Rigel Pharmaceuticals Inc (RIGL) 2025 Q3 法說會逐字稿

Greetings and welcome to the Rigel Pharmaceuticals's financial conference call for the third quarter of 2025.

各位來賓，歡迎參加Rigel Pharmaceuticals公司2025年第三季財務電話會議。

(Operator Instructions) As a reminder, this conference is being recorded.

（操作說明）提醒各位，本次會議正在錄音。

It is now my pleasure to introduce our first speaker, Ray Furey, Rigel's Executive Vice President, General Counsel, and Corporate Secretary. Thank you, Mr. Furey. You may begin.

現在，我很榮幸地向大家介紹我們的第一位演講嘉賓，雷·弗雷，他是 Rigel 公司的執行副總裁、總法律顧問兼公司秘書。謝謝你，弗雷先生。你可以開始了。

Welcome to our third quarter of 2025 financial results and business update conference call.

歡迎參加我們2025年第三季財務業績及業務更新電話會議。

The financial press release for the third quarter of 2025 was issued a short while ago and can be viewed, along with the slides for this presentation, in the News & Events section of our Investor Relations site on rigel.com.

2025 年第三季的財務新聞稿已於不久前發布，您可以在 rigel.com 投資者關係網站的「新聞與活動」部分查看該新聞稿以及本次簡報的幻燈片。

As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and time for regulatory and product development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.

再次提醒大家，在今天的電話會議中，我們可能會就我們的財務前景以及監管和產品開發計劃和時間做出前瞻性陳述。這些聲明存在風險和不確定性，可能導致實際結果與預測結果不同。

A description of these risks can be found in our most recent annual report on Form 10-K for the year ended December 31, 2024; and subsequent filings with the SEC, including our Q3 quarterly report on Form 10-Q, on file with the SEC.

有關這些風險的描述，請參閱我們截至 2024 年 12 月 31 日的最新年度報告（表格 10-K）以及隨後向美國證券交易委員會提交的文件，包括我們向美國證券交易委員會提交的第三季報告（表格 10-Q）。

Any forward-looking statements are made only as today's date. We undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances.

所有前瞻性陳述僅代表截至今日的觀點。我們不承擔任何義務更新這些前瞻性陳述以反映後續事件或情況。

At this time, I'd like to turn the call over to our President and CEO, Raul Rodriguez. Raul?

此時，我想把電話交給我們的總裁兼執行長勞爾·羅德里格斯。勞爾？

Thank you, Ray. Thank you, all, for joining us today.

謝謝你，雷。感謝各位今天蒞臨。

Also with me today are Dave Santos, our Chief Commercial Officer; Lisa Rojkjaer, our Chief Medical Officer; and Dean Schorno, our Chief Financial Officer.

今天和我在一起的還有我們的首席商務官戴夫·桑托斯；我們的首席醫療官麗莎·羅伊克亞爾；以及我們的首席財務官迪恩·肖諾。

On today's call, I will provide an overview of Rigel's business, along with our accomplishments and financial results for the third quarter of 2025.

在今天的電話會議上，我將概述 Rigel 的業務，以及我們在 2025 年第三季的成就和財務表現。

Starting on slide 4, you will see an outline of Rigel's corporate strategy. Our strategic objectives are to grow our Hematology and Oncology business through commercial performance, pipeline expansion, coupled with financial discipline. Our continued execution of the strategy has led to another outstanding quarter for Rigel.

從第 4 張投影片開始，您將看到 Rigel 公司策略的概要。我們的策略目標是透過商業績效、產品線擴張以及財務紀律來發展我們的血液腫瘤業務。我們持續執行該策略，使Rigel又取得了一個出色的季度業績。

For the third quarter, we reported total revenue of $69.5 million, including record net product sales of $64.1 million, a 65% year-over-year increase. Later in the call, Dave will provide more detailed information on our commercial performance for this quarter.

第三季度，我們報告的總收入為 6,950 萬美元，其中包括創紀錄的淨產品銷售額 6,410 萬美元，年增 65%。在稍後的電話會議中，Dave 將提供有關我們本季商業業績的更詳細資訊。

Moving to our development pipeline, we continue to fund and advance our programs during the quarter. This includes our ongoing Phase 1B study of R289, Rigel's potent and selective dual IRAK1 and IRAK4 inhibitor that is being studied in patients with relapse or refractory lower-risk MDS. We have completed enrollment of the dose escalation phase of the study and we will present data from this phase in an oral presentation at the ASH Annual Meeting in December.

接下來談談我們的研發項目，本季我們將繼續為專案提供資金並推進專案進度。這包括我們正在進行的 R289 的 1B 期研究，R289 是 Rigel 公司研發的一種強效且選擇性的雙重 IRAK1 和 IRAK4 抑制劑，目前正在對複發或難治性低危險 MDS 患者進行研究。我們已經完成了該研究劑量遞增階段的受試者招募，我們將在 12 月的 ASH 年會上以口頭報告的形式展示該階段的數據。

In addition, we recently announced the first patient was enrolled in the dose expansion phase of the study, where we will compare two doses of R289 to determine the recommended dose for future registrational and other clinical studies.

此外，我們最近宣布，首位患者已入組該研究的劑量擴展階段，我們將比較兩種劑量的 R289，以確定未來註冊研究和其他臨床研究的建議劑量。

Moving onto olutasidenib, we will have four posters with data in patients with mutant IDH1 AML at the ASH Meeting, supporting the use of olutasidenib in a range of difficult-to-treat mutant IDH1 AML patient populations. We continue to evaluate olutasidenib in other areas where IDH1 plays a role through various strategic collaborations.

接下來是奧魯西地尼，我們將在 ASH 會議上展示四張海報，其中包含突變型 IDH1 AML 患者的數據，支持在各種難以治療的突變型 IDH1 AML 患者群體中使用奧魯西地尼。我們將繼續透過各種策略合作，在 IDH1 發揮作用的其他領域評估奧魯西地尼。

A fifth study with MD Anderson opened for enrollment in September andin October, the first patient enrolled in the CONNECT Phase 2 TarGeT-D study, evaluating olutasidenib in patients with high-grade glioma.

MD 安德森癌症中心於 9 月開始招募第五名患者，10 月，CONNECT 2 期 TarGeT-D 研究的首位患者入組，該研究旨在評估奧魯西地尼治療高級別膠質瘤患者的療效。

In addition, we are planning a collaboration with MyeloMATCH to evaluate olutasidenib in first-line AML and MDS. Lisa will provide the latest updates on our development pipeline later in the call.

此外，我們計劃與 MyeloMATCH 合作，評估 olutasidenib 在第一線 AML 和 MDS 治療中的療效。Lisa將在稍後的電話會議中提供我們開發專案的最新進展。

In terms of Rigel's own study in glioma, we are continuing to evaluate our options.

