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's First Quarter 2023 Financial Results Conference Call. As a reminder, this conference call is being recorded.
您好,歡迎來到 Genmab 2023 年第一季度財務業績電話會議。提醒一下,正在錄製此電話會議。
During this telephone conference, you may be presented with forward-looking statements that include words such as believes, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful 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. Please also note that Genmab may hold your personal data as indicated by you as part of our Investor Relations outreach activities in order to update you on Genmab looking -- going forward. Please refer to our website for more information on Genmab and our privacy policy.
在此電話會議期間,您可能會收到前瞻性陳述,其中包括相信、預期、計劃或預期等詞語。實際結果可能存在重大差異,例如,由於開發項目延遲或不成功。除非法律要求,否則 Genmab 沒有義務更新有關未來的陳述,也沒有義務確認與實際結果相關的此類陳述。另請注意,作為我們投資者關係外展活動的一部分,Genmab 可能會保留您所指示的個人數據,以便讓您了解 Genmab 的最新進展。有關 Genmab 和我們的隱私政策的更多信息,請參閱我們的網站。
I would now like to hand the conference over to your first speaker today, Jan van de Winkel. Please go ahead.
我現在想把會議交給今天的第一位發言人 Jan van de Winkel。請繼續。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Hello, and welcome to Genmab's conference call to discuss the company's financial results for the period ending March 31, 2023. With me today to present these results is our CFO, Anthony Pagano. Let's move to Slide 2.
您好,歡迎參加 Genmab 的電話會議,討論公司截至 2023 年 3 月 31 日的財務業績。今天與我一起介紹這些結果的是我們的首席財務官 Anthony Pagano。讓我們轉到幻燈片 2。
As already said, we will be making forward-looking statements, so please keep that in mind as we go through this call. Let's move to Slide 3.
如前所述,我們將做出前瞻性陳述,因此在我們進行本次電話會議時請牢記這一點。讓我們轉到幻燈片 3。
During today's presentation, we will reference products being developed under some of our strategic collaborations. This slide acknowledges those relationships. Let's move to Slide 4.
在今天的演講中,我們將提及在我們的一些戰略合作下正在開發的產品。這張幻燈片確認了這些關係。讓我們轉到幻燈片 4。
Before we look at our first quarter results, I want to remind you of our consistent track record of success. Our proprietary technologies fuel our robust product engine, which is both expanding and maturing. By the end of this year, there is the potential for 8 approved medicines powered by our innovation, half of which would be DuoBody-based bispecifics. This is validation of the DuoBody technology's potential to create truly differentiated bispecific antibody therapeutics, and our growing recurring revenue streams allow us to continue to invest in our pipeline and in our people. Our world-class team of experienced and dedicated colleagues drives our innovation motivated by the passion for making a difference in the lives of people living with cancer and other serious diseases.
在我們查看第一季度業績之前,我想提醒您我們一貫的成功記錄。我們的專有技術為我們強大的產品引擎提供了動力,該引擎正在擴展和成熟。到今年年底,我們的創新有可能獲得 8 種獲批的藥物,其中一半是基於 DuoBody 的雙特異性藥物。這是對 DuoBody 技術創造真正差異化雙特異性抗體療法的潛力的驗證,我們不斷增長的經常性收入流使我們能夠繼續投資於我們的產品線和我們的員工。我們世界一流的團隊由經驗豐富、敬業的同事組成,他們以改變癌症和其他嚴重疾病患者生活的熱情為動力,推動著我們的創新。
Let's now turn to recent accomplishments that will support our future success. Slide 5. In the first quarter of the year, we continue to lay the groundwork for the potential approval of epcoritamab, and we are very excited for the potential upcoming launch and the opportunity to serve patients with third-line plus diffuse large B-cell lymphoma. The Alliance steel teams across sales and marketing, medical and market access are all in place and have been fully prepared for the launch. And our patient services team is also in place and fully ready. We are actively engaging with the FDA and look forward to the future enhancement at May 21 PDUFA date.
現在讓我們談談最近取得的成就,這些成就將支持我們未來的成功。 Slide 5. 今年第一季度,我們繼續為 epcoritamab 的潛在批准奠定基礎,我們對即將推出的潛在產品以及為三線加瀰漫性大 B 細胞患者提供服務的機會感到非常興奮淋巴瘤。銷售和營銷、醫療和市場准入方面的 Alliance 鋼鐵團隊都已就位,並已為發布做好充分準備。我們的患者服務團隊也已就位並做好充分準備。我們正在積極與 FDA 合作,並期待在 5 月 21 日 PDUFA 日期進行改進。
Pending approval, we anticipate epcoritamab will benefit third-line plus diffuse large B-cell lymphoma patients, where the level of unmet need remains high. This indication will be the first that will enable epcoritamab to become the potential core therapy across the diffuse large B-cell lymphoma, follicular lymphoma and beyond. As part of our effort to deliver epcoritamab to relapse or refractory diffuse large B-cell lymphoma patients together with AbbVie, we launched our first pre-approval and expanded access program. This program provides access to epcoritamab to a lot of our patients in the U.S. and Europe prior to potential regulatory approvals.
在獲得批准之前,我們預計 epcoritamab 將使三線加瀰漫性大 B 細胞淋巴瘤患者受益,這些患者的未滿足需求水平仍然很高。該適應症將成為第一個使 epcoritamab 成為瀰漫性大 B 細胞淋巴瘤、濾泡性淋巴瘤及其他疾病的潛在核心療法的適應症。作為我們與 AbbVie 一起為複發或難治性瀰漫性大 B 細胞淋巴瘤患者提供 epcoritamab 的努力的一部分,我們啟動了我們的第一個預批准和擴大訪問計劃。在潛在的監管批准之前,該計劃為美國和歐洲的許多患者提供了 epcoritamab 的使用權。
Looking beyond relapse refractory diffuse large B-cell lymphoma together with AbbVie, we are committed to a robust clinical development program, evaluating epcoritamab in a variety of patient populations and treatment settings. This includes frontline diffuse large B-cell lymphoma, and I'm just very pleased to say that in February and March, the first patients were dosed in 2 frontline diffuse large B-cell lymphoma studies. The Phase III EPCORE diffuse large B-cell lymphoma II study in combination with R-CHOP and the Phase II EPCORE diffuse large B-cell lymphoma III study with or without lenalidomide in elderly patients.
除了與 AbbVie 一起展望復發難治性瀰漫性大 B 細胞淋巴瘤,我們致力於強大的臨床開發計劃,在各種患者群體和治療環境中評估 epcoritamab。這包括前線瀰漫性大 B 細胞淋巴瘤,我很高興地說,在 2 月和 3 月,第一批患者在 2 項前線瀰漫性大 B 細胞淋巴瘤研究中接受了給藥。 III 期 EPCORE 瀰漫性大 B 細胞淋巴瘤 II 研究結合 R-CHOP 和 II 期 EPCORE 瀰漫性大 B 細胞淋巴瘤 III 研究聯合或不聯合來那度胺用於老年患者。
Turning to recent and upcoming data presentations. Multiple epcoritamab abstracts were accepted for presentation at ASCO, including an oral presentation of data from one of the arms of the EPCORE NHL-2 trial, looking at epcoritamab in combination with rituximab and lenalidomide in patients with high-risk relapsed or refractory follicular lymphoma. We and our partners also had several abstracts accepted for presentation at last month's AACR meeting. These include data from an interim analysis of Part C from the Phase II innovative 207 study of tisotumab vedotin and head and neck cancer or small cell carcinoma of head and neck. Though the number of patients including this in this initial data was small, just 15, the results demonstrated encouraging preliminary antitumor activity and an acceptable safety profile, highlighting tisotumab vedotin potential in solid tumors beyond cervical cancer.
轉向最近和即將到來的數據演示。多個 epcoritamab 摘要被接受在 ASCO 上發表,包括口頭介紹來自 EPCORE NHL-2 試驗之一的數據,研究 epcoritamab 聯合利妥昔單抗和來那度胺治療高危復發或難治性濾泡性淋巴瘤患者。在上個月的 AACR 會議上,我們和我們的合作夥伴也有幾份摘要被接受提交。這些包括來自 tisotumab vedotin 與頭頸癌或頭頸小細胞癌的 II 期創新 207 研究的 C 部分中期分析的數據。儘管此初始數據中包括此在內的患者人數很少,只有 15 人,但結果表明初步抗腫瘤活性和可接受的安全性令人鼓舞,突出了 tisotumab vedotin 在宮頸癌以外的實體瘤中的潛力。
Regarding programs followed by our innovations, DARZALEX continues to redefine the treatment of multiple myeloma. As you've seen, J&J's net sales for daratumumab were up 22% over the first quarter of 2022. And that is generating almost DKK 2 billion in royalties for us, contributing materially to our robust financials.
關於我們創新之後的項目,DARZARLEX 繼續重新定義多發性骨髓瘤的治療。正如您所見,強生的 daratumumab 淨銷售額比 2022 年第一季度增長了 22%。這為我們帶來了近 20 億丹麥克朗的特許權使用費,對我們穩健的財務狀況做出了重大貢獻。
This brings me to the initial resolution of our second arbitration with Janssen relating to our daratumumab license agreement. As we announced last month, the arbitration panel dismissed our claims, though 1 of the 3 arbitrators dissent this. Subsequently, we announced our decision to file a request for a review of the awards. And as the arbitration is confidential, we do not intend to comment further, and we look forward to our continued collaboration with Janssen.
