Iovance Biotherapeutics Inc (IOVA) 2024 Q2 法說會逐字稿

Welcome to the Iovance Biotherapeutics conference call to discuss second quarter 2024 results and recent corporate updates. My name is Daniel, and I will be your operator for today's call.

歡迎參加 Iovance Biotherapeutics 電話會議，討論 2024 年第二季業績和最近的公司動態。我叫丹尼爾，我是今天電話的接線生。

At this time, all participants are in a listen-only mode. Later we will conduct a question and answer session. Please note that this conference is being recorded. I will now turn the call over to Sara Pellegrino, Senior Vice President, Investor Relations and Corporate Communications at Iovance. Sara, you may begin.

此時，所有參與者都處於只聽模式。稍後我們將進行問答環節。請注意，本次會議正在錄製中。我現在將把電話轉給 Iovance 投資者關係和企業傳播部高級副總裁 Sara Pellegrino。薩拉，你可以開始了。

Thank you, operator. Good afternoon and welcome to Iovance conference call and webcast to discuss our second quarter and first half 2024 results and corporate update. Dr. Fred Vogt, our Interim President and Chief Executive Officer, will provide an introduction and summarize key updates for our US commercial launch of Amtagvi including revenue guidance and our pipeline programs.

謝謝你，接線生。下午好，歡迎參加 Iovance 電話會議和網路廣播，討論我們的 2024 年第二季和上半年業績以及公司最新動態。我們的臨時總裁兼執行長 Fred Vogt 博士將介紹並總結我們在美國商業推出 Amtagvi 的關鍵更新，包括收入指導和我們的管道計劃。

Jim Ziegler, EVP Commercial, will highlight additional details of the US commercial launch of Amtagvi, in advanced melanoma; Dr. Igor Bilinsky, Chief Operating Officer, will comment on our commercial manufacturing experience and capacity expansion plans.

商業執行副總裁 Jim Ziegler 將重點介紹 Amtagvi 在美國商業上市治療晚期黑色素瘤的更多細節；營運長 Igor Bilinsky 博士將評論我們的商業製造經驗和產能擴張計劃。

Jean-Marc Bellemin, CFO, will review our financial results, including revenue and financial outlook; and Dr. Frederick Finckenstein, Chief Medical Officer, will review complete key clinical pipeline update. Dr. Brian Gastman, EVP Medical Affairs; and Dr. Raj Puri, EVP Regulatory Strategy are also on the call and available for the Q&A session.

財務長 Jean-Marc Bellemin 將審查我們的財務業績，包括收入和財務前景；首席醫療官 Frederick Finckenstein 博士將審查完整的關鍵臨床管道更新。Brian Gastman 博士，醫療事務執行副總裁；監管策略執行副總裁 Raj Puri 博士也將參加電話會議並參加問答環節。

Earlier this afternoon, we issued a press release that can be found on our corporate website at iovance.com. Before we start, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding Iovance is goals, business focus, business plans and transaction, revenue and revenue guidance, commercial activities, clinical trials and results, regulatory approvals and interaction plans and strategies, research and preclinical activity, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interaction, licenses and collaboration, cash position and expense guidance and future updates.

今天下午早些時候，我們發布了一份新聞稿，您可以在我們的公司網站 iovance.com 上找到該新聞稿。在開始之前，我想提醒大家，本次電話會議期間發表的聲明將包括有關 Iovance 目標、業務重點、業務計劃和交易、收入和收入指導、商業活動、臨床試驗和結果、監管的前瞻性陳述。批准和互動計劃和策略、研究和臨床前活動、我們技術的潛在未來應用、製造能力、監管反饋和指導、付款人互動、許可和協作、現金狀況和費用指導以及未來更新。

Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements that I will turn the call over to Fred.

前瞻性陳述受到眾多風險和不確定性的影響，其中許多風險和不確定性超出了我們的控制範圍，包括我們在 SEC 文件中不時描述的風險和不確定性。我們的結果可能與今天電話會議期間預測的結果有重大差異。我們沒有義務公開更新任何前瞻性聲明，我會將電話轉給 Fred。

Thank you, sir. I am pleased to host this afternoon's conference call to discuss our 2024 second quarter and first half results. We've had a productive year so far at Iovance following our first FDA approval and a successful start in the US commercial launch of Amtagvi for patients with advanced melanoma.

謝謝您，先生。我很高興主持今天下午的電話會議，討論我們 2024 年第二季和上半年的業績。在首次獲得 FDA 批准以及針對晚期黑色素瘤患者的 Amtagvi 在美國商業上市的成功開端之後，迄今為止，我們在 Iovance 度過了富有成效的一年。

Firstly, we were very pleased with the exceptional demand for Amtagvi. For second quarter, product revenue was $31.1 million, inclusive of recognized revenue for Amtagvi and Proleukin, Amtagvi revenue is recognized upon infusion, while Proleukin revenue is recognized upon delivery, typically a few months prior to Amtagvi infusion, providing a strong leading indicator of demand and future Amtagvi revenue.

首先，我們對 Amtagvi 的巨大需求感到非常高興。第二季度，產品收入為3,110 萬美元，包括Amtagvi 和Proleukin 的確認收入，Amtagvi 收入在輸注時確認，而Proleukin 收入在交付時確認，通常在Amtagvi 輸注前幾個月，提供了強有力的領先需求指標以及未來 Amtagvi 的營收。

The initial quarter of product revenue from our US launch demonstrates early success from our team's execution as well as the unmet need, high awareness, broad patient access and motivated authorized treatment centers or ATCs. With Amtagvi already showing, I mean, meaningful benefit for patients treated in the commercial setting.

我們在美國推出的產品第一季的收入證明了我們團隊執行力的早期成功以及未滿足的需求、高認知度、廣泛的患者訪問權限以及積極主動的授權治療中心或 ATC。我的意思是，Amtagvi 已經為商業環境中接受治療的患者帶來了有意義的益處。

We expect continued launch momentum, which I'll return to in a moment. Jim will discuss we have a very engaged network of more than 50 current ATCs. These ATCs are proving that they have the training infrastructure and capabilities to treat patients with integrity.

我們期望持續的發布勢頭，我稍後會再討論這一點。Jim 將討論我們擁有一個由 50 多個現有 ATC 組成的高度活躍的網路。這些 ATC 正在證明他們擁有誠信對待患者的培訓基礎設施和能力。

We also remain on track to have at least 70 agencies by the end of the year, representing the largest ever initial ATC network for cell therapy launch. We've also store in our community referral activities to drive additional demand for these ATCs. Through early success with reimbursement and a strong logistics and scheduling collaboration between Iovance and the ATCs, time to treatment is also becoming faster for patients.

我們還有望在今年年底前擁有至少 70 家機構，代表有史以來最大的細胞療法啟動初始 ATC 網路。我們還在社區推薦活動中進行存儲，以推動對這些 ATC 的額外需求。透過報銷的早期成功以及 Iovance 和 ATC 之間強大的後勤和調度合作，患者的治療時間也變得更快。

In addition, our commercial manufacturing capabilities are successfully delivering impact at an increasing pace. The key takeaways, as Igor will summarize, that we are staffed to provide manufacturing slots to meet current and expected demand. We are scaling up manufacturing according to our growth projections. We have increased capacity and headcount each month since launch and continue ramping up to match ongoing demand growth.

此外，我們的商業製造能力正在以越來越快的速度成功地產生影響。正如伊戈爾總結的那樣，關鍵要點是我們配備了人員來提供製造槽位，以滿足當前和預期的需求。我們正在根據我們的成長預測擴大製造規模。自推出以來，我們每個月都增加了產能和人員數量，並繼續增加以滿足持續的需求成長。

Turning back to launch momentum, this afternoon's press release. We also introduced revenue guidance for the third quarter of full year 2024 and for 2025. This guidance is based upon our ongoing experience and confidence in the strong uptake and significant quarter-over-quarter growth, but impacting demand and corresponding Proleukin sales for the foreseeable future.

回到今天下午的新聞稿中的發布勢頭。我們也推出了 2024 年第三季和 2025 年的營收指引。該指導基於我們的持續經驗和對強勁吸收和顯著季度環比增長的信心，但在可預見的未來影響需求和相應的 Proleukin 銷售。

We used our visibility to the growth rate of infusions adoption across our agency network, manufacturing capacity, and additional launch dynamics to prepare this guidance in the third quarter, we expect total product revenue within the range of $53 million to $55 million. Notably more than 55 patients have been infused impacting since the first commercial infusion in April 2024, including 25 patients infused in the second quarter.

我們利用對整個代理網路輸液採用成長率、製造能力和其他發布動態的了解，在第三季準備了本指南，我們預計產品總收入在 5,300 萬美元至 5,500 萬美元之間。值得注意的是，自 2024 年 4 月首次商業輸注以來，已有超過 55 名患者接受了輸注，其中包括第二季輸注的 25 名患者。

More than 30 patients have already been infused and distributors are restocking Proleukin since the start of the third quarter. Many more infusions are scheduled or anticipated before quarter end in support of our guidance. For full year 2024, we anticipate total product revenue for Amtagvi and Proleukin of $160 million to $165 million.

自第三季初以來，已有 30 多名患者接受了注射，經銷商正在補充 Proleukin。在季度末之前計劃或預計會有更多的輸注，以支持我們的指導。2024 年全年，我們預計 Amtagvi 和 Proleukin 的產品總收入為 1.6 億至 1.65 億美元。

We expect the full year 2024 will reflect continued demand growth, ramp timing and corresponding sales for Proleukin for full year 2025. First calendar year of our newest launch first full calendar year of our US launch, we expect significant year-over-year growth driven by scale up in existing and new ADCs and robust community referral networks contributing to additional demand.

