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 financial results conference call for the first quarter of 2025. As a reminder, this conference call is being recorded.
您好,歡迎參加 Genmab 2025 年第一季財務業績電話會議。提醒一下,本次電話會議正在錄音。
During this telephone conference, you may be presented with forward-looking statements that include words such as beliefs, anticipates, plans, or expects. Actual results may differ materially, for example, as a result of the late or unsuccessful development projects.
在本次電話會議中,您可能會看到前瞻性陳述,其中包括信念、預期、計劃或期望等字眼。實際結果可能會有重大差異,例如由於開發專案延遲或不成功。
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 a part of our investor relations outreach activities in order to update you on Genmab going forward.
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有關的聲明,除非法律要求。另請注意,作為我們投資者關係拓展活動的一部分,Genmab 可能會保留您所指出的個人數據,以便向您更新 Genmab 的未來動態。
Please refer to our website for more information on Genmab and our privacy policy. I would not allow to hand the conference over to your first speaker today, Jan Van De Winkel. Please go ahead.
請參閱我們的網站以獲取有關 Genmab 和我們的隱私權政策的更多資訊。我不會允許將會議交給今天的第一位發言人 Jan Van De Winkel。請繼續。
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Hello and welcome to Genmab,'s conference call to discuss our financial results for the period ending March 31, 2025.
您好,歡迎參加 Genmab 的電話會議,討論截至 2025 年 3 月 31 日的財務表現。
With me today to present these results is our Chief Financial Officer, Anthony Pagano, the Chief Commercial Officer Brad Bailey, and our Chief Medical Officer Tahamtan Ahmadi For the Q&A, we will be joined by our by our Chief Development Officer, Judith Klimovsky.
今天與我一起公佈這些結果的有我們的財務長 Anthony Pagano、首席商務官 Brad Bailey 和首席醫療官 Tahamtan Ahmadi。我們的首席開發長 Judith Klimovsky 也將參與問答環節。
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.
正如我們已經說過的,我們將做出前瞻性的陳述。因此,在我們進行這次通話時請記住這一點。在今天的簡報中,我們將參考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。
In 2025, we continue to advance towards becoming a fully integrated biotech, independently developing and commercializing wholly owned antibody differentiated therapies or disciplined capital allocation strategy and sustained execution support our continued growth and long-term value creation.
2025年,我們將繼續朝著成為一家完全整合的生物技術公司的方向邁進,獨立開發和商業化全資抗體差異化療法或嚴謹的資本配置策略和持續的執行力支持我們持續增長和長期價值創造。
In the first quarter, we continue to deliver on our strategic priorities. Our total revenue grew by 19%, fueled by the solid performance of [Abkindi] and [TIFA] and increased and increased recurring revenue.
第一季度,我們繼續履行我們的策略重點。我們的總收入成長了 19%,這得益於 [Abkindi] 和 [TIFA] 的強勁表現以及不斷增加的經常性收入。
Our investments remain fully aligned with a capital allocation priority supporting key latest pipeline programs and maximizing the success of our commercialized medicines. And we made these important investments while growing and operating or operating profits by 62%.
我們的投資始終與資本配置優先事項完全一致,支持關鍵的最新管道項目並最大限度地提高我們商業化藥物的成功率。我們在進行這些重要投資的同時,營業利潤也成長了 62%。
In addition, in March, we initiated a planned share buyback of up to $2.2 million shares. This year we purchase underscores both our confidence in Jen's future and our commitment to delivering value to shareholders.
此外,3月份,我們啟動了價值高達220萬美元的股票回購計畫。我們今年的收購既彰顯了我們對 Jen 未來的信心,也體現了我們為股東創造價值的承諾。
The end of the quarter with over $3 billion in cash, reinforcing the strength of our financial foundation. And this trend gives us the flexibility for continued growth and expansion. We will continue to prioritize our investments with the laser sharp focus on our latest proprietary clinical pipeline, specifically [aritiop], RAS, and [Aaunimop], and maximizing the success of our commercialized medicines.
本季末我們擁有超過 30 億美元的現金,增強了我們的財務基礎。這種趨勢為我們持續成長和擴張提供了靈活性。我們將繼續優先考慮我們的投資,重點關注我們最新的專有臨床管線,特別是 [aritiop]、RAS 和 [Aaunimop],並最大限度地提高我們商業化藥物的成功。
Now let's turn and focus for a moment on the overall potential of a promising late stage pipeline where we see multiple billion dollar opportunities. [Aliop], Rhinos and aasulimop are all poised to drive significant revenue growth for Genmab by the end of this decades.
現在讓我們暫時把注意力集中到有前景的後期管道的整體潛力上,我們看到了數十億美元的機會。到本世紀末,[Aliop]、Rhinos 和 aasulimop 都將為 Genmab 帶來顯著的收入成長。
Up with its rapid clinical development is positioned to become the core therapy in B cell lymphomas with anticipated peak sales exceeding $3 billion. This will be driven by three expected phase three readouts. Two of these, including in frontline [diffusance] B cell lymphoma, are anticipated by the end of 2026.
隨著臨床的快速發展,Up 預計將成為 B 細胞淋巴瘤的核心治療方法,預計高峰銷售額將超過 30 億美元。這將由預期的第三階段讀數推動。其中兩種藥物,包括第一線[瀰漫性] B 細胞淋巴瘤,預計將於 2026 年底問世。
Excitingly, we recently announced our intention to submit a supplemental biologic license application to the FDA for [echoritimo] and second line follicular lymphoma. And this decision was supported by positive top line results from the phase 3 APO FL1 trial.
令人興奮的是,我們最近宣布打算向 FDA 提交針對 [echoritimo] 和二線濾泡性淋巴瘤的補充生物製品許可申請。這項決定得到了第 3 階段 APO FL1 試驗的積極頂線結果的支持。
We are pleased with the strength of this initial data, and we plan to submit the full results for the presentation at an upcoming medical conference in 2025. Turning to Rhinos, we are exceptionally well positioned to maximize its blockbuster potentials, and I say this because we have got a powerful combination of proven clinical development capabilities, a track record of acceleration and deep expertise in the [yinong] space with TIFAC.
我們對這些初始數據的強度感到非常滿意,並計劃在 2025 年即將召開的醫學會議上提交完整的結果以供展示。談到 Rhinos,我們完全有能力最大限度地發揮其重磅藥物的潛力,我之所以這麼說,是因為我們擁有經過驗證的臨床開發能力、加速發展的記錄以及 TIFAC 在 [yinong] 領域的深厚專業知識。
Based on the exceptionally strong execution of the team, post-acquisition of profound bio, we remain on track to bring rhino S to ovarian cancer patients in 2027. And given its best in class profile, you expect to achieve peak sales exceeding $2 billion.
基於團隊異常強大的執行力,在收購 profound bio 後,我們仍有望在 2027 年將 Rhino S 帶給卵巢癌患者。鑑於其一流的性能,您預計其峰值銷售額將超過 20 億美元。
There is also a meaningful opportunity for novel treatments like acaulimab and non-rival mutation, second line plus non-small cell lung cancer to provide both improved response rate and durability of response.
對於像 acaulimab 和非競爭性突變、二線加非小細胞肺癌這樣的新型治療方法來說,這也是一個有意義的機會,可以提供更高的反應率和反應的持久性。
So here we anticipate a peak sales opportunity of a billion dollars. And as beyond these problems, we are continuing to actively look for opportunities to further grow our pipeline, both organically and inorganically. Now, let's turn to some of our first quarter advancements.
因此,我們預計銷售額的峰值將達到 10 億美元。除了這些問題之外,我們還在繼續積極尋找機會,透過有機和無機的方式進一步擴大我們的產品線。現在,讓我們來回顧一下第一季的一些進展。
[Atkins] first clinical development and regulatory approvals reinforce its market leading position. As I just noted, last week we announced our intend to seek approval in the US for aritiab plus hituximab and selenalidomides in patients with relapse or a factory follicular lymphoma following at least one prior systemic therapy.
[Atkins] 首次臨床開發和監管批准鞏固了其市場領先地位。正如我剛才提到的,上週我們宣布了我們打算在美國尋求批准阿替利聯合希妥昔單抗和硒利度胺用於治療復發或工廠化濾泡性淋巴瘤患者,這些患者至少接受過一次全身治療。
We intend to submit this supplemental BLA in the first half of 2025. And this milestone illustrates our commitment to [Gabbey] to the ongoing development of [aymo].
我們打算在 2025 年上半年提交這份補充 BLA。這一里程碑表明了我們對 [Gabbey] 持續發展的承諾[哎呀]。
In February, Abkeni became the first and only subcutaneous T cell engaging by specific antibody approved in Japan to treat both relapsed or refractory follicular lymphoma and relapsed or refractory large T cell lymphomas after two or more lines of therapy.
今年 2 月,Abkeni 成為日本首個也是唯一一個獲準用於治療復發或難治性濾泡性淋巴瘤以及經過兩線或兩線以上治療後的複發或難治性大 T 細胞淋巴瘤的皮下 T 細胞靶向治療藥物。
In addition, a lit up in combination with [mox ox] was added to the NCCN guidelines for second line patients with diffusland [reson] lymphoma who are ineligible for a transplants. TA expanded its presence with approvals in both Europe and Japan.
此外,針對不適合接受移植的瀰漫性淋巴瘤第二線患者,NCCN 指引中也增加了與 [mox ox] 合併使用的 lit up。TA 獲得歐洲和日本的批准,擴大了其業務範圍。
It's now the first and only ADC approved in both territories for the treatment of recurrence or metastatic or metastatic cervical cancer after prior therapy. Excitingly, the launches of TIFA in Japan and Europe will be the first time that [Ja] will lead commercialization efforts on our own without a partner.
它是目前兩個地區批准用於治療復發或轉移性或先前治療後轉移性子宮頸癌的首個也是唯一一個 ADC。令人興奮的是,TIFA 在日本和歐洲的推出將是 [Ja] 首次在沒有合作夥伴的情況下獨自領導商業化工作。
This will bring us closer to achieving our goal of bringing our own medicines to patients and to strengthen our growing leadership in transforming care for patients with gynecological cancers. This also positions us for success for the potential launch of RNAS.
