Iovance Biotherapeutics Inc (IOVA) 2025 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Iovance Biotherapeutics second-quarter 2025 financial results conference call. (Operator Instructions)

您好，感謝您的支持。歡迎參加 Iovance Biotherapeutics 2025 年第二季財務業績電話會議。（操作員指示）

Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sara Pellegrino, Senior Vice President, Investor Relations and Corporate Communications. Please go ahead.

請注意，今天的會議正在錄音。現在，我想將會議交給今天的發言人、投資者關係和企業傳播高級副總裁 Sara Pellegrino。請繼續。

Thank you, operator. Good afternoon, and thank you for joining the Iovance conference call and webcast to discuss our second quarter and first half 2025 financial results, as well as recent updates.

謝謝您，接線生。下午好，感謝您參加 Iovance 電話會議和網路廣播，討論我們的 2025 年第二季和上半年財務業績以及最新動態。

Dr. Fred Vogt, our Interim Chief Executive Officer and President, will provide an introduction and brief overview of our key financial results, including revenue and revenue guidance, operating expenses and our strategic restructuring; Dan Kirby, Chief Commercial Officer, will discuss product revenue and commercial and regulatory updates for Amtagvi; Dr. Igor Bilinsky, our Chief Operating Officer, will provide a manufacturing update; and Dr. Friedrich Finckenstein, our Chief Medical Officer, will summarize our priority pipeline programs.

我們的臨時執行長兼總裁 Fred Vogt 博士將介紹並簡要概述我們的主要財務業績，包括收入和收入指導、營運費用和我們的策略重組；首席商務官 Dan Kirby 將討論 Amtagvi 的產品收入以及商業和監管更新；我們的首席營運官 Igor Bilinsky 博士將提供優先管道更新；我們的首席醫療官 Friedrich Finckenstein 博士將總結我們的優先管道更新計劃；

Additional members of our leadership team, including Dr. Raj Puri, our Chief Regulatory Officer; and Dr. Brian Gastman, our Executive Vice President of Medical Affairs, will be available for the Q&A session. In addition, our new Chief Financial Officer, Corleen Roche, is joining today's call. Earlier this afternoon, we issued a press release that is available on our corporate website at iovance.com.

我們的領導團隊的其他成員，包括首席監管官 Raj Puri 博士和醫療事務執行副總裁 Brian Gastman 博士，將出席問答環節。此外，我們的新任財務長 Corleen Roche 也將參加今天的電話會議。今天下午早些時候，我們發布了一份新聞稿，可在我們公司網站 iovance.com 上查閱。

Before we start, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding Iovance's goals, business focus, business plans and transactions, revenue and revenue guidance, commercial activities, clinical trials and results, regulatory approvals and interactions, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interactions, restructuring plans and workforce reductions, licenses and collaborations, cash position and expense guidance, and future updates.

在我們開始之前，我想提醒大家，本次電話會議期間的聲明將包括關於 Iovance 的目標、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、監管批准和互動、計劃和戰略、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、付款人現金狀況、重組計劃和工作人員互動

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.

前瞻性陳述受多種風險和不確定性的影響，其中許多是我們無法控制的，包括我們向美國證券交易委員會提交的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中預測的結果有重大差異。我們不承擔公開更新任何前瞻性聲明的義務。

With that, I will turn the call over to Fred.

說完這些，我將把電話轉給弗雷德。

Thank you, Sara, and welcome to the Iovance second quarter and first half 2025 conference call. We are more than a year into our US launch of Amtagvi for advanced melanoma, the first FDA-approved TIL cell therapy. Adoption continues to grow, and for the first time, we surpassed more than 100 patients treated in a single quarter. We are also excited about our first real-world data set for Amtagvi monotherapy in the commercial setting.

謝謝你，薩拉，歡迎參加 Iovance 2025 年第二季和上半年電話會議。我們在美國推出用於治療晚期黑色素瘤的 Amtagvi 已經一年多了，這是第一個獲得 FDA 批准的 TIL 細胞療法。採用率持續成長，我們首次在一個季度內治療的患者數量超過 100 名。我們也對商業環境中 Amtagvi 單一療法的第一個真實世界數據集感到興奮。

Top line results showed a nearly 49% response rate among 41 patients and for 23 patients treated in third line or earlier treatment settings and approximately 61% response rate, all from patients treated in accordance with the label. We look forward to sharing more detailed real-world data at an upcoming medical meeting.

頂線結果顯示，41 名患者和 23 名接受三線或更早治療的患者的反應率接近 49%，而所有患者均按照標籤進行治療，反應率約為 61%。我們期待在即將舉行的醫學會議上分享更詳細的真實世界數據。

Another important growth driver for Amtagvi is onboarding large community practices to join our ATC network. We plan to begin treating patients from these practices in the fourth quarter of this year. Patients in the community are generally earlier in their melanoma treatment journey, and we expect that the higher response rates observed in our real-world data set will also be relevant to these patients.

Amtagvi 的另一個重要成長動力是讓大型社群實踐加入我們的 ATC 網路。我們計劃從今年第四季開始為這些診所的患者提供治療。社區中的患者通常較早開始黑色素瘤治療，我們預計在真實世界數據集中觀察到的更高反應率也與這些患者相關。

Our commercial business is complemented by an exciting pipeline, led by our programs to extend the lifileucel franchise in the new treatment settings in solid tumor types, as well as next-generation approaches. We remain on track for multiple clinical milestones in the second half of this year, including updated data from our registrational trial of lifileucel monotherapy in previously treated advanced non-small cell lung cancer, clinical data for lifileucel monotherapy in endometrial cancer and for IV-4001, our next-generation PD-1 and activated TIL cell therapy.

我們的商業業務由令人興奮的產品線補充，由我們的計劃引領，旨在在實體腫瘤類型的新治療環境中擴展 lifileucel 特許經營權，以及下一代方法。我們將繼續在今年下半年實現多個臨床里程碑，包括 lifileucel 單藥治療先前治療過的晚期非小細胞肺癌的註冊試驗的最新數據、lifileucel 單藥治療子宮內膜癌的臨床數據以及 IV-4001、我們的下一代 PD-1 和活化 TIL 細胞療法的臨床數據。

Today, I will cover financial results at a high level, focusing on revenue, expenses, cash runway and the expected cost savings from our strategic restructuring. I'll begin with revenue and gross margin.

今天，我將從宏觀角度介紹財務業績，重點在於收入、支出、現金流量以及策略重組預期帶來的成本節約。我將從收入和毛利率開始。

In the second quarter, we reported $60 million in total revenue, a 22% growth over the prior quarter of this year. Total revenue included approximately $54 million for Amtagvi infusions and approximately $6 million from Proleukin.

第二季度，我們的總營收為 6,000 萬美元，比今年上一季成長 22%。總收入包括 Amtagvi 輸液約 5,400 萬美元和 Proleukin 約 600 萬美元。

Based on current growth dynamics and with approximately $109 million in total revenue for the first half of 2025, we are reiterating our full year 2025 revenue guidance of $250 million to $300 million, inclusive of sales from Amtagvi in the US and Proleukin globally. We continue to see strong demand for Amtagvi and the potential to achieve US peak sales of $1 billion or more. There's also a significant opportunity to add to the revenue potential in the international markets.