我們預計 2024 年全年將反映 Proleukin 2025 年全年的持續需求成長、成長時間和相應銷售額。這是我們在美國推出最新產品的第一個完整日曆年，我們預計，由於現有和新的ADC 規模擴大以及強大的社區推薦網絡將帶來額外的需求，我們預計將出現顯著的同比增長。

As a result, we anticipate total product revenue will increase to $450 million to $475 million in the full year of 2025. 2026 and beyond, Amtagvi and Proleukin are expected to continue to drive significant additional revenue growth. These products represent more than $1 billion peak opportunity in the US market and the currently approved indication alone.

因此，我們預計 2025 年全年產品總收入將增至 4.5 億至 4.75 億美元。這些產品僅在美國市場和目前批准的適應症中就代表了超過 10 億美元的高峰機會。

Future revenue growth, drivers also include a wider geographic footprint for Amtagvi in previously treated advanced melanoma as well as US and global label expansions to frontline advanced melanoma, non-small cell lung cancer and other indications, as we'll discuss later in the call.

未來收入成長的驅動因素還包括Amtagvi 在先前治療的晚期黑色素瘤中的更廣泛的地理覆蓋，以及美國和全球標籤擴展到一線晚期黑色素瘤、非小細胞肺癌和其他適應症，我們將在電話會議稍後討論。

Gross margins are also expected to increase to greater than 70% over the next several years. This reflects the long-term commercial strength for Amtagvi and Proleukin and highlights a strong future for live events. Globally, Amtagvi represents a multibillion-dollar opportunity to address more than 20,000 previously treated advanced melanoma patients annually across the US in our initial plan geographic program.

未來幾年毛利率預計將增加至 70% 以上。這反映了 Amtagvi 和 Proleukin 的長期商業實力，並凸顯了現場活動的強勁未來。在全球範圍內，Amtagvi 代表了一個價值數十億美元的機會，可以在我們最初的地理計劃中每年為美國各地超過 20,000 名先前接受過治療的晚期黑色素瘤患者提供治療。

Following our recent regulatory submission in the European Union. We remain on track for additional submissions in the UK and Canada this year and Australia, Switzerland in 2025 with commercial launches the follow. Iovance is well positioned to build upon our existing commercial success continued growing globally.

繼我們最近向歐盟提交監管報告後。我們仍有望今年在英國和加拿大以及 2025 年在澳洲和瑞士提交更多申請，隨後進行商業發布。Iovance 處於有利位置，可以在我們現有的商業成功的基礎上繼續在全球範圍內發展。

In addition to impacting our robust and exciting pipeline of even more patients with solid tumors, potentially curative medicines. Our progress includes two registrational trials in other indications, and we are continuously innovating with next-generation cell therapies.

除了影響更多實體瘤患者的強大而令人興奮的產品線外，還有潛在的治療藥物。我們的進展包括兩項其他適應症的註冊試驗，我們正在不斷創新下一代細胞療法。

Further, we'll discuss our pipeline in further detail on this call. First, approval launch and large-scale manufacturing with TIL cell therapy, together with our intellectual property position and deep pipeline provide us with distinct competitive advantages. As a fully integrated company, Iovance is well positioned to maintain the global leader in innovating developing delivering TIL cell therapies for patients with cancer.

此外，我們將在這次電話會議上進一步詳細討論我們的管道。首先，TIL細胞療法的核准上市和大規模生產，加上我們的智慧財產權地位和深厚的產品線，為我們提供了獨特的競爭優勢。作為一家完全整合的公司，Iovance 處於有利地位，能夠在為癌症患者提供 TIL 細胞療法的創新開發方面保持全球領先地位。

I'll now hand over to Jim, our Executive Vice President, Commercial, who will summarize our US commercial activities. Jim?

現在我將把我們的商業執行副總裁吉姆交給他，他將總結我們在美國的商業活動。吉姆？

Thank you, Brent. We are excited about the potential for our US launch of Amtagvi to improve the lives of patients with advanced melanoma as more and more patients are treated with commercial Amtagvi an increasing number of our ATCs are sharing positive feedback and posting stories about their patients who have benefited from Amtagvi in the early months since approval.

謝謝你，布倫特。我們對在美國推出 Amtagvi 改善晚期黑色素瘤患者生活的潛力感到興奮，因為越來越多的患者接受商業 Amtagvi 治療，越來越多的 ATC 正在分享積極的反饋並發布有關患者受益的故事自獲得批准後的最初幾個月，Amtagvi 就發布了該協議。

My objectives today are to highlight our US launch priorities and progress, including adoption and utilization within our expanding ATC network, community referrals, reimbursement and patient access and streamlining and expediting the patient journey. First, our ATC. network is scaling and expanding as planned, which is a key driver of demand, and we expect robust demand to continue.

我今天的目標是強調我們在美國的啟動優先事項和進展，包括在我們不斷擴大的 ATC 網路中的採用和利用、社區轉診、報銷​​和患者訪問以及簡化和加快患者旅程。首先是我們的 ATC。網路正在按計劃擴展和擴展，這是需求的關鍵驅動因素，我們預計強勁的需求將持續下去。

Today, onboarding is complete at more than 50 US ATCs. The centers who were active at approval are scaling up and many have treated multiple patients. Newer ATCs that have recently completed onboarding, including major US cancer centers, are beginning or preparing to treat patients.

如今，美國 50 多家 ATC 的入職培訓已完成。積極申請批准的中心正在擴大規模，許多中心已經治療了多名患者。最近完成入職的新 ATC（包括美國主要癌症中心）正在開始或準備治療患者。

As we look to bring treatment closer to patients. Our goal is to have approximately 70 ATCs in total by year end. Beyond this number, many additional centers have expressed interest in joining our network. Currently more than 90% of treated patients are located within 200 miles of an ATC with 70 ATCs, nearly all melanoma patients will be within a two hour drive to the closest center.

我們希望讓治療更貼近患者。我們的目標是到年底總共有大約 70 個 ATC。除了這個數字之外，還有許多其他中心表示有興趣加入我們的網路。目前，超過 90% 的治療患者都位於 ATC 200 英里範圍內（共有 70 個 ATC），幾乎所有黑色素瘤患者都將在兩小時車程內到達最近的中心。

Community referrals are also driving growth in patient volume and demand within the ATCs. An increasing number of ATCs are proactively building awareness about Amtagvi across their community referral networks. Iovance is rolling out initiatives to further support awareness and referrals by deploying direct outreach and resources into the community.

社區轉診也推動了 ATC 內患者數量和需求的成長。越來越多的 ATC 正在其社區轉診網絡中積極提高對 Amtagvi 的認識。Iovance 正在推出舉措，透過在社區中部署直接外展和資源來進一步支持意識和推薦。

The size and scope of our ATCs and these community referral networks are a testament to the significant unmet need in advanced melanoma. Each center's dedication to offer Amtagvi and interest among community oncologists.

我們的 ATC 和這些社區轉診網絡的規模和範圍證明了晚期黑色素瘤的巨大需求未被滿足。每個中心都致力於提供 Amtagvi 並引起社區腫瘤學家的興趣。

In addition to ATC demand, patient access is critical for adoption and uptake. Our launch data indicates that approximately 75% of Amtagvi patients are covered by private payer as expected, favorable medical coverage policies and reimbursement are facilitating broad access to Amtagvi. First, Amtagvi inclusion in the National Comprehensive Cancer Network or NCCN guidelines, reinforce clinical data and support broad payer coverage.

除了 ATC 需求之外，患者的取得對於採用和採用也至關重要。我們的發布數據表明，約 75% 的 Amtagvi 患者按預期由私人付款人承保，有利的醫療保險政策和報銷正在促進 Amtagvi 的廣泛使用。首先，Amtagvi 納入國家綜合癌症網絡或 NCCN 指南，強化臨床數據並支持廣泛的付款人覆蓋。

We have also achieved significant accomplishments with positive payer coverage in only five months. Since approval as of today, payers responsible for more than 225 million lives or more than 85% of US covered lives have already implemented positive medical coverage policies that are consistent with label, clinical trials and the NCCN guidelines.

我們還在短短五個月內取得了積極的付款人覆蓋率方面的重大成就。自今天獲得批准以來，負責超過 2.25 億生命或超過 85% 的美國承保生命的付款人已經實施了符合標籤、臨床試驗和 NCCN 指南的積極醫療保險政策。

Successful reimbursement is also driving faster time to treatment. The current average time to financial clearance is approximately three weeks, which is a significant reduction from the four to six weeks at initial launch.

成功的報銷也加快了治療時間。目前財務清算的平均時間約為三週，與最初啟動時的四到六週相比顯著縮短。

Improved efficiencies at ATCs, including scheduling in parallel with financial clearance, are also speeding up time to treatment. We expect the trends towards shorter time to treatment to continue as more ATC's gain experience. In summer, we are extremely pleased with the early launch performance. There is strong demand at our ATCs payer coverage policies are in place and favorable and time to treatment is becoming faster.

ATC 效率的提升（包括與財務清算並行的安排）也加快了治療時間。我們預計，隨著更多 ATC 獲得經驗，治療時間縮短的趨勢將持續下去。在夏天，我們對早期的發布表現非常滿意。我們的 ATC 付款人保險政策已到位且有利，治療時間變得越來越快，需求強勁。

These dynamics support the strong growth projections in our product revenue guidance for Amtagvi and Proleukin. I would also like to acknowledge our very talented cross-functional team who worked tirelessly to ensure broad and timely access to Amtagvi. I will now pass the call to Igor Bilinsky, our Chief Operating Officer, to highlight our manufacturing progress.

這些動態支持了我們對 Amtagvi 和 Proleukin 產品收入指引中的強勁成長預測。我還要感謝我們非常有才華的跨職能團隊，他們不懈努力，確保廣泛、及時地訪問 Amtagvi。現在，我將致電我們的營運長伊戈爾·比林斯基 (Igor Bilinsky)，強調我們的製造進度。

Thank you, Jim. Today, I'd like to highlight our commercial and clinical manufacturing capabilities. The progress of our commercial launch as well as our ongoing capacity expansion efforts. Manufacturing is a core competency of items where a laser focus on quality from incoming receipt of tumor samples through manufacturing and product release to outbound shipment of the final products.

