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 Geron Corporation third-quarter 2025 earnings call. (Operator Instructions) I would now like to turn the call over to Dawn Schottlandt, Senior Vice President, Investor Relations and Corporate Affairs. You may begin.
大家好,歡迎參加 Geron 公司 2025 年第三季財報電話會議。(操作員指示)現在,我將把電話轉交給投資者關係和企業事務高級副總裁 Dawn Schottlandt。你可以開始了。
Dawn Schottlandt - Senior Vice President-Investor Relations and Corporate Affairs
Dawn Schottlandt - Senior Vice President-Investor Relations and Corporate Affairs
Good morning, everyone. Welcome to the Geron Corporation third-quarter 2025 earnings conference call.
各位早安。歡迎參加 Geron 公司 2025 年第三季財報電話會議。
Before we begin, please note that during the course of this presentation and question-and-answer session, we will be making forward-looking statements regarding future events, performance, plans, expectations, and other projections, including those relating to the launch, commercial opportunity, and therapeutic potential of RYTELO; anticipated clinical and commercial events and related timelines; the sufficiency of Geron's financial resources; and other statements that are not historical facts. Actual events or results could differ materially.
在開始之前,請注意,在本次演示和問答環節中,我們將對未來事件、業績、計劃、預期和其他預測做出前瞻性陳述,包括與 RYTELO 的上市、商業機會和治療潛力相關的陳述;預期的臨床和商業事件及相關時間表;Geron 財務資源的充足性;以及其他非歷史事實的陳述。實際事件或結果可能與此有重大差異。
Therefore, I refer you to the discussion under the heading, Risk Factors, in Geron's most recent periodic report filed with the SEC which identifies important factors that could cause actual results to differ materially from those contained in the forward-looking statements and our future updates to those risk factors. Geron undertakes no duty or obligation to update our forward-looking statements.
因此,我建議您參閱 Geron 向美國證券交易委員會提交的最新定期報告中「風險因素」標題下的討論,其中列出了可能導致實際結果與前瞻性聲明中包含的結果存在重大差異的重要因素,以及我們未來對這些風險因素的更新。Geron不承擔更新前瞻性聲明的義務或責任。
Joining me in today's call are several members of Geron's management team, Harout Semerjian, Chief Executive Officer; Michelle Robertson, Chief Financial Officer; and Dr. Joseph Eid, Executive Vice President of Research and Development and Chief Medical Officer. Ahmed Elnawawi, our Chief Commercial Officer, will be introducing himself at the beginning of Q&A.
今天與我一起參加電話會議的還有 Geron 管理團隊的幾位成員,包括執行長 Harout Semerjian、財務長 Michelle Robertson 以及研發執行副總裁兼首席醫療官 Joseph Eid 博士。我們的首席商務官艾哈邁德·埃爾納瓦維將在問答環節開始時進行自我介紹。
Before handing the call over to Harout, I'd like to say I'm truly energized to join Geron. This is a company that can change the lives of patients with blood cancers. The work ahead of us is real, but in my three weeks here, my confidence in our ability to deliver has grown every day.
在將電話交給哈魯特之前,我想說,我非常興奮能加入傑倫的團隊。這是一家能夠改變血液癌症患者生活的公司。擺在我們面前的工作確實艱鉅,但我在這裡的三週裡,對我們完成任務的能力越來越有信心。
With that, I'll turn the call over to Harout.
接下來,我會把電話交給哈魯特。
Harout Semerjian - President, Chief Executive Officer, Director
Harout Semerjian - President, Chief Executive Officer, Director
Thank you, Dawn, and good morning, everyone. I'm very excited to be hosting my first earnings call as CEO of Geron. On this call, we will provide a commercial overview, an update on medical affairs and our pipeline, and end with an overview of our financials.
謝謝你,Dawn,大家早安。我非常興奮能夠以 Geron 執行長的身份主持我的第一次財報電話會議。在本次電話會議上,我們將提供商業概況、醫療事務和產品線的最新進展,最後概述我們的財務狀況。
Three months ago, I joined Geron because I saw a company with real promise, a differentiated product that is effective and it addresses the high unmet need in low-risk MDS. Over these past months, I've been deeply impressed by the strength and dedication of our organization. The culture here is patient-focused and resilient, giving me conviction that with improved alignment, we can build an execution-oriented organization that brings the promise of RYTELO to more lower-risk MDS patients.
三個月前,我加入了 Geron,因為我看到了一家真正有前途的公司,它擁有差異化且有效的產品,能夠滿足低風險 MDS 患者尚未得到充分滿足的需求。在過去的幾個月裡,我深深被我們組織的實力和奉獻所打動。這裡的文化以患者為中心,並且具有韌性,這讓我相信,透過改進協調,我們可以建立一個以執行為導向的組織,將 RYTELO 的承諾帶給更多低風險的 MDS 患者。
Let me share four reasons that support our belief. First, RYTELO is a compelling drug. It has demonstrated meaningful efficacy in lower-risk MDS, and it is differentiated in its mechanism of action and clinical profile.
讓我分享支持我們觀點的四個理由。首先,RYTELO 是一種很有前景的藥物。它已證明對低危險群 MDS 具有顯著療效,且其作用機制和臨床特徵與眾不同。
Second, lower-risk MDS is an area of high unmet need with few, if any, potential treatments being studied in the clinic that can provide the differentiation that RYTELO can as a telomerase inhibitor. There is a clear opportunity for RYTELO to be an important therapeutic option in lower-risk MDS.
其次,低危險群 MDS 是一個亟待解決的領域,目前臨床上幾乎沒有(如果有的話)任何潛在治療方法能夠像 RYTELO 作為端粒酶抑制劑那樣提供差異化治療。RYTELO 顯然有機會成為低危險群 MDS 的重要治療選擇。
Third, there is an opportunity to accelerate growth with the right strategy and improved execution. And fourth, the company is well-capitalized. We have a strong cash position which we believe is sufficient to support the robust commercial and medical affairs engagement needed to increase RYTELO utilization.
第三,透過正確的策略和改進的執行,有機會加速成長。第四,該公司資金雄厚。我們擁有雄厚的現金儲備,我們相信這足以支持為提高 RYTELO 的使用率而開展的強有力的商業和醫療事務活動。
Now let me provide you with an overview of our Q3 commercial performance. Net product revenue was $47.2 million for the third quarter. During the quarter, demand for RYTELO was down 3% compared to last quarter. New patient starts in first and second line increased to 36% compared to 30% in Q2. However, new patient starts did not offset the discontinuations we saw from patients using RYTELO in later line.
現在讓我為大家概述一下我們第三季的商業業績。第三季淨產品收入為 4,720 萬美元。本季度,RYTELO 的需求量比上季下降了 3%。第一線和第二線新患者起始治療比例從第二季的 30% 增加到 36%。然而,新患者的加入並沒有抵消我們在後續治療中使用 RYTELO 的患者中觀察到的停藥情況。
It is clear we have work to do on establishing RYTELO as a second line therapy in eligible patients with low-risk MDS and educating HCPs on treatment management. Prescribing accounts increased by 15% in the quarter, with approximately 150 new ordering accounts added in Q3, expanding our footprint to 1,150 accounts.