這讓我想到了我們與楊森就我們的 daratumumab 許可協議進行的第二次仲裁的初步解決方案。正如我們上個月宣布的那樣,仲裁小組駁回了我們的主張,儘管 3 名仲裁員中有 1 人對此表示異議。隨後,我們宣布我們決定提出對獎項進行審查的請求。由於仲裁是保密的,我們不打算進一步評論,我們期待與楊森的繼續合作。
I would also like to acknowledge the appointment of Martine van Vugt to Chief Strategy Officer. Martina has been an integral part of Genmab almost from the beginning. In a new role, she will be responsible for overseeing the key areas of corporate strategy, corporate development, business development and licensing and alliance management. Martine's addition to executive management further strengthens our already exceptional team and will help us to effectively deliver on our 2030 vision.
我還要感謝 Martine van Vugt 被任命為首席戰略官。 Martina 幾乎從一開始就是 Genmab 不可或缺的一部分。在新職位上,她將負責監督公司戰略、公司發展、業務發展和許可以及聯盟管理等關鍵領域。 Martine 加入執行管理層進一步加強了我們已經非常出色的團隊,並將幫助我們有效地實現我們的 2030 年願景。
Finally, I would like to bring to your attention an announcement in March from Lundbeck, Japan. Lu AF82422, which was created by Genmab as part of an agreement at Lundbeck, has been granted pioneer drug designation for the treatment of multiple system atrophy in Japan. And this designation provides further support for the potential of our innovative antibody therapeutics outside of oncology.
最後,我想提請您注意 3 月份來自日本 Lundbeck 的一則公告。 Lu AF82422 由 Genmab 作為 Lundbeck 協議的一部分創建,已在日本獲得治療多系統萎縮的先驅藥物指定。這一指定為我們在腫瘤學之外的創新抗體療法的潛力提供了進一步的支持。
Let's move to Slide 6. When we revealed our updated vision last year, we noted that while we would continue our commitment to antibody therapies for oncology indications, we would also look to move an additional -- into an additional therapeutic area where our antibody expertise could make an impact. I'm very pleased to announce that we are entering the therapeutic area of immunology and inflammation as a stepping stone to achieving our inspirational 2030 vision.
讓我們轉到幻燈片 6。當我們去年公佈更新後的願景時,我們指出,雖然我們將繼續致力於腫瘤適應症的抗體療法,但我們也希望將額外的 - 轉移到我們的抗體專長的額外治療領域可能會產生影響。我很高興地宣布,我們正在進入免疫學和炎症治療領域,以此作為實現我們鼓舞人心的 2030 年願景的墊腳石。
As we announced in April, we entered a multiyear collaboration with Argenx to jointly discover, develop and commercialize novel therapeutic antibodies with applications in immunology as well as in oncology. By partnering with Argenx, we will be able to combine our company's deep knowledge of the biology and therapeutic power of antibodies and have an opportunity to address patient needs in oncology as well as in immunology and inflammation. We look forward to a successful partnership with Argenx and to providing you with updates on the progress of this collaboration once we are ready to bring new product candidates to the clinic. This, of course, will take some time.
正如我們在 4 月份宣布的那樣,我們與 Argenx 進行了多年合作,共同發現、開發和商業化在免疫學和腫瘤學中應用的新型治療抗體。通過與 Argenx 合作,我們將能夠結合我們公司對抗體生物學和治療能力的深入了解,並有機會滿足患者在腫瘤學以及免疫學和炎症方面的需求。我們期待與 Argenx 建立成功的合作夥伴關係,並在我們準備好將新的候選產品引入臨床後,向您提供此次合作的最新進展。當然,這需要一些時間。
I'm pleased to now hand over the call to Anthony to take you through our Q1 2023 financial results. Anthony, the floor is yours.
我很高興現在將電話轉給安東尼,讓您了解我們 2023 年第一季度的財務業績。安東尼,地板是你的。
Anthony Pagano - Executive VP & CFO
Anthony Pagano - Executive VP & CFO
Great. Thanks, Jan. We continue to strengthen our foundation in Q1. And of course, top of mind for everyone is the potential FDA approval of EPCORE later this month. And as we'll see, our financials remain strong.
偉大的。謝謝,Jan。我們在第一季度繼續加強我們的基礎。當然,每個人最關心的是本月晚些時候 EPCORE 可能獲得 FDA 批准。正如我們將看到的,我們的財務狀況依然強勁。
Recurring revenues grew by 33% in Q1. This was principally driven by strong royalties from DARZALEX and other approved medicines. Our solid balance sheet, growing recurring revenues and significant underlying profitability allow us to continue to invest in our business and 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 that we need to succeed.
第一季度經常性收入增長了 33%。這主要是由於 DARZARLEX 和其他獲批藥物的高額特許權使用費推動的。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以非常專注和有紀律的方式繼續投資於我們的業務和管道。其中一個重要部分是繼續建設我們成功所需的團隊和能力。
So let's take a look at those revenues in a bit more detail. We saw robust performance for DARZALEX in the first quarter of 2023. As you can see in the chart, overall, net sales grew by 22%. That's net sales of over $2.2 billion, which translates to almost DKK 2 billion in royalty revenue. This growth was driven by continued strong market shares, including strong adoption of the subcu formulation. For our royalties, we benefited from a higher effective royalty rate and an FX tailwind. And this is partially offset by a negative contractual hedge rate adjustment. So as you can see, DARZALEX remains a key driver of our revenue.
因此,讓我們更詳細地看一下這些收入。我們在 2023 年第一季度看到了 DARZARLEX 的強勁表現。如圖表所示,總體而言,淨銷售額增長了 22%。這是超過 22 億美元的淨銷售額,相當於近 20 億丹麥克朗的特許權使用費收入。這一增長是由持續強勁的市場份額推動的,包括 subcu 配方的廣泛採用。對於我們的特許權使用費,我們受益於更高的有效特許權使用費率和外匯順風。這部分被負合同對沖率調整所抵消。正如您所看到的,DARZARLEX 仍然是我們收入的主要驅動力。
We grew total revenue to nearly DKK 2.9 billion in Q1. And as I've already highlighted, that included a 33% increase in our recurring revenue. And here, to be clear, that's on a reported basis. Excluding some FX tailwinds, recurring revenues grew by 28% on an operational basis. This strong growth was driven by DARZALEX and Kesimpta, was partially offset by lower TEPEZZA net sales, which according to Horizon were negatively impacted by seasonality. Now taken together, this growth really illustrates the power of our recurring revenue.
我們在第一季度的總收入增長到近 29 億丹麥克朗。正如我已經強調的那樣,這包括我們經常性收入增長 33%。在這裡,需要明確的是,這是基於報告的。排除一些外匯順風因素,經常性收入在運營基礎上增長了 28%。這種強勁的增長是由 DARZARLEX 和 Kesimpta 推動的,部分被較低的 TEPEZZA 淨銷售額所抵消,據 Horizon 稱,這受到季節性的負面影響。現在綜合來看,這種增長確實說明了我們經常性收入的力量。
In line with the significant growth opportunities, total OpEx grew 51% in Q1. In R&D, we've accelerated our investment into our product portfolio, especially the advancement and expansion of EPCORE and, of course, other pipeline projects. We've also further strengthened our team to enhance our commercial capabilities and support our expanding pipeline. And of course, that includes the potential launch for EPCORE.
與顯著的增長機會一致,第一季度總運營支出增長了 51%。在研發方面,我們加快了對產品組合的投資,尤其是 EPCORE 的進步和擴展,當然還有其他管道項目。我們還進一步加強了我們的團隊,以增強我們的商業能力並支持我們不斷擴大的管道。當然,這包括 EPCORE 的潛在發布。
Now let's take a look at our financials as a whole. Here, you can see our summary P&L for Q1. Revenue came in at nearly DKK 2.9 billion. That's up 35% on last year. As mentioned previously, that's favorably impacted by a small FX tailwind. Total expenses were about $2.4 billion, with 72% being R&D and 28% SG&A. And here, even with the increased investment, we're still delivering over DKK 430 million of operating profit for the quarter.
現在讓我們來看看我們的整體財務狀況。在這裡,您可以看到我們第一季度的損益摘要。收入接近 29 億丹麥克朗。這比去年增長了 35%。如前所述,這受到小規模外匯順風的有利影響。總支出約為 24 億美元,其中 72% 用於研發,28% 用於 SG&A。在這裡,即使增加了投資,我們本季度的營業利潤仍超過 4.3 億丹麥克朗。
Moving to our net financial items. Here, we have a loss of around $150 million, which was primarily driven by 2 partially offsetting items. First, we've got the weakening of the U.S. dollar against the Danish krone in Q1, and this is negatively impacting the value of our cash and investments. On the other side of the ledger, we have an increase in interest income due to higher effective interest rates. Then we have tax expense of $60 million, which equates to an effective tax rate of 21.2%. And that brings us to our net profit of over DKK 220 million. So as you can see, very solid financial performance to start the year.
轉到我們的淨財務項目。在這裡,我們損失了大約 1.5 億美元,這主要是由 2 個部分抵消的項目造成的。首先,第一季度美元兌丹麥克朗走弱,這對我們的現金和投資價值產生了負面影響。另一方面,由於實際利率上升,我們的利息收入有所增加。然後我們有 6000 萬美元的稅收支出,相當於 21.2% 的有效稅率。這使我們的淨利潤超過 2.2 億丹麥克朗。因此,正如您所看到的,今年年初的財務表現非常穩健。
So with that, let's take a minute to revisit our robust financial framework. First off, our revenue profile on the left. There are currently 6 products on the market that are generating significant recurring revenues, and we see a clear path to potentially expand a number of approved products with the potential approvals for EPCORE and Janssen's talquetamab. Taken together, we expect significant cash inflows in the years to come.
