Adaptimmune Therapeutics PLC (ADAP) 2025 Q1 法說會逐字稿

Hello and welcome to Adaptimmune's first-quarter 2025 business update conference call. (Operator Instructions) the conference is being recorded. (Operator Instructions).

您好，歡迎參加 Adaptimmune 2025 年第一季業務更新電話會議。 （操作員指示）會議正在錄音。（操作員指令）。

I will now turn the call over to Julie Miller of Investor Relations for Adaptimmune. Julie, please go ahead.

現在我將電話轉給 Adaptimmune 投資人關係部門的 Julie Miller。朱莉，請繼續。

Thank you. Good morning, and welcome to Adaptimmune's conference call to discuss our first-quarter 2025 business update. I would ask you to review the full text of our forward-looking statements from this morning's press release. We anticipate making projections during this call, and actual results could differ materially due to several factors, including those outlined in our latest filings with the SEC.

謝謝。早安，歡迎參加 Adaptimmune 電話會議，討論我們 2025 年第一季的業務更新。我希望您能閱讀今天早上新聞稿中的前瞻性聲明全文。我們預計將在本次電話會議中做出預測，但實際結果可能會因多種因素而存在重大差異，包括我們向美國證券交易委員會提交的最新文件中概述的因素。

Adrian Rawcliffe, our Chief Executive Officer, is here with me for the prepared portion of the call, and other members of our leadership team will be available for Q&A. With that, I'll turn the call over to Adrian Rawcliffe. Ad?

我們的執行長 Adrian Rawcliffe 將與我一起參加電話會議的準備部分，我們領導團隊的其他成員也將參加問答環節。說完這些，我會把電話轉給 Adrian Rawcliffe。廣告？

Thanks, Julie, and thank you everybody for joining us today.

謝謝，朱莉，也謝謝大家今天的參加。

We now have one full quarter of Tecelra sales under our belt, and I'm delighted to be able to share with you the momentum that we're seeing with this launch. With 21 patients apheresed so far in 2025, 13 in Q1, and another 8 in the first part of Q2, we now feel confident sharing revenue guidance for the full year of between $35 million and $45 million dollars in Tecelra sales.

現在，我們已經完成了 Tecelra 整整一個季​​度的銷售，我很高興能夠與大家分享我們在此次發布中看到的勢頭。截至目前，2025 年已有 21 名患者接受了血液檢查，其中第一季為 13 名，第二季上半部為 8 名，我們現在有信心全年預測 Tecelra 銷售額將在 3,500 萬至 4,500 萬美元之間。

We believe this is attainable based on the number of patients we've seen through the treatment cycle, as well as the number of authorized treatment centers that we have up and running. As of today, we have a total of 28 centers accepting referrals for patients for Tecelra, and it's very clear that we will have the full network of approximately 30 ATCs up and running by the end of 2025. This is approximately a year earlier than we expected when we launched.

我們相信，根據我們在治療週期內接待的患者數量以及我們已建立並運行的授權治療中心的數量，這是可以實現的。截至今天，我們共有 28 個中心接受 Tecelra 患者的轉診，而且很明顯，到 2025 年底，我們將建立並運行約 30 個 ATC 的完整網路。這比我們推出時預期的大約早了一年。

During these first few quarters of Tecelra launch, we will continue to share key performance indicators in addition to net sales, such as the number of apheresis that I've previously mentioned and the number of Tecelra treatments invoiced. We've invoiced for 14 Tecelra treatments in 2025 to date, with 6 in Q1, resulting in net sales for Q1 of $4 million. We have since invoiced 8 additional treatments in the first few weeks of Q2.

在 Tecelra 上市的最初幾季中，除了淨銷售額之外，我們還將繼續分享關鍵績效指標，例如我之前提到的血液分離數量和 Tecelra 治療的發票數量。迄今為止，我們已為 2025 年的 14 次 Tecelra 治療開立了發票，其中第一季開出了 6 次，第一季的淨銷售額為 400 萬美元。此後，我們在第二季的前幾週又開了 8 份額外治療的發票。

We've also continued to deliver 100% manufacturing success from our US Tecelra manufacturing center in Navy Yard, Philadelphia, with all Tecelra doses released to date meeting specification, with no capacity issues or constraints, and in the first quarter, our average turnaround time from apheresis to not release was 27 days beating our target of 30 days.

