Iovance Biotherapeutics Inc (IOVA) 2025 Q1 法說會逐字稿

Good day and thank you for standing by. Welcome everyone to the Iovance Biotherapeutics first-quarter 2025 financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

您好，感謝您的支持。歡迎大家參加 Iovance Biotherapeutics 2025 年第一季財務業績電話會議。（操作員指示）請注意，今天的會議正在錄音。

I would now like to hand the conference over to your speaker today, Sara Pellegrino, SVP, IR and Corporate Communications. Please go ahead.

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部高級副總裁 Sara Pellegrino。請繼續。

Good afternoon and thank you for joining the Iovance conference call and webcast to discuss our first-quarter 2025 financial results, as well as recent corporate updates. Dr. Fred Vogt, our Interim Chief Executive Officer and President will provide an introduction and focus on the US Commercial launch of Amtagvi, including revenue and revenue guidance.

下午好，感謝您參加 Iovance 電話會議和網路廣播，討論我們 2025 年第一季的財務業績以及最新的公司動態。我們的臨時執行長兼總裁 Fred Vogt 博士將介紹並重點介紹 Amtagvi 在美國的商業發布，包括收入和收入指導。

Dan Kirby, Chief Commercial Officer, will discuss the Amtagvi commercial launch; Dr. Igor Bilinsky, our Chief Operating Officer, will provide a manufacturing update. Jean-Marc Bellemin, our CFO, will review our financial results, including revenue and revenue guidance, gross margin, and cash burn guidance; and Dr. Friedrich Finckenstein, our Chief Medical Officer, will summarize key pipeline programs.

首席商務官 Dan Kirby 將討論 Amtagvi 的商業發布；我們的首席營運長 Igor Bilinsky 博士將提供製造更新資訊。我們的財務長 Jean-Marc Bellemin 將審查我們的財務業績，包括收入和收入指引、毛利率和現金消耗指引；我們的首席醫療官 Friedrich Finckenstein 博士將總結主要的管道項目。

Additional members of our leadership team, including Dr. Raj Puri, our Chief Regulatory Officer; Dr. Brian Gastman, our EVP of Medical Affairs, will be available for the Q&A session.

我們領導團隊的其他成員，包括我們的首席監管官 Raj Puri 博士；我們的醫療事務執行副總裁 Brian Gastman 博士將出席問答環節。

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'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, licenses and collaborations, 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，可以在我們的公司網站 iovance.com 上找到。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、許可和合作、現金狀況和指導

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, Sarah and welcome to the Iovance first quarter 2025 conference call. We are four quarters into our US launch of Amtagvi, the first FDA-approved TIL cell therapy and the first treatment for patients with advanced melanoma who progress following anti-PD-1 treatment and have appropriate targeted therapy.

謝謝你，莎拉，歡迎參加 Iovance 2025 年第一季電話會議。我們在美國推出 Amtagvi 已經四個季度了，這是首個獲得 FDA 批准的 TIL 細胞療法，也是首個針對抗 PD-1 治療後病情出現進展並接受適當標靶治療的晚期黑色素瘤患者的療法。

In the first 12 months of our US launch, we've executed towards our long-term goal -- adoption goals and generated more than $210 million in revenue. This includes infusions from nearly 300 Amtagvi patients in the first launch year, starting with our first infusions in April of 2024.

在我們進入美國市場的前 12 個月裡，我們已經實現了我們的長期目標——採用目標，並創造了超過 2.1 億美元的收入。這包括第一年為近 300 名 Amtagvi 患者進行的輸注，從 2024 年 4 月的第一次輸注開始。

Total first quarter product revenue was $49.3 million, including $43.6 million from more than 80 Amtagvi infusions and $5.7 million from Proleukin sales. Following steady growth throughout 2024, revenue was lower in the first quarter of this year, driven by three key contributors. First, our internal manufacturing facility, the ICTC, completed annual scheduled maintenance in December of last year, as we previously discussed on last quarter's call.

第一季產品總收入為 4,930 萬美元，其中包括來自 80 多種 Amtagvi 輸液的 4,360 萬美元和來自 Proleukin 銷售的 570 萬美元。繼 2024 年全年穩定成長之後，今年第一季的營收有所下降，主要受三個主要因素的影響。首先，正如我們在上個季度的電話會議上討論的那樣，我們的內部製造工廠 ICTC 於去年 12 月完成了年度定期維護。

As a result of limited production starts for multi-week Amtagvi manufacturing across our network, capacity was reduced by more than half for about one month. In addition, volume was impacted by higher rates of patient drop-off and lower manufacturing success rates, but has since rebounded.

由於我們整個網路的數週 Amtagvi 製造生產啟動有限，產能在約一個月內減少了一半以上。此外，銷售量受到病患流失率上升和製造成功率下降的影響，但此後有所反彈。

Today, we are seeing healthy demand with a record number of production starts in the second quarter. Lower Proleukin sales were the second factor contributing to lower first quarter revenue.

今天，我們看到了健康的需求，第二季的生產開工數量創下了歷史新高。Proleukin 銷售額下降是導致第一季營收下降的第二個因素。

We expect two of the three largest US ship wholesalers to start replenishing Proleukin in line with growing Amtagvi demand in the second quarter. We're also growing the other components of our franchise, including sales of Proleukin to third parties for use with manufacturing and clinical research.

我們預計，美國三大船舶批發商中的兩家將在第二季開始補充 Proleukin，以滿足 Amtagvi 不斷增長的需求。我們也正在擴大特許經營的其他部分，包括向第三方銷售 Proleukin 用於製造和臨床研究。

The third contributor to first quarter revenue was the variable pace at which ATCs began treating patients as this differs from center to center. For context, 16% of ATCs have treated more than 10 patients. Our ATCs have ample room to grow, and we anticipate near-term contributions from ATCs that came online in the latter half of 2024 into 2025.

第一季收入的第三個貢獻因素是 ATC 開始治療患者的速度不同，因為各中心的速度不同。具體來說，16% 的 ATC 已經治療過 10 多名患者。我們的 ATC 擁有充足的成長空間，我們預計 2024 年下半年至 2025 年上線的 ATC 將帶來近期貢獻。

We are also confident in our growth prospects under our new Chief Commercial Officer, Dan Kirby. Dan brings a valuable leadership experience in cell therapy commercial organizations since the earliest developments in the field.

我們對新任首席商務長 Dan Kirby 領導下的成長前景充滿信心。自從該領域最早的發展以來，丹就為細胞治療商業組織帶來了寶貴的領導經驗。

In less than three months, Dan is already strengthening our commercial operations to drive ATC adoption and amplify earlier community referrals to our ATC network. The commercial team is working aggressively to implement key learnings from the first year as we continue to execute our US launch. We are also excited about upcoming milestones related to our ex US launch expansion and pipeline development in lung cancer and beyond.

在不到三個月的時間裡，丹已經加強了我們的商業運營，以推動 ATC 的採用並擴大早期社區對我們 ATC 網路的推薦。在我們繼續執行美國市場發布的同時，商業團隊正在積極努力地將第一年學到的關鍵知識付諸實踐。我們也對即將在美國以外地區實現的肺癌及其他領域產品上市擴張和產品線開發相關的里程碑感到興奮。

We anticipate three potential approvals for Amtagvi in the United Kingdom, Canada, and the European Union and additional regulatory submissions are also underway in Australia and Switzerland.

我們預計 Amtagvi 將在英國、加拿大和歐盟獲得三項批准，並且在澳洲和瑞士也正在進行其他監管提交。

We are on track to report updated data from our registrational trial of TIL cell in previously treated advanced non-small cell lung cancer and first clinical data in endometrial cancer. And we continue to advance our robust pipeline of next-generation TIL cell therapies for patients with solid tumors.

我們即將報告先前治療過的晚期非小細胞肺癌的 TIL 細胞註冊試驗的最新數據以及子宮內膜癌的首批臨床數據。我們將繼續推進針對實體瘤患者的下一代 TIL 細胞療法的強大研發管線。

Looking ahead, I will briefly comment on our revised full year revenue guidance and cash spend outlook. We revised our guidance to between $250 million and $300 million in total product revenue for the full year 2025.

展望未來，我將簡要評論我們修訂後的全年收入指引和現金支出前景。我們將 2025 年全年產品總營收預期修改為 2.5 億至 3 億美元之間。

We consider our experience with growth trajectory at the ATCs, timelines for new ATCs to begin treating their first patients and expectations for large community practices and community referrals to drive momentum in the second half of 2025. These demand trends are consistent with the trajectory of other cell therapy launches moving from year one to year two.

我們考慮了 ATC 的成長軌跡經驗、新 ATC 開始治療首批患者的時間表以及對大型社區實踐和社區轉診的期望，以推動 2025 年下半年的發展勢頭。這些需求趨勢與其他細胞療法從第一年到第二年的推出軌跡一致。

After aligning our manufacturing slot plans with our new demand forecast, we are maintaining our prior cash runway guidance into the second half of 2026. We remain confident in a peak sales opportunity of more than $1 billion in the US and more than $2 billion globally for Amtagvi in the current approved indication.

