Genmab A/S (GMAB) 2023 Q4 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Genmab Full Year 2023 Financial Results Conference Call. (Operator Instructions). Please be advised that today's conference is being recorded.

美好的一天，感謝您的支持。歡迎參加 Genmab 2023 年全年財務業績電話會議。 （操作員說明）。請注意，今天的會議正在錄製中。

This presentation contains forward-looking statements. The words believe, expect, anticipate, intend, and plan and similar expressions identify forward-looking statements. All statements other than statements of historical facts included in this presentation including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations, including development plans and objectives relating to our products are forward-looking statements.

本簡報包含前瞻性陳述。 「相信」、「期望」、「預期」、「打算」和「計劃」等詞語以及類似的表達方式均屬於前瞻性陳述。本簡報中除歷史事實陳述外的所有陳述，包括但不限於有關我們的財務狀況、業務策略、未來營運管理計劃和目標的陳述，包括與我們產品相關的發展計劃和目標，均為前瞻性陳述。

Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding our present and future business strategies and the environment in which we will operate in the future.

此類前瞻性陳述涉及已知和未知的風險、不確定性和其他因素，可能導致我們的實際結果、績效或成就與此類前瞻性陳述明示或暗示的任何未來結果、績效或成就有重大差異。此類前瞻性聲明是基於有關我們當前和未來業務策略以及我們未來營運環境的眾多假設。

The important factors that could cause our actual results, performance or achievements to differ materially from those in the forward-looking statements include, among others, risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower-than-expected rate of patient recruitment, unforeseen safety issues resulting from the administration of our products in patients. Uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and the markets, our inability to attract and retain suitably qualified personnel, the enforceability or lack of protection of our patents or proprietary rates, our relationships with affiliated entities, changes and developments in technology, which may render our product obsolete and other factors.

可能導致我們的實際結果、績效或成就與前瞻性陳述中的結果、績效或成就存在重大差異的重要因素包括與產品發現和開發相關的風險、與臨床試驗結果相關的不確定性、慢於預期的病患招募率、因對病患使用我們的產品而導致的不可預見的安全問題。與產品製造相關的不確定性、我們的產品缺乏市場接受度、我們無法管理成長、與我們的業務領域和市場相關的競爭環境、我們無法吸引和留住合適的合格人員、可執行性或缺乏保護我們的專利或專有費率、我們與附屬實體的關係、可能導致我們的產品過時的技術變化和發展以及其他因素。

Further, certain forward-looking statements are based upon assumptions of future events, which may not prove to be accurate. The forward-looking statements in these documents speak only as at the date of this presentation. Genmab does not undertake any obligation to update or revise forward-looking statements in this presentation not to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

此外，某些前瞻性陳述是基於對未來事件的假設，這些假設可能並不準確。這些文件中的前瞻性陳述僅代表截至本簡報發布之日的情況。除非法律要求，Genmab 不承擔更新或修改本簡報中前瞻性聲明的任何義務，也不承擔確認此類陳述以反映做出日期之後或與實際結果相關的後續事件或情況的義務。

At this moment, I would like to hand the conference over to your first speaker today, Jan van de Winkel. Please go ahead.

現在，我想將會議交給今天的第一位發言人揚‧範‧德‧溫克爾 (Jan van de Winkel)。請繼續。

Hello and welcome to Genmab's conference call to discuss the company's financial results for the period ending December 31, 2023. With me today to present these results is our CFO, Anthony Pagano; and our Chief Operating Officer, Anthony Mancini. For the Q&A, we will be joined by our Chief Medical Officer, Tahi Ahmadi.

您好，歡迎參加 Genmab 的電話會議，討論該公司截至 2023 年 12 月 31 日的財務業績。今天與我一起介紹這些業績的是我們的首席財務官 Anthony Pagano；以及我們的營運長安東尼·曼奇尼。我們的首席醫療官 Tahi Ahmadi 將參加問答環節。

Let's move to Slide 2. As I already said, we will be making forward-looking statements, so please keep that in mind as we go through this call.

讓我們轉到投影片 2。正如我已經說過的，我們將做出前瞻性聲明，因此請在我們進行本次電話會議時牢記這一點。

Let's move to Slide 3. During today's presentation, we will reference products being developed under some of our strategic collaborations. This slide acknowledges those relationships.

讓我們轉到投影片 3。在今天的簡報中，我們將參考我們的一些策略合作下正在開發的產品。這張投影片承認了這些關係。

Let's move to Slide 4. Genmab has continued to have transformative growth in all areas of our company. This has been possible because of what makes us unique. We firmly believe in the natural ability of the immune system to fight against disease, and we use our deep understanding of disease mechanisms, [targets] and antibody biology to invent proprietary technologies. This in-house expertise is matched with strategic partnerships that help us to take our products further than we could on our own, and they give us access to high-quality and unique disease targets and additional cutting-edge technologies that can be combined with ours.

讓我們轉到投影片 4。Genmab 在我們公司的所有領域持續實現變革性成長。這之所以成為可能，是因為我們獨一無二。我們堅信免疫系統對抗疾病的天然能力，並利用對疾病機制、[標靶]和抗體生物學的深刻理解來發明專有技術。這種內部專業知識與策略合作夥伴關係相匹配，幫助我們比我們自己的產品走得更遠，並且它們使我們能夠獲得高品質和獨特的疾病目標以及可以與我們的技術相結合的其他尖端技術。

So we leverage a combination of cutting-edge scientific capabilities, our expertise in translational and positioned medicine, data science and AI as well as strategic partnerships to create a robust pipeline of potentially first-in-class and best-in-class products. The success of this model can be seen in the events of 2023. So let's review these now.

因此，我們綜合利用尖端科學能力、轉化醫學和定位醫學、數據科學和人工智慧方面的專業知識以及戰略合作夥伴關係，創建了一系列潛在的一流和一流產品。這種模式的成功可以從2023年發生的事件中看出。現在讓我們回顧一下這些事件。

Slide 5. 2023 was a truly remarkable year with multiple regulatory approvals for epcoritamab and as a reminder, Genmab is the commercial lead of EPKINLY in both the U.S. and Japan. We are pleased that how the launch is progressing so far but the current approvals are only the first step to potentially establishing epcoritamab as the core therapy across diffuse large B-cell lymphoma, follicular lymphoma and beyond.

投影片 5。2023 年確實是非凡的一年，epcoritamab 獲得了多項監管批准，提醒一下，Genmab 是 EPKINLY 在美國和日本的商業領先者。我們很高興看到迄今為止的上市進展，但目前的批准只是將 epcoritamab 確立為瀰漫性大 B 細胞淋巴瘤、濾泡性淋巴瘤等疾病核心療法的第一步。

In June, we announced positive top line results for the follicular lymphoma cohort of the Phase I/II EPCORE NHL-1 trial. This data, along with preliminary dose optimization was presented during the ASH Conference in December. It also supported 2 exciting regulatory actions that we announced in November: that the FDA had granted breakthrough therapy designation to epcoritamab for adults with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy. And that the EMA has validated a Type II variation application for epcoritamab for the same indication.

6 月，我們宣布了 I/II 期 EPCORE NHL-1 試驗濾泡性淋巴瘤隊列的陽性頂線結果。該數據以及初步劑量優化已在 12 月的 ASH 會議上公佈。它也支持我們在11 月宣布的2 項令人興奮的監管行動：FDA 已授予epcoritamab 突破性療法認定，用於治療經過2 線或以上全身治療的成人復發性或難治性濾泡性淋巴瘤。 EMA 已經驗證了 epcoritamab 的 II 型變異申請，用於相同的適應症。

Together with AbbVie, we are advancing a robust clinical development program for epcoritamab across B-cell malignancies.

我們與艾伯維 (AbbVie) 合作，正在推進一項針對 B 細胞惡性腫瘤的 epcoritamab 的強大臨床開發計劃。

In addition to the data in follicular lymphoma, you can also see this in the multiple Phase III studies that we anticipate will be initiated in 2024.

除了濾泡性淋巴瘤的數據外，您還可以在我們預計 2024 年啟動的多項 III 期研究中看到這一點。

Let's move to Slide 6. Epcoritamab is just one example of our maturing pipeline. We also saw progress with TIVDAK last year. As we noted in January, the FDA has accepted an sBLA seeking to convert the accelerated approval of TIVDAK in recurrent or metastatic cervical cancer into a full approval. The EMA has also accepted an MAA for TIVDAK in this indication. Both of these regulatory submissions were supported by the positive results from the confirmatory innovaTV 301 study in cervical cancer. And we look forward to the potential availability of TIVDAK to patients in need outside the U.S.

讓我們轉到幻燈片 6。Epcoritamab 只是我們成熟的產品線之一。去年我們也看到了 TIVDAK 的進展。正如我們在一月份指出的，FDA 已接受一項 sBLA，尋求將 TIVDAK 在復發性或轉移性子宮頸癌中的加速批准轉變為完全批准。 EMA 也接受了 TIVDAK 在此適應症的 MAA。這兩項監管提交均得到了子宮頸癌驗證性 innovaTV 301 研究的積極結果的支持。我們期待美國以外有需要的患者能夠獲得 TIVDAK。

In 2023, we also saw positive data from the innovaTV 207 study for tisotumab vedotin in head and neck cancer. And we are pleased with our plans to actively engage with health authorities on the next steps in this indication as well along with our partner, Seagen, which is now part of Pfizer.

2023 年，我們也看到了 innovaTV 207 研究中 tisotumab vedotin 治療頭頸癌的正面數據。我們很高興計劃與衛生當局以及我們的合作夥伴 Seagen（現已成為輝瑞的一部分）就該適應症的後續步驟積極合作。

Another program that has cleared for very high bar for continued investment in development is Acasunlimab or GEN1046 which we are co-developing with BioNTech. We were very pleased to announce in November that we have planned engagement with health authorities on the design of the pivotal trial for Acasunlimab in second-line non-small cell lung cancer and that we continue to plan to share the data on which this decision was based at a medical conference in the first half of 2024.