顯然,我們還有很多工作要做,才能將 RYTELO 確立為符合條件的低風險 MDS 患者的二線療法,並教育 HCP 進行治療管理。本季處方帳戶數量增加了 15%,第三季新增了約 150 個訂購帳戶,使我們的業務範圍擴大到 1,150 個帳戶。
Lastly, we completed the first shipment of RYTELO to Germany under a named patient early access program. We are preparing for the planned commercialization of RYTELO in select EU markets in 2026.
最後,我們根據指定患者早期使用計劃,完成了向德國的首批 RYTELO 發貨。我們正在為 RYTELO 於 2026 年在部分歐盟市場實現商業化做準備。
Q3 was an important quarter for us as we took stock of what we need to do to ensure RYTELO reaches more patients. We're assessing both internally across people, processes, messaging, and overall effectiveness, and externally with our customers to amplify partnerships and ensure the appropriate usage of RYTELO.
第三季度對我們來說是一個重要的季度,因為我們評估了我們需要做些什麼來確保 RYTELO 惠及更多患者。我們正在從內部評估人員、流程、訊息傳遞和整體效果,同時也在外部與客戶進行評估,以加強合作關係並確保 RYTELO 的正確使用。
We recently announced the addition of Ahmed Elnawawi as our new Chief Commercial Officer. Nawawi is an experienced commercial leader with an established track record of launching multiple global oncology products and leading commercial teams in both biotech and pharma. He brings a wealth of expertise to Geron to execute a strong commercial strategy to support RYTELO growth.
我們最近宣布任命艾哈邁德·埃爾納瓦維為新的首席商務官。Nawawi 是一位經驗豐富的商業領袖,擁有成功推出多款全球腫瘤產品以及領導生物技術和製藥行業商業團隊的良好記錄。他為 Geron 帶來了豐富的專業知識,以執行強有力的商業策略來支持 RYTELO 的成長。
With the recently announced additions to the executive leadership team, along with existing team members, we can realign to accelerate momentum and grow RYTELO. I'm confident we can realize the full value of RYTELO and build a bright future for Geron.
隨著近期宣布的高階主管團隊新增成員,以及現有團隊成員的加入,我們可以重新調整策略,加速發展勢頭,促進 RYTELO 的發展。我相信我們能夠充分發揮 RYTELO 的價值,並為 Geron 創造一個美好的未來。
We believe Geron and RYTELO can be transformational in lower-risk MDS space with improved execution. We have already identified four initial actions to step up our execution and support future revenue growth.
我們相信,透過改進執行,Geron 和 RYTELO 可以在低風險 MDS 領域帶來改變。我們已經確定了四項初步措施,以加強執行力並支持未來的收入成長。
First, we need to substantially increase awareness for RYTELO among US HCPs through a comprehensive, well-coordinated account plan. Our market research is clearly telling us that education is key to increasing usage in the appropriate patients.
首先,我們需要透過全面、協調良好的客戶計劃,大幅提高美國醫療保健專業人員對 RYTELO 的認識。我們的市場調查清楚地表明,教育是提高合適患者使用率的關鍵。
This is especially critical when HCP prescribes RYTELO to the first few patients. Our field-based commercial and medical colleagues have sharpened their approach to customer engagement aimed at educating HCPs on how to use RYTELO, identifying the appropriate patients to start therapy, expanding reach into community sites, improving convergence and retention, and effectively managing patients on therapy. We believe, over time, this push to increase awareness for RYTELO will grow our US prescriber base and drive sales in the US.
當醫護人員給最初幾位患者開立 RYTELO 處方時,這一點尤其重要。我們駐外的商業和醫療同事已經改進了他們的客戶互動方式,旨在教育醫療保健專業人員如何使用 RYTELO,確定適合開始治療的患者,擴大對社區場所的影響,提高融合度和留存率,並有效管理接受治療的患者。我們相信,隨著時間的推移,提高人們對 RYTELO 的認識的這種努力將擴大我們在美國處方醫生的數量,並推動我們在美國的銷售。
Second, we need to significantly and consistently increase our in-person and digital presence in hematology forums. We are just starting to do this through expanded relationships with US KOLs and increased engagement with key patient advocacy groups.
第二,我們需要大幅且持續地增加我們在血液學論壇上的線上和線下影響力。我們正透過擴大與美國關鍵意見領袖的關係以及加強與主要患者權益倡導團體的互動來開始這項工作。
A good example of this would be Geron's efforts at this year's Society of Hematologic Oncology Conference in September in Houston. At the conclusion of this conference, we noticed a surge in engagement from physicians who participated in our multiple advisory boards and other engagement activities, with a positive change in Geron's external perception.
傑倫在今年 9 月於休士頓舉行的血液腫瘤學會會議上的努力就是一個很好的例子。在本次會議結束後,我們注意到參與我們多個諮詢委員會和其他參與活動的醫生的參與度大幅提升,Geron 的外部形像也發生了積極變化。
We received anecdotal feedback that more physicians are beginning to shift their thinking on RYTELO, not just as a third or fourth line option, but as a therapy worth considering earlier. That shift won't happen overnight. But as we continue these efforts throughout 2026, we expect to see an impact on RYTELO utilization.
我們收到一些非正式的回饋,越來越多的醫生開始轉變對 RYTELO 的看法,不再僅僅將其視為第三或第四線選擇,而是將其視為值得更早考慮的療法。這種轉變不會在一夜之間發生。但隨著我們在 2026 年繼續推進這些工作,我們預計 RYTELO 的使用率將受到影響。
Lastly, we're excited to expand our IST program with US clinical sites and HCPs to address additional key medical questions about potential uses of imetelstat and the benefits of telomerase inhibition. The IMerge trial predominantly enrolled sites in Europe. We have work to do to collaborate with US HCPs and give them opportunities for additional research with imetelstat.
最後,我們很高興能與美國臨床中心和醫療保健專業人員擴大我們的 IST 計劃,以解決有關伊美替司他潛在用途和端粒酶抑制益處的其他關鍵醫學問題。IMerge試驗主要在歐洲招募受試者。我們還需要與美國醫療保健專業人員合作,為他們提供更多使用伊美替司他進行研究的機會。
These initial initiatives are just the beginning as we expect to identify additional opportunities to improve execution in the near term. It is important to recognize that the pull-through of the improved execution to revenue growth will take time.
這些初步舉措只是開始,我們預計在近期內將發現更多改進執行的機會。必須認識到,改進的執行力轉化為收入成長需要時間。
As for additional utility of RYTELO, we recently completed enrollment in our IMpactMF Phase 3 clinical trial evaluating imetelstat in relapsed/refractory myofibrosis. We currently project the interim analysis to occur in the second half of 2026, with final analysis projected in the second half of 2028.
