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 First Quarter 2024 Conference Call. As a reminder, this conference call is being recorded.
您好,歡迎參加 Genmab 2024 年第一季電話會議。謹此提醒,本次電話會議正在錄音中。
During this telephone conference, you may be presented with forward-looking statements that 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.
在本次電話會議期間,您可能會收到諸如相信、預期、計劃或期望等詞語的前瞻性陳述。實際結果可能存在重大差異,例如,由於開發專案延遲或不成功。 Genmab 沒有義務更新有關未來的聲明,也沒有義務確認與實際結果相關的此類聲明,除非法律要求。
Please also note that Genmab may hold your personal data as indicated by you as part of our Investor Relations outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy.
另請注意,作為我們投資者關係外展活動的一部分,Genmab 可能會保存您所指定的個人數據,以便您了解 Genmab 的最新情況。請造訪我們的網站,以了解有關 Genmab 的更多資訊以及我們的隱私權政策。
I would now 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 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, 2024. 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, and Chief Development Officer, Judith Klimovsky.
您好,歡迎參加 Genmab 的電話會議,討論該公司截至 2024 年 3 月 31 日的財務業績。以及我們的營運長安東尼·曼奇尼。我們的首席醫療官 Tahi Ahmadi 和首席開發官 Judith Klimovsky 將參加問答環節。
As already said, we will be making forward-looking statements, so please keep that in mind as we go through this call. During today's presentation, we will reference products being developed under some of our strategic collaborations, and this slide acknowledges those relationships.
正如已經說過的,我們將做出前瞻性陳述,因此請在我們進行本次電話會議時牢記這一點。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。
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 pipeline which is both expanding and maturing and our growing revenue streams allow us to continue to invest in our people and in our pipeline. These are investments that will further accelerate our evolution into a fully integrated biotech innovation powerhouse.
在我們查看第一季業績之前,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線提供了動力,該產品線正在不斷擴大和成熟,而且我們不斷增長的收入流使我們能夠繼續投資於我們的員工和我們的產品線。這些投資將進一步加速我們發展成為完全一體化的生物技術創新強國。
In addition to our existing technologies and mid-to late-stage pipeline, a key investment that will enhance our long-term growth profile is the exciting proposed acquisition of ProfoundBio. So let us turn to that briefly now.
除了我們現有的技術和中後期管道外,一項將增強我們長期成長前景的關鍵投資是對 ProfoundBio 的令人興奮的擬議收購。現在讓我們簡單地討論一下這個問題。
The proposed acquisition of ProfoundBio firmly aligns with our core vision and strategy of transforming the lives of people with cancer and other serious diseases. It is highly complementary to our business. And the addition of ProfoundBio's next-generation ADCs, including Rina-S, plus its novel ADC technology will further strengthen our already very strong and innovative mid- to late-stage clinical pipeline. This will also strengthen and accelerate our capabilities in the ADC space. In addition to helping to propel us towards a 100% owned model with more value captures.
擬收購 ProfoundBio 與我們改變癌症和其他嚴重疾病患者生活的核心願景和策略完全一致。它與我們的業務具有很強的互補性。 ProfoundBio 的下一代 ADC(包括 Rina-S)的加入,加上其新穎的 ADC 技術,將進一步加強我們已經非常強大和創新的中後期臨床管道。這也將加強和加速我們在 ADC 領域的能力。除了幫助推動我們邁向 100% 擁有更多價值的模式之外。
So we are investing to unlock meaningful value by the end of the decade with significant upside into the 2030s. We expect to close the acquisition in the first half of 2024, subject to the receipt of regulatory clearances. So now let us turn to other important recent events.
因此,我們正在投資,以期在本十年末釋放有意義的價值,並在 2030 年代實現顯著的成長。我們預計在 2024 年上半年完成收購,但須獲得監管部門的批准。現在讓我們來看看最近發生的其他重要事件。
Epcoritamab continues to receive regulatory approvals and relapsed or refractory diffuse large B-cell lymphoma in various territories with additional filings underway. We and our partner AbbVie, have a robust development plan for epcoritamab. And in the first quarter of the year, we took significant steps to move into follicular lymphoma. In March, we, along with AbbVie, initiated the first of multiple Phase III trials anticipated to start this year.
Epcoritamab 繼續在多個地區獲得監管部門的批准,用於治療復發或難治性瀰漫性大 B 細胞淋巴瘤,並且正在進行更多申請。我們和我們的合作夥伴艾伯維(AbbVie)針對 epcoritamab 制定了穩健的開發計劃。今年第一季度,我們採取了重大舉措,進入濾泡性淋巴瘤領域。今年 3 月,我們與艾伯維 (AbbVie) 一起啟動了預計今年開始的多項 III 期試驗中的第一項。
Epcoritamab in combination with rituximab and lenalidomide for the treatment of patients with previously untreated follicular lymphoma. Looking at relapsed or refractory follicular lymphoma, in addition to the J-NDA submission in Japan, the FDA granted priority review to a supplemental biologic license application for EPKINLY as a treatment for relapsed or refractory follicular lymphoma following at least 2 prior lines of therapy with a PDUFA date of June 28.
Epcoritamab 與利妥昔單抗和來那度胺合併用於治療先前未經治療的濾泡性淋巴瘤患者。著眼於復發或難治性濾泡性淋巴瘤,除了在日本提交的J-NDA 之外,FDA 還對EPKINLY 的補充生物製品許可申請進行了優先審查,該申請用於治療復發性或難治性濾泡性淋巴瘤,此前至少接受過2 種治療PDUFA 日期為 6 月 28 日。
If approved, EPKINLY will be the first and only subcutaneous bispecific antibody approved to treat this indication. And these were not the only regulatory events.
如果獲得批准,EPKINLY 將成為第一個也是唯一一個被批准用於治療該適應症的皮下雙特異性抗體。這些並不是唯一的監管事件。
Excitingly, the FDA has now approved the supplemental biologics license application for Tivdak for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. And this converts the 2021 accelerated approval of Tivdak to a full approval, making Tivdak the first ADC with demonstrated overall survival data to be granted full approval in this patient population.
令人興奮的是,FDA 現已批准 Tivdak 的補充生物製劑許可申請,用於治療化療期間或化療後疾病進展的複發性或轉移性子宮頸癌患者。這將 Tivdak 的 2021 年加速批准轉變為完全批准,使 Tivdak 成為第一個具有已證實的總體生存數據並在該患者群體中獲得完全批准的 ADC。
This approval represents a significant achievement for women with recurrent or metastatic -- and metastatic cervical cancer as it reinforces Tivdak as a survival extending treatment option in patients whose disease has advanced after initial treatment.
這項批准對於患有復發性或轉移性以及轉移性子宮頸癌的女性來說是一項重大成就,因為它強化了 Tivdak 作為初次治療後疾病進展的患者的一種延長生存期的治療選擇。
In addition to this approval, I'm very excited to share that at the end of April, we filed a J-NDA requesting approval for Tivdak for patients with advanced or recurrent cervical cancer in Japan. And this is excellent news for patients in Japan in need of this potential therapy and a milestone for Genmab as we continue to build our presence in Japan.
除了這項批准之外,我非常高興地告訴大家,我們在 4 月底提交了一份 J-NDA,請求批准 Tivdak 在日本用於治療晚期或復發性子宮頸癌患者。對於需要這種潛在療法的日本患者來說,這是個好消息,也是 Genmab 繼續在日本發展業務的里程碑。
I would like to thank the patient and investigators who took part in the clinical trials that form the basis of the U.S. approval and Japanese submission or partners at Pfizer for the collaboration and the passionate and determined teams at Genmab whose hard work and commitments made these events possible.
我要感謝參與臨床試驗的患者和研究人員,這些臨床試驗構成了美國批准和日本提交的基礎,或者輝瑞的合作夥伴的合作,感謝Genmab 熱情而堅定的團隊,他們的辛勤工作和承諾使這些活動得以實現可能的。
Before moving on, I would also like to note that we were very pleased to hear that in March, Tivdak was added to the NCCN Clinical Practice Guidelines in Oncology for Vaginal cancer under Other Recommended Regimens.
在繼續之前,我還想指出,我們很高興聽到 3 月份,Tivdak 被添加到 NCCN 陰道癌腫瘤學臨床實踐指南的其他建議治療方案中。
In the first quarter, there were several data presentations across our programs, including an oral presentation for Tivdak at the SGO Annual Meeting on women's cancer. And presentations for EPKINLY at conferences, including the Annual Meeting of the Japanese Society of Medical Oncology and the AACR Annual meetings.
第一季度,我們的計畫進行了多項數據演示,包括在 SGO 年會上關於女性癌症的 Tivdak 口頭演示。以及 EPKINLY 在會議上的演講,包括日本腫瘤內科學會年會和 AACR 年會。
We are also looking forward to multiple upcoming data presentations at ASCO. These include 2 rapid oral presentations for EPKINLY of new data in both relapsed or refractory and untreated follicular lymphoma. A rapid oral presentation on Tivdak in head and neck cancer and a poster presentation for acasunlimab or GEN1046 in second-line non-small cell lung cancer. And this is, of course, the data that we and our partner, BioNTech, anticipated presenting in the first half of this year. And we are currently engaging with health authorities on the design of a pivotal trial in this patient population with an aim to start this trial in late 2024.