另一個持續投資開發門檻非常高的項目是 Acasunlimab 或 GEN1046，我們正在與 BioNTech 共同開發。我們非常高興地在 11 月宣布，我們計劃與衛生當局合作設計 Acasunlimab 治療二線非小細胞肺癌的關鍵試驗，並且我們繼續計劃分享做出這一決定所依據的數據。基於2024 年上半年的一次醫學會議。

In addition to maturing this program, we are also expanding it with a Phase II trial in endometrial cancer, which is currently recruiting. Moving to progress. We saw with other pipeline programs, as we also noted in November, we remain very encouraged by the clinical efficacy data we are seeing with GEN1042, and we are anticipating that we will have the data we need to determine next steps for this program this year.

除了使該項目變得成熟之外，我們還透過子宮內膜癌的 II 期試驗來擴展該項目，目前正在招募患者。走向進步。我們在其他管道項目中看到了這一點，正如我們在 11 月指出的那樣，我們對 GEN1042 所看到的臨床療效數據仍然感到非常鼓舞，我們預計今年將獲得確定該項目下一步所需的數據。

Looking at some of our earlier stage programs, the Phase I/II trial of GEN1047 or DuoBody-CD3xB7H4 is currently in the dose expansion phase, an important step in progressing our CD3-based bispecific platform in solid tumors. And GEN3017 or DuoBody-CD3xCD30 started recruitment for our first in human clinical trial.

縱觀我們的一些早期項目，GEN1047 或 DuoBody-CD3xB7H4 的 I/II 期試驗目前正處於劑量擴展階段，這是我們在實體瘤領域推進基於 CD3 的雙特異性平台的重要一步。 GEN3017 或 DuoBody-CD3xCD30 開始招募我們的第一個人體臨床試驗。

Finally, we had 2 IND submissions near the end of last year, GEN1059 or DuoBody-EpCAMx4-1BB, which just saw its first patient in a Phase I trial, and GEN1055 or HexaBody-OX40. Both of these antibodies are being co-developed with BioNTech. The success of the Genmab model is also apparent in our move into the therapeutic area of I&I with our partnership with argenx. With a deep scientific knowledge of antibody biology and antibody technology and expansion into this therapeutic area was a logical next step. And with 8 approved medicines on the market, that are based on our cutting-edge innovations, we will continue to have growing recurring revenue streams that we can strategically invest in our company.

最後，我們在去年年底提交了 2 份 IND 申請，分別是 GEN1059 或 DuoBody-EpCAMx4-1BB（剛剛在 I 期試驗中看到了第一位患者）以及 GEN1055 或 HexaBody-OX40。這兩種抗體均是與 BioNTech 共同開發的。 Genmab 模式的成功也體現在我們與 argenx 的合作進入 I&I 治療領域。憑藉對抗體生物學和抗體技術的深入科學知識，下一步擴展到該治療領域是合乎邏輯的。市場上有 8 種基於我們尖端創新的核准藥物，我們將繼續擁有不斷增長的經常性收入流，我們可以對我們的公司進行策略性投資。

Finally, Anthony Pagano, our CFO, will outline our capital allocation strategy focused on fueling growth and enhancing shareholder value. We are investing in our mid- to late-stage pipeline and pursuing growth through targeted business development and acquisitions. After prioritizing these areas, we will consider returning capital to shareholders. And here, we plan to seek authorization for a DKK 3.5 billion buyback at our upcoming AGM.

最後，我們的財務長安東尼·帕加諾將概述我們的資本配置策略，重點是促進成長和提高股東價值。我們正在投資中後期產品線，並透過有針對性的業務開發和收購來追求成長。在優先考慮這些領域之後，我們將考慮向股東返還資本。在這裡，我們計劃在即將召開的年度股東大會上尋求 35 億丹麥克朗回購的授權。

I'm pleased to now turn the call over to Anthony Mancini to take you through our 2023 net product sales, Anthony, the floor is yours.

我現在很高興將電話轉給安東尼·曼奇尼，帶您了解我們 2023 年的產品淨銷售額，安東尼，請發言。

Thanks, Jan. I'll review our Q4 and full year 2023 product revenue performance on Slide 7. Our business is comprised of two key revenue streams: royalty medicines shown here; and in-market or launch medicines, which we commercialize ourselves with partners.

謝謝，Jan。我將在幻燈片 7 上回顧我們的第四季度和 2023 年全年產品收入表現。我們的業務由兩個主要收入來源組成：此處顯示的特許權使用費藥品；我們與合作夥伴一起將上市或上市的藥物商業化。

Our portfolio includes six main royalty medicines DARZALEX, Kesimpta, TEPEZZA, TECVAYLI, RYBREVANT and TALVEY. DARZALEX showed continued strong demand growth in Q4 with over $2.5 billion in net sales, a 22% year-over-year growth and the full year result was over $9.74 billion, driven by volume growth, also a 22% year-on-year growth. Over 450,000 patients have been treated with DARZALEX around the world. We're encouraged by the continued market share gains in the first-line setting.

我們的產品組合包括六種主要專利藥物 DARZALEX、Kesimpta、TEPEZZA、TECVAYLI、RYBREVANT 和 TALVEY。 DARZALEX 在第四季度表現出持續強勁的需求成長，淨銷售額超過 25 億美元，年增 22%，在銷量成長的推動下，全年業績超過 97.4 億美元，年增 22% 。全球已有超過 45 萬名患者接受了 DARZALEX 治療。我們對一線市場份額的持續成長感到鼓舞。

The J&J focus in this setting is anchored by compelling long-term MAIA OS data, which is helping establish DARZALEX as a foundation to overall survival in the first-line multiple myeloma space. With the recent filing of PERSEUS, there are continued growth opportunities ahead with DARZALEX subcu based therapies in the frontline transplant-eligible multiple myeloma space, including maintenance. DARZALEX is also being combined with both newer and older therapies in myeloma like two of our recently approved DuoBody medicines, TECVAYLI and TALVEY. We expect continued growth and usage of DARZALEX as a backbone in later line settings as well.

強生在這一領域的重點是以引人注目的長期 MAIA OS 數據為基礎，這些數據有助於將 DARZALEX 打造成一線多發性骨髓瘤領域整體生存的基礎。隨著 PERSEUS 最近的申請，基於 DARZALEX subcu 的療法在符合移植資格的多發性骨髓瘤一線領域存在持續增長的機會，包括維持。 DARZALEX 也與骨髓瘤的新舊療法相結合，例如我們最近批准的兩種 DuoBody 藥物 TECVAYLI 和 TALVEY。我們預計 DARZALEX 也會持續成長並作為後期生產線設置的支柱。

Kesimpta achieved continued strong demand growth with $640 million in the quarter and $2.2 billion for the full year 2023. Kesimpta demand growth is not only progressing well in the United States, but also ex-U.S. It is now the NBRx share leader in 7 of 10 major markets outside the U.S. over 85,000 patients have now been treated since the launch in August 2020.

Kesimpta 實現了持續強勁的需求成長，本季達到 6.4 億美元，2023 年全年達到 22 億美元。Kesimpta 的需求成長不僅在美國進展順利，在美國以外的地區也進展順利。目前，它是美國以外 10 個主要市場中 7 個市場中 NBRx 市場份額的領導者。自 2020 年 8 月推出以來，已有超過 85,000 名患者接受了治療。

On our other royalty medicines, with the acquisition of Horizon by Amgen, TEPEZZA, the first and only FDA-approved treatment for thyroid eye disease continued to grow in the quarter. TEPEZZA was also approved in Brazil and was submitted for regulatory review in Japan in Q4. European filings are planned in 2024.

在我們的其他專利藥品方面，隨著安進 (Amgen) 收購 Horizo​​​​n，TEPEZZA（第一個也是唯一一個獲得 FDA 批准的甲狀腺眼病治療藥物）在本季度繼續增長。 TEPEZZA 也在巴西獲得批准，並於第四季在日本提交監管審查。計劃於 2024 年向歐洲提交申請。

TECVAYLI and TALVEY, 2 bispecific T-cell engagers based on our DuoBody technology, both in launch mode continue to perform well in relapsed or refractory multiple myeloma.

TECVAYLI 和 TALVEY 是兩種基於我們的 DuoBody 技術的雙特異性 T 細胞接合劑，兩者均處於啟動模式，在復發或難治性多發性骨髓瘤中繼續表現良好。

For RYBREVANT, another DuoBody, data from the Phase III MARIPOSA and Phase III MARIPOSA-2 studies have been filed in Q4 in the first-line treatment of patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer as well as in patients with EGFR-mutated non-small cell lung cancer who failed prior therapy. There have been three submissions based on Phase III data from the RYBREVANT clinical development program in the last four months of 2023. We expect to see continued strong Genmab revenue growth from our diverse royalty medicines portfolio in 2024.

對於另一款 DuoBody RYBREVANT，III 期 MARIPOSA 和 III 期 MARIPOSA-2 研究的數據已於第四季度提交，用於一線治療局部晚期或轉移性 EGFR 突變陽性非小細胞肺癌以及先前治療失敗的EGFR 突變非小細胞肺癌患者。 2023 年最後四個月，已根據 RYBREVANT 臨床開發計畫的 III 期數據提交了三份申請。我們預計 2024 年我們多元化的特許權藥物組合中的 Genmab 收入將持續強勁增長。

Turning to our in-market performance on Slide 8. EPKINLY delivered $36 million in net sales in Q4 and $64 million for the full year 2023, of which $55 million is from the U.S. market. We're very pleased with EPKINLY's early launch demand performance across geographies. In the U.S., we continue to see robust uptake across key accounts.