就Rigel自身在神經膠質瘤的研究而言，我們正在繼續評估我們的各種選擇。

Along with our commercial and development execution, we continue to pursue additional in-licensing deals or asset acquisitions that are synergistic with our capabilities, strategy, and focus, allowing us to add additional avenues to achieve significant growth. Underpinning all our efforts is a continued emphasis on financial discipline, which allowed us to generate $27.9 million of net income in the third quarter and to increase our cash balance to $137.1 million.

除了商業和開發執行之外，我們還將繼續尋求與我們的能力、策略和重點相協同的額外授權交易或資產收購，從而為我們增加實現顯著成長的途徑。我們所有努力的基礎是對財務紀律的持續重視，這使得我們在第三季度實現了 2,790 萬美元的淨收入，並將現金餘額增加到 1.371 億美元。

Now, onto slide 5, which illustrates the growth of our net product sales year over year, we have consistently delivered strong top-line growth. We are accelerating this trend in 2025, already having generated $166.6 million in net product sales year to date, already surpassing net product sales for all of 2024.

現在來看第 5 張投影片，它顯示了我們淨產品銷售額逐年成長的情況，我們一直保持著強勁的營收成長。2025 年，我們將加速這一趨勢，截至目前，淨產品銷售額已達 1.666 億美元，超過了 2024 年全年的淨產品銷售額。

As a result of our outstanding commercial performance year to date, we are raising our 2025 revenue guidance. We now expect total revenue of $285 million to $290 million, an increase from the prior range of $270 million to $280 million. Our new guidance includes net product sales of $225 million to $230 million, This new 2025 outlook reflects anticipated growth of 55% to 59% compared to 2024, exceeding the growth rate that we have delivered over the last four years.

由於我們今年迄今的商業業績表現出色，我們將提高 2025 年的營收預期。我們現在預計總收入為 2.85 億美元至 2.9 億美元，比先前預計的 2.7 億美元至 2.8 億美元有所增加。我們新的業績指引包括淨產品銷售額為 2.25 億至 2.3 億美元。這項新的 2025 年展望反映了與 2024 年相比預計將成長 55% 至 59%，超過了我們過去四年實現的成長率。

Rigel has made tremendous progress in our unique approach that combines strong commercial execution, adding additional products through in-license or acquisition, and financial discipline, all resulting in our ability to fund a potentially transformative internal development pipeline. We continue to focus on executing on our strategy to achieve significant long-term growth.

Rigel 憑藉其獨特的方法取得了巨大的進步，該方法結合了強大的商業執行力、透過引進或收購增加其他產品以及財務紀律，所有這些都使我們能夠為可能具有變革意義的內部研發項目提供資金。我們將繼續專注於執行我們的策略，以實現顯著的長期成長。

Now, with that, I will turn the call to Dave to discuss our Commercial business in more detail. Dave?

現在，我將把電話交給戴夫，讓他更詳細地討論我們的商業業務。戴夫？

Thank you, Raul.

謝謝你，勞爾。

On slide 7, you'll see our three commercial products: TAVALISSE, GAVRETO, REZLIDHIA.

在第 7 張投影片上，您將看到我們的三款商業產品：TAVALISSE、GAVRETO、REZLIDHIA。

Moving to slide 8, we are thrilled to report another excellent quarter from our commercial portfolio, marked by strong year-over-year growth and an all-time high in revenues in the third quarter of 2025. The slide shows how our quarterly and annual net product sales have increased since 2021. We've grown each quarter's sales over the previous year and that growth continues.

翻到第 8 張投影片，我們很高興地報告，我們的商業組合又迎來了一個優秀的季度，實現了強勁的同比增長，並在 2025 年第三季度創下了收入歷史新高。這張投影片顯示了自 2021 年以來，我們的季度和年度淨產品銷售額是如何成長的。我們每季的銷售額都比前一年有所成長，而且這種成長勢頭仍在繼續。

In the third quarter of 2024, we reported $38.9 million. Now, for the third quarter of 2025, we generated a record $64.1 million, an increase of 65%. Our third-quarter commercial portfolio net sales reflect increased demand through carryover from both improved patient affordability that we started to experience earlier in the year; and new patients, which was also augmented by favorable gross-to-net dynamics.

2024 年第三季度，我們報告營收為 3,890 萬美元。現在，在 2025 年第三季度，我們創造了創紀錄的 6,410 萬美元收入，成長了 65%。我們第三季的商業產品組合淨銷售額反映了需求的成長，這得益於年初開始的患者支付能力的提高以及新患者的增加，而有利的毛利淨利動態也促進了這一增長。

As Raul mentioned, our year-to-date 2025 revenue has surpassed our 2024 full-year revenueand on a trailing 12-month basis, we've exceeded $200 million in net product sales, illustrating that our focus on growing our commercial portfolio is being executed in line with our strategy, a remarkable achievement by the team.

正如 Raul 所提到的，我們 2025 年迄今為止的收入已經超過了 2024 年全年的收入，並且在過去 12 個月中，我們的淨產品銷售額已經超過 2 億美元，這表明我們專注於發展商業組合的戰略正在按計劃執行，這是團隊取得的一項了不起的成就。

Our commercial team has been dedicated to execution and driving momentum for our commercial portfolio and I thank them for their continued efforts.

我們的商業團隊一直致力於執行和推動我們的商業組合的發展，我感謝他們的持續努力。

Slide 9 shows a summary of our commercial performance by product. First, on TAVALISSE -- the cornerstone of our business -- I'm pleased to report a record quarter in which we generated $44.7 million in net product sales, an increase of 70% compared to the third quarter of 2024. This growth was driven by increased demand and favorable gross-to-net dynamics.

第 9 張投影片按產品總結了我們的商業表現。首先，關於我們業務的基石——TAVALISSE，我很高興地報告，本季我們實現了創紀錄的淨產品銷售額，達到 4,470 萬美元，比 2024 年第三季成長了 70%。這一增長是由需求增加和有利的毛利淨利變化所推動的。

For GAVRETO, we delivered $11.1 million in net product sales in Q3, an increase of 56% compared to the third quarter of 2024, the first full quarter GAVRETO was commercially available from Rigel. The year-over-year growth was driven by an increase in new patients and carryover demand. GAVRETO is now a stable business that is consistently generating more than $11 million per quarter.

GAVRETO 在第三季實現了 1,110 萬美元的淨產品銷售額，比 2024 年第三季成長了 56%，而 2024 年第三季是 GAVRETO 從 Rigel 公司正式上市的第一個完整季度。同比增長主要由新患者數量增加和延續需求推動。GAVRETO 現在是一家穩定的企業，每季持續創造超過 1,100 萬美元的收入。

Lastly, for REZLIDHIA, we reported $8.3 million in net product sales, an increase of 50% compared to the prior year period, reflecting record demand. During the quarter, we saw an increase in both breadth and depth of prescribers. We continue to believe there is a significant opportunity for growth because our data in the post-Venetoclax patient population is a clear differentiator.