因此,讓我們花點時間重新審視一下我們強大的財務框架。首先,我們的收入概況在左邊。目前市場上有 6 種產品產生了可觀的經常性收入,我們看到了一條明確的途徑,可以擴展一些已獲批准的產品,可能獲得 EPCORE 和楊森(Janssen)的 talquetamab 的批准。綜上所述,我們預計未來幾年會有大量現金流入。
Now moving to the right. We remain focused in our investments as we evolve our organization for continued success. At the top of the list is accelerating and expanding EPCORE, but that's just one of the exciting opportunities that provide us with a compelling rationale for increasing our investment. 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.
現在向右移動。在我們為持續成功而發展我們的組織的過程中,我們仍然專注於我們的投資。排在首位的是加速和擴大 EPCORE,但這只是令人興奮的機會之一,為我們提供了增加投資的令人信服的理由。正如我們之前告訴您的那樣,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。
So with that background, let's now take a look at our guidance. To start, we're on track to meet the financial targets that we outlined back in February. As a reminder, note these projections are based on an assumed U.S. dollar-Danish krone exchange rate of 6.8. If we look at our revenues, we're off to a strong start with marketed products that are generating significant recurring revenues. So we continue to expect our revenue to be in the range of DKK 14.6 billion to DKK 16.1 billion. And most of this is made up of recurring revenue, where we're expecting 25% of operational growth. And as I just noted, for Q1, we're at 28%. For operating expenses, we expect to be in the range of DKK 9.8 billion to DKK 10.6 billion. As I previously highlighted, this step-up in investment is fully in line with our strategy and our focus on creating long-term value. Putting all this together, we're on track to deliver another year of substantial operating profit in a range of DKK 3.9 billion to DKK 6.2 billion.
因此,在這種背景下,讓我們現在看看我們的指南。首先,我們有望實現我們在 2 月份制定的財務目標。提醒一下,請注意這些預測是基於假設的美元兌丹麥克朗匯率 6.8。如果我們看一下我們的收入,我們將以產生可觀經常性收入的營銷產品開局良好。因此,我們繼續預計我們的收入將在 146 億至 161 億丹麥克朗之間。其中大部分由經常性收入組成,我們預計運營增長將達到 25%。正如我剛剛指出的,對於第一季度,我們的比例為 28%。對於運營費用,我們預計在 98 億至 106 億丹麥克朗之間。正如我之前強調的那樣,這種投資的增加完全符合我們的戰略和我們對創造長期價值的關注。綜上所述,我們有望在又一年實現 39 億至 62 億丹麥克朗的可觀營業利潤。
So with that, let me provide a few closing remarks. In summary, we've had a very solid start to the year. We've created growing recurring revenue streams, 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.
因此,讓我發表一些結束語。總而言之,我們今年的開局非常穩健。我們創造了不斷增長的經常性收入流,這為我們提供了重要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非常重要的增長機會.
And on that note, I'm going to hand you back over to Jan.
在那張紙條上,我要把你交還給簡。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Anthony. In the first quarter of 2023, we continue to work towards our 2030 patients, where our KYSO antibody medicines are fundamentally transforming the lives of people with cancer and other serious diseases. As we near the PDUFA date for epcoritamab, we are enthusiastic about its potential launch. We are also looking forward to working with AbbVie to continue to expand EPCORE development with new studies.
謝謝,安東尼。在 2023 年第一季度,我們將繼續為 2030 名患者而努力,我們的 KYSO 抗體藥物將從根本上改變癌症和其他嚴重疾病患者的生活。當我們接近 epcoritamab 的 PDUFA 日期時,我們對其潛在的發布充滿熱情。我們也期待與 AbbVie 合作,通過新的研究繼續擴大 EPCORE 的開發。
We are collaborating with our partner Seagen to establish Tivdak as a clear choice for patients with metastatic cervical cancer. And together, we will continue to broaden the tisotumab vedotin clinical development program. We also very much look forward to data from the clinical expansion cohorts and progress to the next steps of both DuoBody molecules targeting 4-1BB that are in development with together with BioNTech. And we anticipate expanding and advancing other early-stage programs, including the potential for multiple INDs or CTAs this year.
我們正在與我們的合作夥伴 Seagen 合作,將 Tivdak 打造成轉移性宮頸癌患者的明確選擇。我們將一起繼續擴大 tisotumab vedotin 臨床開發計劃。我們也非常期待來自臨床擴展隊列的數據,以及與 BioNTech 一起開發的針對 4-1BB 的兩種 DuoBody 分子的下一步進展。我們預計會擴大和推進其他早期項目,包括今年多個 IND 或 CTA 的潛力。
Fundamental to our success is having the right team and culture in place. We intend to continue to scale our organization on our planned portfolio development and business needs. Finally, we will continue to leverage our solid financial base to support our growth. We have a lot to look forward to in the coming months.
我們成功的基礎是擁有合適的團隊和文化。我們打算繼續根據我們計劃的投資組合開發和業務需求擴展我們的組織。最後,我們將繼續利用我們穩固的財務基礎來支持我們的增長。在接下來的幾個月裡,我們有很多期待。
So that ends our presentation of Genmab's financial results for the first quarter of 2023. Operator, please open the call now for questions.
我們對 Genmab 2023 年第一季度財務業績的介紹到此結束。運營商,請立即打開電話提問。
Operator
Operator
(Operator Instructions) Your first question comes from the line of Michael Schmidt.
(操作員說明)您的第一個問題來自 Michael Schmidt。
Michael Werner Schmidt - Senior Analyst & Senior MD
Michael Werner Schmidt - Senior Analyst & Senior MD
As we head closer to the epcoritamab PDUFA date here later this month, could you just talk about your expectation for potentially required inpatient monitoring around EPCORE and hospitalization that may be required, how that might affect commercialization? And any other expectations as we sort of look forward to seeing the FDA-approved label for the therapy? And then secondly, could you just remind us of your go-forward plans for filing in other indications this year, perhaps, for example, in follicular lymphoma or other cancer types?
當我們在本月晚些時候接近 epcoritamab PDUFA 日期時,您能否談談您對 EPCORE 周圍可能需要的住院監測和可能需要的住院治療的期望,這可能會如何影響商業化?還有什麼其他期望,因為我們有點期待看到 FDA 批准的治療標籤?其次,您能否提醒我們您今年提交其他適應症的前進計劃,例如,濾泡性淋巴瘤或其他癌症類型?
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Michael, for the questions. I can handle both. With regard to the potential label and hospitalizations, that is, of course, a question for the out authorities for the FDA. We are actively discussing with the FDA how to ensure both safe and appropriate use of EPCORE. And I can tell you that, actually, you will see it from the label discussions what the outcome will be as it relates to hospitalization. I think we're in very productive discussions with the authorities, and it's up to them to decide, and then we'll come back to that once we hear the label. But we are very pleased with the progress of the discussions, and we look forward to basically the coming weeks, Michael. I think it will be exciting times.
謝謝邁克爾提出的問題。我可以同時處理這兩個問題。關於潛在的標籤和住院治療,這當然是 FDA 外當局的問題。我們正在積極與 FDA 討論如何確保安全和適當地使用 EPCORE。我可以告訴你,實際上,你會從標籤討論中看到與住院治療相關的結果。我認為我們正在與當局進行非常富有成效的討論,這取決於他們的決定,一旦我們聽到標籤,我們就會回到這個問題上。但我們對討論的進展感到非常滿意,我們基本上期待接下來的幾週,邁克爾。我認為這將是激動人心的時刻。
And as it relates to further submissions, definitely the follicular lymphoma data will come this year. And we are fully scheduled to actually submit based, of course, on positive data from the study to the regulatory authorities and potentially in different territories this year. I will give you further updates, Michael, during this year once we have the data.
由於涉及進一步提交,濾泡性淋巴瘤數據肯定會在今年出現。當然,我們已完全安排好根據研究的積極數據實際提交給監管機構,並可能在今年向不同地區提交。一旦我們有了數據,我會在今年給你進一步的更新,邁克爾。
Operator
Operator
Your next question comes from the line of Jonathan Chang.
你的下一個問題來自 Jonathan Chang 的台詞。
Unidentified Analyst
Unidentified Analyst
On the appeal of the second arbitration resolution, are you able to provide any color on how we should be thinking about time lines and your level of confidence on the outcome? And then second question, maybe just more specifically on GEN1047. Can you discuss how the study is progressing and when we might see initial clinical data from this program?
關於第二項仲裁決議的上訴,您能否就我們應該如何考慮時間表以及您對結果的信心程度提供任何顏色?然後是第二個問題,也許更具體地說是關於 GEN1047。您能否討論一下這項研究的進展情況以及我們何時可以看到該項目的初步臨床數據?
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Jonathan, for the questions. Unfortunately, we cannot give you too much information on the appeal. We definitely will file an appeal to the second arbitration. The time line should still allow for a verdict on that appeal this year and probably after the summer, immediately after the summer. But it's, of course, up to the arbitrators, Jonathan. It's inherently uncertain what the exact timing will be, but we hope definitely for an outcome this year. And levels of confidence, we believe that we are adequately and morally on the right side of the line.
