Immunocore Holdings PLC (IMCR) 2025 Q2 法說會逐字稿

Greetings, and welcome to the Immunocore conference call and webcast. (Operator Instructions) As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Clayton Robertson, Investor Relations. Please go ahead, sir.

您好，歡迎參加 Immunocore 電話會議和網路廣播。（操作員指示）提醒一下，本次會議正在錄音。現在我很高興將電話轉給投資者關係部的克萊頓羅伯森 (Clayton Robertson)。先生，請繼續。

Good morning, and good afternoon. Thank you for joining us on our Q2 and first half 2025 earnings call. During today's call, we will make some forward-looking statements, which are qualified by our Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. Please note that actual results can vary materially from those indicated by these forward-looking statements, including those discussed in our filings with the SEC. On today's call, I'm joined by Bahija Jallal, CEO of Immunocore.

早安，下午好。感謝您參加我們的 2025 年第二季和上半年財報電話會議。在今天的電話會議中，我們將做出一些前瞻性陳述，這些陳述受 1995 年《私人證券訴訟改革法案》的安全港條款的限制。請注意，實際結果可能與這些前瞻性陳述所示的結果有重大差異，包括我們向美國證券交易委員會提交的文件中討論的結果。在今天的電話會議上，Immunocore 執行長 Bahija Jallal 也與我一同出席。

Ralph Torbay, Head of Commercial, will review our KIMMTRAK sales for the second quarter and first half of 2025 and discuss our life cycle management plans for KIMMTRAK. David Berman, our Head of R&D, will provide key updates from our three Phase III clinical trials. Travis Coy, our CFO and Head of Corporate Development, will also provide some key highlights from our financial results reported earlier this morning. Bahija?

商務主管 Ralph Torbay 將回顧我們 2025 年第二季和上半年的 KIMMTRAK 銷售情況，並討論我們對 KIMMTRAK 的生命週期管理計劃。我們的研發主管 David Berman 將提供我們三個 III 期臨床試驗的重要更新。我們的財務長兼企業發展主管 Travis Coy 也將提供我們今天上午報告的財務表現的一些重點。巴希賈？

Thank you, Clay. Good morning, and good afternoon, everyone. Thank you for joining the call today. We are pleased to report that 2025 is off to a strong start, reflected in our robust half year financial results and the progress of our diversified pipeline as we continue to deliver on our mission. Our strategy is anchored on three core pillars: maximizing the value of KIMMTRAK, advancing the clinical portfolio, and innovating for sustainable growth.

謝謝你，克萊。大家早安，下午好。感謝您今天參加電話會議。我們很高興地報告，2025 年開局強勁，這體現在我們強勁的半年財務業績和多元化管道的進展中，因為我們將繼續履行我們的使命。我們的策略以三大核心支柱為基礎：最大化 KIMMTRAK 的價值、推進臨床組合以及實現永續成長的創新。

For the first half of 2025, we generated $192 million in KIMMTRAK revenue, representing 32% growth year-over-year, an impressive milestone four years post launch. These results underscore the real-world impact of our therapies and the trust that patients, health care professionals, and partners place in our science.

2025 年上半年，KIMMTRAK 營收達到 1.92 億美元，年增 32%，這是推出四年來的一個令人印象深刻的里程碑。這些結果強調了我們的療法對現實世界的影響以及患者、醫療保健專業人員和合作夥伴對我們的科學的信任。

Expanding global access to KIMMTRAK remains our top priority. At the same time, we are executing with discipline and urgency across three Phase III melanoma trials, spanning adjuvants, first-line, and late-stage setting. Beyond KIMMTRAK, we are progressing multiple early-stage programs in oncology and infectious diseases.

擴大 KIMMTRAK 的全球訪問仍然是我們的首要任務。同時，我們正在嚴格且緊急地執行三項 III 期黑色素瘤試驗，涵蓋佐劑、第一線和後期治療。除了 KIMMTRAK，我們也正在推動腫瘤學和傳染病領域的多個早期計畫。

We remain on track to file the CTA for our autoimmune candidates in Type 1 diabetes by year-end 2025 and anticipate starting the Phase I trial in 2026. We also expect the CTA for our second autoimmune program next year. Our pipeline is built on rigorous transformational science, always focused on addressing significant unmet medical needs. We recognize the urgency for patients and are committed to advancing our programs thoughtfully and efficiently. Finally, our strong balance sheet enables us to invest in innovating while maintaining financial discipline.

我們仍有望在 2025 年底前為我們的 1 型糖尿病自體免疫候選藥物提交 CTA，並預計在 2026 年開始 I 期試驗。我們也預計明年將推出第二個自體免疫計畫的 CTA。我們的產品線建立在嚴謹的轉化科學之上，並始終專注於解決重大未滿足的醫療需求。我們認識到患者的緊迫性，並致力於周到而有效地推進我們的計劃。最後，我們強勁的資產負債表使我們能夠在保持財務紀律的同時投資創新。

This approach ensures we are well positioned to deliver long-term value for our shareholders. So now, the team will walk you through the details of the quarter, and I'll turn it over to Ralph. Ralph?

這種方法確保我們能夠為股東創造長期價值。現在，團隊將向您介紹本季度的詳細信息，然後我將把它交給拉爾夫。拉爾夫？

Thank you, Bahija. Hello, everyone. I am delighted to share our continued momentum in bringing KIMMTRAK to patients worldwide. We have now launched in 28 countries and are approved in 39 globally, representing exceptional progress in our mission to reach more patients with this transformational medicine. I'm proud that shortly after a very successful launch in the United Kingdom, KIMMTRAK received its fourth Prix Galien this time for Best Biotech Product.

謝謝你，Bahija。大家好。我很高興與大家分享我們繼續將 KIMMTRAK 帶給全球患者的動力。目前，我們的產品已在 28 個國家上市，並在全球 39 個國家獲得批准，這代表著我們在讓更多患者獲得這種轉化藥物的使命上取得了非凡的進展。我很自豪，KIMMTRAK 在英國成功推出後不久就獲得了第四個 Galien 獎，這次是最佳生物技術產品獎。

To support our growth and our mission to reach more patients globally, we have expanded our distribution of KIMMTRAK into Turkey and MENA regions through a partnership with Er-Kim. Now let me take you through our strong commercial performance in the next slide.

為了支持我們的發展和覆蓋全球更多患者的使命，我們透過與 Er-Kim 合作，將 KIMMTRAK 的分銷範圍擴大到土耳其和中東和北非地區。現在，讓我在下一張投影片中向您介紹我們強勁的商業表現。

We delivered $192 million in net sales for the first half of 2025, representing a 32% year-on-year growth. This exceptional performance demonstrates the continued strength of KIMMTRAK across all our markets. In Q2 specifically, we achieved $98 million in net sales, marking our 13th quarter of consecutive growth, a testament to our team's dedication and KIMMTRAK's transformational impact.

2025 年上半年，我們的淨銷售額達到 1.92 億美元，年增 32%。這一出色的表現證明了 KIMMTRAK 在我們所有市場中的持續實力。具體來說，在第二季度，我們實現了 9,800 萬美元的淨銷售額，這是我們連續第 13 個季度實現成長，這證明了我們團隊的奉獻精神和 KIMMTRAK 的轉型影響。

In the United States, we delivered $64 million in net revenue during the second quarter, representing a 15% increase compared to Q2 '24. We continue to see strong duration of therapy at 13 months with a growing market penetration now around 68%. I am pleased that 70% of prescriptions in the United States now come from the community, highlighting the broad acceptance and confidence physicians have in KIMMTRAK. As we enter our fourth year of launch, we continue to expect modest but meaningful growth in this well-established market.

在美國，我們第二季的淨收入為 6,400 萬美元，與 2024 年第二季相比成長了 15%。我們繼續看到 13 個月的治療持續時間的強勁增長，市場滲透率目前不斷增長，約為 68%。我很高興現在美國 70% 的處方來自社區，這突顯了醫生對 KIMMTRAK 的廣泛接受和信任。隨著我們進入推出的第四年，我們繼續期待在這個成熟的市場中實現適度但有意義的成長。

In Europe, we delivered $33 million in Q2 net revenue, representing an exceptional 115% year-on-year quarterly growth. While we are very pleased and well-penetrated across most major European markets, this growth was driven by successful launches in the UK, Poland, and Netherlands, continued growth in mature markets like Germany as well as strong market access achievements. Going forward, we expect to see incremental growth coming from Europe as these launches reach maturity.

在歐洲，我們第二季的淨收入達到 3,300 萬美元，年增 115%。雖然我們對大多數主要歐洲市場都非常滿意且滲透​​率很高，但這一成長得益於英國、波蘭和荷蘭的成功推出、德國等成熟市場的持續成長以及強勁的市場准入成就。展望未來，隨著這些產品的成熟，我們預期歐洲將出現增量成長。

Looking ahead, KIMMTRAK is well positioned for long-term growth with two Phase III clinical trial programs ongoing. Starting with TEBE-AM in cutaneous melanoma, which is on track to complete enrollment within the next 12 months. As we prepare for the potential expansion of KIMMTRAK, we are well positioned with around half of cutaneous melanoma treaters already experienced with KIMMTRAK due to the overlap with uveal melanoma.