我們也繼續在位於費城海軍造船廠的美國 Tecelra 製造中心實現 100% 的生產成功率，迄今為止發布的所有 Tecelra 劑量均符合規格，不存在任何產能問題或限制，並且在第一季度，我們從血液分離到未發布的平均週轉時間為 27 天，超過了 30 天的目標。

On the payer front, we've seen effective patient access to Tecelra with no patient denials to date. So in every aspect, the Tecelra launch is progressing exceptionally well, forming the basis for our projected $400 million of peak sales from our combined Tecelra and Lete-cel sarcoma franchise. The team at Adaptimmune has remained focused, diligent, and absolutely committed to this successful launch.

在付款人方面，我們看到患者能夠有效地使用 Tecelra，迄今為止還沒有患者拒絕使用的情況。因此，從各方面來看，Tecelra 的推出都進展非常順利，為我們預期的 Tecelra 和 Lete-cel 肉瘤特許經營權的 4 億美元高峰銷售額奠定了基礎。Adaptimmune 團隊始終專注、勤奮，並全心致力於此次成功發布。

Also, I'll remind you that the investments in people and infrastructure that we've put in place for Tecelra will be the same for Lete-cel when approved, which we anticipate in 2026. We'll use the same ATC network and work alongside many of the same physicians.

另外，我要提醒大家，我們為 Tecelra 進行的人員和基礎設施投資將與 Lete-cel 獲得批准時的投資相同，我們預計批准時間為 2026 年。我們將使用相同的 ATC 網路並與許多相同的醫生一起工作。

Lete-cel launch readiness activities are underway, and we are fully on target for a rolling BLA initiation before the end of the year. As you know, Lete-cel has the potential to more than double the addressable patients in our sarcoma franchise, as we anticipate an indication of both synovial sarcoma and myxoid/round cell liposarcoma patients whose tumor expressed NY-ESO. It's worth noting that given the ubiquitous nature of NY-ESO expression in myxoid liposarcoma patients, we do not anticipate the need for NY-ESO antigen testing in this population, further simplifying the patient journey and expanding the patient population.

Lete-cel 啟動準備活動正在進行中，我們完全預計在年底前啟動滾動 BLA。如您所知，Lete-cel 有可能使我們的肉瘤特許經營中的可尋址患者數量增加一倍以上，因為我們預計該藥物將適用於腫瘤表達 NY-ESO 的滑膜肉瘤和粘液樣/圓細胞脂肪肉瘤患者。值得注意的是，鑑於 NY-ESO 在黏液樣脂肪肉瘤患者中的普遍表達，我們預計該族群不需要進行 NY-ESO 抗原檢測，進一步簡化了患者的治療過程並擴大了患者群體。

We continue to review strategic options with Cowen as our advisors and are committed to explore all options that benefit patients and shareholders. We look forward to sharing more information on next steps in this process in the upcoming months.

我們將繼續與 Cowen 一起審查策略選擇，並致力於探索所有有利於患者和股東的選擇。我們期待在未來幾個月內分享有關此流程下一步的更多資訊。

And with that, I'll open the call for questions. Operator?

現在，我開始回答問題。操作員？

(Operator Instructions) Marc Frahm, TD Cowen.

（操作員指示）Marc Frahm，TD Cowen。

Thanks for taking my questions. Maybe just one (inaudible) housekeep got some of the numbers you just put out and thanks for all of that clarity. It's just on the apheresis patients -- on the apheresed patients in the quarter so far, I know it's difficult for them to have been treated, but is it theoretically possible for some of them to have already been treated and invoiced. Those are all -- but those eight, none of those are the eight patients who have been invoiced in the quarter as well, right? Is that correct?

感謝您回答我的問題。也許只有一個（聽不清楚）管家得到了您剛剛列出的一些數字，感謝您提供的所有清晰的資訊。這只是針對血液分離患者 - 就本季度迄今為止的血液分離患者而言，我知道他們很難得到治療，但理論上是否有可能其中一些人已經得到治療並開具了發票。這些就是全部了——但是這八個，沒有一個是本季已經開立發票的八個病人，對嗎？對嗎？

I don't have that, but I would doubt it. I think most of those are the patients from the prior course, although there could be one or so. Why don't I ask Cintia to address that. Cintia?

我沒有這個，但我對此表示懷疑。我認為其中大多數是之前病程的患者，儘管也可能有一個左右。我為什麼不請 Cintia 來解決這個問題呢？辛西亞？

Yeah, so the apheresed patients that we've had year to date, which is the 21, that includes patients that have been invoiced already in mostly March and April. So about at least six of them probably have been invoiced already, but we would anticipate that the majority of them will be invoiced in the next month or so.