轉向幻燈片 8 中我們的市場表現。EPKINLY 在第四季度實現了 3600 萬美元的淨銷售額，2023 年全年實現了 6400 萬美元的淨銷售額，其中 5500 萬美元來自美國市場。我們對 EPKINLY 在各個地區的早期發布需求表現感到非常滿意。在美國，我們繼續看到主要客戶的強勁使用。

In Japan, EPKINLY was launched in late November after receiving a national health insurance price listing. We're also highly encouraged by the early launch momentum and overall positive response received from our customers in Japan. We have continued to effectively leverage the first-to-market advantage in the CD3, CD20 class in both the U.S. and Japan. EPKINLY's clinically differentiated profile is making a meaningful impact in our first indication, third-line plus diffuse large B-cell lymphoma in an area of very high unmet medical need.

在日本，EPKINLY 在收到國民健康保險價格清單後於 11 月下旬推出。我們也對早期的推出動能和日本客戶的整體正面回應感到非常鼓舞。我們繼續有效利用美國和日本 CD3、CD20 等級的率先上市優勢。 EPKINLY 的臨床差異化特徵正在對我們的第一個適應症、三線加瀰漫性大 B 細胞淋巴瘤產生有意義的影響，該領域的醫療需求尚未得到滿足。

Our third line plus DLBCL indication is the first step to establishing EPKINLY as the core therapy across B-cell malignancies like follicular lymphoma and in earlier lines of treatment.

我們的第三線加 DLBCL 適應症是將 EPKINLY 確立為濾泡性淋巴瘤等 B 細胞惡性腫瘤和早期治療線的核心療法的第一步。

Turning to TIVDAK. TIVDAK delivered $25 million in net sales in Q4 and $90 million for the full year 2023. This represents the ninth consecutive quarter of demand growth. We are pleased with TIVDAK's performance and growth, primarily driven by an increasing breadth of ordering accounts. [Gyn onc and Med onc] customers continue to provide positive feedback on the impact TIVDAK is making on the lives of women with cervical cancer.

轉向 TIVDAK。 TIVDAK 在第四季度實現了 2,500 萬美元的淨銷售額，2023 年全年實現了 9,000 萬美元的淨銷售額。這代表需求連續第九個季度增長。我們對 TIVDAK 的業績和成長感到滿意，這主要是由訂購帳戶範圍不斷擴大所推動的。 [Gyn onc 和 Med onc] 客戶繼續就 TIVDAK 對患有子宮頸癌的女性的生活產生的影響提供積極的回饋。

On January 9, along with Pfizer, we announced the FDA granted priority review for the sBLA for TIVDAK based on innovaTV 301, which showed meaningful OS data with an FDA PDUFA action date of May 9. The customer reaction to innovaTV 301 has been very positive, with most stating that this data establishes TIVDAK as a clear standard of care in second line plus recurrent metastatic cervical cancer.

1 月 9 日，我們與輝瑞一起宣布 FDA 授予基於 innovaTV 301 的 TIVDAK sBLA 優先審查，該藥物顯示了有意義的 OS 數據，FDA PDUFA 行動日期為 5 月 9 日。客戶對 innovaTV 301 的反應非常積極，大多數人指出，該數據將TIVDAK 確立為二線加復發性轉移性子宮頸癌的明確照護標準。

As an end-to-end biotech, we're very pleased with our in-market medicines performance and look forward to carrying this momentum into 2024. We anticipate that our in-market medicines EPKINLY and TIVDAK will contribute just under 40% of Genmab's total revenue growth in 2024.

作為一家端到端生物技術公司，我們對我們的市場藥品表現非常滿意，並期待將這一勢頭延續到 2024 年。我們預計我們的市場藥品 EPKINLY 和 TIVDAK 將佔 Genmab 銷售額的近 40% 2024 年總收入成長。

I want to take this opportunity to thank our partners, and I want to thank the Genmab team across commercialization, research and development and enabling functions for all they do every day to deliver our commitment to the patients we serve.

我想藉此機會感謝我們的合作夥伴，並感謝 Genmab 團隊在商業化、研發和支援職能方面每天所做的一切，以兌現我們對我們所服務的患者的承諾。

With that, let me hand it off to Anthony Pagano to provide more perspective on our total company performance and our guidance for 2024. Anthony?

接下來，讓我將其交給 Anthony Pagano，他會為我們公司的整體業績和 2024 年的指導提供更多視角。安東尼？

Thanks, Anthony. We continue to strengthen our foundation during 2023. To start, as Jan said, together with our partner, AbbVie, we've achieved our goal of regulatory approvals and launches for EPKINLY in the U.S., Europe and Japan. And as we'll see, our financials for the year were strong.

謝謝，安東尼。我們將在 2023 年繼續加強我們的基礎。正如 Jan 所說，首先，我們與我們的合作夥伴艾伯維 (AbbVie) 一起實現了 EPKINLY 在美國、歐洲和日本獲得監管批准和上市的目標。正如我們將看到的，我們今年的財務狀況非常強勁。

Recurring revenues grew by 22% on a reported basis. And this was principally driven by strong royalties from DARZALEX along with significant growth from the other approved medicines based on our innovations, including TIVDAK and EPKINLY. Our solid balance sheet, growing recurring revenues and significant underlying profitability allow us to continue to invest in our business, in our pipeline in a very focused and disciplined way. And an important part of this has been to continue to build the team and capabilities we need to succeed. So let's take a look at those revenues in a bit more detail.

據報告，經常性收入增加了 22%。這主要是由 DARZALEX 的高額特許權使用費以及基於我們的創新的其他批准藥物（包括 TIVDAK 和 EPKINLY）的顯著增長推動的。我們穩健的資產負債表、不斷增長的經常性收入和顯著的潛在盈利能力使我們能夠繼續以非常專注和嚴格的方式投資於我們的業務和管道。其中一個重要部分是繼續建立我們成功所需的團隊和能力。因此，讓我們更詳細地了解這些收入。

We grew total revenue to around DKK 16.5 billion in 2023. And as I've already highlighted, that included a 22% increase in our recurring revenue. And to be clear, that's on a reported basis. Excluding some FX headwinds, which I've described throughout the year, recurring revenues grew by 31% on an operational basis.

到 2023 年，我們的總收入增加了約 165 億丹麥克朗。正如我已經強調的，其中包括我們的經常性收入成長了 22%。需要明確的是，這是根據報告得出的。排除我在全年所描述的一些外匯不利因素，經常性收入在營運基礎上成長了 31%。

Operational growth in 2023 continued to be strong, driven by higher DARZALEX royalties as well as royalties from other products, and this really illustrates the power of our recurring revenue. We also recognized the first quarters of net product sales for EPKINLY in Q3 and Q4. And we're really pleased with how the launch is progressing so far with around DKK 421 million in sales since launch. Of note, EPKINLY net product sales by Genmab contributed more than 20% of our overall revenue growth in 2023. Overall, our strong recurring revenue growth enables continued highly focused investment, as you can see on the next slide.

在 DARZALEX 特許權使用費以及其他產品特許權使用費增加的推動下，2023 年的營運成長持續強勁，這真正說明了我們經常性收入的力量。我們也確認了 EPKINLY 第三季和第四季的第一季產品淨銷售額。我們對迄今為止的發布進度感到非常滿意，自發布以來銷售額約為 4.21 億丹麥克朗。值得注意的是，Genmab 的EPKINLY 產品淨銷售額占我們2023 年整體收入成長的20% 以上。總體而言，我們強勁的經常性收入成長使我們能夠持續進行高度集中的投資，正如您在下一張幻燈片中看到的那樣。

A year ago, we were very clear that we would continue to invest to capture the opportunities we see in front of us, and that's exactly what we've done here with total OpEx up 33% in 2023. At that time, I outlined our top 4 investment priorities: first, securing a successful EPKINLY launch by investing in our two key markets, the U.S. and Japan.

一年前，我們非常清楚，我們將繼續投資以抓住我們面前的機會，而這正是我們在這裡所做的，到 2023 年總營運支出將增加 33%。當時，我概述了我們的目標四大投資重點：首先，透過投資美國和日本這兩個關鍵市場來確保EPKINLY 的成功推出。

Second, continuing to advance our pipeline. Here, the lion's share of our investment was directed to our most advanced programs, including EPKINLY, TIVDAK, 1046 and 1042.

二是繼續推進管道建設。在這裡，我們的大部分投資都投向了我們最先進的項目，包括 EPKINLY、TIVDAK、1046 和 1042。

Third, investing in a world-class discovery engine. And fourth, foundational investments in enabling functions to achieve required scale. Here, it's important to note that as we exit Q4 of 2023, we believe we have reached scale and our enabling functions. So as you can see, our investments in 2023 were fully in line with these priorities.

第三，投資世界​​一流的發現引擎。第四，對使職能能達到所需規模的基礎性投資。在這裡，值得注意的是，隨著我們退出 2023 年第四季度，我們相信我們已經達到了規模和我們的支援功能。正如您所看到的，我們 2023 年的投資完全符合這些優先事項。

Now with that, let's take a look at our financials as a whole. Here, you can see our summary P&L for 2023. Revenue came in at around DKK 16.5 billion. That's up 14% on last year. Total expenses were about $10.9 billion with 70% being R&D and 30% SG&A. And that compares to 68% in R&D and 32% in SG&A in 2022. And even with this increased investment, we're still delivering around DKK 5.3 billion of operating profit.

現在，讓我們來看看我們的整體財務狀況。在這裡，您可以看到我們 2023 年損益表摘要。收入約為 165 億丹麥克朗。比去年增長了 14%。總支出約 109 億美元，其中 70% 用於研發，30% 用於銷售、管理和行政費用。相較之下，到 2022 年，研發支出將佔 68%，SG&A 支出將佔 32%。即使增加了投資，我們仍能實現約 53 億丹麥克朗的營業利潤。

Moving now to our net financial items. Here, we have a gain of DKK 316 million in 2023. This is driven by an increase in interest income due to higher effective interest rates which offset the negative impact of the weakening U.S. dollar against the Danish kroner. Then we have tax expense of about $1.3 billion, which equates to an effective tax rate of 22.8%. And that brings us to a net profit of nearly DKK 4.4 billion. So as you can see, continued strong underlying financial performance.