展望未來，KIMMTRAK 已為長期成長做好了準備，目前正在進行兩個 III 期臨床試驗計畫。從治療皮膚黑色素瘤的 TEBE-AM 開始，預計在未來 12 個月內完成招募。在我們為 KIMMTRAK 的潛在擴展做準備時，我們已做好準備，由於與葡萄膜黑色素瘤重疊，大約一半的皮膚黑色素瘤治療者已經使用過 KIMMTRAK。

Providing positive data, this experience, coupled with a robust Phase III study design and OS endpoint, will give KIMMTRAK a very strong value proposition in the setting of high unmet need. Second, we have the ATOM study, the only registrational Phase III trial in the adjuvant uveal melanoma setting, where there is currently no standard of care.

透過提供積極的數據，這項經驗加上強大的 III 期研究設計和 OS 終點，將使 KIMMTRAK 在高未滿足需求的環境中具有非常強大的價值主張。其次，我們有 ATOM 研究，這是輔助性葡萄膜黑色素瘤領域中唯一的註冊性 III 期試驗，目前該領域尚無治療標準。

Together, these could bring the benefit of KIMMTRAK to up to 6,000 patients across US and Europe. I'm confident in our team's ability to execute on this vision and continue delivering exceptional long-term growth.

總之，KIMMTRAK 可以為美國和歐洲的多達 6,000 名患者帶來好處。我相信我們的團隊有能力實現這一願景並繼續實現卓越的長期成長。

With that, I would like to hand over to David to discuss these trials in more depth, our clinical progress, and pipeline developments.

接下來，我想讓 David 更深入地討論這些試驗、我們的臨床進展和管道發展。

Thank you, Ralph. I am pleased to share an update on our clinical portfolio. We have a truly unique and broad clinical pipeline, three Phase III trials in oncology with line of sight to completing TEBE-AM. We look forward to new insights maturing over the next 12 months in our earlier-stage oncology and infectious disease clinical programs. And in 2026, we will see the first clinical experience for our platform in autoimmunity.

謝謝你，拉爾夫。我很高興與大家分享我們臨床組合的最新進展。我們擁有真正獨特且廣泛的臨床管線，包括三項腫瘤學 III 期試驗，預計將完成 TEBE-AM。我們期待在未來 12 個月內，我們的早期腫瘤學和傳染病臨床計畫能夠取得新的進展。2026 年，我們將迎來我們平台在自體免疫領域首次臨床應用。

I will now highlight the three registrational trials, starting with TEBE-AM. TEBE-AM is a Phase III randomized trial in melanoma patients who have progressed on checkpoints and targeted therapy. Patients are randomized to KIMMTRAK alone, KIMMTRAK plus pembrolizumab and to a control arm, the primary endpoint being overall survival. This study is enrolling well globally and we project to complete enrollment in the first half of '26. In first-line cutaneous melanoma, patients receive either an anti-PD-1 with or without additional checkpoints or BRAF-targeted therapy.

我現在將重點介紹三項註冊試驗，首先是 TEBE-AM。TEBE-AM 是一項針對在檢查點和標靶治療方面取得進展的黑色素瘤患者進行的 III 期隨機試驗。患者隨機分配接受 KIMMTRAK 單獨治療、KIMMTRAK 加 pembrolizumab 治療和對照組，主要終點是總體存活期。這項研究在全球的招募情況良好，我們預計將在 26 年上半年完成招募。在第一線皮膚黑色素瘤治療中，患者可以接受抗 PD-1 治療，同時或不接受額外的檢查點或 BRAF 標靶治療。

In second-line cutaneous melanoma, patients can switch between these classes of therapy where appropriate. After this, however, there remains the large unmet need. Chemotherapy, retreatment with the same therapies, and clinical trials are frequently a primary option. The only new therapy in this setting are TILs, and no therapy in this setting has yet demonstrated an overall survival benefit, which is the gold standard. This is where we believe the opportunity for KIMMTRAK lies.

在二線皮膚黑色素瘤治療中，患者可以根據情況在這些類型的治療之間切換。然而，在此之後，仍然存在大量未滿足的需求。化療、採用相同療法再次治療以及臨床試驗通常是主要選擇。在這種情況下，唯一的新療法是 TIL，並且在這種情況下還沒有任何療法被證明具有整體生存益處，這是黃金標準。我們相信這正是 KIMMTRAK 的機會所在。

TILs are approved under accelerated approval and only based on response rate. Other options are commonly used but are not considered as having proven benefit. If TEBE-AM is positive, then KIMMTRAK would be the first new therapy with overall survival benefit in second-line melanoma. In addition, KIMMTRAK will provide an off-the-shelf therapy that is easy to administer and familiar to melanoma doctors. There's also another unique factor for KIMMTRAK, the safety profile.

TIL 是在加速審批下獲得批准的，並且僅基於回應率。其他選擇雖然常用，但並未被認為具有已證實的益處。如果 TEBE-AM 呈陽性，那麼 KIMMTRAK 將成為第一個在二線黑色素瘤中具有整體生存獲益的新療法。此外，KIMMTRAK 將提供易於管理且黑色素瘤醫生熟悉的現成治療方法。KIMMTRAK 還有另一個獨特因素，那就是安全性。

Having treated over 1,000 patients with KIMMTRAK, we have established a very clear AE profile that is unique in melanoma. The most frequent treatment-related AEs are mechanism-based, cytokine release syndrome, and rash. They are transient and reversible. They occur early in the first few weeks with no cumulative or novel treatment-related AEs after month one, and we expect KIMMTRAK to have a similar profile in cutaneous melanoma. TEBE-AM is the only ongoing Phase III in adjuvant UM.

我們已經使用 KIMMTRAK 治療了超過 1,000 名患者，建立了黑色素瘤獨有的非常清晰的 AE 特徵。最常見的治療相關不良事件是基於機制的不良事件、細胞激素釋放症候群和皮疹。它們是短暫的和可逆的。它們在最初幾週內早期發生，一個月後沒有累積或新的治療相關不良事件，我們預期 KIMMTRAK 在皮膚黑色素瘤中具有類似的特徵。TEBE-AM 是輔助 UM 領域唯一正在進行的 III 期研究。

High-risk adjuvant UM patients are randomized to KIMMTRAK for observation, the primary endpoints being relapse-free survival. The study, which is sponsored by EORTC, is activated in multiple European countries and EORTC expects to start in the US this fall. ATOM is currently in the initial stages of site activation and patient accrual.

高風險輔助 UM 患者隨機分配到 KIMMTRAK 進行觀察，主要終點是無復發生存期。這項研究由 EORTC 贊助，已在多個歐洲國家啟動，EORTC 預計今年秋季在美國啟動。ATOM 目前正處於站點啟動和患者累積的初始階段。

I will now turn to the third Phase III trial, PRISM-MEL. PRISM-MEL is randomizing first-line cutaneous melanoma patients to brenetafusp plus nivolumab versus either nivolumab monotherapy or Opdualag. The primary endpoint is progression-free survival. We have successfully activated 150 sites globally. In a pre-planned analysis conducted earlier this year, the IDMC reviewed only the safety of the first 30 patients randomized and advised us to continue with no changes to the study. The next step is for the IDMC to select the go-forward dose from the ongoing Phase III study, and I will now give you some context to this.

現在我將討論第三階段 III 期試驗 PRISM-MEL。PRISM-MEL 將第一線皮膚黑色素瘤患者隨機分配接受 brenetafusp 加 nivolumab 治療，或接受 nivolumab 單藥治療或 Opdualag 治療。主要終點是無惡化存活期。我們已成功在全球啟動了 150 個站點。在今年稍早進行的一項預先計劃的分析中，IDMC 僅審查了隨機分組的前 30 名患者的安全性，並建議我們繼續進行研究，不做任何改變。下一步是讓 IDMC 從正在進行的 III 期研究中選擇下一步劑量，現在我將向您介紹一些相關背景資訊。

In the Phase I trial, we observed that both 40 and 160 micrograms had similar clinical activity and both were well tolerated. However, this was from a non-randomized Phase I. Therefore, in discussion with the FDA and as per Project Optimus, we agreed to compare these two doses in a randomized fashion within the ongoing Phase III study. After the first 90 patients are randomized, the IDMC will review safety and RECIST efficacy endpoints such as response rate and disease control rate. The decision on the go-forward dose will be based on a benefit-risk analysis by the IDMC. The IDMC will not review or compare the efficacy from the control arm.

在第一階段試驗中，我們觀察到 40 微克和 160 微克均具有相似的臨床活性，且耐受性良好。然而，這是來自非隨機 I 期的研究。因此，在與 FDA 討論並按照 Optimus 計畫的要求，我們同意在正在進行的 III 期研究中以隨機方式比較這兩種劑量。在前 90 名患者隨機分組後，IDMC 將審查安全性和 RECIST 療效終點，例如緩解率和疾病控制率。關於繼續用藥劑量的決定將基於 IDMC 的效益風險分析。IDMC 不會檢視或比較對照組的療效。

Finally, I will turn to the early- to mid-stage clinical pipeline. As we anticipate significant clinical progress over the next 12 months. In addition to the PRISM-MEL trial in cutaneous melanoma, our PRAME program includes brenetafusp combinations in ovarian and lung as well as the Phase I dose escalation of PRAME half-life extension. Over the next 12 months, we plan to complete this exploration of PRAME to inform next steps.