在將我們的生產時隙計畫與新的需求預測結合後，我們將維持先前的現金流預測直至 2026 年下半年。我們仍然相信，就目前批准的適應症而言，Amtagvi 在美國將有超過 10 億美元的峰值銷售額，在全球將有超過 20 億美元的峰值銷售額。

We also continue to expect that gross margin can exceed 70% in the coming years. Amtagvi and Proleukin are showing steady growth in the second quarter and will accelerate in the second half of the year.

我們也繼續預計未來幾年毛利率可以超過70%。Amtagvi 和 Proleukin 在第二季呈現穩定成長，並將在下半年加速成長。

Current momentum is strong, and we project between 100 and 110 commercial patient infusions in the second quarter. We're also motivated by positive feedback from key opinion leaders and patient success stories that reinforce the unmet medical need and value of Amtagvi.

目前勢頭強勁，我們預計第二季將有 100 至 110 名商業患者輸注。我們也受到關鍵意見領袖的正面回饋和病患成功案例的激勵，這些回饋強化了 Amtagvi 未滿足的醫療需求和價值。

On a macro level, as Igor will describe, we are well prepared to supply ongoing demand to deliver commercial Amtagvi as well as our investigational TIL products to patients around the world. Iovance is competitively positioned with a fully US-based patent portfolio and manufacturing network. Tariffs should have a minimal impact on Amtagvi and Proleukin.

從宏觀層面來看，正如伊戈爾所描述的，我們已做好充分準備，滿足持續的需求，為世界各地的患者提供商業化的 Amtagvi 以及我們研究性的 TIL 產品。Iovance 擁有完全基於美國的專利組合和製造網絡，具有競爭優勢。關稅對 Amtagvi 和 Proleukin 的影響應該很小。

I'm happy to go into more detail during the Q&A, I will now turn the call to Dan Kirby for a detailed commercial launch update.

我很高興在問答環節中詳細介紹，現在我將把電話轉給 Dan Kirby，以獲取詳細的商業發布更新。

Thank you, Fred. Following my first 90 days at Iovance, I'm excited about the potential for Amtagvi to benefit patients around the world. I've identified the strength of our launch as well as opportunities to optimize adoption and accelerate growth.

謝謝你，弗雷德。在 Iovance 工作了 90 天后，我對 Amtagvi 造福世界各地患者的潛力感到興奮。我已經確定了我們發布的優勢以及優化採用和加速成長的機會。

Amtagvi is a game-changer for patients who have failed first-line treatment in melanoma. Amtagvi is also the first cell therapy for patients with solid tumor cancers. I'll begin with my observations of what is going well. First, I'm very impressed by our confident and dedicated commercial organization and cross-functional field teams.

Amtagvi 為黑色素瘤一線治療失敗的患者帶來了福音。Amtagvi 也是首個針對實體腫瘤癌症患者的細胞療法。我首先會觀察一下進展順利的情況。首先，我們自信而專注的商業組織和跨職能的現場團隊給我留下了深刻的印象。

These teams have established a solid foundation for Amtagvi by building awareness of the unmet need in advanced melanoma and strong clinical profile of Amtagvi, activating our 70 ATCs within our treatment network and preparing for the next wave of new centers, securing early inclusion in the NCCN guidelines and favorable reimbursement access for more than 95% of US covered lives.

這些團隊透過提高對晚期黑色素瘤未滿足需求和 Amtagvi 強大臨床特徵的認識，激活我們治療網絡內的 70 個 ATC，為下一波新中心做準備，確保儘早納入 NCCN 指南，並為超過 95% 的美國受保人群提供優惠的報銷渠道，為 Amtagvi 奠定了堅實的基礎。

As a result of this execution, Amtagvi is a successful cell therapy, the first of its kind in solid tumors. Today, I will discuss status and near-term initiatives to improve our performance across three key areas.

此次實施的結果表明，Amtagvi 是一種成功的細胞療法，是治療實體瘤的首個此類療法。今天，我將討論我們在三個關鍵領域的現狀和近期舉措，以提高我們的績效。

First, our ATC network expansion and retention strategy to drive adoption. A second area is to address plans to revamp engagements with medical oncologists to guide earlier consideration for Amtagvi. And the third area is to further establish Amtagvi within the US community oncology networks.

首先，我們的 ATC 網路擴展和保留策略將推動採用。第二個領域是製定計劃，改善與腫瘤內科醫生的合作，以指導對 Amtagvi 的早期考慮。第三個領域是進一步在美國社區腫瘤網絡中建立 Amtagvi。

I'll start with our ATC strategy. In the first year of launch, we strategically prioritized 70 experienced cell therapy centers in most of the major cancer centers, nearly all currently treated melanoma patients and are within a two-hour drive of these ATCs.

我將從我們的 ATC 策略開始。在推出的第一年，我們策略性地優先在大多數主要癌症中心設立了 70 個經驗豐富的細胞治療中心，這些中心幾乎都是目前接受治療的黑色素瘤患者，並且距離這些 ATC 都在兩小時車程內。

Current metrics amongst these 70 centers demonstrate ample growth performance and potential for Amtagvi. 79% or 56 ATCs have completed tumor resections, the starting material for TIL manufacturing. 69% or 48 ATCs have infused or more patients and 16% or 11 ATCs have infused more than 10 patients.

這 70 個中心的當前指標表明 Amtagvi 具有充足的成長績效和潛力。 79% 或 56 個 ATC 已完成腫瘤切除術，這是 TIL 製造的起始材料。 69% 或 48 名 ATC 為至少 10 名患者輸液，16% 或 11 名 ATC 為超過 10 名患者輸液。

ATC adoption is tracking in the right direction. We expect additional growth from the early launch centers with strong and steady patient volume. Newer centers activated later in the launch are currently contributing as they gain experience.

ATC 的採用正朝著正確的方向發展。我們預計早期啟動的中心將憑藉強勁而穩定的患者數量實現進一步增長。在發布後不久啟動的較新的中心目前正在隨著經驗的累積而做出貢獻。

For the next set of ATCs, we are currently in the process of activating more than 10 select high-quality centers, including those aligned to large community networks that have premier access to patients needing Amtagvi as their second-line treatment. These next set of ATCs reflects lessons learned, best practices and the characteristics that distinguish our top-performing ATCs while specifically incorporating clinic referral patterns.

對於下一組 ATC，我們目前正在啟動 10 多個精選高品質中心，其中包括與大型社區網路結盟的中心，這些中心可以為需要 Amtagvi 作為二線治療的患者提供優先治療機會。下一組 ATC 反映了經驗教訓、最佳實踐以及區分我們表現最佳的 ATC 的特徵，同時特別結合了診所轉診模式。

Meanwhile, we continuously collaborate with all of our active ATCs to support early referrals and best practices for procuring tumor samples. As we prepare to commercialize Amtagvi beyond the US, 10 international treatment centers are in process to become ATCs for our planned launches in the United Kingdom, Canada, and Europe. We remain on track to onboard 15 international centers as ATCs by year-end.

同時，我們持續與所有活躍的 ATC 合作，以支持早期轉診和獲取腫瘤樣本的最佳實踐。在我們準備將 Amtagvi 在美國以外地區商業化的過程中，10 個國際治療中心正在籌備中，這些中心將成為我們計劃在英國、加拿大和歐洲推出的 ATC。我們仍有望在年底前將 15 個國際中心納入 ATC 行列。

Turning to the second area of focus. We updated our goal in the last three months to better understand our physicians and how they view Amtagvi. In the initial launch, the team did a great job of educating the cell therapy community and key medical oncologists on the benefits of Amtagvi. From our market research, we see that those physicians view Amtagvi as second-line treatment.

轉向第二個重點領域。我們在過去三個月中更新了我們的目標，以便更好地了解我們的醫生以及他們如何看待 Amtagvi。在首次推出時，團隊在向細胞治療界和主要腫瘤醫學專家宣傳 Amtagvi 的益處方面做得非常出色。從我們的市場調查中，我們發現這些醫生將 Amtagvi 視為二線治療。

We also saw that there is a disconnect in Amtagvi-treatment sequencing between our initial target physicians who view Amtagvi as a second-line treatment and referring medical oncologists in the community who consider Amtagvi as third line or later in therapy. This is a large market opportunity for Amtagvi.

我們還發現，在 Amtagvi 治療順序方面，我們最初的目標醫生將 Amtagvi 視為二線治療，而社區中的轉診腫瘤內科醫生將 Amtagvi 視為三線或更晚的治療，兩者之間存在脫節。這對Amtagvi來說是一個巨大的市場機會。

Our number one goal is to establish Amtagvi as the preferred option for all appropriate patients. To this end, we are educating referring medical oncologists to consider Amtagvi early and bring forward the promise of cell therapy within current solid tumor treatment practices.

我們的首要目標是將 Amtagvi 打造為所有合適患者的首選方案。為此，我們正在教育轉診的腫瘤內科醫生儘早考慮 Amtagvi，並在目前的實體腫瘤治療實踐中發揮細胞療法的潛力。

We have a sizable patient population, and we have a tremendous potential to drive earlier patient referrals to our ATCs. For example, a portion of our ATC -- a portion of patients who initiate the Amtagvi journey die in our hospice prior to surgery shortly after committing to Amtagvi. This is due to late referrals in the community.

