including amortization. A reconciliation to our reported results is included in the appendix.

    在深入探討具體數字之前,請注意,我將要回顧的結果和指導意見不包括收購相關費用(包括攤提)的影響。附錄中包含了與我們報告結果的核對說明。

  • In 2025, total revenue increased 19% to $3.7 billion, reflecting strong execution across our royalty portfolio as well as continued progress for our commercialized medicines. We also continue to improve the quality of our revenue profile with a higher contribution from our own medicines, especially EPKINLY, further diversifying our revenue base.

    2025 年,總營收成長 19% 至 37 億美元,反映出我們在特許權使用費組合方面的強勁執行力,以及我們商業化藥物的持續進展。我們不斷提高收入結構的質量,尤其是自有藥品(特別是 EPKINLY)的貢獻,進一步豐富了我們的收入來源。

  • In addition, we strengthened our long-term growth potential with the addition of petosemtamab to our late-stage pipeline. Alongside the Merus acquisition, we made targeted strategic investments during the year with operating expenses up 13%. The investments we made in building our commercialization capabilities are already delivering for us today.

    此外,我們將 petosemtamab 添加到我們的後期研發管線中,從而增強了我們的長期成長潛力。除了收購 Merus 之外,我們今年還進行了有針對性的策略投資,營運費用成長了 13%。我們在建立商業化能力所做的投資,如今已經開始為我們帶來回報。

  • And importantly, they are positioning us to support expansion into early line for EPKINLY and the potential launches of Rina-S and petosemtamab in 2027. And even with these investments, we expanded operating profit to $1.26 billion, reflecting strong execution and increasing operating leverage as the business scales. Overall, 2025 demonstrates the strength and quality of Genmab's underlying financial performance.

    更重要的是,他們正在為我們提供支持,以拓展 EPKINLY 的早期產品線,並協助 Rina-S 和 petosemtamab 在 2027 年的潛在上市。即使進行了這些投資,我們的營業利潤也成長至 12.6 億美元,這反映了我們強大的執行力和隨著業務規模擴大而不斷提高的營運槓桿。整體而言,2025 年展現了 Genmab 穩健的財務表現和優良的財務品質。

  • Turning to our 2026 guidance. Our framework is straightforward. Revenue growth enables strategic investment, which supports long-term value creation. At the midpoint, we expect 14% total revenue growth driven by continued momentum EPKINLY and our royalty portfolio, further enhancing revenue quality. More specifically, we expect DARZALEX net sales in the range of $15.6 billion to $16.4 billion.

    接下來,我們來看看2026年的指導。我們的框架很簡單。收入成長能夠促進策略性投資,從而支持長期價值創造。預計在中期,總收入將成長 14%,這主要得益於 EPKINLY 的持續成長動能和我們的特許權使用費組合,從而進一步提高收入品質。更具體地說,我們預計 DARZALEX 的淨銷售額將在 156 億美元至 164 億美元之間。

  • As discussed previously, expectations for operating expenses were in a reasonable place. For 2026, the increase in operating expenses reflects planned investments to advance late-stage development from petosemtamab and Rina-S as well as launch Regis activities to support multiple potential product launches.

    如前所述,營運費用預期處於合理範圍內。2026 年營運費用的增加反映了計劃進行的投資,以推進 petosemtamab 和 Rina-S 的後期開發,以及啟動 Regis 活動以支援多個潛在產品的上市。

  • Even with the strategic step-up, our guidance delivers on our commitment to maintain substantial profitability in 2026.

    即使採取了策略性升級措施,我們的預期仍將兌現我們在 2026 年保持可觀獲利能力的承諾。

  • With that, now I would like to provide some context for how revenue growth supports a deliberate increase in investments while delivering [$1.15 billion ] of operating profit at the midpoint for 2026. And you can see this on the chart on the right. What really stands out is the strength of our underlying business, demonstrated by strong organic operating profit growth before our planned investments in petosemtamab.

    接下來,我想說明一下,營收成長如何支持有意識地增加投資,同時在 2026 年中期實現 11.5 億美元的營業利潤。您可以在右側的圖表中看到這一點。真正突出的是我們基礎業務的實力,這體現在我們計劃對 petosemtamab 進行投資之前強勁的內生性營業利潤增長上。

  • Here, we are choosing to reinvest part of the operating leverage now to strengthen future growth drivers, while continuing to manage costs actively and maintain profitability discipline. This balance reinvesting to support growth while driving substantial profitability is a core feature of our operating model.

    在這裡,我們選擇將部分經營槓桿再投資,以加強未來的成長動力,同時繼續積極控製成本並保持獲利能力。這種在支持成長的同時進行再投資並實現可觀盈利的平衡是我們營運模式的核心特徵。

  • Taken together, our 2025 results and 2026 guidance demonstrate consistent delivery against our financial commitments. Our capital allocation framework remains fully aligned with our strategy to drive sustainable growth well into the 2030s.

    綜合來看,我們 2025 年的業績和 2026 年的業績預期表明,我們始終能夠履行財務承諾。我們的資本配置框架與我們的策略完全一致,旨在推動永續成長直至 2030 年代。

  • First, we will continue to invest to accelerate our late-stage pipeline and maximize the success of our commercialized medicines, including launch readiness. These investments are intended to generate meaningful revenue for us in the future. Second, we will continue the rapid integration of Merus to accelerate value capture while maintaining focus and prioritization. And third, we remain committed to deleveraging, targeting gross leverage below 3 times by the end of 2027, maintaining balance sheet strength and flexibility.

    首先,我們將繼續投資,加速後期研發管線的推進,並最大限度地提高已商業化藥物的成功率,包括做好上市準備。這些投資旨在為我們未來創造可觀的收入。其次,我們將持續快速整合 Merus,以加速價值獲取,同時保持專注和優先順序。第三,我們將繼續致力於去槓桿化,目標是到 2027 年底將總槓桿率降至 3 倍以下,維持資產負債表的穩健性和靈活性。

  • In summary, our performance in 2025 underscores our ability to deliver revenue growth, our ability to advance key pipeline assets and our ability to maintain strong profitability through disciplined execution.

    總而言之,我們在 2025 年的業績突顯了我們實現收入成長的能力、推進關鍵管道資產的能力以及透過嚴謹的執行力保持強勁盈利能力的能力。

  • Looking ahead to 2026, we are building on this momentum through disciplined prioritization of our investments continued operating discipline and expansion of market opportunities. This positions us for sustained growth and long-term value creation.

    展望 2026 年,我們將在此基礎上,透過嚴格把控投資優先級、持續保持營運紀律以及拓展市場機遇,繼續保持這一發展勢頭。這將使我們處於持續成長和長期價值創造的地位。

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

    說到這裡,我就把麥克風交還給 Jan 了。

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thank you, Anthony. Our confidence in our ability to execute on key data readouts in 2026 and subsequent high-impact launches in 2027 come from our track records. We have proven that we are excellent evaluators of innovation and that we deliver on our promises. We have also proven that we are disciplined in our execution against our capital allocation framework and in the prioritization of our investments, and we are committed to delivering profitable growth.

    謝謝你,安東尼。我們有信心在 2026 年順利完成關鍵數據解讀,並在 2027 年成功推出具有重大影響力的產品,這源自於我們以往的業績記錄。我們已經證明,我們是優秀的創新評估者,並且我們信守承諾。我們也證明了我們在執行資本配置框架和投資優先順序方面具有很強的紀律性,並且我們致力於實現獲利成長。

  • Genmab is a skilled oncology biotech business with strong momentum and increasingly diversified growth profile and multiple catalysts that has. As we begin 2026, our focus remains on translating our antibody science and development expertise into meaningful breakthroughs for patients and long-term value for shareholders.