謝謝喬納森提出的問題。遺憾的是,我們無法為您提供有關上訴的太多信息。我們一定會向二審提起上訴。時間線仍應允許在今年以及可能在夏天之後,即在夏天之後立即對該上訴作出裁決。但這當然取決於仲裁員喬納森。確切的時間是什麼本質上是不確定的,但我們絕對希望今年能有結果。和信心水平,我們相信我們在道德上充分地站在了正確的一邊。
And actually, we believe that the awards from the first arbitration is very, very clear and that as we understand it will lead to the conclusion that actually the subcutaneous formulation of DARZALEX is a separate product according to the contract, and that is exactly what you will ask the arbitrators in the second arbitration to judge on. And I think we are confident that we're doing the right things. But in the end, it's down to the legal system. I cannot give you any further feedback on that.
事實上,我們認為第一次仲裁的裁決非常非常明確,據我們了解,根據合同,DARZARLEX 的皮下製劑實際上是一個單獨的產品,這正是您所了解的將請仲裁員在第二次仲裁中作出判斷。而且我認為我們有信心我們正在做正確的事情。但最終,這取決於法律體系。我無法就此向您提供任何進一步的反饋。
Then for 1047, we are still doing dose escalation. It's going well. And once we have the whole dose escalation data set enhanced, Jonathan, we will actually present the data as we usually do now for all of our early-stage clinical programs. We want to collect all of the data for the dose escalation, and then we'll actually present at a medical conference and also flag it up to the outside world. So it's going well, and we are progressing with the dose escalation. That's all I can say at this point.
然後對於1047,我們還在做劑量遞增。進行得順利。一旦我們增強了整個劑量遞增數據集,Jonathan,我們將像現在通常為所有早期臨床項目所做的那樣實際呈現數據。我們想收集劑量遞增的所有數據,然後我們將實際出席醫學會議並將其標記給外界。所以它進展順利,我們正在隨著劑量的增加而取得進展。這就是我現在能說的。
Operator
Operator
And the question comes from Peter Welford.
問題來自 Peter Welford。
Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst
Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst
I've got 3 quick ones, if you don't mind. Firstly, just coming back to epcoritamab on the third-line follicular. I wonder if you could possibly set the theme for us as to what you think is a bit of bother to enable a regulatory filing this year. And presumably, again, we're talking response rates, complete response rates and the duration that complete response is maintained. I'm curious if you can give us an update as to what you think the minimum sort of volume of data is to be to go to the regulators, particularly FDA.
如果你不介意的話,我有 3 個快速的。首先,回到三線濾泡上的 epcoritamab。我想知道您是否可以為我們設定主題,即您認為今年提交監管文件有點麻煩。大概,我們再次談論的是反應率、完全反應率和完全反應維持的持續時間。我很好奇您是否可以向我們提供最新信息,說明您認為提交給監管機構(尤其是 FDA)的最小數據量是多少。
Secondly, just on the Argenx deal, or actually more broadly immunology. Is this -- should we think of this as your big step into immunology, if you like? And then there are going to be -- I think you've sort of talked about bolt-on deals where we look at both targets and other sort of technology set that you bring into that. Or should we still think there's likely to be another perhaps even larger sort of in scale and concept deal to come as you move into this new therapeutic area? And then just finally, on the, I guess, a mandatory question, if you like, the 1042 and 1046, any updated thoughts on when we could potentially get data, whether it's likely to be by the end of this year or next year for the dose escalation expansion cohorts?
其次,就 Argenx 交易而言,或者實際上更廣泛的免疫學。這是——我們是否應該將此視為您邁向免疫學的一大步,如果您願意的話?然後會有 - 我想你已經談到了補強交易,我們會研究目標和你帶來的其他類型的技術集。或者,當您進入這個新的治療領域時,我們是否仍然認為可能會有另一筆規模和概念上更大的交易?最後,我想,關於 1042 和 1046 的強制性問題,關於我們何時可能獲得數據的任何最新想法,可能是在今年年底還是明年劑量遞增擴展隊列?
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Peter, for the questions. For the third-line follicular lymphoma data, I don't think we have discussed the bar that you want to hit basically with epcoritamab, but it will definitely be at the level of the overall response rate and the duration. The -- so we are very excited about what we see in the various follicular lymphoma settings, both monotherapy, as in combination, as you know, from last year as we had spectacular data. I think the data actually gets better and better, but we haven't seen the readout on the third-line plus cohort yet. Once we see that readout, we will definitely present the data and also actually discuss them with the regulators in both U.S. and Europe, potentially as well in Japan. But we haven't given the bar we're aiming for publicly at this moment.
謝謝,彼得,提出問題。對於三線濾泡性淋巴瘤數據,我認為我們還沒有討論過 epcoritamab 基本上要達到的標準,但肯定會在總體反應率和持續時間的水平上。 - 所以我們對我們在各種濾泡性淋巴瘤環境中看到的情況感到非常興奮,無論是單一療法,還是聯合療法,正如你所知,從去年開始我們就有了驚人的數據。我認為數據實際上越來越好,但我們還沒有看到三線加隊列的讀數。一旦我們看到讀數,我們肯定會提供數據,並實際與美國和歐洲的監管機構討論,也可能與日本的監管機構進行討論。但我們目前還沒有公開我們的目標標準。
Then as it relates to the Argenx deal, that is indeed a first step into the immunology and inflammation field. And we intend to indeed broaden that a bit further, activity of the company, both organically and inorganically. Organically by getting access to targets, we want to actually use our proprietary technology platforms for, to create better differentiated antibody-based medicines. But also potentially involving inorganic-type deals, as we said publicly, where we can bring in either technology in immunology and inflammation field, proprietary technologies, which we think will complement our suite of technology platforms or perhaps even product candidates into our pipeline to accelerate or move into the immunology and inflammation fields.
然後與 Argenx 交易相關,這確實是進入免疫學和炎症領域的第一步。我們確實打算進一步擴大公司的活動,無論是有機的還是無機的。通過有機地獲得目標,我們希望實際使用我們的專有技術平台來創造更好的差異化抗體藥物。但也可能涉及無機類型的交易,正如我們公開表示的那樣,我們可以在其中引入免疫學和炎症領域的技術、專有技術,我們認為這些技術將補充我們的技術平台套件,甚至可能將候選產品引入我們的管道以加速或進入免疫學和炎症領域。
Separate from that, we already have a number of preclinical programs active with our entirely Genmab programs, where we already are creating or have created the clinical candidates in our preclinical pipeline. We will actually update you further, Peter, once we are ready to move into a CTA filing or an IND filing. So we will progress at multiple fronts. The activity profiles get broader and broader in the immunology and information field. We are very serious about that therapeutic area.
除此之外,我們已經有許多臨床前項目與我們完全的 Genmab 項目一起活躍,我們已經在這些項目中創建或已經在我們的臨床前管道中創建了臨床候選人。彼得,一旦我們準備好進入 CTA 備案或 IND 備案,我們實際上會進一步向您更新。因此,我們將在多個方面取得進展。活動概況在免疫學和信息領域變得越來越廣泛。我們對那個治療領域非常認真。
Hence, the Argenx deal was simply the first step into strategically working with a leading company with a similar science-based focus and purpose-driven approach as we have, which we know very well. And actually working already on 2 targets, one for immunology and inflammation, one for cancer in a 50-50 strategy, but there may be other partnerships following basically further boltening our questions in immunology and inflammation field. So more updates are likely to come in the coming time.
因此,與 Argenx 的交易只是與一家領先公司進行戰略合作的第一步,這家公司與我們擁有類似的基於科學的重點和以目標為導向的方法,我們對此非常了解。實際上已經在研究 2 個目標,一個用於免疫學和炎症,一個用於 50-50 策略中的癌症,但在基本上進一步加強我們在免疫學和炎症領域的問題之後可能還有其他合作夥伴關係。因此,未來可能會有更多更新。
Then 1042, 1046. We are very rapidly progressing now with recruitment in different arms for 1042, 1046. And you will see data likely in the second half of this year for both programs, hopefully, allowing us to move forward to late-stage clinical development, potentially even for both bispecific programs. So we continue to be very, very impressed by the profiles of both bispecific antibodies, but we need more data, also to have productive discussions with the regulators. Because ideally, Peter, we will first share the data that the regulators already have feedback on the potential move to potential late-stage development and then present the data at a medical conference. There's a number of medical conferences in the second half of '23. This, I think, would qualify for some of these datasets.
然後是 1042、1046。我們現在進展非常迅速,招募了 1042、1046 的不同武器。你可能會在今年下半年看到這兩個項目的數據,希望這能讓我們進入後期臨床發展,甚至可能對兩個雙特異性程序。因此,我們繼續對這兩種雙特異性抗體的概況印象深刻,但我們需要更多數據,也需要與監管機構進行富有成效的討論。因為理想情況下,彼得,我們將首先分享監管機構已經對潛在的後期開發的潛在舉措進行反饋的數據,然後在醫學會議上展示這些數據。 23 年下半年有許多醫學會議。我認為,這符合其中一些數據集的條件。
There are multiple datasets being worked on for 1042. We are working on frontline melanoma, lung cancer, head and neck cancer and pancreatic cancer, added together with pembro, pembro plus chemo depending on what the standard of care is. And you will probably not see all of the cohorts this year. Some of the cohorts will likely come next year because some move more quickly than others and generating more robust datasets.
1042 正在處理多個數據集。我們正在研究一線黑色素瘤、肺癌、頭頸癌和胰腺癌,根據護理標準與 pembro、pembro 加化療相結合。今年你可能不會看到所有的隊列。一些隊列可能會在明年出現,因為有些隊列比其他隊列移動得更快,並生成更強大的數據集。
And for 1046, we have also multiple cohorts we are recruiting as we speak, and I can tell you with positive data in several of the cohorts. But not all of these data will likely become available this year, Peter. We'll probably do that once we have enough data to allow us to draw a conclusion on potential next steps in those lines of treatment, in those cancers. But we are getting more and more enthusiastic about these programs, and I think the second half of this year will be the beginning of a data-rich era for these programs.