是的，今年迄今為止，我們已經有 21 名接受血液成分分析的患者，其中包括大部分在 3 月和 4 月已經開立發票的患者。因此，其中至少有六個可能已經開立了發票，但我們預計其中大多數將在下個月左右開立發票。

Okay, and then just thinking forward on that apheresis number, should we -- that's roughly half the quarter, so should we be thinking of kind of mid-teens total number of patients apheresed in Q2, or is there a -- there's a reason based on maybe ATC startups and stuff like that that to think about acceleration of the apheresis throughout the quarter.

好的，然後我們再展望一下血液分離數量，我們應該——這大約是本季度的一半，所以我們應該考慮第二季度血液分離的患者總數在十幾歲左右，或者是否有——可能有理由基於 ATC 的啟動和類似的東西來考慮整個季度血液分離的加速。

I appreciate the voracious appetite for further information, but we're very comfortable with the sales range of guidance that we've provided for 2025, and we're very comfortable telling you what we've done, and we're not giving detailed breakdown by quarter of apheresis invoice double positive or anything else. So we'll carry on reporting the metrics that we've got, and -- but we now feel very confident about the guidance that we have for the year of $35 million to $45 million for Tecelra.

我感謝您對更多資訊的強烈渴望，但我們對我們為 2025 年提供的銷售範圍指導非常滿意，我們很樂意告訴您我們所做的工作，並且我們不會按季度提供單採發票雙陽性或其他任何內容的詳細分類。因此，我們將繼續報告我們所獲得的指標，而且——但我們現在對 Tecelra 今年 3500 萬至 4500 萬美元的預期非常有信心。

Fair enough. Thanks.

很公平。謝謝。

Michael Schmidt, Guggenheim.

古根漢美術館的麥可·施密特。

Hey, this is Paul on for Michael. Thanks for taking our questions. So just on Tecelra, given that we're about nine months out from the approval, is there anything you can alternatively tell us now about how the pace of patient referrals and screening has been trending in the most recent weeks, especially since you're trying to hit your 30 ATC goal faster than expected. And generally, would you expect that to translate to sort of incremental quarter-over-quarter growth, or would you expect maybe some seasonality coming in in the back half?

嘿，我是保羅，代替麥可。感謝您回答我們的問題。那麼就 Tecelra 而言，考慮到我們距離批准還有大約九個月的時間，您能否告訴我們最近幾週患者轉診和篩檢的速度趨勢如何，特別是因為您正試圖比預期更快地實現 30 ATC 目標。總體而言，您是否預計這會轉化為季度環比的增量成長，或者您是否預計下半年會出現一些季節性因素？

Why don't we -- I ask Cintia to comment on that ramp up. Overall, I think we expect incremental growth quarter on quarter, but I'll let Cintia comment on the trends as we see them.

我們為什麼不——我請 Cintia 對這種增長發表評論。總體而言，我認為我們預計季度環比將出現增量成長，但我會讓 Cintia 對我們看到的趨勢發表評論。

Yes, thank you, Adrian. We do expect this growth quarter over quarter, and we're not currently anticipating specific seasonalization. But more so the growth based on the increased awareness, the number of ATCs that are being onboarded, and the natural timing from when we have the patients being apheresed, and then invoice you can see from the numbers that we had in terms of patients invoiced that we had the six in the first quarter and eight already just at the very first weeks of the second quarter, so we will continue to see that incremental growth over time.

是的，謝謝你，阿德里安。我們確實預計這一季度將出現成長，但目前我們還沒有預測具體的季節性變化。但更重要的是，增長基於意識的提高、正在入職的 ATC 數量以及我們從患者接受血液分離術到開具發票的自然時間，您可以從我們收到的開具發票的患者數量中看到，第一季度我們有 6 名患者，而僅在第二季度的頭幾週就已經有 8 名患者，因此，隨著時間的推移，我們將繼續看到這種增量增長。

Great. So then if I could have a quick follow up. So for the 24 patients who have been apheresed to date, anything you can tell us about the average time between when they were confirmed double positive and when they received apheresis, and is there any potential to sort of expedite this time as the commercial experience grows.

偉大的。那我是否可以快速跟進。因此，對於迄今為止已接受單採血液成分術的 24 名患者，您能否告訴我們從他們被確認為雙重陽性到接受單採血液成分術之間的平均時間，並且隨著商業經驗的增長，是否有可能加快這個時間。

Yes, I can address that. Sure. So it varies a lot and we have still very few number of patients if you think about it. The main driver of the difference between when the patient is identified double positive and the patient apheresed is actually the patient schedule. In many times, they need to get closer to the treatment center. About 40% of our patients today are referrals from other sites that are going to the ATCs, and so that can take some time based on the patient's schedule.