    Genmab 是一家技術精湛的腫瘤生物技術公司,擁有強勁的發展勢頭、日益多元化的成長前景和多項成長催化劑。2026 年開始,我們的重點仍然是將我們的抗體科學和開發專長轉化為對患者有意義的突破,並為股東創造長期價值。

  • That ends our formal presentation. Thank you for listening. Operator, please open the call for questions.

    我們的正式報告到此結束。謝謝聆聽。接線員,請開啟提問環節。

  • Operator

    Operator

  • (Operator Instructions) Jonathan Chang, Leerink.

    (操作說明)Jonathan Chang,Leerink。

  • Jonathan Chang - Analyst

    Jonathan Chang - Analyst

  • Can you discuss what the next steps are for EPKINLY following the results of the EPCORE DLBC-1 study. Can you still get the second line plus label with the EPCORE DLBCL-4 combination study. And what was the rationale, I guess, behind using the monotherapy DLBCL-1 study as the confirmatory study in the first place?

    根據 EPCORE DLBC-1 研究的結果,您能否討論一下 EPKINLY 的下一步計畫是什麼?您還能透過 EPCORE DLBCL-4 聯合治療研究獲得二線加強標籤嗎?那麼,當初選擇單藥治療 DLBCL-1 研究作為驗證性研究的理由是什麼呢?

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thanks, Jonathan, for the question. So I will hand it over to Tahi to explain in further detail what the next steps are for the regulatory part for.

    謝謝喬納森的提問。因此,我將把這項工作交給塔希,讓他更詳細地解釋監管方面的下一步。

  • Tahamtan Ahmadi - Executive Vice President, Chief Medical Officer, Head of Experimental Medicines

    Tahamtan Ahmadi - Executive Vice President, Chief Medical Officer, Head of Experimental Medicines

  • Yes. Thank you, Jan, and thank you, Jonathan, for the question. Yes, as already indicated in the press release, I mean, the [05] study is pass by PFS. As a single agent beating a chemo minimal regimen on progression-free survival, but missed the over survival, confounded by key aspects that are already discussed in the community. One is being COVID. The study wasn't -- voted heavily doing the Conway and the other one is the emergence of access to bispecifics, of which we are an important part as well.

    是的。謝謝 Jan,也謝謝 Jonathan 的提問。是的,正如新聞稿中已經指出的那樣,我的意思是,[05] 研究通過了 PFS。作為一種單一藥物,它在無進展生存期方面優於化療最小方案,但在總體生存期方面卻不盡如人意,這其中受到了社區中已經討論過的關鍵因素的影響。其中之一是感染新冠病毒。這項研究並非──投票結果顯示,Conway 的研究成果頗豐,而另一項研究成果則是雙特異性抗體的出現,我們也是其中的重要參與者。

  • So we will have this discussion with the agencies. They are prespecified analysis in the protocol that we already agreed prior to the readout on these two major biases. And so we'll have this conversation both with the FDA and of course, with the European -- authorities in global 30s on the data set, and we're also going to have this realization with you guys once it is in the public domain.

    所以我們會和相關機構進行討論。這些是我們在讀出這兩個主要偏差之前,在協議中預先規定的分析。因此,我們將與美國食品藥物管理局 (FDA) 以及歐洲相關機構就該資料集進行討論,一旦該資料集公開,我們也會與大家分享此資訊。

  • As it relates on the rationale for which was your third question, on the rationale for why this is the confirmatory study, it's important to put yourself back into the situation where we were when this pine program started, this was the first Phase 3 to be initiated.

    至於你第三個問題所提出的理由,為什麼這是一項驗證性研究,重要的是要回到松樹計畫啟動時的情況,這是第一個啟動的第三階段。

  • And hence, it was a confirmatory study because the requirement for an accelerated approval is that you have a confirmatory study, initiative and really actually well on the role that time you file for the accelerate approval, which is why this was initially obviously, for a long time, the only disabuse study, the confirmatory study. Discussions are ongoing with the agencies about all the other Phase 3 studies that we have ongoing to specifically for which we bought already guided that we will have a readout this year.

    因此,這是一項驗證性研究,因為加速審批的要求是,你必須有一項驗證性研究、一項舉措,並且在你申請加速審批時,你確實在發揮著很好的作用,這就是為什麼這在最初很長一段時間內,顯然是唯一的驗證性研究。我們正在與各機構討論所有其他正在進行的 3 期研究,特別是我們已經購買的指導意見,我們將在今年獲得結果。

  • There is absolutely from our end and no indication from any of the health care interaction, any readouts to the findability of the other study that has been conducted and we already guided well went in the first half of this year, which is the combination with EPCORE in second and third line. This is a separate study that was set up separately. This was started and initiated after the Omnicon wave. It is testing a combination regimen with lenalidomide with the fixtuation, as Pat was alluding to earlier. So it's a different study with different opportunities.

    就我們而言,沒有任何跡象表明,也沒有任何醫療保健互動表明,其他研究的可發現性存在問題。我們已經在今年上半年指導進行了一項研究,該研究是將 EPCORE 聯合用於二線和三線治療。這是一項獨立進行的研究。這是在歐米茄熱潮之後開始和發起的。正如 Pat 之前提到的,它正在測試一種將來那度胺與固定療法相結合的聯合治療方案。所以這是一項不同的研究,提供了不同的機會。

  • And we'll be looking forward to have this data in our hands and to also like communicate them to the community and then to engage with health authorities as a -- .

    我們期待著掌握這些數據,並將其傳達給社區,然後與衛生部門進行溝通。——。

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thanks, Tahi . Jonathan, I think that answers your question?

    謝謝,塔希。喬納森,我想這應該可以回答你的問題了吧?

  • Jonathan Chang - Analyst

    Jonathan Chang - Analyst

  • Understood. Thank you very much.

    明白了。非常感謝。

  • Operator

    Operator

  • Asthika Goonewardene, Truist.

    Asthika Goonewardene,Truist。

  • Asthika Goonewardene - Analyst

    Asthika Goonewardene - Analyst

  • So you presented EPCORE outpatient data late last year. Just wanted to get an update from you on how this data has been adapted to change in the practice in the US, I guess, given -- maybe you can give us an idea of what proportion of community clicks that are still sending assuming patients to DLBCL patients do a large center to get that step-up dose wondering.

    所以你們在去年年底展示了EPCORE門診數據。我只是想從您那裡了解一下這些數據是如何適應美國實踐變化的,我想,鑑於——也許您可以告訴我們,有多少比例的社區點擊量仍然會向 DLBCL 患者發送信息,假設患者在大中心接受階梯劑量治療,這令人疑惑。

  • And then just maybe to tag on to Jonathan's question, could you put us at ease and just tell us what you think is the likelihood that you'll be able to convince the regulatory agencies to consider one of the many other EPCORE Phase 3 study readouts that are coming this year as the confirmatory study?

    然後,或許可以接著喬納森的問題問一句,您能否讓我們放心,告訴我們您認為您有多大可能說服監管機構將今年即將公佈的眾多 EPCORE 第三階段研究結果之一視為確證性研究?

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thanks, Asthika, for the questions. I will first hand it over to Tahi and then also Brad will definitely be able to comment on the community center use of ECPORE, I believe. But Tahi, why don't you start with the first question.