至於 RYTELO 的其他用途,我們最近完成了 IMpactMF 3 期臨床試驗的入組,該試驗評估了伊美替司他治療復發/難治性肌纖維化的療效。我們目前預計中期分析將於 2026 年下半年進行,最終分析預計將於 2028 年下半年進行。
Our base case is for the trial to run through the final analysis, as is the case for the majority of trials with overall survival as the primary endpoint. Should we see an opportunity to help patients with data from the interim analysis, we will be ready to explore the next steps rapidly. Success in myofibrosis could double our addressable patient population.
我們的基本目標是讓試驗順利完成最終分析,就像大多數以總存活期為主要終點的試驗一樣。如果我們發現有機會利用中期分析的數據來幫助患者,我們將迅速探索下一步措施。肌纖維化治療的成功可能會使我們的目標患者群體翻倍。
Finally, before handing it over to Joe, I want to reiterate my optimism in Geron's future. Our priorities are clear. We're working to maximize the impact of RYTELO for patients today while advancing our first-in-class telomerase inhibitor to benefit more people tomorrow.
最後,在把它交給喬之前,我想重申我對傑倫未來的樂觀態度。我們的工作重點很明確。我們正在努力最大限度地發揮 RYTELO 對目前患者的影響,同時推進我們首創的端粒酶抑制劑的研發,以造福更多的人。
With that, I'll now hand the call to Joe to review clinical and medical affairs progress.
接下來,我將把電話交給喬,讓他審查臨床和醫療事務的進展。
Joseph Eid - Executive Vice President-Research and Development
Joseph Eid - Executive Vice President-Research and Development
Thank you, Harout. On today's call, I will highlight our upcoming presence at ASH, medical affairs actions we have taken to improve RYTELO execution, including events at SOHO and investigator-sponsored research, and then I'll provide an update on our Phase 3 clinical trials in relapse/refractory myofibrosis.
謝謝你,哈魯特。在今天的電話會議上,我將重點介紹我們即將參加 ASH 會議的情況,我們為改進 RYTELO 的執行而採取的醫療事務行動,包括在 SOHO 會議上的活動和研究者發起的研究,然後我將介紹我們針對複發/難治性肌纖維化的 3 期臨床試驗的最新進展。
First, we had five abstracts accepted for ASH. The data featured new clinical and translational analysis of imetelstat across lower risk myelodysplastic syndrome and myelofibrosis. Two abstracts, including an oral presentation, will feature new analysis from the Phase 3 IMerge trial. The oral presentation offers insight into how early cytopenias observed with imetelstat are on-target pharmacological effects and may be associated with treatment response, offering valuable context for interpreting treatment patterns and managing patient outcomes. This data will help us educate HCPs to better understand, anticipate, and manage these effects, helping to ensure patients are appropriately maintained on therapy.
首先,我們有五篇摘要被ASH會議接受。這些數據對伊美替司他治療低危險群骨髓增生異常症候群和骨髓纖維化進行了新的臨床和轉化分析。兩篇摘要(包括一篇口頭報告)將介紹 IMerge 3 期試驗的最新分析。口頭報告深入分析了使用伊美替司他觀察到的早期細胞減少症是如何產生標靶藥理作用的,以及是否與治療反應相關,為解釋治療模式和管理患者結果提供了有價值的背景。這些數據將幫助我們教育醫護人員更好地了解、預測和管理這些影響,從而幫助確保患者得到適當的治療。
The other IMerge abstract highlights a 42-month landmark analysis of long-term outcomes from the trial. While the analysis was not pre-specified, the totality of the data and the results of the landmark analysis suggests a favorable trend for imetelstat in overall survival, progression-fee survival, and times of progression to AML compared to placebo. Both abstracts highlight the value of the unique mechanism of action of RYTELO in lower-risk MDS disease and its management.
另一篇 IMerge 摘要重點介紹了一項為期 42 個月的里程碑式分析,該分析研究了該試驗的長期結果。雖然分析並非預先設定,但所有數據和里程碑分析的結果表明,與安慰劑相比,imetelstat 在總生存期、無進展生存期和進展為 AML 的時間方面呈現有利趨勢。兩篇摘要都強調了RYTELO在低危險MDS疾病及其治療中的獨特作用機制的價值。
There will also be three additional posters including data from the IMbark and IMproveMF trials in MF and the investigator-sponsored trial, IMpress, in high-risk MDS and AML.
此外,還將有三張海報,其中包括 IMbark 和 IMproveMF 試驗在 MF 中的數據,以及研究者發起的 IMpress 試驗在高危險 MDS 和 AML 中的數據。
We plan to continue our medical engagement at Ash. We are planning an advocacy forum that is designed to bring together patient advocacy organizations and professional societies to raise awareness and provide education on lower-risk MDS and the use of RYTELO as a treatment option. This is the first event of this nature hosted by Geron.
我們計劃繼續在阿什進行醫療活動。我們正在規劃一個倡導論壇,旨在將患者倡導組織和專業協會聚集在一起,以提高人們對低風險 MDS 的認識,並提供使用 RYTELO 作為治療方案的教育。這是 Geron 首次舉辦此類活動。
In addition, we are planning to engage with an increasing number of hematologists at ASH both in one-on-one and group settings. These engagements help us convey new data to physicians as well as collect insights that can help refine our strategy.
此外,我們計劃在 ASH 會議上與越來越多的血液學家進行一對一和小組交流。這些互動有助於我們向醫生傳達新的數據,並收集有助於完善我們策略的見解。
Our presence at ASH will build upon the primary medical affairs efforts taken this quarter that focus on four strategic initiatives: Community site penetration, initiation of ISTs, awareness and education ramp-up, and KOL and advocacy alignment.
我們在 ASH 的亮相將建立在本季度主要醫療事務工作的基礎上,這些工作側重於四項戰略舉措:社區站點滲透、啟動 IST、提高意識和教育水平以及 KOL 和倡導協調。
We strongly recognize that in order for RYTELO to be successful, we need to be successful in a community setting where approximately 80% of lower-risk MDS patients are treated. Last quarter, we described how we are focusing on increasing HCP awareness of RYTELO, particularly in the community setting as well as academic centers that were not part of the Phase 3 pivotal trial.
我們深信,RYTELO 要想取得成功,就必須在社區環境中取得成功,因為大約 80% 的低風險 MDS 患者都在社區環境中接受治療。上個季度,我們介紹了我們如何致力於提高 HCP 對 RYTELO 的認識,尤其是在社區環境以及未參與 3 期關鍵性試驗的學術中心。
Our team has been actively engaged with these sites directly at important medical meetings. The expansion of our medical affairs field team has allowed us to refine our targeting model, better prioritize mid-decile physicians, and improve awareness among community sites.
我們的團隊一直積極參與這些機構的重要醫學會議。我們醫療事務現場團隊的擴充使我們能夠改進目標定位模型,更好地優先考慮中等收入醫生,並提高社區機構的認知度。
We continue to intensify our messaging via webinars and peer-to-peer educational efforts. In our most recent awareness trial utilization tracking, we observed positive shifts in physicians' understanding of RYTELO's efficacy in terms of robust and durable hemoglobin response and appreciation of cytopenias being on-target based on RYTELO's unique mechanism of action.