是的，我可以解決這個問題。當然。所以，如果你仔細想想，情況差異很大，而且我們的患者數量仍然很少。造成患者被確診為雙重陽性和接受血液分離術之間的差異的主要原因實際上是患者的安排。很多時候，他們需要更靠近治療中心。今天，我們約有 40% 的患者是從其他站點轉診到 ATC 的，因此根據患者的時間安排，這可能需要一些時間。

So it can take a couple of days to a couple of weeks depending on that situation. Everything that we can do on our side to expedite that, we certainly do. We don't have any constraints from a capacity perspective, so that is not anything that has been influencing when the patient can be apheresed at this point.

因此，根據具體情況，這可能需要幾天到幾週的時間。我們一定會盡一切努力來加快這一進程。從容量角度來看，我們沒有任何限制，因此這不會影響患者何時可以接受血液分離術。

Great. Appreciate the color.

偉大的。欣賞色彩。

Jonathan Chang, SVB Leerink.

喬納森·張（Jonathan Chang），SVB Leerink。

Hi guys, Jonathan Chang from Leerink Partners. Thanks for taking my questions.

大家好，我是 Leerink Partners 的 Jonathan Chang。感謝您回答我的問題。

First question, how are you thinking about potential impact from regulatory changes on your business? And second question, what would you say are the key learnings from the early launch to date? What is tracked better in line or worse than your initial expectations?

第一個問題，您如何看待監管變化對您的業務的潛在影響？第二個問題，您認為從早期發佈到現在，您獲得的主要經驗是什麼？哪些追蹤結果比您最初的預期更好或更差？

So I'm going to ask Dennis Williams to comment on the regulatory progress that we see with Lete-cel, and then I'm going to ask Cintia to talk about the progress that we've seen since launch and our key learnings from that. Over to you, Dennis.

因此，我將請丹尼斯威廉斯 (Dennis Williams) 評論我們在 Lete-cel 方面看到的監管進展，然後我將請辛西婭 (Cintia) 談談我們自推出以來看到的進展以及我們從中獲得的主要經驗。交給你了，丹尼斯。

Yeah, thanks, Ad. We, like many, right, are constantly watching the environment of the FDA and obviously there's a lot of change going. What I will say though is we've had three formal meetings with the FDA in the last six months. We haven't seen any indication that the FDA is not working as diligently as ever, and I can say for this program, for Lete-cel, they're very engaged, so far so good. And with that, I'll turn it over to Cintia.

是的，謝謝，Ad。我們和許多人一樣，一直在關注 FDA 的環境，顯然它正在發生很多變化。不過我要說的是，在過去的六個月裡，我們已經與 FDA 舉行了三次正式會議。我們沒有看到任何跡象表明 FDA 沒有像以往一樣勤勉工作，我可以說，對於這個項目，對於 Lete-cel，他們非常投入，到目前為止一切都很好。接下來，我將把發言權交給 Cintia。

Thank you, Dennis. And yes, we did learn a lot since we launched the product. I think that the main, I would say, upside, we talked about how fast we have been able to onboard the treatment centers, so that has happened even faster than what we were anticipating, and a lot of it is due to the significant excitement that we're seeing with the sarcoma specialists, how closely they've been working together with the cell therapy specialists in the treatment centers to make sure that we can onboard Tecelra in the sites and it speaks to the high unmet need and the innovation that we're bringing with Tecelra.

謝謝你，丹尼斯。是的，自從我們推出產品以來，我們確實學到了很多東西。我認為主要的好處是我們談到了我們能夠多快地將 Tecelra 引入治療中心，所以這比我們預期的還要快，這在很大程度上是由於我們看到肉瘤專家表現出極大的興奮，他們與治療中心的細胞治療專家密切合作，以確保我們能夠在治療中心引入 Tecelra，這體現了未滿足的巨大需求以及我們透過 Tecelra 帶來的創新。

So that has been positively surprising, and we will be able to complete our full treatment center footprint by the end of the year. The base from a -- patients getting on board is pretty much as we expected. We treated our first patients at the end of last year, and now we're seeing the growth aligned to our original expectations. [No denier] has been positive. The flow from the biomarker testing is also working well, which is something that was new that we had to launch, and it has been working seamlessly.