這將使我們更接近實現將我們自己的藥物帶給患者的目標,並加強我們在改變婦科癌症患者護理方面日益增強的領導地位。這也為我們成功推出 RNAS 奠定了基礎。
Or potential for future success is also reflected in the multiple data presentations that either occurred recently or that we anticipate in the coming months. In March, we presented the highly anticipated updated results of RAS in advance to ovarian cancer at the 2025 Society of Gynecologic Oncology annual meeting on Women's cancer or SGO in Seattle.
或者未來成功的潛力也反映在最近發生或我們預計在未來幾個月發生的多個數據演示中。今年 3 月,我們在西雅圖舉行的 2025 年婦科腫瘤學會女性癌症或 SGO 年會上展示了備受期待的 RAS 提前治療卵巢癌的最新結果。
Last month, we had data from a variety of programs presented at [AHCR]. This included free clinical data from RAS as well as in the early stages by specifics Gen 1,057 and Gen 1,059. And we are now looking forward to ESCO, where we will have multiple presentations including data for rhinos and endometrial cancer.
上個月,我們收集了多個項目的數據[AHCR]。其中包括來自 RAS 的免費臨床數據以及早期階段的具體 Gen 1,057 和 Gen 1,059。我們現在期待 ESCO,我們將在那裡進行多項演示,包括犀牛和子宮內膜癌的數據。
I will now bring you up to date with the status of this program, followed by an overview of the promising RAS data from [SGOA] the floor is yours.
現在我將向您介紹該計劃的最新情況,然後概述來自 [SGOA] 的有希望的 RAS 數據,現在請您發言。
Anthony Pagano - Chief Financial Officer, Executive Vice President
Anthony Pagano - Chief Financial Officer, Executive Vice President
Thank you, John. If you could make sure that we're now on slide 8.
謝謝你,約翰。請確認我們現在位於第 8 張投影片上。
We're confident that [rena S] has the potential to become a best in class treatment for ovarian cancer, endometrial, and other foid receptor alpha expressing solid tumors.
我們相信 [rena S] 有潛力成為治療卵巢癌、子宮內膜癌和其他 Foid 受體 α 表達實體瘤的最佳藥物。
This confidence has led us to accelerate the development of VA first into a phase 3 trial and second line plus platinum resistant ovarian cancer. And also, we are now on track to start a phase 3 study in second line plus endometrial cancer before the end of the year.
這種信心促使我們加速 VA 的開發,首先進入 3 期試驗,然後進入二線加鉑類抗藥性卵巢癌。此外,我們目前正按計畫在今年底前啟動第二線及以上子宮內膜癌的 3 期研究。
Behind this confidence is encouraging data, including the results we will present at ASCO in endometrial cancer, as well as the data that we recently presented at SCO in Prague. Now let's take a brief look at the SGO data. You could go to slide mine, please.
這種信心的背後是令人鼓舞的數據,包括我們將在 ASCO 上展示的子宮內膜癌研究結果,以及我們最近在布拉格 SCO 上展示的數據。現在我們來簡單看一下SGO數據。請您去滑礦。
We told you in February that we intended to present meaningful follow up data from the expansion court for pro early in the first half of 2025. And we did just that last month at SGO. The data presentation included updated efficacy and safety data with around 24 weeks of additional follow up from the data cough up the cutoff previously presented at ESO last year.
我們在二月告訴過您,我們打算在 2025 年上半年初為職業球員提供擴建球場的有意義的後續數據。上個月我們在 SGO 就做了這樣的事。數據展示包括更新的功效和安全性數據,以及自去年 ESO 上展示的數據截止以來約 24 週的額外後續。
As a reminder, these are heavily pre-treated ovarian cancer patients. Regardless of 4 receptor alpha expression. Results showed that VA as those at 120 mg per meter square every 3 weeks, led to a confirmed objective response rate of 55.6%. And this encouraging anti-tomb activity was doable.
需要提醒的是,這些都是接受過大量治療的卵巢癌患者。無論4種受體α表現如何。結果顯示,每 3 週每平方公尺 120 毫克 VA 可確認的客觀反應率為 55.6%。而這次鼓舞人心的反盜墓活動是可行的。
With a median on study follow up of 48 weeks, the median duration of response was not reached, as only one of the 10 patients experienced disease progression. VAS was well tolerated and once again, no signs of oat toxicity or ILD were observed.
研究的中位追蹤時間為 48 週,但未達到中位反應持續時間,因為 10 名患者中只有 1 名出現病情進展。VAS 耐受性良好,再次未觀察到燕麥毒性或 ILD 的跡象。
Altogether, this data reinforces the potential of [reAS] to become a best in class treatment for ovarian cancer. Benefiting a broader patient population than currently approved therapies.
總而言之,這些數據增強了 [reAS] 成為治療卵巢癌最佳療法的潛力。比目前核准的療法更能惠及更廣泛的患者族群。
With a differentiated efficacy signal across the entire patient population. That is, with no need for selection based on 4 receptor alpha expression. Better and differentiated safety profile. That is without oculot toxicity or ID and an unprecedented durability.
針對整個患者族群具有差異化的療效訊號。也就是說,不需要根據 4 種受體 α 表現進行選擇。更好、差異化的安全狀況。它不具有眼毒性或 ID,並且具有前所未有的耐用性。
Now over to Brad for a review of the solid recent commercial performance for [Appindi] and TIFA.
現在請布拉德回顧一下 [Appindi] 和 TIFA 近期的出色商業表現。
Brad Bailey - Executive Vice President, Chief Commercial Officer
Brad Bailey - Executive Vice President, Chief Commercial Officer
Thank you, Anthony.
謝謝你,安東尼。
We started the first quarter of 2025 with solid performance from our commercialized medicines, reinforcing our foundation for continued growth and expansion across our portfolio.
2025 年第一季伊始,我們的商業化藥品表現穩健,為我們整個產品組合的持續成長和擴張奠定了基礎。
We continue to invest strategically in our commercialization capabilities to ensure we are set for long-term success as we enter the exciting next phase of our commercialization strategy with our wholly owned launches initiating in Japan and Europe this year.
我們將繼續對商業化能力進行策略性投資,以確保我們能夠取得長期成功,因為我們將進入商業化策略令人興奮的下一階段,今年我們將在日本和歐洲推出全資產品。
Overall, our commercialized medicines contributed positively to our revenue growth in the quarter, with combined [EPKinley] and TIA sales of 56% year-over-year, accounting for 29% of our total revenue growth.
總體而言,我們的商業化藥品對本季度的收入成長做出了積極貢獻,[EPKinley] 和 TIA 的合併銷售額同比增長 56%,占我們總收入增長的 29%。
As we drive towards our 2030 vision, we see significant opportunity to build on our momentum across the commercialized portfolio, and we expect the contributions of our commercialized medicines to continue to increase.
在我們朝著 2030 年願景邁進的過程中,我們看到了在商業化產品組合中鞏固發展勢頭的重大機遇,我們預計商業化藥物的貢獻將繼續增加。
This is driven in large part by the confidence we have in our ability to capitalize on what we expect to be a $6 billion plus combined market opportunity for at Kinley, Rena S, and [Acasumumab] as the total addressable patient population for these potentially transformative medicines grow significantly.
這在很大程度上源於我們對自身能力的信心,我們預計 Kinley、Rena S 和 [Acasumumab] 的綜合市場機會將達到 60 億美元以上,因為這些具有潛在變革意義的藥物的總可尋址患者群體將大幅增長。
It has become increasingly clear that our investments and our commercialization capabilities are continuing to fuel our success, yielding meaningful results and enabling us to strategically scale to support our long-term growth.
越來越明顯的是,我們的投資和商業化能力正在繼續推動我們的成功,產生有意義的成果,並使我們能夠策略性地擴大規模以支持我們的長期成長。
Turning now to Ep Kinley. In Q1, Kinley posted $90 million in global sales, a 73% year-over-year increase. And we've observed continued growth across geographies with encouraging uptake, strong field execution, and consistent positive feedback from physicians.
現在轉向 Ep Kinley。第一季度,Kinley 全球銷售額達 9,000 萬美元,較去年同期成長 73%。我們觀察到各個地區的持續成長,包括令人鼓舞的採用、強大的現場執行以及來自醫生的一致積極回饋。
We continue to make strong progress, bringing up Kenley to as many patients as possible around the world through our targeted go to market commercialization strategy as we address areas of high and met patient need across diverse sites of care.
我們繼續取得長足進步,透過有針對性的市場商業化策略,為世界各地盡可能多的患者提供 Kenley,同時解決不同護理場所中患者需求較高和得到滿足的領域。
As Jaan touched on earlier, Q1 marked a number of meaningful milestones for our commercialized medicines, and for Kinley in particular. This includes becoming the first and only by specific approved, with a dual indication in 3rd line plus DLBCL and follicular lymphoma in the US, EU, and now Japan as well. It also includes important progress that reinforces E Kinley's clinical profile and potential in earlier lines of therapy.
正如 Jaan 之前提到的,第一季對於我們的商業化藥物,尤其是 Kinley 而言,標誌著許多有意義的里程碑。這包括成為美國、歐盟以及現在的日本首個也是唯一一個獲得特定批准、具有第三線及 DLBCL 和濾泡性淋巴瘤雙重適應症的藥物。它還包括一些重要進展,強化了 E Kinley 的臨床表現和早期治療的潛力。
We're highly encouraged by Ep Kinley's performance to date and its growth potential, particularly as we look ahead to earlier lines of therapy on the horizon. And we're confident that we have the foundation in place for Ep Kinley to become the core therapy across B cell lymphomas.
我們對 Ep Kinley 迄今為止的表現及其成長潛力感到非常鼓舞,特別是當我們展望即將出現的早期治療方法時。我們相信,我們已經為 Ep Kinley 成為 B 細胞淋巴瘤的核心療法奠定了基礎。
In the US we've seen increasing uptake across sites of care, which will continue to be an important growth driver as we move forward. This expanded utilization reinforces at Kinley's uniquely differentiated clinical profile, positive label, and value as the only dual indication by specific in the OBCL NFL.