最後，REZLIDHIA 的淨產品銷售額為 830 萬美元，比去年同期成長了 50%，反映出創紀錄的需求。本季度，我們看到處方醫生的廣度和深度都有所提高。我們仍然相信存在巨大的成長機會，因為我們在接受 Venetoclax 治療後的患者群體中的數據具有明顯的差異化優勢。

Moving to slide 10, we continue to work on expanding access to our products in markets outside of the US. TAVALISSE is commercially available in Japan; in Europe, under the brand name TAVLESSE; and in Canada and Israel via our partners Kissei, Grifols, and Medison. In addition, Kissei's licensing partner, JW Pharmaceutical Corporation, launched TAVALISSE in South Korea in early July, as our partners continue to pursue regulatory approvals for TAVALISSE in new markets.

接下來是第 10 張投影片，我們將繼續努力擴大我們產品在美國以外市場的普及程度。TAVALISSE 在日本有售；在歐洲以 TAVLESSE 品牌銷售；在加拿大和以色列則透過我們的合作夥伴 Kissei、Grifols 和 Medison 銷售。此外，Kissei 的授權合作夥伴 JW Pharmaceutical Corporation 於 7 月初在韓國推出了 TAVALISSE，我們的合作夥伴正在繼續尋求 TAVALISSE 在新市場的監管批准。

For REZLIDHIA, in 2024, we expanded our relationship with Kissei to include several countries in Asia for all potential indications, and wee entered into an exclusive license agreement with Dr. Reddy's for all potential indications throughout Dr. Reddy's territory.

對於 REZLIDHIA，2024 年，我們擴大了與 Kissei 的合作關係，將亞洲多個國家納入所有潛在適應症範圍，並與 Dr. Reddy's 簽訂了獨家許可協議，涵蓋 Dr. Reddy's 區域內的所有潛在適應症。

We are pleased that access to our products is expanding outside the U.S., andwe continue to explore other opportunities for partnerships to bring our products to other markets around the globe.

我們很高興看到我們的產品在美國以外的市場也越來越受歡迎，我們將繼續探索其他合作機會，將我們的產品推向全球其他市場。

I'll now pass the call over to Lisa to provide an update on our development pipeline. Lisa?

現在我將把電話交給 Lisa，讓她介紹我們的開發進度。麗莎？

Thanks, Dave. I will now provide an overview of our pipeline progress and plans for the remainder of the year.

謝謝你，戴夫。接下來，我將概述我們的管道建設進度以及今年剩餘時間的計劃。

I'm on slide 12. Our Hematology and Oncology pipeline strategy is focused on the clinical development of R289, our potent and selective dual IRAK1 and IRAK4 inhibitor in lower-risk myelodysplastic syndrome, or MDS; and the expansion of olutasidenib beyond relapsed or refractory IDH1-mutated AML.

我看到第12張投影片了。我們的血液腫瘤產品線策略重點是 R289 的臨床開發，R289 是一種強效且選擇性的雙重 IRAK1 和 IRAK4 抑制劑，用於治療低危險群骨髓增生異常綜合徵 (MDS)；以及將 olutasidenib 的應用範圍擴展到復發或難治性 IDH1 突變 AML 以外的疾病。

Beginning with R289, our Phase 1b study in patients with relapsed or refractory lower-risk MDS is progressing well. Yesterday, we announced that we'll be providing updated data from the dose escalation portion of the R289 study in an oral presentation at the upcoming ASH Annual Meeting. I'll provide an update on the study, shortly.

從 R289 開始，我們針對復發或難治性低危險群 MDS 患者的 1b 期研究進展順利。昨天，我們宣布將在即將舉行的 ASH 年會上以口頭報告的形式提供 R289 研究劑量遞增部分的最新數據。我稍後會提供該研究的最新進展。

As Raul mentioned, we're proud of our strategic collaborations to advance olutasidenib into additional therapeutic areas. With MD Anderson, olutasidenib is now being evaluated in five clinical studies in IDH1 mutation-positive AML and MDS; and as maintenance therapy in IDH1 mutation-positive glioma by the CONNECT Cancer Consortium. We're also partnering with MyeloMATCH for a planned study in first-line AML and MDS.

正如 Raul 所提到的，我們為透過策略合作將 olutasidenib 推向更多治療領域而感到自豪。目前，MD 安德森癌症中心正在對 olutasidenib 進行五項臨床研究，以評估其在 IDH1 突變陽性 AML 和 MDS 中的療效；CONNECT 癌症聯盟正在評估其作為 IDH1 突變陽性膠質瘤的維持療法的療效。我們也與 MyeloMATCH 合作，計劃進行第一線 AML 和 MDS 研究。

We're also considering additional Rigel-led studies, and we'll provide further updates on that, as we have them.

我們也考慮進行更多由Rigel主導的研究，如有進展，我們將及時更新相關資訊。

Rigel also remains focused on evaluating potential acquisition and in-licensing opportunities that strategically fit our Hematology and Oncology portfolio and infrastructure. We're focused on evaluating differentiated late-stage assets in hematology, oncology, or related areas that are synergistic with our existing commercial portfolio.

Rigel 也持續專注於評估符合我們血液學和腫瘤學產品組合及基礎設施的策略性收購和引進機會。我們專注於評估血液學、腫瘤學或相關領域中具有差異化優勢的後期資產，這些資產與我們現有的商業產品組合具有協同效應。

Now, we will spend a few moments on R289, our novel dual IRAK1 and IRAK4 inhibitor.

現在，我們將花幾分鐘時間介紹 R289，我們新型的雙重 IRAK1 和 IRAK4 抑制劑。

First, on slide 14, I'd like to talk about the treatment landscape for lower-risk MDS. MDS is a clonal disorder of hematopoietic stem cells leading to dysplasia and ineffective hematopoiesis. The main consequences for patients are anemia and transfusion dependence, which adversely impact their quality of life. In addition, infections, iron overload from transfusions, and subsequent organ dysfunction all negatively impact the patient.

首先，在第 14 張投影片上，我想談談低風險 MDS 的治療現況。MDS 是一種造血幹細胞克隆性疾病，會導致造血功能異常和無效造血。對患者的主要後果是貧血和輸血依賴，這會對他們的生活品質產生不利影響。此外，感染、輸血引起的鐵過量以及隨之而來的器官功能障礙都會對患者產生負面影響。

Therapies used in the upfront setting include erythropoiesis-stimulating agents, or ESAs, if patients are eligible for Luspatercept. Luspatercept and, more recently, Imetelstat are also approved for ESA-failure, transfusion-dependent, lower-risk MDS patients. Finally, hypomethylating agents, or HMAs, are also approved. However, the percentage of patients achieving transfusion independence is low.

第一線治療方案包括促紅血球生成劑（ESA），前提是患者符合 Luspatercept 的治療條件。Luspatercept 和最近核准的 Imetelstat 也已獲準用於 ESA 治療失敗、輸血依賴、低風險 MDS 患者。最後，低甲基化劑（HMA）也獲得了批准。然而，實現輸血獨立的患者比例很低。

With eight-week transfusion independence rates approaching 40% with Luspatercept and Imetelstat, there is still a need for safe, effective therapies for transfusion-dependent, lower-risk MDS patients that are relapsed/refractory to or ineligible for ESAs.