我們將繼續透過網路研討會和同儕互助教育活動來加強宣傳。在我們最近一次的認知試驗利用追蹤中,我們觀察到醫生對 RYTELO 的療效有了積極的認識,包括其強勁持久的血紅蛋白反應,以及基於 RYTELO 獨特的作用機制,對細胞減少症的治療效果有了更深刻的理解。
In parallel, we continue to support several investigator-sponsored trials exploring imetelstat in diverse hematological settings, including combination regimens and earlier-line use, as well as real-world evidence. We expect that these independent studies will help build external validation and broaden the clinical and real-world evidence based for imetelstat. We observed high interest in investigating imetelstat in preclinical, clinical, and real-world evidence studies. We received a good number of proposals and we decided to fund a number of these proposals that we expect to commence generating data in 2026.
同時,我們繼續支持多項研究者發起的試驗,探索伊美替司他在不同血液病學環境中的應用,包括聯合治療方案和早期治療,以及真實世界證據。我們期望這些獨立研究將有助於建立外部驗證,並擴大imetelstat的臨床和真實世界證據基礎。我們觀察到,在臨床前研究、臨床研究和真實世界證據研究中,人們對研究伊美替司他表現出了濃厚的興趣。我們收到了許多提案,並決定資助其中一些提案,我們預計這些提案將於 2026 年開始產生數據。
We are also actively engaging with KOLs and advocacy groups to broaden the reach of RYTELO's data narrative. Our goal is to help key opinion leaders become ambassadors, reinforcing that RYTELO can be considered alongside existing therapies in earlier lines rather than a drug of last resort.
我們也積極與關鍵意見領袖和倡導團體合作,以擴大 RYTELO 數據敘事的影響範圍。我們的目標是幫助關鍵意見領袖成為品牌大使,強化這樣一種觀念:RYTELO 可以作為早期治療方案的一部分,與現有療法一起使用,而不是作為最後的治療手段。
These efforts are starting to yield early results. Post-engagement survey suggests that physicians who initially expressed reservations about cytopenia now report a better understanding of the mechanism of action, dose adjustment strategies, and monitoring protocols. Our data confirmed that physicians who have used RYTELO in practice view its profile more favorably than those who have not.
這些努力已開始取得初步成效。參與後調查顯示,最初對細胞減少症持保留意見的醫生現在表示,他們對作用機制、劑量調整策略和監測方案有了更深入的了解。我們的數據證實,在實踐中使用過 RYTELO 的醫生比未使用過 RYTELO 的醫生對其評價更高。
As many of you know, the annual Society of Hematologic Oncology Meeting was a major touch point this quarter. Our team presented real-world case studies, translational biomarker data, and longer-term follow-up from earlier treated patients.
正如你們許多人所知,血液腫瘤學會年會是本季的重要會議。我們的團隊展示了真實世界的案例研究、轉化生物標記數據以及早期治療患者的長期追蹤結果。
The reception was constructive. Among key opinion leaders, we are seeing a growing perspective that RYTELO deserves a position as the number two option for eligible patients with lower-risk MDS after standard CSA therapy, especially in certain high-risks population. This is supported by the recently updated NCCN guidelines that now recommend RYTELO as a treatment for use in low-risk MDS patients with serum EPO over 500 ahead of HMA.
對方的回饋是正面的。在關鍵意見領袖中,我們看到越來越多的人認為,對於接受標準 CSA 治療後符合條件的低風險 MDS 患者,RYTELO 應該成為第二選擇,尤其是對於某些高風險族群。最近更新的 NCCN 指南也支持這一觀點,該指南現在建議將 RYTELO 作為治療方案,用於血清 EPO 超過 500 的低風險 MDS 患者,而不是 HMA。
A central theme during the SOHO meeting was how RYTELO's use fits with luspatercept. We made the case that RYTELO and luspatercept can be complementary rather than mutually exclusive, i.e., that RYTELO does not need to displace luspatercept that can be used sequentially or in stratified patient segments based on its approved label and NCCN guidelines. This narrative struck a chord, and we believe it could help ease some of the challenges in physicians' minds.
SOHO 會議的一個中心主題是 RYTELO 的使用如何與 luspatercept 相契合。我們論證了 RYTELO 和 luspatercept 可以互補而不是相互排斥,也就是說,RYTELO 不需要取代 luspatercept,可以根據其批准的標籤和 NCCN 指南,按順序或在分層患者群體中使用。這種說法引起了共鳴,我們相信它可以幫助緩解醫生們的一些擔憂。
On the clinical front, I am pleased to report that our IMpactMF trial is now fully enrolled with 320 patients from 26 countries. This is a Phase 3 trial in relapse/refractory myeofibrosis and is the first MF clinical trial with overall survival as the primary endpoint. We expect to have interim analysis in the second half of 2026, and the final analysis in the second half of 2028, subject of course to achieving the specified number of death events. With the high bar set for the interim analysis, we are planning for the trial to conclude at its final analysis. This is typical for a trial with the primary endpoint of OS.
在臨床方面,我很高興地報告,我們的 IMpactMF 試驗目前已完成招募,共有來自 26 個國家的 320 名患者。這是一項針對復發/難治性骨髓纖維化的 3 期試驗,也是首個以總存活期為主要終點的 MF 臨床試驗。我們預計將於 2026 年下半年進行中期分析,並於 2028 年下半年進行最終分析,當然,前提是達到規定的死亡事件數。由於中期分析的標準很高,我們計劃在最終分析時結束試驗。對於以總生存期為主要終點的試驗而言,這是典型的。
To close, our medical affairs and R&D teams remain fully aligned with our commercial team. Our combined efforts are focused on evidence generation, physician engagement, and data dissemination to support broader adoption of RYTELO in lower-risk MDS.
最後,我們的醫療事務和研發團隊與我們的商業團隊保持完全一致。我們共同努力,致力於證據生成、醫生參與和數據傳播,以支持在低風險 MDS 中更廣泛地採用 RYTELO。
I'll now turn the call over to Michelle to go over our Q3 financials.
現在我將把電話交給米歇爾,讓她來介紹一下我們第三季的財務狀況。
Michelle Robertson - Chief Financial Officer, Executive Vice President-Finance, Treasurer
Michelle Robertson - Chief Financial Officer, Executive Vice President-Finance, Treasurer
Thank you, Joe, and good morning, everyone. For more detailed results from the third quarter, please refer to the press release we issued this morning which is available on our website.
謝謝你,喬,大家早安。有關第三季的更詳細業績,請參閱我們今天早上發布的新聞稿,該新聞稿可在我們的網站上查閱。
As of September 30, 2025, we had approximately $420 million in cash and marketable securities compared to $503 million as of December 31, 2024. Total net revenue for the three months ended September 30, 2025, was $47 million compared to $28 million in Q3 of 2024.
截至 2025 年 9 月 30 日,我們擁有約 4.2 億美元的現金和有價證券,而截至 2024 年 12 月 31 日,這一數字為 5.03 億美元。截至 2025 年 9 月 30 日止三個月的總淨收入為 4,700 萬美元,而 2024 年第三季為 2,800 萬美元。
Gross to net increased from Q2 to Q3 due to increases in the Medicaid mixed rate, fees from new GPO contracts, and returns from several customers where their supply of RYTELO had reached its expiration date. As of September 30, 2025, ending inventory at distributors was on the high end of our range of two to four weeks.