對於 1046,我們在說話時也有多個隊列,我可以用其中幾個隊列的積極數據告訴你。但並非所有這些數據今年都可能可用,彼得。一旦我們有足夠的數據使我們能夠就這些癌症的這些治療方法的潛在下一步得出結論,我們可能會這樣做。但是我們對這些程序的熱情越來越高,我認為今年下半年將是這些程序數據豐富時代的開始。
Operator
Operator
Your next question comes from the line of Emily Field.
你的下一個問題來自 Emily Field。
Emily Field - Research Analyst
Emily Field - Research Analyst
Maybe just some logistical questions around epcoritamab. Assuming approval on May 21, how quickly after that do you expect to be launching? And then when do you imagine that you would start disclosing revenue or kind of early launch metrics following, hopefully, an approval? And then another question on the Argenx partnership. It sounds like that, that sort of could produce either immunology-targeting assets or oncology-targeting assets. Is that the right way to think about it? And it's more just combining complementary technologies? Or should we think about this really as you are towards producing immunology assets?
也許只是一些關於 epcoritamab 的後勤問題。假設在 5 月 21 日獲得批准,您預計在那之後多快啟動?然後,您認為什麼時候開始披露收入或某種早期發布指標,希望能獲得批准?然後是關於 Argenx 合作夥伴關係的另一個問題。聽起來是這樣,那種可以產生免疫學靶向資產或腫瘤學靶向資產。這是正確的思考方式嗎?它更只是結合互補技術?或者我們是否應該真正考慮這個問題,因為您正在製作免疫學資產?
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Emily, for the questions. For epcoritamab, we hope that we actually get the approval from the U.S. authorities quite quickly and, hopefully, at the latest by May 21, which is in the weekend, but hopefully before that. So -- and what I understand from the team is that we are actually ready to launch very, very quickly after we get a potential approval. All is ready to go. But of course, it depends on how ready we are based on the feedback on the (inaudible) how quickly we can launch. But it would be likely within a matter of weeks, if not shorter, what I understand.
謝謝,艾米麗,提出問題。對於 epcoritamab,我們希望我們能很快獲得美國當局的批准,希望最遲在 5 月 21 日,也就是周末,但希望在此之前。所以——我從團隊那裡了解到,在獲得潛在批准後,我們實際上已經準備好非常、非常快地啟動。一切準備就緒。但是,當然,這取決於我們基於對(聽不清)我們可以多快啟動的反饋的準備程度。但據我所知,這可能會在幾週內發生,甚至更短。
And the revenue reporting, I think we will get some color, I think, in Q2, hopefully, on revenue. And I don't know whether how detailed we will do the reporting. I will definitely give you color, Emily, on how the launch -- initial launch is going. There's a lot of positive feedback from the hospitals and from the doctors, and we are already in discussions with healthcare providers on the positioning of the drug and on the need for that medicine for some time. So I think we have a pretty good feeling for the level of enthusiasm, but I think we will probably in the second half of this year start to give some further detailed color on the launch under the assumption that the product will be approved in the United States.
而收入報告,我認為我們會在第二季度獲得一些顏色,希望在收入方面。而且我不知道我們是否會做多詳細的報告。艾米麗,我一定會給你關於發射的顏色 - 初始發射的進展情況。從醫院和醫生那裡得到了很多積極的反饋,我們已經與醫療保健提供者就藥物的定位和對該藥物的需求進行了一段時間的討論。所以我認為我們對熱情程度有很好的感覺,但我認為我們可能會在今年下半年開始在產品將在美國獲得批准的情況下開始對發布進行更詳細的描述。狀態。
Then Argenx, this is basically all about combining the suites of proprietary antibody technologies, which are not overlapping. They are complementary between both companies and then together work on pathways, which could actually -- until both immunology targets as well as oncology targets. And we actually started already, Emily, on one oncology and one immunology target as we speak. So I think it will feed both pipelines for both the cancer and the immunology and inflammation franchise for both companies. And this is a true 50-50 that we would equally share the expenses and upside from these potential products.
然後是 Argenx,這基本上是關於組合專有抗體技術套件,這些技術並不重疊。它們在兩家公司之間是互補的,然後共同研究途徑,這實際上可能——直到免疫學目標和腫瘤學目標。艾米麗,就在我們說話的時候,我們實際上已經開始研究一種腫瘤學和一種免疫學目標。因此,我認為它將為兩家公司的癌症以及免疫學和炎症專營權提供兩條管道。這是一個真正的 50-50,我們將平均分擔這些潛在產品的費用和好處。
And we are already having -- working on concrete programs as we speak, and I think there's great complementarity. We have, of course, a lot more cancer models and cancer expertise based on Genmab's track record up to now. And Argenx has very, very good immunology expertise and models already operational. So this will actually accelerate, I think, and synergize the activities already ongoing and new activities for both companies. So we're very excited, Emily, about this strategic partnership. I think there's a very good alignment in the scientific focus, and I think this bodes quite well for the future.
我們已經 - 在我們說話的時候正在製定具體的計劃,我認為它們之間存在很大的互補性。當然,根據 Genmab 迄今為止的記錄,我們擁有更多的癌症模型和癌症專業知識。 Argenx 擁有非常非常好的免疫學專業知識和已經投入使用的模型。因此,我認為這實際上會加速並協同兩家公司已經開展的活動和新活動。因此,艾米麗,我們對這種戰略合作夥伴關係感到非常興奮。我認為科學重點非常一致,我認為這預示著未來。
Operator
Operator
Your next question comes from the line of Asthika Goonewardene.
你的下一個問題來自 Asthika Goonewardene。
Asthika Sarith Goonewardene - Research Analyst
Asthika Sarith Goonewardene - Research Analyst
I want to just maybe touch on the question on Argenx. Just want to clarify something. You said you already have one oncology asset that you're sort of working on right now. If it goes into a full provision and maybe to market, is there a scenario that Argenx will actually act under and co-promote this product with you, given that they don't really have much of an oncology franchise? And then I wanted to back up on the question on 1042 and 1046 and make sure I heard this right. Did you say that by the end of the year that you're optimistic of the path forward for both those assets to go forward? Just want to make sure I had the right because I think there was some understanding that it might have been one or the other. So I just want to clarify that, too.
我想談談關於 Argenx 的問題。只是想澄清一些事情。你說你已經擁有一項你現在正在研究的腫瘤學資產。如果它進入全面供應並可能進入市場,考慮到他們實際上沒有太多的腫瘤專營權,Argenx 是否會實際採取行動並與您共同推廣該產品?然後我想支持關於 1042 和 1046 的問題,並確保我沒聽錯。您是否說過到今年年底您對這兩項資產的發展前景持樂觀態度?只是想確保我有權利,因為我認為有人理解它可能是其中之一。所以我也想澄清一下。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
All right, Asthika. That's very nice question. Thank you very much. Now let me start with the Argenx partnership. We actually are very well defined who will take the lead of its programs and very likely for a cancer product, we will definitely share the upside, Asthika. But Genmab will likely be leading the commercialization.
好吧,阿西卡。這是個很好的問題。非常感謝。現在讓我從 Argenx 合作夥伴關係開始。我們實際上非常明確誰將領導其項目,並且很可能對於癌症產品,我們肯定會分享優勢,Asthika。但 Genmab 可能會引領商業化。
But the other party, so Argenx in this case, can co-promote for sure. And the same for immunology and inflammation, it's very likely that, initially, Argenx would lead the commercialization of programs in that area, in immunology area. But Genmab would be entitled to co-promote in a 50-50 basis. So it would be actually for both disease areas of both companies, but the lead will likely be lying with one of the parties, and that has been very clearly defined in the agreement here. So -- but both companies have the option to actually further scale up in commercialization in the disease area, where they're currently not very active in.
但是另一方,在這種情況下是 Argenx,可以肯定地共同推廣。對於免疫學和炎症也是如此,最初,Argenx 很可能會在免疫學領域領導該領域的項目商業化。但 Genmab 將有權以 50-50 的比例共同推廣。因此,這實際上適用於兩家公司的兩個疾病領域,但主導權可能在於其中一方,這已在此處的協議中非常明確地定義。所以——但兩家公司都可以選擇在疾病領域進一步擴大商業化規模,而他們目前在該領域並不十分活躍。
Then as it relates to 1042 and 1046, we hope that at least 1 of those programs can be moved to late-stage clinical development, if not both. And what I said in my answer to, I believe it was for Peter Welford, is that both of the programs are doing very well. And of course, we need more data. And as I already explained before, data is not only response rate, it's also depth of response and duration in the various cohorts for both of the bispecific approaches. But there is a good chance that actually both would move forward to a late-stage clinical development based on data. But it's entirely data present, Asthika. So we'll let the data speak for itself and then take rational decisions, also potentially after we already have shared the data with the regulator and have some feedback on the potential next steps.
然後因為它涉及到 1042 和 1046,我們希望至少有一個項目可以轉移到後期臨床開發,如果不是兩個的話。我在回答中說的是,我相信這是針對 Peter Welford 的,這兩個項目都做得很好。當然,我們需要更多數據。正如我之前已經解釋過的那樣,數據不僅是反應率,它也是兩種雙特異性方法在不同隊列中的反應深度和持續時間。但很有可能實際上兩者都會推進到基於數據的後期臨床開發。但這完全是數據的存在,Asthika。因此,我們會讓數據自己說話,然後做出理性的決定,也可能是在我們已經與監管機構共享數據並對可能的後續步驟獲得一些反饋之後。
Operator
Operator
Your next question comes from the line of Matthew Phipps.