謝謝你，吉姆。今天，我想強調我們的商業和臨床製造能力。我們的商業啟動進展以及我們正在進行的產能擴張工作。製造是專案的核心競爭力，從接收腫瘤樣本到製造和產品放行，再到最終產品的出境運輸，都高度關注品質。

Our established internal manufacturing facility, the Iovance Cell Therapy Center, or iCTC is the core of our manufacturing network located in Philadelphia iCTC is one of the world's largest cell therapy manufacturing facilities. The only one specifically designed for TIL manufacturing, the iCTC has a fully integrated and committed team with deep cell therapy experience.

我們已建立的內部製造設施 Iovance 細胞治療中心 (iCTC) 是我們位於費城的製造網絡的核心 iCTC 是世界上最大的細胞治療製造設施之一。iCTC 是唯一專為 TIL 製造而設計的機構，擁有一支完全整合且忠誠的團隊，擁有深厚的細胞治療經驗。

This facility is approved by the FDA for and targeted commercial manufacturing and has been supplying uptake with the patients since approval, while continuing to serve patients in our global clinical trials. We're actively hiring at iCTC to support the continued ramp in the US commercial demand and our clinical pipeline.

該設施已獲得 FDA 批准進行商業化生產，自批准以來一直供患者使用，同時繼續為我們的全球臨床試驗中的患者提供服務。我們正在 iCTC 積極招募人員，以支持美國商業需求和我們的臨床管道的持續成長。

The iCTC location in Philadelphia provides access to an experienced workforce with cell and gene therapy experience as well as innovative partnerships with local colleges and trade groups within our manufacturing network of contract manufacturing site is also approved by the FDA for commercial manufacturing of Amtagvi and provides additional capacity and flexibility to closely match supply and demand.

位於費城的iCTC 基地提供了擁有細胞和基因治療經驗的經驗豐富的員工隊伍，以及與我們合約生產基地製造網絡內的當地大學和貿易團體的創新合作夥伴關係，該基地還獲得FDA 批准用於Amtagvi的商業生產，並提供了額外的支援產能和靈活性緊密匹配供需。

Turning to commercial manufacturing updates our experience to date has been consistent with our expectations. And with prior clinical experience. We are executing and scaling up as planned. Since the FDA approval in February, we have been continuously increasing our staff manufacturing capacity month-over-month to closely align it with the growing commercial demand.

轉向商業製造更新，我們迄今為止的經驗與我們的預期一致。並具有先前的臨床經驗。我們正在按計劃執行和擴大規模。自二月獲得 FDA 批准以來，我們逐月不斷提高員工的生產能力，以使其與不斷增長的商業需求緊密結合。

We have sufficient capacity and staffing available in our manufacturing network to meet the increasing uptake of the demand. We are now running our manufacturing network at high capacity utilization while ensuring slots availability for our ATCs.

我們的製造網路擁有足夠的產能和人員配置，可以滿足日益增長的需求。我們現在以高產能利用率運行我們的製造網絡，同時確保我們的 ATC 的插槽可用性。

In addition, the turnaround time for integrity has been on target with our launch plans of approximately 34 days from receipt of patient cells at our manufacturing facility to return shipment of the product to the ATC as we scale up. We're also focused on improving cost of goods over time through economies of scale and operational efficiencies and by leveraging our competitive advantage and unique position as the leader in the TIL cell therapy.

此外，隨著我們規模的擴大，從我們的製造工廠收到患者細胞到將產品返回到 ATC，我們的推出計劃大約需要 34 天，以確保完整性的周轉時間達到了目標。我們也致力於透過規模經濟和營運效率，並利用我們的競爭優勢和作為 TIL 細胞療法領導者的獨特地位，隨著時間的推移提高商品成本。

Turning to our facility expansion efforts, they are closely aligned with our demand growth projections. iCTC is built today has the capacity to provide TIL therapies for more than 2000 patients per year. Following the recent EU regulatory submission and additional planned ex US filings, we expect iCTC to provide commercial integrity to patients in Europe and beyond upon potential approvals in those geographies.

談到我們的設施擴建工作，它們與我們的需求成長預測密切相關。如今建成的 iCTC 每年能夠為 2000 多名患者提供 TIL 治療。繼最近向歐盟監管機構提交申請以及計劃在美國提交額外申請後，我們預計 iCTC 在這些地區獲得潛在批准後，將為歐洲及其他地區的患者提供商業誠信。

We're in the process of building out the existing shelf space at iCTC. So this facility can supply TIL therapies for more than 5,000 patients annually in the next few years. Longer term, our vision is to supply TIL cell therapies for over 10,000 patients annually from the iCTC campus.

我們正在擴建 iCTC 的現有貨架空間。因此，該設施在未來幾年內每年可為 5,000 多名患者提供 TIL 治療。從長遠來看，我們的願景是每年為 iCTC 園區的 10,000 多名患者提供 TIL 細胞療法。

We have an option to construct another building on the adjacent lot and plan to drive additional efficiencies by incorporating increased automation in our manufacturing process. Importantly, our manufacturing capabilities are protected by a robust intellectual property portfolio by events currently owns more than 210 granted or allowed US and international patents and patent rights from tug V and other related technologies that are expected to provide exclusivity through at least 2042.

我們可以選擇在相鄰地段建造另一棟建築，並計劃透過在製造過程中提高自動化程度來提高效率。重要的是，我們的製造能力受到強大的智慧財產權組合的保護，目前擁有 210 多項授予或允許的美國和國際專利以及拖船 V 和其他相關技術的專利權，預計至少到 2042 年將提供排他性。

In summary, the Iovance team is excited and firmly committed to manufacturing and delivering of Type B in our investigational TIL cell therapies for patients with cancer.

總之，Iovance 團隊很興奮並堅定地致力於在我們的研究性 TIL 細胞療法中為癌症患者製造和提供 B 型。

I'm available to answer additional questions during the Q&A, and I will now hand the call over to Jean-Marc, our Chief Financial Officer.

我可以在問答期間回答其他問題，現在我將把電話轉給我們的財務長 Jean-Marc。

Thank you, Igor. Today, I will review our current cash position as well as our results for the second quarter and first half ended on June 30, 2024.

謝謝你，伊戈爾。今天，我將回顧我們目前的現金狀況以及截至 2024 年 6 月 30 日的第二季和上半年的業績。

I will also highlight our financial outlook, including revenue and expense guidance as of July 24, 2024, events at an unknown unaudited cash position of approximately $449.6 million, which includes net proceeds of approximately $200 million raised from the at-the-market equity financing facility during the second and third quarter of 2024.

我還將重點介紹我們的財務前景，包括截至2024 年7 月24 日的收入和支出指引、未知未經審計現金頭寸約4.496 億美元的事件，其中包括從市場股權融資籌集的約2 億美元淨收益設施將於 2024 年第二季和第三季建成。

The current cash position and anticipated product revenue are expected to be sufficient to fund current and planned operations into 2026 events at $346.3 million in cash, cash equivalents, investments and restricted cash at the end of December 31, 2023.

目前的現金狀況和預期產品收入預計足以為 2026 年活動中的當前和計劃運營提供資金，截至 2023 年 12 月 31 日，現金、現金等價物、投資和限制性現金為 3.463 億美元。

I will now transition to our second quarter and year to date financial results. Net loss for the second quarter of 2024 was $97.1 million, or $0.64 per share compared to a net loss of $106.5 million or $0.47 per share for the second quarter ended June 30, 2023. Net loss for the first half of 2024 was $210.1 million or $0.76 per share compared to net loss of $213.9 million or $0.98 per share for the six month period ended June 30, 2023.

我現在將過渡到我們第二季和今年迄今的財務表現。2024 年第二季的淨虧損為 9,710 萬美元，即每股 0.64 美元，而截至 2023 年 6 月 30 日的第二季淨虧損為 1.065 億美元，即每股 0.47 美元。2024 年上半年的淨虧損為 2.101 億美元，即每股 0.76 美元，而截至 2023 年 6 月 30 日的六個月期間，淨虧損為 2.139 億美元，即每股 0.98 美元。

Revenue was $31.1 million for the second quarter of 2024 and consisted of product revenue from the initial quarter of antagonist sales as well as recurring revenue from Proleukin. We recognized revenue of $12.8 million from completed and tech the infusion. We also recognized $18.2 million loss in global revenue from Proleukin during your initial quarter in supplying US specialty distributor.

2024 年第二季營收為 3,110 萬美元，包括第一季拮抗劑銷售的產品收入以及 Proleukin 的經常性收入。我們從完成的輸注技術中確認了 1,280 萬美元的收入。我們也意識到，在向美國專業經銷商供貨的第一個季度，Proleukin 的全球收入損失了 1,820 萬美元。

Revenue for the first half of 2024 was $31.8 million and consisted of product revenue from both booking and impacting. Revenue for the first half of 2023 was $0.2 million for global sales of Proleukin, which we began to recognize during the three months period ended June 30, 2023. Revenue increases in the second quarter and first half of 2024 over the prior year periods were primarily attributable to the US launch for integrity as well as significant growth in US protein revenue for use in the antagonist treatment regimen.

2024 年上半年的收入為 3,180 萬美元，包括來自預訂和影響的產品收入。2023 年上半年 Proleukin 全球銷售額的收入為 20 萬美元，我們在截至 2023 年 6 月 30 日的三個月期間開始確認這筆收入。2024 年第二季和上半年營收較上年同期成長主要歸因於美國的完整性上市以及美國用於拮抗劑治療方案的蛋白質收入的顯著成長。

As Fred mentioned, Proleukin is a strong leading indicator for near-term and targeted growth. Revenue recognition for Proleukin is a few months earlier than untimely when specialty distributors and ATCs purchase Proleukin in advance of Amtagvi infusions. Notably, Proleukin second quarter revenue surpassed the annual global revenue for Proleukin in 2023, reflecting strong demand for use with intact.

