Nuvation Bio Inc (NUVB) 2025 Q3 法說會逐字稿

Hello and welcome to Nuvation Bio's third-quarter 2025 financial result and corporate update call.

大家好，歡迎參加Nuvation Bio 2025年第三季財務業績及公司最新進展電話會議。

Today's call is being recorded. A replay will be available.

今天的通話將會被錄音。稍後將提供回放。

(Operator Instructions) A brief question-and-answer session will follow the prepared remarks.

（操作說明）準備好的發言結束後，將進行簡短的問答環節。

Now, I'd like to turn the call over to JR DeVita, Executive Director of Corporate Development & Investor Relations at Nuvation Bio. Please go ahead.

現在，我想把電話交給 Nuvation Bio 公司企業發展與投資者關係執行董事 JR DeVita。請繼續。

Thank you and good afternoon, everyone. Welcome to the Nuvation Bio third-quarter 2025 earnings conference call.

謝謝大家，下午好。歡迎參加 Nuvation Bio 2025 年第三季財報電話會議。

Earlier today, we released financial results for the quarter ending September 30, 2025, and provided a business update. The press release is available on the Investors section of our website at www.nuvationbio.com. A recording of this conference call will also be available on our website, following its completion.

今天早些時候，我們發布了截至 2025 年 9 月 30 日的季度財務業績，並提供了業務最新進展。新聞稿可在我們網站 www.nuvationbio.com 的投資者關係欄位查閱。本次電話會議的錄音也將在會議結束後發佈在我們網站上。

I'd like to remind you that today's call includes forward-looking statements, including statements about the therapeutic and commercial potential of IBTROZI and safusidenib, the components of our anticipated product revenue, expected milestone payments, and our cash runway. Because such statements deal with future events and are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements.

我想提醒各位，今天的電話會議包含前瞻性陳述，包括關於 IBTROZI 和 safusidenib 的治療和商業潛力、我們預期產品收入的組成部分、預期里程碑付款以及我們的現金流狀況的陳述。由於此類聲明涉及未來事件，並且存在許多風險和不確定性，因此實際結果可能與前瞻性聲明中的結果有重大差異。

For a full discussion of these risks and uncertainties, please review our annual report on Form 10-K and our quarterly reports on Form 10-Q that are filed with the US Securities and Exchange Commission.

有關這些風險和不確定性的完整討論，請參閱我們向美國證券交易委員會提交的 10-K 表格年度報告和 10-Q 表格季度報告。

Joining me on today's call to discuss our quarterly results are our Founder, President, and Chief Executive Officer, Dr. David Hung; our Chief Commercial Officer, Colleen Sjogren; and our Chief Financial Officer, Philippe Sauvage.

今天與我一起參加電話會議，討論我們季度業績的有：我們的創始人、總裁兼首席執行官 David Hung 博士；我們的首席商務官 Colleen Sjogren；以及我們的首席財務官 Philippe Sauvage。

David will provide an overview of our key business updates. Colleen will provide details on the commercial launch of IBTROZI. Philippe will discuss our financial and operating updates. David will then conclude with closing remarks.

David 將概述我們的主要業務更新。Colleen 將提供有關 IBTROZI 商業發布的詳細資訊。Philippe將介紹我們的財務和營運最新情況。最後，大衛將作總結發言。

Now, I'll turn the call over to Dr. David Hung. David?

現在，我將把電話交給大衛·洪博士。大衛？

Thanks, JR. Good afternoon, everyone. Thank you for joining us.

謝謝，JR。大家下午好。感謝您的參與。

I'm pleased to share our third-quarter results with you today.

今天我很高興與大家分享我們第三季的業績。

As a reminder: Our lead product, IBTROZI, received full approval from the US FDA on June 11, making the third quarter our first full quarter as a commercial stage company. We are thrilled to report that momentum from the US launch of IBTROZI continues to build in a meaningful, steady manner.

再次提醒：我們的主打產品 IBTROZI 於 6 月 11 日獲得美國 FDA 的全面批准，這使得第三季度成為我們作為商業化階段公司的第一個完整季度。我們很高興地報告，IBTROZI 在美國上市後的發展動能持續穩定增強。

On our last earnings call, we announced that 70 new patients had started IBTROZI between FDA approval and the end of July, which represented approximately 10 new patient starts per week. Going forward, we will report key performance indicators and sales on a quarterly basis. This allows for a direct apples-to-apples comparison of quarter-over-quarter growth, regardless of when we report our results.

在上次財報電話會議上，我們宣布從 FDA 批准到 7 月底，已有 70 名新患者開始接受 IBTROZI 治療，相當於每週約有 10 名新患者開始接受治療。今後，我們將按季度報告關鍵績效指標和銷售情況。這樣一來，無論我們何時公佈業績，都可以對季度環比增長進行直接的同類比較。

Today, we can tell you that 204 new patients started IBTROZI in the third quarter, which represents over 15 new patient starts per week during this period. We are seeing and hearing strong physician appreciation and support for the durable efficacy, robust intracranial activity, and excellent tolerability profile we've discussed previously.

今天，我們可以告訴大家，第三季有 204 名新患者開始接受 IBTROZI 治療，這意味著在此期間每週新增患者超過 15 名。我們看到並聽到醫生們對我們之前討論過的持久療效、強大的顱內活性和良好的耐受性給予了強烈的讚賞和支持。

Importantly, what we're seeing in the field reflects exactly the cadence we were hoping for at this stage, supported by real-world, real-time patient treatment needs.

重要的是，我們在現場看到的情況與我們在這個階段所希望的節奏完全一致，這得益於現實世界中患者的即時治療需求。

While rare disease launches are always complex, we are quite encouraged by the number of patients we have been able to help with IBTROZI at this point in our launch. To put our performance in context, repotrectinib, or AUGTYRO, was approved by the FDA on November 15, 2023. Per retrospective IQVIA data, just 34 new patients started AUGTYRO during its first three full months after approval. While we realize IQVIA does not capture all patients that start therapy, this represents less than three new patient starts per week from December 2023 to the end of February 2024.

儘管罕見疾病藥物的上市總是很複雜，但我們對目前 IBTROZI 已幫助到的患者數量感到非常鼓舞。為了更好地理解我們的表現，需要說明的是，repotrectinib（或稱 AUGTYRO）於 2023 年 11 月 15 日獲得 FDA 批准。根據 IQVIA 的回顧性數據，AUGTYRO 在獲批後的前三個月內僅有 34 名新患者開始接受治療。雖然我們意識到 IQVIA 無法記錄所有開始接受治療的患者，但這代表從 2023 年 12 月到 2024 年 2 月底，每週新增患者不到 3 例。

As evidenced by the volume of new patient starts to date and defining characteristics of its product profile, we believe that IBTROZI is on track to become the new standard of care in ROS1-positive non-small cell lung cancer. This sentiment is already reflected in the practicing physician community, as evidenced by a recent article published last month in Cure Today by Dr. Geoffrey Liu, one of the most prominent KOLs in the ROS1 lung cancer space, on the day that we recently presented at the 2025 World Conference on Lung Cancer, or WCLC.

從迄今為止的新患者數量和產品概況的特徵來看，我們相信 IBTROZI 有望成為 ROS1 陽性非小細胞肺癌的新標準療法。這種情緒已經在執業醫師群體中有所體現，正如上個月在《今日治愈》雜誌上發表的一篇文章所證明的那樣，該文章由 ROS1 肺癌領域最傑出的 KOL 之一 Geoffrey Liu 博士撰寫，而就在我們最近在 2025 年世界肺癌大會（WCLC）上發表報告的當天。

Since its launch, IQVIA data also shows that AUGTYRO has been unable to displace crizotinib, or XALKORI, and become the standard of care in this disease. We believe XALKORI should not be the standard of care because it does not cross the blood-brain barrier. About 36% of newly diagnosed patients with advanced ROS1-positive non-small cell lung cancer have tumors that have already spread to their brain and another 50% of patients previously treated develop brain metastases upon progression. This viewpoint has been echoed by multiple KOLs we have interacted with in the field.

自上市以來，IQVIA 的數據也顯示，AUGTYRO 一直無法取代克唑替尼（XALKORI），成為該疾病的標準治療方法。我們認為 XALKORI 不應該成為標準治療方案，因為它無法穿過血腦屏障。約 36% 的新診斷為 ROS1 陽性晚期非小細胞肺癌的患者，其腫瘤已擴散至腦部；另有 50% 的先前接受過治療的患者在病情進展時出現腦轉移。我們接觸過的許多業內意見領袖也表達了類似的觀點。

Per data published in the Journal of Clinical Oncology, or JCO, IBTROZI demonstrated a confirmed overall response rate, or ORR, of 89%; and a median duration of response, or DOR, of 44 months in TKI-naïve patients; and importantly, a 66% confirmed intracranial response rate in patients with brain metastases who were TKI-pretreated.

根據發表在《臨床腫瘤學雜誌》（JCO）上的數據，IBTROZI 證實了總體緩解率（ORR）為 89%；在 TKI 初治患者中，緩解持續時間（DOR）中位數為 44 個月；更重要的是，在接受過 TKI 預治療的腦轉移患者中，顱內緩解率達到了 66%。

Data published in JCO was based on pooled analyses from the TRUST-I and TRUST-II studies, using a June 2024 data cut-off. Today, we are delighted to report that the median DOR of TKI-naïve patients treated with IBTROZI in the pooled analyses has now increased to 50 months from 44 months, with additional follow-up from a more recent data cut-off date of August 2025.

JCO 上發表的數據是根據 TRUST-I 和 TRUST-II 研究的總結分析，使用 2024 年 6 月的數據截止日期。今天，我們很高興地報告，在匯總分析中，接受 IBTROZI 治療的 TKI 初治患者的中位緩解持續時間 (DOR) 已從 44 個月增加到 50 個月，這是自 2025 年 8 月的最新數據截止日期以來的額外隨訪結果。

These new data are being prepared in a supplemental NDA to support a label update that we plan to submit in the coming weeks. We also plan to provide a more fulsome update from the August 2025 data cut-off at a medical conference in 2026.

這些新數據正在準備一份補充新藥申請中，以支持我們計劃在未來幾週內提交的標籤更新。我們還計劃在 2026 年的醫學會議上提供 2025 年 8 月數據截止日期後的更全面的更新資訊。

These long-term data appear to represent the greatest patient benefit to date in ROS1-positive non-small cell lung cancer. It is also important to note that unlike ongoing studies of other ROS1 TKIs, our pivotal studies did not exclude patients with other concomitant oncogenic mutations, making the results with IBTROZI, we believe, representative and applicable to real-world patients.

這些長期數據似乎代表了迄今為止 ROS1 陽性非小細胞肺癌患者獲得的最大益處。值得注意的是，與其他 ROS1 TKI 的正在進行的研究不同，我們的關鍵性研究並未排除伴有其他致癌突變的患者，因此我們認為 IBTROZI 的結果具有代表性，適用於真實世界的患者。

To our knowledge, we have not seen any approved therapies in any solid tumor oncology indication that have shown efficacy data like those of IBTROZI's combined response rates and durability in the first-line setting.