由於 Medicaid 混合費率的增加、新 GPO 合約的費用以及幾位客戶的 RYTELO 供應到期後的退貨,毛利從第二季度到第三季度有所增長。截至 2025 年 9 月 30 日,分銷商的期末庫存處於我們兩到四周範圍的高端。
Research and development expenses for the three months ended September 30, 2025, were $21 million compared to $20 million for the same period in 2024. The change was primarily due to increased CMC in personnel-related expenses. Selling, general and administrative expenses for the three months ended September 30, 2025, was $39 million compared to $36 million in Q3 last year. The change was due to an increase in sales and marketing headcount and additional investments in marketing programs.
截至 2025 年 9 月 30 日止三個月的研發費用為 2,100 萬美元,而 2024 年同期為 2,000 萬美元。這項變更主要是由於CMC在人員相關費用方面的增加。截至 2025 年 9 月 30 日止三個月的銷售、一般及行政費用為 3,900 萬美元,而去年第三季為 3,600 萬美元。這項變更是由於銷售和行銷人員增加以及對行銷計劃的額外投資所致。
For fiscal year 2025, we expect our total operating expenses to be between $250 million and $260 million, below our previously announced guidance of $270 million to $285 million. We continue to focus on efficiencies and prudently manage our spends while continuing to prioritize investments in our RYTELO commercialization strategy, commercial supply redundancies, and post-marketing commitments, as well as preparations to launch RYTELO in selected EU countries in 2026.
預計 2025 財年的總營運支出將在 2.5 億美元至 2.6 億美元之間,低於先前公佈的 2.7 億美元至 2.85 億美元的預期。我們將繼續專注於提高效率並謹慎管理支出,同時繼續優先投資於 RYTELO 商業化策略、商業供應冗餘和上市後承諾,以及為 2026 年在部分歐盟國家推出 RYTELO 做準備。
Overall, with our current cash and marketable securities and anticipated net revenues from expected US sales of RYTELO, we believe that Geron remains in a strong financial position to fund projected operating expenses for the foreseeable future.
總體而言,憑藉我們目前的現金和有價證券以及預期從 RYTELO 在美國的銷售中獲得的淨收入,我們相信 Geron 仍處於強勁的財務狀況,足以在可預見的未來支付預計的營運費用。
I'll now turn the call back to Harout for closing remarks.
現在我將把電話轉回給哈魯特,請他作總結發言。
Harout Semerjian - President, Chief Executive Officer, Director
Harout Semerjian - President, Chief Executive Officer, Director
Thank you, Michelle. In closing, I want to reinforce three key takeaways from this call. Number one, shifting physician behavior and building a brand in hematology takes time. The urgency across our organization is understood. And we're fully committed to the patients who are depending on us. Number two, improving alignment and generating momentum is our focus. And lastly, RYTELO is a drug that works. With the right execution, we believe it can be positioned for long-term success. We appreciate your support.
謝謝你,米歇爾。最後,我想強調本次通話中的三個關鍵要點。第一,改變醫生的行為並在血液學領域建立品牌需要時間。我們整個組織都明白情勢緊迫。我們始終全力以赴,為依賴我們的患者提供最好的服務。第二,改善協調性和產生動能是我們的重點。最後,RYTELO 是一種有效的藥物。我們相信,只要執行得當,就能取得長期的成功。感謝您的支持。
Before we begin our Q&A, I'd like to hand it over to Nawawi, our new CCO, to say a few words, introducing himself. Nawawi?
在開始問答環節之前,我想把麥克風交給我們的新任首席商務官納瓦維,讓他簡單介紹一下自己。納瓦維?
Ahmed Elnawawi - Executive Vice President, Chief Commercial Officer
Ahmed Elnawawi - Executive Vice President, Chief Commercial Officer
Thank you, Harout. Let me start by saying thank you for the opportunity to be part of the Geron team. I am halfway through my third week, and what I have seen through my one-on-ones and team meetings with the entire commercial organization is that we are deeply committed to patients. We have a drug, RYTELO, that has the potential to address an unmet need in low-risk MDS patients. With improved alignment and our focus on driving operational excellence, I am confident we can grow revenue by delivering RYTELO to eligible patients.
謝謝你,哈魯特。首先,我要感謝Geron團隊給予我成為其中一員的機會。我已經工作了三週,透過與整個商業組織的單獨會面和團隊會議,我發現我們對患者有著深切的承諾。我們有一種名為 RYTELO 的藥物,它有可能滿足低風險 MDS 患者的未滿足需求。透過加強協調並專注於提升營運效率,我相信我們可以透過向符合條件的患者提供 RYTELO 來增加收入。
Harout Semerjian - President, Chief Executive Officer, Director
Harout Semerjian - President, Chief Executive Officer, Director
Thank you, Nawawi. Operator, we're ready for Q&A.
謝謝你,納瓦維。操作員,我們已準備好進行問答環節。
Operator
Operator
(Operator Instructions)
(操作說明)
Tara Bancroft, TD Cowen.
塔拉·班克羅夫特,TD Cowen。
Tara Bancroft - Analyst
Tara Bancroft - Analyst
Good morning, everyone. I have one very quick one and then a real one. So the first one, if you could perhaps, Michelle, give us a little bit more insight into the current growth -- you mentioned increase this quarter, wondering if the previous mid-teens range still applies or if we should amend that.
各位早安。我先做一個很快的,然後再做一個正式的。第一個問題,米歇爾,您能否更深入地介紹一下當前的增長情況——您提到本季度有所增長,我想知道之前十幾個百分點的增長範圍是否仍然適用,或者我們是否應該對此進行修正。
And then, so demand being down 3% this quarter, it's nearly flat, but I'm curious to hear more on what drove that. I know you stated that these discontinuations in later lines is a big factor. But I'm curious to hear if there were other headwinds that you can speak of this quarter that you observe like reluctance to reorder, seasonality. But basically looking for any outlook on those for Q4 that may perhaps be reversing. Thanks so much.
因此,本季需求下降了 3%,幾乎持平,但我很想知道是什麼原因導致了這種情況。我知道您曾說過,後期產品線的停產是重要因素。但我很想知道,在本季您是否還觀察到其他不利因素,例如不願意重新訂購、季節性因素等。但主要目的是了解第四季這些指標是否有可能出現逆轉。非常感謝。
Michelle Robertson - Chief Financial Officer, Executive Vice President-Finance, Treasurer
Michelle Robertson - Chief Financial Officer, Executive Vice President-Finance, Treasurer
Hi Tara. Thanks. Yeah. I believe that the mid to high teens is still applicable for the forecast. What we did, one year in, it's reasonable to review your launch assumptions, check the channel mix, and in our case, we had an increase in the Medicaid channel mix, so we've increased our reserves for those rebates. And going forward, that will kind of moderate itself. We did have some returns.