最後，我將談談早期到中期的臨床流程。我們預計未來 12 個月內臨床將取得重大進展。除了皮膚黑色素瘤的 PRISM-MEL 試驗外，我們的 PRAME 計畫還包括卵巢和肺癌的 brenetafusp 組合以及 PRAME 半衰期延長的 I 期劑量遞增。在接下來的 12 個月內，我們計劃完成對 PRAME 的探索，以便為下一步行動提供參考。

For PIWIL in colorectal cancer, we expect to complete monotherapy dose escalation and initiate combinations in earlier lines of therapy. For HIV, we plan to complete dose escalation, including evaluation of HIV viral control and also we plan to initiate an expansion. The final data for the single-dose escalation of HBV will be presented in a few months at AASLD. Finally, we expect to start dosing the Type 1 diabetes program, our first autoimmune indication. And we plan to submit the CTA for our second autoimmune program for CD1a in atopic dermatitis.

對於大腸直腸癌的 PIWIL，我們期望完成單一療法劑量的遞增，並在早期療法中啟動聯合治療。對於愛滋病毒，我們計劃完成劑量遞增，包括對愛滋病毒控制的評估，我們也計劃啟動擴展。HBV 單劑量遞增的最終數據將在幾個月後在 AASLD 上公佈。最後，我們期望開始實施第 1 型糖尿病治療計劃，這是我們的第一個自體免疫適應症。我們計劃提交針對異位性皮膚炎 CD1a 的第二個自體免疫項目的 CTA。

We are in a unique position for a biotech of our size. We have a commercial product and have invested in two life cycle management Phase III registrational trials, including one in the adjuvant setting. And we have a third Phase III registrational trial in first-line cutaneous melanoma for brenetafusp. Randomized trials take longer to recruit and to read out. But once we have the data, it is definitive.

對於我們這種規模的生技公司來說，我們處於獨特的地位。我們擁有一款商業產品，並已投資兩項生命週期管理 III 期註冊試驗，其中一項是在輔助治療中進行的。我們也進行了針對 brenetafusp 的一線皮膚黑色素瘤治療的第三階段 III 期註冊試驗。隨機試驗需要更長的時間來招募和讀出結果。但一旦我們有了數據，它就是確定的。

We believe we have line of sight to the first of these Phase III trials, TEBE-AM. For our earlier-stage programs, 2026 will be an important year to inform the next steps for PRAME and PIWIL as well as for our HIV and HBV programs. Finally, the next 12 months will bring our first clinical experience in autoimmunity. We believe that this will be the first clinical test ever of a purely PD-1 agonist and one that is tissue-targeted. This is a robust pipeline and I have confidence that our R&D teams will continue to hit our operational milestones.

我們相信我們已經看到了這些 III 期試驗中的第一個，TEBE-AM。對於我們早期的計畫來說，2026 年將是決定 PRAME 和 PIWIL 以及我們的 HIV 和 HBV 計畫的下一步行動的重要一年。最後，未來 12 個月我們將首次獲得自體免疫的臨床經驗。我們相信這將是有史以來第一次純 PD-1 激動劑和組織靶向的臨床試驗。這是一個強大的管道，我相信我們的研發團隊將繼續實現我們的營運里程碑。

I will now hand over to Travis.

現在我將把麥克風交給崔維斯。

Thank you, David. Good morning, and good afternoon, everyone. Earlier today, we released our financial results for the second quarter and six months ended June 30, 2025. Please refer to the press release and our latest SEC filing on Form 10-Q for our full financial results. Let me share some of our key financial highlights for the quarter and touch on expectations for the remainder of 2025.

謝謝你，大衛。大家早安，下午好。今天早些時候，我們發布了截至 2025 年 6 月 30 日的第二季和六個月的財務表現。請參閱新聞稿和我們最新的 SEC 10-Q 表格，以了解我們的完整財務表現。讓我分享本季的一些主要財務亮點，並談談對 2025 年剩餘時間的預期。

We are pleased to report strong performance for KIMMTRAK with Q2 net sales reaching $98 million. This represents a 4% sequential increase over Q1 sales and a 30% increase over Q2 of last year and was driven by volume growth in both the US and Europe. Recently, quarterly revenue from KIMMTRAK has grown sequentially in the range of 4% to 7%. Moving forward, we expect KIMMTRAK to continue growing, albeit more modestly, given that we are in our fourth year on the market.

我們很高興地報告 KIMMTRAK 業績強勁，第二季淨銷售額達到 9,800 萬美元。這意味著銷售額比第一季環比成長 4%，比去年第二季成長 30%，這得益於美國和歐洲銷量的成長。最近，KIMMTRAK 的季度營收連續成長了 4% 至 7%。展望未來，我們預計 KIMMTRAK 將繼續成長，儘管成長速度會比較溫和，因為我們已經進入市場第四年了。

One other revenue-related item to note is that throughout 2024, we booked revenue reserves due to ongoing pricing negotiations in Europe, most notably in France and Germany. The success of those price negotiations in Q1 of this year now results in favorable year-on-year comparisons for Europe. As we think about future performance for Europe and the international regions, we expect incremental growth to come from additional launches.

另一個需要注意的與收入相關的事項是，在整個 2024 年，由於歐洲（尤其是法國和德國）正在進行的價格談判，我們預留了收入儲備。今年第一季價格談判的成功為歐洲帶來了同比有利的業績。當我們考慮歐洲和國際地區的未來表現時，我們預計增量成長將來自額外的發布。

While we continue to advance our portfolio, we saw an increase in our operating expenses this quarter. The growth in R&D spending was primarily driven by ongoing investments in our three Phase III trials as well as advancement of our early-stage research programs as we progress towards initiation of clinical studies.

在我們繼續推進產品組合的同時，本季的營運費用有所增加。研發支出的成長主要得益於我們對三個 III 期試驗的持續投資，以及隨著臨床研究的啟動，我們早期研究計畫的進展。

Consistent with what we said at the beginning of this year, we expect our R&D expenses to increase versus last year as we make data-driven investments in our pipeline. Our SG&A expenses versus last year have increased slightly, primarily due to an increase in general business functions needed to support our growing operations.

與我們今年年初所說的一致，隨著我們對我們的產品線進行數據驅動的投資，我們預計我們的研發費用將比去年增加。我們的銷售、一般及行政費用與去年相比略有增加，這主要是因為支持我們不斷增長的業務所需的一般業務職能有所增加。

We will continue to be disciplined with our SG&A investments. We have averaged $42 million per quarter for the last three quarters and expect those investments to be mostly flat for the remainder of 2025 while allowing for typical quarterly variability. Through the first half of this year versus the same period last year, we are pleased to have our net loss decrease from $36 million to $5 million as revenue has grown more than our operating expenses.

我們將繼續嚴格控制銷售、一般及行政費用 (SG&A) 投資。過去三個季度，我們平均每季度的投資為 4,200 萬美元，預計在 2025 年剩餘時間內，這些投資將基本持平，同時允許典型的季度波動。與去年同期相比，今年上半年我們的淨虧損從 3,600 萬美元減少到 500 萬美元，因為收入成長超過了營運支出。

As of the end of June, we have a strong balance sheet with $883 million in cash and marketable securities. In the second half of 2025, we expect to pay approximately $65 million related to European rebate accruals from prior periods. With a robust foundation built upon strong revenue from KIMMTRAK, expense discipline, and data-driven strategic investments, we are advancing our portfolio to deliver transformative medicines across all three of our therapeutic areas while continuing to expand our reach to patients globally.

截至 6 月底，我們的資產負債表強勁，擁有 8.83 億美元的現金和有價證券。2025 年下半年，我們預計將支付與前期歐洲回扣應計金額相關的約 6,500 萬美元。憑藉 KIMMTRAK 強勁的收入、費用控制和數據驅動的策略投資所建立的堅實基礎，我們正在推進我們的產品組合，以在我們所有三個治療領域提供變革性藥物，同時繼續擴大我們在全球患者的覆蓋範圍。

I'll now turn the call back to Bahija.

我現在將電話轉回給 Bahija。

Thank you, Travis. With our solid first-half year results, we remain focused on delivering continued progress with the life cycle management plans for KIMMTRAK as well as enrolling patients across the multiple ongoing clinical trials from Phase I to Phase III in oncology and infectious diseases. I'm really excited by the expansion of our diversified pipeline into autoimmune as we plan the CTA for our Type 1 diabetes candidate before the end of 2025 and starting clinical trials in the first half of 2026. So there's a lot to come over the next year. I want to thank our shareholders, our partners and most importantly, the patients and families who inspire us every day.

謝謝你，崔維斯。憑藉我們上半年的穩健業績，我們將繼續專注於推動 KIMMTRAK 的生命週期管理計劃的持續進展，以及招募腫瘤學和傳染病領域正在進行的從 I 期到 III 期的多​​個臨床試驗的患者。我們計劃在 2025 年底之前為我們的 1 型糖尿病候選藥物進行 CTA，並在 2026 年上半年開始臨床試驗，因此，我們多元化的藥物管線擴展到自體免疫領域，對此我感到非常興奮。因此，明年還有很多事情要做。我要感謝我們的股東、我們的合作夥伴，最重要的是，感謝每天激勵我們的病人和家屬。

In addition, none of this progress would have been possible without the dedication and expertise of our employees. Their commitment and passion drive our mission forward and are fundamental to our continued success.