現在轉向我們的淨財務項目。在這裡，我們在 2023 年獲得了 3.16 億丹麥克朗的收益。這是由於實際利率上升導致利息收入增加，抵消了美元兌丹麥克朗疲軟的負面影響。那麼我們的稅收支出約為13億美元，相當於有效稅率為22.8%。這為我們帶來了近 44 億丹麥克朗的淨利。正如您所看到的，基本財務表現持續強勁。

And with that, let's take a minute to revisit our robust financial framework. First off, our revenue profile on the left. With the approval of EPKINLY in May and TALVEY in August of 2023, there are now 8 products on the market that are generating significant recurring revenues for us. And we expect significant cash inflows in the years to come.

接下來，讓我們花一點時間回顧一下我們穩健的財務框架。首先，左邊是我們的收入概況。隨著 EPKINLY 於 5 月獲得批准，TALVEY 於 2023 年 8 月獲得批准，目前市場上有 8 種產品正在為我們帶來可觀的經常性收入。我們預計未來幾年將出現大量現金流入。

Moving to the right. We remain focused on our investments as we evolve our organization for continued success. At the top of the list is accelerating and expanding EPCORE with 3 new Phase III trials planned for 2024. But that's just one of the exciting opportunities that provide us with a compelling rationale for investing back in our business. As we've told you before, if we want to seize these meaningful opportunities, we've got to invest, and that's exactly what we're doing. With planned Phase IIIs, not only for EPCORE, but also for TIVDAK and 1046 in 2024.

向右移動。在我們不斷發展我們的組織以取得持續成功的同時，我們仍然專注於我們的投資。首要任務是加速和擴大 EPCORE，計劃於 2024 年進行 3 個新的 III 期試驗。但這只是令人興奮的機會之一，為我們的業務投資提供了令人信服的理由。正如我們之前告訴過您的，如果我們想抓住這些有意義的機會，我們就必須進行投資，而這正是我們正在做的事情。計劃於 2024 年進行 III 期試驗，不僅針對 EPCORE，還針對 TIVDAK 和 1046。

So with that background, let's move to our 2024 financial guidance. Before getting into the specifics, let's cover the highlights. We anticipate strong growth in revenue and operating profit for 2024 at 19% and 10% at the midpoint, respectively. For revenue, this growth will be driven by our royalty medicines and also importantly, we will have over DKK 1.2 billion of growth from EPKINLY and TIVDAK. In fact, EPKINLY and TIVDAK are driving nearly 40% of our total revenue growth in 2024.

有了這樣的背景，我們就​​來看看 2024 年的財務指引。在討論具體細節之前，讓我們先來介紹一下重點內容。我們預計 2024 年營收和營業利潤將強勁成長，中間值分別為 19% 和 10%。就收入而言，這一成長將由我們的專利藥品推動，更重要的是，我們將從 EPKINLY 和 TIVDAK 獲得超過 12 億丹麥克朗的成長。事實上，EPKINLY 和 TIVDAK 推動了我們 2024 年總營收成長的近 40%。

And note, our revenue growth of 19% will exceed our OpEx growth of 18%. On the investment side, our OpEx growth is projected to slow down significantly year-over-year. Last year, we saw a growth of 33%. And now for 2024, we're projecting 18%. And our projected DKK 2 billion increase in OpEx for 2024 at the midpoint is down from the $2.7 billion increase that we saw in 2023.

請注意，我們 19% 的收入成長將超過 18% 的營運支出成長。在投資方面，我們的營運支出成長預計將比去年同期大幅放緩。去年，我們看到了 33% 的成長。現在，我們預計 2024 年將達到 18%。我們預計 2024 年營運支出將增加 20 億丹麥克朗，低於 2023 年 27 億美元的增幅。

So clearly, this is a significant reduction in both percentage terms and absolute Danish kroner terms. The vast majority of the increase in our investments in 2024 is directly related to mid- to late-stage R&D investments. And the increase in SG&A is muted and its primarily related to the annualization or timing impact of investments that came online in 2023 related to the launches of EPKINLY in the U.S. and Japan.

很明顯，無論是百分比還是絕對丹麥克朗，這都是顯著減少。 2024年我們的投資成長絕大多數與中後期研發投資有直接關係。 SG&A 的成長不大，這主要與 2023 年在美國和日本推出 EPKINLY 相關的投資的年化或時間影響有關。

And finally, the significant revenue growth and our continued focused approach to managing our investments translates to a projected double-digit or 10% growth in operating profit at the midpoint of the guidance range. So with that background, let's take a look at the components of our strong recurring revenue.

最後，顯著的收入成長和我們持續專注的投資管理方法意味著預計營業利潤將在指導範圍的中點實現兩位數或 10% 的成長。因此，在這樣的背景下，讓我們來看看我們強勁的經常性收入的組成部分。

For 2024, we anticipate another year of strong underlying revenue growth at 19%. Before I get into the detail, note that these projections are based on an assumed U.S. dollar, Danish krone exchange rate of 6.8%.

對於 2024 年，我們預計基礎收入將持續強勁成長 19%。在詳細介紹之前，請注意，這些預測是基於假設的美元兌丹麥克朗匯率為 6.8% 的情況。

Looking at our total revenue, we're expecting to be in the range of $18.7 billion to DKK 20.5 billion. A significant part of this will come from recurring revenue, where we expect around 25% growth at the midpoint. And as a reminder, our recurring revenue is comprised of our royalties and our net product sales and collaboration revenue. We anticipate that DARZALEX sales will continue to ramp up to be in the range of $10.9 billion to $11.5 billion. So we're projecting DARZALEX royalties to be between DKK 12.6 billion to DKK 13.3 billion.

從我們的總收入來看，我們預計將在 187 億美元至 205 億丹麥克朗之間。其中很大一部分將來自經常性收入，我們預計中點成長率約為 25%。提醒一下，我們的經常性收入包括我們的特許權使用費以及我們的淨產品銷售和協作收入。我們預計 DARZALEX 銷售額將繼續成長，達到 109 億美元至 115 億美元。因此，我們預計 DARZALEX 特許權使用費將在 126 億丹麥克朗至 133 億丹麥克朗之間。

Most excitingly, as mentioned, nearly 40% of the revenue growth is projected to come from our two marketed products: EPKINLY and TIVDAK. This really illustrates how we're crystallizing and realizing value from the important and focused investments we've made over the last several years in both R&D and commercialization.

最令人興奮的是，如前所述，預計近 40% 的營收成長將來自我們的兩種上市產品：EPKINLY 和 TIVDAK。這確實說明了我們如何從過去幾年在研發和商業化方面進行的重要且集中的投資中具體化和實現價值。

Now for our nonrecurring revenue, we expect this to be $1.5 billion at the midpoint. The decrease is primarily related to lower reimbursement revenue. Note that we've included a significant sales milestone related to Kesimpta, both in the bottom and top end of our guidance range.

現在，我們的非經常性收入預計中位數為 15 億美元。減少主要與報銷收入減少有關。請注意，我們已經將與 Kesimpta 相關的重要銷售里程碑納入了我們的指導範圍的底部和頂部。

With that, let's take a look at our planned investments for 2024. We expect total OpEx to be between DKK 12.4 billion and DKK 13.4 billion. This truly reflects the evolution of our pipeline and indeed, our entire business. We have two near-term investment priorities. First, the continued commercialization, development and expansion of EPKINLY, including initiating new Phase III trials that will really maximize its potential.

接下來，讓我們來看看我們 2024 年的投資計畫。我們預計營運支出總額將在 124 億丹麥克朗至 134 億丹麥克朗之間。這真實地反映了我們管道乃至整個業務的演變。我們有兩個近期投資重點。首先，EPKINLY 的持續商業化、開發和擴展，包括啟動新的 III 期試驗，這將真正最大限度地發揮其潛力。

Second is progressing the other promising programs in our pipeline, especially 1046 and TIVDAK. These are our immediate priorities. But we're not just focused on today. In line with our vision, we're also very focused on long-term value creation. We're investing to maximize the value of our current technologies, and we're also investing to generate the next wave of IND candidates and to progress our early-stage pipeline.

其次是推進我們管道中其他有前途的項目，特別是 1046 和 TIVDAK。這些都是我們的當務之急。但我們不僅僅關註今天。根據我們的願景，我們也非常注重長期價值創造。我們正在投資以最大限度地發揮現有技術的價值，我們還進行投資以產生下一波 IND 候選藥物並推進我們的早期管道。

In terms of SG&A, as I highlighted a year ago and mentioned earlier today, we've been super focused on getting this number to scale. Evidence of this is that our total Q4 2023 investment in SG&A was around DKK 900 million. So you can see that off this Q4 2023 run rate, the growth here in 2024 is minor.

就SG&A而言，正如我一年前強調的和今天早些時候提到的，我們一直非常專注於擴大這個數字。證據是，我們 2023 年第四季的 SG&A 投資總額約為 9 億丹麥克朗。因此，您可以看到，根據 2023 年第四季的運行率，2024 年的成長很小。

So with that, let's break out our 2024 investment profile for you with a few numbers on the next slide. Here, we've outlined our incremental investments we're expecting to make for our top priorities in 2024. Starting at the top, you can see the biggest overall increase in investment, will be in advancing our portfolio. More specifically, the several Phase IIIs that were planned for EPCORE, TIVDAK and 1046 that eventually may support revenue growth in the future. This is an investment for now as well as for the future as we look to expand development of our mid- to late-stage programs as well as the growth of our overall portfolio.

因此，讓我們在下一張投影片上用一些數字為您詳細介紹 2024 年的投資概況。在這裡，我們概述了我們預計在 2024 年為首要任務進行的增量投資。從頂部開始，您可以看到最大的整體投資成長將用於推進我們的投資組合。更具體地說，計劃用於 EPCORE、TIVDAK 和 1046 的幾個 III 期項目最終可能會支持未來的收入成長。這是一項針對現在和未來的投資，因為我們希望擴大中後期項目的發展以及整體投資組合的成長。

The continued successful commercialization of EPKINLY will continue to require our focus and investment, especially in our two key markets, the U.S. and Japan. Now having a look at the framework and the constituent parts, let's look at how this all comes together.