我們擁有大量的患者，並且我們有巨大的潛力推動患者更早轉診到我們的 ATC。例如，我們的一部分 ATC——一部分開始 Amtagvi 治療的患者在承諾服用 Amtagvi 後不久，就在手術前在我們的臨終關懷醫院去世了。這是由於社區中的推薦較晚所致。

With our updated plans, we are doubling down on initiatives and medical education efforts with community medical oncologists so we can drive earlier patient referrals and shift the treatment sequence.

根據我們更新的計劃，我們將與社區腫瘤內科醫生加倍開展計劃和醫學教育工作，以便我們能夠推動更早的患者轉診並改變治療順序。

To do this, we will educate practitioners on the benefits of durable responses with onetime cell therapies like Amtagvi versus temporary responses and ongoing side effects seen with other treatments. We will roll out new disease state educational efforts and amplify our presence at relevant medical meetings to provide a better understanding around TIL and cell therapy.

為此，我們將向從業者介紹 Amtagvi 等一次性細胞療法帶來的持久反應與其他治療方法所見的暫時反應和持續副作用相比的益處。我們將推出新的疾病狀態教育工作，並擴大我們在相關醫學會議上的影響力，以便更好地了解 TIL 和細胞療法。

For the first time in advanced melanoma and solid tumors, a cell therapy made from a patient's own immune cells has been shown to induce long-term benefit with curative intent.

在晚期黑色素瘤和實體腫瘤中，首次證明由患者自體免疫細胞製成的細胞療法可以帶來長期治癒效果。

For the third area of focus, we are building relationships within community oncology networks that treat our target Amtagvi patients. We are expanding resources within our community field team to increase frequency, speed, and overall timelines for referrals and to identify new ATC targets.

對於第三個重點領域，我們正在與治療目標 Amtagvi 患者的社區腫瘤學網絡建立關係。我們正在擴大社區實地團隊的資源，以增加轉診的頻率、速度和整體時間表，並確定新的 ATC 目標。

Recently, we have seen increased momentum for patient referrals to current ATCs and identify new ATCs. Since my arrival, we've engaged with executive leadership in every major US community cancer network. We are now collaborating with the top US community clinic networks to identify and onboard several preferred centers for Amtagvi.

最近，我們看到患者轉診至現有 ATC 和確定新 ATC 的勢頭日益增強。自從我來到這裡，我們就與美國每個主要社區癌症網絡的執行領導層進行了接觸。我們目前正在與美國頂級社區診所網路合作，以確定並加入幾個 Amtagvi 首選中心。

We are also focused on breaking down any remaining access barriers to adoption. For example, we are exploring alternative distribution channels that may offer flexibility and broader acceptance of onetime therapies like Amtagvi while maintaining our current pricing strength.

我們也致力於打破任何剩餘的採用障礙。例如，我們正在探索替代分銷管道，這些管道可以提供靈活性並更廣泛地接受像 Amtagvi 這樣的一次性療法，同時保持我們目前的定價優勢。

In addition to Amtagvi, our commercial organization is dedicated to supporting Proleukin across three key business lines: use within Amtagvi, use in manufacturing and clinical use. Aside from the main business tied to Amtagvi, manufacturing and clinical use represent an existing base revenue for Proleukin. My team is focusing on opportunities to increase sales growth in all three areas.

除了 Amtagvi 之外，我們的商業組織還致力於支援 Proleukin 的三個關鍵業務線：Amtagvi 內部使用、製造使用和臨床使用。除了與 Amtagvi 相關的主要業務外，製造和臨床使用是 Proleukin 現有的基本收入。我的團隊正專注於尋找在這三個領域增加銷售成長的機會。

As Fred mentioned, strong Proleukin sales in our main channel will resume throughout the remainder of 2025, including two distributors expected to reorder in the second quarter.

正如弗雷德所提到的，我們主要通路的 Proleukin 銷售將在 2025 年剩餘時間內恢復強勁，其中兩家經銷商預計將在第二季重新訂購。

In summary, I am energized to lead our commercial organization toward a bright future. Launching a first-in-class therapy entails a unique set of opportunities to make a fundamental difference. I am deeply committed to the Iovance vision of pioneering a new treatment paradigm for physicians who treat patients with solid tumors.

總而言之，我充滿活力，能夠帶領我們的商業組織走向光明的未來。推出一流的治療方法意味著一系列獨特的機會，可以帶來根本性的改變。我堅定地致力於 Iovance 的願景，即為治療實體瘤患者的醫生開創一種新的治療模式。

We have barely scratched the surface of Amtagvi's potential to globally address more than 30,000 melanoma patients annually. Amtagvi has tremendous promise in solid tumor cancers, which represent 90% of all cancers.

我們僅僅觸及了 Am​​tagvi 每年在全球範圍內治療超過 30,000 名黑色素瘤患者的潛力。Amtagvi 在治療佔所有癌症 90% 的實體瘤癌症方面具有巨大的前景。

I will now pass the call 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伊戈爾·比林斯基 (Igor Bilinsky)，以介紹我們的製造進度。

Thank you, Dan. Today, I will provide an update on our progress in manufacturing. Our Philadelphia-based manufacturing network consists of two FDA-approved facilities, our internal manufacturing facility, the Iovance Cell Therapy Center, or ICTC, and an American-owned contract manufacturer. This network serves commercial patients in the US as well as clinical trial patients across Europe, Australia, and Asia.

謝謝你，丹。今天，我將介紹我們在製造業方面的進展。我們位於費城的製造網路由兩個 FDA 批准的設施、我們的內部製造設施 Iovance 細胞治療中心 (ICTC) 和一家美國獨資合約製造商組成。該網路為美國的商業患者以及歐洲、澳洲和亞洲的臨床試驗患者提供服務。

Our experience in supplying TIL cell therapies to clinical patients around the world provides a strong foundation for delivering commercial product in the EU, U.K. and Canada in the near-term.

我們在向世界各地的臨床患者提供 TIL 細胞療法方面的經驗為近期在歐盟、英國和加拿大提供商業產品奠定了堅實的基礎。

Today, I'm pleased to report a major step forward in the ongoing review of our marketing authorization application, or MAA, for the European Union approval of Amtagvi.

今天，我很高興地報告，我們在歐盟批准 Amtagvi 的營銷授權申請（MAA）的持續審查中取得了重大進展。

Recently, as part of the MAA process, the European Medicines Agency, or EMA, inspected and confirmed that the ICTC and our contract manufacturers facility are both GMP-compliant. These successful EMA inspections further validate our manufacturing network capabilities to meet regulatory standards from multiple health care authorities as we prepare to serve commercial patients in the European Union. As part of the ongoing launch, we steadily ramped up our staff manufacturing capacity to align with demand while tightly controlling expenses.

最近，作為 MAA 流程的一部分，歐洲藥品管理局 (EMA) 檢查並確認 ICTC 和我們的合約製造商工廠均符合 GMP 標準。這些成功的 EMA 檢查進一步驗證了我們的製造網路能力，以滿足多個醫療保健機構的監管標準，我們準備為歐盟的商業患者提供服務。作為正在進行的發布的一部分，我們穩步提高員工製造能力以滿足需求，同時嚴格控制費用。

As a result of our revised revenue guidance and updated demand forecast, as Fred described, we expect to realize additional cost savings by aligning our manufacturing capacity growth plans with demand. Owning our own manufacturing facility provides us with tremendous flexibility to scale up efficiently when needed.

正如弗雷德所描述的，由於我們修改了收入指導和更新了需求預測，我們期望透過使我們的製造能力成長計劃與需求保持一致來實現額外的成本節約。擁有自己的製造工廠為我們提供了極大的靈活性，可以在需要時有效地擴大規模。

As mentioned previously, ICTC conducted and successfully completed annual scheduled maintenance.

如前所述，ICTC 已開展並成功完成了年度定期維護。

Given the three-week manufacturing process for Amtagvi, the network capacity was reduced by more than 50% for approximately one month in December 2024, thus lowering available capacity for Q1 Amtagvi infusions.

鑑於 Amtagvi 的製造過程需要三週，2024 年 12 月約一個月的網路容量減少了 50% 以上，從而降低了 Q1 Amtagvi 輸液的可用容量。

Following maintenance, production resumed successfully with full capacity available for Q2 Amtagvi infusions. I will also comment on our manufacturing success rate in the first quarter. Delivering final product within defined specifications is critical for treating patients.

維護後，生產成功恢復，Q2 Amtagvi 輸液產能已滿。我還將對我們第一季的製造成功率進行評論。按照規定的規格交付最終產品對於治療患者至關重要。

Throughout the first nine months of the US launch, our commercial manufacturing experience was consistent with prior clinical experience. The rate of patient drop-off in our spec rate increased somewhat in the first quarter, thus impacting our cost of goods and gross margin, as Jean-Marc will further discuss.

在美國上市的前九個月裡，我們的商業製造經驗與先前的臨床經驗一致。我們規格率中患者流失率在第一季有所增加，這影響了我們的商品成本和毛利率，Jean-Marc 將進一步討論。

Following Q1, manufacturing success rate has since rebounded. During this year, we also expect to shorten our manufacturing turnaround time, which is currently 34 days from receipt of sales at the manufacturing facility to Amtagvi being ready for return shipment to the ADC.