我們也期待即將在 ASCO 上進行多個資料演示。其中包括 2 次針對 EPKINLY 的複發性或難治性和未經治療的濾泡性淋巴瘤新數據的快速口頭介紹。關於 Tivdak 治療頭頸癌的快速口頭介紹以及 acasunlimab 或 GEN1046 治療二線非小細胞肺癌的海報介紹。當然,這是我們和我們的合作夥伴 BioNTech 預計在今年上半年提供的數據。我們目前正在與衛生當局合作,針對這群患者設計一項關鍵試驗,目標是在 2024 年底開始這項試驗。
Finally, turning to medicines powered by our innovation. In March, Janssen announced that the FDA approved RYBREVANT in combination with chemotherapy for the first-line treatment of patients with non-small cell lung cancer with EGFR exon 20 insertion mutations, converting to May 2021, accelerated approval to a full approval.
最後,轉向由我們的創新驅動的藥物。 3月,楊森宣布FDA核准RYBREVANT合併化療用於第一線治療EGFR外顯子20插入突變的非小細胞肺癌患者,轉至2021年5月,加速核准至全面核准。
In addition, in Q1, Janssen submitted applications for approval in both the U.S. and Europe for subcutaneous daratumumab based on data from the Phase III PERSEUS study.
此外,楊森在第一季根據 PERSEUS III 期研究的數據,在美國和歐洲提交了皮下注射 daratumumab 的核准申請。
I'm pleased to now hand over the call to Anthony Mancini to take you through our first quarter 2024 net product sales, including for DARZALEX, Anthony, the floor is yours.
我現在很高興將電話轉交給 Anthony Mancini,帶您了解我們 2024 年第一季的產品淨銷售額,包括 DARZALEX,安東尼,請發言。
Anthony Mancini - Executive VP & COO
Anthony Mancini - Executive VP & COO
Thank you, Jan. In Q1, product performance across our 2 key revenue streams, royalty Medicines and Genmab commercialized medicines showed very strong growth. Our portfolio includes royalty medicines: DARZALEX, Kesimpta, TEPEZZA, TECVAYLI, RYBREVANT and TALVEY.
謝謝 Jan。我們的產品組合包括專利藥品:DARZALEX、Kesimpta、TEPEZZA、TECVAYLI、RYBREVANT 和 TALVEY。
DARZALEX demonstrated strong demand growth in Q1 with just under USD 2.7 billion in net sales, a 19% year-over-year growth driven predominantly from share gains in frontline multiple myeloma.
DARZALEX 第一季的需求成長強勁,淨銷售額略低於 27 億美元,較去年同期成長 19%,這主要得益於第一線多發性骨髓瘤的份額成長。
With the recent filing of PERSEUS, there are continued growth opportunities ahead with DARZALEX subcutaneous based therapies in the frontline transplant-eligible multiple myeloma space, including maintenance.
隨著 PERSEUS 最近的申請,DARZALEX 皮下注射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,包括維持治療。
DARZALEX is also being combined with both newer and older therapies in multiple myeloma, including with 2 of our recently approved DuoBody medicines TECVAYLI and TALVEY. We expect continued growth and use of DARZALEX as a backbone in later line settings as well.
DARZALEX 也與多發性骨髓瘤的新舊療法結合使用,包括與我們最近批准的 2 種 DuoBody 藥物 TECVAYLI 和 TALVEY 結合使用。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 $637 million in Q1, a 66% year-on-year growth. Kesimpta demand growth is not only progressing well in the United States, but also outside the United States. It continues to be the new to brand share leader in 7 of 10 major markets outside the U.S.
Kesimpta 實現了持續強勁的需求成長,第一季銷售額達 6.37 億美元,年增 66%。 Kesimpta 的需求成長不僅在美國進展順利,而且在美國以外也進展順利。在美國以外 10 個主要市場中的 7 個市場中,它仍然是新的品牌份額領導者。
The performance across our other recently launched royalty medicines, TECVAYLI, TALVEY and RYBREVANT all bispecifics based on our DuoBody technology, each delivered strong growth in the quarter.
我們最近推出的其他專利藥物 TECVAYLI、TALVEY 和 RYBREVANT 的業績均基於我們的 DuoBody 技術,均在本季度實現了強勁增長。
The TECVAYLI launch is continuing to go very well and delivered $133 million in the quarter with strong uptake and rapid adoption in the U.S. and other key markets, reflecting a best-in-class off-the-shelf BCMA bispecific therapy that's offering deep and durable responses in relapsed or refractory multiple myeloma. We expect to see continued strong Genmab revenue growth from our diverse royalty medicines portfolio in 2024 and beyond.
TECVAYLI 的推出繼續進展順利,本季銷售額達 1.33 億美元,在美國和其他主要市場得到強勁吸收和迅速採用,這反映出同類最佳的現成 BCMA 雙特異性療法可提供深度和持久的療效復發性或難治性多發性骨髓瘤的反應。我們預計 2024 年及以後,我們多樣化的特許權藥品組合的 Genmab 收入將持續強勁增長。
Turning to our Genmab commercialized medicines on Slide 8. EPKINLY delivered USD 54 million in net sales for Q1. With over 90% coming from strong launch performance in both the U.S. and Japan. We are very pleased with the EPKINLY launch performance across geographies. In the U.S., we continue to see robust uptake across key accounts. EPKINLY was launched in Japan late last year, and we're highly encouraged by the early launch update, an overall positive response from our customers there.
轉向幻燈片 8 上我們的 Genmab 商業化藥物。其中超過 90% 來自美國和日本的強勁發布表現。我們對 EPKINLY 在各個地區的發布表現非常滿意。在美國,我們繼續看到主要客戶的強勁使用。 EPKINLY 在去年年底在日本推出,我們對早期的發布更新感到非常鼓舞,那裡的客戶總體上給予了積極的回應。
EPKINLY is the first and only approved bispecific antibody in the U.S., the EU and Japan, for patients with third line plus diffuse large B-cell lymphoma. And we are preparing for potential approvals for EPKINLY in third-line plus follicular lymphoma with U.S. PDUFA date of June 28.
EPKINLY 是美國、歐盟和日本第一個也是唯一一個核准的雙特異性抗體,用於治療第三線加瀰漫性大 B 細胞淋巴瘤患者。我們正在為 EPKINLY 治療三線+濾泡性淋巴瘤的潛在批准做準備,美國 PDUFA 日期為 6 月 28 日。
We're also pleased to announce that earlier this week, the NCCN has included EPKINLY monotherapy as a preferred regimen with a 2a designation in follicular lymphoma after 2 prior lines of therapy. Our first indication in third-line plus DLBCL, an area of significant unmet need is the first step to establishing EPKINLY as the core therapy across B-cell malignancies including follicular lymphoma and in earlier lines of treatment.
我們也很高興地宣布,本週早些時候,NCCN 已將 EPKINLY 單藥療法列為首選治療方案,在經過 2 種先前的治療後,其在濾泡性淋巴瘤中被指定為 2a 級。我們的第一個適應症是三線加DLBCL,這是一個顯著未滿足需求的領域,是將EPKINLY 確立為包括濾泡性淋巴瘤在內的B 細胞惡性腫瘤和早期治療線的核心療法的第一步。
Tivdak delivered $27 million in net sales for Q1, representing the tenth consecutive quarter of demand growth. We're pleased with Tivdak performance which was primarily driven by an increasing breadth of ordering accounts. Gyno and Med Onc customers continue to provide positive feedback on the impact Tivdak is making on the lives of women with cervical cancer.
Tivdak 第一季淨銷售額為 2,700 萬美元,代表需求連續第十個季度成長。我們對 Tivdak 的表現感到滿意,這主要是由訂購帳戶範圍不斷擴大所推動的。 Gyno 和 Med Onc 客戶繼續就 Tivdak 對子宮頸癌女性生活的影響提供正面回饋。
As Jan mentioned, the Japan New Drug Application for Tivdak was submitted in late April. And the FDA approval on April 29 based on the innovative 301 study, which demonstrated a 30% improvement in overall survival and a 33% improvement in progression-free survival will help establish Tivdak as the clear standard of care in second line plus recurrent or metastatic cervical cancer.
正如 Jan 所提到的,Tivdak 的日本新藥申請已於 4 月下旬提交。 FDA 於4 月29 日批准了基於創新301 研究的批准,該研究表明總生存期提高了30%,無進展生存期提高了33%,這將有助於將Tivdak 確立為二線加復發或轉移性治療的明確治療標準子宮頸癌。
We're enthusiastic about the proposed acquisition of Profound Bio, whose lead asset Rina-S is a potential best-in-class ADC in ovarian cancer that would add a second ADC in gynecologic oncology to our portfolio in addition to Tivdak.
我們對 Profound Bio 的擬議收購充滿熱情,其主要資產 Rina-S 是卵巢癌領域潛在的一流 ADC,除了 Tivdak 之外,這將為我們的產品組合添加第二個婦科腫瘤 ADC。
As an end-to-end biotech company, we're very pleased with the performance of our Genmab commercialized medicines and look forward to carrying this momentum through 2024 and beyond. Thanks to our partners and thanks to the entire cross-functional Genmab team for all they do every day to deliver for the patients we serve.
作為一家端到端生技公司,我們對 Genmab 商業化藥物的表現非常滿意,並期待在 2024 年及以後繼續保持這一勢頭。感謝我們的合作夥伴,感謝整個跨職能 Genmab 團隊每天為我們服務的患者所做的一切。
With that, let me hand it off to Anthony Pagano to provide additional perspective on our Q1 financials. Anthony?