根據目前的成長動態，鑑於 2025 年上半年總收入約為 1.09 億美元，我們重申 2025 年全年營收預期為 2.5 億至 3 億美元，其中包括美國 Amtagvi 和全球 Proleukin 的銷售額。我們繼續看到對 Amtagvi 的強勁需求以及實現美國 10 億美元或更多峰值銷售額的潛力。這也為增加國際市場的收入潛力提供了巨大機會。

Gross margin was 31%, excluding noncash items such as intangible amortization, stock-based compensation and reserves primarily for excess Proleukin inventory. Our recent restructuring is expected to improve gross margins in the near term through reduced cost of sales. Gross margins are also expected to increase significantly through near-term optimization of manufacturing capacity utilization over the next several years.

毛利率為 31%，不包括無形資產攤銷、股票薪酬和主要用於 Proleukin 過剩庫存的儲備金等非現金項目。我們最近的重組預計將透過降低銷售成本在短期內提高毛利率。預計未來幾年透過近期優化製造產能利用率也將大幅提高毛利率。

In summary, we are focused on improving our profitability and are pleased with the strong momentum from our US commercial business. Transitioning to second quarter 2025 expenses, total operating expenses were approximately $117 million compared to approximately $102 million in the prior year period. This increase was primarily related to higher headcount and related costs and costs for clinical trials and marketing and advertising support for Amtagvi, partially offset by reductions in stock-based compensation.

總而言之，我們專注於提高獲利能力，並對美國商業業務的強勁發展勢頭感到滿意。過渡到 2025 年第二季的費用，總營運費用約為 1.17 億美元，而去年同期約為 1.02 億美元。這一增長主要與員工人數增加、相關成本增加以及 Amtagvi 的臨床試驗和行銷及廣告支援成本有關，但股票薪酬的減少部分抵消了這一增長。

After experiencing a tremendous period of organizational growth in 2023 and 2024, we are fully committed to streamlining expenses and optimizing business performance through a strategic restructuring announced today. This restructuring includes a workforce reduction of approximately 19% in the third quarter of 2025 and will generate more than $100 million in annual cost savings starting in the fourth quarter of 2025.

在經歷了 2023 年和 2024 年組織的巨大增長期之後，我們全力致力於透過今天宣布的策略重組來精簡開支並優化業務績效。此次重組包括在 2025 年第三季裁員約 19%，並將從 2025 年第四季開始每年節省超過 1 億美元的成本。

As I mentioned earlier, in addition to significantly reducing expenses, this restructuring will also significantly reduce our cost of sales and increase gross margins on an ongoing basis.

正如我之前提到的，除了大幅削減開支之外，此次重組還將大幅降低我們的銷售成本並持續提高毛利率。

I would like to extend our heartfelt appreciation and best wishes to the employees impacted by the reduction in workforce. Realigning our operating plan and cost structure involves some difficult but necessary decisions to ensure financial discipline, while continuing to invest in our commercial launch success. Notably, our registrational and early phase programs remain on track and no significant changes to our product pipeline are expected.

我謹向受到裁員影響的員工表示衷心的感謝和良好的祝福。重新調整我們的營運計劃和成本結構涉及一些困難但必要的決定，以確保財務紀律，同時繼續投資於我們的商業發布成功。值得注意的是，我們的註冊和早期階段計劃仍在按計劃進行，預計我們的產品線不會發生重大變化。

Our net cash burn is significantly reduced over our prior forecast. For the next four quarters through the second quarter of 2025, net cash burn is expected to be less than $245 million, excluding onetime charges of less than $6 million associated with the third quarter strategic restructuring. We will continue to optimize and refine our cost structure through operational excellence initiatives over the next two to three quarters. And importantly, we expect ongoing reductions in expenses and improvements in cost of sales.

我們的淨現金消耗比我們先前的預測大幅減少。截至 2025 年第二季的未來四個季度，預計淨現金消耗將低於 2.45 億美元，不包括與第三季策略重組相關的低於 600 萬美元的一次性費用。我們將在未來兩到三個季度透過卓越營運措施繼續優化和完善我們的成本結構。重要的是，我們預計費用將持續減少，銷售成本將持續改善。

Our current cash position of approximately $307 million in anticipated product revenue, including cost savings from the strategic restructuring are expected to be sufficient to fund current and planned operations into the fourth quarter of 2026. I am happy to go into more detail during the Q&A.

我們目前的現金狀況約為 3.07 億美元的預期產品收入（包括策略重組帶來的成本節省）預計足以資助到 2026 年第四季的當前和計劃營運。我很高興在問答環節中進一步詳細闡述。

Notably, we're excited to welcome our new Chief Financial Officer, Corleen Roche, who joined our team this week. We look forward to Corleen covering the financial results in detail from next quarter onwards, and she's available for today's Q&A session.

值得注意的是，我們很高興歡迎新財務長 Corleen Roche 本週加入我們的團隊。我們期待 Corleen 從下個季度開始詳細介紹財務業績，她可以參加今天的問答環節。

I will now turn the call over to Dan Kirby, Chief Commercial Officer, for a detailed update on our commercial launch and our ex-US regulatory milestones.

現在，我將把電話轉給商務長丹‧柯比 (Dan Kirby)，以詳細介紹我們的商業發布和美國以外的監管里程碑。

Thanks, Fred. I'd like to build on the earlier revenue discussion by highlighting individual product drivers for Amtagvi and Proleukin. I'll also provide an update across our key focus areas to drive U.S. launch performance as well as our strategy for Amtagvi outside of the United States.

謝謝，弗雷德。我想在之前的收入討論的基礎上，重點介紹 Amtagvi 和 Proleukin 的個別產品驅動因素。我還將提供我們重點關注領域的最新情況，以推動美國市場的發布表現以及我們在美國以外的 Amtagvi 策略。

Product revenue from US Amtagvi sales was approximately $54 million in the second quarter of 2025, representing a growth of 24% quarter-over-quarter. A total of 102 commercial patients were treated, representing the highest number of Amtagvi infusions for a single quarter to date. Infusion growth was a direct result of increased field activities in existing ATCs and contribution of new ATCs onboarded earlier this year.

2025年第二季度，美國Amtagvi銷售產品營收約5,400萬美元，較上季成長24%。共有 102 名商業患者接受了治療，這是迄今為止單季 Amtagvi 輸注次數最多的一次。輸液業務的成長直接得益於現有 ATC 現場活動的增加以及今年稍早新加入的 ATC 的貢獻。

Our commercial organization is also dedicated to supporting and growing Proleukin sales. Product revenue from Proleukin was approximately $6 million in the second quarter of 2025, an increase of 2% quarter-over-quarter.

我們的商業組織也致力於支持和增加 Proleukin 的銷售。2025 年第二季度，Proleukin 的產品營收約為 600 萬美元，季增 2%。

Two of the three major US wholesalers restocked during the most recent quarter. As a reminder, first quarter Proleukin sales were attributed primarily to manufacturing and clinical uses, not the main channel tied to Amtagvi use.