正如 Fred 所提到的，Proleukin 是近期目標成長的強大領先指標。當專業經銷商和 ATC 在 Amtagvi 輸注之前購買 Proleukin 時，Proleukin 的收入確認比不合時宜的要早幾個月。值得注意的是，Proleukin 第二季營收超過了 Proleukin 2023 年全球年度收入，反映出對完整使用的強勁需求。

In addition, specialty distributors who purchased Proleukin in the second quarter have already started restocking, and this is another positive signal of the strong and timely launch and increasing demand for Proleukin used at present cost of sales for the three and six months ended June 30, 2024 was $31.4 million and $38.6 million, respectively, primarily related to costs associated with sales of untangling and Proleukin, certain costs associated with patient drop-off and manufacturing success rates, noncash amortization expense for intangible assets and royalties payable on product sales.

此外，在第二季度購買Proleukin的專業經銷商已經開始補貨，這是截至6月30日的三個月和六個月，按目前銷售成本使用的Proleukin的強勁及時推出和需求增加的另一個正向訊號， 2024 年分別為3,140 萬美元和3,860 萬美元，主要與Untangling 和Proleukin 的銷售相關成本、與病患流失和製造成功率相關的某些成本、無形資產的非現金攤銷費用以及產品銷售應付的特許權使用費有關。

Cost of sales for both the three and six months ended June 30, 2023 was $2.1 million, primarily related to non-cash amortization for intangible assets. The increase in cost of sales in the second quarter and first half of 2024 of other prior year periods were primarily attributable to the initiation of commercial, manufacturing and related costs for the US launch of Amtagvi during the first half of 2024.

截至 2023 年 6 月 30 日的三個月和六個月的銷售成本均為 210 萬美元，主要與無形資產的非現金攤銷有關。2024年第二季和2024年上半年銷售成本的增加主要歸因於2024年上半年Amtagvi在美國上市的商業、製造和相關成本的增加。

Cost of sales is a function of volume and capacity utilization, which is already improving as we scale up our available capacity. In addition, education and training to optimize patient selection and tumor samples resections, as well as our continued focus on operational efficiencies are expected to optimize cost of sales over time as we aim to reach our target gross margins of more than 70% over the next several years.

銷售成本是銷售量和產能利用率的函數，隨著我們擴大可用產能，銷售成本已經在改善。此外，旨在優化患者選擇和腫瘤樣本切除的教育和培訓，以及我們對營運效率的持續關注，預計將隨著時間的推移優化銷售成本，因為我們的目標是在未來實現毛利率超過70% 的目標幾年。

Research and development expenses were $62.1 million for the second quarter of 2024 a decrease of $24.2 million compared to $86.3 million for the same period ended June 30, 2023.

2024 年第二季的研發費用為 6,210 萬美元，比截至 2023 年 6 月 30 日止同期的 8,630 萬美元減少了 2,420 萬美元。

Research and development expenses were $141.9 million for the six months ended June 30, 2023, a decrease of $27.2 million compared to $169.1 million for the same period ended June 30, 2020. The decreases in research and development expenses in the second quarter and first half of '24 over the period.

截至2023年6月30日止六個月的研發費用為1.419億美元，較截至2020年6月30日止同期的1.691億美元減少2,720萬美元。24年第二季及上半年研發費用減少。

The prior year periods were primarily attributable to the transition of antagonism to commercial manufacturing, decreased the costs associated with certain clinical activities in the first half of 2024 and the completion of pre-commercial qualification activities in 2023. The decrease in research and development were partially offset by increase in stock-based compensation resulting from growth in Asia.

上一年期間主要歸因於拮抗劑向商業製造的過渡、2024 年上半年某些臨床活動相關成本的減少以及 2023 年商業前資格活動的完成。研發的減少被亞洲成長帶來的股票薪酬增加的部分抵消。

Selling, general and administrative expenses were $39.6 million for the second quarter of June 2024 an increase of $17.7 million compared to $21.9 million for the same period ended June 30, 2023.

2024 年 6 月第二季的銷售、一般及管理費用為 3,960 萬美元，較截至 2023 年 6 月 30 日止同期的 2,190 萬美元增加了 1,770 萬美元。

Selling, general and administrative expenses were $71 million for the first half of '24 and into an increase of $21 million compared to $50 million for the same six month period ended June 30, 2023. The increase in selling, general and administrative expenses in the second quarter and first half of 2024 compared to the prior year periods was primarily attributable to increases in headcount and related costs, including stock-based compensation to support the growth in the overall business and related corporate infrastructure as well as legal costs and costs incurred to support the commercialization of antagonists and it.

2024 年上半年的銷售、一般和管理費用為 7,100 萬美元，與截至 2023 年 6 月 30 日的同一六個月期間的 5,000 萬美元相比，增加了 2,100 萬美元。與去年同期相比，2024 年第二季和上半年銷售、一般和管理費用的增加主要是由於員工人數和相關成本的增加，包括支持整體業務增長的股票薪酬和相關成本公司基礎設施以及法律費用和支持對手及其商業化所產生的費用。

Next, I would like to cover our financial outlook for the entire launch and future expenses. As Fred highlighted in his introduction around the revenue guidance, we expect quarter over quarter and annual growth in product revenue to continue for the next several years with the steepening US adoption curve for Amtagvi.

接下來，我想介紹一下我們對整個發布和未來費用的財務展望。正如 Fred 在關於收入指引的介紹中所強調的那樣，隨著 Amtagvi 在美國的採用曲線不斷陡峭，我們預計未來幾年產品收入將持續逐季增長和年度增長。

Geographic and label expansion as well as new product approvals may also add to our growth trajectory in 2026 and beyond. I will highlight our guidance numbers again. As a reminder, in the third quarter of 2024, we expect total product revenue within the range of $53 million to $55 million. We anticipate total product revenue for the full year of 2024 within the range of $160 million to $165 million in the full year of 2025.

地理和標籤擴張以及新產品批准也可能增加我們 2026 年及以後的成長軌跡。我將再次強調我們的指導數字。提醒一下，我們預計 2024 年第三季的產品總收入將在 5,300 萬美元至 5,500 萬美元之間。我們預計 2024 年全年的產品總收入將在 1.6 億美元至 2025 年全年的 1.65 億美元之間。

We expect a significant share of over year increase in annual product revenue to $450 million to $475 million. In addition, as Fred mentioned, gross margins are expected to increase to greater than 70% over the next several years.

我們預計年產品收入將大幅成長，達到 4.5 億至 4.75 億美元。此外，正如 Fred 所提到的，未來幾年毛利率預計將增至 70% 以上。

Regarding our expense outlook, we continue to radiate full year 2024 forecast burn guidance in the range of $320 million to $314 million, excluding one-time expenses. We will also continue to leverage opportunities to optimize funding for additional information. Please see the company's selected condensed consolidated balance sheet and statement of operation in this afternoon's press release and our Form 10-Q to be filed later today.

關於我們的費用前景，我們繼續提供 2024 年全年預測燒錢指引，範圍為 3.2 億至 3.14 億美元，不包括一次性費用。我們也將繼續利用機會優化更多資訊的資助。請參閱今天下午的新聞稿中公司選定的簡明合併資產負債表和營運報表以及我們將於今天稍後提交的 10-Q 表格。

I will now hand the call to Frederic, our Chief Medical Officer to discuss our clinical part.

我現在將電話轉給我們的首席醫療官 Frederic，討論我們的臨床部分。

Thank you so much. As my colleagues have conveyed integrity is only the tip of the iceberg for the potential of TIL cell therapy in solid tumors, which represent more than 90% of all diagnosed cancers in the US, I would like to acknowledge my own personal excitement and the rewarding experience for Iovance clinical development teams as we hear frequent agency feedback about patients benefiting from impact be in the commercial setting.

太感謝了。正如我的同事所表達的，完整性只是 TIL 細胞治療實體瘤潛力的冰山一角，實體瘤占美國所有診斷癌症的 90% 以上，我想感謝我個人的興奮和回報Iovance 臨床開發團隊的經驗，因為我們經常聽到機構回饋有關患者從商業環境中的影響中受益的訊息。

This is great news that also motivates our clinical teams to develop and deliver TIL cell therapy to cancer patients in additional therapeutic settings and with additional tumor types.

這是個好消息，也激勵我們的臨床團隊在其他治療環境和其他腫瘤類型中為癌症患者開發和提供 TIL 細胞療法。

Today, I will focus on key clinical pipeline highlights, including two ongoing registrational trials from this afternoon's press release I'll begin with the frontline advanced melanoma setting key priority with the potential for life solutions to address thousands of additional patients.

今天，我將重點關注關鍵的臨床管道亮點，包括今天下午新聞稿中正在進行的兩項註冊試驗。名其他患者的問題。

Our global registrational Phase 3 trial TILVANCE-301 remains on track to support accelerated and full approvals of Amtagvi combination with pembrolizumab in frontline advanced melanoma, as well as regular approval of Amtagvi in post-anti-PD-1 melanoma.

我們的全球註冊 3 期試驗 TILVANCE-301 仍在按計劃進行，以支持 Amtagvi 與 pembrolizumab 聯合治療一線晚期黑色素瘤的加速和全面批准，以及 Amtagvi 在抗 PD-1 後黑色素瘤治療中的定期批准。

Enrollment is strong across geographies with high enthusiasm for site participation. More than 40 sites are currently active across 10 countries, including the US, Canada, Europe and Australia with 60 additional sites selected across 18 countries.