第一季之後，製造成功率回升。今年，我們也希望縮短製造週轉時間，目前從製造工廠收到銷售到 Amtagvi 準備返回 ADC 需要 34 天。

In addition, we continue being laser-focused on driving operational efficiencies and economies of scale to optimize the cost of goods and improve gross margin over time.

此外，我們將繼續致力於提高營運效率和規模經濟，以優化商品成本並逐步提高毛利率。

Shifting to the current macroeconomic and geopolitical environment. Iovance is operating at a strategic advantage within the biopharma industry. We expect Amtagvi and Proleukin to see minimal impact from tariffs.

轉向當前的宏觀經濟和地緣政治環境。Iovance 在生物製藥產業擁有戰略優勢。我們預期 Amtagvi 和 Proleukin 受到關稅的影響將微乎其微。

Our intellectual property for Amtagvi and investigational TIL cell therapies is domiciled in the US. Amtagvi manufacturing is based in the US. Most of the Amtagvi cost is US-based with direct materials procured from ex-US vendors currently representing less than 5% of the Amtagvi cost of goods.

我們的 Amtagvi 和研究性 TIL 細胞療法的智慧財產權位於美國。 Amtagvi 製造總部位於美國。 Amtagvi 的大部分成本都在美國，從美國以外的供應商採購的直接材料目前佔 Amtagvi 商品成本的不到 5%。

For Proleukin, we have also brought sufficient Proleukin inventory to the US that we expect to be sufficient for meeting demand into 2027. Our TIL cell therapy expertise and manufacturing capabilities are protected by robust patent estate domiciled in the US

對於 Proleukin，我們也為美國帶來了足夠的 Proleukin 庫存，預計足以滿足 2027 年的需求。我們的TIL細胞治療專業知識和製造能力受到美國強大的專利保護

We own approximately 280 granted or allowed US and international patents and patent rights Amtagvi and other TIL-related technologies. We expect these patents to provide exclusivity through at least 2042.

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。我們預計這些專利將至少在 2042 年之前提供獨佔權。

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

我可以在問答環節回答問題，現在我將把電話交給我們的財務長 Jean-Marc。

Thank you, Igor. Today, I will review our cash position and results for the first quarter of 2025. I will also highlight our financial outlook, including revenue, expense guidance, and gross margin.

謝謝你，伊戈爾。今天，我將回顧我們 2025 年第一季的現金狀況和業績。我還將強調我們的財務前景，包括收入、支出指引和毛利率。

As of March 31, 2025, our cash position was approximately $366 million. Our current cash position is sufficient to fund current and planned operations, including manufacturing expansion into the second half of 2026.

截至 2025 年 3 月 31 日，我們的現金狀況約為 3.66 億美元。我們目前的現金狀況足以資助目前和計劃中的運營，包括到 2026 年下半年的製造擴張。

I will now transition to our financial results. Net loss for the first quarter of 2025 was $116.2 million or $0.36 per share compared to a net loss of $113 million or $0.42 per share for the first quarter of 2024.

現在我將轉達我們的財務表現。2025 年第一季淨虧損為 1.162 億美元，即每股 0.36 美元，而 2024 年第一季淨虧損為 1.13 億美元，即每股 0.42 美元。

Total product revenue consists of Amtagvi infusion in the US and Proleukin sales. Total product revenue was $49.3 million for the first quarter of 2025, including $43.6 million for Amtagvi and $5.7 million for Proleukin compared to total product revenue of $0.7 million for the first quarter of 2024 for Proleukin.

總產品收入包括美國的 Amtagvi 輸液和 Proleukin 銷售。2025 年第一季總產品收入為 4,930 萬美元，其中 Amtagvi 為 4,360 萬美元，Proleukin 為 570 萬美元，而 2024 年第一季 Proleukin 總產品收入為 70 萬美元。

The US commercial launch of Amtagvi and Proleukin sales drove the revenue increase in the first quarter of this year over the prior year period.

Amtagvi 在美國的商業化推出和 Proleukin 的銷售推動了今年第一季營收較去年同期的成長。

I will now highlight our cost of sales, which includes cost of inventory, overhead, and related cash and non-cash expenses that are directly associated with sales of Amtagvi and Proleukin as well as manufacturing costs for Proleukin.

我現在將重點介紹我們的銷售成本，其中包括庫存成本、間接費用以及與 Amtagvi 和 Proleukin 的銷售直接相關的現金和非現金費用以及 Proleukin 的製造成本。

Cost of sales for the first quarter of 2025 was $49.7 million, including $15 million in period costs associated with patient drop-off and manufacturing success rates, an increase quarter-over-quarter, as Igor previously described. $5.4 million for non-cash expenses, including fair market value step-up and intangible asset amortization and $1.3 million in royalties payable on product sales.

2025 年第一季的銷售成本為 4,970 萬美元，其中包括與病患流失和製造成功率相關的 1,500 萬美元期間成本，如 Igor 之前所述，環比有所增加。 540 萬美元為非現金支出，包括公平市場價值提升和無形資產攤銷以及 130 萬美元的產品銷售應付特許權使用費。

During the first quarter of 2024, cost of sales was $7.3 million, primarily related to non-cash amortization for acquired intangible assets. The increase in cost of sales in the first quarter of 2025 over the prior year period was primarily attributable to cash and non-cash expenses associated with Amtagvi product sales tied to the US launch, along with period costs associated with patient drop-off and manufacturing success rates.

2024 年第一季度，銷售成本為 730 萬美元，主要與收購無形資產的非現金攤提有關。2025 年第一季銷售成本較去年同期增加，主要歸因於與美國上市相關的 Amtagvi 產品銷售的現金和非現金支出，以及與病患流失和製造成功率相關的期間成本。

Average standard gross margin is 32% for the first four launch quarters. Standard gross margin for the first quarter of 2025 was 10% or $5 million compared to total product revenue of $49.3 million. First quarter was negatively impacted by lower revenue and higher cost of sales, as previously described.

前四個上市季度的平均標準毛利率為 32%。2025 年第一季的標準毛利率為 10% 或 500 萬美元，而總產品收入為 4,930 萬美元。如前所述，第一季受到收入下降和銷售成本上升的負面影響。

As we increase volume and capacity utilization, we expect gross margin to surpass 70% in the coming years. Our priorities are to drive revenue while optimizing our cost of sales with a correspondingly higher gross margin as we expand our manufacturing, coordinate and continue our focus on ATC engagement and training and realize efficiencies in manufacturing and release testing.

隨著產量和產能利用率的提高，我們預計未來幾年毛利率將超過 70%。我們的首要任務是擴大生產規模，優化銷售成本，提高毛利率，同時協調並持續專注於 ATC 參與和培訓，提高生產和放行測試的效率。

I will now shift to our operating expenses. Research and development expenses were $76.9 million for the first quarter of 2025, a decrease of 4% compared to $79.8 million for the same prior year period that was primarily attributable to the transition of Amtagvi from clinical to commercial manufacturing.

現在我將轉向我們的營運費用。2025 年第一季研發費用為 7,690 萬美元，較去年同期的 7,980 萬美元下降 4%，這主要歸因於 Amtagvi 從臨床到商業製造的轉變。

This decrease was partially offset by higher headcount and related costs, including stock-based compensation and clinical trial costs resulting from continued enrollment in existing trials.

這一減少被更高的員工人數和相關成本（包括股票薪酬和因繼續參加現有試驗而產生的臨床試驗成本）部分抵消。

Selling, general, and administrative expenses were $43.9 million for the first quarter of 2025, an increase of 40% compared to $31.4 million for the prior year period. Higher selling, general, and administrative expenses were 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, marketing and legal costs, and costs to support the commercialization of Amtagvi and Proleukin.

2025 年第一季的銷售、一般及行政費用為 4,390 萬美元，較去年同期的 3,140 萬美元成長 40%。銷售、一般及行政費用的增加主要歸因於員工人數和相關成本的增加，包括股票薪酬，以支持整體業務的成長，以及相關的公司基礎設施、行銷和法律成本，以及支持 Amtagvi 和 Proleukin 商業化的成本。

Looking ahead, we revised our guidance to between $250 million and $300 million in total product revenue for the full year 2025. After aligning our manufacturing slot expansion strategy with our new demand forecast, we are maintaining our current cash runway guidance into the second half of 2026.

展望未來，我們將 2025 年全年產品總營收預期修改為 2.5 億至 3 億美元之間。在將我們的製造時段擴展策略與新的需求預測相結合後，我們將維持目前的現金流量指引至 2026 年下半年。

Cash burn for full year 2025 is expected to remain in line with prior guidance of less than $300 million with a strong focus on optimizing spending and reducing expenses throughout the organization, including flat expenses related to Amtagvi manufacturing headcount expansion for the latter half of 2025.

預計 2025 年全年現金消耗將與先前的指導保持一致，低於 3 億美元，重點是優化整個組織的支出和削減開支，包括與 2025 年下半年 Amtagvi 製造員工人數擴張相關的持平開支。

As we grow revenue and as gross margin improves, we expect further reduction in our net cash spend with ample flexibility to control both capital and operating expenses as we approach breakeven.

隨著收入的成長和毛利率的提高，我們預計淨現金支出將進一步減少，並且在接近盈虧平衡時擁有足夠的靈活性來控制資本和營運支出。

For additional information, please see the company's selected consolidated balance sheet and statements of operations in this afternoon's press release and our Form 10-Q to be filed later today.