據我們所知，目前還沒有任何核准的實體腫瘤治療藥物能夠像 IBTROZI 一樣，在一線治療中展現出如此高的綜合緩解率和持久療效。

Only lorlatinib, or LORBRENA, for ALK-positive non-small cell lung cancer has shown a longer median PFS of greater than five years in its CROWN study. But per its label, LORBRENA's confirmed ORR is 76%.

只有洛拉替尼（或稱 LORBRENA）在 CROWN 研究中顯示，用於治療 ALK 陽性非小細胞肺癌的中位 PFS 超過五年。但根據其標籤顯示，LORBRENA 的確認 ORR 為 76%。

Just as it would be a challenging and significant investment over many years to achieve, much less surpass, the median PFS of LORBRENA in ALK-positive non-small cell lung cancer, we feel it will be equally difficult and lengthy an investment to demonstrate durability data close to that of IBTROZI in ROS1-positive non-small cell lung cancer.

正如要達到 LORBRENA 在 ALK 陽性非小細胞肺癌中的中位 PFS 需要多年的挑戰和重大投資，更不用說超越它了，我們認為要證明 IBTROZI 在 ROS1 陽性非小細胞肺癌中的持久性數據接近其水平，也將是一項同樣困難且漫長的投資。

We also published important new data at both WCLC in September and the European Society of Medical Oncology, or ESMO, in October. At WCLC, we shared updated IBTROZI data from both the pivotal Trust-I and Trust-II studies that supported the data in our label. This included both additional details, which emphasized the consistent durability of IBTROZI's efficacy profile and a more thorough characterization of IBTROZI's well-tolerated safety profile.

我們也分別在 9 月的世界肺癌大會 (WCLC) 和 10 月的歐洲腫瘤內科學會 (ESMO) 上發表了重要的新數據。在 WCLC 上，我們分享了來自關鍵的 Trust-I 和 Trust-II 研究的最新 IBTROZI 數據，這些數據支持了我們標籤中的數據。這包括更多細節，強調了 IBTROZI 療效的持續性和持久性，以及對 IBTROZI 良好耐受性安全性的更全面描述。

Specifically, while our presentation did not summarize all adverse events detailed in our prescribing information, it instead focused on the six most common adverse events seen in clinical studies of IBTROZI. These were increased aspartate aminotransferase, or AST; increased alanine aminotransferase, or ALT; followed, in order, by diarrhea, nausea, vomiting, and dizziness.

具體來說，雖然我們的報告沒有總結處方資訊中詳述的所有不良事件，而是重點介紹了 IBTROZI 臨床研究中最常見的六種不良事件。這些症狀包括天門冬胺酸氨基轉移酶（AST）升高；丙胺酸轉氨酶（ALT）升高；隨後依序出現腹瀉、噁心、嘔吐和頭暈。

Of note, out of the 337 patients with ROS1-positive non-small cell lung cancer treated with IBTROZI in our pivotal studies, the number of patients who discontinued IBTROZI for any of these top six adverse events was one. This represents a discontinuation rate of just 0.3% for the six most common adverse events.

值得注意的是，在我們關鍵研究中，接受 IBTROZI 治療的 337 名 ROS1 陽性非小細胞肺癌患者中，只有一名患者因這六大不良事件中的任何一個而停止使用 IBTROZI。這意味著六種最常見不良事件的停藥率僅為 0.3%。

In addition, the published data show that IBTROZI's clinically apparent adverse offense -- diarrhea, nausea, vomiting, and dizziness -- were transient; majority, Grade 1; and resolved in one to three days. Again, the combined efficacy, durability, and tolerability of IBTROZI are unprecedented in this disease.

此外，已公佈的數據顯示，IBTROZI 的臨床明顯不良反應——腹瀉、噁心、嘔吐和頭暈——是短暫的；大多數為 1 級；並在 1 至 3 天內消退。再次強調，IBTROZI 在疾病中具有前所未有的綜合療效、持久性和耐受性。

Additionally, at the ESMO conference, we presented data on IBTROZI's efficacy in patients who had failed ROZLYTREK, or entrectinib, the only CNS-penetrant first-generation ROS1 TKI. IBTROZI's confirmed ORR, post-entrectinib failure, was 80%. We are not aware of any ROS1 agents approved or in development that can match this response rate.

此外，在 ESMO 會議上，我們展示了 IBTROZI 對 ROZLYTREK（恩曲替尼，唯一能穿透中樞神經系統的第一代 ROS1 TKI）治療失敗的患者的療效數據。IBTROZI 在恩曲替尼治療失敗後確認的 ORR 為 80%。我們目前尚未發現任何已獲批准或正在研發的 ROS1 抑制劑能夠達到這樣的反應率。

Also notably, all 10 patients who failed entrectinib in this study failed for progression, not tolerability. This is an important distinction because showing an 80% confirmed ORR after progression is a much higher bar to achieve than an 80% ORR in patients who failed entrectinib for tolerability but whose tumors are not progressing on Entrectinib. This data is particularly important because, as I noted earlier, intracranial metastases develop in 50% of patients progressing with ROS1-positive non-small cell lung cancer and ROZLYTREK was previously the most tolerable of the currently approved earlier-generation brain-penetrant ROS1 TKIs.

值得注意的是，本研究中所有 10 名因恩曲替尼治療失敗的患者都是由於疾病進展而非耐受性問題而失敗。這是一個重要的區別，因為在疾病進展後獲得 80% 的確認 ORR 比在因耐受性問題而對恩曲替尼治療失敗但腫瘤在恩曲替尼治療期間沒有進展的患者中獲得 80% 的 ORR 要高得多。這項數據尤其重要，因為正如我之前提到的，50% 的 ROS1 陽性非小細胞肺癌患者會出現顱內轉移，而 ROZLYTREK 此前是目前已獲批准的早期腦穿透性 ROS1 TKI 中耐受性最好的藥物。

We believe these results, following progression on ROZLYTREK, help solidify IBTROZI's differentiated profile and activity in the central nervous system. We believe that IBTROZI's robust and durable systemic and intracranial response rates may be due to its unique combination of activities against two important targets, ROS1 and TrkB.

我們相信，在 ROZLYTREK 治療取得進展後，這些結果有助於鞏固 IBTROZI 在中樞神經系統中的差異化特性和活性。我們認為 IBTROZI 具有強勁而持久的全身和顱內反應率，可能是由於其針對兩個重要靶點 ROS1 和 TrkB 的獨特活性組合所致。

As we have previously mentioned, IBTROZI is 11- to 20-fold more selective for ROS1 over TrkB. It is strikingly potent against ROS1, with picomolar level inhibitory activity. However, we believe that modest and tolerable inhibition of TrkB by IBTROZI may also contribute to intracranial disease control.

正如我們之前提到的，IBTROZI 對 ROS1 的選擇性比 TrkB 高 11 到 20 倍。它對 ROS1 具有顯著的抑製作用，抑制活性達到皮摩爾等級。然而，我們認為 IBTROZI 對 TrkB 的適度且可耐受的抑製作用也可能有助於控制顱內疾病。

For published studies, TrkB-signaling has been associated with larger tumor size; higher clinical stage; higher probability of distant metastases, including in the CNS; and worse survival across multiple solid tumor types, including lung cancer.

已發表的研究表明，TrkB 訊號傳導與更大的腫瘤體積、更高的臨床分期、更高的遠端轉移機率（包括中樞神經系統轉移）以及多種實體瘤類型（包括肺癌）的較差存活率有關。

Our view is that IBTROZI strikes the right balance between potent inhibition of ROS1, combined with measured and tolerable TrkB activity. Interestingly, as I just mentioned, the only other approved TKI with a PFS longer than that of IBTROZI is LORBRENA, used in ALK-positive non-small cell lung cancer, which also inhibits TrkB to a measured extent.

我們認為 IBTROZI 在有效抑制 ROS1 和可控且耐受的 TrkB 活性之間取得了適當的平衡。有趣的是，正如我剛才提到的，唯一核准的 TKI 的 PFS 比 IBTROZI 更長的是 LORBRENA，它用於治療 ALK 陽性非小細胞肺癌，也能在一定程度上抑制 TrkB。

We do not believe this is a coincidence. ALK-positive non-small cell lung cancers also frequently metastasize to the brain. LORBRENA's TrkB activity may be one of the key features in striking durability. We believe that IBTROZI's ability to hit ROS1 very hard and TrkB modestly may drive its unique systemic and intracranial response durability and its tolerability profile.

我們認為這並非巧合。ALK陽性非小細胞肺癌也常發生腦轉移。LORBRENA 的 TrkB 活性可能是其持久性的關鍵特徵之一。我們認為 IBTROZI 能夠非常有效地抑制 ROS1，而對 TrkB 的作用較弱，這可能是其獨特的全身和顱內反應持久性以及耐受性的原因。

We also continue to execute on IBTROZI's life cycle management. We recently dosed the first patient in TRUST-IV, our randomized placebo-controlled Phase III study evaluating taletrectinib as adjuvant therapy for patients with resected ROS1-positive early-stage non-small cell lung cancer.

我們將繼續執行 IBTROZI 的生命週期管理。我們最近對 TRUST-IV 的第一位患者進行了給藥，這是一項隨機安慰劑對照的 III 期研究，旨在評估 taletrectinib 作為輔助療法用於接受切除的 ROS1 陽性早期非小細胞肺癌患者。

Surgical resection remains the standard of care for early-stage lung cancer. Yet recurrence is unfortunately common and patients with ROS1 infusions have no approved targeted therapy options in the adjuvant setting today.

手術切除仍是早期肺癌的標準治療方法。然而，不幸的是，復發很常見，目前接受 ROS1 輸注的患者在輔助治療方面還沒有核准的標靶治療方案。

TRUST-IV is designed to address this gap, building on the proven efficacy and safety profile of the (inaudible)-advanced disease, with the goal of delaying or preventing disease recurrence after surgery. We are the first approved ROS1 therapy to initiate a clinical trial in the adjuvant setting, providing an important opportunity to address a key unmet need for patients.

TRUST-IV 旨在彌補這一差距，在（聽不清楚）晚期疾病已證實的療效和安全性基礎上，以延緩或預防手術後疾病復發為目標。我們是第一個獲準在輔助治療領域進行臨床試驗的 ROS1 療法，為解決患者尚未滿足的關鍵需求提供了重要契機。

The fact that we and the dedicated investigators participating in our adjuvant study believe IBTROZI's safety profile is well tolerated to the point that we can help patients earlier in the disease is a particularly positive reflection of this program.

我們和參與輔助治療研究的敬業研究人員都認為 IBTROZI 的安全性良好，能夠幫助患者更早接受治療，這充分體現了該計畫的積極意義。

Finally, in partnership with Nippon Kayaku, we were pleased to receive regulatory approval of IBTROZI in Japan, further expanding access to patients with ROS1-positive non-small cell lung cancer outside the US. We view this milestone as an important step in bringing IBTROZI to patients and providers around the globe, following its approval in China earlier this year.