EPKINLY 的持續成功商業化將繼續需要我們的關注和投資，特別是在我們的兩個關鍵市場，美國和日本。現在來看看框架和組成部分，讓我們看看這一切是如何組合在一起的。

Here, you can see our 2024 guidance. We expect our revenue to be in the range of DKK 18.7 billion to DKK 20.5 billion, and that's up 19% at the midpoint. And most of this is made up of recurring revenue which is comprised of our royalties and net product sales and collaboration revenue from EPKINLY and TIVDAK.

在這裡，您可以查看我們的 2024 年指南。我們預計我們的營收將在 187 億丹麥克朗至 205 億丹麥克朗之間，中間值成長 19%。其中大部分由經常性收入組成，其中包括我們的特許權使用費、產品淨銷售收入以及來自 EPKINLY 和 TIVDAK 的合作收入。

And our recurring revenues is expected to account for 92% of our total revenue in 2024 compared to 88% in 2023 and 81% in 2022. And this really illustrates the improving quality of our revenue profile. For operating expenses, we expect to be in the range of DKK 12.4 billion to DKK 13.4 billion, and that's up 18% at the midpoint. As I've previously highlighted, this step-up in investment is fully in line with our strategy and our focus on creating long-term value.

到 2024 年，我們的經常性收入預計將佔總收入的 92%，而 2023 年為 88%，2022 年為 81%。這確實說明了我們收入狀況的品質不斷提高。對於營運費用，我們預計將在 124 億丹麥克朗至 134 億丹麥克朗之間，中間值成長 18%。正如我之前強調的，這項投資的增加完全符合我們的策略以及我們對創造長期價值的關注。

Putting all this together, we're planning for substantial operating profit in a range of DKK 4.6 billion to DKK 7.1 billion, with the midpoint of guidance, amounting to a significant growth or significant growth in profitability at 10%.

綜上所述，我們計劃實現 46 億丹麥克朗至 71 億丹麥克朗的大幅營運利潤（以指導中位數計算），相當於顯著成長或獲利能力顯著成長 10%。

So now having covered our results for 2023 and our guidance for 2024. Let me now walk you through our focused capital allocation strategy aimed at fueling growth and enhancing shareholder value.

現在我們已經介紹了 2023 年的業績和 2024 年的指導。現在讓我向您介紹我們旨在促進成長和提高股東價值的重點資本配置策略。

First, we will continue to invest in our proprietary pipeline and technology platforms. In particular, we're focused on investing in our mid- and late-stage programs. In addition, we need to invest to maintain our leadership in innovation and antibody tech and delivering on our promise of groundbreaking KYSO medicines.

首先，我們將繼續投資我們的專有管道和技術平台。我們特別注重投資中後期專案。此外，我們需要投資以保持我們在創新和抗體技術方面的領先地位，並兌現我們對突破性 KYSO 藥物的承諾。

Second, we're pursuing focused business development and M&A opportunities. Our objective here is clear: to accelerate our growth trajectory and broaden our portfolio. And here, we'll seek out opportunities that fit within our core focus areas.

其次，我們正在尋求重點業務發展和併購機會。我們的目標很明確：加速我們的成長軌跡並擴大我們的投資組合。在這裡，我們將尋找適合我們核心重點領域的機會。

As you know, historically, we focused on external opportunities where we brought in tools and components to augment our research and discovery engine. Now as we further built out our development and commercialization capabilities, we are well positioned to also consider development and commercial stage opportunities. This will allow us to further leverage investments we made in these areas.

如您所知，從歷史上看，我們專注於外部機會，引入工具和組件來增強我們的研究和發現引擎。現在，隨著我們進一步建立我們的開發和商業化能力，我們也有能力考慮開發和商業化階段的機會。這將使我們能夠進一步利用我們在這些領域的投資。

And finally, at our upcoming AGM, we will be asking for the authorization to launch a DKK 3.5 billion or approximately $500 million share buyback program. This underscores our confidence in Genmab's future and our commitment to delivering value to shareholders, both in the short and long term.

最後，在即將舉行的年度股東大會上，我們將請求授權啟動 35 億丹麥克朗（約 5 億美元）的股票回購計畫。這強調了我們對 Genmab 未來的信心以及我們為股東提供短期和長期價值的承諾。

In summary, our capital allocation strategy is straightforward. Invest in our business and in particular, our mid- to late-stage pipeline and to see growth through focused BD and acquisitions. And after these two priorities are evaluated, we can consider return of capital to our shareholders. And that's what we've done here in terms of the proposal at the upcoming AGM. Taken together, this balanced approach positions us for sustained success and long-term value creation.

總而言之，我們的資本配置策略很簡單。投資我們的業務，特別是我們的中後期產品線，並透過重點業務拓展和收購實現成長。在評估這兩個優先事項之後，我們可以考慮向股東返還資本。這就是我們在即將召開的年度股東大會上提出的提案中所做的。總而言之，這種平衡的方法使我們能夠持續取得成功並創造長期價值。

Now for my final slide, we provide a few closing remarks. In summary, we had a very solid 2023. And our 2024 guidance highlights are highly compelling growth profile. We created additional growing recurring revenue streams, increasingly from our proprietary products, including TIVDAK and EPKINLY. And that gives us a strong backbone of significant underlying profitability, and we're investing those revenues in a highly focused way to realize our vision and to capitalize on the very significant growth opportunities in front of us.

現在，對於我的最後一張投影片，我們提供一些結束語。總而言之，我們的 2023 年表現非常穩健。我們的 2024 年指導要點是非常引人注目的成長概況。我們創造了額外不斷增長的經常性收入流，其中越來越多來自我們的專有產品，包括 TIVDAK 和 EPKINLY。這為我們提供了顯著的潛在盈利能力的強大支柱，我們正在以高度集中的方式投資這些收入，以實現我們的願景並利用我們面前的非常重要的成長機會。

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

關於這一點，我要把你交還給簡。

Thanks, Anthony. So let's move to Slide 21. In 2023, Genmab made great strides towards our 2030 vision, making for a transformative year in company's history and our patient's care. Our KYSO antibody medicines have become a new chapter in transforming the lives of people with cancer and other serious diseases. .

謝謝，安東尼。讓我們轉到投影片 21。2023 年，Genmab 朝著我們的 2030 年願景邁出了一大步，為公司歷史和患者護理帶來了變革。我們的 KYSO 抗體藥物已成為改變癌症和其他嚴重疾病患者生活的新篇章。 。

In 2024, we will continue to work diligently towards this vision with a number of key goals for the company, starting with our currently approved medicines EPKINLY and TIVDAK and as I mentioned, we will work with our partner, AbbVie continue to maximize the potential of epcoritamab with the initiation of new trials as well as an expanded label, with the potential to move into relapsed or refractory follicular lymphoma. We will also work with our new partner, Pfizer, pending health authority feedback to advance the development of TIVDAK in head and neck cancer.

2024 年，我們將繼續努力實現這一願景，為公司設定一些關鍵目標，從我們目前批准的藥物EPKINLY 和TIVDAK 開始，正如我所提到的，我們將與我們的合作夥伴艾伯維(AbbVie)合作，繼續最大限度地發揮epcoritamab 已啟動新試驗以及擴大標籤，有可能進入復發或難治性濾泡性淋巴瘤。我們也將與我們的新合作夥伴輝瑞公司合作，等待衛生當局的回饋，以推進 TIVDAK 在頭頸癌領域的開發。

Turning to our clinical stage programs, along with our partner, BioNTech, we plan to progress both Acasunlimab or GEN1046 and GEN1042. For Acasunlimab, we see the potential to initiate a Phase III trial in second-line non-small cell lung cancer. For GEN1042, we anticipate Phase II data in frontline head and neck cancer that will allow us to determine next steps for the program. So we anticipate expanding and advancing these and other clinical stage programs in our KYSO product portfolio.

談到我們的臨床階段項目，我們計劃與我們的合作夥伴 BioNTech 一起推進 Acasunlimab 或 GEN1046 和 GEN1042。對於 Acasunlimab，我們看到了啟動二線非小細胞肺癌 III 期試驗的潛力。對於 GEN1042，我們預計一線頭頸癌的 II 期數據將使我們能夠確定該計畫的後續步驟。因此，我們預計在 KYSO 產品組合中擴展和推進這些和其他臨床階段項目。

Fundamental to the success of these programs is having the right team and culture in place. We are very well prepared to continue to scale our company based on our planned portfolio development and business needs. We will be maintaining and enhancing the science-driven, patient-focused, courageous, and inspirational Genmab culture and doing so with integrity.

這些計劃成功的基礎是擁有合適的團隊和文化。我們已做好充分準備，根據我們計劃的產品組合開發和業務需求繼續擴大我們的公司規模。我們將保持和加強以科學為驅動、以患者為中心、勇敢和鼓舞人心的 Genmab 文化，並誠信地做到這一點。

Finally, we will continue to leverage our solid financial base to support our growth, including to grow and broaden our exciting product and technology portfolio. We will look at both our existing strategy and new opportunities to do just that. We have much to look forward to in 2024.

最後，我們將繼續利用我們堅實的財務基礎來支持我們的成長，包括發展和擴大我們令人興奮的產品和技術組合。我們將審視現有的策略和新的機會來實現這一目標。 2024 年我們有很多值得期待的事。

That ends our presentation to Genmab's financial results for 2023. So operator, please open the call for questions.

我們對 Genmab 2023 年財務表現的介紹到此結束。操作員，請開始提問。

(Operator Instructions) And now we're going to take our first question, and it comes from line of James Gordon.