此外，如果沒有我們員工的奉獻和專業知識，這些進步都不可能實現。他們的承諾和熱情推動著我們的使命不斷前進，是我們持續成功的基礎。

Together, we are making a difference and I am confident that 2025 will be another year of meaningful progress. So thank you for your continued support, and the team and I will be happy to take your questions.

我們正在共同創造改變，我相信 2025 年將會是另一個有意義進步的一年。感謝您一直以來的支持，我和我的團隊很樂意回答您的問題。

(Operator Instructions) Gil Blum, Needham & Company.

（操作員指示）Gil Blum，Needham & Company。

Good morning, everyone, and congrats on the advancement in this quarter. Maybe a quick question for David as it relates to the design of the study. So we're removing one of the doses. What happens to the patients whose dose is being discontinued? Are they crossing over? Or how will this be analyzed in the larger statistical analysis? Just remind us. Thank you.

大家早安，恭喜本季的進步。也許我想問大衛一個簡單的問題，因為它與研究設計有關。因此，我們要減少其中一劑。停止服藥的患者會怎樣？他們要穿越嗎？或者在更大的統計分析中如何分析這一點？只是提醒我們一下。謝謝。

Hey, Gil, thank you for the question. The patients who are in the not go-forward dose, the dose that's dropped, they will continue on that dose, although the IDMC may also recommend that they switch to the go-forward dose. They will not be included in the ITT analysis.

嘿，吉爾，謝謝你的提問。對於未採用繼續劑量（即降低的劑量）的患者，他們將繼續採用該劑量，儘管 IDMC 也可能建議他們改用繼續劑量。它們不會被納入 ITT 分析中。

Okay, thank you, very helpful. And a question for you, Travis. Clearly, growth is continuing unabated and margins are looking pretty good. Should we start thinking about a breakeven point? Thank you.

好的，謝謝，很有幫助。崔維斯，我想問你一個問題。顯然，成長動能持續不減，利潤率看起來相當不錯。我們是否應該開始考慮損益平衡點？謝謝。

Yeah. Thanks, Gil. I think it's a bit too early to be thinking about profitability. We continue to invest in our three Phase III trials as well as the remainder of the portfolio so we do expect our R&D expenses to increase. I think, we continue to be pleased with the growth from KIMMTRAK, but we do expect that growth to moderate on a sequential basis moving forward, given that we are on the fourth year of market.

是的。謝謝，吉爾。我認為現在考慮獲利能力還為時過早。我們將繼續投資於我們的三個 III 期試驗以及剩餘的投資組合，因此我們預計我們的研發費用將會增加。我認為，我們繼續對 KIMMTRAK 的成長感到滿意，但考慮到我們已進入市場的第四年，我們確實預計未來成長將逐年放緩。

Eric Schmidt, Cantor Fitzgerald.

艾瑞克·施密特、康托·費茲傑拉。

Another question for David, this one on TEBE-AM, possible changing goalposts at the FDA with regard to oncology drug approvals. With regard to TEBE-AM, if you hit on the pembro combination arm but miss on the monotherapy arm, do you have enough evidence to support KIMMTRAK's contribution to the effect? Thanks.

我要問 David 的另一個問題是關於 TEBE-AM 的，FDA 在腫瘤藥物審批方面的目標可能會改變。對於 TEBE-AM，如果您擊中了 pembro 組合組但錯過了單一療法組，您是否有足夠的證據支持 KIMMTRAK 對效果的貢獻？謝謝。

Eric, thank you for that good question. So in that setting, I think there's two arguments. One is the scientific argument that we designed the eligibility such that the patients are unlikely to respond to PD-1 or shouldn't respond to PD-1. But the second is that we know from real-world analysis of patients who have the eligibility for our trial, that a significant proportion actually do get retreatment with anti-PD-1 even though it's believed to be ineffective. So if our control arm reflects that real-world evidence, we do believe we'll have sufficient anti-PD-1 monotherapy in our control arm to provide the contribution of compliance.

艾瑞克，謝謝你提出這個好問題。因此，在這種環境下，我認為有兩個論點。一個是科學論證，我們設計的資格使得病人不太可能對 PD-1 做出反應或不應該對 PD-1 做出反應。但第二點是，我們從對符合試驗條件的患者的真實世界分析中得知，儘管人們認為抗 PD-1 療法無效，但相當一部分患者確實接受了抗 PD-1 療法的再治療。因此，如果我們的對照組反映了現實世界的證據，我們確實相信我們的對照組中將有足夠的抗 PD-1 單一療法來提供依從性的貢獻。

Okay. Thank you. And then a quick one for Travis. Can you quantify what the impact in Europe is from the previously deferred revenue component? Thanks.

好的。謝謝。接下來是崔維斯的簡短演講。您能否量化先前遞延的收入部分對歐洲的影響？謝謝。

Yeah. As I mentioned, those pricing negotiations that we were completing in the first quarter of this year. We were booking revenue reserves last year. The total of those revenue reserves was about $18 million, roughly spread -- roughly, roughly spread evenly in quarter last year. So that gives you some quantification how you can think about it.

是的。正如我所提到的，我們在今年第一季完成了那些定價談判。我們去年就預訂了營收儲備。這些收入儲備總額約為 1800 萬美元，大致分佈在去年季度。這樣，您就可以量化地思考這個問題。

Tyler Van Buren, TD Cowen.

泰勒範布倫 (Tyler Van Buren)，TD Cowen。

Great. Thanks so much. Can you talk about where you think the average duration of therapy for KIMMTRAK will settle out at? Are we about there at 13 months? Or do you think we could add another month or potentially more than that? And then just the second question is, I think Eric alluded to this, but given the recent Replimune CRL, are you seeing a change in stance at the FDA based upon your interactions? Or do you think there's any read-through to your ongoing programs?

偉大的。非常感謝。您能談談您認為 KIMMTRAK 的平均治療時間會穩定在多少嗎？13 個月後我們就到了嗎？或者您認為我們可以再延長一個月甚至更多？然後第二個問題是，我認為 Eric 提到了這一點，但鑑於最近的 Replimune CRL，根據您的互動，您是否看到 FDA 的立場發生了變化？或者您認為您正在進行的計劃是否有任何解釋？

Great. I think, Ralph will start and then David.

偉大的。我認為，拉爾夫會先開始，然後是大衛。

Sure. Thank you, Tyler. So look, we're very happy with what we're seeing from a duration of therapy perspective because obviously, that means that patients are doing very well.

當然。謝謝你，泰勒。所以，從治療持續時間的角度來看，我們對所看到的結果感到非常滿意，因為顯然這意味著患者的狀況非常好。

In terms of where it's going to go, it's actually -- this is my first experience with the medicine having a better real-world duration of therapy than in clinical trials, which -- so it's hard for me to give you exactly where this is going to go. That being said, we're in our fourth year of launch. So we do expect this to be significantly moderating and currently is at 13 months.

至於它的未來走向，實際上——這是我第一次體驗到這種藥物在現實世界中的治療持續時間比在臨床試驗中的治療持續時間更長，因此——我很難確切地告訴你它的未來走向。話雖如此，我們已經進入了第四年。因此，我們確實預計這一進程將顯著緩和，目前已是 13 個月。

I think, Tyler, with respect to your second question, we haven't seen any changes yet. And maybe the other thing just to mention is that the review division that reviews KIMMTRAK and PRISM-MEL is the Melanoma Solid Oncology Group. And so we have been getting insight from them before we started the trial and during the trial.

泰勒，關於你的第二個問題，我認為我們還沒有看到任何變化。也許還要提一下的是，審查 KIMMTRAK 和 PRISM-MEL 的審查部門是黑色素瘤實體腫瘤學組。因此，我們在試驗開始之前和試驗期間一直從他們那裡獲得見解。

Our Phase III trials are well designed. The uses a survival endpoint. It's randomized with the homogenous population. And as I said to Eric, I believe we'll have enough anti-PD-1 in the control arm to provide contribution of components. The PRISM-MEL first-line Phase III also well-designed randomized trial also with input from the FDA.

我們的第三階段試驗設計得很好。使用生存終點。它是與同質人群隨機化的。正如我對 Eric 所說的那樣，我相信對照組中有足夠的抗 PD-1 來提供成分貢獻。PRISM-MEL 一線 III 期隨機試驗也是精心設計的，並且得到了 FDA 的投入。

Jessica Fye, JPMorgan.

潔西卡費伊（Jessica Fye），摩根大通。

Hi, thank you. This is Adam on for Jess. Thanks for taking our question. Two for you. Can you share some details as to what drove the growth in the US and will this trend continue? And my second one is can you update us on the time line of the Phase III ATOM trial? When could we see data? Thank you.

你好，謝謝。這是亞當為傑西表演的。感謝您回答我們的問題。給你兩個。您能否分享一些有關推動美國成長的細節以及這種趨勢是否會持續下去？我的第二個問題是，您能否向我們介紹第三階段 ATOM 試驗的時間表？我們什麼時候可以看到數據？謝謝。

Sure. Ralph, do you want to start? And Mohammed, do you want to--?