你的下一個問題來自 Matthew Phipps。
Matthew Christopher Phipps - Senior Biotechnology Research Analyst
Matthew Christopher Phipps - Senior Biotechnology Research Analyst
One on Tivdak. Just curious how much more data you would want to see in head and neck to make a decision on moving that forward and the rationale for a different dose in head and neck versus cervical. Is that exposure or safety-related? And then kind of lastly, if the pending Seagen acquisition make it a little bit more difficult to come to these joint decisions on Tivdak development near term?
一個在 Tivdak 上。只是好奇您希望在頭頸部看到多少數據才能做出向前推進的決定,以及頭頸部與頸部不同劑量的基本原理。這是暴露還是安全相關?最後一點,如果即將進行的 Seagen 收購讓短期內就 Tivdak 開發做出這些聯合決定變得有點困難?
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
So thank you very much for the questions. For 2 questions, basically, Tivdak. The data is very, very encouraging. It's early data in head and neck in second-line plus head and neck. We -- by this time, we already have more data, and I think the pattern is consistent of what we presented recently, and we will actually collect a bit more data and then decide on next steps together with Seagen. We wanted -- the frequency of dosing is actually a bit higher here than in the labeled dosing for cervical cancer. And that is actually to get actually a higher amount of the medicine in the patients more effectively with still acceptable safety profile. So we are very encouraged by this data, and I think that we actually will collect in the coming months enough data to allow us to make a rationalization on next steps. And we have firm plans for that together with Seagen.
非常感謝您提出的問題。對於 2 個問題,基本上,Tivdak。數據非常非常鼓舞人心。這是二線加上頭頸的頭頸早期數據。我們 - 到這個時候,我們已經有了更多的數據,我認為這種模式與我們最近提出的一致,我們實際上會收集更多的數據,然後與 Seagen 一起決定下一步。我們想要 - 這裡的給藥頻率實際上比標記的宮頸癌給藥頻率高一點。這實際上是為了在患者體內更有效地獲得更多的藥物,同時安全性仍然可以接受。因此,我們對這些數據感到非常鼓舞,我認為我們實際上將在未來幾個月內收集足夠的數據,使我們能夠對後續步驟進行合理化。我們與 Seagen 一起制定了堅定的計劃。
What I can also tell you is that we heard from Seagen by this time that the potential acquirer Pfizer of Seagen is also very excited about the data. In the meantime, I think we have already spoken with some of the colleagues from Pfizer and assuming that the transaction goes through, I think that actually -- I think there is a very, very good level of enthusiasm for Tivdak to move to the next stages in the second solid cancer outside of cervical cancer. And then in the second half of this year, we also hope to see frontline data in cervical cancer and combinations and triplets and quadruplets regimens. But also there, I think the data shapes up very nicely.
我還可以告訴你的是,我們這次從 Seagen 那裡聽說,Seagen 的潛在收購方輝瑞公司也對這些數據感到非常興奮。與此同時,我認為我們已經與輝瑞公司的一些同事進行了交談,並假設交易已經完成,我認為實際上 - 我認為 Tivdak 有非常非常高的熱情進入下一個宮頸癌以外的第二實體癌的分期。然後在今年下半年,我們也希望看到宮頸癌的一線數據以及聯合療法和三聯療法和四聯療法。但也在那裡,我認為數據的形狀非常好。
So I think that hopefully with Seagen or with Seagen and the new ownership, we will actually move not only to a second-line plus head and neck cancer in the course of this year, but potentially also to further in cervical cancer later on perhaps, even first-line head and neck cancer a bit further from that. So we're actually very encouraged by the profile of the medicine, it's very, very potent and it's very well manageable safety. So I believe that we have a good chance of creating a much more impactful medicine here with Tivdak in the coming time with Seagen and also with the potential new owners of the assets from the U.S. perspective.
所以我認為,希望與 Seagen 或 Seagen 以及新的所有權一起,我們實際上不僅會在今年的過程中轉向二線加頭頸癌,而且可能還會在以後進一步發展宮頸癌,就連一線頭頸癌都離那更遠了一點。所以我們實際上對這種藥物的概況感到非常鼓舞,它非常非常有效,而且安全性非常好。因此,我相信在未來與 Seagen 以及從美國角度來看資產的潛在新所有者一起,我們很有可能在這裡與 Tivdak 一起創造一種更具影響力的藥物。
Operator
Operator
Your next question comes from the line of James Gordon.
你的下一個問題來自 James Gordon。
James Daniel Gordon - Senior Analyst
James Daniel Gordon - Senior Analyst
James Gordon, JPMorgan. Two questions, please. One was about CD38 in competition. So can you just remind us how much of DARZALEX sales are still coming from use in refractory patients? And I ask because some people have been a bit worried about (inaudible) competition. And do you think (inaudible) is going to have any impact on DARZALEX in the next couple of years as it moves into earlier treatment lines? And assuming we do get competition in the frontline potentially around 2027, how much of a headwind do you think that would be, given I know there were some manufacturing issues and administration issues? So how much of a threat there? Another part of that question also, just there are new therapies coming along in multiple myeloma, including CAR-T. Do you think that does mean change or any less likely to want to go for HexaBody CD38 if there's other things like CAR-T that may be a little more promising?
詹姆斯戈登,摩根大通。請教兩個問題。一個是關於 CD38 的比賽。那麼您能否提醒我們,有多少 DARZARLEX 銷售額仍來自難治性患者的使用?我問是因為有些人有點擔心(聽不清)競爭。您認為(聽不清)在未來幾年內會在 DARZARLEX 進入早期治療線時對它產生任何影響嗎?假設我們確實在 2027 年左右在前線獲得競爭,鑑於我知道存在一些製造問題和管理問題,您認為這會有多大的阻力?那麼那裡的威脅有多大?該問題的另一部分也是多發性骨髓瘤的新療法,包括 CAR-T。你認為這是否意味著改變或不太可能想要使用 HexaBody CD38,如果有其他東西,如 CAR-T,可能更有希望嗎?
And then the second question was on M&A. In terms of inorganic and dealmaking, do you have what you need in-house to do your own ADCs? Because I know you did a deal there. Or might you actually hunt for getting a link or a new payloads and actually ADCs might be where you want to expand into? And a final clarification, just on dealmaking. Are you done in terms of immunology in terms of looking for a larger partner? Or could you also -- as well as Argenx try and do an immunology deal with a large cap pharma company?
然後第二個問題是關於併購的。在無機和交易方面,你是否擁有內部所需的東西來做你自己的 ADC?因為我知道你在那裡做了一筆交易。或者你可能真的在尋找鏈接或新的有效載荷,而實際上 ADC 可能是你想要擴展的地方?最後澄清一下,只是關於交易。在尋找更大的合作夥伴方面,您在免疫學方面完成了嗎?或者你也可以 - 以及 Argenx 嘗試與一家大型製藥公司進行免疫學交易?
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, James. I think there are more than 2 questions for sure, but let me try to go over that in an orderly manner. So first and then to all DARZALEX and CD38 competition, what I clearly see is that actually maybe I should go first over the (inaudible) data because you asked about basically the second line. Overall, in the U.S. in March, that was 40% of the patients are treated with DARZALEX, and the 39% of the new patient starts in the front line. 36% of the patients are getting treated with DARZALEX, with 39% of the new patients start and the second line, 53% of the patients and the same 53% in the third-line setting. So there's still a lot usage in combination.
謝謝,詹姆斯。我認為肯定有兩個以上的問題,但讓我試著有條不紊地複習一下。所以首先,然後是所有 DARZARLEX 和 CD38 競爭,我清楚地看到,實際上也許我應該首先討論(聽不清)數據,因為你問的基本上是第二行。總體而言,3 月份在美國,有 40% 的患者接受了 DARZARLEX 治療,而 39% 的新患者開始在一線工作。 36% 的患者正在接受 DARZARLEX 治療,其中 39% 的新患者開始接受二線治療,53% 的患者和同樣的 53% 接受三線治療。所以結合使用還是有很多的。
And what I understand that actually, DARZALEX is the perfect combination drug, not only for the bispecifics like now TECVAYLI and potentially soon talquetamab but also for potential combination with CAR-T. And Janssen is already having a Phase III trial combining CAR-T with DARZALEX. So I don't think that actually that there will be a lot of competition for the position of the CD38.
據我了解,實際上,DARZARLEX 是一種完美的組合藥物,不僅適用於雙特異性藥物,如現在的 TECVAYLI 和可能很快推出的 talquetamab,還適用於與 CAR-T 的潛在組合。 Janssen 已經在進行 CAR-T 與 DARZARLEX 結合的 III 期試驗。所以我不認為實際上會有很多人爭奪 CD38 的位置。
And then the question for you asked is would Johnson be interested in HexaBody CD38, I think so because of several reasons. One is if HexaBody CD38 would be much more potent in the clinic than DARZALEX, that could be a fantastic next-generation combination partner for all of these other medicines in multiple myeloma. And also in the context of IRA legislation and complexity from that perspective, it could be very smart for Janssen to actually switch at some point, DARZALEX for a next-generation CD38 targeted medicines.