接下來,讓我將其交給安東尼·帕加諾,他將提供有關我們第一季財務狀況的更多觀點。安東尼?
Anthony Pagano - Executive VP & CFO
Anthony Pagano - Executive VP & CFO
Great. Thanks, Anthony. We continue to strengthen our foundation in Q1. Having reached our goal of successful regulatory approvals and launches for EPKINLY in the U.S., Europe and Japan in 2023. We are pleased with how the launches are progressing into Q1. Now we're looking forward to the potential for additional approvals in these territories for late line follicular lymphoma, and continuing to expand and accelerate EPCORE's clinical development. And as we see, our financials remain strong.
偉大的。謝謝,安東尼。我們在第一季繼續鞏固我們的基礎。我們已經實現了 2023 年 EPKINLY 在美國、歐洲和日本成功獲得監管批准並上市的目標。現在,我們期待在這些地區獲得更多針對晚期濾泡性淋巴瘤的批准,並繼續擴大和加速 EPCORE 的臨床開發。正如我們所看到的,我們的財務狀況仍然強勁。
Recurring revenues grew by 42% in Q1. This was principally driven by strong royalties from DARZALEX, Kesimpta and other approved medicines as well as net product sales for EPKINLY. Our solid balance sheet, growing recurring revenues and significant underlying profitability allow us to continue to invest in our business and our pipeline at 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.
第一季經常性收入成長 42%。這主要是由於 DARZALEX、Kesimpta 和其他批准藥物的強勁特許權使用費以及 EPKINLY 的產品淨銷售額推動的。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集中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。
So let's take a look at those revenues in a bit more detail. We grew total revenue to over DKK 4.1 billion in Q1. And as I've already highlighted, that included a 42% increase in our recurring revenue.
因此,讓我們更詳細地了解這些收入。第一季我們的總營收超過 41 億丹麥克朗。正如我已經強調過的,這包括我們的經常性收入成長了 42%。
This strong growth was driven by higher DARZALEX and Kesimpta royalties as well as royalties from other products, and we're really pleased with how EPKINLY and Tivdak are performing. Taken together, these 2 products contributed 27% of the total growth in revenue that we realized in Q1. And this really illustrates the power of our recurring revenue. And overall, this strong recurring revenue growth enables our continued highly focused investment, as you can see on the next slide.
這一強勁增長是由 DARZALEX 和 Kesimpta 特許權使用費以及其他產品特許權使用費增加所推動的,我們對 EPKINLY 和 Tivdak 的表現非常滿意。總的來說,這兩種產品貢獻了我們第一季實現的總收入成長的 27%。這確實說明了我們經常性收入的力量。總體而言,這種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。
In line with our significant growth opportunities, total OpEx grew 31% in Q1. In R&D, we've accelerated our investment into our product portfolio, especially the advancement of our mid- to late-stage pipeline. Here, we're expanding the development for EPKINLY, Tivdak, GEN1046 and GEN1042, and we continue to invest to secure a successful EPKINLY launch in our 2 key markets. the U.S. and Japan.
與我們的重大成長機會一致,第一季總營運支出成長了 31%。在研發方面,我們加快了產品組合的投入,特別是中後期管線的進展。在這裡,我們正在擴大 EPKINLY、Tivdak、GEN1046 和 GEN1042 的開發,並繼續投資以確保 EPKINLY 在我們的兩個主要市場成功推出。美國和日本。
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 over DKK 4.1 billion, and that's up 46% on last year. Total expenses were just under DKK 3.2 billion with 73% being R&D and 27% SG&A. And even with the increased investment, we're still delivering over DKK 800 million of operating profit, and that's up more than 90%.
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的損益表摘要。營收超過 41 億丹麥克朗,比去年成長 46%。總支出略低於 32 億丹麥克朗,其中 73% 用於研發,27% 用於銷售、一般管理費用。即使增加了投資,我們仍能實現超過 8 億丹麥克朗的營業利潤,增幅超過 90%。
Moving now to our net financial items. Here, we have a gain of DKK 915 million. This gain was driven by the strengthening of the dollar against the Krona in Q1 as well as by an increase in interest income. Then we have tax expense of just over DKK 390 million, which equates to an effective tax rate of 22.8%. And that brings us to our net profit of over DKK 1.3 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,我們獲得了 9.15 億丹麥克朗的收益。這項收益是由第一季美元兌克朗走強以及利息收入增加所推動的。那麼我們的稅收支出剛好超過 3.9 億丹麥克朗,相當於 22.8% 的有效稅率。這使我們的淨利潤超過 13 億丹麥克朗。正如您所看到的,基本財務表現持續強勁。
With that, let's take a minute to revisit our robust financial framework. First off, our revenue profile on the left. There are now 8 products in the market that are generating recurring revenues for us. Three of these are already blockbusters and the remaining 5 all have significant potential for future revenue growth. So for this year, we're anticipating 25% recurring revenue growth at the midpoint and we expect significant cash inflows in the years to come.
接下來,讓我們花一點時間重新檢視一下我們穩健的財務架構。首先,左邊是我們的收入概況。目前市面上有 8 種產品為我們帶來經常性收入。其中 3 個已經是重磅炸彈,其餘 5 個都具有未來收入成長的巨大潛力。因此,今年,我們預計經常性收入將成長 25%,並且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. And 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 investing back into 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 the Phase III trials we anticipate will start 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。其中最重要的是加速和擴展 [EPCORE],但這只是令人興奮的機會之一,它為我們重新投資我們的業務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。這正是我們正在做的事情。我們預計 III 期試驗將於 2024 年開始。
And on top of this, we also have the proposed acquisition of ProfoundBio, including its most advanced program, Rina-S. Rina-S is potentially best-in-class and registration trial ready. We anticipate the first potential approval for Rina-S in 2027. And importantly, we are anticipating blockbuster peak sales potential.
除此之外,我們也提議收購 ProfoundBio,包括其最先進的項目 Rina-S。 Rina-S 可能是同類中最好的,並且已準備好註冊試用。我們預計 Rina-S 將於 2027 年首次獲得批准。
So with that background, let's now take a look at our guidance. Here, you can see our existing guidance, which we announced in February. We're currently on track to meet these financial targets, excluding the impact of the proposed ProfoundBio acquisition and related deal costs. We continue to anticipate strong growth in revenue for 2024 of 19% at the midpoint, driven by both our royalty medicines and importantly, we anticipate that 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,我們現在來看看我們的指導。在這裡,您可以看到我們在二月宣布的現有指南。我們目前正在實現這些財務目標,不包括擬議的 ProfoundBio 收購和相關交易成本的影響。我們繼續預計,在我們的專利藥品的推動下,2024 年收入將強勁增長,中間值將達到 19%,重要的是,我們預計 EPKINLY 和 Tivdak 的收入將超過 12 億丹麥克朗。事實上,EPKINLY 和 Tivdak 推動了我們 2024 年總營收成長的近 40%。
Now as I told you back in April, we anticipate that the proposed acquisition of ProfoundBio will impact our guidance.
現在,正如我在 4 月告訴您的那樣,我們預計擬議的 ProfoundBio 收購將影響我們的指導。
Pending closing of the deal, OpEx before transaction expenses are now anticipated to be at or moderately above the upper end of the guidance range of DKK 12.4 billion to DKK 13.4 billion. The anticipated increase reflects the incremental R&D investment to support the advancement of ProfoundBio's clinical programs, primarily Rina-S. This potential incremental investment is fully in line with our previously communicated priority of increasingly focusing our investment on mid- to late-stage R&D programs with high potential. And finally, as a reminder, we plan to update our overall guidance no later than our second quarter 2024 earnings.
在交易完成之前,不計交易費用的營運支出預計將達到或略高於 124 億丹麥克朗至 134 億丹麥克朗指引範圍的上限。預期的成長反映了支持 ProfoundBio 臨床計畫(主要是 Rina-S)進展的研發投資增量。這種潛在的增量投資完全符合我們先前傳達的優先重點,即越來越多地將投資集中在具有高潛力的中後期研發項目上。最後,提醒一下,我們計劃在 2024 年第二季財報公佈前更新我們的整體指引。
Now let me provide a few closing remarks. In summary, we've had a very solid start to the year. We have growing recurring revenue streams, increasingly from our proprietary products. 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.
現在讓我做一些結束語。總而言之,我們今年有一個非常好的開局。我們的經常性收入來源不斷增長,其中越來越多來自我們的專有產品。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。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Anthony. Let's move to our final slide. Over the past few months, we have made significant progress towards our 2024 goals especially for EPKINLY, we made strides towards both goals you see here with the initiation of a new Phase III trial as well as priority review from the FDA for relapsed or refractory follicular lymphoma. We look forward to the PDUFA date and potential approval of this new indication in June. And of course, we are extremely pleased with the recent approval for Tivdak. We're also very much looking forward to presenting the Phase II acasunlimab data at ASCO next month.