你好,塔拉。謝謝。是的。我認為十幾度到十度的氣溫仍然適用於預測。一年過去了,我們理應重新審視我們的啟動假設,檢查管道組合,就我們而言,醫療補助管道組合有所增加,因此我們增加了這些回扣的儲備金。未來這種情況會逐漸緩和。我們確實收到了一些退貨。
So we also looked at our rate of returns and threw that up and adjusted that and increased that moderately. And then we did expand our GPO contract business. So we have some additional fees this quarter. And we'll see those going forward also. But we still feel confident that we'll be in the mid to high teens going forward.
所以我們也查看了我們的回報率,並對其進行了調整,適度提高了回報率。然後,我們擴大了GPO合約業務。因此,本季我們將收取一些額外費用。我們未來還會看到這些變化。但我們仍然有信心,未來我們的成長率將保持在十幾到二十幾的水平。
Ahmed Elnawawi - Executive Vice President, Chief Commercial Officer
Ahmed Elnawawi - Executive Vice President, Chief Commercial Officer
Right. Great.
正確的。偉大的。
Harout Semerjian - President, Chief Executive Officer, Director
Harout Semerjian - President, Chief Executive Officer, Director
Yeah. Hi Tara. Thanks for the questions. Yeah. I mean, you'll see basically what we're doing, there's a lot of reset and making sure that we have a strong base going forward. Regarding your question about the demand side, I mean, it is 3%. That's the accurate number. I agree with you, it's flattish. Given that our base number of patients, where we are, a few patients can make a difference one way or the other. So keeping that in mind.
是的。你好,塔拉。謝謝大家的提問。是的。我的意思是,你基本上會看到我們正在做的事情,那就是進行大量的調整,確保我們未來有一個堅實的基礎。關於你提出的需求方面的問題,我的意思是,需求量是 3%。這是準確的數字。我同意你的看法,它確實比較平坦。鑑於我們目前的患者數量,少數患者的加入可能會對結果產生影響。所以要記住這一點。
What we're seeing is that we are getting new patients, but the discontinuation of patients who existed or who came in on the brand, they're really later-line patients. And unfortunately, those patients are much more beaten up and they don't stay on therapy for very long.
我們看到的情況是,我們獲得了新的患者,但那些曾經使用過或使用該品牌藥物的患者,實際上都是後期患者,他們的病情有所好轉。不幸的是,這些患者病情更為嚴重,而且他們接受治療的時間也不長。
So what we really want to make sure that we're doing is we're getting the right patients upfront in the early setting and that's going to happen by really driving the education, the brand awareness, and the additional actions we're taking, beyond just sending in a rep. That's where we believe that by doing the surround sound, that can drive the right patients to start on therapy. And that's where we're saying we have work to do, on that part, where we're -- well, so that's the focus area that we have.
因此,我們真正想要確保的是,在早期階段就能找到合適的患者,而這需要我們大力推進教育、提高品牌知名度,以及採取其他行動,而不僅僅是派代表上門。我們相信,透過環繞聲技術,可以促使合適的患者開始接受治療。這就是我們所說的,我們在這方面還有很多工作要做,我們——嗯,這就是我們關注的重點領域。
Tara Bancroft - Analyst
Tara Bancroft - Analyst
Okay. Great. Surround sound, I like that. Thanks, everyone.
好的。偉大的。環繞立體聲,我喜歡。謝謝大家。
Operator
Operator
Stephen Willey, Stifel.
Stephen Willey,Stifel。
Stephen Willey - Analyst
Stephen Willey - Analyst
Good morning, Thanks for taking the question. I guess you talked about the growth in ordering accounts. I think 15% sequentially. Do we know anything about just the breadth of prescribing at this point and how many of those ordering accounts have either already written the script and/or are new to the brand? And then I just have a follow-up.
早上好,感謝您回答這個問題。我想你談到了訂單帳戶的成長。我認為會按順序增長15%。我們目前對處方範圍了解多少?有多少訂購帳戶已經開立了處方,或者有多少是該品牌的新用戶?然後我還有一個後續問題。
Harout Semerjian - President, Chief Executive Officer, Director
Harout Semerjian - President, Chief Executive Officer, Director
Good morning, Steve. Thanks for the question. I mean, we're pleased to see the continuous increase in the number of new accounts coming on board. So another 150 accounts have ordered RYTELO this quarter versus last quarter. So that puts us this year to more than 500 new accounts ordering RYTELO versus last year. So that breadth of folks getting on board, we're pleased with that. I think that the work we have is making sure the depth is there and the right patients are the ones who are being put, namely, earlier lines of patients. So repeat business was about 80% of accounts that we ordered in the last quarter. So we're pleased with that.
早安,史蒂夫。謝謝你的提問。我的意思是,我們很高興看到新註冊帳戶的數量持續增長。因此,與上季度相比,本季又有 150 個帳戶訂購了 RYTELO。因此,今年訂購 RYTELO 的新帳戶數量比去年增加了 500 多個。看到這麼多人加入我們,我們感到非常高興。我認為我們現在的工作是確保有足夠的資源,並且把合適的病人,也就是早期病人,納入治療。因此,上個季度我們訂購的客戶中,回頭客約佔 80%。我們對此感到滿意。
I think that's not our bigger challenge. Where we want to focus on is getting the breadth of patients, especially having these first patients, especially in the community, to really have a a right start, we call it. So basically, get the right patient on, how to manage effectively the first few patients especially in a community setting. And that, we believe, will lead to a depth of prescription which can really be helpful for patients. So that's kind of some of our focus areas. The breadth of accounts, it's actually going in the right direction in terms of additional accounts, over time, increasing their coming on board with RYTELO.
我認為這並非我們面臨的更大挑戰。我們希望重點關注的是擴大患者群體,特別是讓這些首批患者,尤其是在社區中的患者,真正擁有一個良好的開端,我們稱之為「良好的開端」。所以,關鍵在於找到合適的患者,以及如何有效管理最初的幾位患者,尤其是在社區環境中。我們相信,這將帶來更深入的處方,這對患者來說真的很有幫助。所以,這些算是我們的一些重點領域。從帳戶數量來看,RYTELO 的帳戶覆蓋範圍實際上正朝著正確的方向發展,隨著時間的推移,越來越多的帳戶加入 RYTELO。
Stephen Willey - Analyst
Stephen Willey - Analyst
Okay. That's helpful. And then, do you have any idea what average duration of therapy looks like at this point? I know you're talking about use primarily occurring in these later-line patients. I know the label calls for six cycles, I guess, on the minimum. I'm just curious what you're seeing, if anything, on the duration of therapy side. Thanks.