美國三大批發商中有兩家在最近一個季度補充了庫存。提醒一下，第一季 Proleukin 的銷售主要歸因於製造和臨床用途，而不是與 Amtagvi 使用相關的主要管道。

These two channels represent additional revenue growth opportunities for Proleukin. Now that wholesalers are reordering from the main channel, we expect Proleukin revenue to begin to reflect Amtagvi demand.

這兩個管道為 Proleukin 帶來了額外的收入成長機會。現在批發商正在從主通路重新訂貨，我們預計 Proleukin 的收入將開始反映 Amtagvi 的需求。

Looking forward to the remainder of the year, we are confident in continued growth for Amtagvi and Proleukin. We are confirming our full year 2025 total revenue guidance of $250 million to $300 million. This aligns with our US Amtagvi growth forecast, including expected momentum from community referral activities and large community practices.

展望今年剩餘時間，我們對 Amtagvi 和 Proleukin 的持續成長充滿信心。我們確認 2025 年全年總營收預期為 2.5 億至 3 億美元。這與我們對美國 Amtagvi 的成長預測一致，包括來自社區推薦活動和大型社區實踐的預期動力。

As a reminder, our 2025 guidance includes sales of Amtagvi only in the United States, as well as Proleukin. Amtagvi has the opportunity to address more than 30,000 patients globally with previously treated advanced melanoma. As Fred stated, we continue to see the potential to achieve Amtagvi US peak sales of equal to or greater than $1 billion. There is also a significant opportunity to add to this potential through international sales of Amtagvi.

提醒一下，我們的 2025 年指引僅包括 Amtagvi 在美國的銷售，以及 Proleukin。Amtagvi 有機會為全球 30,000 多名接受過治療的晚期黑色素瘤患者提供治療。正如弗雷德所說，我們繼續看到 Amtagvi 在美國實現銷售額高峰等於或超過 10 億美元的潛力。透過 Amtagvi 的國際銷售，還有一個重大機會可以增加這一潛力。

Moving on to key launch performance drivers. Our number one goal is to establish Amtagvi as the preferred option for all appropriate patients. Amtagvi is a game changer for melanoma patients, who have failed first-line treatment. For the first time in advanced melanoma and solid tumors, cell therapy made from the patient's own cells has been shown to induce long-term benefit with curative intent.

繼續討論關鍵的發布效能驅動因素。我們的首要目標是將 Amtagvi 打造為所有合適患者的首選方案。對於一線治療失敗的黑色素瘤患者來說，Amtagvi 是一個改變遊戲規則的藥物。在晚期黑色素瘤和實體腫瘤中，首次證明由患者自身細胞製成的細胞療法可以帶來長期治癒效果。

On last quarter's call, I highlighted three key areas to drive performance and would like to comment on our progress. First, adoption across our ATC network continues with strong steady growth at early centers, new centers treating patients and increased integration with community practices.

在上個季度的電話會議上，我強調了推動績效的三個關鍵領域，並想對我們的進展進行評論。首先，我們的 ATC 網路繼續採用早期中心、治療患者的新中心以及與社區實踐的加強融合，實現強勁而穩定的成長。

A second performance driver is engaging medical oncologists to guide earlier consideration for Amtagvi. Our first real-world data shows approximately half of all patients responding, including 60% of patients responding in earlier treatment settings. These results reinforce our messaging in the field and can guide earlier treatment practices within the scope of our label.

第二個績效驅動因素是讓腫瘤醫學專家指導對 Amtagvi 的早期考量。我們的第一批真實世界數據顯示，大約一半的患者有反應，其中包括 60% 在早期治療環境中有反應的患者。這些結果強化了我們在該領域的訊息傳遞，並可引導我們標籤範圍內的早期治療實踐。

Our disease education focuses on the benefits of durable responses with onetime cell therapies like Amtagvi versus temporary responses and ongoing side effects seen with other treatments.

我們的疾病教育重點在於一次性細胞療法（如 Amtagvi）帶來的持久反應，以及其他治療方法所見的暫時反應和持續副作用。

The third area is to penetrate US community oncology networks and increase the frequency, speed and overall timeliness for Amtagvi referrals. Last quarter, I mentioned that we are working to identify alternative distribution channels on top of our traditional specialty distributor model, such as specialty pharmacy that may offer flexibility to support community access for onetime therapies like Amtagvi.

第三個領域是滲透美國社區腫瘤網絡，提高Amtagvi轉診的頻率、速度和整體及時性。上個季度，我提到我們正在努力在傳統專業分銷商模式的基礎上尋找替代分銷管道，例如可以提供靈活性以支持社區獲得 Amtagvi 等一次性療法的專業藥房。

In direct response to requests from large community practices, we entered our first agreement with McKesson's Biologics Specialty Pharmacy and other transactions are planned. This new channel will allow hospitals to have the choice to either buy Amtagvi directly or go through a specialty pharmacy where they do not have to directly purchase the product.

為了直接回應大型社區診所的要求，我們與 McKesson 的 Biologics Specialty Pharmacy 達成了第一份協議，並計劃進行其他交易。透過這項新管道，醫院可以選擇直接購買 Amtagvi，也可以透過專科藥局購買，而無需直接購買產品。

Transitioning to our ex-US strategy, we are making progress toward approval in four additional markets. Canadian approval is expected imminently, and we are making progress toward approval in the UK. We gained priority review for our submission in Australia. We are also in the submission process for Switzerland.

轉向我們的美國以外策略，我們正在爭取在另外四個市場獲得批准。預計加拿大將很快批准，我們也正在爭取英國的批准。我們的提交在澳洲獲得了優先審查。我們也正在向瑞士提交申請。

In the European Union, as noted in the press release today, we recently withdrew our submission from the European Medicines Agency following lack of alignment during discussions of our clinical data. We are currently evaluating strategic options such as including a virtual control arm in the submission to make Amtagvi and TIL therapy broadly accessible to advanced melanoma patients with unmet medical need in Europe.

在歐盟，正如今天的新聞稿中所述，由於在討論我們的臨床數據時缺乏一致性，我們最近撤回了向歐洲藥品管理局提交的申請。我們目前正在評估策略選擇，例如在提交的方案中加入虛擬對照組，以使歐洲未滿足醫療需求的晚期黑色素瘤患者能夠廣泛使用 Amtagvi 和 TIL 療法。

We look forward to providing updates on our regulatory interactions in the near future. As stated previously, our full year 2025 total revenue guidance does not include Amtagvi sales outside of the United States.

我們期待在不久的將來提供有關我們監管互動的最新資訊。如前所述，我們對 2025 年全年總收入的預期不包括 Amtagvi 在美國以外的銷售額。

As part of the restructuring, our customer-facing teams remain well resourced and focused to deliver Amtagvi infusions for patients, drive demand and generate revenue for Amtagvi and Proleukin to move Iovance forward. I am committed and motivated to lead our commercial organization towards success. I'm deeply committed to Iovance's mission of pioneering a new treatment paradigm for physicians, who treat patients with solid tumors, which represent 90% of all cancers.

作為重組的一部分，我們面向客戶的團隊仍然資源充足，專注於為患者提供 Amtagvi 輸液，推動需求並為 Amtagvi 和 Proleukin 創造收入，推動 Iovance 向前發展。我致力於並有動力帶領我們的商業組織走向成功。我全心全意致力於 Iovance 的使命，為治療實體瘤患者的醫生開創一種新的治療模式，實體瘤佔所有癌症的 90%。

I will now pass the call over to Igor Bilinsky, our Chief Operating Officer, to highlight our manufacturing progress.