    謝謝Asthika提出的問題。我會先把它交給 Tahi,然後我相信 Brad 也肯定能夠對 ECPORE 的社區中心使用情況發表評論。但是塔希,為什麼不先回答第一個問題呢?

  • Tahamtan Ahmadi - Executive Vice President, Chief Medical Officer, Head of Experimental Medicines

    Tahamtan Ahmadi - Executive Vice President, Chief Medical Officer, Head of Experimental Medicines

  • Thank you, I actually get this question. So I'm going to reiterate the degree, but reaffirm what I said earlier. We have, at this point, three Phase 3s, in the few such piece, one that we already announced the results. And then two, that we already announced, we're going to have the results this year, one in the first half, at least. And the other one, we have not committed to that.

    謝謝,我確實明白這個問題。所以我要重申一下程度,但也要重申我之前說過的話。目前,我們有三項第三階段研究,其中一項我們已經公佈了結果。還有兩個我們已經宣布的,我們將在今年公佈結果,至少上半年會公佈一項。至於另一件事,我們還沒有做出承諾。

  • So we are extremely comfortable to a degree also by the person already said on the glove program, but also generally speaking, that this is really not a concern on our end in terms of the confirmation trial. I know we have two major Phase 3s that are reading out.

    因此,正如之前在手套項目上提到的那樣,我們對此感到非常放心,而且總的來說,就確認試驗而言,這真的不是我們擔心的問題。我知道我們有兩個主要的第三階段數據正在公佈。

  • In addition to a study that was positive on PFS but confounded ones. So this is I can -- as much as I can say at this point, we are not concerned about this. And I don't see a reason to be concerned also if you look at the precedent that was set by wash.

    除了對 PFS 有正面影響但存在混雜因素的研究之外。所以,就目前我能說的而言,我們並不擔心這個問題。而且,如果你看看華盛頓州確立的先例,我也看不出有什麼理由感到擔憂。

  • On the outpatient, I'll leave it to Brad to talk about the pattern of prescription. But what I would say to the outpatient study is that, that was an important strategy for a variety of reasons. One is, of course, what Brad talked about parts patents in the community, but it's also incredibly important component for our overall regulatory strategy to modify the label and to have label language that then also facilitates administration of the community and Brad, you can take it from here.

    關於門診病人,我會讓布拉德來談談處方模式。但我想對門診研究說的是,基於多種原因,這是一個重要的策略。當然,其中之一是布拉德在社區中談到的零件專利,但修改標籤並使用便於社區管理的標籤語言,也是我們整體監管策略中極其重要的組成部分。布拉德,接下來就交給你了。

  • Brad Bailey - Executive Vice President and Chief Commercial Officer

    Brad Bailey - Executive Vice President and Chief Commercial Officer

  • Yes. Just dovetailing off that, you're absolutely correct. And we do see this as certainly an enabler if you will. And as we continue to evolve and receive physician feedback specifically moving into even earlier more early lines of therapy. So this is a potential -- a great opportunity for us.

    是的。正好印證了這一點,你的說法完全正確。我們認為這無疑是一種促成因素。隨著我們不斷發展並收到醫生的回饋,我們將進一步推動更早的治療方案。所以這對我們來說是一個潛在的——一個巨大的機會。

  • Operator

    Operator

  • Xian Deng, UBS.

    鄧賢,瑞銀。

  • Xian Deng - Analyst

    Xian Deng - Analyst

  • Yes, here from UBS. So I have one on Rina-S, please. So given the pivotal Phase 2 that's due to come out this year, and given this is kind of pivotal Phase 2, and they're -- it's not a formal Phase 3. So just wondering, what's the difference when you can decide you are going to have a readout what is the definition of this? Because I guess here, you don't have to have the formal PFS here and it's open label 12.

    是的,我是瑞銀的。所以,我這裡有一個關於 Rina-S 的。鑑於今年即將公佈的關鍵性第二階段,而且這算是關鍵性的第二階段,而且──這並不是正式的第三階段。所以我想知道,當你決定要進行讀數時,這有什麼區別?這個讀數的定義是什麼?因為我猜在這裡,你不需要正式的 PFS,而且它是開放標籤 12。

  • So that's the first question. And then sorry, the second one, sir, just a very quick yes and no question, please. So for EPKINLY frontline DLBCL trial, just wondering, can you confirm whether you have passed the interim, please.

    這是第一個問題。抱歉,先生,第二個問題,請您快速問一個是非題。所以關於EPKINLY一線DLBCL試驗,請問您能否確認是否已經通過了中期試驗?

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thanks, Xian, for the question. The first one, I will ask Judith to address and Thai can give a very short answer on the second question. Why don't you start on the Phase 2 data for Rina?

    謝謝Xian的提問。第一個問題,我會請茱蒂絲回答;第二個問題,泰伊可以簡單回答。為什麼不開始著手處理 Rina 的第二期臨床試驗數據呢?

  • Judith Klimovsky - Executive Vice President, Chief Development Officer

    Judith Klimovsky - Executive Vice President, Chief Development Officer

  • So -- the study design or the pivotal arm with a potential outcome of being supportive of accelerated approval and accelerated approval is a path that the FDA has for -- when the results support with the substantial benefit over current standard of care with endpoints that can predict a substantial benefit.

    因此,研究設計或關鍵性研究方案的潛在結果可能支持加速批准,而加速批准是 FDA 為此類研究提供的途徑——當結果支持與當前標準治療相比具有實質益處,且終點能夠預測實質益處時。

  • So the way the Phase 2 design is for ORR and duration of response, which is our validated endpoint assure for clinical benefit. Now the asserted approval is also dependent on having Phase 3s with clinical endpoint. As you know, we have at study ongoing, which is a Phase 3 with PFS as always as the primary endpoint.

    因此,第二階段的設計目標是客觀緩解率 (ORR) 和緩解持續時間,這是我們已驗證的終點,可確保臨床效益。現在,所宣稱的批准也取決於是否進行了以臨床終點為指標的 3 期臨床試驗。如您所知,我們目前正在進行一項研究,這是一項 3 期研究,以 PFS 作為主要終點。

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thank you. And then maybe Tahi you get some color on the frontline diffuse large B cell lymphoma study.

    謝謝。然後,Tahi,或許你能從一線瀰漫性大B細胞淋巴瘤研究中獲得一些資訊。

  • Tahamtan Ahmadi - Executive Vice President, Chief Medical Officer, Head of Experimental Medicines

    Tahamtan Ahmadi - Executive Vice President, Chief Medical Officer, Head of Experimental Medicines

  • Thank you for the question. And I appreciate the attempt of a yes-no question, but we're just going to reiterate what we've been saying publicly at JPMorgan that we expect to read out for the study to happen in '26.

    謝謝你的提問。我很欣賞你們嘗試提出是非題,但我們只想重申摩根大通一直在公開表示的觀點,即我們預計在 2026 年公佈這項研究的結果。

  • Operator

    Operator

  • Rajan Sharma, Goldman Sachs.

    Rajan Sharma,高盛集團。

  • Rajan Sharma - Analyst

    Rajan Sharma - Analyst

  • Just same with EPKINLY. Could you just discuss your expectations into the EPCORE DBCL-4 trial. What do you think is a clinically meaningful outcome here, especially relative to Lunsumio and POLIVY?

    EPKINLY的情況也是一樣。您能否談談您對EPCORE DBCL-4試驗的期望?您認為在這裡,具有臨床意義的結果是什麼,特別是相對於 Lunsumio 和 POLIVY 而言?