謝謝,安東尼。讓我們來看最後一張投影片。在過去的幾個月裡,我們在實現2024 年目標方面取得了重大進展,尤其是對於EPKINLY,我們在實現您在此處看到的兩個目標方面取得了長足進步,啟動了一項新的III 期試驗以及FDA 對復發或難治性卵泡的優先審查淋巴瘤。我們期待 PDUFA 日期以及該新適應症可能在 6 月獲得批准。當然,我們對 Tivdak 最近獲得批准感到非常高興。我們也非常期待下個月在 ASCO 上展示二期 acasunlimab 數據。
We continue to have a lot to look forward to in 2024, and we look forward to providing you with additional updates. That ends our presentation of Genmab's financial results for the first quarter of 2024. Operator, please open the call for questions.
2024 年我們仍然有很多值得期待的事情,我們期待為您提供更多更新。我們對 Genmab 2024 年第一季財務業績的介紹到此結束。
Operator
Operator
(Operator Instructions). And your first question comes from the line of James Gordon.
(操作員說明)。你的第一個問題來自詹姆斯戈登。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Maybe move on to the next one, operator, and then take James back when he is back online. .
也許轉到下一位接線員,然後在詹姆斯恢復在線時將其接回。 。
Operator
Operator
Of course, Yes, of course. The next question comes from the line of Sachin Jain.
當然,是的,當然。下一個問題來自 Sachin Jain。
Sachin Jain - MD & Research Analyst
Sachin Jain - MD & Research Analyst
Just 2 pipeline questions, if I may. Firstly, just post recent FDA, MRD negativity in first-line myeloma. Just wondered on your headline thoughts as to how that may change development and whether you sense any shift in J&Js? Whether this is a key decision metric for them as part of the HexaBody decision I expect at the end of this year, early into next year.
如果可以的話,只有兩個管道問題。首先,最近 FDA 批准一線骨髓瘤 MRD 呈陰性。只是想知道您對這可能如何改變發展的主要想法以及您是否感覺到強生公司有任何變化?我預計這是否是他們的關鍵決策指標,作為 HexaBody 決策的一部分,預計在今年年底、明年初進行。
And then secondly, on GEN1046, just 2 quick questions. One at ASCO, should we be thinking about potential OS data in addition to the PFS you flagged before? And then on the Phase III trial design discussions with the regulators, just wondering if that's taking a little bit longer than expected and if there any specific aspects of the design that are holding us up at this moment.
其次,關於 GEN1046,只有 2 個簡短的問題。 ASCO 的一員,除了您先前標記的 PFS 之外,我們是否還應該考慮潛在的作業系統資料?然後是與監管機構討論第三階段試驗設計,只是想知道這是否比預期花費的時間要長一些,以及目前設計中是否有任何具體方面阻礙了我們。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Sachin, for the questions. So I think I'm going to hand over both of the questions to Tahi, and then maybe Judith can add to that. Tahi, why don't you start with the MRD-negative molecular endpoints.
謝謝薩欽提出的問題。所以我想我要把這兩個問題交給塔希,然後也許茱蒂絲可以補充。 Tahi,為什麼不從 MRD 陰性分子終點開始呢?
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
Sure. Thank you for the question. So the first question, MRD-negative, I think the reaction generally to this is that this is a good thing for patients with multiple myeloma because it's frankly allows the opportunity to the development of novel mechanisms in front line, which otherwise would have been extremely challenging.
當然。感謝你的提問。所以第一個問題,MRD 陰性,我認為對此的普遍反應是,這對於多發性骨髓瘤患者來說是一件好事,因為坦率地說,它為一線開發新機制提供了機會,否則的話,這將是非常糟糕的。
And I think as it relates to J&J they also in their own call recognized the opportunity that MRD negativity as a surrogate endpoint provides for the development of novel mechanisms in multiple myeloma. I think we can leave it at that.
我認為,由於與強生有關,他們也在自己的呼籲中認識到 MRD 陰性作為替代終點為多發性骨髓瘤新機制的開發提供了機會。我想我們可以就此罷休。
As it relates to 1046, where we actually had all of our health authority interactions. So we met with the FDA and the European and Japanese Health Authorities and have gotten the feedback incorporating as we speak. And are continually operationalizing towards activating the study by the end of the year. So there's nothing really to hold up.
因為它與 1046 相關,我們實際上在那裡進行了所有衛生當局的互動。因此,我們會見了 FDA 以及歐洲和日本衛生當局,並在我們發言時收到了回饋。並不斷實施,以期在年底前啟動這項研究。所以真的沒有什麼好堅持的。
Your other question around the specifics of the abstract. We've done this many times. I try to avoid getting into the details of the abstract or the presentation. But I would, again, emphasize that OS is the appropriate endpoint in that space. And of course, an important data point -- probably the most important data point in the decision-making process for us.
你的另一個問題是關於摘要的細節。我們已經做過很多次了。我盡量避免深入研究摘要或簡報的細節。但我想再次強調,作業系統是該領域的適當端點。當然,還有一個重要的數據點——可能是我們決策過程中最重要的數據點。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks. Tahi, I think, Sachin, we probably need to keep it to that.
謝謝。 Tahi,我想,Sachin,我們可能需要堅持下去。
Thanks, Sachin, for the questions. So maybe, operator, let's see whether we can get James Gordon back.
謝謝薩欽提出的問題。所以也許,接線員,讓我們看看能否讓詹姆斯·戈登回來。
Operator
Operator
One moment please. At the moment he's not in the queue, would you like to move on to the next question?
稍等一會兒。目前他不在隊列中,您想繼續下一個問題嗎?
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Absolutely, Operator, please move on to the next one. He may have lost the line.
當然,操作員,請繼續下一個。他可能已經斷線了。
Operator
Operator
Your next question comes from the line of Vikram Purohit.
你的下一個問題來自維克拉姆·普羅希特(Vikram Purohit)。
Vikram Purohit - VP & Equity Analyst
Vikram Purohit - VP & Equity Analyst
So we had 2, one on GEN3014, and then one on just your thoughts on business development broadly. So on 3014, I just wanted to see if there's any updated thoughts from your side on time lines to the next data update? And then also how much of a time lapse there may be between the release of the data and the potential decision from J&J regarding potential next steps.
所以我們有 2 篇文章,一篇關於 GEN3014,然後一篇關於您對業務發展的廣泛想法。那麼在3014,我只是想看看你們對於下一次資料更新的時間軸是否有任何更新的想法?然後,從資料發佈到強生就潛在的後續步驟做出潛在決定之間可能存在多少時間間隔。
And then on business development, moving forward, how are you thinking about prioritizing between opportunities in oncology and potential efforts in immunology?
然後在業務發展方面,展望未來,您如何考慮腫瘤學機會和免疫學潛在努力之間的優先順序?
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks for the question. So I will pass the first one to Tahi. So let me start with the second one on BD.
謝謝你的提問。所以我會將第一個傳給 Tahi。那麼讓我從 BD 的第二個開始。
I mean we are going to be very, very focused on oncology. I mean, currently, the dominant focus is on oncology. And priority one is to actually as it relates to the opportunities is closing ProfoundBio acquisition, which we hope to do after getting a regulatory clearance in the coming months and then integrate and execute the development plan for Rina-S.
我的意思是我們將非常非常關注腫瘤學。我的意思是,目前的主要焦點是腫瘤學。第一個優先事項實際上是關閉 ProfoundBio 收購,因為這與機會有關,我們希望在未來幾個月內獲得監管許可後完成收購,然後整合並執行 Rina-S 的開發計劃。
And then beyond that, we continue to look for opportunities such as bringing in tools and components for the R&D engine. And oncology is getting a lot of attention, but also I&I because we are increasingly also looking at immunology and inflammation. But the dominant focus is oncology for the time being.
除此之外,我們繼續尋找機會,例如為研發引擎引入工具和組件。腫瘤學受到了很多關注,I&I 也受到了很多關注,因為我們也越來越關注免疫學和發炎。但目前的主要焦點是腫瘤學。
So let me move to Tahi now for the Gen3014 data and the decision timing for J&J. Tahi?
現在讓我轉到 Tahi,了解 Gen3014 數據和強生的決策時間。塔希?
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
Yes. I think on this particular question, I think we have been very clear and consistent. There's a pre-agreed data set with J&J that includes a number of patients and the number of months follow-up for these patients and also I have in previous calls repeatedly reiterated that the -- there's a predefined time window and that is relatively confined for J&J to make that decision. And if you take this all together, you can imagine that -- we said we are continuing to operations towards providing that data by the end of the year and the time window probably between that data becoming public and a decision is not that long. We should probably leave it at that. I don't think we can be more specific on this. But it's a very clearly laid out timetable window actually.
是的。我認為在這個具體問題上,我們的態度非常明確且一致。強生公司有一個預先商定的資料集,其中包括一些患者以及這些患者的追蹤月數,而且我在之前的電話中反覆重申——有一個預定義的時間窗口,並且對於這些患者來說相對有限。強生公司就做出這個決定。如果你把這一切放在一起,你可以想像——我們說我們將繼續努力在年底前提供這些數據,而從數據公開到做出決定之間的時間窗口可能不會那麼長。我們或許該就此罷休。我認為我們不能對此說得更具體。但這實際上是一個非常清晰的時間表視窗。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks Tahi. Thanks Vikram for the questions. So let's move back to the operator.
謝謝塔希。感謝維克拉姆的提問。那麼讓我們回到運算符。
Operator
Operator
Your next question comes from the line of Xian Deng.
你的下一個問題來自鄧賢的台詞。
Xian Deng - Analyst
Xian Deng - Analyst
Could you hear me all right?
你聽得到我說話嗎?
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Yes, we can hear you. .