在美國,我們看到各個護理站點的採用率不斷提高,這將繼續成為我們未來發展的重要成長動力。這種擴大的利用強化了 Kinley 獨特的臨床特徵、積極標籤和作為 OBCL NFL 中唯一雙重適應症的價值。
In Japan The launch of Ekili and 3rd line plus relapsed or refractory follicular lymphoma is going extremely well, building on the uptake we've seen in LBCL and driven by national and field-level activities and account activation.
在日本,Ekili 和第三線及復發或難治性濾泡性淋巴瘤的推出進展非常順利,這建立在我們在 LBCL 中看到的吸收基礎上,並受到國家和現場級活動和帳戶激活的推動。
Across all other markets, we've experienced growth with that killing through our partner Apathy. Globally, Ed Kinley has received more regulatory approvals across both DLBCL and FL than any other by specific, with approvals in more than 50 countries presently. This positions up Kenley well for continued growth and utilization across markets.
在所有其他市場中,我們都透過合作夥伴 Apathy 實現了成長。在全球範圍內,Ed Kinley 在瀰漫大B細胞淋巴瘤和濾泡性淋巴瘤領域獲得的監管批准比其他任何藥物都多,目前已在 50 多個國家獲得批准。這使得 Kenley 能夠在各個市場中持續成長和利用。
As we look ahead, we remain focused on accelerating the adoption of EKinley, rapidly identifying patients across diverse sites of care, and advancing our robust development program across histologies and earlier lines of therapy to further establish EKinley as the core therapy across B cell lymphomas.
展望未來,我們將繼續致力於加速 EKinley 的採用,快速識別不同護理站點的患者,並推進我們在組織學和早期治療領域的強大開發計劃,以進一步確立 EKinley 作為 B 細胞淋巴瘤核心療法的地位。
Next we'll turn to Tiddat. Strong and stable performance in the US in Q1 was driven by the depth and breadth of sites of care using Tip deck. Sales during the quarter were $33 million which is up 22% over Q1 2024.
接下來我們轉向提達特。美國第一季強勁而穩定的表現得益於使用 Tip deck 的護理站點的深度和廣度。本季銷售額為 3,300 萬美元,比 2024 年第一季成長 22%。
As we shared during our Q4 earnings call, TIPAC was updated to a Category 1 preferred treatment and obtained a new Category 2B designation for its use in combination with [Pembro] for PDL1 positive patients, further reinforcing its potential as the clear answer in recurrent and metastatic cervical cancer.
正如我們在第四季度收益電話會議上所分享的那樣,TIPAC 已更新為 1 類首選治療藥物,並獲得了新的 2B 類稱號,用於與 [Pembro] 聯合用於治療 PDL1 陽性患者,進一步增強了其作為複發性和轉移性子宮頸癌明確答案的潛力。
In March, Timak received approvals in both Japan and the EU for [JyMA] will lead commercialization independently. Recognizing the significant need facing patients in Japan and Europe, our teams are working closely with health authorities to bring TIA to patients in these regions as quickly as possible.
今年 3 月,Timak 獲得日本和歐盟的批准,[JyMA] 將獨立領導商業化進程。認識到日本和歐洲患者面臨的巨大需求,我們的團隊正在與衛生當局密切合作,盡快為這些地區的患者提供 TIA 治療。
Together, these approvals mark a significant milestone for Genmab, ushering us into the next phase of our commercialization strategy as we bring TIDAC to more patients around the world and grow our [gynoch] portfolio globally.
總之,這些批准標誌著 Genmab 的一個重要里程碑,引領我們進入商業化策略的下一階段,我們將把 TIDAC 帶給世界各地的更多患者,並在全球範圍內擴大我們的 [婦科] 產品組合。
With continued solid performance across our commercialized brands and progress expanding our commercial portfolio, we feel confident in how we're positioned to continue executing our growth strategy now and in the future.
隨著我們商業化品牌的持續穩健表現和商業組合的不斷擴大,我們對現在和將來如何繼續執行我們的成長策略充滿信心。
Looking ahead, we will continue to make the necessary investments in our commercialization capabilities to fuel our success, competitively scale our business, and drive strong results. As we build upon the launch success of both Epkinley and TEDAC, we are laser focused on expanding utilization of these life-changing treatments and bringing them to as many patients as possible around the world.
展望未來,我們將繼續對商業化能力進行必要的投資,以推動我們的成功,有競爭力地擴大我們的業務規模,並取得強勁的業績。在 Epkinley 和 TEDAC 成功上市的基礎上,我們致力於擴大這些改變生活的治療方法的利用,並將它們帶給全世界盡可能多的患者。
These efforts mark a meaningful and disciplined shift towards the next phase in our commercialization strategy. Our strategic expansion into new markets will enable us to transform treatment paradigms at global scale.
這些努力標誌著我們的商業化策略向下一階段邁出了有意義且有紀律的一步。我們對新市場的策略擴張將使我們能夠在全球範圍內改變治療模式。
With that, I'll hand the call over to over to Anthony to discuss our financials further.
說完這些,我將把電話交給安東尼,進一步討論我們的財務狀況。
Anthony Pagano - Chief Financial Officer, Executive Vice President
Anthony Pagano - Chief Financial Officer, Executive Vice President
Thanks, Brad.
謝謝,布拉德。
In 11, we delivered solid revenue growth driven by sustained recurring revenues and the solid market performance of our products. We've also significantly enhanced our long-term growth potential as we continue to gather promising data for Rena S and at Kinley.
11年,我們實現了穩健的收入成長,這得益於持續的經常性收入和我們產品穩健的市場表現。隨著我們繼續為 Rena S 和 Kinley 收集有希望的數據,我們也顯著增強了我們的長期成長潛力。
And as we'll see, our financials remain strong. We achieved 19% total revenue growth. And importantly, we grew our recurring revenues by 33%. This was driven by strong royalties from Darselex and Kasinta, and importantly, this growth was also driven by product sales from E Kinley and Tibdec, which together represented around 29% of our total revenue growth.
正如我們所見,我們的財務狀況依然強勁。我們實現了19%的總收入成長。重要的是,我們的經常性收入成長了 33%。這是由 Darselex 和 Kasinta 的強勁特許權使用費推動的,更重要的是,這一增長也受到 E Kinley 和 Tibdec 產品銷售的推動,它們合計占我們總收入增長的 29% 左右。
Looking at [Darselex], where we continue to see strong growth. Overall, net sales grew by around 20%. That's net sales of over $3.2 billion for the quarter, which translates to $450 million in royalty revenue. This growth was driven by continued share gains and strong performance in the frontline settings.
看看[Darselex],我們繼續看到強勁的成長。總體而言,淨銷售額成長了約20%。本季淨銷售額超過 32 億美元,相當於 4.5 億美元的特許權使用費收入。這一增長得益於持續的市場份額增長和一線市場的強勁表現。
So you can see that the quality of our revenue profile continues to improve. In fact, in Q1 of this year, the current revenues represented 95% of our total revenues, and that compares to 85% in Q1 last year. So it's really clear that the investments we've made in building out our commercialization teams and capabilities are paying off.
所以你可以看到我們的收入狀況品質持續改善。事實上,今年第一季,當期營收占我們總營收的 95%,而去年第一季這一比例為 85%。因此,很明顯,我們在建立商業化團隊和能力方面所做的投資正在獲得回報。
And this sets us up well, as we prepare for potential expansion into earlier lines for F Kinley, including Second line FL and the potential launch of Rita S in 2027. And we continue to take a disciplined approach to these investments.
這為我們做好了準備,因為我們準備將 F Kinley 擴展到早期產品線,包括第二條產品線 FL 以及 2027 年可能推出的 Rita S。我們將繼續對這些投資採取嚴謹的態度。
Total operating expenses in the first quarter were $485 million and that's up 5% compared to the first quarter of last year and we managed our investments strategically. Prioritizing our high impact phase 3 programs, and focused investments in our commercialization capabilities.
第一季的總營運費用為 4.85 億美元,比去年第一季成長 5%,我們對投資進行了策略性管理。優先考慮我們影響深遠的第三階段計劃,並專注於投資我們的商業化能力。
Our operational discipline contributed to our operating profit growth of an impressive impressive 62% in the first quarter. So here you can see that we continue to deliver on our commitments. Next, looking at our net financial items, here we have a net gain of 56 million.
我們的營運紀律促使我們第一季的營業利潤成長了令人印象深刻的 62%。所以在這裡您可以看到我們繼續履行我們的承諾。接下來,看看我們的淨財務項目,這裡有 5,600 萬的淨收益。
Then moving on to tax, we have tax expense of around $49 million which equates to an effective tax rate of 20.3%. Taken together, our net profit amounts to $195 million for the quarter. So as you can see, continued strong underlying financial performance.
然後談到稅收,我們的稅費約為 4900 萬美元,相當於有效稅率為 20.3%。總體而言,本季我們的淨利潤達到 1.95 億美元。因此,正如您所看到的,基礎財務表現持續強勁。
With that, let's move to our 2025 financial guidance. We remain on track to achieve our existing financial guidance with projected double digit revenue and profit growth. We expect our revenue to be in the range of around $3.3 million to $3.7 billion delivering a robust 12% growth at the midpoint.
有了這些,我們來看看 2025 年的財務指引。我們仍有望實現現有的財務指導目標,預計收入和利潤將實現兩位數成長。我們預計我們的營收將在 330 萬美元至 37 億美元之間,中間值將實現 12% 的強勁成長。
And this is despite our non-recurring revenue decreasing by more than $100 million. So, it's our recurring revenues from royalty medicines and increasingly from Ep Kinley and TIA, that's driving the anticipated growth in 2025.
儘管我們的非經常性收入減少了 1 億多美元,但情況仍然如此。因此,正是來自特許藥品以及日益增長的 Ep Kinley 和 TIA 的經常性收入推動了 2025 年的預期成長。
In total for the year, we expect our recurring revenues to grow by 18%. For operating expenses, we expect to be in a range of around $2.1 million to $2.2 billion. And this reflects our disciplined approach to investments as well as rigorous portfolio prioritization.