欲了解更多信息，請參閱今天下午新聞稿中的公司精選合併資產負債表和經營報表以及我們今天晚些時候提交的 10-Q 表。

I will now hand the call to Friedrich, our Chief Medical Officer, to discuss our clinical pipeline.

現在我將把電話交給我們的首席醫療官弗里德里希，討論我們的臨床管線。

Thank you, Jean-Marc. Building on the team's comments about Amtagvi, the durability of responses following one-time treatment is a key differentiator from other available and emerging therapies. We will present five-year results from our C-144-01 trial at the American Society of Clinical Oncology or ASCO Annual Meeting on June 2nd. Compared to prior data updates, these results show consistent trends for overall survival and durability over a five-year period.

謝謝你，讓-馬克。根據團隊對 Amtagvi 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。我們將於 6 月 2 日在美國臨床腫瘤學會或 ASCO 年會上展示 C-144-01 試驗的五年結果。與先前的數據更新相比，這些結果顯示出五年內整體存活率和耐久性的一致趨勢。

Our clinical programs and next-generation approaches are the next frontier for TIL cell therapy in solid tumors, which represent more than 90% of all diagnosed cancers in the US. Future growth drivers include global label expansion for Lifileucel into frontline advanced melanoma, other solid tumor types such as non-small cell lung cancer, and next-generation therapies.

我們的臨床計畫和下一代方法是實體瘤 TIL 細胞治療的下一個前沿，而實體腫瘤占美國所有確診癌症的 90% 以上。未來的成長動力包括將 Lifileucel 的全球標籤擴展到一線晚期黑色素瘤、非小細胞肺癌等其他實體腫瘤類型以及下一代療法。

Today, I will summarize our latest pipeline updates. First, we are making progress towards the broader commercial opportunity for Amtagvi in frontline advanced melanoma. Our global registrational Phase 3 trial, TILVANCE-301, remains on track to support accelerated and full approvals of Amtagvi in combination with pembrolizumab in frontline advanced melanoma as well as regular approval of Amtagvi in our initial indication in post anti-PD-1 melanoma.

今天，我將總結我們最新的管道更新。首先，我們正在為 Amtagvi 在前線晚期黑色素瘤領域的更廣泛商業機會取得進展。我們的全球註冊 3 期試驗 TILVANCE-301 仍在按計劃進行，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，以及定期批准 Amtagvi 用於治療抗 PD-1 後黑色素瘤的初步適應症。

A proof-of-concept cohort is also investigating Lifileucel in combination with nivolumab and relatimab in the US. Our registrational program in advanced non-small cell lung cancer, the single-arm Phase 2 IOV-LUN-202 clinical study is designed to show efficacy and safety of Lifileucel monotherapy in patients progressing after anti-PD-1 therapy.

在美國，一個概念驗證隊列也正在研究 Lifileucel 與 nivolumab 和 relatimab 的合併用藥。我們的晚期非小細胞肺癌註冊計畫單臂 2 期 IOV-LUN-202 臨床研究旨在展示 Lifileucel 單藥療法對抗 PD-1 治療後病情進展患者的療效和安全性。

There is a significant unmet medical need as most patients progress and chemotherapy, the current standard-of-care in this treatment setting provides limited rate and duration of responses.

隨著大多數患者的病情進展和化療，存在著巨大的未滿足的醫療需求，而這種治療環境下的現行標準治療方法只能提供有限的反應速度和反應持續時間。

We remain on track as planned to share additional data from IOV-LUN-202 in the second half of 2025. The trial is designed with the potential to support a potential regulatory decision on US accelerated approval in post anti-PD-1 non-small cell lung cancer in 2027.

我們將繼續按計劃在 2025 年下半年分享來自 IOV-LUN-202 的更多數據。該試驗旨在支持美國在 2027 年就抗 PD-1 非小細胞肺癌加速審批做出潛在監管決定。

In frontline non-small cell lung cancer, our strategy is to establish a new regimen consisting of Lifileucel plus pembrolizumab following standard-of-care chemotherapy pembrolizumab.

在一線非小細胞肺癌治療中，我們的策略是在標準化療帕博利珠單抗之後建立一種由 Lifileucel 加帕博利珠單抗組成的新方案。

Multiple cohorts are investigating patients with EGFR wild-type non-small cell lung cancer who are the majority of patients with an unmet medical need in this treatment setting.

多個隊列正在研究 EGFR 野生型非小細胞肺癌患者，他們是這種治療環境中未滿足醫療需求的患者中的大多數。

Turning to another significant opportunity, advanced endometrial cancer, our IOV-END-201 clinical trial is investigating Lifileucel as the frontline standard-of-care of chemotherapy and anti-PD-1. We look forward to sharing initial data from END-201 in the second half of this year.

談到另一個重要機遇，晚期子宮內膜癌，我們的 IOV-END-201 臨床試驗正在研究 Lifileucel 作為化療和抗 PD-1 的一線標準治療方法。我們期待在今年下半年分享 END-201 的初始數據。

As the leader in TIL cell therapy, Iovance is also at the forefront of next-generation approaches to optimize TIL and TIL treatment regimens. I'll briefly summarize our three lead next-generation programs. Our PD-1 inactivated TIL cell therapy, IOV-4001, continues to enroll patients in a trial in previously treated advanced melanoma or non-small cell lung cancer.

作為 TIL 細胞治療領域的領導者，Iovance 也處於優化 TIL 和 TIL 治療方案的下一代方法的前沿。我將簡要總結我們的三個領先的下一代專案。我們的 PD-1 滅活 TIL 細胞療法 IOV-4001 繼續招募先前接受過治療的晚期黑色素瘤或非小細胞肺癌患者參與試驗。

Building on our successful Proleukin franchise, we are treating patients in a Phase 1/2 clinical trial of IOV-3001, a second-generation modified IL-2 analog for use with the TIL cell therapy treatment regimen.

在我們成功的 Proleukin 特許經營權的基礎上，我們正​​在對 IOV-3001 進行 1/2 期臨床試驗的患者進行治療，IOV-3001 是一種第二代改良 IL-2 類似物，用於與 TIL 細胞療法治療方案一起使用。

And lastly, IOV-5001 is a genetically engineered inducible and tethered IL-12 TIL cell therapy with potential for enhanced activity, which could facilitate expansion into a wide range of common solid tumor cancers beyond our current pipeline with significant market opportunity. We plan to submit an investigational new drug application to FDA this year for IOV-5001. I'm happy to address questions about these programs and additional trials during the Q&A session.

最後，IOV-5001 是一種基因工程誘導和束縛 IL-12 TIL 細胞療法，具有增強活性的潛力，可以促進擴展到我們目前產品線之外的各種常見實體瘤癌症，具有巨大的市場機會。我們計劃今年向 FDA 提交 IOV-5001 的新藥研究申請。我很高興在問答環節回答有關這些計劃和額外試驗的問題。

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

我現在將電話轉給接線生，開始問答環節。

(Operator Instructions)

（操作員指示）

Andrew Tsai, Jefferies. Your line is open.

安德魯·蔡（Andrew Tsai），傑富瑞（Jefferies）。您的線路已開通。

Hey. Thanks. Good afternoon. Thanks for taking my question. Appreciate the update. My question is around the line of sight you're having amidst the revised guidance. Presumably, you do have some direct line of sight, maybe at least a month in advance into the number of patients who are waiting to get dosed in the Q. Can you confirm whether you're seeing or have seen a spike or an inflection in patient uptake as of today to give you the confidence around your guidance of 110 patients for Q2? Thank you.

嘿。謝謝。午安.感謝您回答我的問題。感謝更新。我的問題是關於您在修訂指南中所看到的視線。據推測，您確實有一些直接的了解，也許至少提前一個月就可以了解 Q 中等待服藥的患者數量。您能否確認截至今天您是否看到或已經看到患者接受量激增或下降，以便讓您對第二季度 110 名患者的指導有信心？謝謝。

So Andrew, this is Dan. Thank you very much. Yes, we're confident in that number, and we are seeing demand, as we stated in the script, in quarter two be strong.

安德魯，這是丹。非常感謝。是的，我們對這個數字很有信心，而且正如我們在腳本中所述，我們看到第二季的需求將會強勁。

Tyler Van Buren, TD Cowen.

泰勒範布倫 (Tyler Van Buren)，TD Cowen。

Hey guys. Thanks very much for all the information. So, for the 11 ATCs that have infused more than 10 patients, were most of them involved in the clinical program? And it's just a matter of getting the other ones that weren't up to speed?

嘿，大家好。非常感謝您提供的所有資訊。那麼，對於已經為 10 多名患者輸注的 11 位 ATC 來說，他們中的大多數是否都參與了臨床計劃？這只是讓其他沒有跟上速度的人得到改善的問題嗎？

Maybe you could discuss the barriers of the other 37 ATCs that have infused more than one patient but haven't infused 10 plus and what tactics you're employing to get them to increase their utilization?