使用 Luspatercept 和 Imetelstat 治療後，8 週的輸血獨立率接近 40%，但對於輸血依賴型、低風險的 MDS 患者，如果其對 ESA 治療無效或不適合接受 ESA 治療，仍需要安全有效的治療方法。

Now, I'll shift focus to the R289 program.

現在，我將把注意力轉移到 R289 程式上。

On slide 15, you can see the value proposition of R289 in lower-risk MDS. There are about 12,000 previously treated lower-risk MDS patients in the U.S. As mentioned on the previous slide, there's a high unmet need for therapies in this disease area, particularly for transfusion-dependent patients.

在第 15 張投影片中，您可以看到 R289 在低風險 MDS 中的價值主張。美國約有 12,000 名先前接受過治療的低風險 MDS 患者。如上一張投影片所提到的，該疾病領域對治療的需求遠未得到滿足，特別是對於輸血依賴型患者而言。

Dysregulation of inflammatory-signaling is key to the pathogenesis of lower-risk MDS, and IRAK 1 and 4 mediate this process. Blocking both IRAK1 and 4 may suppress marrow inflammation and leukemic stem and progenitor cell function and restore normal hematopoiesis.

發炎訊號失調是低風險 MDS 發病機制的關鍵，IRAK 1 和 4 介導此過程。同時阻斷 IRAK1 和 4 可能抑制骨髓發炎和白血病幹細胞及祖細胞功能，並恢復正常的造血功能。

R835, the active moiety of R289, blocks toll-like receptor and IL-1 receptor-signaling in vitro and was active in various preclinical models of inflammation. Clinical proof of concept of this anti-inflammatory effect came from a healthy volunteer study in which R835 markedly suppressed LPS-induced cytokine release compared to placebo.

R289 的活性部分 R835 在體外阻斷了 Toll 樣受體和 IL-1 受體訊號傳導，並在各種發炎的臨床前模型中表現出活性。此抗發炎作用的臨床概念驗證來自一項健康志願者研究，該研究發現，與安慰劑相比，R835 能顯著抑制 LPS 誘導的細胞激素釋放。

As a reminder, R289, which is currently being evaluated in the clinic, is the oral prodrug that is rapidly converted to R835 in the gut.

提醒一下，目前正在臨床評估的 R289 是一種口服前藥，可在腸道內迅速轉化為 R835。

From the FDA, R289 has fast-track designation for the treatment of patients with previously treated transfusion-dependent, lower-risk MDS and orphan drug designation for MDS, giving the molecule an expedited regulatory pathway, potential priority review, and seven years of market exclusivity upon approval. Both of these designations underscore the agency's interest in this rare disease, the unmet need of the patient population, and the FDA's willingness to collaborate with Rigel in the development of R289.

R289 已獲得美國食品藥物管理局 (FDA) 的快速通道資格，用於治療先前接受過治療的輸血依賴型低風險 MDS 患者，並被授予 MDS 孤兒藥資格，這使得該分子能夠獲得快速監管途徑、潛在的優先審查，並在獲批後享有七年的市場獨佔權。這兩項認定都凸顯了該機構對這種罕見疾病的關注、患者群體未被滿足的需求，以及 FDA 與 Rigel 合作開發 R289 的意願。

In addition, R289 has, thus far, demonstrated a promising clinical profile in our Phase 1b study. At ASH in 2024, we presented promising preliminary safety and efficacy data from the Phase 1b study in elderly, heavily pretreated patients. And we look forward to sharing updated data from the dose escalation part of the study soon in an oral presentation at this year's ASH Meeting.

此外，到目前為止，R289 在我們的 1b 期研究中已顯示出良好的臨床前景。在 2024 年的 ASH 會議上，我們展示了針對老年、接受過大量治療的患者所進行的 1b 期研究的有希望的初步安全性和有效性數據。我們期待盡快在今年的 ASH 會議上以口頭報告的形式分享該研究劑量遞增部分的最新數據。

On slide 16, you'll see the design of our multicenter, open-label Phase 1b study in patients with relapsed/refractory, lower-risk MDS that are either transfusion-dependent or have symptomatic anemia. The study aims to evaluate the safety, PK, and preliminary activity of R289 in this patient population, as well as select a dose for future studies.

在第 16 張投影片中，您將看到我們針對復發/難治性、低風險 MDS 患者（這些患者要麼依賴輸血，要麼有症狀性貧血）開展的多中心、開放標籤 1b 期研究的設計。該研究旨在評估 R289 在該患者群體中的安全性、藥物動力學和初步活性，並為未來的研究選擇劑量。

We completed enrollment in the dose escalation part of the study in July, andthe first patient in the dose expansion phase was enrolled last month. In this part of the study, up to 40 transfusion-dependent relapsed/refractory, lower-risk MDS patients will be randomized to receive R289 doses of either 500 milligrams once or twice daily in order to select the recommended Phase 2 dose for future clinical studies.

我們在 7 月完成了劑量遞增研究部分的入組工作，上個月入組了第一個劑量擴展階段的患者。在本研究的這一部分中，將隨機選擇 40 名輸血依賴型復發/難治性低風險 MDS 患者，分別接受每日一次或兩次 500 毫克的 R289 劑量，以便為未來的臨床研究選擇建議的 2 期劑量。

Once this occurs, we will evaluate R289 in a cohort of less heavily pretreated patients who are relapsed/refractory to or ineligible for ESAs. We anticipate that we will have sufficient data to make a decision on the recommended Phase 2 dose in the second half of next year; after which, we would plan to have a follow-up discussion with the FDA about a potential pivotal study design.

一旦這種情況發生，我們將對一組接受較少治療、對 ESA 治療無效或不適合接受 ESA 治療的患者進行 R289 評估。我們預計明年下半年將有足夠的數據來決定建議的二期劑量；之後，我們將計劃與 FDA 就潛在的關鍵性研究設計進行後續討論。

For now, updated dose escalation data using an October 28 data cut-off date will be shared in an oral presentation at the ASH Meeting on Sunday, December 7. We're very pleased with the progress we've made this year with our R289 clinical program.

目前，使用 10 月 28 日資料截止日期更新的劑量遞增資料將在 12 月 7 日星期日的 ASH 會議上以口頭報告的形式分享。我們對今年 R289 臨床計畫的進展感到非常滿意。

Now, I'll transition to our strategic collaborations to evaluate olutasidenib and other cancers harboring IDH1 mutations.

現在，我將過渡到我們為評估奧魯西地尼和其他攜帶 IDH1 突變的癌症而進行的策略合作。

On slide 18, we summarize our strategic alliance with the MD Anderson Cancer Center to advance olutasidenib more broadly into AML, MDS, and beyond. A fifth study under the strategic alliance opened for enrollment in September. This study will evaluate olutasidenib in combination with co-targeted therapies in patients with relapsed/refractory, IDH1-mutated myeloid malignancies harboring activated signaling pathway mutations. Enrollment also continues in the other four studies.