是的,我們能聽到你的聲音。 。
Xian Deng - Analyst
Xian Deng - Analyst
Yes. Perfect. Yes, 3 questions, please, if I may, all on 1046, please. The first one is your data so far on liver tox seems to be quite manageable. But just wondering what are your thoughts on the long-term safety profile on that side, any potential for accumulated liver tox for the patient who you use it for longer? Have you seen any accumulated sort of liver tox data? That's the first one.
是的。完美的。是的,如果可以的話,請問 3 個問題,請全部在 1046 上回答。第一個是迄今為止關於肝毒性的數據似乎是相當容易控制的。但只是想知道您對這方面的長期安全性有何看法,對於長期使用它的患者是否有可能累積肝臟毒素?您有看過任何累積的肝臟毒性數據嗎?這是第一個。
And the second question is -- so just wondering, I mean, I understand the 1046 for ASCO, this is a poster presentation, not an oral presentation. So just wondering whether it's possible to disclose the data cutoff for the abstract you submitted? And what is the data cutoff for -- roughly for the actual data to be presented, please? Just wondering whether the data has evolved a lot since that.
第二個問題是——所以只是想知道,我的意思是,我理解 ASCO 的 1046,這是一個海報演示,而不是口頭演示。所以只是想知道是否可以披露您提交的摘要的數據截止日期?數據截止值是多少——大致上是為了要呈現的實際數據?只是想知道自那時起數據是否發生了很大變化。
And then the third one is, given the feedback you had from the FDA on Phase III trial design, just wondering whether you could disclose that you will focus on PD-1 positive only? Or is going to be more defined such as PD-1 high only.
第三個問題是,考慮到 FDA 對 III 期試驗設計的回饋,您是否可以透露您將只關注 PD-1 陽性?或將更加明確,例如僅 PD-1 高。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Xian. These are very good questions. I will again hand them over to Tahi, and then maybe Judith can step in there. Tahi, on liver Tox maybe to start off with. Tahi, are you there?
謝謝,西安。這些都是非常好的問題。我會再次將它們交給塔希,然後也許茱蒂絲可以介入。 Tahi,也許可以從肝臟毒素開始。塔希,你在嗎?
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
I was on mute. Thank you for the question. On liver tox you're absolutely correct, and we have now a substantial amount of experience with the asset also in combination with PD-1 and also a decent follow-up. It seems manageable, in our hands. Patients can get reexposed after a recovery period. And broadly speaking, tolerate the reexposure really well. And we have absolutely no evidence with accumulation of liver toxicity with a, as I said, a substantial amount of patients across many trials with a relatively long follow-up. So that was the first question.
我當時處於靜音狀態。感謝你的提問。關於肝毒素,您是絕對正確的,我們現在對該資產與 PD-1 結合擁有豐富的經驗,並且還有不錯的後續行動。在我們手中,這似乎是可控的。患者在恢復期後可能會再次暴露於病毒。從廣義上講,對再次暴露的耐受性非常好。正如我所說,我們絕對沒有證據表明肝毒性的積累,正如我所說,在許多試驗中進行的大量患者的隨訪時間相對較長。這是第一個問題。
The second question was on cutoff. I'm not really going to go into the specifics, but previous calls already indicated that there is a cutoff use for the abstract and then there is an updated, more timely cutoff use for the presentation. So there will be updated data at the presentation that will follow up, obviously and more data as in the abstract.
第二個問題是關於截止的。我並不打算詳細討論細節,但先前的電話已經表明摘要有一個截止使用,然後有一個更新的、更及時的演示截止使用。因此,簡報中將會有更新的數據,顯然,摘要中會有更多數據。
And then the last question was on the trial is on the population, and I think we've also been very clear on this. The intent is -- and then there's nothing changed on this to explore the combination of 1046 plus pembro in control against the current standard of care which is [docetaxel] in patients who are PD-L1 positive and PD-L1 positivity here, predominantly is necessary because the drug is PDL1x4-1BB and it requires PD-L1 in tumor cells to activate 4-1BB on T cells.
最後一個問題是關於試驗的人口問題,我認為我們對此也非常清楚。目的是——然後沒有任何改變來探索 1046 加 pembro 的組合作為對照當前護理標準的控制,即在 PD-L1 陽性和 PD-L1 陽性患者中使用 [多西紫杉醇],主要是必要的,因為該藥物是PDL1x4-1BB,並且需要腫瘤細胞中的PD-L1 來活化T 細胞上的4-1BB。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thank you, Tahi, very clear. Thanks, Xian. Move on to the next operator.
謝謝塔希,非常清楚。謝謝,西安。繼續下一個操作員。
Operator
Operator
Your next question comes from the line of Etzer Darout.
你的下一個問題來自 Etzer Darout。
Etzer Darout - MD & Senior Biotechnology Analyst
Etzer Darout - MD & Senior Biotechnology Analyst
Just a couple of questions, if you can, on sort of Phase III design. First, around Tivdak. In head and neck, your -- sort of thoughts around sort of the patient population, control arm for that study as well as sort of your -- sort of expectations around sort of the initial indication for Rina-S for the 2027 potential launch that you highlight in terms of sort of what population you would go into today in sort of the line of treatment as well? Just a little bit more color on those Phase III designs, if you can?
如果可以的話,請問幾個關於第三階段設計的問題。首先,圍繞著蒂夫達克。在頭部和頸部,您對患者群體、該研究的控制臂的想法以及對 Rina-S 2027 年可能推出的初步跡象的期望您還強調了今天將針對哪些人群進行治療?如果可以的話,在第三階段的設計上再多一點顏色吧?
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Etzer, for the question. So Judith, why don't you take the first one on head and neck design for Phase III for Tivdak. And then Tahi can potentially give a bit more color on the Rina-S first trial.
謝謝埃澤提出的問題。那麼朱迪思,為什麼不為 Tivdak 進行第三階段的第一個頭部和頸部設計呢?然後 Tahi 可能會為 Rina-S 的第一次試驗帶來更多的色彩。
We hope to actually put into place several trials, but the one leading to the potential 2027 initial approval. Judith, maybe you can start.
我們希望能夠實際進行幾項試驗,但這項試驗可能會在 2027 年獲得初步批准。朱迪絲,也許你可以開始了。
Judith V. Klimovsky - Executive VP & Chief Development Officer
Judith V. Klimovsky - Executive VP & Chief Development Officer
Yes. So with the Phase III, we are engaging with head authorities as we speak, to finalize the details of the study design, but it's based on the initial data presented at ASTRO and the updated data that will be presented in an oral this year at ASCO. So more to come so -- but the population that we presented at ASTRO consistent with what we will present the second third line after checkpoint inhibitors, platinum and we allow for cetuximab as well. And as you know, the 3 of them are given almost in the majority of patient in ASTRO. And with regard to the Phase III design, more to come based on the interaction that we are currently having.
是的。因此,對於第三階段,我們正在與主管機關進行接觸,以最終確定研究設計的細節,但它是基於 ASTRO 上提供的初始數據以及今年將在 ASCO 上以口頭形式提出的更新數據。未來還會有更多——但我們在 ASTRO 上展示的人群與我們將在檢查點抑製劑、鉑類和西妥昔單抗之後展示的第二個三線產品一致。如您所知,ASTRO 中幾乎大多數患者都接受了這 3 種治療。關於第三階段的設計,更多的內容將基於我們目前正在進行的互動。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks. Thanks Judith, and maybe we can move to Rina-S and then maybe, Tahi, you can start and potential, Judith, you can add to that. Tahi?
謝謝。謝謝朱迪思,也許我們可以轉向 Rina-S,然後也許,塔希,你可以開始和潛力,朱迪思,你可以補充這一點。塔希?
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
Yes, I want to be very careful what I'm going to say because we're still in the HOS period. And so I'm going to stay with what ProfoundBio has publicly already stated on their end, which is that they are planning to initiate a Phase III in (inaudible). And that they are planning to initiate a study that looks at folate receptor expression across the spectrum.
是的,我要非常小心我要說的話,因為我們仍處於居屋時期。因此,我將堅持 ProfoundBio 已經公開聲明的立場,即他們計劃在(聽不清楚)啟動第三階段。他們計劃啟動一項研究,觀察整個譜系的葉酸受體表現。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Tahi. I think that's very wise to stay on the right side of the line because we still need regulatory clearance for that proposed acquisition We could probably also not be (inaudible) further details at this moment. We will do that after we hopefully execute successfully.
謝謝,塔希。我認為保持正確的立場是非常明智的,因為我們仍然需要對擬議的收購進行監管審批,目前我們可能也不會(聽不清楚)進一步的細節。我們將在希望執行成功後這樣做。
Thanks. Let's move on to the next analyst.
謝謝。讓我們轉向下一位分析師。
Operator
Operator
Your next question comes from the line of Yaron Werber.
你的下一個問題來自 Yaron Werber。
Unidentified Analyst
Unidentified Analyst
This is [Jana] on for Yaron. Congrats on the quarter. I have 2, one on DARZALEX and one on EPKINLY. You mentioned on the call that DARZALEX you expect it to continue to have some presence in the relapsed refractory setting. Can you actually give us a breakdown of DARZALEX share across lines of therapy. And then for EPKINLY, how are you thinking about advantage of kind of subcutaneous administration versus (inaudible) advantage of fixed-duration dosing? And do you think that EPKINLY is also going to have fixed-duration dosing over time?