（操作員說明）現在我們要回答第一個問題，它來自詹姆斯·戈登（James Gordon）。

James Gordon, JPMorgan. My question is just one would be on the buyback. Just how should we read the buyback? Should we think of this as a batch of confidence that J&J opts in on HexaBody-CD38. So this is a great value by the shares? Or is it a bit more opportunistic about your share price in general? Or that you aren't finding attractive pipeline you could buy in, just isn't much out there good valuations and it's inefficient -- have lots of cash on the balance sheet. So how should we read the decision to do the buyback, please?

詹姆斯‧戈登，摩根大通。我的問題只是一個關於回購的問題。那我們該如何解讀回購呢？我們是否應該將此視為強生選擇 HexaBody-CD38 的信心？那麼這支股票的價值是否很高？或者說，你的股價整體上是否更具機會主義色彩？或者你沒有找到有吸引力的管道可以購買，只是沒有太多好的估值而且效率低下——資產負債表上有大量現金。那我們該如何解讀回購決定呢？

So James, the decision to go for the $500 million buyback is actually a sign of confidence in our capacity to further build value for shareholders. As Anthony and I explained, we first will invest in the pipeline, and we are going to robustly progress our pipeline and technology platforms this year with multiple Phase III trials initiated for at least 3 or more of our programs. .

因此，詹姆斯決定進行 5 億美元的回購，實際上表明我們對我們進一步為股東創造價值的能力充滿信心。正如安東尼和我所解釋的，我們首先將投資管道，今年我們將大力推進我們的管道和技術平台，為至少 3 個或更多項目啟動多個 III 期試驗。 。

Second, we really are looking very, very actively at other product candidates, which could actually help us to turbo-accelerate our growth trajectory and broaden the portfolio, so we actually can increase revenue much quicker in the coming years than better own products in the pipeline.

其次，我們確實非常非常積極地尋找其他候選產品，這實際上可以幫助我們加速成長軌跡並擴大產品組合，因此我們實際上可以在未來幾年比更好的自有產品更快地增加收入。管道。

And then finally, you can see this as sign of confidence. We believe that this is the right moment to show really strong confidence in our future. And the commitment to deliver value to shareholders. So it's a sign of strength and confidence in our own ability to further build value to our shareholders. So there will be a lot of activity this year.

最後，你可以將其視為自信的標誌。我們相信，現在是對我們的未來表現出真正堅定信心的正確時刻。以及為股東創造價值的承諾。因此，這是我們對自己進一步為股東創造價值的能力的實力和信心的標誌。所以今年會有很多活動。

Now we're going to take our next question and it comes from line of Kaveri Pohlman.

現在我們要回答下一個問題，它來自 Kaveri Pohlman。

My question is basically on EPKINLY. Now that it has a well-established profile, any thoughts of developing it for autoimmune diseases?

我的問題基本上是關於 EPKINLY 的。既然它已經有了完善的概況，有沒有考慮將其開髮用於自體免疫疾病？

Right now, we are focusing on B-cell cancers that is going to dramatically expand into different cancers, not only diffuse B-cell lymphoma and follicular but we're also certainly going to press forward in CLL as well as potentially some other B-cell cancers. And we are not considering to move into autoimmune at this moment, Kaveri, but that may very well change in the future.

目前，我們專注於B 細胞癌症，這些癌症將顯著擴展到不同的癌症，不僅是瀰漫性B 細胞淋巴瘤和濾泡性癌症，而且我們肯定也會在CLL 以及潛在的其他一些B-細胞癌症方面取得進展。細胞癌。卡維裡，我們目前不考慮進入自體免疫狀態，但這種情況將來很可能會改變。

Now we will take our next question. And the next question comes from the line of Peter Verdult.

現在我們將提出下一個問題。下一個問題來自 Peter Verdult。

Pete Verdult from Citi. Just one question maybe for you [Deirdre] or Tahi. Just on scene setting for 1046 in the second-line non-small cell lung cancer trial. Could you just remind us how many patients and duration of follow-up you have on what you base that decision? And then just what would you consider to be the PFS and OS hurdles you would be looking to beat in that setting?

來自花旗銀行的 Pete Verdult。也許只有一個問題要問你[迪爾德麗]或塔希。就在二線非小細胞肺癌試驗中 1046 的場景設定。您能否提醒我們您的決定基於多少患者以及追蹤持續時間？那麼您認為在這種情況下您希望克服的 PFS 和作業系統障礙是什麼？

Thanks, Peter for the question. So I hand it over to Tahi. Tahi, you're best placed, I think, to answer this question for Peter.

謝謝彼得提出的問題。所以我把它交給塔希。塔希，我認為你最適合為彼得回答這個問題。

Yes. Sure. Thanks for the question. Well, I mean, we've decidedly never really commented on what number we actually base the decision but trial as it is designed was enrolling 40 patients in different cohorts. And these patients we have and sort of follow-up is reasonable, there will be -- earlier look that we presented at -- in an Abstract that was submitted in the near future that we presented at a conference, and there will be a more updated look at the conference on the data also with longer follow-up.

是的。當然。謝謝你的提問。嗯，我的意思是，我們絕對從未真正評論過我們實際做出決定的人數是多少，但試驗的設計是在不同的隊列中招募了 40 名患者。我們對這些患者的隨訪是合理的，我們在不久的將來在一次會議上提交的摘要中將會有 - 早些時候的介紹，並且將會有更多更新了會議上的數據，並進行了更長時間的追蹤。

What the PFS is actually mean, PFS is a little bit problematic. If you think about -- all fair to us because of this in the entire population broadly driven by the patients who are actually not responding to therapy. So a better way to think about this is actually landmark PFS. So how many patients are actually still in remission or have not progressed, or not died -- at let's say, 6 months, I think that would be something where I would guide you to pay attention to because that [clear] episode is also what's going to drive.

PFS 其實是什麼意思，PFS 有一點問題。如果你想一想——這對我們來說都是公平的，因為整個人群普遍都是由實際上對治療沒有反應的患者所驅動的。因此，更好的思考方式其實是具有里程碑意義的 PFS。那麼，有多少患者實際上仍處於緩解狀態，或者沒有進展，或者沒有死亡——比方說，6 個月，我認為這將是我會引導您注意的事情，因為那個[明確]事件也是要去開車。

The next part, which is the overall survival question, I think hey, there's plenty of data sets that the overall survival, somewhere hovers around 11 months. So we look at this as a -- since this is an I/O opportunity that the strength of the data comes to the duration of the response that we're observing in those patients where traditionally it has been incredibly hard to get any response with an I/O approach since they have already exhausted I/O approach. And we also believe that this actually increases the probability of success in winning on these trials given the fact that the number of trials have been negative where -- the focus was maybe a little bit too much on initiative or reduction, but not on durability of responses, if that makes sense.

下一部分是總體生存期問題，我認為嘿，有大量數據集表明總體生存期在 11 個月左右徘徊。因此，我們將此視為 - 因為這是一個 I/O 機會，數據的強度取決於我們在那些傳統上很難獲得任何反應的患者中觀察到的反應持續時間。I/O 方法，因為他們已經用盡了I/O 方法。我們也相信，這實際上增加了在這些試驗中獲勝的可能性，因為試驗的數量一直是負數，重點可能有點過多地放在主動性或減少性上，而不是放在持久性上。回應，如果有道理的話。

Now we're going to take our next question. And it comes from line of Sachin Jain.

現在我們要回答下一個問題。它來自 Sachin Jain 的血統。

Just to go back on the capital allocation. I wonder if you could just clarify, Anthony, the size of the BD opportunities you're looking at, I think you phrased them as more later stage than what you've done before. So if you could just give us a sense of what stage, development commercial stage, size of assets?

只是回到資本配置。安東尼，我想知道你是否可以澄清一下你正在尋找的 BD 機會的規模，我認為你將它們表述為比你之前所做的更晚的階段。那麼您能否讓我們了解什麼階段、開發商業階段、資產規模？

And then just a quick follow-up question. HexaBody-CD38 wasn't really mentioned today. Thank you for clarifying the 1046 data, it will be coming in 1H. Should we expect any further dose expansion data from the cohort, we saw at ASH at any point, 1H pre the head-to-head 2H?

然後是一個快速的後續問題。今天並沒有真正提到 HexaBody-CD38。感謝您澄清 1046 數據，它將在 1 小時內到來。我們是否應該期待來自該隊列的任何進一步的劑量擴展數據，我們在 ASH 上的任何時間點（即頭對頭 2H 之前的 1H）？

Thanks, Sachin for the question. So Anthony Pagano on the capital allocation and then maybe, Tahi, you can give a bit more color on the head-to-head data with the HexaBody-CD38, next. Maybe, Anthony, you can start?

謝謝薩欽的提問。安東尼·帕加諾 (Anthony Pagano) 談了資本分配，然後，塔希 (Tahi)，接下來你可以對 HexaBody-CD38 的頭對頭數據進行更多說明。安東尼，也許你可以開始了？

Yes. Sure thing. And thanks, Sachin. Yes. As you highlighted and just reiterate what I said on the call, when I talked about, I think, a little bit more informally over the last year or so that we would be willing to open up the aperture in terms of what we would be thinking about for external opportunities.

是的。當然可以。謝謝，薩欽。是的。正如你強調並重申我在電話中所說的話，當我談論時，我認為，在過去一年左右的時間裡，我們願意以更非正式的方式談論我們的想法關於外部機會。

It is fully in line with if you think about the concept of natural ownership, were you a good evaluator and then good owners. And over the last couple of years, we've invested quite a bit to build out our mid- to late-stage development capabilities as well as our commercialization capability.

如果你考慮自然所有權的概念，如果你是一個好的評估者，然後是好的所有者，那麼它完全符合。在過去的幾年裡，我們投入了大量資金來增強我們的中後期開發能力以及商業化能力。

So we're looking to leverage those investments as we move forward. And here, we're therefore, pursuing potential BD and M&A opportunities that align with our core focus areas. And of course, as you would expect that Sachin, any external opportunities will be carefully evaluated. And only if they clear the high bar that we set for ourselves, both internally but also for these external opportunities, so they clear this high bar will be moved forward.