在第 18 張投影片中，我們總結了我們與 MD 安德森癌症中心的策略聯盟，以更廣泛地將奧魯西地尼應用於 AML、MDS 及其他領域。該策略聯盟下的第五項研究於9月開始招募受試者。本研究將評估奧魯西地尼合併標靶治療對攜帶活化訊號路徑突變的復發/難治性 IDH1 突變髓系惡性腫瘤患者的療效。其他四項研究的招募工作也持續進行。

On slide 19, we're also proud of our collaboration with CONNECT, a global pediatric neuro-oncology consortium, which is evaluating olutasidenib in adolescents and young adults with high-grade glioma, an area of high unmet medical need.

在第 19 張投影片中，我們也自豪地介紹了與 CONNECT（一個全球兒科神經腫瘤聯盟）的合作，該聯盟正在評估奧魯西地尼在青少年和年輕成人高級別膠質瘤患者中的療效，這是一個醫療需求尚未得到滿足的領域。

In CONNECT's TarGet trial, a molecularly guided Phase 2 umbrella clinical trial for high-grade glioma, the Rigel-sponsored arm of the study, TarGet-D, will evaluate a post-radiotherapy maintenance regimen of olutasidenib in combination with temozolomide, followed by olutasidenib monotherapy in newly diagnosed patients between 12 and 39 years of age with IDH mutation-positive, high-grade glioma.

在 CONNECT 的 TarGet 試驗中，一項針對高級別膠質瘤的分子指導的 2 期傘式臨床試驗，由 Rigel 贊助的 TarGet-D 研究組將評估奧魯西地尼聯合替莫唑胺的放療後維持治療方案，隨後對 12 至 39 歲新診斷的 IDH 突變陽性高級別尼藥。

I'm pleased to report that this study enrolled its first patient in October. We, along with CONNECT, are excited about olutasidenib's potential to provide a much-needed new treatment option to this underserved patient population.

我很高興地報告，這項研究已在 10 月招募了第一位患者。我們和 CONNECT 都對 olutasidenib 有望為這一服務不足的患者群體提供急需的新治療選擇感到興奮。

On slide 20, I want to share with you our new partnership with MyeloMATCH, which will also evaluate olutasidenib in IDH1-mutated AML and MDS. MyeloMATCH is a group of precision medicine clinical trials for patients with MDS or AML, led by the NIH and National Cancer Institute.

在第 20 張投影片上，我想與大家分享我們與 MyeloMATCH 的新合作關係，該合作關係還將評估 olutasidenib 在 IDH1 突變 AML 和 MDS 中的療效。MyeloMATCH 是由美國國立衛生研究院和國家癌症研究所主導的針對 MDS 或 AML 患者的一系列精準醫療臨床試驗。

This initiative is very compelling. Patients with newly diagnosed MDS or AML will go through an initial screening process before being assigned to a clinical trial evaluating targeted therapy for their specific disease mutational profile. Based on the promising data for olutasidenib in relapsed/refractory IDH1-mutated AML, the NCI was interested in studying olutasidenib in combination with other agents in patients with newly diagnosed IDH1-mutated AML and MDS.

這項措施非常引人注目。新確診的 MDS 或 AML 患者在被分配到評估針對其特定疾病突變譜的標靶治療的臨床試驗之前，將經歷初步篩選過程。鑑於奧魯西地尼在復發/難治性 IDH1 突變 AML 中的有希望的數據，美國國家癌症研究所 (NCI) 有興趣研究奧魯西地尼與其他藥物聯合用於新診斷的 IDH1 突變 AML 和 MDS 患者。

We're pleased to be participating in this important program and look forward to providing you with updates as the trial advances.

我們很高興能夠參與這項重要的計劃，並期待隨著試驗的進展向您提供最新資訊。

Before I wrap up my remarks, I'd like to highlight Rigel's presentations at the upcoming ASH Annual Meeting in December, which you can see on slide 21.

在我結束演講之前，我想重點介紹 Rigel 在即將於 12 月舉行的 ASH 年會上的演講，您可以在第 21 頁幻燈片上看到。

For R289, we're pleased to share updated data from the dose escalation part of our Phase 1b study in lower-risk MDS. In the abstract published yesterday, with data as of July 15, you'll see R289 continues to be generally well-tolerated in a heavily pretreated patient population, the majority of whom were high-transfusion burden at baseline. Preliminary signs of efficacy were observed with R289 doses of at least 500 milligrams once daily and higher. At the meeting, there will be an oral presentation of updated data using an October 28 data cut, on Sunday, December 7.

對於 R289，我們很高興分享來自低風險 MDS 1b 期研究劑量遞增部分的最新數據。在昨天發布的摘要中，根據 7 月 15 日的數據，你會看到 R289 在大量接受過預先治療的患者群體中仍然具有良好的耐受性，其中大多數患者在基線時輸血負擔較重。每天一次服用至少 500 毫克 R289 及以上劑量時，觀察到了初步療效跡象。會議將於 12 月 7 日星期日舉行，屆時將以 10 月 28 日的數據為基準，對更新後的數據進行口頭報告。

Additionally, four poster presentations for olutasidenib in patients with IDH1-mutated AML are planned. These presentations contribute to the growing body of data supporting the use of olutasidenib in patients with relapsed-or-refractory IDH1-mutated AML, including those who have previously been treated with a Venetoclax-based regimen.

此外，還計劃進行四場關於奧魯西地尼治療 IDH1 突變型 AML 患者的海報展示。這些報告為支持在復發或難治性 IDH1 突變 AML 患者（包括先前接受過 Venetoclax 方案治療的患者）中使用 olutasidenib 提供了越來越多的數據。

Now, I'll pass the call to Dean to discuss our partnered program with Eli Lilly and our financial results for the quarter. Dean?

現在，我將把電話轉給迪恩，讓他討論我們與禮來公司的合作項目以及我們本季的財務表現。院長？

Thank you, Lisa.

謝謝你，麗莎。

I'm on slide 23. I'd like to provide a brief update on our collaboration with Lilly.

我看到第23張投影片了。我想簡單報告我們與禮來公司的合作進展。

Ocadusertib, the non-CNS-penetrant RIPK1 inhibitor, previously referred to as R552, is currently being studied in an adaptive Phase 2a, 2b clinical trial in up to 380 patients with active, moderate-to-severe rheumatoid arthritis. Enrollment in the Phase 2a study is ongoing.

Ocadusertib 是一種非中樞神經系統穿透性 RIPK1 抑制劑，以前被稱為 R552，目前正在一項適應性 2a、2b 期臨床試驗中進行研究，受試者多達 380 名患有活動性中度至重度類風濕性關節炎的患者。2a期研究的受試者招募工作正在進行中。

As most of you know, we also have a CNS-penetrant program with Lilly, whereby Lilly was considering for preclinical development a variety of RIPK1 inhibitor candidates to pass the blood-brain barrier. In October, Lilly notified us that it will terminate the CNS disease program, which will become effective after 60 days.