當然。拉爾夫，你想開始嗎？穆罕默德，你想──？

Sure. So Adam, again, really pleased with the growth that we've had, $64.1 million in the US. That's a 15% year-on-year quarterly growth. Look, the progress has mostly come from what we've been saying, which is we're trying to penetrate deeper into the community and get that experience with KIMMTRAK as well. So we went from 65% to 68%.

當然。因此，亞當再次對我們的成長感到非常高興，在美國取得了 6,410 萬美元的成長。這意味著季度同比增長 15%。你看，進展主要來自於我們一直在說的話，那就是我們正試圖更深入地融入社區，並透過 KIMMTRAK 獲得這種經驗。因此我們從 65% 上升到了 68%。

And now we're -- with duration of therapy, we also see that increasing from 12 months to 13 months. That being said, we're in our fourth year of launch. So I do expect the growth to be moderating, as Travis has mentioned.

現在，隨著治療時間的延長，我們也看到治療時間從 12 個月增加到 13 個月。話雖如此，我們已經進入了第四年。因此我確實預計增長將會放緩，正如特拉維斯所提到的。

TEBE-AM, next growth then?

TEBE-AM，下一個成長點是什麼？

And with TEBE-AM, we actually -- we have line of sight to the final enrollment within the next 12 months, which actually puts us in the midterm growth potential if the data is positive. And then after that, we have ATOM, which is the question that you've asked, and I'll pass it on to David for that answer.

透過 TEBE-AM，我們實際上可以預見未來 12 個月內的最終註冊人數，如果數據是正面的，這實際上使我們具有中期成長潛力。然後，我們有了 ATOM，這是您提出的問題，我會將其傳遞給 David 以獲得答案。

Mohammed?

穆罕默德？

Yeah. I can answer it. So with ATOM, obviously, it's an adjuvant study. We're in the early stages of site activation. Obviously, this is sponsored by the EORTC so they're actually running the trial. For these type of trials, typically, it can take up to three years for accrual and then it's an event-free survival endpoint. So I think we need to wait until we have the sites activated and we're at steady state before we can make a more precise prediction of when to expect readout from the trial.

是的。我可以回答。因此，對於 ATOM 來說，顯然是一項輔助研究。我們正處於站點啟動的早期階段。顯然，這是由 EORTC 贊助的，所以他們實際上正在進行試驗。對於此類試驗，通常需要長達三年的時間才能達到無事件存活終點。因此我認為我們需要等到站點啟動並且達到穩定狀態後才能更精確地預測何時可以得到試驗結果。

Great. Thanks for expanding.

偉大的。感謝您的擴充。

(Operator Instructions) Jonathan Chang, Leerink Partners.

（操作員指示）Jonathan Chang，Leerink Partners。

Hi. This is Albert Agustinus dialing in for Jonathan Chang. My question is are you also still on track to present data for the TEBE-AM study in the second half of '26?

你好。我是阿爾伯特·阿古斯丁 (Albert Agustinus)，正在為喬納森·張 (Jonathan Chang) 撥打電話。我的問題是，您是否仍將在 26 年下半年提供 TEBE-AM 研究的數據？

So Albert, we're on track to complete randomization of the study. That's certainly within our control. The endpoint is always driven by events, so that obviously depends on when the events occur. Right now, we've speculated that it could be in the second half of of '25 now -- sorry, of '26, apologies. Now there's always a cone of uncertainty. And as you get more events, you can narrow that uncertainty more precisely. So as we get more events, we'll be able to narrow that cone and predict better when those events can occur.

所以艾伯特，我們正在按計畫完成研究的隨機化。這當然在我們的控制範圍內。端點總是由事件驅動，因此顯然取決於事件發生的時間。現在，我們推測它可能會在 2025 年下半年——抱歉，是 2026 年，抱歉。現在總是存在著不確定性。隨著你獲得更多事件，你可以更精確地縮小不確定性。因此，隨著我們獲得更多事件，我們將能夠縮小範圍並更好地預測這些事件何時發生。

Michael Schmidt, Guggenheim Partners.

古根漢合夥公司的麥可‧施密特。

Hey. This is Paul on for Michael. Thanks for taking our question. For KIMMTRAK, I had a quick follow-up on the duration discussion. Have you observed any meaningful differences in the real-world duration of therapy depending on whether patients are treated in academic settings versus the community where there might be some different logistical challenges? And then also on KIMMTRAK, I wondered if you could comment briefly on the potential evolution of competition in the uveal melanoma space. There's a late-line oral regimen in development for the HLA-negative setting that's also generating some survival data across allcomers.

嘿。這是保羅代替麥可。感謝您回答我們的問題。對於 KIMMTRAK，我對持續時間討論進行了快速跟進。您是否觀察到，在現實世界中，治療持續時間是否存在任何有意義的差異，這取決於患者是在學術環境中接受治療，還是在可能存在不同後勤挑戰的社區中接受治療？然後同樣在 KIMMTRAK 上，我想知道您是否可以簡要評論一下葡萄膜黑色素瘤領域競爭的潛在演變。目前針對 HLA 陰性環境的晚期口服治療方案正在開發中，該方案也正在為所有患者產生一些存活數據。

How would you expect KIMMTRAK to be positioned against a possible off-label competitor, particularly in oral regimen? And in general, what does your market research tell you about the longer-term role for KIMMTRAK in uveal melanoma?

您認為 KIMMTRAK 在與潛在非上市競爭對手的競爭中將處於怎樣的定位，尤其是在口服療法方面？總的來說，您的市場調查告訴您 KIMMTRAK 在治療葡萄膜黑色素瘤的長期作用是什麼？

Thank you, Paul, for the questions. So with regard to the duration of therapy, it's actually -- we're seeing very similar numbers in the academic setting in the community. Keep in mind, community is also closer to home. So for these patients, it's a very convenient aspect to go in and out of the office.

謝謝保羅提出的問題。因此，就治療持續時間而言，實際上——我們在社區的學術環境中看到的數字非常相似。請記住，社區也離家更近。因此對於這些患者來說，進出診所非常方便。

Importantly, actually, and I think one of the reasons the duration of therapy is being driven is the safety profile. We don't see a lot of events happening after the first few cycles, which actually makes it a much more tolerable medicine for patients. In fact, we've seen patients who have been back to work seven years after being on KIMMTRAK, which is actually very impressive.

實際上，重要的是，我認為治療持續時間受到驅動的原因之一是安全性。在最初幾個週期後，我們並沒有看到太多事件發生，這實際上使其成為對患者更容易耐受的藥物。事實上，我們已經看到一些患者在接受 KIMMTRAK 治療七年後重返工作崗位，這確實非常令人印象深刻。

With regard to the therapies in development for HLA-A*02:01 negative patients, there, while we don't underestimate competitors and it's great to see development in this high unmet need population, for the positive, we have established KIMMTRAK as a standard of care. It's the number one prescribed drug. We have completely shifted the OS bar to now 22 months of median.

關於針對 HLA-A*02:01 陰性患者正在開發的療法，雖然我們不會低估競爭對手，並且很高興看到這一高未滿足需求人群的發展，但積極的一面是，我們已經將 KIMMTRAK 確立為護理標準。它是排名第一的處方藥。我們已將 OS 標準完全轉移到現在的中位數 22 個月。

We have three-year long-term overall survival, which is unprecedented in a setting like uveal melanoma. And as we discussed the long-term safety and patients doing well from a DOT perspective, it all speaks to this excellent profile and establishment.

我們的長期整體存活期為三年，這在葡萄膜黑色素瘤等疾病中是前所未有的。當我們從 DOT 的角度討論長期安全性和患者的良好表現時，這一切都證明了這個優秀的形象和機構。

James Shin, Deutsche Bank.

德意志銀行的詹姆斯辛 (James Shin)。

Hey, good morning, guys. Thanks for taking this question. First one is for Dave. Just to piggyback on what Eric and Tyler asked on TEBE-AM. And I appreciate all the comments you made about contribution component and OS being the primary. But the peers that had FDA turmoil, they also had agreement, it sounded like, but there was not complete agreement. So I guess a more pointed way to ask is has IMCR checked in with FDA were the right people at to confirm TEBE's design is acceptable? And then could you -- relative to, I think -- and this one's for Travis. I think you said duration is now 13 months in the US. How is -- it's very early in Europe, but how is duration trending relative to how duration trended in the US?

嘿，大家早安。感謝您回答這個問題。第一個是給戴夫的。只是為了回應 Eric 和 Tyler 在 TEBE-AM 上提出的問題。我感謝您對貢獻組件和作業系統作為主要部分所提出的所有評論。但經歷過 FDA 動盪的同行們聽起來也達成了一致，但並沒有完全達成一致。因此，我想更尖銳的問題是，IMCR 是否已與 FDA 核實是否有合適的人員來確認 TEBE 的設計是否可接受？然後你能——相對而言，我認為——這個是給特拉維斯的。我認為您說的是美國現在的期限是 13 個月。歐洲的情況還很早，但相對於美國的持續時間趨勢而言，持續時間趨勢如何？

Yeah. so I'll take the first one. There were two issues with the recent news. The first was the issue on a Phase II single-arm combination. And so that doesn't apply to us because we're having a Phase III trial that's randomized with overall survival benefit. So that's, I think, point number one.