這真是令人驚訝，我們將能夠在今年年底前完成我們整個治療中心的建設。從患者人數來看，情況與我們預期的差不多。我們在去年年底治療了第一批患者，現在我們看到的成長與我們最初的預期一致。 [無否認] 一直保持正面態度。生物標記測試的流程也運作良好，這是我們推出的新產品，並且一直運作順暢。

And I think the other upside has been the manufacturing success rates. We have had 100% success rates that is, as far as I know, unheard of in cellular therapies, and we've been able to achieve a turnaround time for the patients that we have been treating. So, so far so good. We're very excited. I think the team has been working really hard to make sure that that can [now] take place across all the different functions at Adaptimmune and with the medical community as well. So, so far so good.

我認為另一個好處是製造成功率。我們的成功率達到了 100%，據我所知，這在細胞療法中是聞所未聞的，而且我們能夠為所治療的患者實現短時間的治癒。所以，到目前為止一切都很好。我們非常興奮。我認為團隊一直在努力工作，以確保這一點現在能夠在 Adaptimmune 的所有不同職能部門以及醫學界實現。所以，到目前為止一切都很好。

Got it. Thanks for taking my questions.

知道了。感謝您回答我的問題。

Arthur He, HC Wainwright.

亞瑟·何，HC·溫賴特。

Congrats on the progress. So I just have the two quick ones. So first, for the -- you mentioned in the last quarter call that the patient emphasized is mostly from the early activated sensors. So could you give us more color on current status of that metrics?

恭喜你取得進展。所以我只有兩個簡短的。首先，您在上個季度的電話中提到，患者強調的問題主要來自早期啟動的感測器。那麼您能否向我們詳細介紹一下該指標的當前狀態呢？

Yeah, I think you're referring to the -- just for clarification, you're referring to the fact that most of the patients that we had at that point in time, apheresed, were from the patients from the centers that were started at the beginning of that. Maybe I'll ask Cintia to comment on the -- on what we want to say about the current spread.

是的，我認為您指的是——只是為了澄清一下，您指的是這樣一個事實，即我們當時接收的大多數患者，都是來自當時成立的中心的患者。也許我會請 Cintia 對當前的傳播發表評論。

Yes, thank you, Adrian. So yeah, we had the most number of patients invoiced so far from the ones that were activated earlier, but we have about -- patients that have been identified right now in more than 40 patients in more than 40 centers. And about 80% of the treatment centers have -- are in the process of at least testing at least one patient, so we are seeing a very good spread across all the treatment centers in terms of patient identification to be tested than having patients being apheresed and eventually turning into invoices, but the spread has been fairly consistent across all the treatment centers.

是的，謝謝你，阿德里安。是的，到目前為止，我們收到的患者數量是先前啟動的患者數量中最多的，但是我們現在已經確定了來自 40 多個中心的 40 多名患者。大約 80% 的治療中心已經對一名患者至少進行了檢測，因此，我們看到所有治療中心在患者身份識別和檢測方面的進展都非常好，而不是讓患者進行血液採集並最終生成發票，但所有治療中心的進展都相當一致。

Thanks, Cintia. And also for -- I just want to follow up on the -- between the double positive patient to the patient who get the [apheresis]. Is that still remain like almost nearly 100% for this case?

謝謝，辛西亞。另外，我只是想跟進一下雙重陽性患者和接受[單採血液成分術]對於這個案例來說，這個比例是否仍然接近 100%？

So we don't have a line of sight to all the patients that have been identified as level positives. We do offer sponsored testing, so we have an approximate volume of patients that are going through that route that we really can't know about all the patients that are being tracked across all the different sites. What we do know is that from the moment that the patient gets enrolled in our portal and we receive a purchase order, from that moment on, we have not had any cancellations so far and we have not had any manufacturing failures as well.

因此，我們無法了解所有確診為陽性的患者。我們確實提供贊助測試，因此我們可以大致了解透過該途徑接受檢測的患者數量，但我們無法真正了解在所有不同站點進行追蹤的所有患者的數量。我們所知道的是，從患者在我們的入口網站註冊並收到採購訂單的那一刻起，到目前為止，我們還沒有任何取消訂單的情況，也沒有任何製造故障。

Awesome. Thanks for taking my question.

驚人的。感謝您回答我的問題。

Graig Suvannavejh, Mizuho.