然後你問的問題是約翰遜是否會對 HexaBody CD38 感興趣,我認為有幾個原因。一個是如果 HexaBody CD38 在臨床上比 DARZARLEX 更有效,那麼它可能成為所有這些其他藥物在多發性骨髓瘤中的理想下一代組合夥伴。而且從這個角度來看,在 IRA 立法和復雜性的背景下,楊森在某個時候實際轉換 DARZARLEX 為下一代 CD38 靶向藥物可能是非常明智的。
So I think the interest level should go up and not go down. We are now doing the head-to-head trial against subcu DARZALEX as we reflected in the Q1 report, James. So I think with more data next year, I think the interest level should potentially go up rather than go down. And we're not that worried about competition for DARZALEX. I think DARZALEX has found a place as a core therapy, as a backbone therapy in multiple myeloma, and not only with the current agents, with the IMiDs and proteasome inhibitors, but also with the bispecifics, the new bispecifics and potentially even with CAR-T.
所以我認為利率水平應該上升而不是下降。正如我們在第一季度報告中所反映的那樣,我們現在正在對 subcu DARZALEX 進行頭對頭試驗,James。因此,我認為隨著明年更多數據的出現,我認為利率水平可能會上升而不是下降。我們並不擔心 DARZARLEX 的競爭。我認為 DARZARLEX 已經找到了一席之地作為核心療法,作為多發性骨髓瘤的骨幹療法,不僅與當前的藥物、IMiD 和蛋白酶體抑製劑一起,而且與雙特異性藥物、新的雙特異性藥物甚至可能與 CAR- T.
Then your second question as it relates to M&A. ADCs, we are actually having a lot of deals in place for ADCs. And we flagged up several, actually, not only (inaudible) like with Synaffix. And we also work together with AbbVie in the ADC field. But also, we actually also have access to immune activators via the Bolt Therapeutics interaction. And actually, a number of other deals have been done in the ADC field. This, we have not even flagged up perfectly because there were early-stage deals on building blocks and components we need for building an ADC next-generation antibody therapeutic.
那麼你的第二個問題與併購有關。 ADC,我們實際上有很多針對 ADC 的交易。我們標記了幾個,實際上,不僅僅是(聽不清)像 Synaffix。在ADC領域我們也和AbbVie有合作。而且,我們實際上也可以通過 Bolt Therapeutics 相互作用獲得免疫激活劑。實際上,在 ADC 領域已經完成了許多其他交易。這一點,我們甚至還沒有完美地標記出來,因為我們在構建 ADC 下一代抗體療法所需的構建模塊和組件方面存在早期交易。
But ADCs are a very, very significant part already of our preclinical pipeline, James. So potentially, we could go broader because we like ADCs. I just -- you just heard my enthusiasm about Tivdak, the tisotumab vedotin, ADC together with Seagen, it's doing better and better, and this will become a very meaningful medicine, we believe, not only for cervical cancer, but also for other solid tumors in the future. But we see actually a lot of potential for ADCs, and we already have a fair number in our preclinical pipeline. And some of them will likely move to the clinic in the coming time.
但 ADC 已經是我們臨床前管道中非常非常重要的一部分,James。所以有可能,我們可以走得更遠,因為我們喜歡 ADC。我只是 - 你剛剛聽到我對 Tivdak、tisotumab vedotin、ADC 和 Seagen 的熱情,它做得越來越好,我們相信這將成為一種非常有意義的藥物,不僅對宮頸癌,而且對其他固體未來的腫瘤。但我們實際上看到了 ADC 的巨大潛力,而且我們的臨床前管道中已經有相當數量的 ADC。他們中的一些人可能會在未來一段時間內搬到診所。
And your third question is about immunology and inflammation, potentially deals with large cap. That would be possible, I think. There is a lot of interest for our technology platforms. I mean that is one of the reasons that we move into immunology and inflammation. So we believe that by having access to our proprietary antibody technology platforms, James, we can actually make much better therapeutics for immunology and inflammation that the current generation of naked antibody approaches is already making a big impact in some of these areas to think about the TNF alpha blockers, the IL-17 blockers, IL-23, the targeted antibody therapeutics.
你的第三個問題是關於免疫學和炎症,可能涉及大盤股。我認為那是可能的。人們對我們的技術平台很感興趣。我的意思是這是我們進入免疫學和炎症的原因之一。因此,我們相信,通過使用我們專有的抗體技術平台,James,我們實際上可以為免疫學和炎症做出更好的治療,當前一代的裸抗體方法已經在其中一些領域產生了巨大影響,以考慮TNF α 阻斷劑、IL-17 阻斷劑、IL-23、靶向抗體療法。
We believe that by having smart use of our proprietary technology platform, we can actually make much better targeted medicines for immunology and inflammation diseases. And I can say there is a lot of interest from -- also from large cap pharma and working with us in these areas. But of course, the pitfall is that we are not going to do any deal unless we actually can hold on to 50% product ownership to the end, if not more, James. And that is going to be more difficult and challenging, we believe, at a large cap pharma because they would likely like to own more of the products than we are willing to give to them.
我們相信,通過巧妙地使用我們的專有技術平台,我們實際上可以為免疫學和炎症疾病開發出更好的靶向藥物。我可以說有很多興趣來自 - 也來自大型製藥公司並在這些領域與我們合作。但當然,陷阱是我們不會做任何交易,除非我們真的能堅持到最後,如果不是更多,詹姆斯,50% 的產品所有權。我們認為,對於一家大型製藥公司來說,這將變得更加困難和具有挑戰性,因為他們可能希望擁有比我們願意提供給他們的更多的產品。
So in that context, I think it is actually likely that we see more deals and more activity from Genmab and perhaps even in the M&A field, but not necessarily with large cap pharma because they are likely not going to be very enthusiastic of giving up 50% of the upside or more to a biotech company. The times are changing. I think we will see more activity in this area. We are very enthusiastic of now more robustly marching into the immunology and inflammation therapeutic area and more to come in the future, James. That's probably where I want to leave it at this point.
因此,在這種情況下,我認為我們實際上可能會看到來自 Genmab 的更多交易和更多活動,甚至可能在併購領域,但不一定是大型製藥公司,因為他們可能不會非常熱衷於放棄 50生物技術公司的上行空間百分比或更多。時代在變。我認為我們會在這個領域看到更多的活動。詹姆斯,我們現在非常熱衷於更強有力地進軍免疫學和炎症治療領域,未來還會有更多。這可能就是我現在想離開的地方。
Operator
Operator
And the question comes from the line of Peter Verdult.
問題來自 Peter Verdult 的台詞。
Peter Verdult - MD
Peter Verdult - MD
Peter Verdult, Citi. Two questions, please. First, for Tahi or for Jan. Just with the Polivy approval now in frontline DLBCL done and dusted. Could you remind us how quickly do you intend to initiate a frontline DLBCL study with Polivy and EPCORE? That's question #1. And then question #2 for Anthony. I think I know the answer, but just with the cash pile growing ever bigger, is there a point in time going forward, is there a tipping point where there will be a change in your cash allocation priorities? Or do we -- should we just assume that you continue piling up the cash to give you full flexibility to follow the science and push things into place should need be? I just wanted to know whether there's a tipping point where you would perhaps consider other capital allocation priorities.
Peter Verdult,花旗銀行。請教兩個問題。首先,對於 Tahi 或 Jan。只要 Polivy 批准現在在前線 DLBCL 完成並塵埃落定。您能否提醒我們,您打算多快啟動 Polivy 和 EPCORE 的一線 DLBCL 研究?這是問題#1。然後是安東尼的問題#2。我想我知道答案,但隨著現金儲備越來越大,是否有一個時間點向前發展,是否有一個轉折點,您的現金分配優先級會發生變化?或者我們——我們是否應該假設你繼續積累現金,讓你有充分的靈活性來遵循科學並將事情推進到位?我只是想知道是否存在一個轉折點,您可能會考慮其他資本分配優先事項。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Peter, for the 2 questions. I can tell you that we are planning a number of frontline studies as we speak. And we will absolutely detail them at the point that we get regulatory feedback so that we can initiate those studies. And that actually is also not only other antibodies or antibody drug conjugates, but also small molecules, and even chemo in some instances. So you know that in the diffuse large B-cell lymphoma, we already have the R-CHOP combination with EPCORE ongoing and recruiting as we speak. But there will be more frontline studies, and we will give you further updates once we get feedback from the regulators on the combinations and the exact way we want to combine a bit epcoritamab, but a clinical program for EPCORE will become quite a bit broader in the coming time. Then handing over to Anthony for the second question.
彼得,謝謝你提出的兩個問題。我可以告訴你,我們正在計劃一些前線研究。我們將在收到監管反饋時絕對詳細說明它們,以便我們可以啟動這些研究。實際上,不僅是其他抗體或抗體藥物偶聯物,還有小分子,在某些情況下甚至是化療。所以你知道,在瀰漫性大 B 細胞淋巴瘤中,我們已經有了 R-CHOP 與 EPCORE 的組合,正如我們所說的那樣,正在進行和招募。但是會有更多的一線研究,一旦我們從監管機構那裡得到關於這些組合的反饋以及我們想要組合一點 epcoritamab 的確切方式,我們會為您提供進一步的更新,但 EPCORE 的臨床計劃將變得相當廣泛即將到來的時間。然後交給安東尼回答第二個問題。
Anthony Pagano - Executive VP & CFO
Anthony Pagano - Executive VP & CFO
Yes. Thanks, Peter. To be clear, our capital allocation priorities absolutely remain unchanged. As you highlighted, as we continue on this growth trajectory and looking at the really exciting growth opportunities that we have, we think having that full flexibility of our balance sheet, that strong balance sheet to be absolutely essential to make sure we have the capital to invest in all of the exciting organic opportunities, and as Jan highlighted, if the right opportunity presents itself from a BD&L perspective or otherwise that we have that balance sheet and deploy that capital appropriately.