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thanks, Rajan, for the question. Tahi, can you handle the -- address the DBCL-4 question?

    謝謝拉詹的提問。Tahi,可以處理一下關於 DBCL-4 的問題嗎?

  • Tahamtan Ahmadi - Executive Vice President, Chief Medical Officer, Head of Experimental Medicines

    Tahamtan Ahmadi - Executive Vice President, Chief Medical Officer, Head of Experimental Medicines

  • What many anticipation is that it will actually be a trial that we registered, which is the first differentiation to the studies that you mentioned that I think the intent as a study that has a -- as I said, combination with lenalidomide that was involved exclusively after the -- which was a significant confounder for a lot of the studies that were run with the bispecifics in the diffuse such piece space, not only the diffuse relevant to this conversation.

    許多人期待的是我們註冊的一項試驗,這與您提到的研究的第一個區別在於,我認為這項研究的目的是——正如我所說,與來那度胺聯合使用,並且僅在——之後進行——這對於許多在彌散空間中使用雙特異性抗體的研究來說是一個重要的混雜因素,而不僅僅是與本次討論相關的彌散空間。

  • And we're really excited and looking forward to this data set, which will also have a larger portion of second-line patient. And so the expectation is that this is a trial that will be positive and then will lead to registration in second that line.

    我們對此資料集感到非常興奮和期待,該資料集還將包含更大比例的二線患者。因此,預計這項試驗將會取得積極成果,然後將在第二步註冊。

  • Operator

    Operator

  • Judah Frommer, Morgan Stanley.

    猶大‧弗洛默,摩根士丹利。

  • Judah Frommer - Equity Analyst

    Judah Frommer - Equity Analyst

  • Just curious on your thoughts on the Pembro approval in PRO recently and kind of implications for Reni-S. And then maybe just more high level, we appreciate the guidance on DARZALEX. But I guess just kind of given positive data in combo with biospecific at ASH. Just curious if you have any kind of high-level thoughts on the DARZALEX trajectory over the coming years, maybe versus where your expectations were 6, 12 months ago for that drug?

    我很好奇您對 Pembro 在 PRO 中獲得批准有何看法,以及這對 Reni-S 有何影響。然後,或許從更高層面來說,我們感謝 DARZALEX 的指導。但我想,這大概是因為在 ASH 上結合生物特異性數據得出了積極的結論。我只是好奇您對達雷妥尤單抗(DARZALEX)未來幾年的發展軌跡有什麼高屋建瓴的看法,也許可以和您6個月前、12個月前對該藥物的預期相比如何?

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thanks, Judah. Judith, you just can you start and maybe Tahi can chip in.

    謝謝你,猶大。茱蒂思,你先開始吧,也許塔希可以幫忙。

  • Judith Klimovsky - Executive Vice President, Chief Development Officer

    Judith Klimovsky - Executive Vice President, Chief Development Officer

  • So we are aware -- of the data and the approval. I think it's a good potential option for patients. However, two things and not to underestimate. First that the approval is in PD-L1 positive CPS1 above 1%. And this income is around 70% of the population and be the combination includes weekly tax sold, which is not minor for patients. So on the one hand, it's great that patients have another option. On the other hand, we believe that line can be more transformative and served the full broad population.

    所以我們已經了解了數據和審批情況。我認為這對患者來說是一個很好的潛在選擇。然而,有兩件事不容低估。首先,該批准適用於 PD-L1 陽性 CPS1 大於 1% 的患者。而這筆收入約佔總人口的 70%,也包括每週的稅收收入,這對患者來說並非小數目。所以一方面,患者有另一種選擇是好事。另一方面,我們認為這條線路可以更具變革性,並服務於廣大民眾。

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thanks, Judith. I think that addresses your question, Judah. So let's move on to the next one.

    謝謝你,朱迪絲。我想我已經回答了你的問題,猶大。那我們來看下一個吧。

  • Operator

    Operator

  • James Gordon, Barclays.

    詹姆斯·戈登,巴克萊銀行。

  • James Gordon - Equity Analyst

    James Gordon - Equity Analyst

  • James Gordon from Barclays. Also a question on EPKINLY in first-line DLBCL. So my question was, what are you hoping to see when the trial reports in terms of the OS benefit? Would you hope to see a strong OS benefit even though it is a first-line trial and some other agents like POLIVY has struggled to do that? I know that related to lack of OS benefit.

    巴克萊銀行的詹姆斯‧戈登。另外還有一個關於EPKINLY在DLBCL第一線治療的問題。所以我的問題是,您希望在試驗報告中看到 OS 獲益的什麼結果?即使是第一線試驗,而其他一些藥物(如 POLIVY)卻難以達到預期效果,您是否希望看到顯著的 OS 獲益?我知道這與作業系統缺乏優勢有關。

  • And then connected to it, just what is the efficacy bar? Are you just hoping to be start? Would you need to be materially better than POLIVY -- given that Roche are doing a CD3 CD20 on top of POLIVY? And maybe also just thoughts on MONJUVI frontline trial as well in terms of whether that sets any sort of bar.

    那麼,與之相關的效能標準究竟是什麼呢?你只是想開始嗎?鑑於羅氏在 POLIVY 的基礎上又推出了 CD3 CD20,你的產品是否需要在實質上優於 POLIVY?或許還可以談談 MONJUVI 第一線試驗,看看它是否設定了某種標準。

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thank you, James, for the questions. This is definitely Tahi questions and very exciting questions. So let's see what Tahi answers.

    謝謝詹姆斯提出的問題。這絕對是塔希的問題,而且是非常令人興奮的問題。讓我們看看塔希會怎麼回答。

  • Tahamtan Ahmadi - Executive Vice President, Chief Medical Officer, Head of Experimental Medicines

    Tahamtan Ahmadi - Executive Vice President, Chief Medical Officer, Head of Experimental Medicines

  • Let's provide my best to answer your questions in the sequence. I think the first point that I think we've been very clear for a while is that the primary endpoint is PFS. The expectation on our end, the anticipation and the excitement is that we believe that in combination with ASH will be transformative. Of course, the data will have to show it.

    我會盡我所能按順序回答您的問題。我認為我們已經非常明確地指出,主要終點是 PFS。我們這邊的期望、期待和興奮之處在於,我們相信它與 ASH 的結合將會帶來改變。當然,最終還是要靠數據來證明。

  • We've been arguing for a while that the robust Phase 2 data sets have been quite informative in our development on the second half for the follicular lymphoma. Just to remind everybody again, the Phase 3 mimic almost to a point the efficacy that we had seen in the second line data set in combination with lend square, R2 in second half follicular lymphoma and if you then go back and visit the data that's in the public domain on -- combination with EPKINLY and IPF 3 to 5, in particular, pay attention to the CR, which is the most relevant data point.

    我們一直認為,可靠的 2 期資料集對我們開發濾泡性淋巴瘤的後半部非常有幫助。再次提醒大家,3 期試驗在某種程度上模擬了我們在二線資料集中看到的療效,該試驗合併 Lend Square 治療 R2 型濾泡性淋巴瘤的療效。如果您回顧公開數據,特別是合併 EPKINLY 治療 IPF 3 至 5 型的試驗,請注意 CR 值,這是最相關的數據點。

  • So there is a reason, and this is where the excitement enthusiasm the expectation comes from our end to believe that the study will be quite positive. I'm not going to speculate on what positive really, really means. But certainly, on a compound by compound, we anticipate that it's going to exceed the current reported Phase 3 data sets that are positive.