也許您可以討論一下其他 37 個 ATC 所面臨的障礙，這些 ATC 已經為多名患者輸液，但還沒有為 10 名以上患者輸液，以及您採用了什麼策略來讓他們提高利用率？

Yes, Tyler, I'll start, and I'll pass it over to Dan to give you a little bit more on the second part of that question. On the trial, only a few of those ATCs were actually involved in the trial. It's not necessarily a correlation between the clinical trial unit at the site and their experience and what the site does with commercial Amtagvi.

是的，泰勒，我先開始，然後我會把問題交給丹，讓他就這個問題的第二部分給你更多答案。在審判中，只有少數 ATC 真正參與了審判。該地點的臨床試驗單位及其經驗與該地點對商業 Amtagvi 的處理方式之間不一定存在關聯。

A lot of times it's different people, and we have to work closely with that unit at each ATC to get them up to speed. So, there is some learning there, but we're able to overcome it.

很多時候都是不同的人，我們必須與每個 ATC 的部門密切合作，以使他們快速掌握情況。所以，我們還需要學習一些東西，但我們能夠克服它。

And obviously, we're learning quite a bit ourselves about how to do that, and we're getting better and better all the time. And that's why we have confidence that many of those other ATCs are going to come along quickly. And in fact, we're seeing that today. But Dan, do you want to take the second part of the question?

顯然，我們自己也在學習如何做到這一點，而且我們正在變得越來越好。這就是為什麼我們有信心許多其他 ATC 將會迅速跟進。事實上，我們今天就看到了這一點。但丹，你想回答問題的第二部分嗎？

Sure. And looking at just with cell therapy in general, there's actually patients coming into treat and there's a cell therapy experience level at these centers. So, what we'll say is that the larger centers that got off to a quicker start, those are the ones with the infrastructure from various cell therapy launches that were ready for Amtagvi to enter in.

當然。就細胞療法而言，實際上有患者來接受治療，而這些中心具有一定的細胞療法經驗水平。因此，我們要說的是，那些起步較快的大型中心，都具備了推出各種細胞療法所需的基礎設施，為 Amtagvi 的進入做好了準備。

The other ones are ramping up to speed. They're doing this with other cell therapies as well. But infrastructure such as billing, mechanism, cell therapy lab, et cetera, are coming online with that. So we are seeing them increase their ramp a lot quicker once they get that infrastructure in place. Does that answer your question?

其餘的正在加速發展。他們也在其他細胞療法中進行了同樣的嘗試。但計費、機制、細胞治療實驗室等基礎設施正隨之上線。因此，我們看到，一旦他們建立了基礎設施，他們的坡道就會增加得更快。這回答了你的問題嗎？

Yes. Thank you.

是的。謝謝。

Thank you.

謝謝。

Salim Syed, Mizuho.

薩利姆賽義德，瑞穗。

Great. Thanks for the question guys and there color there. I guess on your guidance kind of going forward here for 2025, if I'm doing my math correctly here and assuming something like 20% Proleukin, sort of backing into that the balance of the year, you're going to have something like 250 or 325 infusions.

偉大的。謝謝大家的提問，以及他們的色彩。我想，根據您對 2025 年的指導，如果我的計算正確的話，假設 Proleukin 的比例為 20%，那麼按照這個比例計算，今年的餘額將達到 250 或 325 次輸液。

So, roughly like, call it, 100, 110, something like 100 per quarter roughly. Is that a correct way to sort of think about this, which essentially apply no growth versus like the 2Q number?

因此，大致可以這麼說，100、110，大約每季 100 個。這是一種正確的思考方式嗎？與第二季的數據相比，它基本上沒有成長？

No, Salim, that's not how you want to think about it. We're actually -- right now, as you know, we did $164 million in revenue last year, including quite a bit of Proleukin. And what we're projecting is $250 million to $300 million this year, which is some growth there, obviously. That's fiscal year aligned.

不，薩利姆，你不該這麼想。事實上，如你所知，我們去年的收入為 1.64 億美元，其中包括相當一部分 Proleukin。我們預計今年的營收將達到 2.5 億至 3 億美元，顯然會有所成長。這與財政年度一致。

If you want to think of it as just infusions, though, you can look at the four quarters. We infused our first two patients back in April of 2024. And through to the end of March, we were about 280-some patients infused.

但是，如果您只想將其視為輸液，那麼您可以看看四個季度。我們於 2024 年 4 月為首兩名患者進行了輸血。截至三月底，我們已為約 280 名患者進行了輸液。

Our guidance implies that in this year, we'll probably get over 500 patients infused and that's in the four quarters of the fiscal year. And of course, there'll be another quarter into 2026 that will grow more.

我們的指導意味著，今年我們可能會為超過 500 名患者註入血液，而且這是在本財政年度的四個季度內。當然，到 2026 年，還有一個季度還會有更大的成長。

So, you are looking at like a 50% or more growth rate there as you go through this time period year-over-year, and there's a lot of upside there as well. And Dan, do you want to add to that?

因此，您會看到，隨著這段時期的逐年增長，成長率將達到 50% 或更高，而且還有很大的上升空間。丹，你還有什麼要補充的嗎？

Sure. So, what I would say is the way you can look at this is that we expect continued growth throughout this year. So it will not be flattening, it will continue to grow. That's driven by two factors. One, as we talked about the increase of adoption in our centers, both the ones that started in the very beginning and the ones that ramped up through 2024 and the addition of new ATCs that have enhanced referral networks within the community to get patients not only in quantity, but also quality, meaning they're getting earlier referrals.

當然。所以，我想說的是，你可以這樣看待這個問題：我們預計今年全年將繼續成長。所以它不會變平，而是會繼續成長。這是由兩個因素造成的。首先，正如我們所討論的，我們中心採用率的提高，包括從一開始就採用的，以及到 2024 年逐步增加的，以及增加新的 ATC，這些都增強了社區內的轉診網絡，不僅在數量上，而且在質量上都得到了提升，這意味著他們可以更早地獲得轉診。

Okay. Thank you so much.

好的。太感謝了。

Andrea Newkirk, Goldman Sachs.

高盛的安德里亞紐柯克 (Andrea Newkirk)。

Good afternoon. Thanks for taking the question. Maybe a follow-up there, Fred, on what your guidance is implying per infusion. I just want to make sure I understood this. But are you suggesting that 500 infusions should be on top for 2025? And if that's the case, then what are you assuming for Proleukin through the remainder of this year even after the uptick expected in 2Q?

午安.感謝您回答這個問題。弗雷德，也許可以跟進一下您的指導對每次輸液的含義。我只是想確保我理解了這一點。但您是否建議 2025 年的輸液量應達到 500 次？如果情況確實如此，那麼即使預計第二季會出現上漲，您對 Proleukin 今年剩餘時間的表現有何預期？

So if you just take the guidance we gave, subtract off the number like what Salim just gave you for Proleukin and divide that through by 550 or so, you're going to get something in the high 400s, close to 500 depending. And if you think there's some upside here, there could be some upside on top of that. Does that answer the question?

因此，如果您只是按照我們提供的指導，減去 Salim 剛剛給您的 Proleukin 的數字，然後除以 550 左右，您將獲得 400 多一點，接近 500 一點，具體取決於具體數字。如果你認為這裡有一些好處，那麼在此基礎上可能會有更多好處。這回答了問題嗎？

Okay. Thank you. And then just really quickly, Igor, could you just speak to what drove the higher patient drops or lower manufacturing success in the quarter? And what gives you the confidence that this will reverse on the forward?

好的。謝謝。那麼，伊戈爾，您能否快速談談導致本季患者人數下降或製造成功率下降的原因是什麼？您如何確信這種情況會在未來扭轉？

So some of this -- thanks for the question, Andrea. Some of this or much of this is related to patient selection and the tumor procurement technique. And as I mentioned, we already saw the return to normal rebound in the Q2 so far.

所以其中一些——感謝安德里亞的提問。其中一些或大部分與患者選擇和腫瘤獲取技術有關。正如我所提到的，到目前為止，我們已經看到第二季度恢復正常的反彈。

What gives us confidence is the success rate trends that we see among ATCs who have been up and running for a long time and the experience curve that they've been able to achieve. So, that gives us confidence that it's teachable and can be translated to other ATCs across the network.

讓我們充滿信心的是，我們看到了長期運作的 ATC 的成功率趨勢以及他們所取得的經驗曲線。因此，我們相信它是可教授的，並且可以轉化為網路上的其他 ATC。

Yanan Zhu, Wells Fargo.

朱亞南，富國銀行。

Thanks for taking our questions. First, a clarifying question. I must be missing something. So, assuming each Amtagvi product is roughly north of $500,000, that's $0.5 million. And then if there's 500 patients infused this year, that alone will be $250 million, which is the lower bound of the guidance.

感謝您回答我們的問題。首先，澄清一個問題。我肯定遺漏了什麼。因此，假設每件 Amtagvi 產品的價格約為 50 萬美元，那就是 50 萬美元。如果今年有 500 名患者接受輸液，那麼這項費用將達到 2.5 億美元，這是指導價值的下限。

So, if that's the case, then adding IL-2 on top of that, the lower bound of guidance should really be above $250 million. So, I'm trying to see is my assumption for per patient price off? And -- thank you for clarifying.