現在我將把電話轉給我們的營運長 Igor Bilinsky，以介紹我們的製造進度。

Thank you, Dan. I will focus today's manufacturing update on commercial performance and recent organizational changes. I'll also build on Fred's introductory comments about our ongoing initiatives to improve gross margins.

謝謝你，丹。今天的製造業更新我將專注於商業表現和最近的組織變化。我還將根據弗雷德的介紹評論，介紹我們正在採取的提高毛利率的舉措。

Our internal manufacturing facility, the Iovance Cell Therapy Center, or iCTC, supplies the vast majority of patients today for both commercial and clinical manufacturing. Our contract manufacturer provides second source through [next up], owning our own facility and relying more and more on internal manufacturing provides us with full control to maintain high quality, implement operational efficiencies, and optimize cost of sales. iCTC also offers the flexibility to scale up rapidly when needed.

我們的內部製造設施，Iovance 細胞治療中心（iCTC），為當今絕大多數患者提供商業和臨床製造服務。我們的合約製造商透過 [next up] 提供第二貨源，擁有自己的工廠並越來越多地依賴內部製造，使我們能夠完全控制以保持高品質、實現營運效率並優化銷售成本。 iCTC 也提供了在需要時快速擴展的靈活性。

Manufacturing success delivering final product to patients within defined specifications is critical for providing therapies for patients and for recognizing revenue. Across functional areas of Iovance from manufacturing to medical affairs and commercial, we are focused and committed to improving success rates. As a result, the success rate in the second quarter rebounded compared to the first quarter with lower patient drop-offs and lower out-of-spec rates, and we continue to see an improvement in the third quarter to date.

製造業成功按照規定的規格向患者提供最終產品對於為患者提供治療和確認收入至關重要。在 Iovance 的各個職能領域，從製造到醫療事務和商業，我們都專注並致力於提高成功率。因此，與第一季相比，第二季的成功率有所反彈，患者流失率和不合格率均降低，並且我們迄今為止在第三季度繼續看到改善。

I'd also like to highlight that as planned, we delivered on our goal to shorten manufacturing turnaround time, which is now 33 days from receipt of sales at the manufacturing facility to Amtagvi readiness for return shipment to the ATC.

我還想強調的是，我們按照計劃實現了縮短製造週轉時間的目標，從製造工廠收到銷售到 Amtagvi 準備返回 ATC 只需 33 天。

Turning to our strategic restructuring, our manufacturing organization has been realigned for operational excellence. We previously staffed our manufacturing network to provide the capacity to meet our prior revenue guidance. Now we have rightsized and optimized the capacity and headcount to align with the revised guidance and growth projections. Our streamlined manufacturing organization and ongoing implementation of operational efficiencies are expected to increase capacity utilization, reduce costs and improve gross margins in the second half of 2025 and beyond.

談到我們的策略重組，我們的製造組織已經進行了重新調整，以實現卓越營運。我們之前已為製造網絡配備了人員，以提供滿足我們先前收入預期的能力。現在，我們已經調整並優化了產能和員工人數，以符合修訂後的指導和成長預測。我們精簡的製造組織和持續實施的營運效率預計將在 2025 年下半年及以後提高產能利用率、降低成本並提高毛利率。

Shifting to the current macroeconomic and geopolitical environment, I'll reiterate that Iovance is operating as a strategic advantage within the biopharma industry.

轉向當前的宏觀經濟和地緣政治環境，我要重申，Iovance 在生物製藥產業中具有戰略優勢。

We continue to expect Amtagvi and Proleukin to see minimal impact from tariffs. Regarding our intellectual property, our TIL cell therapy expertise and manufacturing capabilities are protected by a robust patent estate that is domiciled in the US. We own approximately 280 granted or allowed US and international patents and patent rights for Amtagvi and other TIL-related technologies expected to provide exclusivity through at least 2042.

我們仍然預期 Amtagvi 和 Proleukin 受到關稅的影響將微乎其微。關於我們的智慧財產權，我們的 TIL 細胞治療專業知識和製造能力受到位於美國的強大專利保護。我們擁有約 280 項已授予或允許的美國和國際專利以及 Amtagvi 和其他 TIL 相關技術的專利權，預計至少在 2042 年之前提供獨家經營權。

I'm available to answer questions during the Q&A session, and I will now hand the call to Dr. Friedrich Finckenstein, our Chief Medical Officer, to discuss our clinical pipeline.

我可以在問答環節回答問題，現在我將把電話交給我們的首席醫療官 Friedrich Finckenstein 博士，討論我們的臨床流程。

Thank you, Igor. Building on my colleagues' comments about Amtagvi or lifileucel, the durability of responses following onetime treatment is a key differentiator from other available and emerging therapies.

謝謝你，伊戈爾。根據我的同事對 Amtagvi 或 lifileucel 的評論，一次性治療後的反應持久性是與其他現有和新興療法的關鍵區別。

This durability message was reinforced in the recent publication of the final five-year analysis from our C-144-01 trial in the Journal of Clinical Oncology and the simultaneous presentation at the American Society of Clinical Oncology Annual Meeting.

我們最近在《臨床腫瘤學雜誌》上發表了 C-144-01 試驗的最終五年分析報告，並在美國臨床腫瘤學會年會上同時進行了報告，這進一步證實了這一持久性信息。

Unprecedented durability and duration of follow-up were demonstrated in previously treated advanced melanoma patients. 31% of patients responded with nearly one-third of responders ongoing. The five-year overall survival rate was almost 20%.

在先前接受過治療的晚期黑色素瘤患者中，表現出了前所未有的持久性和追蹤時間。 31％ 的患者有反應，近三分之一的反應者正在持續治療。五年整體存活率接近20%。

In the real-world treatment settings, we are excited to see even better response rates of approximately 50% overall and 60% in less heavily treated patients following lifileucel. We look forward to presenting this real-world data at a future medical meeting. Following the strategic restructuring, our priorities are to expand Amtagvi into additional solid tumor types and earlier lines of therapy and to advance our key next-generation TIL and TIL treatment regimens.

在現實世界的治療環境中，我們很高興地看到，使用 lifileucel 後，整體反應率約為 50%，而接受治療較少的患者的反應率則達到 60%。我們期待在未來的醫學會議上展示這些真實世界的數據。在策略重組之後，我們的首要任務是將 Amtagvi 擴展到更多實體腫瘤類型和早期治療領域，並推進我們的關鍵下一代 TIL 和 TIL 治療方案。

In frontline advanced melanoma, TILVANCE-301 is our global registrational Phase 3 trial designed with FDA and EMA input to show the contribution of components. We are investigating Amtagvi in combination with pembrolizumab compared to pembrolizumab alone. TILVANCE-301 remains on track as the confirmatory trial for Amtagvi monotherapy in our initial indication, and this trial could also support accelerated and full approvals of Amtagvi in combination with pembrolizumab in frontline advanced melanoma. We look forward to sharing results from several clinical trials before the end of the year for lifileucel in non-small cell lung and endometrial cancers, as well as on our PD-1 inactivated TIL cell therapy, IOV-4001.