總體而言,我們預計今年的經常性收入將成長 18%。對於營運費用,我們預計在 210 萬美元至 22 億美元之間。這反映了我們嚴謹的投資方法以及嚴格的投資組合優先順序。
Putting all this together, we're planning for operating profit in a range between $895 million to nearly $1.4 billion. With the midpoint of guidance amounting to 1.1 billion of operating profit and year-over-year growth of 16%. Now, to give you just a bit of color on FX.
綜合以上因素,我們計劃實現營業利潤在 8.95 億美元至近 14 億美元之間。預計中位數為營業利潤11億美元,年增16%。現在,讓我們來簡單介紹一下 FX。
Every 10 points move in the exchange rate relative to our guidance rate, which was $1 kronor at 7.2%, that's worth around $5 million in operating income or loss at the midpoint. So in summary, our guidance really highlights our continued focus and disciplined approach to our investments and operational efficiency, all while advancing our pipeline and enhancing shareholder value.
相對於我們的指導匯率(即 7.2% 的匯率,1 克朗兌 1 美元),匯率每變動 10 點,中間值就相當於 500 萬美元的營業收入或損失。總而言之,我們的指導確實強調了我們對投資和營運效率的持續關注和嚴謹態度,同時推進我們的產品線並提高股東價值。
Now, let me wrap things up. Our performance in the first quarter of 2025 really underscores our ability to deliver solid revenue growth, advance key pipeline assets, and maintain strong profitability through discipline execution.
現在,讓我總結一下。我們在 2025 年第一季的業績確實凸顯了我們實現穩健收入成長、推進關鍵管道資產以及透過嚴格執行保持強勁獲利能力的能力。
Looking ahead to the rest of 2025, we're building on this momentum by further prioritizing our investments and expanding market opportunities. And we're, of course, monitoring the current geopolitical situation, including tariffs and the potential impact on our guidance on our business.
展望 2025 年剩餘時間,我們將進一步優先考慮投資並擴大市場機會,以此鞏固這一勢頭。當然,我們正在關注當前的地緣政治局勢,包括關稅以及對我們業務指導的潛在影響。
At this stage, we do not anticipate a significant impact on our 2025 financial guidance. And what's important to note here is that even in these volatile times, our very strong financial foundation, coupled with our continued financial rigor and disciplined capital allocation strategy enables us to position Genmab for growth and expansion, as well as create value for our shareholders and patients.
現階段,我們預計這不會對我們的 2025 年財務指引產生重大影響。這裡值得注意的是,即使在這些動盪的時期,我們非常強大的財務基礎,加上我們持續的財務嚴謹性和嚴謹的資本配置策略,使我們能夠為 Genmab 的成長和擴張做好準備,並為我們的股東和患者創造價值。
And on that note, I'm going to hand you back over to Jan.
關於這一點,我將把您的發言權交還給 Jan。
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Thank you, Anthony. Let's move to our final slide.
謝謝你,安東尼。讓我們進入最後一張投影片。
While we face geop geopolitical uncertainty, the fundamentals of our business are strong, and our strategic priorities for 2025 and beyond remain unchanged. The expanded the reach of both T Kinley and TIFA with additional regulatory approvals, with more to come.
儘管我們面臨地緣政治的不確定性,但我們的業務基本面依然強勁,我們 2025 年及以後的戰略重點保持不變。T Kinley 和 TIFA 的業務範圍透過獲得更多監管批准而擴大,未來還將獲得更多批准。
As he announced on our intends to submit a normal supplemental biologics license application for Arimo in the first half of this year. Farkas SunliMO and RAS, we anticipate presenting additional support of clinical data.
正如他在我們的網站上宣布的那樣,他打算在今年上半年為 Arimo 提交一份正常的補充生物製劑許可申請。Farkas SunliMO 和 RAS,我們期待提供額外的臨床數據支援。
Both have the potential to move into broader indications that new clinical trials, including the potential expansion of Rhino S into endometrial cancer. And we will continue to actively look for opportunities to grow our pipelines, both organically and inorganically positioning us for long term growth and value creation.
兩者都有潛力進入新的臨床試驗的更廣泛適應症,包括將 Rhino S 擴展到子宮內膜癌的潛在治療領域。我們將繼續積極尋找機會擴大我們的產品線,透過有機和無機的方式為我們的長期成長和價值創造做好準備。
In summary, in the first quarter of 2025, a solid financial performance, including from Ainley and TIFA, reinforced the strength of our financial foundation. This strong foundation is coupled with the disciplined capital allocation strategy that prioritizes investment in our high impact phase 3 programs, and maximizing the success of our commercialized medicines putting together, we are set up for long-term success.
總而言之,2025 年第一季度,包括 Ainley 和 TIFA 在內的穩健財務表現增強了我們財務基礎的實力。這項堅實基礎與嚴格的資本配置策略相結合,該策略優先投資於我們具有高影響力的 3 期項目,並最大限度地提高我們商業化藥品的成功率,我們為長期成功做好了準備。
Having set the stage for sustained innovation, operational excellence, and value creation through the decade and beyond. So before we move to Q&A, I'm pleased to announce that we will hold a virtual review of the Rhina S data presented at both SGO and ESCO on June 2nd. Details will be available on our websites, and we look forward to a lively and energizing events.
為未來十年及以後的持續創新、卓越營運和價值創造奠定了基礎。因此,在我們進入問答環節之前,我很高興地宣布,我們將於 6 月 2 日對 SGO 和 ESCO 上展示的 Rhina S 數據進行虛擬審查。詳細資訊將在我們的網站上公佈,我們期待一場生動活潑的活動。
And that answers formal presentation, operator, please open the call for questions now.
這就是正式介紹的答案,接線員,現在請打開問答環節。
Operator
Operator
(Operator Instructions)
(操作員指示)
Jonathan Chang, LeeRink.
Jonathan Chang,LeeRink。
Jonathan Chang - Analyst
Jonathan Chang - Analyst
This is you went.
這就是你去的。
On for Jonathan. Thanks for taking our questions. So two from us. First one, can you help set expectations for the upcoming renal endometrial cancer data presentation at ESCO? And second, related to that, how should we be thinking about the commercial opportunity of renal as in endometrial cancer and how does that compare to the opportunity in ovarian cancer?
喬納森上場。感謝您回答我們的問題。我們有兩個。首先,您能否協助設定對即將在 ESCO 舉行的腎臟子宮內膜癌資料演示的期望?其次,與此相關的是,我們應該如何看待腎臟癌和子宮內膜癌的商業機會,以及這與卵巢癌的機會相比如何?
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Thanks for the questions. I will handle on the first one to tie, and I mean, of course, you're still under embargo. We cannot, give you too much information, but you can definitely shed some color on the on the data to be presented at SCO. And then, Anthony Pagano can can definitely say a bit more about the potential commercial potential for Rhino S. And if needed, Brad can add to that. Tai, why did you start?
感謝您的提問。我將處理第一個綁定的問題,我的意思是,當然,你仍然處於禁運之下。我們不能向您提供太多信息,但您肯定可以對 SCO 上展示的數據提供一些說明。然後,Anthony Pagano 肯定可以多談談 Rhino S 的潛在商業潛力。如果需要,Brad 也可以補充一些。泰,為什麼開始?
Yes, thank you for the question. So, as, Yang was saying, we're obviously an embargo, so I cannot give you a detailed preview of the data, but as we said before, the data in our minds is, very compelling. I think it underscores the potential for VAS to be a best in class ADC in endometrial. It's going to be important to understand that the treatment paradigms have shifted in endometrial now most patients are getting. A combination of checkpoints and chemotherapy in combination frontline.
是的,謝謝你的提問。因此,正如楊所說,我們顯然處於禁運狀態,所以我無法向您提供詳細的數據預覽,但正如我們之前所說,我們心中的數據非常引人注目。我認為它強調了 VAS 成為子宮內膜領域最佳 ADC 的潛力。重要的是要了解,現在大多數患者接受的子宮內膜治療模式已經改變了。合併前線檢查點和化療的組合。
So we're very excited about the ficacy signal. It's a signal that also underscores a second hypothesis that's very important for you as that is that, because of the profile of the drug, it really has an efficacy cost the expression of 4 receptor alpha.
因此,我們對 ficacy 訊號感到非常興奮。這個訊號也強調了對您來說非常重要的第二個假設,即由於藥物的特性,它確實對 4 受體 α 的表達具有療效成本。
Positive tumors and that in a nutshell also has a readout to other opportunities in our minds. So that's kind of like how I would frame the data. And then, I'll ask Anthony and Brad to comment on the opportunity in the.
陽性腫瘤,簡而言之,也在我們的腦海中讀出了其他機會。這有點像我建立數據的方式。然後,我會請安東尼和布萊德對這個機會發表評論。
Anthony Pagano - Chief Financial Officer, Executive Vice President
Anthony Pagano - Chief Financial Officer, Executive Vice President
Yeah, I think, it's important to kind of remember the journey we've been on with Rena S. When we, made the acquisition and announced it back in April of last year, so a little over a year ago, we outlined an overall, our excitement for the program, our excitement around what we can really do with this asset in our hands.
是的,我認為,記住我們與 Rena S 一起走過的旅程是很重要的。當我們在去年 4 月進行收購並宣布這一消息時,也就是一年多以前,我們概述了我們對該計劃的總體興奮之情,以及我們對能夠利用手中的這項資產真正做什麼的興奮之情。
And really, if you look back on what we said a couple of important things at that point. We said at that stage it was a billion dollars dollar plus opportunity and that we could, very excited about, really putting our foot in the gas pedal from a development perspective, and that could potentially lead to the first approval in 2027. Now, let's fast forward 13 months and look.
事實上,如果你回顧我們當時所說的一些重要的事情。我們當時說,這是一個價值十億美元以上的機會,我們非常高興,從開發的角度真正加大了力度,這有可能在 2027 年獲得首次批准。現在,讓我們快轉 13 個月看看。
What we've, accomplished. We've provided meaningful data, to the market to really reinforce the business case, at least in second line [plusroc] shared last year reinforced at STO this year, and we look to further expand that, into, data represented ASCO for endometrial cancer.