因此，我們希望在前進的過程中充分利用這些投資。因此，我們在這裡尋求與我們的核心重點領域一致的潛在業務發展和併購機會。當然，正如薩欽所期望的那樣，任何外部機會都會被仔細評估。只有他們清除了我們為自己設定的高標準，無論是內部還是外部機會，這樣他們清除了這個高標準才會向前推進。

We're going to take that same focused and disciplined approach that we've utilized in evaluating our organic investments as well as that the same approach we've taken, making the discovery-oriented inorganic investments that we've made here, historically. And any external opportunities and we carefully selected again, this is really important to align with our core focused areas and to complement our existing portfolio, bring in novel antibody technologies or expand our presence in some key therapeutic areas.

我們將採用與評估我們的有機投資相同的專注和嚴格的方法，以及我們過去所採取的以發現為導向的無機投資的方法。我們再次仔細選擇任何外部機會，這對於與我們的核心重點領域保持一致並補充我們現有的產品組合、引入新型抗體技術或擴大我們在一些關鍵治療領域的業務非常重要。

Further, any focused BD and M&A for clinical or commercial stage programs is really guess is an important point to allow us to leverage the investments we've made and the capabilities we've built out in these key areas over the last number of years.

此外，任何專注於臨床或商業階段專案的業務發展和併購確實是一個重要的點，使我們能夠利用過去幾年在這些關鍵領域所做的投資和建立的能力。

Particularly on your question, Sachin, in terms of deal size, I'm not going to provide any guardrails out there right now. But again, as you would expect, the starting point will be to ensure that any external opportunity fully aligns with our strategic objectives and our core focus areas and most importantly, right, that it offers a clear path to creating value for our shareholders. So hopefully, that gives you a little bit more color. But at this point, we're not going to put out any specific guardrail.

特別是關於你的問題，薩欽，就交易規模而言，我現在不會提供任何保護措施。但正如您所期望的那樣，出發點將是確保任何外部機會完全符合我們的策略目標和核心重點領域，最重要的是，它為我們的股東創造價值提供了一條清晰的道路。希望這能帶給你更多的色彩。但目前，我們不會設置任何具體的護欄。

And to add to that, Anthony, these molecules will need to be best-in-class or first-in-class at the minimum, Sachin. So we are going to be very, very critical there, and we have firepower and we have the ability to execute and leverage on the investments we made over the last few years.

除此之外，安東尼，這些分子至少需要是一流的或一流的，薩欽。因此，我們將在這方面非常非常關鍵，我們擁有火力，我們有能力執行和利用我們過去幾年所做的投資。

Let's move to Tahi now, and maybe ask Tahi to give some further color on the HexaBody-CD38 data this year. Tahi?

現在讓我們轉向 Tahi，也許請 Tahi 為今年的 HexaBody-CD38 數據提供更多資訊。塔希？

I will try my best. I mean I think there is not much to add to the commentary we've made over the last couple of months essentially. In that the head-to-head is ongoing, it is on track in the timelines [aggressively]. Yes. I think we end up -- very successfully enrolling these patients. And we are on track to have all patients enrolled and then with a sufficient follow-up and to then have that discussion with Janssen once we have that follow-up.

我會盡力。我的意思是，我認為我們過去幾個月所做的評論基本上沒有什麼可補充的。由於正面交鋒正在進行中，因此它在時間軸上[積極地]步入正軌。是的。我認為我們最終非常成功地招募了這些患者。我們有望讓所有患者入組，然後進行充分的隨訪，一旦我們進行了隨訪，就與楊森進行討論。

And it's important to [understand the problems]. That's important as getting the patients in because it will, in the end, be a decision made on, I suspect, response rate, but also better response percentage of patients who achieved VGPR better. And of course, also under the assumption that the safety profile is not materially different from DARZALEX given the fact that the success of DARZALEX to a large degree is also depending on the relative ease of combination. So that's what we are generating right now. And then when we have the data, we'll have the conversation with our colleagues at Janssen and eventually also present that to the public and the plan is on track.

[理解問題]很重要。這對於讓患者參與其中很重要，因為我懷疑，這最終將取決於緩解率，以及更好地實現 VGPR 的患者的更好的緩解百分比。當然，也假設安全性與 DARZALEX 沒有本質上的不同，因為 DARZALEX 的成功在很大程度上也取決於組合的相對容易程度。這就是我們現在正在生成的。然後，當我們獲得數據時，我們將與楊森的同事進行對話，並最終向公眾展示該數據，並且該計劃已步入正軌。

Tahi, apologies the question was whether we would get any further dose expansion data relative to what we saw at ASH?

Tahi，抱歉，問題是我們是否會獲得與我們在 ASH 上看到的相關的進一步劑量擴展數據？

No, no. We went straight into the head-to-head because that's really relevant. So the next data update that you will get is the actual head to head, which is I think will be most informative for all parties involved, including you.

不，不。我們直接進行了正面交鋒，因為這確實很重要。因此，您將獲得的下一個數據更新是實際的面對面的數據更新，我認為這對於包括您在內的所有相關方來說都是最有資訊的。

And then the next question comes from the line of [Jonathan Chan]

然後下一個問題來自[Jonathan Chan]

On the 2024 net product sales and expense guidance, are you able to provide any more color around how those break down by program? And maybe just adding on that, on the early Epcoritamab launch, how has that impacted your thinking on the CD20/CD3 competitive landscape? and your ability to be the market leader in this space?

在 2024 年淨產品銷售與費用指引中，您能否提供更多關於如何按計畫細分的資訊？也許只是補充一點，在 Epcoritab 的早期推出中，這對您對 CD20/CD3 競爭格局的看法有何影響？您有能力成為該領域的市場領導者嗎？

Thanks, Jonathan for the question. So the first one can -- I think will be handled by Anthony Pagano. And the second one, certainly, Anthony Mancini can give you a bit more color there because we're very optimistic about EPKINLY. Anthony Pagano, maybe you can start?

謝謝喬納森的提問。所以第一個可以——我認為將由安東尼·帕加諾處理。當然，第二個，安東尼·曼奇尼（Anthony Mancini）可以給你更多的色彩，因為我們對 EPKINLY 非常樂觀。安東尼·帕加諾，也許你可以開始？

Yes. Thanks, Jonathan. I think in my prepared remarks, I gave quite a bit of detail in terms of breaking down both the overall composition of our revenue. As you can see, we kind of took it to a different level in terms of breaking out the net product sales and the collaboration revenue, gave kind of very explicit guidance there, combining EPKINLY and TIVDAK can give you a good sense of the overall trajectory. We're not going to provide specific guidance for EPKINLY or TIVDAK at this stage.

是的。謝謝，喬納森。我認為在我準備好的發言中，我提供了相當多的細節來分解我們收入的整體組成。正如您所看到的，我們在細分產品淨銷售額和協作收入方面將其提升到了不同的水平，並給出了非常明確的指導，結合 EPKINLY 和 TIVDAK 可以讓您很好地了解整體軌跡。現階段我們不會為 EPKINLY 或 TIVDAK 提供具體指引。

You would also have noted Jonathan, did highlight in terms of the nonrecurring revenue, the step-down being driven by reimbursement revenue declining and that being partially offset by an increase in milestones. And there I highlighted Kesimpta. I can also share with everybody on the call that in addition to the significant sales milestone Kesimpta, will also have a relatively significant milestone related to epcoritamab with the filing and acceptance of the filing in the U.S. for the refractory late line FL indication. That's another significant milestone. So it's probably about much detail as we can give on revenue.

您還可能注意到喬納森確實強調了非經常性收入，報銷收入下降導致了下降，而里程碑的增加部分抵消了這一下降。在那裡我強調了 Kesimpta。我還可以在電話會議上與大家分享，除了 Kesimpta 的重大銷售里程碑之外，與 epcoritamab 相關的相對重要的里程碑也將是在美國提交並接受難治性晚期 FL 適應症的申請。這是另一個重要的里程碑。因此，這可能是我們可以提供的有關收入的更多細節。

In terms of OpEx, again, here, I think if you look at the detailed page that we presented really highlighting where the vast majority of the growth is going to our mid- to late-stage programs, particularly, Epcoritamab is driving a fair amount of the year-over-year increase.

就營運支出而言，再次，我認為，如果您查看我們提供的詳細頁面，確實強調了絕大多數增長將流向我們的中後期項目，特別是 Epcoritab 正在推動相當大的增長的同比增長。

And then secondly, behind that, you'd have 1046 and TIVDAK with the potential launch of the Phase IIIs there. And then there is still a substantial increase in investment doing continued expansion work for 1042 and also a fair amount of expansion work and other related work for our [CD3 B7-H4] program.

其次，在這之後，您將擁有 1046 和 TIVDAK，並可能在那裡推出第三階段。然後，1042 的持續擴建工作以及我們的 [CD3 B7-H4] 計劃的大量擴建工作和其他相關工作仍然大幅增加。

As you can see, that's driving around -- in totality, the point that is mentioned are driving around DKK 1.6 billion of our total investment increase and I provided a lot of color in terms of SG&A and how we're really getting that number to scale. It's been a key focus area in terms of really driving operational performance, if you like, in our business and getting that number to scale. As we exit Q4 of 2023, we feel we've made a ton of progress here moving forward. So that's the additional color I'd provide in terms of the top line revenue and the investments.

正如您所看到的，這正在推動——總的來說，所提到的這一點推動了我們總投資增長約16 億丹麥克朗，我在SG&A 方面提供了很多信息，以及我們如何真正實現這一數字規模。如果你願意的話，這一直是我們業務中真正推動營運績效並擴大這一數字的關鍵焦點領域。隨著 2023 年第四季的結束，我們感覺我們已經取得了巨大的進展。這就是我在營收和投資方面提供的額外色彩。

Maybe Anthony Mancini, do you want to provide maybe any additional color, particularly, as it relates to EPKINLY?