是的。所以我選擇第一個。最近的新聞有兩個問題。第一個是關於第二階段單臂組合的問題。所以這不適用於我們，因為我們正在進行一項隨機的具有整體生存益處的 III 期試驗。我認為這是第一點。

Within the Phase III trial, the last interaction we had was last year, but it was with the right folks at the FDA. And I will just repeat that our analysis of real-world evidence for the eligibility of our trial indicates somewhere in the mid-30s% of patients still get retreated with an anti-PD-1, even though we know it doesn't really work. And I do believe that, that will be reflected in our trial. And if so, then we believe we will have sufficient COC contribution of components if only the combination arm is the one that went.

在第三階段試驗中，我們最後一次互動是在去年，但那是與 FDA 的合適人員進行的。我只想重申，我們對試驗合格性的真實世界證據的分析表明，大約 35% 的患者仍然會使用抗 PD-1 療法進行治療，儘管我們知道它實際上不起作用。我確實相信，這將反映在我們的審判中。如果是這樣，那麼我們相信，只要組合臂是可行的，我們將擁有足夠的 COC 組件貢獻。

With regard to the duration of therapy in Europe, I mean, it's good to keep in mind that we were launched in 28 countries, many of which are European countries, and there are different launch stages. So where we see mature markets such as Germany and France, we actually see an excellent duration of therapy that is similar to what we see in the US, whereas obviously, some other markets like the UK where we recently launched, it's still maturing. But we do expect to see some consistency across markets.

關於在歐洲的治療持續時間，我的意思是，請記住，我們已經在 28 個國家推出了治療，其中許多是歐洲國家，並且有不同的推出階段。因此，在德國和法國等成熟市場中，我們實際上看到了與美國類似的出色治療持續時間，而顯然，在我們最近推出產品的英國等一些其他市場中，治療仍在成熟中。但我們確實希望看到各個市場呈現出一定的一致性。

Graig Suvannavejh, HC Wainwright.

Graig Suvannavejh，HC Wainwright。

Hi, this is Doug on for Graig actually from Mizuho. Congrats on a strong quarter. I'm interested mainly in ex-US growth and what we could be looking forward to. So if we're expecting sort of low- to mid-single digits overall growth, how might this be broken down between the US, the EU and the rest of the world?

大家好，我是瑞穗的 Doug，代替 Graig 發言。恭喜本季業績強勁。我主要對美國以外地區的成長以及我們可以期待的事情感興趣。因此，如果我們預期整體成長率將達到低至中等個位數，那麼美國、歐盟和世界其他國家的成長率將如何分配？

Yeah. I think, Ralph and Travis, do you want to take that?

是的。我想，拉爾夫和崔維斯，你們想接受這個嗎？

Sure. I'll start with the answer. So Doug, ex-US, we're seeing roughly that contributes around 65% of our revenue today. We do expect that to be the case -- sorry, 35% of our revenue today. We do expect that to be the case moving forward.

當然。我先來回答一下這個問題。因此，Doug（美國以外的人）大致為我們今天的收入貢獻了 65% 左右。我們確實預期情況會是這樣——抱歉，占我們今天收入的 35%。我們確實希望這種情況能夠持續下去。

We delivered obviously $33 million, which is 115% year-on-year growth. That had to do with underlying demand, of course, growing, but also with some good news from a pricing perspective.

我們的營業額顯然達到了 3,300 萬美元，年增 115%。當然，這與潛在需求的成長有關，但從定價角度來看也有一些好消息。

Travis, anything you want to add from a growth perspective?

崔維斯，從成長的角度看，您還有什麼要補充的嗎？

I think you covered it well.

我認為你講得很好。

Patrick Trucchio, HC Wainwright.

派崔克·特魯基奧、HC·溫賴特。

Thanks, good morning. Just a clarification question on KIMMTRAK. With the second quarter growth, have you or could you tell us how much of this was attributable to new patient starts versus those longer treatment durations? And then my question is on the HIV program. I think you mentioned ongoing dose escalation and plans to initiate an expansion. What criteria will you use to trigger the expansion? And what are the expectations around improved viral control at higher doses?

謝謝，早安。只是想澄清一下有關 KIMMTRAK 的問題。對於第二季的成長，您是否可以告訴我們其中有多少是由於新患者的開始治療，還是由於治療時間較長？我的問題是關於愛滋病項目。我認為您提到了持續增加劑量併計劃啟動擴展。您將使用什麼標準來觸發擴充功能？那麼，對於更高劑量下病毒控制效果的預期如何呢？

Go ahead, Ralph.

繼續吧，拉爾夫。

So it's a little bit of both, right? I mean it's mostly has come from penetration. We've gone from 65% to 68% in the US as well as obviously, we see some growth in Europe from the new launches. So that's, I think, what is the majority of the growth and what also remains ahead of us. DOT is obviously contributing from a tailwind perspective, which is great to see.

所以兩者都有一點，對吧？我的意思是它主要來自於滲透。我們在美國市場的佔有率已從 65% 上升至 68%，顯然，我們在歐洲也因新產品的推出而看到了一些成長。所以，我認為，這就是成長的主要內容，也是我們未來仍需努力的方向。DOT 顯然從順風角度做出了貢獻，這是令人高興的。

Patrick, with regard to the HIV, I think first, I will say just as a reminder that the data that we showed earlier was really exciting to us because we showed we were having some effect in viral control and time to rebound and reservoir.

派崔克，關於愛滋病毒，我想首先，我要提醒大家的是，我們之前展示的數據確實讓我們感到興奮，因為我們表明我們在病毒控制和反彈和儲存時間方面取得了一些效果。

Now that obviously is not the TPP because you need to have viral control going out much longer. But the initial trial was limited to 12 weeks, the initial protocol, and so that's what we showed. Now we're continuing to go higher. And secondly, what we want to see is we want to see viral control beyond 12 weeks.

現在這顯然不是 TPP，因為你需要更長時間的病毒控制。但初步試驗僅限於 12 週，這是初步方案，所以我們展示的就是這樣。現在我們正繼續攀登。其次，我們希望看到的是，病毒控制能夠持續 12 週以上。

So with the new amendment, we now have the option of extending viral control beyond 12 weeks. So we want to see in the small number of patients that at least we can have viral control beyond 12 weeks. And so that would trigger the expansion. And then --

因此，根據新修正案，我們現在可以選擇將病毒控制延長至 12 週以上。因此，我們希望看到，在少數患者中，至少能夠在 12 週後控制病毒。這將引發擴張。進而--

The right dose?

正確的劑量？

Yes. And yes, of course, get the right dose because we only have a few patients at each cohort so we need to get a larger cohort. In terms of viral control, this is -- we've talked about the TPP, which is probably a couple of viral control. We don't know what to expect. This is our first -- this is the world's first foray for this. And so I think we're going with our eyes open but it is certainly intriguing where we are now.

是的。是的，當然要選擇正確的劑量，因為每個隊列只有少數患者，所以我們需要獲得更大的隊列。就病毒控製而言，這是——我們已經討論了 TPP，這可能是一些病毒控制措施。我們不知道會發生什麼事。這是我們的第一次——這是世界上第一次嘗試。所以我認為我們會保持警惕，但我們目前的處境確實很有趣。

Jack Allen, Baird.

傑克艾倫，貝爾德。

Hey, thanks so much for taking the questions, and congratulations on the progress made over the course of the quarter. Two quick ones from me, the first of which is on TEBE-AM. I was just hoping you could provide any additional color on the powering assumptions you have there. I know you talked a little bit about the control arm, including PD-1 retreatment potentially, but I'd love to hear how you're thinking about the control overall survival there. And then more of a logistical question, but you mentioned that you'll have potential PIWIL data next year? I wanted to also ask if we could get PRAME half-life extended or [PRAME-A24] data as well next year.

嘿，非常感謝您回答這些問題，並祝賀您在本季度取得的進展。我快速講兩個問題，第一個是關於 TEBE-AM 的。我只是希望您能為您在那裡所作的假設提供更多的說明。我知道您談到了對照組，包括可能的 PD-1 再治療，但我很想聽聽您對對照組整體存活率的看法。然後更多的是一個後勤問題，但您提到明年您將有潛在的 PIWIL 數據？我還想問我們明年是否可以取得 PRAME 半衰期延長或 [PRAME-A24] 數據。

David, do you want to start with AM?

大衛，你想從 AM 開始嗎？

Yeah, I can. So with regard to the historical control arm, Jack, I think we're looking at a one-year survival of 55%. That's been historically what the survival has been. And so that's what we've modeled for the control arm and you can see that in multiple different trials. And we'll have a better timing of the events within the next six to nine months.

是的，我可以。因此，就歷史對照組而言，傑克，我認為我們預計一年存活率為 55%。從歷史上看，這就是生存的意義。這就是我們為對照組建立的模型，您可以在多次不同的試驗中看到這一點。我們將在未來六到九個月內更好地安排活動時間。

With regard to the data release, so both PIWIL and HLE are dose escalating well, and we should complete dose escalation for both of them in the next 12 months. So it is possible HLE can be shared next year as well.

關於數據發布，PIWIL 和 HLE 的劑量遞增都進展順利，我們應該在未來 12 個月內完成它們的劑量遞增。因此明年 HLE 也有可能共享。

Peter Lawson, Barclays.