瑞穗的 Graig Suvannavejh。

Thank you for taking my questions and congratulations on a really nice launch so far. Two questions if I could, and one is really with regards to perhaps some recent news on the financing front, you chose to pay down $25 million of the financing obligation that you had. It was a bit earlier than we anticipated, so I was wondering if you could walk us through the process there.

感謝您回答我的問題，並祝賀您迄今為止的順利發布。如果可以的話，我有兩個問題，一個是關於融資方面的一些最新消息，您選擇償還 2500 萬美元的融資債務。這比我們預期的要早一點，所以我想知道您是否可以向我們介紹整個過程。

And then just given -- my second question then is on where the company is on total liquidity relative to the spend we saw on the first quarter and the revenue. Just wondering how we should think about the sustainability of operations cash run going forward.

然後剛才給的——我的第二個問題是，相對於我們在第一季看到的支出和收入，公司的總流動性處於什麼水平。只是想知道我們應該如何看待未來營運現金流的可持續性。

Yeah, it's Gavin speaking. Hi Greg. With regards to the pay down or the debt principle, that was actually done in March and we announced that in our 10-K announcement, and that was the -- the reason for that was really to continue to manage our balance sheets and leverage and valuation there. It wasn't impactful on our cash runway at that time, and it managed a key stakeholders. We announced that probably eight or nine weeks ago now and continued to -- continue to have a good relationship with our debt provider.

是的，我是加文。你好，格雷格。關於償還債務或債務本金，這實際上是在三月完成的，我們在 10-K 公告中宣布了這一點，這樣做的原因實際上是為了繼續管理我們的資產負債表、槓桿和估值。它當時對我們的現金流沒有影響，而且它管理著關鍵的利害關係人。我們大概在八、九週前就宣布了這一消息，並繼續與我們的債務提供者保持良好的關係。

In terms of the cash position, we had a going concern -- a substantial debt ongoing concern in the 10-K and that does remain, so clearly less than 12 months cash. We're not going to get detailed cash guidance and cash runway guidance really because it's impacted by a number of factors.

就現金狀況而言，我們有一個持續經營的經營狀況——在 10-K 中有一個持續經營的大量債務，而且這種情況仍然存在，因此顯然少於 12 個月的現金。我們實際上不會獲得詳細的現金指導和現金跑道指導，因為它受到許多因素的影響。

One, of course, is the successful launch of Tecelra, we've just been talking to and how that ramps. Second is the cost reduction actions that we took. We announced a restructuring in November that was executed in February. We announced in March further cost reductions associated with our PRAME ADP-520 programs. And that has impacted on the Q1 spend, so that there are costs associated with that restructuring which makes the Q1 spend higher than a normalized run rate would look like.

其一當然是 Tecelra 的成功推出，我們剛剛討論了它的發展。第二是我們採取的降低成本的措施。我們於 11 月宣布了重組計劃，並於 2 月實施。我們在三月宣布了與 PRAME ADP-520 項目相關的進一步成本削減。這對第一季的支出產生了影響，因此與重組相關的成本使得第一季的支出高於正常的運作率。

And finally, we're working through with the TD Cowan strategic options, so all of those sort of [planes] making giving cash runway guidance inappropriate at the moment.

最後，我們正在研究 TD Cowan 戰略選擇，因此所有這些類型的 [飛機] 目前都不適合提供現金跑道指導。

Thanks. Can I follow up with an additional question?

謝謝。我可以再問一個問題嗎？

Sure.

當然。

Great, thanks so much. Just with respect to the guidance -- the revenue guidance for the year, very impressive that you were able to provide guidance. I don't see many companies in the first year of a launch feeling comfortable enough to be in a position to do so. So my question is, could you just maybe provide some color as to some of the underlying assumptions that give you the comfort to indeed be able to provide that guidance for the year which is ahead of our estimates. So, congrats there.

太好了，非常感謝。僅就指導而言——年度收入指導，您能夠提供指導，這令人印象深刻。我發現，很多公司在產品發表的第一年都沒有足夠信心實現這個目標。所以我的問題是，您能否提供一些基本假設，讓您能夠放心地為今年的業績提供超出我們預期的指導。那麼，恭喜你。

Yeah, so I think one of the -- there's a couple of things, so one of the advantages that I think you have in the cell therapy space is that as we referred to, we can see the funnel of patients coming through, from a reasonable perspective. And so, if you think about that guidance, that looks like it's $35 million to $45 million. Now that's roughly, approximately, between 50 and 70 patients treated for the year.