最後，我們很高興與日本化藥株式會社合作，並獲得了日本監管機構對 IBTROZI 的批准，進一步擴大了美國以外 ROS1 陽性非小細胞肺癌患者的用藥範圍。我們認為，在今年稍早在中國獲得批准後，這一里程碑是把 IBTROZI 帶給全球患者和醫療服務提供者的重要一步。

In short, we believe our launch performance, the latest updates reconfirming IBTROZI's efficacy and tolerability profile; and the additional development and regulatory achievements all show why IBTROZI is poised to be the new standard of care for patients with ROS1-positive non-small cell lung cancer.

總之，我們相信，我們的上市表現、最新進展再次證實了 IBTROZI 的療效和耐受性，以及其他研發和監管方面的成就，都表明 IBTROZI 有望成為 ROS1 陽性非小細胞肺癌患者的新標準療法。

We also made important progress on the rest of our pipeline. Allow me to turn briefly to safusidenib. Safusidenib is a mutant IDH1 inhibitor being developed for diffuse IDH1-mutant glioma, a devastating brain cancer for which there are very few treatment options available today. Each year, there are approximately 2,400 new cases of IDH1-mutant glioma in the US, split almost evenly between low grade, including Grade 2; and high grade, including Grades 3 and 4.

我們在其他專案方面也取得了重要進展。請容許我簡要地談談沙夫西尼布。Safusidenib 是一種突變型 IDH1 抑制劑，目前正在開髮用於治療瀰漫性 IDH1 突變型膠質瘤，這是一種毀滅性的腦癌，目前可用的治療選擇非常少。美國每年約有 2400 例新的 IDH1 突變型膠質瘤病例，其中低度（包括 2 級）和高級別（包括 3 級和 4 級）病例幾乎各佔一半。

An important difference from ROS1-positive non-small cell lung cancer is that patients newly diagnosed with low-grade and high-grade IDH1-mutant glioma live approximately 10 to 15 and 3 to 7 years, respectively. Therefore, patients may benefit from an approved therapy for many years. As a result, the market opportunity is materially larger.

與 ROS1 陽性非小細胞肺癌的一個重要差異是，新診斷為低度和高等級 IDH1 突變膠質瘤的患者分別可以存活約 10 至 15 年和 3 至 7 年。因此，患者可以從核准的療法中獲益多年。因此，市場機會就大得多。

The only treatment option available for patients with IDH1-mutant glioma is vorasidenib, which was approved by the US FDA in August 2024 for only Grade 2 patients. In its pivotal INDIGO study, which, again, included only Grade 2 patients with non-enhancing disease, vorasidenib demonstrated a median PFS of 27.7 months and an ORR of 11%. Strikingly, the launch of vorasidenib has greatly surpassed analysts' expectations by approximately 20-fold.

對於 IDH1 突變型膠質瘤患者，唯一可用的治療方案是 vorasidenib，該藥物於 2024 年 8 月獲得美國 FDA 批准，但僅適用於 2 級患者。在關鍵的 INDIGO 研究中（研究同樣只納入了 2 級非增強性疾病患者），vorasidenib 的中位 PFS 為 27.7 個月，ORR 為 11%。令人驚訝的是，vorasidenib 的上市效果遠遠超出分析師的預期，大約超出了 20 倍。

For background, vorasidenib is commercialized by Servier, a private company who acquired the program from Agios. Although Servier does not report sales of vorasidenib, they can be gleaned from the royalties received and reported by Royalty Pharma, who, in May 2024, paid Agios $905 million for a 15% royalty on net sales of vorasidenib in the US.

作為背景訊息，vorasidenib 由 Servier 公司商業化，Servier 是一家私人公司，該公司從 Agios 公司收購了該項目。儘管 Servier 沒有公佈 vorasidenib 的銷售額，但可以從 Royalty Pharma 收到的特許權使用費中推斷出來。 Royalty Pharma 在 2024 年 5 月向 Agios 支付了 9.05 億美元，獲得了 vorasidenib 在美國淨銷售額的 15% 特許權使用費。

Royalty Pharma recently disclosed in an investor update that US net sales of vorasidenib were over $550 million since launch compared to analysts' projections of approximately $30 million over the same timeframe, including $223 million in net revenue in the second quarter of 2025 alone. Based on this, vorasidenib is quickly approaching an annual run rate of $1 billion in US net sales.

Royalty Pharma 最近在投資者更新中披露，自 vorasidenib 上市以來，其在美國的淨銷售額已超過 5.5 億美元，而分析師此前預測同期淨銷售額約為 3000 萬美元，其中僅 2025 年第二季度的淨收入就達到了 2.23 億美元。基於此，vorasidenib 在美國的年淨銷售額正迅速接近 10 億美元。

We believe this is consistent with what we have said is a significant commercial opportunity for our IDH1 inhibitor, safusidenib. As a reminder, vorasidenib is approved in Grade 2 IDH1/2-mutant glioma. There are no therapies approved in the IDH1-mutant high-grade or high-risk/lower-grade settings.

我們認為這與我們所說的 IDH1 抑制劑 safusidenib 具有重大商業機會的說法是一致的。提醒一下，vorasidenib 已獲準用於治療 2 級 IDH1/2 突變型膠質瘤。目前尚無針對 IDH1 突變型高等級或高風險/低度疾病的核准療法。

While we acknowledge the complexity of cross-trial comparison, in a clinical study run by our partner, Daiichi Sankyo, safusidenib showed an ORR of 33% in patients with recurrent low-grade IDH1-mutant glioma, which is 3 times the ORR vorasidenib showed in its pivotal INDIGO study. More importantly, safusidenib demonstrated a 17% ORR in high-grade IDH1-mutant glioma, including two complete responses lasting multiple years. These complete responses include a GBM, or glioblastoma multiforme, the worst of all gliomas, which is now referred to as Grade 4 astrocytoma.

雖然我們承認跨試驗比較的複雜性，但在我們的合作夥伴第一三共株式會社開展的一項臨床研究中，safusidenib 在復發性低級別 IDH1 突變膠質瘤患者中顯示出 33% 的 ORR，是 vorasidenib 在其關鍵性 INDIGO 研究中顯示的 ORR 的 3 倍。更重要的是，safusidenib 在高等級 IDH1 突變膠質瘤中顯示出 17% 的 ORR，其中包括兩個持續多年的完全緩解。這些完全緩解病例包括膠質母細胞瘤（GBM），即多形性膠質母細胞瘤，這是所有膠質瘤中最嚴重的一種，現在被稱為 4 級星狀細胞瘤。

To our knowledge, no other IDH1 inhibitors have demonstrated responses of this kind in high-grade IDH1-mutant glioma. We believe this speaks to the emerging and promising clinical profile of safusidenib.

據我們所知，還沒有其他 IDH1 抑制劑在高等級 IDH1 突變型膠質瘤中表現出這種反應。我們認為這體現了沙夫西尼新興且前景廣闊的臨床特性。

Based on data generated to date, we have begun dosing patients in a global randomized study, evaluating the efficacy and safety of safusidenib versus placebo for the maintenance treatment of high-grade IDH1-mutant glioma, following standard of care treatment. Specifically, we define the population as patients with newly diagnosed IDH1-mutant Grade 3 astrocytoma with certain high-risk features or Grade 4 disease.

根據目前產生的數據，我們已開始在全球隨機研究中對患者進行給藥，以評估沙夫西尼與安慰劑相比，在標準治療後對高級別 IDH1 突變膠質瘤進行維持治療的療效和安全性。具體來說，我們將該族群定義為新診斷的 IDH1 突變型 3 級星狀細胞瘤患者，具有某些高風險特徵或 4 級疾病。

Following a successful meeting with the US FDA, we're actively preparing a protocol amendment to modify the trial into a pivotal Phase III study by increasing the size to approximately 300 patients, which should support potential regulatory approvals. Please refer to clinicaltrials.gov for additional details on the study design.

在與美國 FDA 成功會面後，我們正在積極準備方案修訂，將試驗修改為關鍵的 III 期研究，將樣本量增加到約 300 名患者，這應該有助於獲得潛在的監管批准。有關研究設計的更多詳細信息，請參閱 clinicaltrials.gov。

Other important elements coming from the FDA meeting include agreement on PFS as the primary endpoint, which could support full approval; agreement on the dose of 250 milligrams BID without further need for dose optimization in this setting; and agreement on the defined patient population with the potential to also include patients with IDH1-mutant high-risk Grade 2 or low-grade gliomas, a patient group that might not be best served by vorasidenib, given its pivotal INDIGO study design. For example, the INDIGO study excluded Grade 2 patients with enhancing disease. Enhancing disease is known for having a higher risk of progression.

FDA 會議的其他重要內容包括：同意將 PFS 作為主要終點，這可能支持完全批准；同意每日兩次 250 毫克的劑量，無需在此情況下進一步優化劑量；以及同意確定患者人群，並有可能包括 IDH1 突變的高危 2 級或低級別膠質瘤患者，鑑於 vorasidenib 的關鍵性 INDIGO 研究設計，該患者群體可能並非適用的人群。例如，INDIGO 研究排除了 2 級增強型疾病患者。已知增強型疾病具有較高的進展風險。

Considering the high unmet need and the exciting profile of safusidenib, we are optimistic about the speed of recruitment in this trial. That said, we want to be transparent on the length of this study. Given the agreed-upon PFS endpoint and natural history of disease, this study will take years to complete. In addition, I'd reiterate that the blinded protocol will prevent us from disclosing public updates until enough events have occurred. We estimate that the study will be completed in 2029.

考慮到目前未滿足的龐大需求以及safusidenib令人興奮的特性，我們對本次試驗的招募速度持樂觀態度。儘管如此，我們還是想就這項研究的持續時間保持透明。鑑於既定的 PFS 終點和疾病的自然病程，這項研究需要數年時間才能完成。此外，我還要重申，保密協議將阻止我們在發生足夠多的事件之前披露公開的最新消息。我們預計研究將於 2029 年完成。

Finally, we want to share an update on our discussions with FDA regarding the development of (inaudible) in Grade 2 IDH1-mutant glioma where (inaudible) is approved. These discussions were incredibly collaborative but it was clear that to receive approval, we would need to demonstrate a PFS benefit of safusidenib in a single randomized study with sufficient representation of US patients. This would naturally result in including vorasidenib as a control arm, given any other control arm in the US would be considered unethical.

最後，我們想分享我們與 FDA 就 2 級 IDH1 突變膠質瘤的（聽不清楚）開發進行的討論的最新進展，其中（聽不清楚）已獲批准。這些討論非常具有合作性，但很明顯，要獲得批准，我們需要在一項具有足夠美國患者代表性的隨機研究中證明 safusidenib 的 PFS 獲益。這自然會導致沃拉西地尼作為對照組，因為在美國，任何其他對照組都會被認為是不道德的。

While vorasidenib may be approved or achieving approvals in ex-US regions, accessibility and reimbursement is highly variable. It would take too long to enroll a study supported by a PFS endpoint solely in the US.