我們已經取得的成就。我們向市場提供了有意義的數據,以真正強化商業案例,至少在去年分享的第二線 [plusroc] 中得到了今年在 STO 上的強化,我們希望進一步擴展它,將其擴展到代表子宮內膜癌的 ASCO 數據。
And what we did earlier this year is we really outlined a framework how this potentially is not only a $1 billion plus opportunity, but potentially a $2 billion plus opportunity and really outline the building blocks of that $2 billion plus opportunity, which includes second line plus pro, second line plus endometrial, second line plus PSO, and front line, endometrial.
我們今年稍早所做的是,我們真正勾勒出一個框架,說明這不僅可能是一個 10 億美元以上的機會,而且可能是一個 20 億美元以上的機會,並真正概述了這個 20 億美元以上機會的構成要素,其中包括二線加專業、二線加子宮內膜、二線加 PSO 和一線加子宮內膜。
And as what our our plan here moving forward is to present more and more data to give you confidence that that $2 billion plus, target is is achieved. So I think what we can really say about this, overall, Is that endometrial looking at the patient numbers does represent a meaningful component of that $2 billion.
我們未來的計畫是提供越來越多的數據,讓大家相信 20 億美元以上的目標已經實現。因此,我認為,總體而言,我們真正可以說的是,從患者數量來看,子宮內膜癌確實佔了 20 億美元的重要組成部分。
We've not broken down the specifics other than to give you a sense of the size of the potential patient populations. But overall, we're very happy owners of Arena S, and since we've owned the program, we've made significant progress in really putting our foot in the gas pedal, both in ovarian as well as endometrial cancer. But, maybe you want to put a little bit more color here.
除了讓您了解潛在患者群體的規模之外,我們並沒有詳細說明具體情況。但總的來說,我們很高興成為 Arena S 的擁有者,自從我們擁有這個計畫以來,我們在卵巢癌和子宮內膜癌治療方面取得了重大進展。但是,也許您想在這裡添加更多顏色。
Brad Bailey - Executive Vice President, Chief Commercial Officer
Brad Bailey - Executive Vice President, Chief Commercial Officer
Yeah, thanks, Anthony. I think, as has been stated from Dianne Anthony, certainly Green is a potential primary growth driver for us in the future, and we have confidence, there, of which both endometrial and ovarian are meaningful, to this overall development plan and so more to come, but, certainly encouraged here at this point.
是的,謝謝,安東尼。我認為,正如黛安·安東尼 (Dianne Anthony) 所說,綠色無疑是我們未來潛在的主要成長動力,我們有信心,子宮內膜和卵巢對這個整體發展計畫以及未來的發展都具有重要意義,但目前我們對此充滿信心。
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Thanks, Brad. Thanks you for the question. I think we can move on to the next analyst.
謝謝,布拉德。謝謝你的提問。我想我們可以繼續討論下一位分析師了。
Operator
Operator
Yaron Weber from TD Securities.
道明證券的 Yaron Weber。
Unidentified participant
Unidentified participant
On for your own. Following up with that first question on rena S, what do you think is the efficacy bar in endometrial cancer now that you see that the paradigm we're treating it is shifting to kind of use CPI combination in first line?
為了你自己。接下來是關於 Rena S 的第一個問題,既然您看到我們治療子宮內膜癌的模式正在轉變為在第一線使用 CPI 組合,您認為子宮內膜癌的療效標準是什麼?
And then secondly on Eilumab, obviously you're going to have another update on that this year. Can you give us a little more detail on the timing of this presentation since it looks like it's not going to be the AO and what we might see and also what you would consider a success for Epsilimab?
其次,關於 Eilumab,顯然今年你會對此進行另一次更新。由於看起來這次演示不會是 AO,您能否向我們詳細介紹一下這次演示的時間安排,以及我們可能會看到什麼,以及您認為 Epsilimab 的成功之處是什麼?
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Thank you for the question. So Thai, I think, can handle the efficacy bar question for endometrial cancer and then use it maybe you can give a bit of color on the data which we intend to present which we are very excited about this year and timing and what you would consider a success. So maybe you can start.
謝謝你的提問。因此,我認為 Thai 可以處理子宮內膜癌的療效標準問題,然後使用它,也許您可以對我們打算呈現的數據給出一些說明,我們對今年和時間感到非常興奮,以及您認為什麼是成功。所以也許你可以開始。
Anthony Pagano - Chief Financial Officer, Executive Vice President
Anthony Pagano - Chief Financial Officer, Executive Vice President
Yeah, thank you again for the question. And, as I excluded in my response to the first question, of course, there's also a shift in the patient flow now that patients actually getting chemotherapy in combination with checkpoint, in frontline. But historically, the second line has been an indication where the response rates to chemotherapies are maybe in the 10 to 15% range.
是的,再次感謝您的提問。當然,正如我在回答第一個問題時所排除的那樣,現在患者流量也發生了變化,患者實際上在前線接受化療和檢查點聯合治療。但從歷史上看,第二線治療對化療的反應率可能在 10% 到 15% 的範圍內。
And I want to just reiterate the point that I think we feel very comfortable that the data that is going to be presented, in the very near future and publicly available will underscore the point that this is, really a best in class profile from an efficacy point of view as well as a.
我想重申這一點,我認為我們非常有信心,即將呈現並公開的數據將強調這一點,從功效的角度來看,這確實是一流的。
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Durability point of view.
耐用性的觀點。
Thanks guy. Maybe you it on Aasulimo.
謝謝你。也許你在 Aasulimo 上。
Yeah, thank you, yeah. So for acaulli we said, that it would be age 2 2025, and the reason is the longer follow up, the meaningful, the more meaningful will be the data that would present because as the primary end point in that very setting is overall survival.
是的,謝謝,是的。因此,對於 acaulli 來說,我們說,那將是 2025 年,原因是追蹤時間越長,呈現的數據就越有意義,因為在那種環境下的主要終點就是整體存活率。
And for overall survival, the comparator is the cetaxel with a median of 11 months. So we want to have the follow up meeting to give us the data to support, beating on the primary. So this is the reason and that is age to 2025 to give meaningful follow up. And I told you already the part that you need to be so this is the, just to put the study in the right context.
整體存活期,對照組為西他賽,其中位存活期為 11 個月。因此,我們希望召開後續會議,為我們提供數據支持,以擊敗初選。這就是原因,並且要到 2025 年才能進行有意義的後續追蹤。我已經告訴你需要的部分,所以這只是將研究放在正確的背景下。
And the data in the right context. Thank you what I can add to that is that the phase three is progressing very nicely, so recruiting patients there and we are, continuously excited about, what we see.
以及正確上下文中的資料。謝謝,我可以補充的是,第三階段進展非常順利,因此在那裡招募患者,我們對所看到的結果感到興奮。
Let's move on to the next, analyst.
讓我們繼續下一個,分析師。
Operator
Operator
Xian Deng, UBS. Your line is open. Please ask your question.
鄧賢,瑞銀。您的線路已開通。請提出你的問題。
Xian Deng - Analyst
Xian Deng - Analyst
Hey, thank you for taking my questions. To, at Kiley, please. The first one, so just wondering, so 190 million sales for this quarter, just wondering if you could give us a sense of a rough split between follicular lymphoma and DLBCL please.
嘿,謝謝你回答我的問題。請到 Kiley。第一個問題,我只是想知道,本季的銷售額為 1.9 億美元,只是想知道您是否可以讓我們大致了解一下濾泡性淋巴瘤和 DLBCL 之間的差異。
The reason I'm asking is that if I assume sort of 60 million AIDS, looking at the previous quarter for DLBCL, that means kind of 20 to 30 million or so for follicular lymphoma, that actually looks really good. Versus what Roche has achieved. So just wondering, any color on that, and what's the differentiating factor that the feedback there, particularly in follicular lymphoma, that would be great. The second question is, at Kingly second line plus fol follicular lymphoma, Give me now you plan to submit.
我之所以問這個問題,是因為如果我假設愛滋病患者人數為 6000 萬,看看上一季的 DLBCL 數據,那就意味著濾泡性淋巴瘤患者人數約為 2000 萬到 3000 萬左右,這看起來確實很不錯。與羅氏所取得的成就相比。所以只是想知道,對此有什麼看法,以及那裡的反饋的區別因素是什麼,特別是在濾泡性淋巴瘤方面,那就太好了。第二個問題是,Kingly二線加濾泡性淋巴瘤,請告訴我現在您打算提交什麼。
In the first half of this year. So just wondering, appreciate you highlighted that the patient population here is about 9,000 patients, but just wondering what is your expected duration for this for this cohort place, because, 1 year or 2 year usage makes a huge difference in terms of sales?
今年上半年。所以只是想知道,感謝您強調這裡的患者人數約為 9,000 名患者,但只是想知道您對這個群體的預期持續時間是多久,因為 1 年或 2 年的使用對銷售而言有很大差異?
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Thank you, Lucian for these excellent questions and the first one is, going to Brad, to give you a bit more color on sales for can lead.
謝謝 Lucian 提出的這些非常好的問題,第一個問題,是 Brad 提出的,他將為你提供更多關於罐頭銷售的細節。
And the second one, I will hand over to Tai to, talk a bit more about the very exciting sealine plus follicleon form data and so much as we can speak about it at this time cause the data in embargo, but, Brad, why don't you start with a bit more color on cells.
第二個問題,我將交給 Tai,讓他進一步討論非常令人興奮的海線和卵泡形態數據,由於數據處於禁運狀態,我們目前只能談論這些數據,但是,Brad,你為什麼不先從細胞的更多顏色開始呢?
Brad Bailey - Executive Vice President, Chief Commercial Officer
Brad Bailey - Executive Vice President, Chief Commercial Officer
No, thank you for the question as well and, well, really not in a position to size, contribution of sales specifically seeing continued robust uptake and strong momentum following the respective FL launches and positive responses from providers both in the US and Japan as well as Europe.