    所以,我們有理由相信這項研究會取得相當正面的成果,這也是我們感到興奮、熱情和期待的原因。我不想去揣測「積極」究竟意味著什麼。但可以肯定的是,就單一化合物而言,我們預計它將超過目前已報導的積極的 3 期臨床試驗數據。

  • As it relates to OS, you're absolutely right in the PFS, an endpoint that lags to a degree also by a change on practice, but also because of the impact on PFS. So I think this is a discussion we can have once we have the data set we can have a conversation on the scale of improvement in PFS and how that translates to us.

    就 OS 而言,您在 PFS 中的說法完全正確,該終點在一定程度上存在滯後,這不僅是因為實踐的變化,也是因為對 PFS 的影響。所以我認為,一旦我們有了資料集,我們就可以討論 PFS 的改進規模以及這對我們意味著什麼。

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thanks, Tahi. I think we have to leave it to that, but that was a very good answer. Thanks, Jim, for the question. Let's move on to the next question.

    謝謝你,塔希。我想我們只能到此為止了,但這確實是一個很好的答案。謝謝你的提問,吉姆。我們來看下一個問題。

  • Operator

    Operator

  • Zain Ebrahim, JPMorgan.

    Zain Ebrahim,摩根大通。

  • Zain Ebrahim - Analyst

    Zain Ebrahim - Analyst

  • A quick clarification question on EPKINLY just in the first-line DLBCL trial in terms of the events tracking how those are tracking relative to your expectations given reiteration of 2026 as opposed to narrowing it down to the first half?

    關於EPKINLY的第一線DLBCL試驗,我有一個需要快速澄清的問題:考慮到試驗時間定在2026年而不是上半年,這些事件的進展情況與您的預期相比如何?

  • And then my actual question was on the Merus acquisition. But following the acquisition completion, have you spoken to the FDA about the charge design for the ongoing Phase 3 trials. And based on those conversations, how confident you are the objective response rate is sufficient as a regulatory point?

    然後,我真正的問題是關於 Merus 的收購案。但是收購完成後,您是否與 FDA 討論過正在進行的 3 期試驗的收費方案設計?基於這些對話,您對客觀回應率作為監管要點的充分性有多大信心?

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thanks, Zain, for the question. So I'll ask Tahi to talk a bit about events tracking, if we can, and then Judith can potentially address the Pito question on trial design in head and neck council. Tahi, why don't you thought.

    謝謝Zain的提問。所以,如果可以的話,我會請 Tahi 談談事件跟踪,然後 Judith 可以就 Pito 在頭頸外科委員會提出的試驗設計問題發表看法。塔希,為什麼不想想呢?

  • Tahamtan Ahmadi - Executive Vice President, Chief Medical Officer, Head of Experimental Medicines

    Tahamtan Ahmadi - Executive Vice President, Chief Medical Officer, Head of Experimental Medicines

  • On events tracking, I don't necessarily think this is what we do in calls like this that we give a commentary on events tracking. So this is not something that we can do right now. But we obviously do track them.

    關於事件跟踪,我並不認為我們在這樣的電話會議上會專門對事件跟踪進行評論。所以,我們現在還做不到這一點。但我們顯然會追蹤它們。

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • All right. Then let's move on to Judith and then maybe some feedback on the design of the head and neck pivotal trials for Pito.

    好的。接下來我們來談談 Judith,然後或許可以就 Pito 的頭部和頸部關鍵試驗的設計提出一些回饋意見。

  • Judith Klimovsky - Executive Vice President, Chief Development Officer

    Judith Klimovsky - Executive Vice President, Chief Development Officer

  • As we all know, I mean, the 2 Phase 3 studies have dual endpoint ORR and OS, which I would say, as you know, the ORIGAMI-5 published as well ORR and OS . So it's quite under that in areas of unmet medical need, the FDA and even other health authorities can be prone to earlier endpoint that can be good or at associated with more overall survival. So we feel good with the dual endpoint that both studies have. And of course, as part of the integration, we are digging operational characteristics of the studies, but we are pleased with the design as is initially and with all end point.

    如我們所知,我的意思是,這兩項 3 期研究均以 ORR 和 OS 為雙終點,如您所知,ORIGAMI-5 也發表了 ORR 和 OS 數據。因此,在未滿足的醫療需求領域,FDA 甚至其他衛生機構可能會傾向於更早的終點,這可能與更高的整體存活率有關,或至少是良好的終點。因此,我們對這兩項研究的雙重終點感到滿意。當然,作為整合的一部分,我們正在深入研究這些研究的操作特性,但我們對目前的設計以及所有終點都感到滿意。

  • Operator

    Operator

  • Suzanne van Voorthuizen, Van Lanschot Kempen.

    蘇珊娜·範·沃爾特赫伊森,範·蘭肖特·肯彭。

  • Suzanne van Voorthuizen - Analyst

    Suzanne van Voorthuizen - Analyst

  • This is Suzanne from Kempen. I was wondering for Peto, whether we should be expecting a Phase 1/2 data update in head and neck cancer during this year at a medical conference? Considering especially the frontline data sets for the mature since ASCO last year. This could be very insightful for the market ahead of the Phase 3 readouts. And if there is a data update, could you elaborate what you believe the expectations should be on duration metrics and survival, for example?

    這是來自肯彭的蘇珊娜。我想問Peto,我們是否可以期待在今年的醫學會議上看到關於頭頸癌1/2期臨床試驗數據的最新進展?尤其要考慮到自去年ASCO以來成熟的第一線資料集。在第三階段試驗結果公佈之前,這對市場來說可能非常有參考價值。如果有數據更新,您能否詳細說明一下您認為在持續時間指標和生存率方面應該抱持怎樣的預期?

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thanks, Suzanne, for the questions. I will ask Judith to comment on that. Suzanne, as you know, we hope to see one or both of the Phase 3 data this year, but you asked specifically about the Phase 1/2 data.

    謝謝蘇珊娜的提問。我會請朱迪絲對此發表評論。Suzanne,如你所知,我們希望今年能看到 3 期臨床試驗中的一個或兩個數據,但你特別詢問的是 1/2 期臨床試驗的數據。

  • Judith Klimovsky - Executive Vice President, Chief Development Officer

    Judith Klimovsky - Executive Vice President, Chief Development Officer

  • I want to reinforce that the last readout for the Peto pembro combination with about 15 months follow-up, which allowed to see 79% of patients a 12-month landmark overall survival. And so of course, there is sensing, but the sensor happened after the 12, 16 months, is what you expect from the control arm.

    我想強調的是,Peto pembro 聯合療法的最後一次讀數,追蹤時間約為 15 個月,結果顯示 79% 的患者達到了 12 個月的總生存期里程碑。所以當然會有感應,但感應發生在 12、16 個月之後,這是控制臂的預期表現。

  • So what I'm trying to say is that the last ASCO 2025 presentation from Merus is very informative in terms of the probability of success of the Phase 2. And you can take advantage of that presentation already.

    所以我想說的是,Merus 在 2025 年 ASCO 會議上的最後一次演講,對於二期臨床試驗的成功機率來說,是非常有啟發性的。您現在就可以利用這份簡報了。

  • Operator

    Operator

  • Yaron Werber, TD Securities.

    Yaron Werber,TD證券。

  • Yaron Werber - Analyst

    Yaron Werber - Analyst

  • So a quick question, just as a natural follow-up. The OrigAMI-5 study, as you mentioned, use KEYTRUDA chemo as a combo, presumably in patients with more bulky, aggressive disease in frontline. Would you consider doing the same sort of trial design with Peto?