各地區的報名人數都非常多，現場參與的熱情也很高。目前，有 40 多個站點活躍在 10 個國家/地區，包括美國、加拿大、歐洲和澳大利亞，另外還在 18 個國家/地區選擇了 60 個站點。

Total events have carefully feasibility assessments for each site selection at which time the sites also commit to participate. Site activation includes institutional Ethics Board approvals and scientific review of the TIL advance trial design, including the pembrolizumab monotherapy control arm and its fit with local standard of care for the enrolled patient population.

Total events 對每個場地選擇都進行了仔細的可行性評估，屆時場地也承諾參與。現場活化包括機構倫理委員會的批准和對 TIL 預先試驗設計的科學審查，包括派姆單抗單一療法對照組及其與登記患者群體的當地護理標準的一致性。

We also believe the option to cross over to TIL therapy from the control arm is attractive to patients. As a reminder, filled up for year one is supported by previously published data on two monotherapy in the pre immune checkpoint inhibitor, ARS. and importantly, life loosely beta in advanced melanoma patients who were naive to immune checkpoint inhibitors in cohort 1A of our IOV-COM-202 trials in solid tumors.

我們也相信從對照組轉向 TIL 治療的選擇對患者很有吸引力。提醒一下，第一年的填滿是由先前發布的前免疫檢查點抑制劑 ARS 的兩種單一療法的數據所支持的。重要的是，在我們的 IOV-COM-202 實體瘤試驗的隊列 1A 中，未曾接受過免疫檢查點抑制劑的晚期黑色素瘤患者的生活鬆散地處於 beta 狀態。

In our after oral presentation in May, updated Cohort 1A data demonstrated at an unprecedented rate depth and durability of responses, including a more than 60% of our 30% confirmed complete response rate and a differentiated safety profile. New proof of concept Cohort 1B is also beginning in the IOV-COM-202 trial to investigate my solution in combination with nivolumab and relatlimab in patients with frontline advanced melanoma. This novel combination represents another potential best in class frontline alternative for physicians and patients.

在我們 5 月的口頭報告後，更新的隊列 1A 數據以前所未有的速度深度和持久性顯示了反應，包括我們 30% 確認的完全反應率的 60% 以上以及差異化的安全概況。新的概念驗證隊列 1B 也在 IOV-COM-202 試驗中開始，以研究我的解決方案與 nivolumab 和 relatlimab 聯合治療一線晚期黑色素瘤患者的情況。這種新穎的組合代表了醫生和患者的另一種潛在的最佳一線替代方案。

Shifting to non-small cell lung cancer, enrollment continues to accelerate with strong demand in our single arm registrational Phase 2 trial, IOV-LUN-202 in post anti-PD-1 non-small cell lung cancer. We expect to complete enrollment and report top line data for the IOV-LUN-202 registrational cohorts in 2025 and submit the potential supplemental biologics license application to the FDA in 2026.

轉向非小細胞肺癌，隨著我們單臂註冊 2 期試驗 IOV-LUN-202 治療 PD-1 後非小細胞肺癌的強勁需求，入組人數繼續加速。我們預計在 2025 年完成 IOV-LUN-202 註冊隊列的註冊並報告頂線數據，並於 2026 年向 FDA 提交潛在的補充生物製劑許可申請。

We are confident in the IOV-LUN-202 trial based on the positive preliminary data. Also, the FDA provided positive regulatory feedback on our proposed potency matrix as well as the single arm trial designed to support accelerated approval of life and loosely post anti PD-1 non-small cell lung cancer we have also initiated the multicenter IOV-END-201 Phase two trial to investigate lifileucel in post-anti-PD-1 endometrial cancer patients regardless of mismatch repair or MMR status.

基於正面的初步數據，我們對 IOV-LUN-202 試驗充滿信心。此外，FDA 對我們提出的效力矩陣以及旨在支持加速批准生命和鬆散後抗 PD-1 非小細胞肺癌的單臂試驗提供了積極的監管反饋，我們還啟動了多中心 IOV-END- 201 研究lifileucel 在抗PD-1 後子宮內膜癌患者的第二期試驗，無論錯配修復或MMR 狀態如何。

There is an unmet medical need and no currently approved treatment options for the vast majority of patients with endometrial cancer in the post anti-PD-1 treatments. This unmet need will become more relevant as immune checkpoint inhibitors move into the frontline setting in combination with chemotherapy, combined with the enthusiasm from gynecological oncologists, we expect IOV-END-201 to enroll quickly, and we look forward to presenting initial data soon.

對於絕大多數子宮內膜癌患者，在接受抗 PD-1 治療後，醫療需求尚未滿足，目前還沒有批准的治療方案。隨著免疫檢查點抑制劑與化療聯合進入第一線環境，加上婦科腫瘤學家的熱情，這種未滿足的需求將變得更加重要，我們預計IOV-END-201 能夠迅速入組，並期待很快提供初步數據。

As the leader until cell therapy, Iovance is at the forefront of next-generation approaches to optimize TIL until treatment regimen. We are investigating next-generation PD-1 inactivated TIL cell therapy, IOB-4001 in the clinical trial and previously treated advanced melanoma and non-small cell lung cancer patients. Two additional next-generation programs are in IND-enabling studies and our approach in clinical trials in the near term.

作為細胞治療領域的領導者，Iovance 處於優化 TIL 直至治療方案的下一代方法的前沿。我們正在臨床試驗中研究下一代 PD-1 滅活 TIL 細胞療法 IOB-4001 以及先前治療過的晚期黑色素瘤和非小細胞肺癌患者。另外兩個下一代計畫正在進行 IND 支持研究，我們的方法將在近期進行臨床試驗。

IOV-3001 is the next generation interleukin-2 or IL-2 analog for use with the TIL treatment regimen. Preclinical data supports the potential for improved safety with robust effector TIL cell expansion driven by IOV-3001. IOV-5001 because it's genetically engineered TIL cell therapy with inducible interleukin-12 or IL-12. IOV-5001 has augmented TIL antitumor activity in preclinical studies and may improve safety via the tethering of IL2 to the TIL.

IOV-3001 是下一代白細胞介素 2 或 IL-2 類似物，與 TIL 治療方案一起使用。臨床前數據支持 IOV-3001 驅動的穩健效應 TIL 細胞擴增具有提高安全性的潛力。IOV-5001，因為它是採用誘導型白細胞介素 12 或 IL-12 進行基因工程 TIL 細胞療法。IOV-5001 在臨床前研究中增強了 TIL 的抗腫瘤活性，並可能透過將 IL2 與 TIL 結合來提高安全性。

As noted in this afternoon's press release, we've renewed our cooperative research and development agreement or trade up to collaborate with the US National Cancer Institute or NCI, on preclinical and clinical development of enhanced tumor reactive TIL product.

正如今天下午的新聞稿中所指出的，我們已續簽合作研發協議或與美國國家癌症研究所 (NCI) 合作，以進行增強型腫瘤反應性 TIL 產品的臨床前和臨床開發。

Additional details about our development programs are included in today's press release as well as the corporate slide deck and scientific presentations on our website. I'm happy to address questions about these programs and additional trials during the Q&A session.

有關我們開發計劃的更多詳細資訊包含在今天的新聞稿以及我們網站上的公司幻燈片和科學簡報中。我很高興在問答環節中解答有關這些計劃和其他試驗的問題。

I'll now turn the call over to the operator to begin the question-and-answer session to ask a question.

我現在將把電話轉給接線員，開始問答環節來提問。

{34:00}

{34:00}

(Operator Instructions)

（操作員說明）

Michael Yee, Jefferies.

麥可葉，杰弗里斯。

Hey guys, thanks congrats on a good day, good execution of the launch and good guidance. We just wanted to ask two questions on the guidance. Does the guidance number include Proleukin revenues built into that? I know it's not a huge amount, but just want to make it Square and accurate.

嘿夥計們，謝謝恭喜你度過了美好的一天，發布的執行良好，指導也很好。我們只是想問有關該指南的兩個問題。指導數字是否包括其中的 Proleukin 收入？我知道這不是一個很大的數字，但只是想讓它變得方形和準確。

And then can you talk to some the $18 million of Proleukin as a leading indicator. Does that imply a certain amount of patience or a short amount of time? Or is it just distributors buying it up. We're trying to back into that as maybe a queue of demand. And so I just want to think about your got your numbers on Proleukin and perhaps related to that, if I may just asked differently, do you have any numbers on the patient enrollment forms to think about 2Q? Thanks so much.

然後你可以和一些人談論價值 1800 萬美元的 Proleukin 作為領先指標嗎？這是否意味著一定的耐心或較短的時間？或者只是經銷商購買它。我們正在嘗試將其視為可能的需求隊列。所以我只想想一下您在 Proleukin 上的數據，也許與此相關，如果我可以換個方式問，您在患者登記表上有任何數字可以考慮 2Q 嗎？非常感謝。

Yeah, Mike, the guidance does include Proleukin. So all the guidance numbers that we put out include Proleukin revenues as well as Amtagvi revenues.

是的，麥克，該指南確實包括 Proleukin。因此，我們發布的所有指導數字都包括 Proleukin 收入以及 Amtagvi 收入。

Now on the Proleukin revenue number for this quarter, that represents sort of the leading indicator for what we think will be impacting demand over the next couple of quarters. You can model it any way you see fit. It's a large number of infusions would give me, the number of infusions through growth if you grow originally is more than 55 down.

現在來看看本季的 Proleukin 營收數據，這代表了我們認為將影響未來幾季需求的領先指標。您可以按照您認為合適的任何方式對其進行建模。這是大量的輸液會給我，如果你原本成長的話，透過成長的輸液次數會下降55以上。

And you can use that to kind of estimate where we're going. But the whole point of us giving guidance so that you can rely on our internal understanding of infusions and Proleukin demands that we see with the upswing is going to look like here as a very positive uptake of both Proleukin and especially Amtagvi.