巴克萊銀行的彼得·勞森。

Great. Thanks so much. Just like to ask on your updated thoughts around the current shifts in US trade policy, whether there's anything we should think differently around tariffs, IP, et cetera, how that affects your manufacturing costs or supply chain? Thank you.

偉大的。非常感謝。只是想問您對當前美國貿易政策變化的最新看法，我們是否應該對關稅、智慧財產權等議題有不同的看法，這會對您的製造成本或供應鏈產生什麼影響？謝謝。

Definitely. Travis, do you want to take that?

確實。崔維斯，你想接受這個嗎？

Yeah, happy to. Yes. Thanks, Peter, for the question. Regarding tariffs, there's been -- certainly has been a lot of uncertainty in the last few months and we continue to monitor the situation very closely. Europe is manufactured in -- I'm sorry, KIMMTRAK is manufactured in Europe.

是的，很高興。是的。謝謝彼得提出這個問題。關於關稅，過去幾個月確實存在著許多不確定性，我們將繼續密切關注局勢。歐洲製造—抱歉，KIMMTRAK 是在歐洲製造的。

So if tariffs do come to play, we do expect a potential not immediate impact on our cost of goods sold. But given that uncertainty that I referenced, what we've really been focused on is ensuring we have patient continuity and supply. And so we have about 18 months of inventory in the United States. So that impact, if it were to come to pass, would be not immediate, as I mentioned.

因此，如果關稅確實發揮作用，我們預計這可能會對我們的銷售成本產生潛在的但不是立即的影響。但考慮到我提到的不確定性，我們真正關注的是確保患者的連續性和供應。因此我們在美國有大約 18 個月的庫存。因此，正如我所提到的，這種影響即使發生，也不會是立竿見影的。

Justin Zelin, BTIG.

BTIG 的 Justin Zelin。

Thanks for taking my question. I'll ask some commercial questions for Ralph. You mentioned growth coming from launch in new markets. Any particular you'd like to call out? And would you look to launch there with partnerships or on your own? And you've also mentioned increasing use in the community setting. Any tactics that were most effective in engaging new prescribers to drive the growth in the community settings?

感謝您回答我的問題。我會向拉爾夫詢問一些商業問題。您提到了透過開拓新市場而實現的成長。您想特別指出什麼嗎？您是否希望透過合作夥伴或自己開展業務？您也提到了在社區環境中使用率的增加。有哪些最有效的策略可以吸引新的處方者來推動社區環境的發展？

Thanks for the question, Justin. So in terms of new markets, we're currently prosecuting three launches, the first one being the UK, Poland, and Netherlands. And that's contributing to the growth that we're seeing in Europe to a certain extent.

謝謝你的提問，賈斯汀。因此，就新市場而言，我們目前正在進行三項發布，第一項是英國、波蘭和荷蘭。這在一定程度上促進了我們在歐洲看到的成長。

We also recently announced a partnership with Er-Kim, which actually takes us into Turkey, which is actually a good market as well because it's fairly sizable and has a high HLA-A*02:01 expression around 50%, so it looks like Europe from that perspective. And the Middle East and Africa regions as well as part of that partnership. And then from there, in the US, we continue to work at going deeper into the community.

我們最近也宣布與 Er-Kim 建立合作夥伴關係，這實際上將我們帶入了土耳其，這實際上也是一個很好的市場，因為它的規模相當大，並且 HLA-A*02:01 表達率高達 50% 左右，所以從這個角度來看它就像歐洲一樣。以及中東和非洲地區以及該夥伴關係的一部分。然後從那裡開始，在美國，我們繼續努力深入社區。

Obviously, we're not expanding our operations to do that. We actually are leveraging a lot of triggers and next best action, the usual aspects, but we're actually infusing a lot of AI that helps us with predicting where patients are going to relapse and sending our reps after that or after that. So we're doing it, but we're doing it in a smart way.

顯然，我們不會為了實現這一目標而擴大業務。我們實際上利用了很多觸發器和下一個最佳行動，這些都是常見的方面，但我們實際上註入了許多人工智慧來幫助我們預測患者復發的位置，並在復發後或復發後發送我們的代表。所以我們正在這樣做，但我們以一種聰明的方式去做。

Rajan Sharma, Goldman Sachs.

高盛的拉詹·夏爾馬。

Hi, thanks for taking my question. So it seems like having sufficient US trial centers and representative patient populations in clinical trials is increasingly a focus at the FDA given recent AdCom? So it'd just be helpful if you could outline your confidence that both TEBE-AM and ATOM have sufficient US trial centers but also have planned patient demographics, which are reflective of the real-world populations.

你好，謝謝你回答我的問題。因此，鑑於最近的 AdCom，FDA 似乎越來越關注是否擁有足夠的美國試驗中心和臨床試驗中具有代表性的患者群體？因此，如果您能概述一下您的信心，即 TEBE-AM 和 ATOM 都擁有足夠的美國試驗中心，並且擁有計劃的患者人口統計數據，這些統計數據能夠反映現實世界的人口，那將會很有幫助。

And then just on KIMMTRAK. Could you just talk to us about where penetration is in Europe relative to the US and where you think that lands? And then specifically in the community setting in the US, where do you think that could land long term?

然後就在 KIMMTRAK 上。您能否與我們談談歐洲相對於美國的滲透率情況以及您認為歐洲的滲透率最終會達到什麼水平？那麼具體到美國的社區環境中，您認為這可以長期實現嗎？

David, do you want to start?

大衛，你想開始嗎？

Sure, yes. So the bottom line is, yes, we have confidence that the site footprint will meet the requirements from the FDA. First of all, almost all of our trial sites are either US, Western Europe, Canada, Australia, UK. So places where the standard of care is the same as the US. We do have enough sites in the US for both trials, for all three trials actually to ensure that we will have sufficient patients from the US. But I will reemphasize that the standard of care and practice is the same in the countries, the most part where we are studying as the US

當然，是的。所以底線是，是的，我們有信心該場地的佔地面積將滿足 FDA 的要求。首先，我們幾乎所有的試驗地點都在美國、西歐、加拿大、澳洲、英國。因此，這些地方的護理標準與美國相同。我們在美國確實有足夠的場地進行這兩項試驗，實際上對於所有三項試驗來說，以確保我們有足夠的來自美國的患者。但我要再次強調，我們所研究的大多數國家的護理和實踐標準都是一樣的，就像美國一樣

So Rajan, on KIMMTRAK in Europe, we see actually very good penetration in markets like Germany and France, where we've launched for over four years, we are seeing above 80% penetration. And actually, that's a great guide because in the US, obviously, the US is the size of many of these markets put together so there's a lot more work to be done in the community. But we use that as a guide because we do think that we can get to higher numbers. That's the effort that we're putting in today. In the academic centers, we're above 80%. In community, this is where the work, as I've been mentioning, needs to continue.

因此，拉詹，就歐洲的 KIMMTRAK 而言，我們看到在德國和法國等市場的滲透率實際上非常好，我們在這些市場推出 KIMMTRAK 已有四年多的時間，滲透率已超過 80％。事實上，這是一個很好的指南，因為在美國，顯然美國的規模相當於許多此類市場的總和，因此社區中還有很多工作要做。但我們以此為指導，因為我們確實認為我們可以達到更高的數字。這就是我們今天所做的努力。在學術中心，我們的比例超過了80%。正如我一直提到的，在社區中，這項工作需要繼續下去。

Romy O'Connor, Van Lanschot Kempen.

羅密·奧康納，範·蘭肖特·肯彭。

Hi, thank you for taking my questions. I just wanted to know whether you can update us on your current efforts of brenetafusp in lung and ovarian and whether the ctDNA and the T cell fitness data insights collected influence any strategies going forward with these programs?

你好，謝謝你回答我的問題。我只是想知道您是否可以向我們介紹一下您目前在肺癌和卵巢癌中對 brenetafusp 的研究進展，以及收集到的 ctDNA 和 T 細胞健康數據洞察是否會影響這些項目未來的策略？

Yeah. I see our PRAME exploration as three clinical experiments, which are -- certainly take into account everything we've learned. Following up on the signal of ovarian, the T cell fitness had to go into earlier lines of therapy, and there was reason to believe why addition of chemotherapy makes sense. So we are continuing that exploration. And yes, ctDNA and T cell fitness continue to be important.

是的。我將我們的 PRAME 探索視為三項臨床實驗，當然這些實驗當然會考慮到我們所學到的一切。根據卵巢訊號，T 細胞適應性必須進入早期治療，並且有理由相信添加化療是有意義的。因此我們正在繼續探索。是的，ctDNA 和 T 細胞適應性仍然很重要。

Same in lung cancer. It just happens, as we talked about that in lung cancer, in late-line lung cancer, T cell fitness is among the lowest of all the populations, and that's why we need to look in earlier lines. And then finally, HLE is ongoing, and we've taken all of the insights from the brenetafusp and applied them to HLE as well.

肺癌也一樣。正如我們所說，在肺癌中，在晚期肺癌中，T 細胞適應性是所有人群中最低的，這就是為什麼我們需要研究早期肺癌。最後，HLE 仍在進行中，我們從 brenetafusp 中汲取了所有見解，並將它們應用於 HLE。

Sean Laaman, Morgan Stanley.