在一線晚期黑色素瘤中，TILVANCE-301 是我們根據 FDA 和 EMA 的意見設計的全球註冊 3 期試驗，旨在展示各成分的貢獻。我們正在研究 Amtagvi 與 pembrolizumab 聯合使用與單獨使用 pembrolizumab 進行比較。TILVANCE-301 作為我們初步適應症中 Amtagvi 單藥治療的確認性試驗仍在按計劃進行，並且該試驗還可以支持加速和全面批准 Amtagvi 與 pembrolizumab 聯合用於治療一線晚期黑色素瘤。我們期待在今年年底之前分享 lifileucel 在非小細胞肺癌和子宮內膜癌以及 PD-1 滅活 TIL 細胞療法 IOV-4001 方面的幾項臨床試驗的結果。

IOV-LUN-202 is our registrational program intended to extend the label for lifileucel monotherapy to include previously treated advanced non-small cell lung cancer. This trial design aligns with FDA guidance for single-arm trials to support accelerated approvals for single agents in conditions with unmet medical need.

IOV-LUN-202 是我們的註冊計劃，旨在擴展 lifileucel 單一療法的標籤，以包括先前治療過的晚期非小細胞肺癌。該試驗設計符合 FDA 對單臂試驗的指導，以支持在未滿足醫療需求的情況下加速批准單一藥物。

Chemotherapy, the current standard of care in this treatment setting provides limited rate and duration of responses. The FDA previously provided positive regulatory feedback on the IOV-LUN-202 clinical trial design and the proposed potency assay matrix to support registration. We expect data from IOV-LUN-202 to support a potential regulatory decision on US accelerated approval in 2027 for previously treated non-small cell lung cancer patients.

化療是這種治療環境下的當前標準治療方法，但其反應速度和持續時間有限。FDA 先前已就 IOV-LUN-202 臨床試驗設計和建議的效力測定矩陣提供了積極的監管回饋，以支持註冊。我們預計 IOV-LUN-202 的數據將支持美國在 2027 年加速批准先前接受過治療的非小細胞肺癌患者的潛在監管決定。

In our IOV-END-201 clinical trial, we've seen promising signs of initial efficacy for lifileucel monotherapy in previously treated patients with advanced endometrial cancer. Our PD-1 inactivated TIL cell therapy, IOV-4001 is in a first-in-human trial and reflects our leadership in next-generation approaches to optimize TIL and TIL treatment regimens. We are also treating patients in a Phase 1/2 clinical trial of IOV-3001, a next-generation IL-2 for use with the TIL cell therapy treatment regimen.

在我們的 IOV-END-201 臨床試驗中，我們看到了 lifileucel 單藥治療對先前接受過治療的晚期子宮內膜癌患者的初步療效的良好跡象。我們的 PD-1 滅活 TIL 細胞療法 IOV-4001 正在進行首次人體試驗，反映了我們在優化 TIL 和 TIL 治療方案的下一代方法方面的領導地位。我們也在 IOV-3001 的 1/2 期臨床試驗中對患者進行治療，IOV-3001 是一種用於 TIL 細胞療法治療方案的下一代 IL-2。

Finally, we plan to submit an investigational new drug application to FDA early next year for IOV-5001. This genetically engineered inducible and tethered IL-12 TIL cell therapy may expand our development opportunities into a wide range of common solid tumor cancers.

最後，我們計劃在明年初向 FDA 提交 IOV-5001 的新藥研究申請。這種基因工程誘導和束縛的 IL-12 TIL 細胞療法可能會將我們的開發機會擴展到多種常見的實體腫瘤癌症。

I'm happy to address questions during the Q&A session. And I'll now turn the call over to the operator to begin the question-and-answer session.

我很樂意在問答環節解答問題。現在我將把電話轉給接線員，開始問答環節。

(Operator Instructions) Yanan Zhu, Wells Fargo.

（操作員指示） 朱亞南，富國銀行。

Well, great. Thanks for taking our questions and congrats on the quarter. I was wondering, can you talk about the patient number from 1Q to 2Q, because I don't think we had a good sense of exactly how many patients you infused last quarter -- in 1Q. So I wanted to understand the growth in patient number.

嗯，太好了。感謝您回答我們的問題，並祝賀本季取得的成績。我想知道，您能否談談從第一季到第二季的患者人數，因為我認為我們並不清楚上個季度（即第一季）您到底接收了多少患者。所以我想了解患者數量的成長情況。

And I also think you might have increased the price. So perhaps talk about the price change and impact for Amtagvi revenue as well. And if you can also comment on where do you think those infusion numbers will go in the coming quarters relative to your guidance and confidence, that will be super helpful. Thank you.

我還認為您可能已經提高了價格。因此也許也可以談談價格變化及其對 Amtagvi 收入的影響。如果您還能評論一下，相對於您的指導和信心，您認為未來幾季的注入數字將會如何變化，那將非常有幫助。謝謝。

Thanks, Yan. I'll start, and then I'll ask Dan Kirby to add some comments to this, too. So the number of infusions we had this quarter was 102 -- last quarter, it was 83. So that was substantial growth over last quarter, obviously. There was a price increase that came into effect on April 1, which took the price of the product of Amtagvi to USD562,000. We expect growth, and I'll let Dan talk about what we expect in the second half of this year.

謝謝，Yan。我先開始，然後我會請 Dan Kirby 也對此添加一些評論。因此，本季我們的輸液次數為 102 次，上季為 83 次。因此，這顯然比上一季有了大幅成長。自 4 月 1 日起，Amtagvi 產品的價格上漲至 562,000 美元。我們預計會有成長，我會讓丹談談我們對今年下半年的期望。

Go ahead, Dan.

繼續吧，丹。

Sure. So for the price increase, I think your question was, did we see any impact of the price increase on demand. We did see -- we did not see any impact. In fact, demand increased after the price. So we didn't factor that in as being any kind of headwinds to follow. So with that, we also look at the future and where we see patients coming in. We have our new centers coming on as we've talked about in previous quarters, and they continue to ramp up demand as well as our existing centers.

當然。因此，對於價格上漲，我想你的問題是，我們是否看到價格上漲對需求有任何影響。我們確實看到——我們沒有看到任何影響。事實上，價格上漲後需求增加。因此，我們沒有將其視為任何需要應對的不利因素。因此，我們也展望未來並展望患者的到來。正如我們在前幾季所討論的那樣，我們的新中心即將投入使用，它們和我們現有的中心一樣，繼續增加需求。

What we do see in the future happening is we're in the process of opening some ATCs that are closer in the community networks. I mentioned the distribution channel we added, that is specifically at their request, which gives us access to hospitals that normally were not going to purchase Amtagvi. So we do see demand in the second half continuing to be strong to meet the guidance that we provided.

我們確實看到未來會發生的情況是，我們正在開放一些距離社區網路更近的 ATC。我提到了我們增加的分銷管道，這是應他們的要求而專門增加的，這使我們能夠接觸到通常不會購買 Amtagvi 的醫院。因此，我們確實看到下半年的需求持續強勁，以達到我們所提供的指導。

Sorry, if I may quickly follow up. I think I heard the growth in patient number was from 83 to 102?