雖然 vorasidenib 可能已在美國以外的地區獲得批准或正在獲得批准，但其可及性和報銷情況差異很大。僅在美國進行以 PFS 為終點的研究，需要太長時間才能完成。

An alternative is for us to supply vorasidenib. But the cost would easily exceed $100 million, which is simply not a financially prudent business decision. Therefore, we've decided not to pursue a head-to-head low-grade glioma study on our own at this time and to instead focus our resources and efforts on the high-grade maintenance study.

另一個方案是由我們提供沃拉西地尼。但成本很容易超過 1 億美元，這顯然不是一個明智的商業決策。因此，我們決定目前不自行進行低度膠質瘤的頭對頭研究，而是將資源和精力集中在高級別維持治療研究。

However, as we've alluded to above, some Grade 2 subsets were excluded from the vorasidenib INDIGO pivotal study, such as high-risk Grade 2 patients, which are still low-grade gliomas. We will therefore likely enroll Grade 2 or low-grade subsets with high-risk features, which still represents an unmet need with no approved therapy.

然而，正如我們上面提到的，一些 2 級亞組被排除在 vorasidenib INDIGO 關鍵性研究之外，例如高風險 2 級患者，他們仍然是低度膠質瘤。因此，我們可能會招募具有高風險特徵的 2 級或低階亞組患者，這仍然代表著一種尚未滿足的需求，目前還沒有核准的療法。

We will continue to explore whether there are other pathways to pursue development in a portion of the low-grade population or other IDH1-mutant glioma patient subsets that could potentially benefit from safusidenib and, also, remain flexible around further partnerships in the development of this program.

我們將繼續探索是否有其他途徑，在部分低級別人群或其他可能受益於 safusidenib 的 IDH1 突變膠質瘤患者亞群中開展開發，同時，我們也將在進一步合作開發該項目方面保持靈活性。

Lastly, NUV-1511 is the first clinical candidate from our drug-drug conjugate, or DDC, platform and represents a new modality in targeted cancer therapy. We plan to provide an update from our Phase I dose escalation study in difficult-to-treat solid tumors in the near term.

最後，NUV-1511 是我們藥物偶聯物（DDC）平台的首個臨床候選藥物，代表了標靶癌症治療的新模式。我們計劃在近期內提供針對難治性實體腫瘤的 I 期劑量遞增研究的最新結果。

We remain confident that we have the team, strategy, and mindset to execute our program successfully; build lasting value; and, most importantly, serve patients.

我們仍然相信，我們擁有成功執行我們計劃所需的團隊、策略和思維方式；創造持久價值；最重要的是，服務患者。

With that, I'll turn it over to Colleen.

接下來，我將把麥克風交給科琳。

Thank you, David.

謝謝你，大衛。

Today, I am excited to share that due to the efforts of our incredible field team, our launch of IBTROZI continues to build impressive momentum. Since approval on June 11, our team has effectively executed our launch plan across the organization. Specifically, the precise execution of our launch strategy by our sales, marketing, and market access team has helped providers quickly identify appropriate patients and ensure these patients have timely access to this important next-generation therapy.

今天，我很高興地宣布，由於我們出色的現場團隊的努力，IBTROZI 的上市繼續保持著令人矚目的勢頭。自6月11日獲得批准以來，我們的團隊已在整個組織內有效地執行了我們的發布計劃。具體來說，我們的銷售、行銷和市場准入團隊精準執行了我們的上市策略，幫助醫療機構快速識別合適的患者，並確保這些患者能夠及時獲得這種重要的下一代療法。

In our first full quarter of launch, 204 new patients started treatment with IBTROZI, equivalent to over 15 new patient starts per week. That is 5 times greater than the next most recent therapeutic benchmark in this syndication. This underscores that a significant medical need in ROS1-positive non-small cell lung cancer still exists.

在上市後的第一個完整季度，共有 204 名新患者開始接受 IBTROZI 治療，相當於每週新增 15 名患者。這比該聯合研究中最近的治療基準高出 5 倍。這凸顯了 ROS1 陽性非小細胞肺癌領域仍存在重大的醫療需求。

Even in these early days, it is clear to us that IBTROZI's compelling efficacy and safety profile is addressing this need. While ultra-rare disease launches require a multi-faceted approach, this early momentum demonstrates that we have the right team, the right plan and strategy, and a practice-changing therapy with a differentiated clinical profile in IBTROZI.

即使在早期階段，我們也清楚地看到 IBTROZI 的顯著療效和安全性能夠滿足這項需求。雖然罕見疾病藥物的上市需要多方面的方法，但這種早期勢頭表明，我們擁有合適的團隊、正確的計劃和策略，以及具有差異化臨床特徵的改變實踐的療法 IBTROZI。

There is swift adoption from prescribers across the country in all channels, including independent delivery networks, or IDNs; academic centers; and large community practices. Through the end of the third quarter, providers across 98% of our 47 sales territories had written prescriptions for IBTROZI, including multiple repeat prescribers.

全國各地的處方醫生在各個管道（包括獨立醫療服務網絡 (IDN)、學術中心和大型社區診所）都迅速採用了這種療法。截至第三季末，我們 47 個銷售區域中 98% 的醫療服務提供者已開立 IBTROZI 處方，其中包括多位重複處方者。

At this point in our launch, we have engaged nearly all of our Tier 1 and Tier 2 target accounts. Our field-facing interactions and results reinforce that physicians are quickly gaining comfort prescribing IBTROZI for their appropriate patients.

在產品發布初期，我們幾乎與所有一級和二級目標客戶建立了聯繫。我們與第一線人員的互動和結果證實，醫生們正在迅速地為合適的患者開立 IBTROZI 處方。

On the market access front, payer engagement continues to be constructive and effective. As of the end of the quarter, IBTROZI was covered by payers representing more than 80% of covered lives, up from 58% just two months prior. The incredible effort of our market access team is reflected in this truly phenomenal growth in coverage.

在市場准入方面，支付方的參與仍然具有建設性和有效性。截至本季末，IBTROZI 的承保支付方涵蓋了超過 80% 的承保人群，而兩個月前這一比例僅為 58%。我們市場准入團隊付出的巨大努力體現在了覆蓋範圍的這一驚人增長。

Our patient support program, [Nuvation Connect], continues to play a critical role, supporting patients beginning treatment quickly while reimbursement is being secured. We are encouraged that while our free trial program was intended to last up to one month, we continue to convert patients in a matter of weeks, highlighting both payer receptivity and prescriber conviction.

我們的病患支援計畫 [Nuvation Connect] 繼續發揮至關重要的作用，在確保報銷的同時，為病患提供快速開始治療的支援。令人欣慰的是，雖然我們的免費試用計劃原本計劃持續一個月，但我們在幾週內就成功轉化了患者，這凸顯了支付方的接受度和處方醫生的信心。

Now, let's look at some of the backgrounds of key segments of patients who have been prescribed IBTROZI, as they highlight the broad potential of this therapy.

現在，讓我們來看看接受 IBTROZI 治療的一些關鍵患者群體的背景，因為他們突顯了這種療法的廣泛潛力。

First, we are seeing use from providers in both academic and community settings, nationwide. To date, nearly 75% of our new patient starts have come from academic centers or independent delivery networks. This is to be expected, as these centers are typically quicker to adopt new and innovative products; while community centers, where the majority of ROS1 patients are located, are just now starting to come online. Over time, we expect the majority of new patient starts to come from the community setting; in turn, supporting prescription growth and continued momentum.

首先，我們看到全國各地的學術機構和社區機構都在使用該產品。迄今為止，我們近 75% 的新患者都來自學術中心或獨立醫療服務網絡。這是意料之中的，因為這些中心通常能更快地採用新的創新產品；而 ROS1 患者大多所在的社區中心才剛開始上線。隨著時間的推移，我們預計大部分新患者將來自社區；反過來，這將支持處方成長和持續發展勢頭。

In addition, IBTROZI is being prescribed across both TKI-naïve and TKI-pretreated patient populations. We have limited visibility into the characteristics of all patients on our therapy but we do have insight into patients that come through our support program, Nuvation Connect.

此外，IBTROZI 已被用於 TKI 初治患者和 TKI 預治患者群體。我們對接受我們治療的所有患者的特徵了解有限，但我們確實對透過我們的支持計劃 Nuvation Connect 獲得幫助的患者有所了解。

Our data shows encouraging signs that the percentage of TKI-naïve patients prescribed IBTROZI is increasing. We were expecting a higher proportion of TKI-pretreated patients to make up the majority of new patients at launch but the greatest opportunity for long-term patient impact and treatment with IBTROZI remains in the first-line setting, which is further bolstered by the latest data cut providing for a 50-month median duration of response, based on pooled data from Trust-I and Trust-II studies.

我們的數據顯示，接受 IBTROZI 治療的 TKI 初治患者比例正在增加，令人鼓舞。我們原本預計，在上市初期，接受過 TKI 治療的患者將佔新患者的大多數，但 IBTROZI 能夠對患者產生長期影響和治療效果的最大機會仍然在於一線治療，最新的數據進一步證實了這一點，根據 Trust-I 和 Trust-II 研究的匯總數據，中位緩解持續時間為 50 個月。

In the second-line setting, consistent with what we reported on our last earnings call, we continue to see switches from all three of the other therapies approved for this indication. Reasons for this have included disease progression, toxicity, brain penetrance, or HCP preference.

在二線治療方面，正如我們在上次財報電話會議上所報告的那樣，我們繼續看到患者從所有其他三種獲準用於該適應症的療法轉向使用本療法。造成這種情況的原因包括疾病惡化、毒性、腦滲透性或醫護人員偏好。

In addition, multiple key opinion leaders have shared that IBTROZI's efficacy profile, specifically the prolonged durability in TKI-naïve patients, is best in class. They have elected to switch their TKI-pretreated patients as a result, even if they had not progressed or had toxicity issues.

此外，多位關鍵意見領袖表示，IBTROZI 的療效，特別是其在 TKI 初治患者中的持久療效，是同類最佳的。因此，他們選擇對接受 TKI 治療的患者進行換藥，即使這些患者病情沒有進展或沒有毒性問題。

Since launch, we are learning that IBTROZI's clinical efficacy profile is resonating strongly with physicians. They also appreciate that IBTROZI's safety profile is well-defined; manageable; and, most importantly, allows patients the possibility to remain on therapy for years and stay ahead of their disease.

自上市以來，我們了解到 IBTROZI 的臨床療效已獲得了醫師的強烈認可。他們也讚賞 IBTROZI 的安全性特徵明確且易於管理，最重要的是，它使患者能夠長期接受治療並控制病情。

Looking ahead, we are focused on deepening adoption in the US and continuing to raise awareness of the importance of oncogenic driver testing. Today, DNA-based testing identifies roughly 3,000 advanced ROS1-positive non-small cell lung cancer patients annually in the US. As the field shifts towards RNA-based testing, which publication suggests may detect approximately 30% more ROS1 fusion, the annual addressable population could potentially expand to roughly 4,000 patients in the US alone.