這是亞龍 (Yaron) 的 [Jana]。恭喜本季。我有 2 個,一個在 DARZALEX 上,一個在 EPKINLY 上。您在電話中提到 DARZALEX 預計將繼續在復發難治性治療中發揮作用。您能否給我們詳細介紹一下 DARZALEX 在各個治療領域的份額?那麼對於 EPKINLY,您如何看待皮下給藥的優勢與固定給藥時間(聽不清楚)的優勢?您認為 EPKINLY 也會隨著時間的推移進行固定給藥時間嗎?
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks very much for the questions. And Anthony Mancini, I think best go into the first question and then Tahi can give further color on subcu of EPKINLY and then -- and fixed-duration of dosing in the newer studies. Maybe, Anthony Mancini, you can start .
非常感謝您的提問。安東尼·曼奇尼(Anthony Mancini),我認為最好先討論第一個問題,然後塔希(Tahi)可以對EPKINLY 的subcu 進行進一步的闡述,然後- 以及在較新的研究中固定給藥持續時間。安東尼·曼奇尼,也許你可以開始了。
Anthony Mancini - Executive VP & COO
Anthony Mancini - Executive VP & COO
Yes. So thanks for the question. I'll just start by summarizing what I said earlier, which is the DARZALEX share gains are really driven by a frontline continued growth in frontline. So if you look at the frontline new patient share, it's now 53%, which is a over 14% absolute growth versus same time last year, which is really the key driver. And I would just -- the other -- the other key number is overall, DARZALEX patient share was about 43%. This is based on IQVIA brand ImpactRx data. And the new patient share overall is exceeding the total patient share with a year-on-year 4-point uptake versus last year on an absolute basis.
是的。謝謝你的提問。我首先總結我之前所說的,即 DARZALEX 份額的成長實際上是由一線的持續成長所推動的。因此,如果你看一下一線新患者比例,現在為 53%,與去年同期相比絕對增長超過 14%,這確實是關鍵驅動力。我想說的是——另一個——另一個關鍵數字是總體而言,DARZALEX 患者的比例約為 43%。這是基於 IQVIA 品牌 ImpactRx 資料。總體而言,新患者份額超過了總患者份額,與去年相比,絕對值年增了 4 個百分點。
So we continue to see that leading indicator being really important to predict continued growth of DARZALEX. Front line and second line were where the majority of the growth came and at the expense of third and fourth line. I think I'll leave it there and pass it to Tahi to talk a little bit about duration. I'm happy to add in on that one, too. Tahi?
因此,我們繼續認為領先指標對於預測 DARZALEX 的持續成長非常重要。一線和二線是大部分成長的地方,但犧牲了三線和四線。我想我會把它留在那裡,然後交給 Tahi 來討論一下持續時間。我也很高興加入這一點。塔希?
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
Yes, sure. So I'll take the first question and also answer the second question. So generally, I think this discussion, this messaging around duration of treatment is a very academic one in my mind. As you noted, in combination, EPKINLY will also be given in a fixed duration because in combination the efficacy is, of course, enhanced and the CR rates are higher. So potential to achieve long-term durable emissions is higher.
是的,當然。所以我將回答第一個問題並回答第二個問題。所以總的來說,我認為這次討論,關於治療持續時間的資訊在我看來是非常學術性的。正如您所指出的,EPKINLY 也將在固定的時間內合併給藥,因為合併用藥的療效當然會增強,CR 率也會更高。因此實現長期持久排放的潛力更大。
I would say like the final judgment on whether it is wise to stop treatment in the relapsed refractory setting with a single agent will probably come from the updated longer-term follow-up data and then people can cost compare anyhow they can swap if they would like so. But they can probably not start if they are forced to stop by label. So that's my first thing.
我想說的是,關於在復發難治性情況下停止使用單一藥物治療是否明智的最終判斷可能會來自更新的長期隨訪數據,然後人們可以無論如何進行成本比較,如果他們願意的話,他們可以交換像這樣。但如果他們被標籤強迫停下來,他們很可能無法開始。這是我的第一件事。
I think this is a less of an important differentiator, frankly, as you can hear from my commentary, then IV versus subcu because fundamentally subcu route together with the also optimized safety profile gives us the opportunity to reach the patients with completely different health care settings then, I think (inaudible) whether it is IV administration.
坦白說,我認為這是一個不太重要的區別,正如您從我的評論中聽到的那樣,然後是IV 與subcu,因為從根本上說,subcu 路線加上同樣優化的安全性使我們有機會接觸到具有完全不同醫療保健環境的患者然後,我想(聽不清楚)是否是靜脈注射。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Tahi. Maybe you can give a bit more color on the more recent studies and earlier lines of treatment, where we don't use fixed -- where we also use a fixed duration.
謝謝,塔希。也許你可以對最近的研究和早期的治療方案提供更多的信息,我們不使用固定的治療方案 - 我們也使用固定的持續時間。
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
Yes. So all ASCO studies that are in combination (inaudible) and diffuse large B-cell or in follicular lymphoma, in combination have a fixed duration treatment. And that, as I kind of alluded to in the earlier commentary, is a function of our belief that in combination, we have seen increase significantly in times increased CR rates, and this is fundamentally all about CR. The durability of the remission, which is driven by the CR, a potential to give these patients the benefit of a very long, sometimes maybe possibly a curative response to EPKINLY is significantly enhanced when it comes to combination and then it makes sense to think about stopping treatment vis-a-vis a similar therapy, at least in the refractory to diffuse large B-cell setting.
是的。因此,所有聯合(聽不清楚)和瀰漫性大 B 細胞或濾泡性淋巴瘤聯合的 ASCO 研究都有固定的治療時間。正如我在之前的評論中提到的那樣,這是我們信念的一個功能,結合起來,我們已經看到 CR 率顯著增加,而這從根本上來說都是關於 CR 的。由 CR 驅動的緩解的持久性,有可能使這些患者受益於很長一段時間,有時可能是 EPKINLY 的治癒反應,當涉及到組合時,這種反應會顯著增強,然後考慮是有意義的停止治療與類似療法相比,至少在難治性瀰漫性大B 細胞環境中。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Tahi. I think that should be -- hopefully, it's clear now Jana. All right. Thanks.
謝謝,塔希。我認為這應該是——希望現在已經很清楚了,賈娜。好的。謝謝。
Let's move on to the next.
讓我們繼續下一步。
Operator
Operator
Your next question comes from the line of Asthika Goonewardene.
您的下一個問題來自 Asthika Goonewardene。
Asthika Sarith Goonewardene - Research Analyst
Asthika Sarith Goonewardene - Research Analyst
So I've got a couple on EPKINLY, please. How much of your sales are coming from academic centers versus community? And then are you getting any pushback from the community practitioners about having to send the patient to the academic center to get -- to be admitted for the monitoring required on just the 1 dose?
我在 EPKINLY 上有一些,謝謝。您的銷售額有多少來自學術中心與社區?然後,您是否會受到社區從業者的任何反對,認為必須將患者送往學術中心才能入院接受僅 1 劑所需的監測?
Related to that, how are things going with the outpatient study? I'm wondering when we could see that data presented and perhaps filed? And then if I can sneak one in on 1046 on the pivotal trial design that you discussed with regulators. I'm wondering if you had any differential dosing of 1046 based on PD-L1 status, maybe in the 1% to 49%, if you were dosing at a different rate versus patients who had about 50% PD-L1 expression?
與此相關的是,門診研究進展如何?我想知道我們什麼時候可以看到這些資料的提交和歸檔?然後我能否偷偷地透露您與監管機構討論過的關鍵試驗設計 1046。我想知道您是否根據 PD-L1 狀態對 1046 進行了不同的劑量調整,可能在 1% 到 49% 之間,如果您與 PD-L1 表達約為 50% 的患者的劑量不同?
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Asthika, for the questions. So the first 2, I think I want to hand over to Anthony Mancini and Tahi can address the last one, Anthony?
謝謝阿斯提卡提出的問題。所以前兩個,我想我想交給安東尼·曼奇尼,塔希可以解決最後一個,安東尼?
Anthony Mancini - Executive VP & COO
Anthony Mancini - Executive VP & COO
Yes. Thanks, Asthika, for the question. So I think it's a great question, academic versus community. I think in the earlier -- in the early part of our launch, we really had a focus on new starts that -- where were heavily pretreated patients were being treated. That was really largely academic focused. We've started to see in recent months now that there's been a modest shift beyond the major academic centers. Of course, our key accounts are primarily major research institutions and health systems that have CAR-T capabilities.
是的。謝謝阿斯提卡提出的問題。所以我認為這是一個很好的問題,學術與社區。我認為在早期——在我們推出的早期階段,我們確實關注新的開始——那些接受過大量預處理的患者正在接受治療。這實際上主要是學術性的。近幾個月來,我們開始看到主要學術中心以外的地區也發生了適度的轉變。當然,我們的大客戶主要是擁有CAR-T能力的主要研究機構和衛生系統。
So we have seen a shift of late beyond major academic centers, and we're encouraged by our ability to get to broader sites of care. And we've now seen large physician group practices starting to use EPKINLY, but it's at the early stages Asthika at this point in the community. Of course, that's a U.S. dynamic in Japan. It's really a hospital-based dynamic overall.