正如你們大多數人所知，我們還與禮來公司開展了一項中樞神經系統滲透性藥物項目，禮來公司正在考慮對各種 RIPK1 抑制劑候選藥物進行臨床前開發，以使其能夠穿過血腦屏障。10 月份，禮來公司通知我們，它將終止中樞神經系統疾病項目，該終止將在 60 天後生效。

We continue to be very excited about our collaboration with Lilly, as they are an ideal partner to explore the key role the RIPK1 inhibitors play in TNF-signaling and pro-inflammatory necroptosis, which could support broad potential in RA, psoriasis, and IBD.

我們仍然對與禮來公司的合作感到非常興奮，因為他們是探索 RIPK1 抑制劑在 TNF 信號傳導和促炎性壞死性凋亡中的關鍵作用的理想合作夥伴，這可能支持其在 RA、銀屑病和 IBD 方面的廣泛應用潛力。

We also note that we are entitled to receive milestones and tiered royalty payments on future net sales of ocadusertib.

我們還注意到，我們有權就 ocadusertib 未來的淨銷售額獲得里程碑付款和分級特許權使用費。

Moving on to slide 25, we reported net product sales of $64.1 million for the third quarter, a growth of 65% year over year, including TAVALISSE net product sales of $44.7 million, a growth of 70% year over year; GAVRETO net product sales of $11.1 million, a growth of 56% year over year; lastly, we reported REZLIDHIA net product sales of $8.3 million, a growth of 50% year over year. Our net product sales were recorded net of estimated discounts, chargebacks, rebates, returns, copay assistance, and other allowances of $21.6 million.

接下來是第 25 張投影片，我們報告第三季淨產品銷售額為 6,410 萬美元，較去年同期成長 65%，其中包括 TAVALISSE 淨產品銷售額為 4,470 萬美元，較去年同期成長 65%，其中包括 TAVALISSE 淨產品銷售額為 4,470 萬美元，較去年同期成長 65%，其中包括 TAVALISSE 淨產品銷售額為 4,470 萬美元，年成長 70%；GAVRETO 淨產品銷售額為 1,110 萬美元，較去年同期成長 56%為基礎成長 56%，我們報告為 1,110 萬美元，年淨銷售額為 56%；最後為 56%。我們的淨產品銷售額已扣除估計的折扣、退款、回扣、退貨、共同支付援助和其他補貼 2,160 萬美元。

We also reported $5.4 million in contract revenues from our collaborations for the third quarter, primarily consisting of $3.1 million of revenue from Grifols, $1.8 million of revenue from Kissei, and $200,000 of revenue from Medison, related to delivery of drug supplies and earned royalties. This brings our total revenue for the third quarter to $69.5 million.

第三季度，我們還報告了合作合約收入 540 萬美元，主要包括 Grifols 提供的 310 萬美元收入、Kissei 提供的 180 萬美元收入以及 Medison 提供的 20 萬美元收入，這些收入與藥品供應和已賺取的特許權使用費有關。這使得我們第三季的總收入達到 6,950 萬美元。

Moving to the next slide, 26, our cost of product sales was approximately $4.8 million for the third quarter of 2025. Total cost and expenses were $41 million compared to $41.3 million for the same period of 2024. The decrease in cost and expenses was mainly due to lower cost of product sales, as the prior period included a sub-licensing fee, partially offset by increased research and development costs, driven by the timing of clinical activities related to olutasidenib and R289 and higher personnel-related costs.

接下來是第 26 張投影片，2025 年第三季我們的產品銷售成本約為 480 萬美元。總成本和費用為 4,100 萬美元，而 2024 年同期為 4,130 萬美元。成本和費用的下降主要是由於產品銷售成本降低，因為前一時期包括了分許可費，但部分被研發成本的增加所抵消，研發成本的增加是由於與 olutasidenib 和 R289 相關的臨床活動的時間安排以及更高的人員相關成本所致。

We reported net income of $27.9 million for the third quarter compared to $12.4 million for the same period as 2024. We ended the third quarter with cash, cash equivalents, and short-term investments of $137.1 million compared to $77.3 million as of the end of 2024.

我們公佈第三季淨收入為 2,790 萬美元，而 2024 年同期為 1,240 萬美元。第三季末，我們的現金、現金等價物和短期投資為 1.371 億美元，而截至 2024 年底，這一數字為 7,730 萬美元。

Now, for our financial outlook for 2025, based on our strong performance to date, we're raising our total revenue guidance to approximately $285 million to $290 million, an increase from the prior range of $270 million to $280 million. This includes updated net product sales expectations of approximately $225 million to $230 million, an increase from the prior range of $210 million to $220 million, andcontract revenues from collaborations are approximately $60 million.

現在，鑑於我們迄今為止的強勁表現，我們對 2025 年的財務展望將總收入預期上調至約 2.85 億美元至 2.9 億美元，高於先前的 2.7 億美元至 2.8 億美元。其中包括更新後的淨產品銷售預期，約 2.25 億美元至 2.3 億美元，高於先前的 2.1 億美元至 2.2 億美元範圍；合作合約收入約為 6,000 萬美元。

We continue to anticipate reporting positive net income for the full-year 2025, while finding existing and new clinical development opportunities.

我們繼續預計 2025 年將全年實現正淨收入，同時尋找現有和新的臨床開發機會。

With that, I'd like to turn the call back over to Raul. Raul?

那麼，我想把電話交還給勞爾。勞爾？

Thank you, Dean.

謝謝你，院長。

Moving on to slide 27, our 2025 results year to date are a culmination of the successful execution of the corporate strategy that we put in place several years ago, one aspect of which is to grow our Commercial business. As you can see, we've reported strong year-to-date sales. Because of this strong performance, we have raised our net product sales expectations for 2025 and now expect to generate growth of 55% to 59% year over year as compared to the 32% average growth that we have seen over the last four years.

接下來是第 27 張投影片，我們 2025 年迄今的業績是我們幾年前製定的企業策略成功執行的成果，其中一個面向是發展我們的商業業務。如您所見，我們今年迄今的銷售業績表現強勁。由於這一強勁的業績，我們提高了 2025 年的淨產品銷售預期，現在預計將年增 55% 至 59%，而過去四年的平均成長率為 32%。

Moving on to slide 28, for the remainder of 2025, we will continue our focus on driving our corporate strategy. We aim to increase sales of our commercial products and deliver on our updated revenue and profit guidance; and so allowing us to fund key development programs in our internal pipeline.

接下來請看第 28 頁，在 2025 年剩餘的時間裡，我們將繼續專注於推進公司策略。我們的目標是提高商業產品的銷量，實現更新後的收入和利潤預期；從而為內部研發項目中的關鍵項目提供資金。

And we are advancing these development programs. Enrollment in theour dose escalation phase of our Phase 1b study of R289 in patients with lower-risk MDS is complete, andwe look forward to presenting updated data from the study at the ASH Meeting in December. Enrollment in the dose expansion phase of the study is ongoing.