你可以用它來估計我們要去的地方。但我們提供指導的全部意義在於，您可以依賴我們對輸液和 Proleukin 要求的內部理解，我們看到隨著上升，這將看起來像 Proleukin 和特別是 Amtagvi 的非常積極的吸收。

Yes, just to clarify, it's a buying up a certain amount from distributors, but not like a one for one or a certain amount of time. It's just an indicator?

是的，澄清一下，這是從經銷商購買一定數量的產品，但不是一次性或一定時間的購買。這只是一個指標嗎？

It's just an indicator. And they've already started restocking. I can't stress that more. They've already sort of reloading because they sold a lot of that product already.

這只是一個指標。而且他們已經開始補貨了。我不能再強調這一點了。他們已經重新加載了，因為他們已經售出了很多該產品。

Got it. Thank you.

知道了。謝謝。

Peter Lawson, Barclays.

彼得·勞森，巴克萊銀行。

Thanks again, Fred, and congrats on the progress. And the Q3 guidance. What's the breakout of IL-2 versus TIL same question for the full year as well. And then for the IL-2 revenues this quarter, what was the proportion of that IL-2 that was useful for TIL therapy?

再次感謝弗雷德，並祝賀取得的進展。以及第三季的指引。IL-2 與 TIL 的突破是什麼，全年也是同樣的問題。那麼對於本季的 IL-2 收入來說，可用於 TIL 治療的 IL-2 的比例是多少？

Yes, we don't have. We're not going to provide guidance on the individual products, we're just going to provide the aggregate guidance. You can probably model it by understanding the amount of Proleukin that's use for Amtagvi patient, because I'm going to answer your second question I had at time here.

是的，我們沒有。我們不會提供單一產品的指導，我們只會提供整體指導。您也許可以透過了解 Amtagvi 患者使用的 Proleukin 量來對其進行建模，因為我將回答您當時在這裡提出的第二個問題。

We don't know exactly how much of our Proleukin gets used in the Amtagvi regimen, but you can hear from Jean-Marc's comments earlier and from the experience of Proleukin in the industry for many years, it's got to be the vast majority of it getting used for Amtagvi. We have no way of tracking that from an accounting perspective, but it's being. Obviously, the massive upswing in Proleukin sales was driven by Amtagvi.

我們不知道我們的Proleukin到底有多少用在Amtagvi方案中，但是你可以聽Jean-Marc之前的評論以及Proleukin在行業多年的經驗來看，肯定是絕大多數習慣了 Amtagvi。我們無法從會計角度追蹤這一點，但它確實存在。顯然，Proleukin 銷售額的大幅成長是由 Amtagvi 推動的。

Got you. Okay, thanks so much.

明白你了。好的，非常感謝。

Andrea Tan, Goldman Sachs.

安德里亞·譚，高盛。

Good afternoon. Thanks for taking the question. And Fred, I'm curious here just given where you stand on in the launch, you're six months in what is driving your confidence for a full year '25 guidance, given where you are now? And then just curious if you plan on providing on metrics around demand such as the patient enrollment or screening as you have in the in past quarters? Thanks so much.

午安.感謝您提出問題。Fred，我很好奇，考慮到您在發布過程中的立場，您在六個月的時間裡，考慮到您現在的情況，是什麼推動了您對 25 年全年指導的信心？然後只是好奇您是否計劃提供有關需求的指標，例如像過去幾季那樣的患者入組或篩檢？非常感謝。

We may provide some additional guidance on -- we're not, you won't hear us talking about enrollments anymore. It's really not relevant. Anymore of the matter is now infusions, which is a revenue generating event. So we may talk a bit about that as we go over the next, whatever, four or five quarters here. But really what we're trying to do with the guidance is give you the big numbers, you don't have to worry about enrollments and that sort of thing. You can figure out exactly what we're seeing in terms of infusions.

我們可能會提供一些額外的指導 - 我們不會，您不會再聽到我們談論註冊。這確實不相關。現在最重要的是輸液，這是一項創收活動。因此，我們可能會在接下來的四、五個季度討論這個問題。但實際上，我們試圖透過指導做的是給你大量的數字，你不必擔心入學率之類的事情。您可以準確地了解我們在輸液方面所看到的情況。

What's giving us guidance on that fiscal year '25 guidance for full-year 2012 guidance we can see the launch. We see how we're doing. We know all the dynamics know how many ATCs are coming onboard. We know what they think they're going to do. We know our manufacturing capacity and all the details around that stuff. That would be very difficult, I think, for the street to model in some cases.

是什麼為我們提供了 25 財年指導以及 2012 年全年指導的指導，我們可以看到發布。我們看看我們做得怎麼樣。我們知道所有動態都知道有多少 ATC 即將加入。我們知道他們認為他們會做什麼。我們了解我們的製造能力以及相關的所有細節。我認為，在某些情況下，對街道進行建模會非常困難。

So we're going to provide it for you so you have clarity on what we're seeing. And we are very, very confident in that guidance based on what we're seeing so far and the additional launch because you've got such a good picture of launch dynamics right now.

因此，我們將為您提供它，以便您清楚地了解我們所看到的內容。根據我們迄今為止所看到的情況和額外的發布，我們對這項指導非常非常有信心，因為你們現在已經對發布動態有了很好的了解。

Thanks so much.

非常感謝。

Yanan Zhu, Wells Fargo Securities.

朱亞楠，富國銀行證券。

Great. Thanks for taking our questions and congrats on the progress here. So I guess a couple of questions on patient numbers. You gave the patient the infusion number of infusions for since the start of this quarter, which is 30 patients. Given that there will be you have talked about month-to-month increase and over quarter increase. Can we assume that over the next two months. And within the current quarter, you will have patient numbers that will exceed the 30 patient number there.

偉大的。感謝您提出我們的問題，並祝賀我們的進展。所以我想有幾個關於患者數量的問題。您向患者提供了自本季度開始以來的輸液次數，即 30 名患者。鑑於您會談到逐月增長和環比增長。我們可以假設在接下來的兩個月內。在本季度內，患者人數將超過 30 名。

And on also on patient number, I just want wanted to understand on here, has there been patients that have been resected around the same time as the 30 patient and who did not receive the product, i.e., trying to get a sense of the ongoing attrition rate and whether that's due to manufacturing issues or patient progression? If you can give some color there, that would be super helpful. Thank you.

還有關於患者數量，我只是想了解，是否有患者與 30 名患者大約在同一時間接受了切除手術，並且沒有收到產品，即試圖了解正在進行的情況損耗率以及這是否是由於製造問題或患者進展造成的？如果你可以在那裡給一些顏色，那就非常有幫助了。謝謝。

To answer your second question first, the patient dropout rate and manufacturing success rate remained consistent with what we saw in the clinical trial experience. So we're seeing that today. We can obviously further optimize our working on that. Part of the reason we're giving guidance so that you don't have to necessarily factor that all in.

首先回答你的第二個問題，病人退出率和生產成功率與我們在臨床試驗中看到的結果一致。所以我們今天看到了這一點。顯然我們可以進一步優化我們的工作。我們提供指導的部分原因是這樣您就不必將所有因素都考慮在內。

We can see that pretty clearly understand that. And as we go, we may provide more details on that once we have a larger end in our dataset here. But right now, we feel very good about those numbers.

我們可以很清楚地看到這一點。隨著我們的進展，一旦我們的資料集中有了更大的結果，我們可能會提供更多詳細資訊。但現在，我們對這些數字感覺非常好。

And then you asked a question. I can fully understand what you're getting at with the patient numbers. We've already done more than 30 patients this quarter, meaning Q3 quarter. We currently sit in that we did in this quarter second quarter that we're reporting for. We expect that to obviously accelerate considerably, such that by the end of Q3, the numbers will be much higher. I'm not sure if that answers your question or if you want to phrase it differently, I can try it again.

然後你問了一個問題。我完全理解你對病人數量的理解。本季（即第三季）我們已經治療了 30 多名患者。我們目前正坐在我們報告的本季第二季所做的事情上。我們預計這一趨勢將明顯加速，到第三季末，這一數字將會高得多。我不確定這是否能回答您的問題，或者如果您想以不同的方式表達它，我可以再試一次。

Right. So given that you have used more than 30 patients this quarter, but this quarter is still have a couple of months to go. Right. So I'm just trying to understand what's your assumption for this quarter?

正確的。鑑於本季度您已經使用了 30 多名患者，但本季還有幾個月的時間。正確的。所以我只是想了解您對本季的假設是什麼？

The patient number for this quarter, given that you only give the revenue guidance, which includes Proleukin and at this current stage, I think it's a little harder for us to understand the Proleukin revenue contribution because there's a lot of stocking going on. So it's hard for us to see that patient number.

本季的患者人數，考慮到您只給出了收入指導，其中包括 Proleukin，在現階段，我認為我們很難理解 Proleukin 的收入貢獻，因為有大量的備貨。所以我們很難看到這個病人的數量。

If you can help us understand the patient number for this quarter that would be helpful.

如果您能幫助我們了解本季的患者人數，將會很有幫助。

We have an estimated number for this quarter, that's a lot higher than 30. I can't give you that number today. I can tell you that it will be significantly higher and will that will track out the way we think it will track out to give you $53 million to $55 million. In revenue with a good portion that being Proleukin, especially restocking Proleukin. That's the most color I can give you right now.

我們預計本季的數量遠高於 30。今天我不能給你那個號碼。我可以告訴你，它會明顯更高，並且會以我們認為的方式為你帶來 5300 萬至 5500 萬美元。收入中很大一部分是Proleukin，尤其是補充Proleukin。這是我現在能給你的最多的顏色。

Got it. Thanks and congrats again.

知道了。再次感謝並恭喜。

Tyler Van Buren, TD Cowen.

泰勒·範布倫，TD·考恩。

Hey, guys. Thanks for taking the questions. Just a couple. So you gave basically some metrics on time to manufacturing, which is consistent and reimbursement, but what's the average time from the beginning from opt into infusion?