抱歉，如果我可以快速跟進的話。我好像聽說病人數量從 83 人增加到了 102 人？

Sorry. 85 to 102, Yan.

抱歉。 85 到 102，Yan。

85 to 102. That's a pretty good growth. Do you anticipate similar growth going forward? Or any color there? Just so we have a better sense about what to expect in the coming quarters? Thank you.

85至102。這是一個相當不錯的增長。您預計未來還會出現類似的成長嗎？或有任何顏色嗎？只是為了讓我們更了解未來幾季會發生什麼？謝謝。

We anticipate demand to continue to be strong. As far as quarter-on-quarter growth, we don't want to guide to that. We want to till stick to the $250 million to $300 million range that we have in our guidance with it, which would indicate second half demand will be strong.

我們預計需求將持續強勁。就季度環比成長而言，我們不想給出這樣的預期。我們希望堅持我們預期的 2.5 億至 3 億美元的範圍，這表明下半年的需求將會強勁。

Peter Lawson, Barclays.

巴克萊銀行的彼得·勞森。

Great. Thanks so much. Thanks for the detail on the call. Just -- first is just as we think about the guidance, just your level of confidence around Proleukin, you mentioned it kind of accelerating in the second half. Kind of what gives you that level of confidence? And what do you think the Proleukin number could be? And has there been any changes in the number of Proleukin injections? Thank you.

偉大的。非常感謝。感謝您在通話中提供的詳細資訊。只是 — — 首先，正如我們所考慮的指導，您對 Proleukin 的信心水平，您提到它在下半年有所加速。是什麼讓您如此有信心？您認為 Proleukin 的數值可能是多少？Proleukin 注射次數有變化嗎？謝謝。

Hi, Peter, I'll take that question. I think for Proleukin in the mainline channel, what we did see as evidenced in the revenue from Q1 was we're seeing the manufacturing and the clinical trial channel that represented the Q1 revenue. In Q2, we started seeing the reordering at a regular basis from two of the top three wholesalers in the US. So what we expect to see moving forward is those orders continuing in from the two and then the third one coming on later this year. So it will start to reflect more of the Amtagvi utilization.

你好，彼得，我來回答這個問題。我認為，對於主線通路中的 Proleukin，我們確實從第一季的收入中看到了製造和臨床試驗管道代表了第一季的收入。在第二季度，我們開始看到美國三大批發商中的兩家定期重新訂購。因此，我們預計這兩家公司的訂單將繼續增加，第三家公司的訂單將在今年稍後增加。因此它將開始更多地反映 Amtagvi 的利用率。

Along with that, we are seeing strong demand to use with Amtagvi. So we have not seen the number of doses. Again, it's zero to six doses with one dose of Amtagvi. We're not seeing the doses of Proleukin change by center. Each one will do it differently, but the average doses remain consistent.

除此之外，我們也看到了對 Amtagvi 的強烈需求。所以我們還沒有看到劑量的數量。再次強調，一劑 Amtagvi 需要服用零到六劑。我們沒有看到 Proleukin 的劑量隨著中心而變化。每個人的做法都不同，但平均劑量保持一致。

And then finally, we do anticipate those other two channels we've been talking about that we booked revenue in Q1 on continuing to order throughout the year. So you'll see some pickup in in Proleukin based on the fact that the wholesalers are coming online.

最後，我們確實預計，我們一直在談論的另外兩個管道將在第一季實現收入，並全年繼續訂購。因此，由於批發商正在上線，你會看到 Proleukin 的銷量有所回升。

Perfect. Thank you so much.

完美的。太感謝了。

Andrew Tsai, Jefferies.

安德魯·蔡（Andrew Tsai），傑富瑞（Jefferies）。

So if the guidance for net cash burn is going to be less than $235 million over the next year, and I believe restructuring happens later in the year, it feels as if you're expecting gross margins to improve meaningfully, maybe even as early as Q3 relative to Q2 and Q1. Is that accurate? And if so, can you give us some color why that could be the case in terms of a meaningful margin improvement?

因此，如果明年淨現金消耗的預期低於 2.35 億美元，而且我相信重組將在今年晚些時候進行，那麼感覺就像您預計毛利率將大幅提高，甚至可能早在第三季度相對於第二季度和第一季度就會提高。這樣準確嗎？如果是的話，您能否從利潤率顯著提高的角度解釋為什麼會發生這種情況？

Yes, Andrew, thank you for the question. It was $245 million, not $235 million. You can see it in the press release and in our remarks there, but your question is still a good question.

是的，安德魯，謝謝你的提問。實際金額是 2.45 億美元，而不是 2.35 億美元。您可以在新聞稿和我們的評論中看到這一點，但您的問題仍然是一個好問題。

Yes, we expect margins to improve. That's the whole name of the game right now. We're pushing very hard. And a lot of the restructuring activities are really focused on improving margin.

是的，我們預期利潤率會提高。這就是現在遊戲的全部名稱。我們正在非常努力地推進。許多重組活動實際上都集中在提高利潤率。

Now we're going to enter a phase of operational excellence over the next couple of quarters to really tighten down on cost of sales and do a lot of work to improve margins even more.

現在，我們將在接下來的幾個季度進入卓越營運階段，真正降低銷售成本，並做大量工作來進一步提高利潤率。

And as volume ramps up, we'll also see improvements in margins because cost of sales will stay low while revenue goes up, especially as we scale up and use our iCTC facility. So you're absolutely right, we expect to see margin growth. And again, this quarter, we saw a good margin.

隨著銷售量的增加，我們還將看到利潤率的提高，因為銷售成本將保持在低位而收入將上升，特別是當我們擴大規模並使用我們的 iCTC 設施時。所以您完全正確，我們預期利潤率會成長。本季度，我們再次看到了良好的利潤率。

If you back out the noncash items and things like that, you see a very good margin on a cash basis that we have already now. As you see more Proleukin sales increase and as you see us do all those things, I think you'll see margins go up significantly.

如果您退出非現金項目和類似的東西，您會看到我們現在已經擁有的現金基礎上非常好的利潤率。隨著您看到 Proleukin 的銷量不斷增加，並且看到我們做所有這些事情，我認為您會看到利潤率大幅上升。

Thank you.

謝謝。

Salim Syed, Mizuho.

薩利姆賽義德，瑞穗。

This is Manav for Salim. Could you elaborate on the decision to withdraw the marketing authorization application in Europe? What was the feedback with the EMA? And what are the steps that you're planning to take to commercialize in Europe?

這是 Salim 的 Manav。能否詳細說明撤回歐洲上市許可申請的決定？EMA 的回饋如何？您計劃採取哪些措施在歐洲商業化？

And regarding the announced restructuring, are you also planning to reduce R&D expenses? And if so, could you comment on any specific actions you would be planning to take to reduce, for example, clinical expenses?

關於宣布的重組，您是否也計劃減少研發費用？如果是的話，您能否評論一下您計劃採取哪些具體措施來降低臨床費用？

Yeah, I'll take the second question first. We did reduce some R&D expenses, but we are not expecting any significant changes in our clinical pipeline as we discussed on the call.