展望未來，我們將專注於深化在美國的推廣應用，並持續提高人們對致癌驅動基因檢測重要性的認識。目前，在美國，基於 DNA 的檢測每年可發現約 3,000 名 ROS1 陽性晚期非小細胞肺癌患者。隨著該領域轉向基於 RNA 的檢測，有出版物表明，這種檢測方法可以檢測到大約 30% 以上的 ROS1 融合，僅在美國，每年可接觸的患者人數就可能增加到大約 4,000 人。

So given IBTROZI's median duration of response of 50 months, we would expect the theoretical maximum number of patients treated with IBTROZI to potentially be over 16,000 patients early in the fifth year, post-approval.

因此，鑑於 IBTROZI 的平均緩解持續時間為 50 個月，我們預計在核准後的第五年初期，接受 IBTROZI 治療的理論最大患者人數可能會超過 16,000 人。

IBTROZI's unprecedented durability in ROS1-positive non-small cell lung cancer turns a small incidence population into a substantial prevalence population, generating an opportunity to help a much larger patient population than we had previously articulated. This example is based on first-line patients only and does not count any patients in the pretreated population, which further increases the addressable population over this timeframe.

IBTROZI 在 ROS1 陽性非小細胞肺癌中前所未有的持久性，將小規模發病人群轉變為龐大的患病人群，從而為幫助比我們之前所設想的更大的患者群體創造了機會。此範例僅基於第一線患者，不包含任何已接受治療的患者，這進一步增加了該時間段內可治療的患者群體。

As David noted, we recently initiated the TRUST-IV study to evaluate the IBTROZI as an adjuvant therapy for patients with resected ROS1-positive early-stage non-small cell lung cancer. From my standpoint, this is important for three reasons.

正如 David 指出的那樣，我們最近啟動了 TRUST-IV 研究，以評估 IBTROZI 作為切除的 ROS1 陽性早期非小細胞肺癌患者的輔助療法。在我看來，這一點很重要，原因有三。

First, thoracic thought leaders have encouraged us to pursue approval in earlier-stage non-small cell lung cancer. This speaks to the efficacy and, importantly, the safety profile of IBTROZI, as taking a medicine for many years requires that it be tolerable.

首先，胸腔外科領域的思想領袖鼓勵我們尋求在早期非小細胞肺癌中獲得批准。這說明了 IBTROZI 的療效，更重要的是，也說明了其安全性，因為長期服藥需要其具有良好的耐受性。

Second, potential approval in the adjuvant setting can further expand the number of patients we can support with IBTROZI.

其次，在輔助治療領域獲得潛在批准，可以進一步擴大我們能夠使用 IBTROZI 治療的患者數量。

Third, success in this study can solidify IBTROZI as the leader in ROS1-positive non-small cell lung cancer, as we are the only company to have pursued an adjuvant study in the ROS1 patient population.

第三，這項研究的成功可以鞏固 IBTROZI 在 ROS1 陽性非小細胞肺癌領域的領先地位，因為我們是唯一一家在 ROS1 患者群體中進行輔助治療研究的公司。

To give you an example in this field, I would point you to osimertinib, or TAGRISSO, on EGFR-positive non-small cell lung cancer. Following its approval in the adjuvant setting, there was an exponential increase in prescriptions of the medicine. In fact, it became one of the most widely prescribed lung cancer treatments globally.

舉個例子來說，我會向您推薦奧希替尼（或泰瑞沙），它用於治療 EGFR 陽性非小細胞肺癌。該藥獲準用於輔助治療後，處方量呈指數級增長。事實上，它已成為全球最廣泛使用的肺癌治療方法之一。

Finally, I want to highlight the efforts of our remarkable field team. Their deep experience in rare disease and dedication to oncology, coupled with IBTROZI's outstanding efficacy and safety profile, have led to the fastest ROS1 launch in history. We believe this early adoption of IBTROZI supports our conviction that it is quickly emerging as the new standard of care and ROS1-positive non-small-cell lung cancer, delivering meaningful benefit for patients.

最後，我想重點表揚我們傑出的現場團隊所付出的努力。他們在罕見疾病領域的深厚經驗和對腫瘤學的奉獻精神，加上 IBTROZI 出色的療效和安全性，使得 ROS1 成為歷史上上市速度最快的產品。我們相信，IBTROZI 的早期應用印證了我們的信念，即它正在迅速成為治療 ROS1 陽性非小細胞肺癌的新標準療法，為患者帶來有意義的益處。

Now, I'll turn it over to Philippe.

現在，我把麥克風交給菲利普。

Thanks, Colleen. Good afternoon, everyone.

謝謝你，科琳。大家下午好。

For detailed first-quarter 2025 financials, please refer to our earnings press release, which is available on our website.

有關 2025 年第一季的詳細財務數據，請參閱我們網站上發布的獲利新聞稿。

Now, let's go over some important highlights from the quarter.

現在，讓我們回顧一下本季的一些重要亮點。

We are so proud that this is our first full quarter reporting as a commercial stage company. I am pleased to inform you that in the first quarter, we generated $13.1 million in total revenue, which includes $7.7 million in net product revenue from IBTROZI.

我們非常自豪，這是我們作為一家商業化階段公司的第一個完整季度報告。我很高興地通知您，第一季我們共創造了 1,310 萬美元的總收入，其中包括 IBTROZI 的 770 萬美元淨產品收入。

While there was some channel stocking at the start of the launch, growth is now purely driven by treating new patients with IBTROZI, as our limited distribution model keeps inventory proportionally in line with new levels of prescription. Today, stocking no longer makes up the material amount of our product revenue. We expect that to be the case from here on out.

雖然在上市初期有一些通路庫存，但現在成長完全是由使用 IBTROZI 治療新患者所驅動的，因為我們有限的分銷模式使庫存與新的處方水平成比例地保持一致。如今，庫存不再是我們產品收入的主要來源。我們預計這種情況今後仍將持續。

This is important when comparing the launch of IBTROZI to other medicines from the market where channel stocking and not new patient stocks did make up a material part of revenue in the first few quarters of approval.

在將 IBTROZI 的上市與其他市場上的藥物進行比較時，這一點很重要。在其他藥物獲批後的最初幾季中，通路庫存而非新患者庫存構成了收入的重要組成部分。

Lastly, while some patients have been enrolled in our pretrial program, we will expect nearly all patients on this program to generate full commercial revenue in their second month of IBTROZI at the latest.

最後，雖然一些患者已經參加了我們的試驗前計劃，但我們預計該計劃中的幾乎所有患者最遲將在服用 IBTROZI 的第二個月產生全部商業收入。

Our approach to access has been extremely successful, with a very high level of coverage (inaudible), post-approval. Our level of gross-to-net has naturally increased, based on contracting, in the vicinity of 20%. We expect this level to slightly increase over time and then, stabilize, based on our balance of business with commercial, Medicare, Medicaid, [free 40B] plans, and the limited amounts of free medicine provided today.

我們採取的訪問方式非常成功，在獲得批准後，覆蓋率非常高（聽不清楚）。由於收縮，我們的毛利潤與淨利潤之比自然增長了約 20%。我們預計這一水平會隨著時間的推移而略有上升，然後趨於穩定，這取決於我們與商業保險、聯邦醫療保險、醫療補助、[免費 40B] 計劃的業務平衡，以及目前提供的有限數量的免費藥品。

As of the end of the quarter, more than 80% of lives are covered across the US payer label, an outstanding number this early in the launch, which gives providers strong confidence in coverage for a choice. But in that and IBTROZI's very favorable profiles, we have everything we need for continued prescription growth and success.

截至本季末，美國支付方標籤涵蓋了超過 80% 的人口，在推出初期就取得瞭如此驚人的數字，這讓醫療服務提供者對保障範圍的選擇權充滿信心。但憑藉這一點以及 IBTROZI 非常有利的各項指標，我們擁有了處方量持續成長和成功所需的一切。

The remaining revenue comes from our collaboration and license agreements, including product supply, royalty revenue, and research and development services. While our current royalty revenue comes from our commercialization partner in China, Innovent Biologics, we expect to begin receiving additional royalty revenue from our partner in Japan, Nippon Kayaku, following approval in September of this year.

剩餘收入來自我們的合作和授權協議，包括產品供應、特許權使用費收入以及研發服務。雖然我們目前的特許權使用費收入來自我們在中國的商業化合作夥伴信達生物，但我們預計在今年 9 月獲得批准後，我們將開始從我們在日本的合作夥伴日本化藥株式會社獲得額外的特許權使用費收入。

Notably, we expect IBTROZI to be approved for reimbursement within the fourth quarter, which will result in a $25 million milestone payment from Nippon Kayaku to Innovent Bio and the start of our royalty payments.

值得注意的是，我們預計 IBTROZI 將在第四季度獲得報銷批准，屆時日本化藥株式會社將向信達生物支付 2500 萬美元的里程碑付款，並且我們將開始收到特許權使用費。

We are also in late-stage discussions with potential IBTROZY commercialization partners in Europe and other ex-US territories. This will further reinforce our revenue and cash position.

我們目前也正與歐洲和其他美國以外地區的潛在 IBTROZY 商業化合作夥伴進行後期洽談。這將進一步鞏固我們的收入和現金狀況。

We will report key performance indicators related to IBTROZY and corresponding net revenue on a quarterly basis from now on. To us, the real metric of success is the number of patients we can help with our differentiated therapy. This is what we will focus on in the near term. We are not yet providing net revenue guidance but plan to at the appropriate time.

從現在開始，我們將按季度報告與 IBTROZY 相關的關鍵績效指標和相應的淨收入。對我們來說，衡量成功的真正標準是我們能夠透過差異化療法幫助多少患者。這是我們近期工作的重點。我們目前暫不提供淨收入預期，但計劃在適當的時候提供。

Still, it is important to note that if we consider our new patient starts in the quarter, we are already at a level of annualized net revenue of more than $55 million if these patients were to remain on IBTROZI just for the next 12 months. However, given IBTROZI's 50-month median DOR, we believe there is a considerably larger commercial opportunity ahead of us.

不過，值得注意的是，如果我們考慮本季新入院的患者，如果這些患者在接下來的 12 個月內繼續接受 IBTROZI 治療，我們的年化淨收入已經超過 5,500 萬美元。然而，鑑於 IBTROZI 的平均 DOR 為 50 個月，我們認為未來將有更大的商業機會。

On the expense side, R&D expenses for the quarter were $28.8 million, as we continued investment in IBTROZI and in our clinical stage pipeline. SG&A expenses were $37.4 million, primarily driven by support for commercialization. This includes personal related expenses tied to commercial operations, as well as strategic investments in medical education, payer engagement, patient support programs, and marketing.

在支出方面，本季研發支出為 2,880 萬美元，因為我們繼續投資於 IBTROZI 和我們的臨床階段產品線。銷售、一般及行政費用為 3,740 萬美元，主要原因是支持商業化。這包括與商業運營相關的個人支出，以及在醫學教育、支付方參與、患者支援計劃和行銷方面的策略投資。

We have the right size of field team, with 47 oncology account managers. We do not expect field and commercial team numbers to go up.