好的。那很有幫助。那麼,您知道目前平均治療持續時間大概是多少嗎?我知道你指的是主要發生在這些後期治療患者的使用情況。我知道標籤上說至少要六個循環。我只是好奇,在治療持續時間方面,你觀察到了什麼情況(如果有的話)。謝謝。
Harout Semerjian - President, Chief Executive Officer, Director
Harout Semerjian - President, Chief Executive Officer, Director
Yeah. Thank you, Steve. What we have said is in the real world, we're seeing the therapy duration in line with IMerge in a similar patient population. So keeping in mind that in IMerge, there were predominantly more second line patients; and in the real world, there's more third, fourth, fifth line patients. That's where the difference is happening. So that's where we want to make sure that we continue to encourage physicians to use RYTELO in earlier lines of therapy to really mimic what we're seeing in IMerge and beyond. Because currently, it's apples to oranges; IMerge is more second line; and real world is more third, fourth line which is shorter than that eight months that we've seen in IMerge.
是的。謝謝你,史蒂夫。我們已經說過,在現實世界中,在類似的患者群體中,我們看到的治療持續時間與 IMerge 的治療持續時間一致。因此,需要注意的是,在 IMerge 中,二線患者相對較少;而在現實世界中,三線、四線、五線患者較多。這就是差別所在。因此,我們希望確保繼續鼓勵醫生在早期治療中使用 RYTELO,以真正模擬我們在 IMerge 及其他研究中看到的情況。因為目前兩者無法相提並論;IMerge 更像是第二線;而現實世界更像是第三線、第四線,比我們在 IMerge 中看到的八個月短得多。
Stephen Willey - Analyst
Stephen Willey - Analyst
Understood. Thanks for taking the questions.
明白了。謝謝您回答問題。
Operator
Operator
Corinne Johnson, Goldman Sachs.
科琳·約翰遜,高盛集團。
Unidentified Participant
Unidentified Participant
Hi. This is [Anupam] on behalf of Corinne. Maybe can you talk about the revised operating expense guidance for the year? Where are you finding the savings or the efficiencies in the budget? And what should we expect with respect to the OpEx cadence for the next year?
你好。我是阿努帕姆,代表科琳。您能否談談修訂後的年度營運費用預期?你在預算中是如何找到節省開支或提高效率的?那麼,我們應該對明年的營運支出節奏抱持著怎樣的預期呢?
Michelle Robertson - Chief Financial Officer, Executive Vice President-Finance, Treasurer
Michelle Robertson - Chief Financial Officer, Executive Vice President-Finance, Treasurer
Thanks. I mean, we're not giving guidance just yet for 2026 full year spend. But for 2025, in the past, I have mentioned that we have levers to pull, particularly around some of our CMC investment. And we've also slowed down just some of the infrastructure, organizational infrastructure investments related to IT systems. And we were able to pull in our full-year OpEx this year to the $250 million to $260 million. So we feel pretty confident in those numbers.
謝謝。我的意思是,我們目前還不會對 2026 年全年支出給予指導意見。但對於 2025 年,我過去曾提到過,我們有一些手段可以運用,尤其是在我們的一些 CMC 投資方面。我們也放緩了一些與 IT 系統相關的基礎設施和組織基礎設施投資。我們今年的全年營運支出達到了 2.5 億至 2.6 億美元。所以我們對這些數據相當有信心。
Unidentified Participant
Unidentified Participant
Okay. Thank you.
好的。謝謝。
Operator
Operator
Emily Bodnar, H.C. Wainwright.
艾米莉·博德納,H.C. 溫賴特。
Emily Bodnar - Analyst
Emily Bodnar - Analyst
All right. Thanks for taking the questions. I have one on your sales force. I believe a few quarters ago, you mentioned that you would have the sales force fully hired by the third quarter. So I'm curious if that's been completed. And also any commentary you can give on what metrics you're using to evaluate the sales force and their impact on demand generation? And also if you can give an update on your EU partner search, if that's still ongoing? Thanks.
好的。謝謝您回答問題。我這裡有一位在你銷售團隊裡。我記得幾個季度前,您提到過會在第三季之前完成銷售團隊的招募工作。所以我想知道這件事是否已經完成了。另外,您能否就您用來評估銷售團隊及其對需求創造的影響的指標提供一些看法?另外,如果歐盟合作夥伴的尋找工作仍在進行中,能否提供最新進展?謝謝。
Harout Semerjian - President, Chief Executive Officer, Director
Harout Semerjian - President, Chief Executive Officer, Director
Thank you, Emily. Good question. So yes, we have reported last quarter that we have hired our field force, and I would say our customer engagement folks because it was beyond just the commercial people. We also doubled our MSLs in the field. So both have been done in the last quarter. The training has happened over the summer time. And now, we do have an effective customer engagement folks both on the commercial side and also on the medical side.
謝謝你,艾米麗。問得好。是的,我們上個季度報告稱,我們已經招募了現場服務人員,而且我認為也包括了客戶互動人員,因為這不僅限於銷售人員。我們也把現場的醫學聯絡官人數增加了一倍。所以這兩項工作都在上個季度完成了。培訓是在夏季進行的。現在,我們在商業方面和醫療方面都擁有高效的客戶互動團隊。
Where the focus has now been is not just on the number of bodies that we have, but on the effectiveness of all the customer-facing folks and then, with the head office people to really be effective to be outcomes focused rather than activity focused. So there's quite a bit of work happening in the background on the operational excellence type. And that's where I'm very excited with Nawawi coming on board and together with the rest of the ELC that we really drive the appropriate uptake of RYTELO and the right patients. So that's regarding the sales force and the execution piece.
現在的重點不僅在於我們擁有多少員工,還在於所有面向客戶的員工的效率,以及總部員工的效率,要真正做到以結果為導向,而不是以活動為導向。因此,在卓越營運方面,幕後有很多工作正在進行中。正因如此,我非常高興 Nawawi 加入我們,與 ELC 的其他成員一起,真正推動 RYTELO 的適當推廣,並惠及合適的患者。以上是關於銷售團隊和執行環節的內容。
Regarding the EU, we remain excited. I mean, we do have an approval in the EU which really sets us apart, and we're very excited about that. We want to make sure that we're good stewards for our investments. That's where the focus at this point of our own internal efforts are on the US. Obviously, for two reasons, US being the largest market; but also the fact that IMerge has had much more robust uses in Europe rather than in the US. So from our own efforts, we're focusing on the US. But then also making sure that we're having the dialogue with appropriate potential partners in Europe and beyond because the whole idea is that RYTELO, we believe, needs to be everywhere helping patients across the world. We don't need to be everywhere as Geron ourselves.
對於歐盟,我們依然充滿期待。我的意思是,我們確實獲得了歐盟的批准,這讓我們脫穎而出,我們對此感到非常興奮。我們希望確保我們對投資物盡其用。目前,我們內部工作的重點是美國。顯然,原因有二:一是美國是最大的市場;二是IMerge在歐洲的應用比在美國更廣泛。因此,我們正透過自身的努力,將重點放在美國。但同時,我們也確保與歐洲及其他地區的潛在合作夥伴進行對話,因為我們相信,RYTELO 的理念是應該遍及世界各地,幫助世界各地的患者。我們不需要像傑倫那樣無所不在。
So those conversations are happening as we speak. But we want to make sure that it's the right people, it's the right timing. We are always having the patient in mind, so we're pleased to start seeing that we have our first named patient sales happening in Germany. But we will make sure that it's really the appropriate setup whatever we come up with, especially now that we have half of the ELC is new. And there's a reset that we're doing internally and ensuring that we have the appropriate in a conversations given how much collective partnership opportunities we have across the world. So stay tuned on that. That's ongoing. And we will update the market as we have new updates.