我們正在推動這些發展計劃。針對低危險群 MDS 患者的 R289 1b 期研究的劑量遞增階段的入組工作已經完成，我們期待在 12 月的 ASH 會議上公佈該研究的最新數據。該研究的劑量擴展階段的受試者招募工作正在進行中。

For olutasidenib, our strategic collaborations are advancing, with enrollment of the five MD Anderson studies and the CONNECT studies all ongoing. We continue to support the advancement of these strategic collaborations, while working on the initiation of a new study with MyeloMATCH. And, we're evaluating our options for a Rigel-led study in glioma.

對於奧魯西地尼，我們的策略合作正在推進，五項 MD 安德森癌症中心研究和 CONNECT 研究的入組工作正在進行中。我們將繼續支持這些策略合作的推進，同時與 MyeloMATCH 合作啟動一項新的研究。而且，我們正在評估由 Rigel 主導的神經膠質瘤研究的各種方案。

As we've done in the past, we are also evaluating new in-licensing and product acquisition opportunities to expand our product portfolio with synergistic, late-stage assets, which could be funded through a combination of internal and external funds.

正如我們過去所做的那樣，我們也在評估新的引進授權和產品收購機會，以透過具有協同效應的後期資產來擴展我們的產品組合，這些資產可以透過內部和外部資金的組合來提供資金。

In closing, Rigel has continued to demonstrate the strength of our business in the third quarter of 2025. We aim to finish the year with a strong fourth quarter, supported by sustained financial discipline.

綜上所述，Rigel 在 2025 年第三季持續展現了我們業務的強勁實力。我們的目標是在持續的財務紀律支撐下，以強勁的第四季度業績為今年畫上圓滿的句號。

I also want to reiterate: Our proven strategy has built Rigel into a profitable, growing, sustainable business that is well positioned for growth, as we head into 2026.

我還要重申：我們行之有效的策略已將 Rigel 打造成一家獲利、不斷成長、可持續發展的企業，為 2026 年的成長奠定了良好的基礎。

With that, I'd like to thank you for your interest. We will now open the call to your questions. Operator?

在此，我感謝您的關注。現在開始回答各位的問題。操作員？

Thank you. I'll be conducting a question-and-answer session.

謝謝。我將進行問答環節。

(Operator Instructions)

（操作說明）

Yigal Nochomovitz, Citigroup.

Yigal Nochomovitz，花旗集團。

Hi. This is Caroline, on for Yigal. Thanks for taking our question.

你好。這裡是卡洛琳，為您報道伊加爾。感謝您回答我們的問題。

We were wondering how you see the competitive positioning of R289 in lower-risk MDS versus RYTELO. Maybe it's too early to say but for the potential registrational study, would you do something similar to RYTELO's placebo-controlled study? Would you exclude patients who received RYTELO from your study?

我們想知道您如何看待 R289 在低風險 MDS 治療中與 RYTELO 的競爭定位。現在下結論可能為時過早，但對於潛在的註冊研究，你們會採取類似於RYTELO的安慰劑對照研究嗎？你會將接受 RYTELO 治療的患者排除在研究之外嗎？

I'll ask Lisa to comment. I also have a comment on that.

我會請麗莎發表意見。我對此也有一些看法。

Yeah. I think that it might be a little bit too early.

是的。我覺得現在可能有點早。

Thanks for the question, Caroline. Really good question.

謝謝你的提問，卡洛琳。問得好。

I think it might be a little early to speculate on that one. First of all, now, we're in a different patient population than Imetelstat was. We're in patients that are much more heavily pretreated; have received HMAs.

我覺得現在就此妄下結論可能還太早。首先，我們現在面對的是與伊美替司他治療時不同的患者族群。我們現在遇到的患者都接受過大量的預處理；他們接受過HMA治療。

You'll recall that the patients in the Phase 3 randomized study for RYTELO had not received prior HMAs so I would say that we're very pleased with the preliminary activity and safety profile that we're seeing, thus far.

您應該記得，RYTELO 的 3 期隨機研究中的患者之前沒有接受過 HMA 治療，因此我想說，到目前為止，我們對所看到的初步活性和安全性概況非常滿意。

It's definitely a bit too early to talk about our plans for registration study but I think our plan will be to get through dose expansion, pick the dose. As I mentioned, we will also then be opening a cohort of less heavily pretreated patients that are more akin to the recent Luspatercept and Imetelstat studies. So we'll have a look at the activity there. And then, we'll decide on what our next plans will be.

現在談論我們的註冊研究計劃肯定還為時過早，但我認為我們的計劃是完成劑量擴展，然後選擇合適的劑量。正如我之前提到的，我們還將進行一項針對預處理程度較低的患者的研究，這些患者更類似於最近的 Luspatercept 和 Imetelstat 研究。所以我們將了解那裡的活動情況。然後，我們將決定下一步的計劃。

Suffice it to say, we think that there's a broad range of opportunities for this product in lower-risk MDS after ESAs, even after ESAs is an area where, as you may have seen in the slide, we tend to explore a bit more once we know the dose because that opens up an even larger opportunity set.

總而言之，我們認為該產品在 ESA 治療後的低風險 MDS 患者中具有廣泛的應用前景，即使在 ESA 治療後，正如您可能在幻燈片中看到的那樣，我們傾向於在確定劑量後進行更深入的探索，因為這會帶來更大的應用前景。

So it's exciting to have that range of opportunity with this product, including before-and-after Luspatercept, potentially.

因此，這款產品擁有如此廣泛的機會令人興奮，包括可能在 Luspatercept 療程前後進行評估。

Joe Pantginis, H.C. Wainwright.

喬·潘特吉尼斯，H.C. 溫賴特。

Hey, everybody. Good afternoon. Thanks for all the details today. Great to see the launches continuing to be strong.

大家好。午安.感謝您今天提供的所有詳細資訊。很高興看到產品發布持續強勁。

Two questions first.

先問兩個問題。

For 289, you mentioned the potential for looking at priority reviews so I want to get maybe some profile views out of you guys with regard to maybe the level of data that you feel might be needed; the parameters for the profile of the drug, say, the importance for reducing transfusions -- wanted to get your views there.

對於 289，您提到了優先審查的可能性，所以我想聽聽你們對藥物概況的看法，例如你們認為可能需要的數據水平；藥物概況的參數，例如減少輸血的重要性——我想聽聽你們的看法。

Yeah. I think I'll take that. Thanks for the question, Joe.

是的。我想我接受這個。謝謝你的提問，喬。

I think that, given that we have the fast track designation, that really opens up potential for priority review. That underpins the comment there.

我認為，鑑於我們獲得了快速通道資格，這確實為優先審查創造了可能性。這正是那條評論的依據。

Again, I think that we're going to have to see how the data continues to evolve in the dose expansion part of the study.