不,也感謝您的提問,嗯,實際上無法衡量銷售貢獻,特別是在 FL 分別推出後,看到持續強勁的成長勢頭和強勁勢頭,以及美國、日本和歐洲供應商的積極響應。
US specifically contributed, to the accelerated growth post-approval FL certainly did across sites of care, most significantly in the community setting, and, this was further solidifying the value of the dual indication.
美國對 FL 獲批後在各個護理場所(尤其是社區環境中)的加速增長做出了特別的貢獻,這進一步鞏固了雙重適應症的價值。
As well as also from a label perspective hearing from providers that the clinical profile sub 2 as well as the no hospitalization specifically for FL is has been a key benefit and certainly seen some very positive although early in Japan, very positive responses from providers as well as the market regarding FL there as well.
此外,從標籤角度來看,從供應商那裡聽說臨床概況 2 以下以及專門針對 FL 的無需住院治療是一個關鍵優勢,並且肯定看到了一些非常積極的反應,儘管早期是在日本,但供應商以及市場對 FL 的反應也非常積極。
I'll turn over time on the duration.
我將根據持續時間來調整時間。
Anthony Pagano - Chief Financial Officer, Executive Vice President
Anthony Pagano - Chief Financial Officer, Executive Vice President
Thank you for the question. And so, there's probably a few things that I would say to that. Number one, the duration of treatment is actually fixed in this particular study, meaning that, the regimen is a 12-month, duration treatment of lenalidomide, rituximab, and then echoriumab.
謝謝你的提問。因此,我可能會對此說幾句話。首先,在這個特定的研究中,治療持續時間實際上是固定的,這意味著治療方案是一個為期 12 個月的治療,依次為來那度胺、利妥昔單抗和 echoriumab。
As I said, it's, really impossible for us really to preview any of the data that has to some degree, something to do with the fact that the study is ongoing still and reading out for its, primary PFS endpoint. This submission, as we alluded in the press release, is based on an interim primarily on over response. Obviously, the agency had access to all data and obviously that was, very exciting to us.
正如我所說的,我們實際上不可能預覽任何數據,這些數據在某種程度上與研究仍在進行中以及其主要 PFS 終點的結果有關。正如我們在新聞稿中提到的,此次提交主要是基於對過度反應的臨時決定。顯然,該機構可以存取所有數據,這顯然讓我們非常興奮。
So I think 11 thing to look out, as this, progresses and we will be able to share with you is the magnitude of the effects. And because obviously this is a somewhat unprecedented regulatory, pathway that we're taking and we're really excited about the opportunity?
因此,我認為需要注意的 11 件事是,隨著這一進程的推進,我們將能夠與你們分享其影響的程度。顯然,這是我們所採取的一種前所未有的監管途徑,我們對這個機會感到非常興奮?
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Thanks, guys. So more to commercy on very exciting times. Let's move on to the next question operator.
謝謝大家。因此,在非常令人興奮的時刻,商業活動會更加豐富。讓我們繼續討論下一個問題運算子。
Operator
Operator
(Operator instructions)
(操作員指示)
Michael Schmidt, Guggenheim Partner
古根漢合夥人麥可‧施密特
Unidentified participant 2 Schmidt - Anlayst
Unidentified participant 2 Schmidt - Anlayst
Hi, this is Paul on for Michael. Thanks for taking our question. I had a couple follow ups on EPO. So first, congrats on the recent top line data and with our squared and follicular. Can you just talk a little bit more about your confidence in the regulatory approval based on just the OR co primary?
大家好,我是保羅,代表麥可。感謝您回答我們的問題。我對 EPO 進行了幾次跟進。首先,恭喜我們獲得最近的頂線數據以及平方和卵泡數據。您能否僅根據 OR co primary 再多談談您對監管部門批准的信心?
Would you expect the agency to, factor in or. Or the interim PFS as well. And then just on the landscape, there's a CD 19 are squared regimen that's also in review right now. How do you expect FCO to potentially compete, understanding that we haven't seen the full data yet, is there a sort of balance of safety and efficacy that physicians would really consider in the setting?
您是否希望該機構考慮或考慮。或臨時 PFS。然後就景觀而言,有一個 CD 19 平方方案現在也正在審查中。考慮到我們尚未看到完整的數據,您認為 FCO 將在哪些方面具有競爭力?醫生在實際應用中是否會真正考慮安全性和有效性之間的平衡?
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Thanks, Paul, for the questions. I think I'll hand both of them over to Tai, and we are very confident about the data. But Tai, why don't you give a bit more color to Paul?
謝謝保羅提出的問題。我想我會把這兩項都交給Tai,我們對數據非常有信心。但是 Tai,為什麼不給 Paul 多一點色彩呢?
Anthony Pagano - Chief Financial Officer, Executive Vice President
Anthony Pagano - Chief Financial Officer, Executive Vice President
Yeah, so as much as I can try, what I can tell you is obviously, starting with the fact that we at some point received breakthrough designation for this particular indication that was already based on some phase two data that we had shared with the agency, continuing then that.
是的,所以我會盡我所能,我能告訴你的顯然是,首先,我們在某個時候獲得了針對這一特定適應症的突破性認定,而這已經基於我們與該機構分享的一些第二階段數據,然後繼續下去。
We are now moving forward with this submission in a really unprecedented setting that already should tell you that there's been some data shared with the agency in totality, frankly, that has, allowed us to engage and then get positive feedback and such that we are then, committing to a submission, before the end of, the first half.
我們現在正在一個前所未有的環境下推進這一提交,這已經告訴你,我們已經與該機構共享了一些數據,坦率地說,這使我們能夠參與並得到積極的反饋,因此我們承諾在上半年結束前提交一份報告。
And so then I would say this is going to be a discussion about, how profoundly, the treatment paradigms are changed based on the effect size, as it relates to the positioning vis a vis competition. So more to come. But we're very happy and very excited to share this in the near future.
所以我想說,這將是一場關於治療模式如何根據效果大小發生深刻變化的討論,因為它與競爭定位有關。未來還會有更多。但我們非常高興並且非常興奮能夠在不久的將來分享這一點。
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Maybe a bit more color on the [CD 19 R] square combination and versus the AO R square or can't you comment on that I but.
也許 [CD 19 R] 方塊組合和 AO R 方塊的顏色會更豐富一些,或者您不能對此發表評論。
Anthony Pagano - Chief Financial Officer, Executive Vice President
Anthony Pagano - Chief Financial Officer, Executive Vice President
I mean the data for for [Tafa] is obviously in the public domain.
我的意思是 [Tafa] 的資料顯然屬於公共領域。
So it's hard for me to answer this question without getting into some, discussion on previewing too much of the data because as I said before, there is a strong need for us to maintain the integrity of the study as we're waiting for the interim PFS. You just mentioned one of the reasons why that is important for us.
因此,如果不涉及預覽過多數據的討論,我很難回答這個問題,因為正如我之前所說,在等待中期 PFS 時,我們非常需要保持研究的完整性。您剛才提到了這對我們很重要的原因之一。
So, I cannot really get too much into it except that I can share my confidence that, this will not be necessarily a topic once a day that is, publicly available.
因此,我無法深入探討這個問題,但我可以分享我的信心,這不一定是一個每天一次、公開的話題。
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
I think that's good enough, I think, thanks a lot. Thanks Paul, for the questions.
我認為這已經足夠好了,我想,非常感謝。謝謝保羅提出的問題。
Operator
Operator
Yifeng Liu, HSBC.
劉亦鋒,匯豐銀行。
Yifeng Liu - Analyst
Yifeng Liu - Analyst
Hello, thanks for taking my questions. I've got 21 is I was wondering if you could comment on the sort of environment for for BD now I've given all the macro volatility and and on tariffs and etc. Could you maybe provide some some update on the BD side and secondly it's on your R&D cost. And obviously a good result in first quarter, but you sort of reiterate our guidance.
您好,感謝您回答我的問題。我有 21 個問題,我想知道您是否可以評論一下 BD 的環境,現在我已經給出了所有的宏觀波動和關稅等。您能否提供一些關於 BD 方面的更新,其次是關於您的研發成本。顯然,第一季的業績不錯,但你重申了我們的指導。
Xian Deng - Analyst
Xian Deng - Analyst
I just wonder is is R&D cost most of the second half weed and how should we think about that? Thanks.
我只是想知道研發成本是否佔據了下半年雜草的大部分,我們該如何看待這一點?謝謝。
It's a very good question. So I will definitely hand the second one over to Anthony. I will take the BD environment question myself. It's actually an excellent environment for BD if you are a company looking for assets which can potentially complement our pipeline because it's actually very challenging times for smaller biotechs.
這是一個非常好的問題。所以我肯定會把第二個交給安東尼。我將親自回答 BD 環境問題。如果您是一家正在尋找能夠補充我們產品線的資產的公司,那麼對於 BD 來說,這實際上是一個極好的環境,因為對於小型生物技術公司來說,這實際上是一個非常具有挑戰性的時期。
It's innovative, but it, it's our need for cash and support. I think this is very difficult, for them, so this, to actually then partner a a molecule or hand over a molecule. To a company with a robust cash position like Jamoop and a strong financial foundation is really a very good starting point, and I can assure you that we have a number of very good candidates either late stage or late stage ready molecules on the radar screen, which we are discussing. So we believe that this is actually a very good environment for for BD.
這是創新,但我們需要資金和支持。我認為這對他們來說非常困難,所以實際上要與一個分子合作或交出一個分子。對於像 Jamoop 這樣擁有雄厚現金狀況和強大財務基礎的公司來說,這確實是一個非常好的起點,我可以向你們保證,我們有許多非常好的候選藥物,無論是處於後期階段還是準備進入後期階段的分子,我們都在討論中。因此我們相信這對 BD 來說實際上是一個非常好的環境。
If you are on the on the acquire acquiring sites, not when you're on the selling side, I think this puts a bit more pressure on the system. That's where I can probably leave it at at this moment and then hand over to Anthony to talk a bit more about R&D costs. Anthony.