嘿，夥計們。感謝您提出問題。只是一對。因此，您基本上給出了一些關於製造時間的指標，這是一致的和報銷的，但是從選擇輸注開始的平均時間是多少？

And then the second one is around kind of how much you're netting per infusion and gross margins. I suppose if you guide to target gross margin of 70% over the next few years, that would assume roughly 360 on the 515 list. So it has to be lower currently.

第二個是關於每次輸液的淨收入和毛利率。我想，如果您將未來幾年的毛利率目標設定為 70%，則假設 515 名單中的公司大約為 360。所以目前它必須更低。

And we're getting some inbounds with cost sales being the same as product revenue for this quarter. So more color on that and how much is fixed first variable and how it might evolve over time would be super helpful.

我們收到了一些收入，本季的成本銷售與產品收入相同。因此，更多的顏色以及第一個變數的固定程度以及它如何隨著時間的推移而演變將會非常有幫助。

Sure. We are currently right now, Tyler, see the entire enrollment process. The reimbursement approval with financial loss in case agreement, all the stuff we talked about endlessly of non-life calls as well as scheduling getting aligned for reception at the whole thing takes about three to four weeks right now.

當然。泰勒，我們現在正在查看整個註冊過程。案件協議中經濟損失的報銷批准、我們無休止地談論的非人壽電話的所有內容以及整個過程中安排接待時間大約需要三到四個星期。

So I hope that answers the first part of your question there. That's where it is today, and that's getting quite close to where we wanted to be long term.

所以我希望這能回答你問題的第一部分。這就是今天的情況，而且已經非常接近我們想要的長期目標。

On the netting, I think with respect to gross margin and we've obviously give you the number. Are you asking about gross to net on the product on Amtagvi, you mentioned discounting and I'm not sure exactly what you were talking about from a financial perspective. Gross-to-net on the product, very low.

在淨額方面，我認為就毛利率而言，我們顯然已經給了你這個數字。您是否詢問 Amtagvi 上產品的毛淨值，您提到了折扣，但我不確定您從財務角度到底在談論什麼。產品的毛淨值非常低。

Yeah. Currently, how much you're netting with each infusion and how you expect that to evolve in the coming quarters?

是的。目前，您每次輸液的淨收入是多少？

It's a gross-to-net right now, less than 0.5%, and we expect it to stay around there, less than 0.5%.

目前毛淨比低於 0.5%，我們預計它將保持在這個水平，低於 0.5%。

But I guess the question is cost of sales are the same as product revenue. So there's a lot I mean, there's a lot of that fixed, I mean and obviously, if it's a 70% gross margin, it's not 0.5% currently, right?

但我想問題是銷售成本與產品收入相同。所以我的意思是，有很多是固定的，我的意思是，顯然，如果毛利率是 70%，那麼目前不是 0.5%，對嗎？

I think so, I'm going to probably need Jean-Marc help here, but maybe just some of this is lost in the definition of cost of sales that we're using.

我想是的，我可能需要 Jean-Marc 的幫助，但也許我們正在使用的銷售成本的定義中丟失了其中的一些內容。

Jean-marc, you want to comment?

讓-馬克，你想發表評論嗎？

Yeah, adjusting the timing inventory to answer your third question. So what you will see in the 10-Q and all the details, obviously your cost of sales. So in total, which is a $38 million, we should look at the reserve to date to June 2024.

是的，調整計時清單來回答你的第三個問題。因此，您將在 10-Q 中看到的內容以及所有詳細信息，顯然是您的銷售成本。因此，我們應該考慮截至 2024 年 6 月的儲備金總計 3,800 萬美元。

As you know, we don't have any specific your gross margin to give for product or product by product because it's a total, but just know that on the cost of sales, you will have, of course, other things than only cost of product, cost of goods sold itself because you have intangible asset that you need to take into account your royalty to take into account.

如您所知，我們沒有為產品或產品提供任何具體的毛利率，因為它是總計，但只要知道在銷售成本上，當然，除了銷售成本之外，您還會有其他因素產品，商品銷售成本本身，因為你有無形資產，你需要考慮你的特許權使用費。

So you cannot draw exactly what's the conclusion and the gross margin that we are committed to, again in the next several years to reach the 70% because we believe that where we stand today in terms of cost of sales for our products make us confident for reaching the 70% in the next few years.

因此，您無法準確得出結論以及我們承諾在未來幾年內再次達到 70% 的毛利率，因為我們相信，就我們產品的銷售成本而言，我們今天的立場使我們對未來幾年將達到70% 。

Thanks.

謝謝。

Ben Burnett, Stifel.

本·伯內特，斯蒂菲爾。

Thank you very much. And again, appreciate or congrats on all the progress on a great quarter. Question just on the cash guidance that Jean-Marc you're talking about, to what extent do you consider product revenue when calculating the cash runway?

非常感謝。再次感謝或恭喜這個季度取得的所有進展。關於讓-馬克所說的現金指導的問題，在計算現金跑道時，您在多大程度上考慮了產品收入？

Yeah, we do take into account the product revenue, but to be honest with you, Ben, we are very conservative. So that's why we're confident and are saying with the recent, $200 million we just raised or to be able to go into 2026. And that includes you know all the spending in term of that investment in term of increasing your manufacturing capability and capacity and all operational spend. So we are very conservative and I'm very confident about that.

是的，我們確實考慮了產品收入，但老實說，Ben，我們非常保守。這就是為什麼我們充滿信心，並表示我們最近剛籌集了 2 億美元，或能夠進入 2026 年。這包括您知道在提高製造能力和產能方面的所有投資支出以及所有營運支出。所以我們非常保守，我對此非常有信心。

Okay. Thank you. And just to clarify, so when thinking about kind of the spending going forward, we shouldn't just assume that the cash guidance is assuming the product guidance exactly.

好的。謝謝。只是為了澄清，所以在考慮未來的支出類型時，我們不應該只是假設現金指導完全假設了產品指導。

We do take into account what we are telling you around the $450 million for $475 million in 2025. Obviously, this is our baseline to look into our cash burn from further cash overall situation for next year. But that's the top line after you have to take into account also as you know, some are one-time expenses. We managed to increase in capability and capacity at iCTC, for example, that, again very confident into it. We're giving the guidance you know through 2026 other as a cash in the end.

我們確實考慮到了我們所告訴您的 2025 年 4.75 億美元的收入約為 4.5 億美元。顯然，這是我們從明年進一步現金總體情況來調查現金消耗的基準。但這是最重要的，正如你所知，有些是一次性費用。例如，我們設法提高了 iCTC 的能力和能力，對此我們再次充滿信心。我們將提供截至 2026 年的指導意見，最終以現金形式提供。

Okay. And maybe just one follow up. What is kind of the timeframe for expanding the manufacturing capacity to 5,000?

好的。也許只是一個後續行動。產能擴大到5000台的時間安排是怎麼樣的？

Igor, do you want to handle that one?

伊戈爾，你想處理那個嗎？

So right now, the network is built to a couple of thousand patients per year capacity and within the existing iCTC facility, as you recall, we have shelf space that we're now building out and then build out will bring iCTC to over 5,000 patients per year capacity and that buildout should be completed in a couple of years.

所以現在，該網路的建造容量是每年容納數千名患者，並且在現有的 iCTC 設施內，正如您所記得的，我們現在正在擴建的貨架空間，然後擴建將為超過 5,000 名患者提供 iCTC每年的產能和擴建應在幾年內完成。

Okay, great. Thank you very much.

好的，太好了。非常感謝。

Of course.

當然。

Colleen Kusy, Braid.

科琳‧庫西，《辮子》。

Great.

偉大的。

Thanks for taking our question. Questions and congrats on the progress on. Can you comment on the manufacturing success rate and just kind of what happens when there is an unsuccessful manufacturing run, does that just get filtered into COGS? And then for the fiscal year 2025 guidance, how much of is the contribution expected to be from Europe?

感謝您提出我們的問題。問題和祝賀的進展。您能否評論一下製造成功率以及當製造運作不成功時會發生什麼，這是否會被過濾到銷貨成本中？那麼對於 2025 財年的指導，預計有多少貢獻將來自歐洲？

Yeah. Jean-Marc, do you want to talk a little bit about how it works with the manufacturing, like an out of spec and how that goes in the COGS?

是的。Jean-Marc，您想談談它在製造方面的運作方式嗎？

So going thanks for the question. I appreciate that. The out of spec and all the scrap will go and you will see that in the queue. As part of our cost of sales because when the project is not being infused by division because of efficient sales, all the situation like that and no out of spec, of course, we have to take into account, what stage of our production it was. So it will be taken into account as part of cost of sales.

謝謝你的提問。我很欣賞這一點。不符合規格的產品和所有廢料都會消失，您會在佇列中看到它們。作為我們銷售成本的一部分，因為當項目因高效銷售而沒有被部門注入時，所有類似的情況並且沒有超出規格，當然，我們必須考慮到它處於生產的哪個階段。因此，它將被視為銷售成本的一部分。

If it is going into potentially some gain of you know, and it's case-by-case situation, clinical use, then we will switch into OpEx. We will switch it back to OpEx as part of our clinical spend in that case.

如果它可能會帶來一些潛在的收益，並且根據具體情況進行臨床使用，那麼我們將轉向營運支出。在這種情況下，我們將把它轉回營運支出，作為我們臨床支出的一部分。

And Colleen, I can answer no, the European revenue is not factored in anything right now, that will come online. As I said in my remarks, a little bit later, we expect it will give us even more tailwinds in 2026 and beyond.

科琳，我可以回答不，歐洲收入目前沒有考慮到任何將在網路上公佈的內容。正如我在演講中所說，稍後，我們預計它將在 2026 年及以後為我們帶來更多順風車。

Great. Thanks for taking our questions and congrats on the progress.

偉大的。感謝您提出問題並祝賀我們的進展。

Asthika Goonewardene, Truist.