我們擁有適當規模的現場團隊，其中包括 47 名腫瘤客戶經理。我們預計現場和商業團隊的數量不會增加。

Turning to the balance sheet, we ended the quarter with $549 million in cash, cash equivalents, and marketable securities. An additional $50 million is available to us under our term-loan agreement with Sagard Healthcare Partners until June 30, 2026. As we have stated previously, we believe our cash balance is sufficient to fund operations through profitability.

從資產負債表來看，本季末我們擁有現金、現金等價物及有價證券共 5.49 億美元。根據我們與 Sagard Healthcare Partners 簽訂的定期貸款協議，到 2026 年 6 月 30 日，我們還可以額外獲得 5,000 萬美元。正如我們之前所說，我們相信我們的現金餘額足以透過獲利來維持營運。

Our previous projections included the cost of a head-to-the-head study of safusidenib against vorasidenib. After discussion with the FDA, we decided to not conduct this study and instead focus on executing a registration-enabling study in the high-grade IDH-mutant glioma setting, while also including patients with high-risk, low-grade tumors. This was a prudent financial decision, based on a careful evaluation of the cost and time needed to complete a fully-powered head-to-head study to support US approval; and generates significant flexibility for us to allocate these saved funds elsewhere.

我們先前的預測包括了沙夫西尼與沃拉西尼進行頭對頭研究的成本。與 FDA 討論後，我們決定不進行這項研究，而是專注於在高級別 IDH 突變膠質瘤環境中進行一項註冊研究，同時納入高風險、低度腫瘤患者。這是一項審慎的財務決策，基於對完成一項全面有效的頭對頭研究以支持美國批准所需的成本和時間的仔細評估；並且為我們提供了很大的靈活性，可以將節省下來的資金分配到其他地方。

Even the substantial cost of the head-to-head study against vorasidenib that was previously in our budget issued lower (inaudible) expenses and further support our ability to reach profitability. This expanded runway gives us further flexibility, as we continue to pursue additional attractive, underappreciated, and undervalued assets that can make an impact on patients' lives.

即使是先前預算中與 vorasidenib 進行頭對頭研究的巨額費用，也降低了（聽不清楚）支出，並進一步支持了我們實現盈利的能力。擴大的投資空間使我們擁有更大的靈活性，我們將繼續尋求其他有吸引力的、被低估的和被忽視的資產，這些資產可以對患者的生活產生影響。

Operationally, we remain an agile organization, with the flexibility to redirect resources as insights emerge into both commercial launch, development of our pipeline, and evaluation of other exciting external opportunities. That discipline, combined with your early IBTROZI performance and a robust cash balance, positions us to execute on our 2025 objectives, while we plan for 2026 and beyond.

在營運方面，我們仍然是一個敏捷的組織，能夠靈活地重新分配資源，以便在商業發布、產品線開發以及評估其他令人興奮的外部機會等方面獲得新的見解。這種自律，加上您早期的 IBTROZI 業績和穩健的現金餘額，使我們能夠實現 2025 年的目標，同時我們也在為 2026 年及以後的發展做好規劃。

We have one of the sector's best teams, (inaudible) -- with more to come -- combined with the right structure, resources, flexibility, and agility to continue to grow and make an impact.

我們擁有業內最優秀的團隊之一（聽不清楚）——而且未來還會有更多優秀團隊加入——再加上合適的組織架構、資源、靈活性和敏捷性，我們將繼續成長並產生影響力。

I'll now hand it back to David.

現在我把它還給大衛。

Thank you, Philippe.

謝謝你，菲利普。

Before we move to Q&A, I want to emphasize how proud I am of our team and the progress they have made. We are encouraged by the strong early adoption of IBTROZI across patients with advanced ROS1-positive non-small cell lung cancer, the feedback we're hearing from physicians and patients, and the momentum we are building as a commercial company.

在進入問答環節之前，我想強調我對我們的團隊以及他們所取得的進步感到多麼自豪。IBTROZI 在 ROS1 陽性晚期非小細胞肺癌患者中早期應用廣泛，我們對此感到鼓舞；我們也收到了來自醫生和患者的反饋；作為一家商業公司，我們正努力發展壯大。

This is only the beginning. With IBTROZI's differentiated profile and growing adoption, coupled with the breadth of our pipeline and a robust cash balance, I believe we are well-positioned to create meaningful impact for patients and long-term value for shareholders.

這只是個開始。憑藉 IBTROZI 的差異化優勢和不斷增長的市場接受度，再加上我們廣泛的產品線和強勁的現金儲備，我相信我們有能力為患者創造有意義的影響，並為股東創造長期價值。

With that, I'll ask the operator to open the line for questions.

這樣，我就可以請接線生開通提問專線了。

Thank you so much. We'll now begin our Q&A session.

太感謝了。現在開始問答環節。

(Operator Instructions)

（操作說明）

Kaveri Pohlman, Clear Street.

卡維裡·波爾曼，克利爾街。

Good afternoon. Thanks for taking my question. Congratulations on the progress.

午安.謝謝您回答我的問題。恭喜你取得進展。

Maybe just a couple on IBTROZI. With more clarity and experience, curious if you would be able to provide any guidance on sales for this year. Also, how do you see the current and future trends in usage between treatment lines or first-line and second-line settings, relative to your expectations? What key factors or strategies could influence greater uptake in first line?

或許只有 IBTROZI 上的那幾位。憑藉更清晰的思路和更豐富的經驗，我很想知道您是否能夠就今年的銷售情況提供一些指導。另外，您如何看待目前和未來不同治療方案（第一線和二線治療方案）的使用趨勢，與您的預期相比如何？哪些關鍵因素或策略可以提高第一線治療的接受度？

I have a follow-up.

我還有一個後續問題。

Hi, Kaveri. Thanks for listening to us.

你好，卡維裡。謝謝收聽。

As we said in the past, we are not going to provide any guidance on our numbers. But we are very comfortable with the level of consensus today. We think that what we accomplished in Q3, with $7.7 million in net sales in the US, is a very, very strong number for Q3 and, therefore, for full year.

正如我們之前所說，我們不會對我們的數字提供任何指導。但我們對目前的共識程度非常滿意。我們認為，第三季在美國的淨銷售額達到 770 萬美元，對於第三季乃至全年來說，都是一個非常非常強勁的數字。

Kaveri, to answer your second question, clearly, we're seeing an uptake in all lines of patients. But because the PFS of patients in the second line is going to be shorter than the PFS in the first line, over time, as we get turnover of patients, we are going to see increasing proportion of first-line patients. We would anticipate that to grow.

Kaveri，回答你的第二個問題，很明顯，我們看到所有類型的患者都對該產品的需求增加。但是，由於二線治療患者的無惡化存活期 (PFS) 將比第一線治療患者的無惡化存活期 (PFS) 短，隨著時間的推移，隨著患者的更替，我們將看到一線治療患者的比例不斷增加。我們預計這一數字將會成長。

We're capturing a significant number of patients at this stage of our launch. We would expect that to continue to grow and accelerate.

在產品上市的現階段，我們已經吸引了大量患者。我們預計這一趨勢將繼續增長並加速發展。

Got it. Thank you.

知道了。謝謝。

For Expanded Access Program, first, can you tell us how many patients were on that program? Could you provide insight into overall impact and future direction of EAP and the Fast Access Program or the Free Trial Program? Specifically, how do you see these initiatives evolving and what potential do they have to support adoption, as physicians gain more experience with the commercialized drug?

首先，關於擴大准入計劃，您能告訴我們有多少患者參加了該計劃嗎？您能否就員工協助方案 (EAP)、快速存取計畫或免費試用計畫的整體影響和未來發展方向提供一些見解？具體來說，您認為這些措施將如何發展，隨著醫生對商業化藥物的經驗越來越豐富，它們在促進藥物推廣方面有哪些潛力？

Thank you.

謝謝。

Thank you, Kaveri.

謝謝你，卡維裡。

For Expanded Access Program, you might remember we told you in the last quarter that we had only six patients on these EAPs that were converted to commercial (inaudible), only six of them. We didn't convert any patients from our clinical trials because they're still on trial. As David pointed out, it's a very, very long duration. We expect them to stay on trial for a very long time. So it's only six patients that convert to EAP.

對於擴大准入計劃，您可能還記得我們在上個季度告訴過您，我們只有六名參加這些 EAP 計劃的患者轉為商業（聽不清楚），只有六名。我們沒有將任何臨床試驗中的患者轉為正式患者，因為他們仍在試驗階段。正如大衛指出的那樣，這是一個非常非常長的時間。我們預計他們的審判將持續很長時間。所以只有六名患者轉為 EAP（員工協助方案）。

I wanted to come back to another point I was making back to your question about consensus, obviously, as we said, if patients were to stay for the full year on IBTROZI, you're looking at roughly $55 million. So that should help us and help you to document the sales for next year.

我想回到我剛才提到的關於共識的問題上來，顯然，正如我們所說，如果患者要接受 IBTROZI 治療一整年，費用大約為 5500 萬美元。這樣應該可以幫助我們和你們記錄明年的銷售情況。

Farzin Haque, Jefferies

法爾津哈克，傑富瑞集團

Hi, everyone. Congrats on the quarter. Thank you for taking my question.

大家好。恭喜你本季取得佳績。感謝您回答我的問題。

Can you provide some color on the gross-to-net and payer mix; and then, timeline for submitting the supplemental NDA to update the label for IBTROZI?

能否提供一些關於毛利與淨利比率和支付方構成的資訊；以及提交補充新藥申請以更新 IBTROZI 標籤的時間表？

Thank you, Farzin, for the question.

謝謝法爾津的提問。

I'll start by the gross-to-net and the payer mix. We communicated about our gross-to-net of roughly 20%, so far, because we're starting to see the various payers coming online. We believe that we would have something in the vicinity of 40% coming from Medicare; a little bit less than 10% from Medicaid; and maybe 20% additional from free 40Bs. It's slightly lower, right now.

我先從毛利與淨利的比率以及付款人構成說起。我們已經溝通了我們目前約 20% 的毛利率與淨利率之比，因為我們開始看到各種付款方上線。我們認為，大約 40% 的資金將來自聯邦醫療保險；略低於 10% 的資金將來自醫療補助；另外可能還有 20% 的資金來自免費的 40B 計劃。現在略低一些。

Obviously, all of those payer mix, Medicare, Medicaid, free 40Bs, are taking the rebates to certain levels. Some of them are being, as you know, legal. Like, 23.1% in Medicaid.

顯然，所有這些支付方組合，包括聯邦醫療保險、醫療補助和免費的 40B 計劃，都將回扣提高到了一定水平。正如你所知，他們中的一些人是合法的。例如，23.1%的人參加了醫療補助計劃。

So all of these to say that with the collection of payer mix that we see and, we expect, looking ahead; and the contracting that we've done, we have, for the quarter, about 20%. We think it's still going to go a little bit higher over the next few quarters and then, it will stabilize.