如果您在收購網站上,而不是在銷售網站上,我認為這會對系統造成更大的壓力。現在我大概可以就此打住,然後交給安東尼進一步討論研發成本的問題。安東尼。
Tahamtan Ahmadi - Executive Vice President, Chief Medical Officer, Head of Experimental Medicines
Tahamtan Ahmadi - Executive Vice President, Chief Medical Officer, Head of Experimental Medicines
Yeah, thanks, Jan. We've outlined a really clear strategy about how we're going to invest, across our business, really focusing on the late stage assets at Kinley, Rena S and Aaumumab, as well as focused and disciplined investments and our commercialization capabilities and really building out some of our markets in a really focused way. And Q1 is fully, reflective of of that.
是的,謝謝,Jan。我們已經制定了一個非常清晰的策略,關於如何在整個業務中進行投資,真正關注 Kinley、Rena S 和 Aaumumab 的後期資產,以及有針對性和有紀律的投資和我們的商業化能力,並真正以非常專注的方式構建我們的一些市場。Q1 充分反映了這一點。
Now, In terms of the expected growth that we're going to expect here in Q2, Q3, in Q4, getting to your question around R&D expenses, it's going to be fully in line with that. Really there's going to be three primary drivers of the growth here for the balance of 2025. The first is going to be the wrap up of the phase 3, 1,046 or [Aasu] trial.
現在,就我們預期的第二季、第三季和第四季的成長而言,關於研發費用的問題,它將完全符合這一預期。事實上,到 2025 年,這裡的成長將有三個主要驅動力。首先是第三階段、1,046 或 [Aasu] 試驗的結束。
That was a trial that was launched last year. It will continue to ramp up and scale up during the course of 2025. The same is true for Rena S and Second line plus PRC. Here we again started that trial late last year and we'll be ramping up during the course of 2025. And then, of course, in the second half of the year, we announced that we expect the phase 3, 2nd line plus endometrial trial to really be in launch mode.
這是去年啟動的一項試驗。到 2025 年,這一規模將繼續擴大。Rena S和Second line plus PRC也是如此。我們在去年底再次開始了這項試驗,並將在 2025 年期間加大力度。然後,當然,在下半年,我們宣布我們預計第 3 階段、第 2 線加子宮內膜試驗將真正進入啟動模式。
So those will be the three primary drivers. Again, those investments are fully in line with our state of objective investing and prioritizing investments in our late stage pipeline.
因此這將是三個主要驅動因素。再次強調,這些投資完全符合我們的客觀投資狀況以及對後期管道投資的優先考慮。
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Thanks very much. Thanks. Thanks, let's move on to the next, question, please.
非常感謝。謝謝。謝謝,請讓我們繼續下一個問題。
Operator
Operator
Vikram Purohit, Morgan Stanley.
摩根士丹利的維克拉姆·普羅希特(Vikram Purohit)。
Vikram Purohit - Analyst
Vikram Purohit - Analyst
Great, good afternoon. Thank you for taking our questions. We had to first on.
太好了,下午好。感謝您回答我們的問題。我們必須先上。
The topic of your work in immunology. I know you have a partnership with organics focused on some early stage immunology work and you've also alluded to previously, I think, the potential for at Kinley in INI, so I just wanted to see if there's any updates on your thinking there for a future potential efforts in INI and how much of an internal priority that is for you right now, when you look at different opportunities across your pipeline?
您在免疫學領域的工作主題。我知道您與一些專注於早期免疫學工作的有機企業建立了合作夥伴關係,而且您之前也提到過,我認為,INI 在 Kinley 的潛力,所以我只是想看看您對 INI 未來潛在努力的想法是否有任何更新,以及當您考慮整個管道中的不同機會時,這對您來說現在有多大的內部優先事項?
And then secondly, I was just curious on determining next steps for Gen 1,042. I think, your milestone calendar mentions you're going to be. Deciding on next steps there this year. Just wanted to see how you're thinking about that decision and kind of what determines the go no go there?
其次,我只是好奇如何確定 Gen 1,042 的下一步。我認為,您的里程碑日曆提到了您將會這樣做。決定今年的下一步。只是想看看您是如何考慮這個決定的,以及是什麼決定了您是否可以去那裡?
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Thanks, Vikram for the questions. I can take the first one on immunology, and then I will ask you to give a bit more color on 10:42 next steps, for that, by specific, program. So we're very excited about the potential to use our expertise in INI.
謝謝 Vikram 提出的問題。我可以先討論免疫學,然後我會請你透過具體的計畫對 10:42 下一步進行更詳細的說明。因此,我們對在 INI 領域運用我們的專業知識的潛力感到非常興奮。
And we actually have a number of programs which we wholly own and we have also programs where we work together with ourgenics. They're all preclinical com, but we are very excited about the potential of some of these programs, but they are at the stage that we are creating the preclinical candidates for selection towards developing them in the clinic.
實際上,我們擁有多個完全屬於自己的項目,也有一些與 Ourgenics 合作的項目。它們都是臨床前階段的,但我們對其中一些項目的潛力感到非常興奮,但它們正處於創建臨床前候選藥物以供選擇以便在臨床中開發它們的階段。
The majority of our activities is still going to be based also in the coming years on oncology, so more than 80% of our efforts is in oncology, but we're getting increasingly interested in also losing our expertise, that includes the whole breadth of the antibody based AUD candidate expertise, also in other settings, and INI is I think an excellent, one, but it's a bit early stage.
在未來幾年中,我們的大部分活動仍將以腫瘤學為基礎,因此我們 80% 以上的精力將投入到腫瘤學領域,但我們對失去我們的專業知識越來越感興趣,這包括基於抗體的整個 AUD 候選藥物專業知識,也包括在其他環境中的專業知識,我認為 INI 是一個非常好的選擇,但它還處於早期階段。
[Ain] is, I think, probably the most advanced. In a molecule which we want to move into INI we're discussing right now with our partner Afi, how to do that exactly and which the indications, etc. So more to come in the coming time. De portfolio is dominated by oncology opportunities, but as we already have shown both with Kasinta.
我認為 [Ain] 可能是最先進的。對於我們想要轉入 INI 的分子,我們目前正在與合作夥伴 Afi 討論如何具體做到這一點以及有哪些適應症等。因此,未來還會有更多內容。投資組合以腫瘤學機會為主,但正如我們已經透過 Kasinta 展示的那樣。
Vikram Purohit - Analyst
Vikram Purohit - Analyst
And also the path is that, of course, molecules this can originally developed for, oncology indications, can be excellent drugs, and other indications and INI. Is the area where antibody-based medicines have made an incredible difference to the treatment of patients, so we believe that we can be very strong there, but it's lagging behind the cancer focused opportunities. So I will stop there and then ask you to give a bit of call on 10:42 next steps.
當然,路徑也是這樣的,這種最初為腫瘤適應症而開發的分子可以成為優秀的藥物,也可以用於其他適應症和 INI。在這個領域,基於抗體的藥物對患者的治療產生了令人難以置信的影響,因此我們相信我們可以在這個領域非常強大,但它落後於以癌症為重點的機會。因此我將就此停下來,然後請您就 10:42 下一步做出一些說明。
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Yeah.
是的。
I don't know whether we have still on board, but 104 is.
我不知道我們是否還在船上,但有 104 個人。
Operator
Operator
Connected.
已連線。
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Oh, disconnected. Okay. So now let me do that.
噢,斷線了。好的。那麼現在就讓我來做這件事。
Operator
Operator
You can you have.
你可以擁有。
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
You did?
你做到了嗎?
Alright, let me answer that question and on 10:42 next steps, we are waiting on duration data, and we will take a decision on next step for 1,042. The CD 441 will be antibody and of course we're still collecting data, especially in the head and neck cancer setting, front line setting.
好的,讓我來回答這個問題,在 10:42 的下一步中,我們正在等待持續時間數據,然後我們將對 1,042 的下一步做出決定。CD 441 將是抗體,當然我們仍在收集數據,特別是在頭頸癌環境和第一線環境中。
And so that decision will be taken in the second half of this year, and we are waiting for more duration data to really get a good feeling for what the strengths of our data versus the evolving landscape and how the neck as we, as there's a lot of new developments and have a neck and we want our our candidates or candidates to be very competitive also in the evolving therapeutic landscape and in order to do that well and also to rigorously prioritize our attention on the different product candidates, we really need more of a duration data, duration of response data, and we will get that in the second half of this year. I will leave it with that if you come.
因此,我們將在今年下半年做出決定,我們正在等待更多的持續時間數據,以真正了解我們的數據相對於不斷發展的格局的優勢以及頸部的情況,因為有很多新的發展,我們希望我們的候選人或候選人在不斷發展的治療領域也具有很強的競爭力,為了做好這一點,並嚴格優先考慮不同的產品候選者,我們確實需要更多數據、持續時間的數據、持續半年數據、持續時間和候選人,我們確實需要更多的數據如果你來的話我就把它留下來。
Operator
Operator
Asthika Goonewardene, Truist Securities.
Asthika Goonewardene,Truist 證券公司。
Asthika Goonewardene - Analyst
Asthika Goonewardene - Analyst
Hi guys, thanks for taking the questions. So I got a couple, please. So on RAS, I want to just, close the loop on other tumor types beyond ovar and endometrial. There were expansion cohorts and lung and other tumor types which I thought would be fairly mature, this year for you to report data on, but you're not talking about them.
大家好,感謝你們回答問題。所以我買了幾件。因此,對於 RAS,我只想關閉卵巢癌和子宮內膜癌以外的其他腫瘤類型的循環。我認為今年你們報告的數據已經相當成熟,但你們卻沒有談論這些擴展隊列和肺癌及其他腫瘤類型。
Is that because they're still ongoing and the data is not ready yet, or are you deprioritizing development in those other tumor types outside of ovarian and endometrial? If the latter is it a full of the alpha expression issue.
這是因為它們仍在進行中且數據尚未準備好,還是因為您降低了卵巢癌和子宮內膜癌以外的其他腫瘤類型的開發的優先順序?如果是後者,則它充滿了 alpha 表達式問題。
And then second, on Columbi, the, your competitor Columbi has an ad com coming up May 20th to discuss the SPLA for Starglow. It's a little odd given that Starle looks like a pretty successful trial with an OS benefit. So what do you think is the question that the FDA wants the panel to discuss? And do you anticipate the same might be, that FO might, face the same kind of question as well?