是的，我先回答第二個問題。我們確實減少了一些研發費用，但正如我們在電話會議上討論的那樣，我們預計臨床流程不會發生任何重大變化。

With respect to the EMA, we withdrew what we learned late in the review process that we need to include an additional analysis in our submission. So what we want to do is go back and resubmit with an additional analysis such as the virtual control arm. We do not -- our strategy does not require us to run additional clinical trials, and we think that can happen relatively quickly.

關於 EMA，我們撤回了在審查過程後期了解到的需要在提交內容中納入額外分析的資訊。因此，我們想要做的是返回並重新提交附加分析，例如虛擬控制臂。我們的策略不需要我們進行額外的臨床試驗，我們認為這可以相對快速地實現。

We'll be seeking scientific advice from the EMA soon to try and get back in there and work on that again with them. But that was really what the issue was. It has to do with the data package that was submitted, which we submitted was similar to the FDA package and Health Canada package and everything else, and they would like to see some more. And the easiest route for us to do that is to withdraw and resubmit.

我們很快就會向 EMA 尋求科學建議，嘗試重新與他們合作。但這正是問題的所在。這與提交的資料包有關，我們提交的資料包與 FDA 資料包、加拿大衛生部資料包和其他所有資料包類似，他們希望看到更多。對我們來說，最簡單的方法就是撤回並重新提交。

Tyler Van Buren, TD Cowen.

泰勒範布倫 (Tyler Van Buren)，TD Cowen。

This is Nick on for Tyler. Thanks for the question. Can you provide an update on how infusions are tracking for Amtagvi quarter-to-date? And then second, in the first earnings call -- in the first quarter earnings call, you noted that 69% of ATCs have infused patient, while 16% infused 10 or more. Can you provide an update on these metrics and the plan to increase prescribing?

這是尼克 (Nick) 代替泰勒 (Tyler)。謝謝你的提問。您能否提供有關 Amtagvi 本季迄今為止輸液情況的最新資訊？其次，在第一次收益電話會議—第一季財報電話會議中，您注意到 69% 的 ATC 為病患輸液，而 16% 的 ATC 則為 10 位或更多病患輸液。您能否提供有關這些指標的最新情況以及增加處方的計劃？

I'll take that one. Thanks for the question. For the infusions quarter-to-date, we do see strong demand. However, we can't comment on how many infusions quarter-to-date. That's been our policy.

我要那個。謝謝你的提問。對於本季迄今的輸液，我們確實看到了強勁的需求。然而，我們無法評論本季迄今的輸液次數。這就是我們的政策。

As far as the percentage increase with it, those percents, they have gone up. Obviously, we have not appreciably a lot more centers that came on in the last quarter. However, we went up to 24% infusion. So those numbers by centers are going up with it, but they -- we decided not to continually track those as a metric.

就百分比的增加而言，這些百分比已經上升了。顯然，我們在上個季度並沒有明顯增加中鋒人數。然而，我們的輸液量上升到了 24%。因此，這些中心的數字也在上升，但是——我們決定不再將這些數字作為指標進行持續追蹤。

Thank you.

謝謝。

Colleen Kusy, Baird.

科琳·庫西，貝爾德。

So this EMA feedback on melanoma, do you expect this to impact your path forward in PD-1 treated non-small cell lung cancer?

那麼，EMA 對黑色素瘤的回饋，您是否預期這會影響您在 PD-1 治療非小細胞肺癌方面的發展？

No, not right now. Absolutely not. It has nothing to do with the United States whatsoever. And Raj Puri, you can comment on this.

不，現在還不行。絕對不是。這與美國毫無關係。Raj Puri，你可以對此發表評論。

Yeah. I think, Colleen, any impact on the going forward continuing non-small cell lung cancer.

是的。科琳，我認為，這會對非小細胞肺癌的持續發展產生任何影響。

Great. And one quick follow-up. What sort of issues does moving to a specialty pharmacy solve for centers versus just buying through you directly?

偉大的。還有一個快速的後續行動。與直接向您購買相比，轉向專業藥房可以為中心解決哪些問題？

It's a great question. It really solves -- if you think about the hospitals that are involved with the community clinics and you get close to where the patients are, a lot of times, you're dealing with medium-sized hospitals that have all the capabilities to administer Amtagvi. However, onetime therapies that have higher price tags, the finance department does not want to bring those in.

這是一個很好的問題。它確實解決了問題——如果你想想那些與社區診所合作的醫院，並且你靠近病人所在的地方，很多時候，你正在與擁有管理 Amtagvi 所有能力的中型醫院打交道。然而，由於一次性療法的價格較高，財務部門不願意引進這些療法。

So they would rather go a route, where they would go through a specialty pharmacy, where the purchase would happen through the specialty pharmacy and the specialty pharmacy would get reimbursed from the payer versus the purchase happening directly from the finance department at the hospital.

因此，他們寧願選擇透過專業藥房購買藥物，然後透過專業藥房從付款人處獲得報銷，而不是直接從醫院的財務部門購買。

Great, thank you.

太好了，謝謝。

(Operator Instructions) Reni Benjamin, Citizens.

（操作員指示）雷尼·本傑明，公民。

Hey, guys. Thanks for taking the questions. Maybe one, can you just talk a little bit about the numbers in terms of patient drop-offs versus the manufacturing kind of out-of-spec rates? I think Igor had some prepared remarks regarding that. Can you just talk about the specifics from first quarter to second quarter and how you see that potentially improving throughout the rest of the year?

嘿，大家好。感謝您回答這些問題。或許首先，您能否簡單談談病患流失率與製造業不合格率之間的數字？我認為伊戈爾對此已經準備好了一些發言。您能否談談第一季到第二季的具體情況，以及您認為今年剩餘時間內情況可能會如何改善？

And then kind of just going back to a previous question regarding McKesson, how do you see this potentially improving revenues going forward? Like, is this something that should kind of minimally increase revenues? Like how should we be thinking about the number of patients these one-off hospitals, how much they might use this?

然後回到之前關於麥克森的問題，您認為這對未來收入的提升有何潛在作用？比如，這是否能最低限度地增加收入？例如，我們應該如何考慮這些一次性醫院的病患數量，他們可能會使用多少這種設備？

Reni, thanks for the question. So on the first part of the question, the -- as I mentioned, the manufacturing success rates normalized in the second quarter compared to the increase in the first quarter. So both the out-of-spec rate and the patient drop-off rates decreased, and we're seeing further improvement in the third quarter so far.

Reni，謝謝你的提問。因此，關於問題的第一部分，正如我所提到的，與第一季的成長相比，第二季的製造成功率已恢復正常。因此，不合格率和患者流失率均有所下降，到目前為止，我們看到第三季情況進一步改善。

And as you can see in the Q, you will see in the Q, the scrap costs went down in the second quarter compared to the first quarter, if you want to quantify that. Beyond that, we're not sharing the exact percentages. But again, you can look at the scrap costs and see the decrease in both absolute terms and the relative percentage.

正如您在 Q 中看到的那樣，如果您想量化這一點，您會發現第二季的廢品成本與第一季相比有所下降。除此之外，我們不會分享確切的百分比。但是，您可以再次查看廢料成本，並看到絕對值和相對百分比的下降。

And I'll answer the question regarding both patient drop-off as well as the impact of specialty pharmacy, which are a little bit related. So patient drop-off does remain somewhat consistent, although we did see that we were getting patients a bit earlier in this quarter versus previous quarters. And we weren't seeing as many patients that were not making even the tissue procurement. So we are making strides in that avenue.