因此,我們最近看到了主要學術中心之外的轉變,並且我們對我們到達更廣泛的護理場所的能力感到鼓舞。我們現在已經看到大型醫生團體開始使用 EPKINLY,但 Asthika 目前在社區還處於早期階段。當然,這是美國在日本的動態。這確實是一個以醫院為基礎的整體動態。
But I think this will continue to evolve over time. And as data evolves with outpatient data, as you mentioned and optimization data, both in DLBCL and FL, I think we'll start to see more large physician group practices start to use EPKINLY in a greater way. But again, this is the shift. And with that, maybe I'll pass it to you -- to Tahi to talk about the next 1046 design question.
但我認為隨著時間的推移,這種情況將繼續發展。正如您所提到的,隨著門診數據和優化數據的發展,無論是 DLBCL 還是 FL,我認為我們將開始看到更多大型醫生團體開始以更大的方式使用 EPKINLY。但這又是一個轉變。說到這裡,也許我會把它交給你——交給 Tahi 來討論下一個 1046 設計問題。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Maybe Tahi can start with the status of the outpatient study, the Phase II outpatient study. That's one of the questions from Asthika. Any update, Tahi, on the status of that Phase II study?
也許Tahi可以從門診研究的現況開始,二期門診研究。這是阿斯提卡提出的問題之一。 Tahi,關於第二階段研究的狀態有什麼更新嗎?
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
Well, I mean it's growing quite well. And I think there are also plans to present some of the data towards the end of the year, but that's probably all I can say. It's a happy (inaudible) study, actually, right. So that's all data.
嗯,我的意思是它生長得很好。我認為還計劃在年底前提供一些數據,但這可能就是我能說的全部。事實上,這是一項令人愉快(聽不清楚)的研究,對吧。這就是所有數據。
And on 1046. Well, the simple question is -- the answer is no. So 1 dose on schedule regardless of the PD-L1 status. Also I'm [not] sure if I would understand how that would work with the bispecific that wants to engage 4-1BB. But simple answer, one dose, one schedule.
1046 嗯,簡單的問題是──答案是否定的。因此,無論 PD-L1 狀態如何,都按計畫注射 1 劑。另外,我[不確定]確定我是否能理解這將如何與想要參與 4-1BB 的雙特異性抗體一起工作。但答案很簡單,一劑,一個時間表。
Operator
Operator
Your next question comes from the line of Emily Field.
你的下一個問題來自艾米麗·菲爾德。
Emily Field - Head of European Pharmaceuticals Equity Research
Emily Field - Head of European Pharmaceuticals Equity Research
I'll just have 2 quick ones. So the first one for acasunlimab, are we going to be seeing the data at ASCO in the poster for both cohort A and cohort B. And then a question on DARZALEX and just sort of the multiple myeloma competitive environment. Obviously, earlier, we saw the DREAMM-7 data for Blenrep, which would test DARZALEX in the comparator arm? I know this is second line plus and the share numbers you gave earlier in first line are super helpful. But are you seeing that assets reentry into the market based on the data you've seen so far as a competitive threat to DARZALEX?
我只要兩個快點的。因此,關於 acasunlimab 的第一個問題是,我們將在 ASCO 的海報中看到 A 組和 B 組的數據。 然後是關於 DARZALEX 的問題以及多發性骨髓瘤競爭環境。顯然,早些時候,我們看到了 Blenrep 的 DREAMM-7 數據,它將在比較器臂中測試 DARZALEX?我知道這是第二行加上您之前在第一行提供的共享號碼非常有幫助。但是,根據您迄今為止所看到的數據,您是否認為資產重新進入市場對 DARZALEX 構成競爭威脅?
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. I think, Tahi, you can probably handle both of the questions. The data at the poster at ASCO for acasunlimab and then the Blenrep, new data from GSK and the impact on the DARZALEX landscape.
謝謝艾米麗的提問。我想,塔希,你可能可以解決這兩個問題。 ASCO 海報上的 acasunlimab 和 Blenrep 的數據、GSK 的新數據以及對 DARZALEX 景觀的影響。
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
While so the first thing, I'll take the 1046 and I'll give my impression on the Blenrep data and maybe Anthony Mancini may also have his own view on this.
首先,我會選擇 1046,並給出我對 Blenrep 數據的印象,也許 Anthony Mancini 對此也有自己的看法。
But on 1046, what you will see is, the data that we used to make the decision. And obviously, the decision was twofold: one, what is the appropriate dosing schedule and b, overall is there a path forward? What's the proof of concept for this combination. And we'll see essentially the answer to both of these questions. So that means you will see the relevant data from the arms.
但在 1046 上,您將看到的是我們用來做出決定的數據。顯然,這個決定是雙重的:一、適當的給藥方案是什麼;二、整體上有前進的道路嗎?這種組合的概念證明是什麼?我們將從本質上看到這兩個問題的答案。這意味著您將看到來自武器的相關數據。
On Blenrep, I don't want to sound this way, but it's almost -- it feels like it's a little bit, I think, a little bit too late. As the treatment paradigm has changed and daratumumab has moved into earlier lines, I think the study asked the question. That was certainly relevant at a time when it was designed, but may not be necessarily relevant at the time it was answered. I don't know if Anthony wants to add further to that.
在 Blenrep 上,我不想這樣說,但我認為,這幾乎——感覺有點太晚了。隨著治療模式的改變以及達雷妥尤單抗已進入早期生產線,我認為這項研究提出了這個問題。這在設計時肯定是相關的,但在回答時可能不一定相關。我不知道安東尼是否願意補充這一點。
Anthony Mancini - Executive VP & COO
Anthony Mancini - Executive VP & COO
No, I think you covered it Tahi.
不,我想你已經報道塔希了。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
All right. I think we need to leave it with that, Emily. I think there's now probably better BCMA-targeted molecules like bispecifics and teclistamab is doing really well, as you heard from Anthony Mancini.
好的。我想我們需要就此置之不理,艾蜜莉。我認為現在可能有更好的 BCMA 靶向分子,如雙特異性藥物和 teclistamab,效果非常好,正如您從 Anthony Mancini 那裡聽到的那樣。
All right. Operator, let's move to the next question.
好的。接線員,我們進入下一個問題。
Operator
Operator
Your next question comes from the line of Peter Verdult.
你的下一個問題來自 Peter Verdult。
Peter Verdult - MD
Peter Verdult - MD
Two questions, please. To Jan and Tahi. I -- and I ask your patience here, but I just want to ask Sachin's question differently. On this GEN1046 data, we're going to see why we're going to Phase III. Can I -- rather than trying to be (inaudible) I mean it's a big area, huge commercial opportunity but also very competitive. So my simple question is, is there enough data to materially change consensus (inaudible) in this drug? Do you feel that there could be a pivotal moment in terms of how people view 1046, given how long we've been waiting for this data to come through? So that's question number one.
請教兩個問題。致簡和塔希。我——我在這裡請求你們耐心等待,但我只是想以不同的方式問薩欽的問題。根據 GEN1046 數據,我們將了解為什麼要進入第三階段。我可以——而不是試圖成為(聽不清楚),我的意思是這是一個很大的領域,巨大的商業機會,但也非常有競爭力。所以我的簡單問題是,是否有足夠的數據來實質改變這種藥物的共識(聽不清楚)?考慮到我們等待這項數據已經等了很長時間,您是否認為人們如何看待 1046 可能會出現一個關鍵時刻?這是第一個問題。
And then number two, for Anthony Pagano. Just ballpark, when we think about ProFound (sic) [ProfoundBio] on an annualized basis, is a good starting point to think over cost base around $100 million, including what might be can you get to prosecute Rina-S? Just anything you can help us with in terms of a run rate in terms of the ProfoundBio cost base?
然後是第二名,安東尼·帕加諾。當我們按年計算 ProFound(原文如此)[ProfoundBio] 時,大概是一個很好的起點,可以考慮 1 億美元左右的成本基礎,包括起訴 Rina-S 可能得到什麼?您可以在 ProfoundBio 成本基礎的運行率方面為我們提供任何幫助嗎?
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. The first one, I will move on to Tahi because he is really on top of that data together with Judith. And we are very excited to present that. And I think it's going to be very clear, Peter. And take -- an underlining the decisions we have taken towards pivotal. But, Tahi, maybe you can give a bit more color for Peter.
謝謝彼得提出的問題。第一個,我將轉向塔希,因為他和茱蒂絲一起真正掌握了這些數據。我們非常高興能夠介紹這一點。我認為這會非常清楚,彼得。並強調我們為實現關鍵目標所做的決定。但是,塔希,也許你可以給彼得多一點色彩。
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
Tahamtan Ahmadi - Executive VP, Chief Medical Officer & Head of Experimental Medicines
Yes. (inaudible) why. It's not that easy because I don't necessarily know how you guys are going to react. Because it all depends on like what one has in mind in terms of expectations and reality.
是的。 (聽不清楚)為什麼。這並不容易,因為我不一定知道你們會如何反應。因為這一切都取決於人們對期望和現實的想法。
The way I look at this and the way I think was in the way we think about this and the reason we are excited is of course something like this. This is going to be a IO option with the similar benefits that immuno-oncology approaches in the past have shown when they were compared against chemotherapy (inaudible) in that we would be -- what we hope to achieve the study which we hope you will appreciate in the data set is that efficacy is important, durability is probably even more important and over survival is (inaudible) .