因此，如果情況確實如此，那麼在此基礎上加上 IL-2，指導的下限實際上應該在 2.5 億美元以上。所以，我想看看我對每位患者價格的假設是否正確？並且—感謝您的澄清。

My actual question is on COGS. And can you talk about the -- it seems like COGS -- as a ratio of revenue has increased over the last quarter. Just wanted to understand what proportion of the COGS is due to patient attrition, i.e., patient passing away cannot get the product or manufacturing failure. If you can give us some color there. Thank you.

我的實際問題是關於 COGS 的。您能否談談——看起來 COGS ——作為收入比率在上個季度有所增加。只是想了解 COGS 中有多少比例是由於患者流失造成的，即患者去世後無法獲得產品或製造失敗。如果您能給我們一些顏色的話。謝謝。

Yes. Yanan, on the first part, our guidance, we consider this guidance to be fairly conservative. So, as you go and do your math there, there's going to be some upside on what we're giving here.

是的。延安，關於第一部分，我們的指導，我們認為這個指導是相當保守的。因此，當您去那裡進行計算時，您會發現我們在這裡給出的東西會有一些好處。

If we get to 500 infusions, it might be above 300 on the upper end. And that's something that we really want to -- with this new guidance, we really want to show that we can actually exceed guidance here and do well here with this launch. So, it's not going to work out exactly to where you might think maybe it's 450 patients if you want to be more conservative.

如果我們進行 500 次輸液，那麼最高數量可能會超過 300 次。這正是我們真正想要的——透過這個新指南，我們真的想證明我們實際上可以超越指南，並在這次發布中取得良好的成績。因此，如果你想更保守一點，那麼結果可能不完全是你想像中的 450 名患者。

However, it's still growth. It's still growth over the first three quarters of the launch. If you want to look at it on a fiscal year basis or four quarters, you want to look at it on a launch year basis. But again, the first four quarters of our launch, we treated about 280-some patients.

但它仍在成長。在推出後的前三個季度中，它仍然保持成長。如果您想按財政年度或四個季度來查看它，那麼您需要按發布年份來查看它。但在我們推出服務後的前四個季度，我們治療了大約 280 名患者。

Now, for the COGS question, let me ask -- and that's the ratio of scrap and Jean-Marc and maybe Igor might need to help out with that one.

現在，對於 COGS 問題，讓我問一下——這是廢品率，Jean-Marc 和 Igor 可能需要幫忙解決這個問題。

Can I just say one thing -- so one of the things -- I mean, first, the quarter, the $250 million is a 50% growth over 2024 sales, revenue, I should say. So, that is definitely a growth in the lower end for it. And yes, the -- we would love to have upside to that.

我可以說一件事嗎——其中一件事——我的意思是，首先，本季的 2.5 億美元比 2024 年的銷售額、收入增長了 50%。所以，這對它來說絕對是一個低端的成長。是的，我們很樂意實現這一點。

The second part, when you talk about patient health, I just want to clarify that statement. Those are patients who went to hospice or died prior to the manufacturing process starting. They went there before we had tumor procurement. So, therefore, they would not be affecting COGS.

第二部分，當您談到患者健康時，我只是想澄清這一說法。這些患者在製造過程開始之前就已經進入安寧療護醫院或去世了。在我們採購腫瘤之前他們就去了那裡。因此，它們不會影響 COGS。

And Igor, do you want to take the COGS question? You and Jean-Marc?

伊戈爾，你想回答 COGS 問題嗎？你和 Jean-Marc 嗎？

I think Jean-Marc may need to take that.

我認為 Jean-Marc 可能需要接受這一點。

Yes. I'm happy to take the COGS question. So, yes, you're correct. We had an increase -- and the overall cost of sales together, as Igor mentioned during the script is that we see a spike in the out of spec on the first quarter that we know will improve over time, but you have to think also relative to the overall revenue.

是的。我很高興回答 COGS 問題。是的，你是對的。我們的總銷售成本有所增加，正如伊戈爾在腳本中提到的那樣，我們看到第一季超出規格的情況出現了激增，我們知道這種情況會隨著時間的推移而改善，但你也必須考慮相對於整體收入的情況。

So, yes, the cost of goods and the cost of sales has increased in Q1, particularly related to revenue, but we know this will definitely improve in Q2. And our standard gross margin remained positive in Q1, as you heard me saying.

所以，是的，第一季的商品成本和銷售成本增加，尤其是與收入相關的成本，但我們知道第二季的情況肯定會有所改善。正如您所聽到的，我們的標準毛利率在第一季保持為正值。

Got it. Thanks for the color.

知道了。謝謝你的顏色。

Colleen Kusy, Baird.

科琳·庫西，貝爾德。

Good afternoon. Thanks for taking our question. So, you reported patient dropout and out-of-spec rate together, but can we assume that, that out-of-spec rate went up? And if so, what drove that? Was it anything to do with the annual maintenance? And then would we expect that same one-month interruption going forward every year? Thank you.

午安.感謝您回答我們的問題。因此，您同時報告了患者退出率和不合格率，但我們可以假設不合格率上升了嗎？如果是的話，是什麼原因導致的呢？這和年度維護有關係嗎？那麼，我們是否會預期每年都會出現同樣的一個月的中斷？謝謝。

So, Colleen, thanks for the question. So, again, regarding the patient drop-offs and manufacturing success rate, these closely relate to each ATC's track record in patient selection and tumor tissue procurement.

科琳，謝謝你的提問。因此，再次強調，關於患者流失和製造成功率，這些與每個 ATC 在患者選擇和腫瘤組織採購方面的記錄密切相關。

And again, the increase we saw in Q1, we believe it to be transient. It's already normalized in Q2 to-date. So, that's what we believe is driving it. We have new ATCs, new surgeons and some of that needs to be optimized over time, which our teams are working on. What was the second part of the question?

再次強調，我們認為第一季看到的成長只是暫時的。到目前為止，第二季度已經恢復正常。所以，我們相信這就是推動它發展的因素。我們有新的 ATC、新的外科醫生，其中一些需要隨著時間的推移進行優化，我們的團隊正在努力。問題的第二部分是什麼？

Just the annual maintenance, whether that will be a similar one month, 50% reduction in capacity?

僅每年的維護，是否也會出現類似的一個月，容量減少 50% 的情況？

Annual maintenance, so we are now completing build-out of the shelf space at ICTC. Once that shelf space is operational, which will not be this year, but should be later on. Once that shelf space is operational, then we don't need to -- the maintenance will only affect part of the ICTC facility, not all. So, does that--

每年進行一次維護，因此我們現在正在完成 ICTC 貨架空間的擴建。一旦該貨架空間投入運營，這不會是今年，但應該會在稍後。一旦該貨架空間投入運營，我們就不需要了——維護只會影響 ICTC 設施的一部分，而不是全部。那麼，這是否——

It will have less impact.

其影響會較小。

It will have less impact.

其影響會較小。

But yes, Colleen, this is -- it is an annual event that you have to do it.

但是的，科琳，這是——這是你必須做的年度活動。

But for now, this year, we'll still need to do it. But in the subsequent years, again, once the ICTC is fully built out and fully up and running, we will not see that effect.

但就目前而言，今年我們仍然需要這樣做。但在隨後的幾年裡，一旦 ICTC 完全建成並全面投入運行，我們就不會再看到這種影響。

Helpful. Thank you.

很有幫助。謝謝。

Peter Lawson, Barclays.

巴克萊銀行的彼得·勞森。

Great. Thank you so much. Just going back to kind of manufacturing success, has that returned back to normal levels? And was that also related to the -- I thought you had a problem in 4Q as well associated with the same thing. Is the same thing kind of spread into 1Q or a separate issue?

偉大的。太感謝了。回到製造業的成功，它是否已經恢復到正常水準？這是否也與——我認為您在第四季度也遇到了與同一件事有關的問題。同樣的事情是否會蔓延到第一季度，還是單獨的問題？

I'm not really sure, Peter, what you're asking out there. The important point is we didn't talk about that in the last quarter at all. What we did mention back then is there was going to be a shutdown, and we were in the process of, at that point, actually hitting the shutdown. But no, we don't--

彼得，我不太清楚你在問什麼。重要的一點是我們在上個季度根本沒有談論這個問題。我們當時確實提到過，將會進行關閉，而且當時我們實際上正處於關閉的過程中。但不，我們不——

That doesn't -- there was no issue with manufacturing success rate in Q4. No, Q4 was actually a good quarter.

這並不是說第四季的製造成功率沒有問題。不，第四季度實際上是一個好季度。

The important thing to remember here, Peter, is rebounded already. Again, we think it has to do with individual activities in some of the ATCs and how they procure tumor as well as some things that we can learn from throughout the entire process and how we can improve those things. And it looks like it's already rebounded pretty well, and we're back in the zone where we think we were during the first part of the launch.

彼得，這裡要記住的重要一點是，已經反彈了。再次，我們認為這與一些 ATC 中的個別活動以及它們如何獲取腫瘤有關，也與我們可以在整個過程中學到的一些東西以及如何改善這些事情有關。看起來它已經反彈得相當好，我們又回到了發射初期的狀態。

Got you. Thank you. And is there any way of breaking out sort of the revenue weakness you had and lower guidance, kind of how much of that's due to demand uncertainty or and/or manufacturing uncertainty?

明白了。謝謝。有什麼方法可以解釋您所遇到的收入疲軟和預期下調的問題，其中有多少是由於需求不確定性或製造業不確定性造成的？

No, I don't really think there's a way of doing that. No, that would be very complicated to analyze that. I can't Dan or Friedrich.