其次,關於 Columbi,你的競爭對手 Columbi 將於 5 月 20 日舉行廣告發布會,討論 Starglow 的 SPLA。這有點奇怪,因為 Starle 看起來是一個非常成功的試驗,並且具有作業系統優勢。那麼您認為 FDA 希望專家小組討論的問題是什麼?您是否預期 FO 也可能面臨同樣的問題?
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Thanks Ashthika, for the questions. I think I will ask Tai to initially start with both of these and then see whether we, can add further to the second question maybe via you that. Tai, why don't you start with the, or tumor types, and the level of interest for Ran because I can tell you I think it's sky high, it's not lowering at all.
感謝 Ashthika 提出的問題。我想我會讓 Tai 首先從這兩個問題開始,然後看看我們是否可以透過你進一步補充第二個問題。Tai,為什麼不從腫瘤類型和 Ran 的興趣程度開始呢?因為我可以告訴你,我認為它非常高,根本沒有降低。
Anthony Pagano - Chief Financial Officer, Executive Vice President
Anthony Pagano - Chief Financial Officer, Executive Vice President
Yeah, just, the, thanks for the question, I just, for also to clarify.
是的,只是,謝謝你的提問,我只是想澄清一下。
We obviously inherited a protocol from profound fire, but not all of the things that were initially in there were actually operationalized. We did, mention this on the call, I think, in response to a question from you previously, opened up a coed in, noon and lung cancer, and are actively enrolling patients, in that study.
我們顯然繼承了深火的協議,但最初存在的東西並非都真正得以實施。我想,我們在電話中確實提到了這一點,是為了回答您之前提出的一個問題,我們開設了一項男女同校的、針對肺癌的研究,並且正在積極招募患者參與這項研究。
And, there will be more activity on this. I promise you very soon, that we can also share, in the public domain. As Yan was saying, actually, the more data we generate and the endometrial data to some degree is the the additional layer of data that helps us understand, the profile, the opportunity for VRS.
而且,這方面還會有更多的活動。我很快向你們保證,我們也可以在公共領域分享。正如 Yan 所說,實際上,我們產生的數據越多,子宮內膜數據在某種程度上就是額外的數據層,可以幫助我們了解概況和 VRS 的機會。
The more we get convinced that, NAS has an opportunity across the spectrum of, [fo] receptor alpha expression. We know that in ovarian and in endometrial patients who have low or even are negative by the assay respond to tunas and so that actually increases our confidence. We never had any other tumor type, open.
我們越發確信,NAS 在整個 [fo] 受體 α 表現範圍內都有機會。我們知道,卵巢和子宮內膜患者對鮪魚的反應較低甚至呈現陰性,這實際上增加了我們的信心。我們從未發現過任何其他類型的腫瘤。
We have not enrolled any other patients outside of, endometrial, ovarian, or lung cancer at this point. But there also will be additional activities before the end of the year. So more to come. On the ODAC, it's not really appropriate for us to speculate on why or why not the FDA, has asked for an ODAC, for that study. I think if you look into that study and into the public data, there are some things we could, think about, as it relates to your patients.
目前,我們尚未招募子宮內膜癌、卵巢癌或肺癌以外的任何其他患者。但今年年底前還會有其他活動。未來還會有更多。關於 ODAC,我們不太適合去猜測 FDA 為何要求或不要求為該研究提供 ODAC。我認為,如果你研究這項研究和公開數據,我們可以思考一些與你的病人相關的事情。
But anyway, we focused on Finney. We're very confident in how we are developing, moving, AI forward in the dual indications. We're very excited, as I mentioned, earlier, for the first, for the data, and we're also, anxiously looking forward to have a readout on the frontline research research study sometime in 26, if the events coming in, based on the the core, and that is, what we are focused on.
但無論如何,我們的注意力都集中在芬尼身上。我們對如何在雙重指示中開發和推動人工智慧的發展非常有信心。正如我之前提到的,我們對這些數據感到非常興奮,我們也焦急地期待在 26 日的某個時候獲得一線研究的研究結果,看看事件是否基於核心,這就是我們所關注的。
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Yeah, no, the only thing to add is we just, you mentioned, yeah, is that EPO in conjunction with GO got NPCN endorsement as to a which is very encouraging and very good for patients in the US.
是的,不,唯一要補充的是,您剛才提到,EPO 與 GO 聯合獲得了 NPCN 的認可,這對美國患者來說非常令人鼓舞,非常有利。
Asthika Goonewardene - Analyst
Asthika Goonewardene - Analyst
Thank you that. I think we'll leave it with that [Ashleya], but thanks for the question, sir.
謝謝你。我想我們就此打住 [Ashleya],不過還是感謝您的提問,先生。
Operator
Operator
Matthew Phipps, William Blair.
馬修菲普斯、威廉布萊爾。
Matthew Phipps - Analyst
Matthew Phipps - Analyst
Thanks for a question. Great to see [Kimly] move forward with the project front runner here and second line follicular. Wondering if you all are thinking about or have any agreements to use the project front runner and any other ongoing or planned phase 3 studies. I know the frontline follicular study also has a complete response endpoint. Perhaps that is maybe designed also for a potential project front runner path?
謝謝你的提問。很高興看到 [Kimly] 在該計畫的領跑者和二線毛囊治療方面取得進展。想知道你們是否正在考慮或有任何協議使用專案領導者以及任何其他正在進行或計劃中的第 3 階段研究。我知道一線濾泡研究也有一個完全緩解終點。也許這也是為潛在專案領跑者路徑而設計的?
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Thank you for the for the question and I think that you can probably address that whether we have any discussions with the FDA on other programs like Front runner.
感謝您的提問,我想您可以回答一下我們是否與 FDA 就 Front runner 等其他項目進行過討論。
Anthony Pagano - Chief Financial Officer, Executive Vice President
Anthony Pagano - Chief Financial Officer, Executive Vice President
Yeah, so I think, thank you, broadly speaking.
是的,所以我認為,從廣義上講,謝謝你。
Conversations about novel approaches are easier if you have compelling data and are not so straightforward in a theoretical vacuum without any data. So, obviously, what we've said before is we continue to explore opportunities to accelerate.
如果您擁有令人信服的數據,那麼關於新方法的討論就會變得更容易,而不是在沒有任何數據的理論真空中那麼直接。因此,顯然,我們之前說過,我們將繼續探索加速的機會。
Access for patients, particularly when we feel that the data is profound and meaningful to patients. This was one of the situations where, we took an innovative approach and, based on the data, I had a a positive interaction with the STA and that's why we were able to move forward and we'll continue to do that in whatever study comes out with other data we have if the data is compelling and we feel there is an opportunity to bring this to patients.
為患者提供存取權限,特別是當我們認為數據對患者意義深遠且有意義時。在這種情況下,我們採取了一種創新方法,並且根據數據,我與 STA 進行了積極的互動,這就是我們能夠向前邁進的原因,並且如果數據令人信服並且我們覺得有機會將其帶給患者,我們將繼續這樣做。
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Earlier. Thanks, bye. Let's move on.
早些時候。謝謝,再見。我們繼續吧。
Operator
Operator
Rajan Sharma from Goldman Sachs.
高盛的拉詹夏爾馬 (Rajan Sharma)。
Rajan Sharma - Analyst
Rajan Sharma - Analyst
Hi, thanks for taking, the question. Just one from me and it's, maybe a bit of housekeeping. I just noticed on your, slides you're going to a core [DLBCL2] trial readout in in 2026, but clinicaltrials.gov still has the primary completion date of mid-27. Could you just help us reconcile that? Is it just a case of clinical trials.gov not being updated?
你好,謝謝你回答這個問題。這只是我的一個建議,也許只是一點家事。我剛剛在您的幻燈片上註意到,您將在 2026 年完成核心 [DLBCL2] 試驗讀數,但 clinicaltrials.gov 仍將主要完成日期定為 27 年中期。您能幫我們解決這個問題嗎?這僅僅是 clinical trials.gov 未更新的情況嗎?
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
Thanks, Rajan for the question. [Tai], can you comment on that?
謝謝 Rajan 提出的問題。 [Tai],您能對此發表評論嗎?
Anthony Pagano - Chief Financial Officer, Executive Vice President
Anthony Pagano - Chief Financial Officer, Executive Vice President
Yeah, the, again, thank you for the question. Generally speaking, I wouldn't, take clinical trials of golf as the, most validated resource to figure out when studies read out.
是的,再次感謝您的提問。一般來說,我不會將高爾夫臨床試驗作為最有效的資源來決定研究何時結束。
Judith Klimovsky - Executive Vice President, Chief Development Officer
Judith Klimovsky - Executive Vice President, Chief Development Officer
These studies are obviously events driven, and, then they're also depending a little bit on the speed of accrual. I think we had this, in multiple of our calls where we pointed out that the core of both the second line follicle former and the frontline, the [fus] such visa, was, significantly faster than initially projected, and that always means that you have a compression of a patient accrual but also an opportunity to collect events and get the results, maybe at a earlier time of the previous projected.
這些研究顯然是由事件驅動的,而且它們也有點依賴累積的速度。我認為我們在多次電話會議中都提到過這一點,我們指出二線卵泡形成劑和一線藥物(例如融合疫苗)的療效都比最初預計的要快得多,這意味著患者人數會有所增加,但也有機會收集事件並獲得結果,可能比之前預計的要早。
Jan van de Winkel - President, Chief Executive Officer
Jan van de Winkel - President, Chief Executive Officer
I think that's very clear, Tai. Thanks a lot. Thanks, Rajan, for the qfinaluestions.
我認為這非常清楚,Tai。多謝。謝謝 Rajan 提出的最後問題。
So thank you all for calling in today to discuss general's financial results for the first quarter of 2025. And if you have any additional questions, please reach out to our investor relations team. We very much look forward to speaking with you again soon.
非常感謝大家今天來電討論通用 2025 年第一季的財務表現。如果您有任何其他問題,請聯絡我們的投資者關係團隊。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. Have a nice day.
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。祝你今天過得愉快。