是的，所以我認為其中之一——有幾件事，所以我認為你們在細胞治療領域的優勢之一是，正如我們所提到的，我們可以從合理的角度看到患者的漏斗。因此，如果你考慮這個指導，它看起來應該是 3500 萬到 4500 萬美元。每年治療的患者約有 50 至 70 名。

And so, you think about that in the context of having apheresed 21 patients seeing an increasing ramp going into coming through Q1 and into Q2. We've also now got experience as to what the net sales price looks like, at least for a relatively small number of patients, and you put all those and the confidence in the manufacturing, meaning that we -- so far, we've been able to deliver 100% of the patients that we've apheresed, which is, I think, extraordinary, as Cintia pointed out, for a cell therapy launch and a real testament to the to the manufacturing team here.

因此，您可以想像一下，在為 21 名患者進行血液採集的背景下，血液樣本在進入 Q1 和 Q2 時呈現不斷增加的趨勢。我們現在也對淨銷售價格的情況有了經驗，至少對於相對較少的患者來說是這樣，而我們將所有這些和信心都放在了製造上，這意味著我們 - 到目前為止，我們已經能夠為 100％ 的患者提供血液，正如 Cintia 指出的那樣，我認為，對於細胞療法的推出來說，這是非同尋常的，也是對這裡的製造團隊的真實證明。

You put all of that together and I think you can see that as we go through the remainder of Q2, which we have good visibility to into Q3 and Q4 with the increasing ATCs that we've got, we feel quite comfortable about that $35 million to $45 million range.

把所有這些放在一起，我想你就會發現，隨著我們度過第二季度的剩餘時間，隨著 ATC 的增加，我們對第三季度和第四季度有很好的了解，我們對 3500 萬美元到 4500 萬美元的範圍感到很滿意。

Okay. Thank you very much and congratulations again.

好的。非常感謝，再次恭喜。

(Operator Instructions) Peter Lawson, Barclays.

（操作員指示）巴克萊銀行的彼得·勞森。

It's Alex on for Peter. Thanks for taking our questions. Just a clarification on the -- question on drop off rate, I guess specifically what percentage of patients end up getting an infusion relative to patients that get apheresed, is that 100% or --?

亞歷克斯 (Alex) 代替彼得 (Peter)。感謝您回答我們的問題。只是想澄清一下——關於退出率的問題，我猜具體來說，相對於接受血液分離的患者，最終接受輸液的患者比例是多少，是 100% 還是--？

It has been so far.

至今為止都是如此。

Okay, great. And then my other question was just around any manufacturing maintenance work that would be required at some point this year and if yes, when that could happen.

好的，太好了。然後我的另一個問題是，今年某個時候是否需要進行製造維護工作，如果需要，什麼時候可以進行。

Yeah, that's a pertinent question given the environment and other companies. John, do you want to talk about our maintenance plans for the year?

是的，考慮到環境和其他公司，這是一個中肯的問題。約翰，你想談談我們今年的維護計畫嗎？

Yeah, absolutely. So this is John, I lead the manufacturing group. And we don't have plans and we managed to put a significant shutdown like you've maybe seen other places. We do a lot of our maintenance on kind of a rolling way of doing that, and we managed to not impact the capacity when we do that. So for this year, we don't have one of those plans.

是的，絕對是如此。我是約翰，負責領導製造小組。我們沒有計劃，但我們設法實施了大規模關閉，就像您可能在其他地方看到的那樣。我們採用滾動的方式進行大量維護，並設法在這樣做時不影響容量。所以今年我們沒有這樣的計畫。

Okay, great, thank you. And then just one final one if I may, any price increases plan in 2025?

好的，太好了，謝謝。最後再問一個問題，2025 年有漲價計畫嗎？

We've not made any announcements about price increases.

我們尚未發布任何有關漲價的公告。

Okay, great. Thanks for taking our questions.

好的，太好了。感謝您回答我們的問題。

Yanan Zhu, Wells Fargo Securities.

朱亞南，富國證券。

Thanks for taking our questions. Could you comment on COGS and how it is tracking to your expectation?

感謝您回答我們的問題。您能否評論一下 COGS 以及它如何追蹤您的預期？

It's early days actually, and we're first quarter in and I think I said beforehand, COGS for the first few quarters are going to be a little bit higher than we think they're going to normalize to because under GAAP, we're consuming pre-purchase products.

現在實際上還為時過早，我們才剛剛進入第一季度，我想我之前就說過，前幾季的銷貨成本會比我們認為的正常水平高一點，因為根據 GAAP，我們正在消費預購產品。

You mean COGS is going to be higher or the. margins?