不，我真的不認為有辦法做到這一點。不，分析起來會非常複雜。我不能是丹或弗里德里希。

I mean we see demand being consistent and growing, especially with the new centers coming on with it and now the ones ramping up. So, demand is not an issue for that part of it with it. And I think Igor address the manufacturing.

我的意思是，我們看到需求持續成長，特別是隨著新中心的出現和現在中心的不斷擴大。因此，對於這部分而言，需求不是問題。我認為伊戈爾談到了製造業。

Sure. And the manufacturing success rate, the trend over time from the beginning of launch, the success rates are improving, and we expect that to continue this year.

當然。製造成功率，從發射開始就一直呈上升趨勢，成功率不斷提高，我們預計今年這種趨勢將持續下去。

Again, the guidance, Peter, is really driven by ATC launch dynamics more than anything. It's not really about uncertainty in those areas.

再次強調，彼得，該指導實際上主要受到 ATC 發射動力的驅動。這實際上與這些領域的不確定性無關。

Got you. Okay. Thanks so much.

明白了。好的。非常感謝。

Reni Benjamin, Citizens.

雷尼·班傑明（Reni Benjamin），公民。

Hey guys. Thanks for taking the questions. Igor, you had mentioned that these different ATCs are doing things slightly different. I'm kind of curious, what are the strategies, the different strategies that you guys are employing right now to kind of get all these ATCs rolling in the same direction to improve all these -- improve the various manufacturing things to help improve kind of the overall processes there?

嘿，大家好。感謝您回答這些問題。伊戈爾，你曾提到這些不同的 ATC 所做的事情略有不同。我有點好奇，你們現在採用的策略是什麼，不同的策略是什麼，以使所有這些 ATC 朝著同一個方向發展，以改進所有這些——改進各種製造工藝，以幫助改善那裡的整體流程？

And then just as a second question, it's a revised guidance. I guess we were all kind of surprised to begin with when last year, you provided guidance for this year. I'm kind of curious as to -- I get being conservative now, why provide guidance for 2025 way back in 2024 to begin with?

然後作為第二個問題，這是一個修訂後的指南。我想，當去年您為今年提供指導時，我們一開始都會感到有些驚訝。我有點好奇——我現在很保守，為什麼要早在 2024 年就提供 2025 年的指導？

So the first part, perhaps Dan can answer.

因此，第一部分，也許丹可以回答。

Sure. I can also throw over to Brian for that. One of the things we're seeing for the tumor tissue procurement that's happening at the centers and replicating the successes that we're seeing with the surgeons that are doing it better than others. We actually have our field teams out there now to really focus and actually on the medical affairs side. So, I'll hand to Brian.

當然。我也可以把它交給 Brian。我們看到，各中心正在進行的腫瘤組織採集工作正在複製我們所看到的外科醫生的成功經驗，而這些外科醫生做得比其他人更好。事實上，我們現在有實地團隊真正專注於醫療事務方面。因此，我將交給 Brian。

But Brian, can you talk about how your field teams are addressing that at the centers to replicate success?

但是布萊恩，您能談談您的現場團隊如何在中心解決這個問題以複製成功嗎？

Yes, I think one of the things that's happening is we recognize that these centers continue to grow internally and keep adding new members. And what we've been doing really, we call it a white glove service where we're getting in there and actually certainly for the newer surgeons to actually go from -- we call it the start program, start to finish program where we actually go in and we'll walk through the surgery and beyond with them to try to make sure that every case is as successful as possible.

是的，我認為正在發生的事情之一是我們認識到這些中心在內部不斷發展並不斷增加新成員。我們實際上一直在做的是，我們稱之為白手套服務，實際上對於較新的外科醫生來說，我們實際上從 - 我們稱之為啟動程序，從開始到結束的程序，我們會真正進入並與他們一起完成手術及後續工作，以確保每個病例都盡可能成功。

We've had very good feedback. They're enjoying it, especially the new centers and the new surgeons, and we're hoping to try to really speed up those learning curves for our newest ATCs so that they can learn from the successes of our best ATCs that have been around a long time.

我們收到了非常好的回饋。他們很享受這一切，尤其是新的中心和新的外科醫生，我們希望嘗試真正加快我們最新的 ATC 的學習曲線，以便他們可以從我們長期存在的最佳 ATC 的成功中學習。

I guess I can get the second part of your question, Reni. Back in August, we were trying to give investors our best line of sight to what we thought was going to happen. At that point, we were very well aware of the high demand for the product, and we were ramping up our manufacturing as fast as we could. So, we built our model on the back of how many manufacturing slots we would make available maximum ramp.

我想我可以理解你問題的第二部分，雷尼。早在八月份，我們就試圖讓投資人了解我們認為將要發生的事情。那時，我們非常清楚該產品的需求量很大，我們正在盡快提高產量。因此，我們根據可提供最大坡道的製造槽數量建立了我們的模型。

Now, as we've gone, we've learned a lot about the launch, especially recently as we watch some of the dynamics with the ATCs, we looked at our experience with growth trajectories there. We look at the time lines it takes for new ATCs to come on board and begin treating their first patients and how they work through their processes. We're onboarding these large community practices, which takes some time, and we're doing the community referral process, which takes a lot of time, too.

現在，隨著我們的進展，我們已經了解了很多有關發布的信息，特別是最近，當我們觀察 ATC 的一些動態時，我們研究了那裡的增長軌蹟的經驗。我們研究了新 ATC 加入並開始治療第一批患者所需的時間表以及他們如何完成流程。我們正在參與這些大型社區實踐，這需要一些時間，而且我們正在進行社區推薦流程，這也需要很多時間。

And as we looked at that, we just decided that it was better and more accurate for us to forecast guidance that we gave today to show you that we can still make this product grow very, very substantially.

當我們審視這一點時，我們認為，我們今天給出的預測指導會更好、更準確，這向大家表明，我們仍然可以使該產品實現非常非常大的成長。

But now what we're going to do is we're just going to limit some of our manufacturing slots. It ends up being essentially almost a neutral with respect to how we use our cash, and we'll roll forward and we'll continue to succeed on the launch. But we think we'll do it on terms that are, I think, a little bit more in line with what we actually see at the ATCs.

但現在我們要做的只是限制一些生產時段。最終，就我們如何使用現金而言，它基本上是中性的，我們將繼續前進，並將繼續在發布中取得成功。但我們認為，我們會按照與我們在 ATC 實際看到的更一致的方式去做。

Asthika Goonewardene, Truist.

Asthika Goonewardene，Truist。

Hi, this is Corrina for Asthika. Thanks for taking the questions. What percentage of the product is currently being manufactured at the ICTC versus contract manufacturer? And then also, again, on lower manufacturing success rate, some of the clinicians they noted that there's a need for a larger amount of tissue to improve success rate. Can you comment on that? Thanks.

大家好，我是 Asthika 的 Corrina。感謝您回答這些問題。目前，該產品在 ICTC 生產的佔比與合約製造商生產的比例是多少？而且，再次，關於較低的製造成功率，一些臨床醫生指出，需要更多的組織來提高成功率。您能對此發表評論嗎？謝謝。

So I'll take the first part. ICTC, our internal manufacturing facility is responsible for most of the manufacturing volume and has significantly higher capacity than our contract manufacturer. And then the second part, perhaps I'll turn it over to Brian.

所以我選擇第一部分。ICTC 是我們的內部製造工廠，負責大部分製造量，其產能明顯高於我們的合約製造商。然後第二部分，也許我會把它交給布萊恩。

Yes. I mean we've made a lot of guidance changes in terms of best surgical practices. It goes from volume of tumor to handling of tumor in general and preparing it before it's being sent.

是的。我的意思是我們在最佳手術實踐方面做出了很多指導改變。它涉及從腫瘤體積到腫瘤的一般處理以及發送前的準備。

To be honest with you, do we need all the tumor that we get sent? Not always, but we generally guide towards what I would call the average ATC, the average surgeon because the best surgeons probably don't need any guidance and probably the below average need a lot of guidance. And so in general, we do try to ask them for as much tumor that reasonably fits into our -- into the vial that we give them.

說實話，我們需要送來所有腫瘤嗎？並非總是如此，但我們通常會指導我所說的平均水平的 ATC，即平均水平的外科醫生，因為最好的外科醫生可能不需要任何指導，而低於平均水平的外科醫生可能需要大量指導。因此，一般來說，我們確實會嘗試向他們索取盡可能多的腫瘤，以合理地放入我們給他們的小瓶子中。

All right. Thank you.

好的。謝謝。

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

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

Thank you again for joining the Iovance Biotherapeutics first 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 data presentation and investor event at the upcoming ASCO Annual Meeting in Chicago.

再次感謝您參加 Iovance Biotherapeutics 2025 年第一季財務業績和公司更新電話會議。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，包括即將於芝加哥舉行的 ASCO 年會上的數據展示和投資者活動。

We are motivated by the stories we continue to hear about the patients who benefit from Iovance TIL cell therapies in our clinical trials 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.

我們不斷聽到有關在商業環境下的臨床試驗中受益於 Iovance TIL 細胞療法的患者的故事，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。