    那麼,我再問一個問題,這只是一個很自然的後續問題。如您所提到的,OrigAMI-5 研究採用 KEYTRUDA 化療作為聯合療法,大概是用於第一線治療病情較重、侵襲性較強的患者。您是否考慮對 Peto 進行相同的試驗設計?

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Judith, you address that question from Yaron on OrigAMI-5?

    Judith,你如何回答 Yaron 在 OrigAMI-5 上提出的問題?

  • Judith Klimovsky - Executive Vice President, Chief Development Officer

    Judith Klimovsky - Executive Vice President, Chief Development Officer

  • So first, let me now that we are stand behind the original strategy, which is combining it peto with pembro. And the reason is that the 65% ORR furthermore with six CRs is unprecedented even in the context of what we know for pembro chemo. So we are very pleased that our -- in place a strategy that could offer a chemo-free option for patients.

    首先,我要說明我們仍然支持最初的策略,將 peto 與 pembro 結合。原因是,65% 的 ORR 以及 6 例 CR 即使在我們所知的帕博利珠單抗化療的背景下也是前所未有的。因此,我們非常高興我們制定了一項策略,可以為患者提供無需化療的選擇。

  • Having said that, given the data that you have seen and we have seen on peto we believe that the CDP potentially could be expanded on many different directions. This could be one, but we are very -- we think that the chemo-free combination for patients that can offer almost double what the chemo can offer is a very good value proposition for patients.

    話雖如此,鑑於您和我們在 peto 上看到的數據,我們認為 CDP 有可能在許多不同的方向上擴展。這可能是其中之一,但我們非常——我們認為,對於患者而言,無需化療的聯合療法可以提供幾乎是化療兩倍的療效,這是一個非常好的價值主張。

  • Operator

    Operator

  • Qize Ding, Rothschild & Co.

    丁啟澤,羅斯柴爾德公司

  • Qize Ding - Analyst

    Qize Ding - Analyst

  • So I noticed that the petosemtamab is a Phase 2 stage for combining pembrolizumab in first-line non-small cell lung cancer. Just wanted to clarify, is this a new trial that was started in Q4 2025? If so, could you please share your high-level thoughts and expectations behind this study?

    所以我注意到,petosemtamab 是與 pembrolizumab 聯合用於一線非小細胞肺癌治療的 2 期臨床試驗。我想確認一下,這是2025年第四季啟動的新試驗嗎?如果是這樣,您能否分享一下您對這項研究的整體想法和期望?

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thanks, Qize, for the question. Judith, can you comment on the lung cancer trial for Peto?

    謝謝Qize的提問。茱迪思,可以談談佩託的肺癌試驗嗎?

  • Judith Klimovsky - Executive Vice President, Chief Development Officer

    Judith Klimovsky - Executive Vice President, Chief Development Officer

  • Yes, yes, I can. So as we know, EGFR is a good target for lung cancer. The study was planned as a signal seeking in the indications where cetuximab showed the maximum benefit. And in combination with pembro, given that what we know, which is the synergy between Peto and pembro. So it's a signal-seeking study, and we will update you when we have data.

    是的,是的,我可以。眾所周知,EGFR 是肺癌治療的良好標靶。該研究旨在尋找西妥昔單抗療效最大的適應症的訊號。結合 pembro,鑑於我們所知,Peto 和 pembro 之間存在協同作用。所以這是一項訊號探索研究,一旦我們有了數據,我們會及時通知您。

  • Operator

    Operator

  • Matthew Phipps, William Blair.

    馬修·菲普斯,威廉·布萊爾。

  • Matt Phipps - Analyst

    Matt Phipps - Analyst

  • Just to confirm, you listed an additional Phase 3 for Peto in 2026. Is that the locally advanced trial that you've already talked about or something else? And do you anticipate providing any update from the colorectal cancer cohorts that we saw in the fall or maybe thoughts on the development plan there?

    再次確認一下,您列出的 Peto 的第三階段計劃是在 2026 年。是你之前提到的本地先進試驗,還是別的?您預計會提供我們在秋季看到的結直腸癌隊列研究的最新進展嗎?或者您對該領域的發展計劃有什麼想法?

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thank you, Matt, for the question. So Judith, maybe you can address both of them.

    謝謝馬特的提問。所以朱迪思,或許你可以同時和他們兩個談談。

  • Judith Klimovsky - Executive Vice President, Chief Development Officer

    Judith Klimovsky - Executive Vice President, Chief Development Officer

  • Yes. Thank you for the question. So yes, that Merus presented in December on colorectal was very encouraging, albeit a limited number of patients as was shown publicly each one of the cohorts is to enroll 40, 40 and 60. So this data set is growing. And as the data is growing, we plan to inform the medical community.

    是的。謝謝你的提問。所以,是的,Merus 在 12 月發表的關於結直腸癌的研究結果非常令人鼓舞,儘管患者數量有限,正如公開顯示的那樣,每個隊列分別招募 40、40 和 60 名患者。所以這個資料集還在不斷成長。隨著數據的成長,我們計劃將資訊傳遞給醫學界。

  • And we have not decided when but the data set is growing. And in terms of future Phase 3s, we already mentioned the locally advanced head and neck, and we are actively working on a comprehensive clinical development plan.

    我們尚未決定何時進行,但數據集正在不斷增長。至於未來的 3 期臨床試驗,我們已經提到了局部晚期頭頸部腫瘤,我們正在積極制定全面的臨床開發計劃。

  • Operator

    Operator

  • Victor Floch, BNP Paribas.

    Victor Floch,法國巴黎銀行。

  • Victor Floch - Analyst

    Victor Floch - Analyst

  • Victor Flock from BNP Paribas. So maybe a quick one on the pipeline. And I mean, most significantly, your early-stage pipeline, which has been significantly streamlined over the last months. And to my knowledge, only content now to second stage bispecifics.

    來自法國巴黎銀行的 Victor Flock。所以,或許可以先快速推進一下專案。最重要的是,你們的早期研發流程在過去幾個月裡得到了極大的簡化。據我所知,目前只有第二階段的雙特異性抗體。

  • So I just wanted to hear your thoughts and maybe whether you can discuss your priorities moving forward in terms of platform technologies and therapeutic areas because I can't really like see any ADCs. So maybe I mean, whether you can discuss like what are the technologies behind the two recent INDs you've done. But so moving forward, whether you can discuss whether you believe you have enough candidates in-house? Or should we expect also some early-stage M&A at some point?

    所以我想聽聽您的想法,也許您能談談您未來在平台技術和治療領域方面的優先事項嗎?因為我目前還沒有看到任何抗體藥物偶聯物(ADC)。所以,我的意思是,您能否討論一下您最近提交的兩項IND背後的技術是什麼?那麼,展望未來,您能否討論一下您認為公司內部是否有足夠的候選人?或者我們也應該預期在某個階段會出現一些早期併購活動?

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Victor, let me start off here and Tahi can definitely chip in. We have recently actually had three IND filings, one for a bispecific antibody, one for ADC, making use of the linker and payload technology, which we acquired ProfoundBio, which is a bispecific, also including the HaxeBody technology. So when you look at our whole pipeline overall, the 45% is ADC right now, 50% is Duobody based, so bispecific based and 5% Hexabody-based, Victor.