Asthika Goonewardene，真理主義者。

Hey guys, thanks for the question and appreciate all the color and the patience with all my questions today on this. I'm going to ask one more on the guidance here. Maybe can give a little color on the proportion of the product revenue guidance that that is attributed to Proleukin.

嘿夥計們，感謝您提出這個問題，並感謝所有的色彩和耐心回答我今天提出的所有問題。我要再問一個關於這裡的指導的問題。也許可以對歸因於 Proleukin 的產品收入指導比例進行一些說明。

Is that right to assume that the contribution slightly down with each progressing period buys a fixed component each period and then each period provided? And then of the 25 patients that were treated in 2Q what proportion of these patients will reinforce reimbursement sort on a single case basis? And how is that shifting through 30 patients already treated to date in 3Q? Thanks.

假設每個階段的貢獻略有下降，每個階段都會購買一個固定組成部分，然後每個階段都會提供，這樣的假設是否正確？那麼在第二季度接受治療的 25 名患者中，有多少比例的患者會在單一病例的基礎上加強報銷排序？第三季迄今已接受治療的 30 名患者的情況有何變化？謝謝。

Asthika, the way to think about it is if Amtagvi has a price, Proleukin as a price you multiply that probably comprised by number of biology expect. You're going to get to what I think you referred to was a fixed combination, which is a fixed percentage.

Asthika，思考這個問題的方法是，如果 Amtagvi 有一個價格，Proleukin 作為一個價格，你乘以可能由生物學期望的數量組成的價格。您將得到我認為您提到的固定組合，即固定百分比。

So ultimately integrity patients that get Proleukin, there's going to be a percentage between the total cost of those two drugs, what percentage Proleukin contribute and what percentage Amtagvi contributes. You can calculate it pretty easily.

因此，最終要保證接受 Proleukin 的患者的誠信，這兩種藥物的總成本之間會有一個百分比，即 Proleukin 貢獻的百分比和 Amtagvi 貢獻的百分比。你可以很容易地計算出來。

It's roughly in the ballpark of about 15%. We can calculate that out a little more detail for you, but I'm sure you can do the math.

大約在 15% 左右。我們可以為您計算更多細節，但我相信您可以計算出來。

For the 25 patients in the single case agreement. We do silicates agreements for every patient. They just go faster and faster. Maybe Jim, could you add a little color on how -- those 25 patients?

對於單例協議中的25名患者。我們為每位患者簽訂矽酸鹽協議。他們只是走得越來越快。也許吉姆，你能否為這 25 名患者添加一些色彩？

Yeah, thanks, Fred. So the payer mix that we're seeing currently in the early days of launch mirrors what we had previously shared prior to launch. So prior authorizations in single case agreements primarily applied to the private payers, which you will recall was about three-quarters of the patients. That's what we're seeing right now in the early months of launch, a payer mix that's very consistent. So about 75%.

是的，謝謝，弗雷德。因此，我們目前在發布初期看到的付款人組合反映了我們之前在發布前分享的內容。因此，單一案例協議中的事先授權主要適用於私人付款人，您可能還記得，大約有四分之三的患者。這就是我們在推出的最初幾個月所看到的，付款人組合非常一致。所以大約75%。

Thanks, guys.

謝謝，夥計們。

Reni Benjamin, Citizen's JMP.

Reni Benjamin，公民 JMP。

Hey, guys. Thanks for taking the questions. And congratulations on a great quarter and great guidance. Couple for us. Maybe just starting off, can you talk a little bit about how you're managing and working with some ATCs, especially as it comes to maybe constraints and how they're dealing with prioritizing CAR Ts versus TIL infusion and how that's kind of going forward.

嘿，夥計們。感謝您提出問題。恭喜您取得了出色的季度業績和出色的指導。對我們來說是情侶。也許剛開始，您能談談您如何管理和與一些 ATC 合作，特別是涉及到可能的限制，以及他們如何處理優先考慮 CAR T 與 TIL 輸注的問題，以及未來的進展如何。

And I guess also we heard a lot of arguments this quarter, patients were dying before they get the infusion. Maybe you can talk a little bit about how the what the patients are kind of looking at now as they're being enrolled, has it changed any or they have a healthier, less lines of therapy?

我想我們這個季度也聽到了很多爭論，病人在接受輸液之前就已經死亡了。也許你可以談談患者在入組時的看法，是否有所改變，或者他們有更健康、更少的治療方案？

And then the other I mean, where do you guys didn't have enough slots and that there is just a backlog and then waiting for cells to get process. Can you talk maybe a little bit about that, whether or not there was a backlog? Thank you.

然後我的意思是，你們哪裡沒有足夠的槽位，只有積壓的訂單，然後等待單元得到處理。您能否談談這個問題，無論是否有積壓？謝謝。

Jim, do you want to take the first part of that? Maybe, Brian, I think the second part.

吉姆，你想聽第一部分嗎？也許，布萊恩，我想是第二部。

Yeah, sure. So I think, Reni. As we work with the ATCs, we work with them almost on a daily basis, especially the top ATCs, how they decide and allocate beds between parties until I'm not exactly sure. But I do know that in terms of demand in scheduling patients for Amtagvi, that doesn't seem to be a concern. Just as prior to launch, there was a lot of concern around the lack of hospital beds. It does not appear to be any type of a restraint at all.

是的，當然。所以我想，雷尼。當我們與 ATC 合作時，我們幾乎每天都與他們合作，尤其是頂級 ATC，他們如何決定並在各方之間分配床位，直到我不太確定。但我確實知道，就安排患者前往 Amtagvi 的需求而言，這似乎並不是一個問題。正如啟動之前一樣，人們對醫院床位的缺乏感到非常擔憂。它看起來根本不是什麼類型的限制。

In terms of patients dying before infusions. I guess what I would say is similar to other CAR Ts where there is a high unmet need and the lack of available treatments.

就輸注前患者死亡而言。我想我想說的與其他 CAR T 類似，有很高的未滿足需求和缺乏可用的治療方法。

Yes, you do have some patients that may progress or may die before therapy. But as we are well into launch now into our system six months, I think patient selection is getting much better and we're not seeing those same trends. I would just reiterate that the demand that we're seeing at the ATCs, the operational readiness looks really, really good and it reinforces the confidence behind our guidance. Brian?

是的，確實有一些患者在治療前可能會病情進展或死亡。但由於我們的系統已經投入使用六個月了，我認為患者選擇變得越來越好，我們沒有看到相同的趨勢。我只想重申，我們在空中交通管制中看到的需求、營運準備看起來真的非常好，這增強了我們指導背後的信心。布萊恩？

Yeah, we are, I would say having being said, Jim, one thing that we've done at Iovance, I think it is not the only one of its kind. It's certainly rather unique has developed as we call it, peer-to-peer, which is really former health care providers are speaking to current health care providers and assessing patients is a partnership.

是的，我們是，吉姆，我想說的是，我們在 Iovance 所做的一件事，我認為這不是唯一的一件這樣的事情。它確實是相當獨特的，我們稱之為點對點，這實際上是前醫療保健提供者與現任醫療保健提供者交談，並評估患者是一種夥伴關係。

We've all learned about the current commercial patient population out there. And I think what really made the biggest improvement is patient selection, people understanding who are the most appropriate and even more so that these are authorized treatments are speaking to the referring doctors tried to get them to understand earlier, what is that percentage send the patients to them.

我們都了解了目前的商業患者群體。我認為真正取得最大進步的是患者選擇，人們了解誰是最合適的，甚至更重要的是，這些被授權的治療正在與轉診醫生交談，試圖讓他們儘早了解，發送給患者的百分比是多少給他們。

So we can move this process up and make patients who right now may not be the best candidate. There is a point in their earlier in their journey when they weren't better candidates and having this relationship that we have with all the authorized treatment centers is starting to bear fruit. And that's why I think you're seeing less and less of what you were describing.

因此，我們可以將這個過程提前，讓目前可能不是最佳候選者的患者接受治療。在他們的早期旅程中，有一個時刻，他們並不是更好的候選人，而我們與所有授權治療中心的這種關係正在開始結出碩果。這就是為什麼我認為你所看到的你所描述的內容越來越少。

Thanks, guys, and congrats.

謝謝你們，恭喜你們。

Thank you. I'm showing no further questions at this time. I would now like to turn it back to Fred Vogt for closing remarks.

謝謝。我目前沒有提出任何進一步的問題。現在我想請弗雷德·沃格特發表結束語。

Thank you again for joining the Iovance Biotherapeutics second quarter and first half 2024 financial results and corporate update conference call. We're honored to disclose the first revenues for the first commercial TIL cell therapy and look forward to providing further updates on the progress of our Amtagvi launch as well as continued developments in our pipeline and future updates.

再次感謝您參加 Iovance Biotherapeutics 2024 年第二季和上半年財務業績和公司更新電話會議。我們很榮幸地披露首個商業化 TIL 細胞療法的第一筆收入，並期待提供有關 Amtagvi 上市進展以及我們管道的持續發展和未來更新的進一步更新。

It's already been a monumental year for Iovance and we continue to be motivated, as we hear media and social media, how Amtagvi is providing hope to patients with metastatic melanoma. As always, we're thankful for the patient's, healthcare and advocacy communities, our partners and our exceptional Iovance team. I would also like to thank our shareholders and covering analysts for their support. Please feel free to reach out to our investor relations team for follow-up. Thank you.

對於 Iovance 來說，今年已經是具有里程碑意義的一年，當我們聽到媒體和社交媒體報導 Amtagvi 如何為轉移性黑色素瘤患者帶來希望時，我們繼續受到激勵。一如既往，我們感謝患者、醫療保健和倡導社區、我們的合作夥伴以及我們出色的 Iovance 團隊。我還要感謝我們的股東和分析師的支持。請隨時聯絡我們的投資者關係團隊進行後續追蹤。謝謝。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。