我看待這個問題的方式和我思考的方式就是我們思考這個問題的方式以及我們興奮的原因當然是這樣的。這將是一種 IO 選項,與過去的免疫腫瘤學方法與化療(聽不清楚)進行比較時所顯示的類似益處一樣,我們希望實現這項研究,我們希望您能做到這一點數據集中的體會是,功效很重要,耐用性可能更重要,而生存期則更重要(聽不清楚)。
And so it is indeed a competitive space. But I think it's also fair to say that a lot of the approaches have not met the criteria that I just laid out. They've met maybe one, but not all of them. And I think this is how we look at it. This is why we are excited about it. It's in many ways, also validation of a long effort to validate [4-1BB] mechanism. And that enough itself also has some value for us.
所以這確實是一個競爭空間。但我認為可以公平地說,許多方法都沒有達到我剛剛提出的標準。他們可能見過其中一個,但不是全部。我認為這就是我們的看法。這就是我們對此感到興奮的原因。從許多方面來說,這也是對驗證 [4-1BB] 機制的長期努力的驗證。這本身就對我們有一定的價值。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Tahi. I think we should keep it with that. And then finally, also a question for Anthony Pagano., I was worried that there wouldn't be a question for you, Anthony, but now you can go.
謝謝,塔希。我認為我們應該保留這一點。最後,還有一個問題要問安東尼·帕加諾。
Anthony Pagano - Executive VP & CFO
Anthony Pagano - Executive VP & CFO
I stayed on the line, Jan, don't worry. And thanks, Pete. Yes, maybe to start off with the shorter term, Pete, in terms of our 2024 guidance. And it's what we indicated as part of announcing the proposed acquisition and I reiterated again today that for 2024, we expect to be at or moderately above the upper end of our current guidance range, which is DKK 12.4 million to DKK 13.4 billion. And to be clear, as I sort of think about what the upper band of that could be, it's certainly going to have a 13 handle on it, meaning our OpEx numbers when I start with the 13. We're really focused on, as you would expect, continue to manage our overall investments in a focused and disciplined way as we've done historically.
我一直在線,簡,別擔心。謝謝,皮特。是的,皮特,根據我們 2024 年的指導,也許可以從短期開始。這就是我們在宣布擬議收購時所表示的內容,我今天再次重申,到 2024 年,我們預計將達到或略高於當前指導範圍的上限,即 1240 萬丹麥克朗至 134 億丹麥克朗。需要明確的是,當我考慮上限可能是多少時,它肯定會有 13 個手柄,這意味著當我從 13 開始時我們的營運支出數字。繼續以集中且嚴格的方式管理我們的整體投資,就像我們過去所做的那樣。
Now if I kind of zoom out a little bit, Pete, as you'd expect, we have to invest to unlock the full potential particularly around Rina-S, as well as our existing late-stage programs. So as I highlighted on our call to announce the proposed acquisition of Profound, we do expect R&D investments to step up over the near to medium term. What you should be really clear on though is that we fully intend to remain substantially profitable through the -- throughout this investment period. So we're going to manage our expenses accordingly. And that means that moving forward, we're going to continue to be focused and disciplined in our approach to allocate the capital across these mid- to late-stage R&D programs with the most potential.
現在,如果我稍微縮小一點,皮特,正如你所期望的那樣,我們必須投資以釋放全部潛力,特別是圍繞 Rina-S 以及我們現有的後期項目。因此,正如我在宣布擬議收購 Profound 的電話會議中所強調的那樣,我們確實預計研發投資將在中短期內加大。不過,您真正應該清楚的是,我們完全打算在整個投資期間保持大幅獲利。因此,我們將相應地管理我們的開支。這意味著,展望未來,我們將繼續集中精力並嚴格遵守我們的方法,在這些最具潛力的中後期研發項目中分配資本。
As we've done in the past, we're not going to shy away from deprioritizing other programs, particularly early-stage programs that won't meet our high bar for continued development. And then finally, and as we talk about Rina-S in a little bit more detail, we expect Rina-S could be accretive to earnings by the first full year of launch, given its potential approval in 2027. And as Jan highlighted, we do anticipate that we're going to unlock meaningful value from this program by the end of the decade with significant further upside into the 2030s.
正如我們過去所做的那樣,我們不會迴避降低其他專案的優先級,特別是那些不符合我們持續開發高標準的早期專案。最後,當我們更詳細地討論 Rina-S 時,鑑於其可能在 2027 年獲得批准,我們預計 Rina-S 可能會在推出的第一個全年增加收益。預計,到本十年末,我們將從該計劃中釋放出有意義的價值,並在2030 年代進一步取得顯著的成長。
Maybe one other point, Pete, you might have seen this in the Q1 print. When we gave our guidance for 2024, we're very clear that we're already managing our investments, particularly as it relates to SG&A. You can see the SG&A print here in Q1 is further evidence of that. We're absolutely focused on making the appropriate investments to run our business the right way.
也許還有一點,皮特,你可能已經在第一季的印刷品中看到了這一點。當我們給予 2024 年的指導時,我們非常清楚我們已經在管理我們的投資,特別是與 SG&A 相關的投資。您可以在第一季看到 SG&A 印刷品,這進一步證明了這一點。我們絕對專注於進行適當的投資,以正確的方式經營我們的業務。
But also, when we have clear investment opportunities, particularly the, let's call it, registration trials. We can't shy away from making these investments. And likewise, when the data aren't clearing the very high bar, we can't shy away from that either.
而且,當我們有明確的投資機會時,特別是我們稱之為註冊試驗的機會。我們不能迴避進行這些投資。同樣,當數據沒有達到很高的標準時,我們也不能迴避這一點。
So I'm not going to give you a precise number. We've highlighted, Pete, that we are anticipating starting Phase III for Rina-S, and you can do some of your normal modeling as you expect what the incremental investment is to run Rina-S. And we'll be back as part of our Q2 earnings to provide some incremental detail, particularly as it relates to 2024 numbers.
所以我不會給你一個準確的數字。 Pete,我們已經強調,我們預計將開始 Rina-S 的第三階段,您可以按照預期運行 Rina-S 的增量投資進行一些正常建模。作為第二季收益的一部分,我們將回來提供一些增量細節,特別是與 2024 年數字相關的細節。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Anthony. Thanks Peter. Let's see whether there are further questions, operator?
謝謝,安東尼。謝謝彼得。接線員,我們看看是否還有其他問題?
Operator
Operator
The question comes from the line of [Suzanne van Voorthuizen].
這個問題來自[Suzanne van Voorthuizen]。
Unidentified Analyst
Unidentified Analyst
This is Suzanne from (inaudible). I got disconnected for a bit, so apologies if this is maybe a repetitive question. But I wondered if you can elaborate on the tisotumab data set in head and neck cancer that is coming at ASTRO. Could you remind us of the potential that you see for the drug in this setting and expand on what we should expect for next month's update in terms of sample, size, efficacy metrics and follow-ups on.
這是來自(聽不清楚)的蘇珊娜。我暫時斷線了,所以如果這可能是重複的問題,我深表歉意。但我想知道您是否可以詳細說明 ASTRO 即將推出的頭頸癌 tisotumab 資料集。您能否提醒我們您認為該藥物在這種情況下的潛力,並詳細說明我們對下個月的更新在樣本、規模、功效指標和後續行動方面的預期。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Suzanne, for the question. And I think, yes, you did miss, I think, some of the updates, but I'll ask Judith give you further color on the data set at ASTRO for head and neck and Tivdak, tisotumab vedotin. Judith?
謝謝蘇珊娜提出的問題。我想,是的,我認為你確實錯過了一些更新,但我會請 Judith 為你提供有關 ASTRO 頭頸部數據集和 Tivdak、tisotumab vedotin 的進一步資訊。朱迪思?
Judith V. Klimovsky - Executive VP & Chief Development Officer
Judith V. Klimovsky - Executive VP & Chief Development Officer
Yes. So the data is based on Phase II study RMC. The initial data was presented at ASTRO. So this is a much more substantial data set with longer follow-up. But data setting is the same. So it's patients with head and neck that fail standard of care, meaning PD-1, chemo and cetuximab.
是的。因此,該數據基於 II 期研究 RMC。初始數據已在 ASTRO 上發布。所以這是一個更重要的數據集,並且有更長的追蹤時間。但數據設定是一樣的。因此,頭頸部患者未能達到標準護理,即 PD-1、化療和西妥昔單抗。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
Thanks, Judith. And only a few weeks, Suzanne, then you will know it all.
謝謝,朱迪思。只要幾週時間,蘇珊娜,你就會知道這一切。
Let's see, operator whether there are further questions.
讓我們看看操作員是否還有其他問題。
Operator
Operator
Thank you. In the interest of time, I will hand back for closing remarks.
謝謝。由於時間關係,我將交出結束語。
Jan G.J. van de Winkel - Co-Founder, President & CEO
Jan G.J. van de Winkel - Co-Founder, President & CEO
All right. So thank you all for calling in today to discuss Genmab's Financial Results for the First Quarter of 2024.
好的。感謝大家今天致電討論 Genmab 2024 年第一季的財務表現。
If you have additional questions, don't hesitate to reach out to our Investor Relations team. We hope that you all stay safe and keep optimistic, and we very much look forward to speaking with you all again soon.
如果您還有其他問題,請隨時聯絡我們的投資者關係團隊。我們希望大家保持安全並保持樂觀,我們非常期待很快能再次與大家交談。
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。您現在可以斷開連線。