    Victor,我先開始吧,Tahi肯定也能貢獻一些力量。我們最近實際上提交了三份 IND 申請,一份是雙特異性抗體,一份是 ADC,利用了我們收購 ProfoundBio 後獲得的連接子和有效載荷技術,這是一種雙特異性抗體,也包括 HaxeBody 技術。所以,縱觀我們整個產品線,目前 45% 是 ADC,50% 是基於雙特異性抗體的藥物,5% 是基於六特異性抗體的藥物,Victor 是其中之一。

  • But right now, we are integrating both the Merus pipeline and the Genmab pipeline and only prioritize the high-impact ones. Basically for further development. So we have a very, I think, diversified pipeline, all based on next-generation antibody technologies. But I will stop here and maybe Tahi can give you a bit more color on the organic pipeline, which is still a key priority for the company to actually fill the pipeline with candidates which can then be promoted to meta late-stage programs and due time.

    但目前,我們正在整合 Merus 和 Genmab 的產品線,並且只優先考慮那些具有高影響力的產品。主要是為了進一步發展。因此,我認為我們擁有非常多元化的產品線,全部基於下一代抗體技術。但我今天就到此為止,也許 Tahi 可以更詳細地介紹一下有機人才培養管道,這仍然是公司的一項關鍵優先事項,即真正地為人才培養渠道補充候選人,然後這些候選人可以晉升到後期項目,並按時完成。

  • Tahamtan Ahmadi - Executive Vice President, Chief Medical Officer, Head of Experimental Medicines

    Tahamtan Ahmadi - Executive Vice President, Chief Medical Officer, Head of Experimental Medicines

  • Yes, yes. I mean you're kind of framed this already like -- as you said, when we have three INDs that we file towards the end of the year with -- that are all expecting dosing this month. More to come on this end in this year as well. And our focuses are now, particularly also after the integration of Merus and the capabilities that came through that integration continue to be in antibodies and then they fall into these categories of next-generation ADC platforms, which is interest of our research in Suzhou and next-generation bispecific and bispecific platforms, there is obviously a focus on our research capabilities in Utrecht and that's what we're going to continue to do that.

    是的,是的。我的意思是,你已經把這件事定型了——就像你說的,我們今年年底會提交三個IND申請——預計這個月就能開始給藥。今年晚些時候,這方面還會有更多消息。我們現在的重點,尤其是在整合 Merus 之後,以及透過整合獲得的能力,仍然是抗體,它們屬於下一代 ADC 平台(這是我們蘇州研究的重點)和下一代雙特異性平台(顯然,我們烏得勒支的研究能力也專注於這些平台),我們將繼續這樣做。

  • There is, of course, a change now with a very heavily focused late-stage landscape within general with Peto being positioned in head and neck and maybe or see in the future also opportunities in colorectal with Rina being positioned in the GynOc space in ovarian and endometrial but also maybe possibly based on data also opportunities and other receptor alpha tumor stays very clearly.

    當然,現在情況有所變化,整體而言,後期治療領域非常集中,Peto 定位於頭頸部,未來或許在結直腸癌領域也有機會,Rina 定位於婦科腫瘤領域,包括卵巢癌和子宮內膜癌,但根據數據,或許也有機會,其他受體α腫瘤的治療前景非常明確。

  • Also a change on how we think internally about where our focus should be, right? So it's not completely a disease area focus, but without a doubt, we're starting to get into a space where we also started to think what combinatorial strategies for our internal assets. But generally speaking, you should expect more to come from our internal capabilities. And that in and of itself does not preclude that we will not continue to look for external innovation because that's what we're going to do.

    這同時也需要我們內在思考,重新檢視我們應該關注的重點,對嗎?所以,雖然它並不完全專注於某個疾病領域,但毫無疑問,我們開始進入一個領域,在這個領域,我們也開始思考如何為我們的內在資產制定組合策略。但總的來說,你應該期待我們內部能力能帶來更多成果。但這本身並不排除我們將不再尋求外部創新,因為這正是我們要做的事。

  • Operator

    Operator

  • Matthias Haggblom, Handelsbanken.

    馬蒂亞斯·哈格布洛姆,德國商業銀行。

  • Mattias Haggblom - Analyst

    Mattias Haggblom - Analyst

  • And I had one on Peto, an asset which you now own. Help me think about what you need in terms of additional information from ongoing or future clinical trials to specify our current sales potential from multibillion dollar to an actual number like you have for EPKINLY and Rina-S.

    我之前在 Peto 上投資過一個項目,現在這個項目歸你所有了。請幫我思考一下,您需要從正在進行或未來的臨床試驗中獲得哪些額外信息,才能將我們目前的銷售潛力從數十億美元具體化為像 EPKINLY 和 Rina-S 那樣的實際數字。

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thanks, Matthias, for the question. And I will hand it off with pleasure to Anthony Pagano to see what he's willing to say about the multibillion dollar potential of these molecules.

    謝謝馬蒂亞斯的提問。我將很樂意把這個問題交給安東尼·帕加諾,看看他願意對這些分子數十億美元的潛在價值發表什麼看法。

  • Anthony Pagano - Chief Financial Officer, Executive Vice President

    Anthony Pagano - Chief Financial Officer, Executive Vice President

  • Yes. Thanks, Matthias. So if you've heard from us since the time of the acquisition, we're highly encouraged by the data we've seen so far for petosemtamab highly encouraged by the outside in recognition from the FDA in terms of the breakthrough therapy designation and really looking forward here to one or more data readouts -- pivotal readouts during the course of 2026 and equally looking forward to potentially expanding into earlier lines in terms of starting a first Phase 3 and locally advanced head and neck cancer.

    是的。謝謝你,馬蒂亞斯。如果您自收購以來一直關注我們的動態,那麼我們對目前為止看到的 petosemtamab 數據感到非常鼓舞,對 FDA 授予其突破性療法認定表示高度認可也感到非常鼓舞,我們非常期待在 2026 年獲得一項或多項關鍵數據,並同樣期待著有可能將業務拓展到更早期的治療領域,例如啟動首個 3 期臨床試驗。

  • So if we look at this overall, petosemtamab has the characteristics of potentially being best-in-class first-in-class, and we're really focused on expanding accelerating it also make it broadest in class, starting, of course, in head and neck cancer. For now, we're going to remain with our guidance in terms of multibillion blockbuster potential. As we continue to review the opportunity, refine our CDP, see more data, we'll look for the right time to update that.

    因此,從整體來看,petosemtamab 具有成為同類最佳首創藥物的特徵,我們正致力於加速擴大其應用範圍,使其成為同類藥物中最廣泛的,當然,首先是從頭頸癌開始。目前,我們仍將維持先前關於其具有數十億美元票房潛力的預測。隨著我們不斷評估這項機遇,完善我們的客戶數據平台 (CDP),並獲得更多數據,我們將尋找合適的時機進行更新。

  • So I'm not going to front run this, Matthias, in terms of guiding to when we're going to potentially update guidance. But the key takeaway here really is that we're very happy owners of petosemtamab, and we look forward to seeing the data later in 2026 and continue to expand and accelerate the CDP.

    所以,馬蒂亞斯,我不會提前透露我們何時可能會更新指導意見。但關鍵在於,我們非常高興擁有 petosemtamab,我們期待在 2026 年稍後看到相關數據,並繼續擴大和加速 CDP。

  • Operator

    Operator

  • Sarah Bi, Guggenheim Partners.