綜上所述，根據我們目前看到的和我們預期的付款人組合情況，以及我們已完成的合同，本季度我們預計收入將達到 20% 左右。我們認為未來幾季價格還會小幅上漲，然後趨於穩定。

Farzan, to answer your question on the timing of the sNDA, we anticipate submitting that by the end of the week. G

Farzan，關於您提出的 sNDA 時間安排問題，我們預計將在本週末之前提交。G

Got it. And then, on the IDH-1 program, are you saying more on the powering assumptions? And then, like, I know the pre-specified stratification so perhaps something on the crossover provisions for these high-grade (inaudible) studies?

知道了。那麼，關於 IDH-1 程序，您是否要更多地談談其背後的假設？然後，我知道預先設定的分層，所以也許可以談談這些高水平（聽不清楚）研究的交叉條款？

I'm not sure I captured the second part of your question but we haven't given detail on the powering assumptions, except to say that we anticipate a trial size at 350 per arm will enable us to get registration.

我不確定我是否理解了您問題的第二部分，但我們還沒有詳細說明統計假設，只是說我們預計每組 350 人的試驗規模將使我們能夠獲得註冊。

Got it. It's just 2029 data test expectations. The number of events. You're not saying how many number of events to accumulate to get to that?

知道了。這只是 2029 年的數據測試預期。事件數量。你沒有說明需要累積多少事件才能達到那個目標？

That's correct.

沒錯。

Okay. Thank you so much.

好的。太感謝了。

Sumit Roy, Jones Research.

Sumit Roy，Jones Research。

Hi, everyone. Congratulations, again, on the quarter.

大家好。再次恭喜你本季取得佳績。

On the projection of the -- so, right now you are getting almost 15 patients every week so 60 a month. Could you give us some guidance on -- is that a fair number for next couple quarters to go with? Or following the initial excitement, we should trim the total number of new patients a little bit?

根據預測——所以，目前你們每週大約有 15 位病人，也就是每月 60 位。您能否就未來幾季的預期數字提供一些指導意見——這個數字是否合理？或者，在最初的興奮過後，我們是否應該稍微減少新患者總數？

Any color on the (inaudible) number or the refilling on the prescription, if you can provide.

如果可以的話，請提供處方上（聽不清楚）號碼或續藥資訊的任何顏色。

Hi, Soumit. Thanks for your question.

你好，Soumit。謝謝你的提問。

As we said, there is no bolus so we expect this is going to be a continuous growth for us, with no bolus of patients. There are new cancer patients, unfortunately, every day. For ROS1-positive lung cancer patients, we believe IBTOZI is the best drug out there. So this will continue to increase. This is a rhythm.

正如我們所說，沒有激增，所以我們預計這將是我們的持續增長，而不會出現患者數量的激增。不幸的是，每天都有新的癌症患者。對於 ROS1 陽性肺癌患者，我們認為 IBTOZI 是目前最好的藥物。所以這個數字還會繼續增加。這是一種節奏。

As we discussed in the past, unfortunately, the number you can get from IQVIA today are still not accurate for us. We expect this is going to get better probably in the next quarter, maybe sometimes in February, March. That's what they told us. But today, obviously, you cannot get those numbers in a very good manner from IQVIA, which is why we're communicating about it.

正如我們之前討論過的，遺憾的是，目前從 IQVIA 獲得的數據對我們來說仍然不準確。我們預計這種情況可能會在下一季好轉，也許會在二月或三月。他們是這麼告訴我們的。但很顯然，如今你無法從 IQVIA 獲得這些數據，這就是我們進行溝通的原因。

In terms of growth, Colleen was saying there is still a lot of potential for us to grow because the majority of the patients are in the community setting, where we are doing a lot of efforts to promote IBTROZI because, today, despite the majority of patients out there, we still get a majority of patients from university center, very academic center, specialized center.

就成長而言，Colleen 表示我們仍有很大的成長潛力，因為大多數患者都在社區環境中，我們正在努力推廣 IBTROZI，因為如今，儘管大多數患者都在社區中，但我們仍然從大學中心、學術中心、專科中心獲得大多數患者。

So there is still a lot of patients out there for us to put on IBTOZI or to help them with our drug. That's what we're trying to do, right now.

所以，還有很多患者需要我們用 IBTOZI 治療，或是需要我們的藥物來幫助他們。這就是我們目前正在努力做的事情。

I would also emphasize that growth is going to come from several areas. Number one is beliefs that we're going to organically grow as we penetrate the market more and more.

我還要強調，成長將來自多個領域。第一點是，我們堅信隨著我們不斷深入市場，我們將實現有機成長。

But, also, we are making efforts to increase testing awareness. I think that should also increase the commercial opportunity.

但同時，我們也在努力提高人們對檢測的認識。我認為這應該也會增加商業機會。

But, finally, as you know, given the durability of IBTROZI, after a year, patients who continue on IBTROZI are going to start to get revenue stacking. So independent of new patients, just having patients past the one-year mark continue to stack revenues and with our median now DLR of 50 months, now, we're talking about a stack into the fifth year, not just the fourth year, as we had previously discussed.

但最後，如您所知，鑑於 IBTROZI 的持久性，一年後，繼續服用 IBTROZI 的患者將開始獲得收入累積。因此，即使不考慮新患者，只要患者超過一年，就能持續增加收入。而我們現在的DLR中位數是50個月，這意味著收入可以持續到第五年，而不僅僅是第四年，正如我們之前討論的那樣。

So I think there are a number of avenues for growth.

所以我認為有很多發展途徑。

Okay. You mentioned briefly you're in the final stages for a European partnership, is that something we should expect in fourth quarter, finalization of the deal? Any nature you are looking at? Code partnership, cost revenue share, or is it going to be completely out-licensed, royalty-based, with the option payment?

好的。您剛才簡要提到您正處於與歐洲企業合作的最後階段，我們是否可以期待在第四季度看到交易最終敲定？你在欣賞哪種自然景觀？是代碼合作、成本收益分成，還是完全對外授權、基於版稅並輔以選擇權付款？

We are in very advanced conversation. Honestly, we are very advanced in our conversation, right now. So I would expect that we could give you all the details you need sometimes in Q4.

我們正在進行非常深入的對話。說實話，我們現在已經聊得非常深入了。因此，我預計我們可以在第四季度向您提供您需要的所有詳細資訊。

Okay. One last one, the Nippon, the $25 million milestone, is that something we should include in the fourth quarter or more in the first quarter?

好的。最後一點，關於日本項目，2500萬美元的里程碑，我們應該把它算在第四季還是第一季？

No. This is a fourth-quarter event because this is not the approval from a regulatory perspective but the reimbursement list. So this is imminent, considering the typical timeline to negotiate price in Japan.

不。這是第四季發生的事件，因為這不是監管方面的批准，而是報銷清單的確定。考慮到日本典型的價格談判時間，這事很快就要發生了。

Great. Thank you, again, for taking all the questions. Congrats.

偉大的。再次感謝您回答所有問題。恭喜。

Leonid Timashev, RBC Capital Markets.

列昂尼德‧蒂馬舍夫，加拿大皇家銀行資本市場。

Hey, thanks for taking my questions.

嘿，謝謝你回答我的問題。

I wanted to drill down a little bit more on the first-line versus second- and later-line use. In the real world, practically, how many patients are truly treatment-naïve? Again, what I'm asking -- are there patients that are switching early and that might be somewhere in between what you would consider a first-line and a second-line patient? How do you think that might impact the real-world duration of response that you might have?

我想更深入探討第一線藥物與第二線及後續藥物的使用情況。在現實世界中，實際上有多少患者是真正沒有接受過治療的？我再次想問的是——是否有一些患者很早就開始轉換治療方案，他們可能介於您認為的第一線患者和二線患者之間？你認為這會對你實際的反應持續時間產生什麼影響？

And then, maybe, from a commercial perspective, as well, If competitors come on the market later with later-line labels, how effectively you might be able to corner off the market by being in first line or is there some wiggle room in what is truly a second-line versus a first-line patient?

此外，從商業角度來看，如果競爭對手後來帶著後續治療標籤進入市場，那麼你透過佔據第一線市場來有效壟斷市場的能力如何？或者，在真正的二線患者和第一線患者之間是否存在一些迴旋餘地？

Thanks. First of all, if you just look at DNA testing, based on DNA testing alone, there's an incidence of 3,000 new patients per year in the US alone. By definition, a new diagnosis means they are treatment-naïve. But that's authority out there. We would expect, given our data, that we would expect to become the treatment of choice for those patients.

謝謝。首先，如果只看 DNA 檢測，僅根據 DNA 檢測，光是在美國每年就有 3000 例新患者。根據定義，新確診的患者意味著他們之前沒有接受過治療。但那是外界的權威。根據我們的數據，我們預計我們將成為這些患者的首選治療方案。

For the prevalence pool of ROS1 patients that are already out there, who have been diagnosed in previous years and who have taken other therapies, other TKIs, as you've heard from Colleen, we're already seeing those patients being switched to IBTROZI, either for progression or for tolerability; and, in some cases, for nothing, just because our data are better.

對於目前已確診的 ROS1 患者群體，包括那些在前幾年被診斷出患有 ROS1 並接受過其他療法（如其他 TKI）的患者，正如 Colleen 所說，我們已經看到這些患者因為病情進展或耐受性問題而轉用 IBTROZI；在某些情況下，甚至完全沒有其他原因，僅僅是因為我們的數據更好。

So we will eventually capture -- we believe we will capture the vast majority of all TKI-experienced patients. But as we completely capture that pool, then we will continue to grow the market by new patients, which we think will be, if the standard of care just remains DNA testing, be 3,000 new patients a year in the US.

因此，我們最終將會——我們相信我們將將絕大多數接受過 TKI 治療的患者納入我們的研究範圍。但隨著我們完全佔領了這部分人群，我們將繼續透過新增患者來擴大市場，我們認為，如果護理標準仍然是 DNA 檢測，那麼美國每年將新增 3000 名患者。

We think the standard of care is going to change to RNA testing. That's going to go to about 4,000 new patients per year. We would expect to capture the majority of that.

我們認為，未來的治療標準將會轉變為RNA檢測。那將使每年新增患者人數達到約 4000 人。我們預計能夠獲得其中大部分的收益。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Great. Thanks so much. Congrats on a really nice start. Also, a couple of questions.

偉大的。非常感謝。恭喜你開局非常順利。另外，還有幾個問題。

We're backing into, let's say, 108 patients, on average, on therapy. You started 208 -- I'm sorry, 204. So it almost seems like we're in a pretty good run rate. You can actually grow fairly substantially in Q4. It sounds like you're comfortable with consensus for next year. I don't know if you can share with us what you think consensus is next year.