也許安東尼·曼奇尼（Anthony Mancini），你想提供任何額外的顏色，特別是與 EPKINLY 相關的顏色嗎？

Yes. Thanks, Anthony, and thanks, Jonathan, for the question. I think if I understand the question, its a little bit about based on how our start has gone. What confidence do we have in our performance going forward to be the market leader.

是的。謝謝安東尼，也謝謝喬納森提出的問題。我想，如果我理解這個問題，那就有點基於我們的起步狀況。我們對未來成為市場領導者的表現有什麼信心？

And I would say that the healthy uptick we've seen driven really by strong execution gives us a high degree of confidence that we can continue to retain our market leader status, particularly the reactions that we're getting, the strong access that we're getting in the U.S. And now that we know more about the profile really the feedback that we're getting from customers and the enthusiasm based on the reactions they're seeing with patients around not just the power of the overall responses, but the manageable safety profile and the seamless and efficient step-up dosing and subcutaneous administration as well as reduced patient in-office administration time and efficiency and throughput, we think we're really well positioned to continue to retain a market leadership position, and we're really excited about additional launches in the B-cell malignancy space with FL being next on the docket. So Jonathan, we feel really confident that we can continue to perform strongly going forward.

我想說的是，我們所看到的健康成長確實是由強有力的執行力推動的，這讓我們對我們能夠繼續保持市場領導者地位充滿信心，特別是我們得到的反應，我們獲得的強大准入機會。現在我們對資料有了更多的了解，真正了解了我們從客戶那裡得到的反饋以及基於他們在患者身上看到的反應的熱情，不僅是整體反應的力量，而且是可管理的安全性、無縫、高效的逐步給藥和皮下給藥，以及減少患者在診室給藥時間、效率和吞吐量，我們認為我們確實處於有利位置，可以繼續保持市場領導地位，並且我們對於B 細胞惡性腫瘤領域的更多推出感到非常興奮，下一個計畫就是FL。所以喬納森，我們非常有信心我們能夠繼續表現強勁。

Now we're going to take our next question. And the next question comes from the line of Michael Schmidt.

現在我們要回答下一個問題。下一個問題來自邁克爾·施密特。

This is Paul on for Michael. My question was touched on a bit in prior questions. But generally, what can we expect from your immunology efforts in the coming year, either internally or externally? Is this possibly an area of BD focus and then along those lines, on your collaboration with argenx, which I think is approaching a year, any near-term plans to disclose target or program from that either in oncology or immunology?

這是保羅替補邁克爾。我的問題在之前的問題中有所涉及。但總的來說，我們對你們來年的免疫學工作（無論是內部還是外部）有何期望？這是否可能是 BD 關注的一個領域，然後沿著這些思路，關於您與 argenx 的合作（我認為已經接近一年），有任何近期計劃來披露腫瘤學或免疫學領域的目標或計劃嗎？

Thanks, Paul. I think I can handle those questions. So we have a lot of activity in the I&I area. And these are twofold, basically. We have our own programs. We have a number of programs which Genmab is working on itself. .

謝謝，保羅。我想我可以解決這些問題。因此，我們在 I&I 領域開展了大量活動。基本上，這些都是雙重的。我們有自己的計劃。 Genmab 正在自行開發許多專案。 。

And we actually have a number of programs, and we actually expanded the number together with argenx, where we actually work in I&I as sellers in oncology. This year, you probably not hear a lot from those programs, Paul, because we only actually speak about these problems once we have a clinical candidate selected to move into the clinic imminently because we learned that in the hard way.

我們實際上有很多項目，而且我們實際上與 argenx 一起擴大了項目數量，我們實際上在 I&I 中作為腫瘤學銷售人員工作。保羅，今年，你可能不會從這些計畫中聽到很多，因為只有在我們選擇了即將進入診所的臨床候選人後，我們才會真正談論這些問題，因為我們透過艱難的方式了解到了這一點。

In the past, we don't get any credit basically for early-stage programs, which you flag up. But we get credit once they move into the clinic, and they begin to build further value for the company for stakeholders.

過去，我們基本上不會因為您提出的早期項目而獲得任何榮譽。但一旦他們進入診所，我們就會得到認可，他們開始為公司的利害關係人創造進一步的價值。

And so not from the argenx or from our own programs, I think they are too early stage. We are in the process of selecting the clinical candidates. But we are certainly looking as it relates to investments in BD into candidates outside of the company, and that could be a way, Paul, to actually accelerate the development in the I&I area for Genmab by simply acquiring a product candidate in late-stage development or even commercial stage to develop further.

所以不是來自 argenx 或我們自己的項目，我認為它們還處於早期階段。我們正在選擇臨床候選人。但我們當然正在考慮，因為這與 BD 對公司外部候選產品的投資有關，Paul，這可能是一種方式，透過簡單地收購處於後期開發的候選產品來真正加速 Genmab 在 I&I 領域的開發甚至商業階段進一步發展。

And then as Anthony Pagano explained, leverage considerable investments in development and also large-scale development of antibody-based medicines in that area. I think it's too early to say more explicitly speak about that. But we certainly are looking very, very proactively at the landscape. And we are looking at some candidate targets and timing is very difficult to give further color on. But actually, that is a realistic area where you could see a progress from Genmab in 2024. I think we should move on to the next question, operator?

然後，正如安東尼·帕加諾（Anthony Pagano）所解釋的那樣，在該領域利用大量投資來開發和大規模開發基於抗體的藥物。我認為現在更明確地談論這一點還為時過早。但我們確實正在非常非常積極地審視這一情況。我們正在研究一些候選目標，但時機很難給出進一步的說明。但實際上，這是一個現實的領域，你可以在 2024 年看到 Genmab 的進展。我認為我們應該繼續討論下一個問題，運營商？

Now we're going to take our last question for today. And it comes from the line of Peter Welford.

現在我們要回答今天的最後一個問題。它來自彼得·韋爾福德（Peter Welford）的血統。

Can you hear me?

你聽得到我嗎？

Yes. Yes, Peter.

是的。是的，彼得。

So just a question on the outlook, please. I guess, for Anthony. Really, the question is -- so I'm trying to just piece together the pieces as far as -- you talk about the fact that when did the reimbursement revenue that you're assuming within 2024, is going to decrease.

請教一個關於前景的問題。我想，對於安東尼來說。事實上，問題是——所以我試圖將這些碎片拼湊起來——你談到了這樣一個事實，即你假設的 2024 年報銷收入什麼時候會減少。

But equally, you talked about a significant parts of the investment in R&D is related to 1042 and 1046, which obviously are shared, I guess, with BioNTech. So I guess I'm trying to square that given that presumably 50% will be paid back to you. And equally, why the gross profit guidance less the forecast for the operating expenses doesn't give you the EBIT outlook. So what the sort of disparity is to get from gross profit down to EBIT based on your OpEx outlook?

但同樣，您談到研發投資的很大一部分與 1042 和 1046 有關，我猜這顯然是與 BioNTech 共享的。所以我想我正在嘗試將其平方，因為大約 50% 會返還給你。同樣，為什麼毛利指導減去營運費用預測並不能給出息稅前利潤的前景。那麼，根據您的營運支出前景，從毛利到息稅前利潤的差異是多少？

Thanks, Peter. Anthony?

謝謝，彼得。安東尼？

Yes. Thanks, Peter. In terms of the reimbursement revenue and what you're pointing out, that number coming down, but investment in 1042 and 1046 and other BioNTech partnered programs going up this is all true and both true at the same time.

是的。謝謝，彼得。就報銷收入和您所指出的而言，這個數字有所下降，但對 1042 和 1046 以及其他 BioNTech 合作項目的投資卻在增加，這是事實，同時也是事實。

In terms of what's driving that, there are probably -- there are two things. First is the composition of the work that's being done by the parties. So to the extent that BioNTech is doing more work for certain of the programs, that will not flow through. Reimbursement revenue will only pick up half of the cost.

就驅動因素而言，可能有兩件事。首先是各方正在進行的工作的組成。因此，就 BioNTech 為某些專案做更多工作而言，這不會成功。報銷收入只能彌補成本的一半。

And secondly, for some of the larger investments we're making for 1042 and 1046, we have just looked at our overall setup with BioNTech in terms of how some of those contracts are set up with third parties and looking to optimize our cash flow. And some of that then translates through into slightly different accounting where I'm only picking up half of the cost in my P&L and not picking up 100% like we had done historically and then 50% coming back through the reimbursement line, Peter.

其次，對於我們對 1042 和 1046 進行的一些較大投資，我們剛剛審視了我們與 BioNTech 的整體設置，包括如何與第三方簽訂其中一些合同，並尋求優化我們的現金流。其中一些會轉化為稍微不同的會計，我只在損益表中提取一半的成本，而不是像我們歷史上所做的那樣提取 100%，然後通過報銷線返回 50%，彼得。

In terms of your more granular question on this sort of very specific thing, I'm going to have to suggest that we take that -- have you follow up with Andrew. We can work through the mechanics of your other question as it relates to how the P&L, all flows together.

就你對這種非常具體的事情提出的更具體的問題而言，我不得不建議我們接受——你讓安德魯跟進。我們可以解決您的其他問題的機制，因為它與損益表如何一起流動有關。

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.

今天沒有其他問題了。現在我想將會議交給發言人揚范德溫克爾 (Jan van de Winkel) 發表閉幕詞。

So thank you all for calling in today to discuss general financial results for 2023. And if you have additional questions, that is certainly possible, then please reach out to the Investor Relations colleagues from Genmab. We hope that you all stay safe, keep optimistic and remain healthy, and we very much look forward to speaking with you all again soon.

因此，感謝大家今天致電討論 2023 年的整體財務表現。如果您還有其他問題（當然是可能的），請聯絡 Genmab 的投資者關係同事。我們希望大家保持安全、保持樂觀、保持健康，我們非常期待很快能再次與大家交談。

That does conclude our conference for today. Thank you for participating. You may -- might now all disconnect. Have a nice day.

我們今天的會議到此結束。感謝您的參與。你們現在可能會斷開連線。祝你今天過得愉快。