    莎拉畢,古根漢合夥人。

  • Sarah Bi - Analyst

    Sarah Bi - Analyst

  • Just Sarah on for Michael Schmidt from Guggenheim. I wanted to quickly circle back to Rina-S, if you could comment on the size of the opportunities for Rina-S in and outside of Gynecol, including in the ongoing Phase 2? And then separately, super quickly, if you could clarify the terms of the debt offering announced late last year.

    只有莎拉在古根漢美術館為麥可·施密特介紹。我想快速地再談 Rina-S,您能否談談 Rina-S 在婦科領域內外的發展機遇,包括正在進行的 2 期臨床試驗?另外,能否盡快澄清一下去年底宣布的債務發行條款?

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thank you, Sarah. Anthony, can you address both questions for the size of the opportunity for Rina and also the debt offering terms?

    謝謝你,莎拉。安東尼,你能否回答一下關於Rina的投資機會規模以及債務發行條款這兩個問題?

  • Anthony Pagano - Chief Financial Officer, Executive Vice President

    Anthony Pagano - Chief Financial Officer, Executive Vice President

  • Sure. Happy to do so. First of all, everything I've just said about pitosentomab, I would echo for Rina-S .Very happy owners of Rina-S, and the team is really here looking for any opportunities to expand and accelerate the opportunity. Again looking forward to the first potentially pivotal and registrational data here during the course of 2026, initially in the platinum-resistant ovarian cancer setting.

    當然。我很樂意這樣做。首先,我剛才對匹托森托單抗所說的一切,我也同樣適用於Rina-S。Rina-S 的所有者們非常高興,團隊也確實在積極尋找任何機會來拓展業務並加速發展。再次期待在 2026 年獲得首批可能具有關鍵意義的註冊數據,最初是在鉑耐藥性卵巢癌領域。

  • Today, I can reiterate our overall guidance of $2 billion plus for Rina-S that's really underpinned by second line plus PROC, second line plus endometrial, second line plus PSOC and then also moving forward to frontline endometrial opportunity.

    今天,我可以重申我們對 Rina-S 的總體指導,即超過 20 億美元,這主要得益於二線加 PROC、二線加子宮內膜、二線加 PSOC,以及向一線子宮內膜機會的推進。

  • What's important to note for those first three indications that I've mentioned, second line PROC, second line endometrial second-line PSOC, we've already initiated phase 3 trials. So very excited about the opportunity. Very excited about what we're seeing in terms of the data so far, both in PROC and endometrial cancer.

    需要注意的是,對於我提到的前三個適應症,即二線 PROC、二線子宮內膜癌、第二線 PSOC,我們已經啟動了 3 期試驗。我非常興奮能有這個機會。就目前的數據而言,無論是在攝護腺癌或子宮內膜癌方面,我們都感到非常興奮。

  • So that takeaway as we continue to reiterate our peak year sales guidance of $2 billion plus and a very significant amount of clinical development work is ongoing to underpin that investment -- that peak year sales guidance, excuse me.

    因此,我們重申我們預計的年銷售高峰期目標為 20 億美元以上,並且正在進行大量的臨床開發工作以支持這項投資——抱歉,我說的是年銷售高峰期目標。

  • In terms of the overall debt offering. First of all, we're very pleased with the demand for the offering, both in quantum in terms of also the high-quality nature of the investors that ultimately subscribed to the deal. Again, it's $5.5 billion with roughly $2.5 billion of it being fixed. Another $3 billion is floating rate debt based upon a spread over three months [SOFR].

    就整體債務發行而言。首先,我們對此次發行的需求非常滿意,無論是發行規模還是最終認購該筆交易的投資者的高品質。再次強調,總金額為 55 億美元,其中約 25 億美元是用於修復的。另有30億美元是浮動利率債務,利率是基於三個月的利差。[SOFR]。

  • Now what we have done for the $3 billion that is floating around $1.6 billion being of that. We've hedged back to make it fixed. So net $4.1 billion is now fixed. As well as the remaining being floating.

    現在,我們已經處理了流水線上的30億美元,其中16億美元已經到位。我們已經採取了對沖措施來解決這個問題。因此,淨額41億美元現在已確定。其餘部分則漂浮在水面上。

  • One thing I would leave you with is that we've committed and remain committed to getting below 3 times gross leverage by the end of 2027. And what may be other data point to kind of help you sort of thing is through would be if you look at the kind of weighted average based upon current market conditions, the weighted average sort of effective interest rate of the debt is around 6.6%. So that's I can help for now.

    最後我想強調的是,我們已經承諾並將繼續致力於在 2027 年底前將總槓桿率降至 3 倍以下。或許還有一點數據可以幫助你,那就是,如果你查看基於當前市場狀況的加權平均值,債務的加權平均有效利率約為 6.6%。所以目前我能提供的幫助就這些了。

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thanks, Anthony. Thanks, Sara, for the questions. Let's see whether there's any further questions, operator?

    謝謝你,安東尼。謝謝薩拉提出的問題。操作員,請問還有其他問題嗎?

  • Operator

    Operator

  • Benjamin Jackson, Jeffries.

    班傑明·傑克遜,傑弗里斯。

  • Benjamin Jackson - Equity Analyst

    Benjamin Jackson - Equity Analyst

  • So just one for me. I guess, longer term, are you able to comment on how you're thinking about the level of sales and marketing investments needed to be made ahead of any potential launches, given that you're now starting to get into the later stages of a lot of this pivotal data. So how comfortable are you with how big and where the team is located today? And how much more scale needs to be achieved in terms of fee on the floor?

    那我就吃一個。我想,從長遠來看,鑑於您現在開始進入許多關鍵數據的後期階段,您能否就任何潛在產品發布之前需要進行的銷售和行銷投資水平發表一下看法?那麼,您對目前團隊的規模和辦公地點是否滿意?那麼,在現場收費方面,還需要達到多大的規模呢?

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thanks, Ben, for the question. And I will ask Brad to give you -- give a short feedback here. Brad?

    謝謝本的提問。我會請布拉德在這裡給你一些簡短的回饋。布拉德?

  • Brad Bailey - Executive Vice President and Chief Commercial Officer

    Brad Bailey - Executive Vice President and Chief Commercial Officer

  • Yes. Thank you for the question. And we continue to be disciplined on OpEx is guided, and certainly, we'll invest strategically to strengthen the development and commercialization to bring our medicines to as many patients as possible. We're strong with where we are today, both US and Japan and early signs in Europe are encouraging, and I look forward to sharing more in the not too distant future.

    是的。謝謝你的提問。我們將繼續嚴格控制營運支出,並進行策略性投資,以加強藥物研發和商業化,使盡可能多的患者能夠使用我們的藥物。我們目前在美國和日本的情況都很樂觀,歐洲的早期跡像也令人鼓舞,我期待在不久的將來與大家分享更多資訊。

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • Thanks, Brad. So more to come, Ben, in the future.

    謝謝你,布拉德。所以,本,未來還會有更多精彩內容。

  • Benjamin Jackson - Equity Analyst

    Benjamin Jackson - Equity Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Thank you, Benjamin. There are no further questions for today. I would now like to hand the conference over to your speaker, Jan Van De Winkel for any closing remarks.

    謝謝你,班傑明。今天沒有其他問題了。現在我謹將會議交給發言人 Jan Van De Winkel,請他作總結發言。

  • Jan van De Winkel - President, Chief Executive Officer

    Jan van De Winkel - President, Chief Executive Officer

  • 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 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您聯繫。

  • Operator

    Operator

  • This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.

    今天的電話會議到此結束。感謝您的參與。現在你們都可以斷開連結了。祝你今天過得愉快。