我們估計平均有 108 名患者正在接受治療。你一開始是 208——對不起，是 204。所以看起來我們目前的運行速度相當不錯。實際上，第四季你的成長空間相當可觀。聽起來你對明年達成共識的做法感到滿意。我不知道您能否和我們分享您對明年共識的看法。

And then, secondly, it looks like you're doing $4 million to $5 million, $5.5 million in collaboration license revs quarterly, is that a good runway to take into the next quarter, next year? Thank you.

其次，你們的季度合作授權收入似乎在 400 萬到 500 萬美元，甚至 550 萬美元之間，這樣的收入水準能否支撐到下一個季度，甚至明年呢？謝謝。

Thanks, Yaron.

謝謝你，亞倫。

I'll start with the collaboration point. A large chunk of our collaboration revenue from the quarter comes from our deferred revenue with Nippon Kayaku. So when we did the deal, we got, basically, deferred revenue that we recognize now because we have executed everything that we needed to do because -- by the case they are approved. So that's as simple as that. This collaboration revenue from that part of purely R&D collaboration revenue will go down.

我先從合作這一點說起。本季我們合作收入的大部分來自與日本化藥株式會社的遞延收入。所以，當我們達成這筆交易時，我們基本上獲得了遞延收入，現在我們確認這筆收入，因為我們已經完成了所有需要做的事情，因為——根據情況，它們都獲得了批准。事情就是這麼簡單。來自純粹研發合作收入部分的這部分合作收入將會下降。

But, on the other hand, as you pointed out, we will start to get more and more collaboration revenue driven by royalties. So far, royalties have been only coming from China, with Innovent. As I pointed out in previous calls, because they were not on the (inaudible) list, (inaudible) should prefer not to reimburse, Those royalty revenues were typically small. Now, they're going to increase if they get on the (inaudible) list.

但另一方面，正如你所指出的，我們將開始獲得越來越多的由版稅驅動的合作收入。到目前為止，專利費只來自中國，由信達生物技術有限公司支付。正如我在之前的電話中指出的那樣，因為他們不在（聽不清楚）名單上，（聽不清楚）最好不要報銷，這些版稅收入通常很少。如果他們上了（聽不清楚）名單，他們的人數就會增加。

At the same time, royalty revenues coming from Nippon Kayaku will increase, as well, because it will be on the market.

同時，由於日本化藥將推出市場，其帶來的版稅收入也將增加。

Finally, if we conclude during Q4 our partnership in Europe, we will have other collaboration revenues potentially coming from that.

最後，如果我們在第四季結束與歐洲的合作，我們可能會從中獲得其他合作收入。

So this part of our collaboration revenue from this quarter will disappear. But we'll have lots of other things coming up, in the terms of royalties.

因此，本季這部分合作收入將不復存在。但就版稅而言，我們還有很多其他的事情要做。

I think to your point about consensus, what we have for consensus in 2026 is about $115 million. As I pointed out, if we were to keep all the patients that we have seen starting on IBTROZI in Q3 -- so 204 -- this is an annual revenue of $55 million already.

關於您提到的共識，我認為 2026 年的共識約為 1.15 億美元。正如我指出的那樣，如果我們保留所有在第三季度開始接受 IBTROZI 治療的患者——也就是 204 人——這已經能帶來 5500 萬美元的年收入。

Considering a very, very long duration of response that even, typically, second-line patients will be on therapy for more than a year; the fact that all therapy is so tolerable that we don't believe that people will just go on this and then, go to something else, all of these accumulate revenue for next year.

考慮到療效持續時間非常非常長，即使是二線患者通常也會接受一年以上的治療；而且所有療法的耐受性都非常好，我們不認為人們會接受這種療法後就轉而接受其他療法，所有這些都會為明年積累收入。

$55 million is just patients that have started in Q3 staying on therapy for a full year. So that's all the reason why we're very comfortable with consensus next year.

5500萬美元僅僅是第三季度開始接受治療並堅持治療滿一年的患者的費用。所以，這就是我們對明年採取共識制非常有信心的全部原因。

David Nierengarten, Wedbush.

David Nierengarten，Wedbush。

Hey. Thanks for taking the question. Just a couple from me.

嘿。感謝您回答這個問題。我這裡也有幾個例子。

First off, there's a competitor around the corner who will be filing for approval. I was just wondering how you're preparing marketplace and your salesforce for that.

首先，附近有一家競爭對手即將提交審批申請。我只是想知道你們是如何為市場和銷售團隊做準備的。

On the Salesforce, also, is it fair to assume that your salesforce marketing efforts are fully built out at this point, with incremental ads over the next year? Or do you continue to plan on building out sales and marketing efforts? Thanks.

另外，在 Salesforce 方面，是否可以合理地假設您的 Salesforce 行銷工作目前已經全面展開，並在未來一年內逐步增加廣告投放？還是您繼續計劃擴大銷售和行銷力道？謝謝。

Well, David, I will respond to your first question by saying that there actually are no data from any drug, either approved or in development, that have been able to match our metrics. A 50-month DLR is unprecedented in this space.

好的，大衛，關於你的第一個問題，我想說，目前沒有任何藥物，無論是已獲批准的還是正在研發的，能夠達到我們的標準。50 個月的 DLR 在這個領域是前所未有的。

As I said, in the history of oncology, there's only one other drug that has a PFS or DLR that long. That drug has a response rate that's 76%, you might recall. Our first-line response rate was 89%.

正如我所說，在腫瘤學的歷史上，只有另一種藥物的 PFS 或 DLR 如此之長。你可能還記得，那種藥物的有效率是76%。我們的第一輪回應率為 89%。

So I would say that we feel extremely confident. If you look at the rate of our launch, we're capturing all lines of therapy but we would anticipate by next year, we will have captured a very sizable chunk of the second-line market; and next year, there are no new competitors in the first-line setting.

所以我覺得我們很有信心。從我們的產品上市速度來看，我們已經佔據了所有治療領域，但我們預計到明年，我們將佔據二線治療市場相當大的份額；而且明年，一線治療領域將沒有新的競爭對手。

So our only competitors in the first-line setting will be agents that are not being currently actively promoted. At which, we have data that, I would just say, there's really no match on any metric.

因此，我們在一線市場的唯一競爭對手將是那些目前沒有積極推廣的代理商。對此，我們掌握的數據，我只能說，在任何指標上，都找不到匹配項。

Our salesforce is full-time. We don't anticipate any increase.

我們的銷售團隊是全職的。我們預計不會有任何成長。

Okay. Great. Thanks. Nice quarter, guys.

好的。偉大的。謝謝。夥計們，這季度不錯。

Silvan Tuerkcan, Citizens.

Silvan Tuerkcan，公民。

Yeah. Thank you. Congrats, also, from me on the quarter.

是的。謝謝。也恭喜你本季取得佳績。

Just maybe to Colleen, what will be the added benefit of the marketing, basically the day after you get the new label with this new long DLR that you're showing? Maybe could you characterize also, today, with these 15 new patients per week that you're adding, what is that in terms of market share versus the competitors that are approved out there, right now? Thank you.

對科琳來說，或許在拿到帶有你展示的這種新型長DLR的新標籤的第二天，行銷的額外好處是什麼？您能否也分析一下，目前每週新增 15 名患者，與目前已核准的競爭對手相比，市佔率為何？謝謝。

Yeah. Thanks for your question.

是的。謝謝你的提問。

Well, the new label gives you opportunity, as you know, to be in front of your healthcare providers again, with new information. It's just going to solidify the story of IBTROZI.

如您所知，新的標籤讓您有機會再次與您的醫療保健提供者見面，並帶來新的資訊。這只會進一步鞏固 IBTROZI 的故事。

What we're hearing anecdotally from many of the HCPs, already, is that really is becoming the new standard of care in these ROS1-positive patients. So, for us, it just adds to the collection of positive data we already have in the efficacy and safety profile.

我們已經從許多醫療保健專業人員那裡聽到這樣的消息：這確實正在成為 ROS1 陽性患者的新標準治療方案。因此，對我們來說，這只是為我們已有的療效和安全性方面的正面數據錦上添花。

But with such a durable response now, as David mentioned, we don't know of any other oral oncolytic in any space with this type of DLR. So it's just the opportunity to continue to make sure that the [ATPs] are updated on this data.

但正如大衛所提到的，由於目前這種反應非常持久，我們不知道任何其他口服抗腫瘤藥物在任何領域都有這種類型的DLR。所以，這只是一個繼續確保[ATP]根據這些數據進行更新的機會。

It's really exciting for us. It's great to have something new for the OAMs, the Oncology Account Managers, going on.

這真的讓我們很興奮。很高興看到腫瘤客戶經理 (OAM) 們有了新的發展方向。

Secondly, you asked about market share so I'm going to turn that to you, Philippe, for you to take that one.

其次，你問到了市佔率的問題，所以這個問題就交給你來回答吧，菲利普。

Yeah. It's typical to compare the market share, right now, for the reason we said about the limitation of IQVIA. So this is something that, over time, will get better once we are really in a comparable basis with the other guys.

是的。目前比較市場佔有率是很常見的做法，原因正如我們之前提到的 IQVIA 的限制。所以隨著時間的推移，當我們真正與其他球隊處於可比地位時，這種情況會好轉的。

What is clear is that when you look at our launch and our history of launch, we are doing much better and much faster than any other drone launch in that space. We, after just three complete months, again, two or four patients starting in three complete rounds, that's 5 times or 6 times better than the latest launch in the space. So this is increasingly, really, the dominant player in terms of new patients.

顯而易見的是，縱觀我們的發射和發射歷史，我們在該領域做得比任何其他無人機發射都要好得多、快得多。僅僅三個月後，我們又一次讓兩到四名患者開始了三個完整的療程，這比該領域最新的產品好 5 到 6 倍。所以，就新增患者而言，它確實越來越佔據​​主導地位。

All right. Thank you. Maybe one follow-up, if I may.

好的。謝謝。如果可以的話，我想再補充一點。

On NUV-1511, your drug-drug conjugate, the data that we expect by year-end, how insightful will that be? How needle-moving for the company? What will you be able to tell us about that data? Thank you.

關於 NUV-1511（您的藥物偶聯物），我們預計到年底將獲得的數據，會有多大的參考價值？這對公司有多大影響？關於這些數據，您能告訴我們些什麼？謝謝。

We'll just present the data we've accumulated, to date, in our clinical trial.

我們將展示迄今為止我們在臨床試驗中累積的數據。

Great. Thanks.

偉大的。謝謝。

Thank you. There seem to be no questions waiting at this time so I'll pass it back over to the management team for any closing or further remarks.

謝謝。目前似乎沒有其他問題需要解答，所以我將把這個問題交還給管理團隊，讓他們做最後的總結或補充說明。

I just want to thank you, all, for dialing in. We really look forward to keeping you apprised of our progress. I will look forward, again, next quarter.

我只想感謝各位撥入電話。我們非常期待能及時向您報告我們的進展。我將再次期待下一季。

Thanks so much.

非常感謝。

Thank you. That will conclude today's call.

謝謝。今天的電話會議到此結束。

Thank you for your participation. You may now disconnect your line.

感謝您的參與。現在您可以斷開線路了。