是的。謝謝,彼得。需要明確的是,我們的資本配置重點絕對保持不變。正如您所強調的那樣,隨著我們繼續沿著這一增長軌道前進,並著眼於我們擁有的真正令人興奮的增長機會,我們認為資產負債表具有充分的靈活性,強大的資產負債表對於確保我們擁有資本是絕對必要的投資所有令人興奮的有機機會,正如 Jan 強調的那樣,如果從 BD&L 的角度或其他方面出現合適的機會,我們就會擁有該資產負債表並適當地部署該資本。
So the headline message, Peter, to answer your question directly is that our capital allocation priorities remain unchanged. And again, that balance sheet strength is going to be important as we continue to build out our business on multiple fronts for the next couple of years and potentially beyond.
因此,彼得,直接回答你問題的標題信息是我們的資本配置優先事項保持不變。再一次,隨著我們在未來幾年甚至更長時間內繼續在多個方面發展我們的業務,資產負債表的實力將變得很重要。
Operator
Operator
The next question comes from the line of Yaron Werber.
下一個問題來自 Yaron Werber。
Yaron Benjamin Werber - MD & Senior Biotechnology Analyst
Yaron Benjamin Werber - MD & Senior Biotechnology Analyst
This is Gina on for Yaron. Going back to your GEN3014, the HexaBody-CD38. Can you give us any more details on the trial designs, just how many patients you have in your head-to-head and other arms to the trial? And then also, what you think are the efficacy and safety benchmarks to move that program forward? And also as a follow-up kind of second question going back to GEN1042 and 1046, given that you think that there's a possibility for advancing both of these into late-stage clinical, have you thought about how you want to position these 2 assets relative to each other? Or perhaps what indications or settings do you think would be more safer one versus the other?
這是 Yaron 的 Gina。回到您的 GEN3014,HexaBody-CD38。你能給我們更多關於試驗設計的細節嗎?你有多少患者在你的頭對頭和其他手臂上進行試驗?然後,您認為推進該計劃的有效性和安全性基準是什麼?還有作為追溯至 GEN1042 和 1046 的第二個問題,鑑於您認為有可能將這兩項推進到後期臨床,您是否考慮過如何定位這兩項資產的相對位置對彼此?或者您認為哪種適應症或設置比另一種更安全?
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thank you for the question. So with HexaBody-CD38 or 3014, they had to have 2 arms with CD38 naive collapsed refractory multiple myeloma. We haven't specified the size of the arms, but we hope that we actually can recruit them both this year. And actually, recruitment is going well at this moment, and you will hear next year the clinical data very likely also of that head-to-head arm, with HexaBody-CD38.
感謝你的提問。因此,對於 HexaBody-CD38 或 3014,他們必須有 2 個手臂患有 CD38 幼稚塌陷難治性多發性骨髓瘤。我們還沒有具體說明手臂的大小,但我們希望今年能真正招募到他們。實際上,此時的招募進展順利,明年你很可能還會聽到 HexaBody-CD38 的頭對頭手臂的臨床數據。
Then second question as it relates to 1042, 1046, the 4-1BB targeted bispecifics. We believe that we can actually position them differently in different solid tumors and different lines of treatment. As you know, we are testing 1042 in frontline melanoma, frontline lung cancer, frontline head and neck, and frontline pancreatic. At this moment, you have only seen a few patients data in head and neck. But very likely 1042 will be positioned in the frontline area for one or more of these solid tumors.
然後是第二個問題,因為它涉及 1042、1046,即 4-1BB 靶向雙特異性抗體。我們相信,我們實際上可以在不同的實體瘤和不同的治療方案中對它們進行不同的定位。如您所知,我們正在前線黑色素瘤、前線肺癌、前線頭頸部和前線胰腺癌中測試 1042。此刻,您只看到了頭頸部的少數患者數據。但很可能 1042 將被定位在這些實體瘤中的一種或多種的前線區域。
And 1046, I think the most likely is that we will actually go initially for lung cancer for non-small cell lung carcinoma, collapse refractory after checkpoint inhibitor for that because we have the most impressive data there until now. But there's also other cancers which we have not yet specified, where we see very good responses for 1046. So we have no worries about the positioning of these 2 bispecifics. We think that they will be positioned in the end in different tumors and different lines of treatment. More to come this year.
而 1046,我認為最有可能的是我們實際上將首先針對非小細胞肺癌進行肺癌治療,檢查點抑製劑治療後出現難治性塌陷,因為到目前為止我們擁有最令人印象深刻的數據。但也有我們尚未指定的其他癌症,我們看到 1046 的反應非常好。因此我們不用擔心這 2 個雙特異性抗體的定位。我們認為它們最終將定位於不同的腫瘤和不同的治療線。今年還會有更多。
Operator
Operator
And the question comes from the line of Rajan Sharma.
問題來自 Rajan Sharma。
Rajan Sharma - Research Analyst
Rajan Sharma - Research Analyst
First one, just on OpEx. And could you just help us think about kind of phasing through 2023 and if there could be potentially a peak quarter through the year? And then secondly, just on DARZALEX. And could you provide any clarity on kind of what proportion of revenue were subcu in Q1 and how you see that progressing through the course of the year?
第一個,僅在 OpEx 上。你能不能幫我們考慮一下到 2023 年的分階段,以及全年是否可能有一個高峰季度?其次,就在 DARZARLEX 上。您能否明確說明第一季度子收入佔收入的比例,以及您如何看待這一年的進展情況?
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Rajan. I will hand over both questions to Anthony. Anthony, please?
謝謝,拉詹。我將把這兩個問題交給安東尼。安東尼,請問?
Anthony Pagano - Executive VP & CFO
Anthony Pagano - Executive VP & CFO
Yes. Sure thing. I mean maybe sort of stepping back and looking at our overall investment profile, particularly the drivers, as we sort of thought about transitioning from 2022, 2023. I highlighted back in February, 4 key areas where we're really looking to deploy that capital and what was the drivers of the increase in OpEx year-over-year. As a reminder, those 4 areas, number one, was the portfolio advancement. That was making up around DKK 1.3 billion of the increase on a year-over-year basis at our guidance midpoint. We then had the further build-out and market build for U.S. and Japan of around DKK 400 million.
是的。當然可以。我的意思是,當我們考慮從 2022 年、2023 年開始過渡時,可能會退後一步,看看我們的整體投資概況,尤其是驅動因素。我在 2 月份強調了我們真正希望部署資金的 4 個關鍵領域運營支出同比增長的驅動因素是什麼?提醒一下,這 4 個領域,第一,是投資組合的進步。在我們的指導中點,這占同比增長的約 13 億丹麥克朗。然後,我們為美國和日本進行了約 4 億丹麥克朗的進一步擴建和市場建設。
Then we had really investing and scaling up our world-class discovery engine, including the investments to move into a new therapeutic area of around DKK 100 million. And then finally, in the enabling functions, some very important foundational investments in these functions to achieve the required scale. So these are the 4 areas that we highlighted as part of the reasons behind the growth drivers between 2022 and 2023. And as I look at the results in Q1 so far, that's exactly where that increase is as I look at the year-over-year figures. And as I sit here today, that absolutely remains true.
然後我們真正投資並擴大了我們世界級的發現引擎,包括投資約 1 億丹麥克朗進入新的治療領域。最後,在支持功能中,對這些功能進行一些非常重要的基礎投資,以達到所需的規模。因此,這些是我們強調的 4 個領域,作為 2022 年至 2023 年增長動力背後的部分原因。當我看到目前為止第一季度的結果時,這正是我看的同比增長的地方 -年的數字。當我今天坐在這裡時,這絕對是正確的。
Now particularly on your question on phasing. Look, this can be lumpy as a function of various spend, CMC or manufacturing investments. So no explicit quarterly phasing guidance, Rajan, other than to reiterate our full year guidance in the overall range of DKK 9.8 billion to DKK 10.6 billion.
現在特別是關於分階段的問題。看,這可能是各種支出、CMC 或製造投資的函數。因此,拉詹,除了重申我們在 98 億至 106 億丹麥克朗的總體範圍內的全年指導外,沒有明確的季度分階段指導。
In terms of the subcu split in Q1, our commentary is going to be very limited, just limited to the U.S. market. And more recently, we've seen that in the high 80s or around 88% being subcu. Now outside of the U.S., our visibility is much more limited, and we're not in a position to really share that information. What I can say is that in terms of the 88%, that's in line with our overall thinking and projections for a year. Again, what I highlighted back in February when we gave our full year guidance is we're expecting to be on a full year basis globally in the 90% range.
就第一季度的 subcu 拆分而言,我們的評論將非常有限,僅限於美國市場。最近,我們看到在 80 年代的高位或大約 88% 的人是 subcu。現在在美國之外,我們的知名度要有限得多,我們無法真正分享這些信息。我能說的是,就88%而言,這符合我們一年的整體思路和預測。同樣,我在 2 月份給出全年指導時強調的是,我們預計全年在全球範圍內達到 90%。
Operator
Operator
There are no further questions at this time, so I would like to hand back for closing remarks.
目前沒有其他問題,所以我想返回結束語。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thank you all for calling in today to discuss Genmab's financial results for the first quarter of 2023. If you have any additional questions, please reach out to our Investor Relations team. We hope that you all stay safe, keep optimistic and remain healthy. And we very much look forward to speaking with you again soon.
感謝大家今天來電討論 Genmab 2023 年第一季度的財務業績。如果您有任何其他問題,請聯繫我們的投資者關係團隊。我們希望大家保持安全,保持樂觀並保持健康。我們非常期待很快再次與您交談。
Operator
Operator
This concludes today's conference call. Thank you for participating. You may now disconnect.
今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。