我認為，我們還需要觀察劑量擴展研究部分的數據如何繼續發展。

Got it. And then, just quickly, well, this is a very important unmet medical need with oluta for the CONNECT study in glioma. Would you be able to provide some of the benchmarks we'd be looking to beat with IDH1 mutations in this patient population?

知道了。然後，簡單來說，這是 CONNECT 研究中針對膠質瘤的 oluta 的一個非常重要的未滿足的醫療需求。您能否提供一些我們希望在IDH1突變患者群體中超越的基準指標？

Well, I think that's an interesting question, as well.

嗯，我也覺得這個問題很有趣。

As far as I'm aware, this is a novel approach to taking patients that are post-chemo radiation. This is more of a maintenance approach so the combined with temozolomide for 12 months initially followed by maintenance therapy. The comparison is versus a historical control. So I don't think there's specific data for in this maintenance setting.

據我所知，這是對接受化療和放療後的患者進行治療的一種新方法。這更像是一種維持治療方案，因此最初會與替莫唑胺聯合治療 12 個月，然後進行維持治療。此比較是與歷史對照組進行的。所以我認為在這種維護環境下沒有具體數據。

that's helpful in the sense that there might be a -- or considering a low bar of success there. Appreciate the comments.

從某種意義上說，這很有幫助，因為這可能意味著——或者說，成功的標準很低。感謝您的評論。

(Operator Instructions)

（操作說明）

Farzin Haque, Jefferies.

Farzin Haque，傑富瑞集團。

Hi. Thank you for taking our questions. This is Amin Makarem on for Farzin. A couple of questions from us.

你好。感謝您回答我們的問題。這裡是 Amin Makarem 為 Farzin 報道。我們有幾個問題。

First, you mentioned improvements in Q3 gross to net. What was the rate by brand and the expected Q1 and Q4 rates, especially for oral products under the Medicaid Part D redesign that has been improving access and affordability?

首先，您提到了第三季毛利與淨利的對比改善。按品牌劃分的成長率是多少？預計第一季和第四季的成長率是多少？特別是根據 Medicaid D 部分改革（旨在提高可及性和可負擔性）制定的口服產品改革方案？

I have a follow-up.

我還有後續問題。

Yeah. I can start. And then, Dave can layer on top of this.

是的。我可以開始了。然後，Dave 可以在此基礎上進行疊加。

We haven't provided specific guidance with respect to product by product our gross to net. We have said that we've had favorable gross-to-net dynamics with the patient, patient affordability. Therefore, as we think about our gross to net, there's a variety of factors that factor into it.

我們沒有提供各產品毛利與淨利的具體指引。我們曾說過，我們在毛利和淨利方面都取得了良好的進展，患者能夠負擔得起。因此，當我們考慮毛利與淨利的換算時，有很多因素會影響到它。

We've got the mix, the type of patient and payer. We've got the different legislation, like the IRA. And so all of those factor into the overall gross to net.

我們已經具備了合適的組合，包括患者類型和支付方。我們有不同的法律法規，例如《愛爾蘭共和國法》。因此，所有這些因素都會影響最終的總毛利與淨利之比。

It's been favorable the last several quarters now. That's the level of detail we give; again, not product by product.

近幾個季度以來情況一直不錯。這就是我們提供的詳細程度；再次強調，不是逐個產品提供。

Dave, do you have --?

戴夫，你有嗎？——？

Yeah. The only thing I would add is that our gross to net has a number of different factors, like Dean said. But one of the things that we try to do is provide access to patients through patient services. Of course, we want to distribute our products to patients.

是的。我唯一要補充的是，正如迪恩所說，我們的毛利與淨利潤之間存在許多不同的關聯因素。但我們努力實現的目標之一，就是透過病患服務為病患提供便利。當然，我們希望將產品分發給患者。

We have made significant strides in improving the efficiency of both our patient services and distribution network. That has also helped to improve our gross net, which I think goes to what Raul is saying: Our strategy is to grow our sales and improve our efficiency. That's exactly what we're doing.

我們在提高病患服務和配送網路的效率方面取得了顯著進展。這也有助於提高我們的毛淨額，我認為這正印證了勞爾所說的話：我們的策略是提高銷售額和效率。這正是我們正在做的。

So I think all of these things are adding up to just a marvelous year for us.

所以我覺得所有這些因素加起來，對我們來說將是精彩的一年。

Okay. Great. Helpful. Thanks.

好的。偉大的。很有幫助。謝謝。

How are you setting expectations for the updated data at ASH for R289 in lower-risk MDS patients? How much data beyond the abstract do you plan to present?

您如何看待ASH會議上R289在低危險MDS患者的最新數據？除了摘要之外，您計劃展示多少數據？

Yeah. I can take that one. Thanks for the question.

是的。我可以接受這個。謝謝你的提問。

We're going to be -- with the October 28 data cut-off date that I mentioned, we will have 16 weeks of follow-up on all of the patients. So all of the patients -- that includes all the patients in the 500-mg BID dose level.

我們將——正如我所提到的，截至 10 月 28 日的數據截止日期，我們將對所有患者進行 16 週的追蹤。所以所有患者——包括所有接受 500 毫克 BID 劑量水平的患者。

That's all I'm going to say on that one.

關於這件事，我就說這麼多。

Yeah. Really, it's a good data set with that final dose group. We're having data from that final dose group, which we're eager to share.

是的。確實，最後一組劑量的數據很好。我們正在收集最後一組劑量組的數據，我們很想與​​大家分享。

Thank you. We reached the end of our question answer session.

謝謝。我們的問答環節結束了。

I'd like to turn the floor back over to Mr. Raul Rodriguez for any further closing comments.

我謹將發言權交還給勞爾·羅德里格斯先生，請他作最後的總結發言。

Well, thank you. I appreciate your questions.

謝謝。感謝您的提問。

Thank you, everyone, for joining us on the call today and your continued interest in Rigel.

感謝各位今天參加我們的電話會議，也感謝大家一直以來對Rigel的關注。

So far, 2025 has been a tremendous year for both our commercial portfolio and advancing our development pipeline. We look forward to sharing that data at the ASH Meeting that we mentioned on R289 in December.

到目前為止，2025 年對於我們的商業產品組合和推進研發專案而言都是碩果累累的一年。我們期待在 12 月 R289 會議上提到的 ASH 會議上分享這些數據。

To our employees, I'd like to thank you for your continued dedication to the company. It is through your innovation, integrity, and your commitment to patients that we've reached this successful place.

我謹代表全體員工，感謝你們對公司的持續奉獻。正是憑藉著你們的創新精神、正直品格以及對病人的奉獻精神，我們才取得了今天的成就。

So I look forward to updating you on our future progress. You, all, have a good afternoon-evening.

我期待著向您匯報我們未來的進展。祝各位下午/晚上愉快。

Thank you. That does conclude today's teleconference and webcast.

謝謝。今天的電話會議和網路直播到此結束。

You may disconnect your line at this time. Have a wonderful day.

現在您可以斷開線路了。祝您有美好的一天。

We thank you for your participation today.

感謝您今天的參與。