所以,這些對話此刻正在進行中。但我們希望確保選對了人,也選對了時機。我們始終以患者為中心,因此我們很高興看到我們在德國開始了首筆指定患者銷售。但我們會確保無論最終採取什麼方案,都是真正合適的,尤其是現在我們有一半的ELC是新的。我們正在內部進行調整,確保我們在對話中採取適當的方式,因為我們在世界各地擁有大量的集體合作機會。敬請關注。此事仍在進行中。我們會根據最新情況及時更新市場資訊。
Emily Bodnar - Analyst
Emily Bodnar - Analyst
Sure. Thank you.
當然。謝謝。
Operator
Operator
(Operator Instructions)
(操作說明)
Faisal Khurshid, Leerink Partners.
Faisal Khurshid,Leerink Partners。
Faisal Khurshid - Analyst
Faisal Khurshid - Analyst
Hey. Thanks for taking the question. Just wanted to ask if you could sort of characterize your level of confidence that you've figured out what the issues are and that you truly believe that awareness is the main lever to pull here? And also if you have any updated views on the timeline to see your return to growth here based on your efforts and expanded field force?
嘿。感謝您回答這個問題。我只是想問一下,您能否大致描述一下您對已經弄清楚問題所在有多大的信心,以及您是否真心相信提高意識是解決問題的關鍵?另外,根據您目前的努力和不斷擴大的銷售團隊,您對何時能夠恢復成長有任何最新的看法嗎?
Harout Semerjian - President, Chief Executive Officer, Director
Harout Semerjian - President, Chief Executive Officer, Director
Yeah. Thank you, Faisal. I mean, look, we will not be here if we don't have confidence. I mean, we have very high confidence. I personally have high confidence. And every leader who's here has high confidence, be it newly joined or folks who've been here and who really believe in RYTELO. So confidence is definitely there, it's a prerequisite. But that's not enough, Faisal, right?
是的。謝謝你,費薩爾。我的意思是,你看,如果我們沒有信心,我們就不會站在這裡。我的意思是,我們非常有信心。我個人非常有信心。這裡的每一位領導者都充滿信心,無論是新加入的還是在這裡工作多年的,他們都真心相信 RYTELO。所以自信是絕對必要的,它是先決條件。但這還不夠,費薩爾,對吧?
Positive thinking is not where we're going. We really are focused on execution of key areas such as brand awareness. I mean that's one of the prerequisites, in my opinion at least, that we want to make sure that more and more hematologists when asked, do you know RYTELO in lower-risk MDS? The answer is yes. We want to make sure that physicians know how to use it, be it on the academic centers or be it in the community.
正向思考並不是我們前進的方向。我們真正專注於品牌知名度等關鍵領域的執行。我的意思是,至少在我看來,這是我們希望確保越來越多的血液科醫生在被問及“您是否了解低危險 MDS 中的 RYTELO?”時能夠回答的先決條件之一。答案是肯定的。我們希望確保醫生們知道如何使用它,無論是在學術中心還是在社區。
That's why we're really increasing our search on the ISTs because having hands-on experience with a drug like RYTELO by our US hematologist is an important aspect of what we do. At the same time, on the community level, we want to make sure that our community physicians who are dealing with all kinds of different hematology and oncology situations and lower-risk MDS might not be the largest pool of patients they have, that they are able to effectively select the right patients and put them on the right therapy, manage the first couple of cycles of the adverse events so that they can get to the efficacy that we've seen in IMerge and others.
這就是為什麼我們正在加強對 IST 的搜尋力度,因為美國血液學家對 RYTELO 等藥物的實際操作經驗是我們工作中一個重要的方面。同時,在社區層面,我們希望確保我們的社區醫生能夠有效地選擇合適的患者,並讓他們接受正確的治療,管理最初幾個療程的不良反應,從而達到我們在 IMerge 和其他研究中看到的療效。
So from a confidence perspective, Faisal, we definitely have the confidence. But beyond the confidence, we do believe we have the right identification of the diagnosis and some of the key programs that are now in place. And we look forward to continuing to update the market on that.
所以從信心的角度來看,費薩爾,我們絕對有信心。但除了信心之外,我們確實相信我們已經正確識別了診斷結果,而一些關鍵項目現在已經到位。我們期待繼續向市場通報這方面的最新進展。
At the same time, we are saying that these things do take time. I mean it just is. And there's nothing wrong with that. Just that it does take time. So we want to be also very open in terms of these are not light switch moments. We have the cash, we have the people, we have the plans, and we look forward to updating you as we start expanding our demand.
同時,我們也想說,這些事情確實需要時間。我的意思是,事實就是如此。這沒什麼不好。只是確實需要時間。所以我們也想坦誠地說明,這些並非一蹴可幾的事。我們有資金,我們有人才,我們有計劃,隨著我們需求的擴大,我們期待向您報告最新情況。
Faisal Khurshid - Analyst
Faisal Khurshid - Analyst
Got it. And then do you have a timeline that you're willing to kind of guide the street on when we should expect growth?
知道了。那麼,您能否給出一個時間表,大致說明我們應該何時才能看到成長?
Harout Semerjian - President, Chief Executive Officer, Director
Harout Semerjian - President, Chief Executive Officer, Director
We're saying at this point -- this is a 2026 growth story, Faisal. And we're not getting any guidance at this point on our top line. But we look forward to that something that we plan to tackle in the near future. So we're assessing at this point. But we think now we've put our heads down, get to work. And in 2026, this is a growth story over there. But we're not giving any specific guidelines in terms of if it's going to start growing on March 31 or April 15. That's not what we're saying. But we are very confident about the trajectory and as you're seeing, I mean, this has been a very important quarter to really level set many of the things that we need to do to ensure that we're doing the right things and then over time, growing the demand appropriately.
我們現在要說的是──這是一個關於2026年成長的故事,費薩爾。目前我們還沒有收到任何關於營收的指導意見。但我們期待著解決這個問題,我們計劃在不久的將來著手解決。所以,我們目前正在進行評估。但我們認為現在應該埋頭苦幹。到 2026 年,那裡將會迎來成長。但我們沒有給出任何具體指導方針,說明它是在 3 月 31 日還是 4 月 15 日開始成長。我們並不是那個意思。但我們對發展軌跡非常有信心,正如你所看到的,我的意思是,本季度對於真正理順我們需要做的許多事情至關重要,以確保我們做正確的事情,然後隨著時間的推移,適當地增長需求。
Faisal Khurshid - Analyst
Faisal Khurshid - Analyst
Appreciate it. Thank you.
謝謝。謝謝。
Operator
Operator
This concludes the question-and-answer session, and we'll conclude today's conference call. We thank you all for joining. You may now disconnect.
問答環節到此結束,今天的電話會議也到此結束。感謝各位的參與。您現在可以斷開連線了。