我將回答有關患者流失以及專業藥房的影響的問題，這兩個問題有點相關。因此，儘管我們確實看到本季與前幾季相比患者人數有所減少，但患者人數的下降確實保持了一定的一致性。我們並沒有看到很多患者甚至沒有進行組織採集。因此，我們正朝著這個方向大步前進。

The impact of specialty pharmacy allows us to actually get closer to those patients, so we can get healthier patients upstream. And how we should be thinking about that is we're starting our journey right now.

專業藥房的影響使我們實際上能夠更接近這些患者，因此我們可以為上游的患者提供更健康的身體。我們應該這樣想，我們現在就開始我們的旅程。

Other cell therapies are following our lead. Gene therapies and other therapies that are higher priced have already gone down this road successfully. So as we think about how this could have an impact on it, this could get us next to those clinics that are affiliated with those hospitals inside of the network that they can treat patients inside of their network without the cost burden.

其他細胞療法正在效仿我們的做法。基因療法和其他價格更高的療法已經成功地走上了這條道路。因此，當我們思考這將如何產生影響時，這可能會讓我們與那些隸屬於網路內醫院的診所相媲美，這些診所可以在網路內治療患者，而無需承擔費用負擔。

So it could have a big impact long term. We already have several accounts right now that have requested it that we're opening up this channel for. So we will have some impact later this year.

因此，它可能會產生長期的巨大影響。目前已經有幾個帳戶向我們提出請求，我們將為他們開放這個頻道。因此我們今年晚些時候會產生一些影響。

Got it. And if I can just have a quick follow-up just regarding the clinical trials that are ongoing for Friedrich. Just can you provide us any color in terms of how many patients are enrolled in each of these studies? How many patients' worth of data might we see for non-small cell as well as the other ones that we're expecting like endometrial in the second half of this year?

知道了。我能否快速跟進一下弗里德里希正在進行的臨床試驗。您能否告訴我們每項研究中有多少患者參與？今年下半年，我們可以看到多少非小細胞癌以及我們預期的其他癌症（如子宮內膜癌）患者的數據？

Yes. Happy to respond to that. So I think what we said is that we're going to share data by the end of the year. We will provide that information as part of those updates. I don't think that we will predefine at which patient number we would be doing that.

是的。很高興回答這個問題。所以我認為我們說過我們將在今年年底前共享數據。我們將在更新中提供該資訊。我認為我們不會預先定義哪個病人編號進行該操作。

Okay. Thank you.

好的。謝謝。

David Dai, UBS.

瑞銀集團戴維戴（David Dai）。

Hey, guys. Yeah, thanks for taking our questions. So first question is just around thinking about the patient ramp for Amtagvi, based on current run rate, we calculated that the patients need to grow about 26 to 32 patients per quarter over the next couple of quarters to hit the midpoint of the guidance. Could you just provide any detail that you're on track to hit that patient growth?

嘿，大家好。是的，感謝您回答我們的問題。因此，第一個問題只是圍繞著 Amtagvi 的患者成長進行思考，根據目前的運行率，我們計算出在接下來的幾個季度中，每季度需要增加約 26 至 32 名患者才能達到指導的中點。您能否提供一些細節，表明您正按計劃實現患者數量的增長？

And secondly, on the ATCs, you have 80 right now. How many of these ATCs are newly activated compared to last quarter? And how many are still being activated?

其次，在 ATC 方面，目前有 80 個。與上一季相比，有多少 ATC 是新啟用的？還有多少正在被啟動？

So one of the things -- so I'll take that question with it. As far as the patient ramp, just to let you know, the $250 million to $300 million is combined revenue between Proleukin and Amtagvi. So on the math there, those numbers aren't [$26 million to $30 million] per quarter each quarter to grow to hit those numbers in the range.

所以其中一件事——所以我會回答這個問題。就患者數量而言，需要說明的是，2.5 億至 3 億美元是 Proleukin 和 Amtagvi 的總收入。因此從數學上講，這些數字並不是每個季度都增長到 [2600 萬美元到 3000 萬美元] 才能達到這個範圍內的數字。

But we are confident that we are tracking towards that range and seeing Amtagvi demand continue to strengthen and grow towards the end of the year as well as Proleukin, as we mentioned before, having all three wholesalers starting to order very soon, two of those doing so currently in the main channel give us our path forward to hit within that guidance.

但我們確信，我們正在朝著這個範圍邁進，並且看到 Amtagvi 的需求在年底繼續增強和增長，就像我們之前提到的那樣，Proleukin 也一樣，所有三家批發商都很快開始訂購，其中兩家目前在主要渠道訂購，這為我們提供了在該指導範圍內前進的道路。

The second question regarding how many new ATCs, again, we're focusing on quality, not quantity. We have opened several ATCs in the last quarter with it. Each one of those has been carefully vetted to have referral patterns in place so they can get earlier patients in there.

第二個問題是關於有多少新的 ATC，同樣，我們關注的是質量，而不是數量。我們在上個季度用它開設了幾個 ATC。每一個醫院都經過了仔細的審查，並製定了轉診模式，以便可以更早接收患者。

And we are seeing -- and I'm not going to give the exact numbers here. We are seeing a substantial number of patients coming in the queue, both that have been already infused by them, but also to where they are enrolling in there to have manufacturing done for Amtagvi for their patients.

我們看到——但我不會在這裡給出確切的數字。我們看到大量患者正在排隊，其中既有已經接受過他們注射的患者，也有正在排隊等待他們為其患者製造 Amtagvi 的患者。

Thank you. I'm showing no further questions at this time. I would now like to turn it back to Fred Vogt, Interim Chief Executive Officer and President, for closing remarks.

謝謝。我目前沒有其他問題。現在我想請臨時執行長兼總裁 Fred Vogt 致閉幕詞。

Thank you, again, for joining the Iovance Biotherapeutics second-quarter 2025 financial results and corporate update conference call. We look forward to providing future updates on our growing commercial and clinical portfolio, including our Amtagvi real-world data presentation and planned data updates from our long endometrial and next-generation TIL studies.

再次感謝您參加 Iovance Biotherapeutics 2025 年第二季財務表現與公司更新電話會議。我們期待提供有關我們不斷增長的商業和臨床產品組合的未來更新，包括我們的 Amtagvi 真實世界數據展示以及我們長期子宮內膜和下一代 TIL 研究的計劃數據更新。

We are motivated by the stories we continue to hear about the patients who benefit from Iovance TIL cell therapies in our clinical trials and in the commercial setting. I'm confident that Iovance will remain the global leader in innovating, developing and delivering current and future generations of TIL cell therapies for patients with cancer.

我們不斷聽到有關患者在臨床試驗和商業環境中受益於 Iovance TIL 細胞療法的故事，這激勵著我們。我相信，Iovance 將繼續在為癌症患者創新、開發和提供當前和未來幾代 TIL 細胞療法方面保持全球領先地位。

As always, we are thankful to the patients, health care and advocacy communities, our partners and our exceptional Iovance team. I would also like to thank our shareholders and covering analysts for their support. Thank you.

像往常一樣，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。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。