摩根士丹利的肖恩拉曼。

I don't think I quite got it. So at the risk of repetition, just the future competitive positioning for KIMMTRAK and particularly in relation to what we know so far about (inaudible) that would be very useful. Thank you.

我覺得我還沒有完全理解。因此，儘管有重複的風險，但 KIMMTRAK 未來的競爭定位以及特別是與我們目前所了解的（聽不清楚）相關的資訊將非常有用。謝謝。

So look, I mean, first of all, not much is known to date. But it's good to see this development in the HLA-A*02:01 negative patients because there's still a very high unmet need there. I mean, the median OS is 12 months. That being said, with KIMMTRAK and HLA-A*02:01 positive, the median OS is 22 months. We have 27% of patients alive at three years, which is exceptional, I mean, unheard of in this disease. So it is -- we are standard of care across most major markets.

所以，首先，我的意思是，迄今為止我們還不知道太多。但很高興看到 HLA-A*02:01 陰性患者取得這項進展，因為該類患者仍有大量未滿足的需求。我的意思是，中位 OS 為 12 個月。話雖如此，如果 KIM​​之間TRAK 和 HLA-A*02:01 呈陽性，則中位 OS 為 22 個月。我們有 27% 的患者在三年內存活，這是一個非常特殊的數字，我的意思是，對於這種疾病來說，這是聞所未聞的。事實確實如此——我們是大多數主要市場的護理標準。

In fact, 28 markets, as we mentioned, numer one prescribed medicine in HLA-A*02:01 positive. And I think, David, is there anything you'd like to add?

事實上，正如我們所提到的，28 個市場中，HLA-A*02:01 呈陽性的處方藥數量排名第一。我想，大衛，您還有什麼要補充的嗎？

Yeah, Ralph, thanks. A couple of things I'll add from the analogs in cutaneous melanoma because right now, there's only one therapy approved in uveal, that's KIMMTRAK. But in cutaneous, you have targeted therapy and you have immunotherapy. And what we've learned in randomized trials is you get better long-term survival if you start with immunotherapy and then you go to targeted therapy. If you do the reverse, starting with just reducing the tumor and then getting immunotherapy, the survival isn't good.

是的，拉爾夫，謝謝。我將補充一些關於皮膚黑色素瘤類似物的內容，因為目前，只有一種用於治療葡萄膜黑色素瘤的療法獲得批准，那就是 KIMMTRAK。但在皮膚方面，有標靶治療和免疫療法。我們在隨機試驗中了解到，如果先進行免疫療法，然後再進行標靶療法，則可以獲得更好的長期存活率。如果反其道而行之，先縮小腫瘤，然後再進行免疫治療，存活率就不會高。

So we don't know how that plays out but that's our best analog. As Ralph said, just as a reminder, we've established 22 months overall survival, and I think that's the hurdle for any new therapy coming on the market.

所以我們不知道結果會如何，但這是我們最好的類比。正如拉爾夫所說，提醒一下，我們已經確定了 22 個月的總生存期，我認為這是任何新療法上市的障礙。

David Dai, UBS.

瑞銀集團戴維戴（David Dai）。

Great. Thanks for taking my questions. I have a couple. One is on the duration of therapy of 13 months. I'm just curious what do you think is driving that long duration of therapy in the real world? So our physician check suggests that a lot of patients are -- continue to be on therapy after disease progression. Is that what you're seeing in the real world versus the clinical experience?

偉大的。感謝您回答我的問題。我有一對。一項是治療持續時間為13個月。我只是好奇，您認為在現實世界中是什麼推動瞭如此長時間的治療？因此，我們的醫生檢查表明，許多患者在病情進展後仍在繼續接受治療。這是您在現實世界中看到的情況與臨床經驗中看到的嗎？

The second question is on the treatment in frontline melanoma for penetaxib. Curious in terms of your thoughts around the control arm. How many of those patients are going to -- can you break down the percentage of patients who are going to be enrolled on the nivo monotherapy versus nivo plus rela?

第二個問題是關於 penetaxib 在第一線黑色素瘤治療的應用。好奇您對控制臂的看法。其中有多少患者將接受 nivo 單一療法治療，以及接受 nivo 加 rela 療法治療的患者百分比？

Sure. So happy to start with the duration of therapy question. So I think, first and foremost, and this is true of any medicine is patients are feeling good. And David actually today spoke about our safety profile, our long-term safety profile. And you can see there's not much happening, not much new happening, especially after several years.

當然。很高興開始討論治療持續時間的問題。所以我認為，首先，任何藥物都應讓患者感覺良好。實際上，大衛今天談到了我們的安全狀況，我們的長期安全狀況。你會發現，沒有發生太多事情，也沒有太多新鮮事發生，尤其是幾年後。

In fact, from a treatment beyond progression perspective, which is the characteristic of our therapy, we are seeing a lot of that happening in the community where patients are in stable disease or have progressed, and the physician keep them on because the patient is feeling good and it's feeling that -- and then we see the disease still in control.

事實上，從超越進展治療的角度來看，這是我們治療的特點，我們在社區中看到很多這樣的情況，患者的病情穩定或已經取得進展，而醫生繼續讓他們繼續治療，因為患者感覺良好，而且感覺如此——然後我們看到病情仍然得到控制。

In fact, they also use sometimes radiation therapy and other local interventions to help control that disease. So we're seeing a lot of that in the real world. And I mean, I mentioned the patient that we recently met has been alive for seven years. And they still have disease, they have for seven years, going into the office every week to get KIMMTRAK and feeling good, their job. So I think it's this quality of life component that makes it compelling.

事實上，他們有時也會使用放射療法和其他局部幹預措施來幫助控制疾病。我們在現實世界中看到了很多這樣的情況。我的意思是，我提到我們最近遇到的病人已經活了七年。他們仍然患有疾病，已經七年了，每週都去辦公室領取 KIMMTRAK，感覺很好，可以繼續工作。所以我認為正是這種生活品質因素讓它引人注目。

Yes. With regard to the question, a minority of the patients will likely get Opdualag, and we believe the majority will get nivolumab. However, David, I will say I remain confident that we will beat both of them. And the reason is because as a monotherapy in late-line, cutaneous melanoma, brenetafusp had greater activity in cross trial than Opdualag in a similar population. So it's going to be a minority. I don't yet know the exact number yet because we're still enrolling.

是的。關於這個問題，少數患者可能會接受 Opdualag 治療，而我們認為大多數患者會接受 nivolumab 治療。然而，大衛，我會說我仍然有信心我們會擊敗他們兩個。原因在於，作為晚期皮膚黑色素瘤的單一療法，brenetafusp 在相似人群中的交叉試驗中比 Opdualag 具有更高的活性。所以這將是少數。我還不知道確切的數字，因為我們仍在招生。

Jeff Jones, Oppenheimer.

傑夫瓊斯，奧本海默。

Good morning, afternoon, folks, and thanks for taking the question. Two quick ones from us. In terms of, as you noted, building an 18-month inventory in the US, can you remind us what the shelf life is on the product? And then in terms of the revenue reported, rest of world ex-US and ex-EU revenues were down. And can you give us some color there?

大家早安、下午好，感謝你們回答這個問題。我們快速說兩句話。正如您所說，關於在美國建立 18 個月的庫存，您能否提醒我們產品的保質期是多長？從報告的收入來看，除美國和歐盟以外的世界其他地區的收入均有所下降。您能給我們講講這個嗎？

Yes. Thanks, Jeff. I'm happy to take both of those. We have a three-year drug product stability, which -- part of which is allowing us, obviously, to have that 18 months of inventory in the US. And then with respect to the international region, we typically see a lot of variability in the international region due to various buying patterns and just how that region operates.

是的。謝謝，傑夫。我很樂意接受這兩個。我們的藥品穩定性為三年，這顯然使我們在美國擁有 18 個月的庫存。然後就國際區域而言，我們通常會看到國際區域由於各種購買模式和該地區的運作方式而存在很大的差異。

So it's not atypical for us to have a little bit lower quarter. I'd consider this quarter within that typical variability that we've seen. If you look at the quarters last year, I think, we ranged from about $1.5 million to about $4.3 million. So we're -- as I mentioned, there's a lot of variability that we see throughout the international region. We do expect incremental growth to continue from additional product launches there.

因此，我們的季度業績略低一些並不罕見。我認為本季處於我們所見的典型變化範圍內。如果你看去年各季度的數據，我認為我們的收入範圍在 150 萬美元到 430 萬美元之間。所以，正如我所提到的，我們看到整個國際地區存在著許多變化。我們確實預計，隨著更多產品的推出，增量成長將繼續。

Thank you. We reached the end of our question-and-answer session. I'd like to turn the floor back over for any further closing comments.

謝謝。我們的問答環節已經結束。我想再次請大家發表進一步的結論。

Yes. Thank you very much. With that, we'll conclude this call. I just want to reiterate one more time our thanks for all your support, and thanks to our patients and their families and our employees. Thank you very much.

是的。非常感謝。至此，我們就結束本次通話。我只想再次重申我們對你們所有支持的感謝，並感謝我們的病人及其家人和我們的員工。非常感謝。

Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.

謝謝。今天的電話會議和網路直播到此結束。此時您可以斷開線路，祝您有美好的一天。我們感謝您今天的參與。