您的意思是 COGS 將會更高還是。邊距？

The margin is going to be higher, to clarify. Lower COGS, higher margins. The margin in Q1 was around about 78%. We think long on average is around about 70%.

需要澄清的是，利潤率將會更高。更低的銷貨成本，更高的利潤率。第一季的利潤率約為78%。我們認為平均多頭部位約為 70%。

Got it. Thanks. And could you -- now that you're in the market, could you talk about the annual incidence rate for the eligible patient population? Any change compared with when you were planning the launch.

知道了。謝謝。既然您已經進入市場，您能談談符合條件的患者群體的年發病率嗎？與您計劃發佈時相比有任何變化嗎？

I'll ask Cintia to comment on her insights. Cintia?

我會請 Cintia 對她的見解作出評論。辛西亞？

Yes, thank you, Adrian. So we -- from the pace that we're seeing the patients being onboarded, it is pretty in line to our expectations and to the literature and the information that we have used for our forecasting of about 1,000 patients a year that are being diagnosed with synovial sarcoma, and then pretty much all of them are going to be going through a round of chemotherapy, potentially surgery, and we can treat all the patients that have been previously exposed to chemotherapy. So it has been quite in line with to what we have planned.

是的，謝謝你，阿德里安。因此，從我們看到的患者入院速度來看，這非常符合我們的預期，也符合我們用來預測每年約有 1,000 名被診斷患有滑膜肉瘤的患者所使用的文獻和信息，然後幾乎所有患者都將接受一輪化療，可能還要接受手術，我們可以治療所有之前接受過化療的患者。所以這與我們的計劃完全一致。

Maybe lastly, just about the patient you're treating this quarter and in the near term, do you feel if this -- is there any element of warehoused patients or are these reflecting the incidence rate up to this point?

最後，關於您本季和短期內治療的患者，您是否覺得這其中是否存在倉儲患者的因素，或者這些是否反映了迄今為止的發病率？

Yeah, so that is for the months after launch, a good number of patients that I would call more the prevalent patient population that we're going to be treating for a while. We can see that the pace of the patients being treated depends a little bit on when they're tested. We know that synovial sarcoma is relatively speaking in comparison to other hematological malignancies like lymphoma or even [ALL]. It is a slower progressing condition and so there is a number of patients that we are seeing now that are part of the prevalent pool and eventually then I think we're going to reach, we start to treat more of the incident population.

是的，這就是在推出後的幾個月內，我們將在一段時間內治療相當多的患者，我更願意稱他們為普遍的患者群體。我們可以看到，患者接受治療的速度在一定程度上取決於他們接受檢測的時間。我們知道滑膜肉瘤相對於其他血液系統惡性腫瘤，如淋巴瘤，甚至[全部]。這是一種進展較慢的疾病，因此我們現在看到的許多患者都屬於患病人群，最終我認為我們將開始治療更多的發病人群。

I would say that probably by sometime next year that we would see a more, I would say, a steady number of new patients getting in every month, but I -- we didn't see really that (inaudible) of patients that were seen in other therapies, but it is natural that we would expect to treat more of the prevalent patients in the first month after the launch and then it gets to the incident population, but not a dramatic bubble.

我想說，可能到明年某個時候，我們會看到每個月有更多，我想說，穩定數量的新患者入院，但我 - 我們並沒有真正看到其他療法中出現的患者數量（聽不清），但很自然地，我們期望在推出後的第一個月治療更多的流行患者，然後再治療發病人群，但不會出現劇烈的泡沫。

Great, thanks. That's super helpful. Thank you.

太好了，謝謝。這非常有幫助。謝謝。

This concludes our question-and-answer session. I will turn the conference back over to Adrian Rawcliffe for any closing remarks.

我們的問答環節到此結束。我將把會議交還給 Adrian Rawcliffe 並邀請他作結語。

Thank you, everybody, for joining us. Thank you for your questions, and great to be able to update you on the fantastic momentum that we're seeing with the launch of Tecelra and the progress with the rest of the sarcoma franchise. I look forward to updating you further in due course. Take care. Bye.

謝謝大家加入我們。感謝您的提問，很高興能夠向您通報 Tecelra 的推出所呈現的良好勢頭以及其他肉瘤藥物系列的進展。我期待在適當的時候向您提供進一步的更新資訊。小心。再見。

This brings to a close today's conference call. You may disconnect your line. Thank you for participating and have a pleasant day.

今天的電話會議到此結束。您可以斷開線路。感謝您的參與並祝您有個愉快的一天。