Outlook Therapeutics Inc (OTLK) 2024 Q3 法說會逐字稿

Greetings, and Welcome to the Outlook Therapeutics corporate third-quarter fiscal year 2024 update conference call and webcast. (Operator Instructions)

您好，歡迎參加 Outlook Therapeutics 公司 2024 財年第三季更新電話會議和網路廣播。（操作員說明）

It is now my pleasure to introduce your host, Jenene Thomas, Investor Relations. Thank you. Please go ahead.

現在我很高興向您介紹主持人，投資者關係部門的 Jenene Thomas。謝謝。請繼續。

Thank you, Donna.

謝謝你，唐娜。

At this time, I'd like to remind our listeners that remarks made during this webcast may state management's intentions, beliefs, expectations or future projections, including, but not limited to, our expectations about the timing of clinical trials and commercial launch and the sufficiency of our cash resources. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the safe harbor provisions of the federal securities laws and are based on Outlook Therapeutics current expectations, and actual results could differ materially.

此時，我想提醒我們的聽眾，在本次網路廣播中發表的言論可能表明管理層的意圖、信念、期望或未來預測，包括但不限於我們對臨床試驗和商業發佈時間的期望以及我們的現金資源充足。這些均為前瞻性陳述，涉及風險和不確定性。本次電話會議的前瞻性陳述是根據聯邦證券法的安全港條款做出的，並基於 Outlook Therapeutics 目前的預期，實際結果可能存在重大差異。

As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from these contemplated by such forward-looking statements are discussed in the periodic reports Outlook Therapeutics files with the Securities and Exchange Commission. These documents are available in the Investors section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully.

因此，您不應過度依賴任何前瞻性陳述。Outlook Therapeutics 向美國證券交易委員會提交的定期報告文件中討論了一些可能導致實際結果與此類前瞻性陳述預期結果有重大差異的因素。這些文件可在公司網站的投資者部分和美國證券交易委員會的網站上找到。我們鼓勵您仔細查看這些文件。

Additionally, certain information contained in this webcast relates to or is based on studies, publications, sources and other data obtained from third-party sources and the company's own estimates and research. While the company believes these third-party sources to be reliable as of the date of this presentation, it is not independently verified and makes no representation as to the adequacy, fairness, accuracy or completeness of or at any independent sources verified any information obtained from third-party sources.

此外，本網路廣播中包含的某些資訊涉及或基於從第三方來源獲得的研究、出版物、來源和其他數據以及公司自己的估計和研究。儘管該公司認為截至本簡報發布之日這些第三方來源是可靠的，但它未經獨立核實，也沒有對從任何獨立來源核實的任何資訊的充分性、公平性、準確性或完整性發表任何聲明。

During the call, management will discuss non-GAAP financial measures, which are not prepared in accordance with generally accepted accounting principles. Definitions of these non-GAAP financial measures, along with reconciliations to the most direct comparable GAAP financial measures are included in the Outlook Therapeutics third quarter's earnings release, which has been furnished to the SEC and is available on the company's website at ir.outlooktherapeutics.com.

在電話會議期間，管理階層將討論非公認會計原則財務指標，這些指標不符合公認會計原則。這些非 GAAP 財務指標的定義以及與最直接可比較 GAAP 財務指標的調整均包含在 Outlook Therapeutics 第三季度的收益報告中，該報告已提交給 SEC，並可在該公司網站 ir.outlooktherapeutics 上查閱。 .

Joining us on the call from Outlook Therapeutics leadership team are Russell Trenary, President and Chief Executive Officer; and Lawrence Kenyon, Chief Financial Officer of Outlook Therapeutics.

Outlook Therapeutics 領導團隊總裁兼執行長 Russell Trenary 參加了我們的電話會議；勞倫斯凱尼恩 (Lawrence Kenyon)，Outlook Therapeutics 財務長。

I'd now like to turn the call over to Russ Trenary. Please proceed.

我現在想把電話轉給 Russ Trenary。請繼續。

Thank you, Janine, and thank you to everyone joining us for our third-quarter fiscal year 2024 conference call and webcast.

謝謝 Janine，也謝謝大家參加我們的 2024 財年第三季電話會議和網路廣播。

As we begin today's call, I think it's important for me to start with our mission, and that is quite simply to achieve the first ever approval for an ophthalmic formulation of bevacizumab for the treatment of retina diseases, initially in the EU, UK, and US. We're working toward achieving that mission in real time. We already received marketing authorization in both the European Union and the United Kingdom and are advancing toward the launch of the first approved ophthalmic bevacizumab approved for the treatment of wet AMD in those key markets.

在我們開始今天的電話會議時，我認為對我來說重要的是從我們的使命開始，這很簡單，就是首先在歐盟、英國和美國首次批准用於治療視網膜疾病的貝伐單抗眼科製劑。我們正在努力即時實現這項使命。我們已經在歐盟和英國獲得了行銷授權，並正在努力在這些關鍵市場推出第一個批准用於治療濕性 AMD 的眼科貝伐單抗。

We're also making good progress here in the United States with our ongoing NORSE EIGHT clinical trial, which, if successful, will serve as the basis for resubmitting our BLA with the FDA, which we expect to occur in the first calendar quarter of 2025. More on that in a minute.

我們在美國正在進行的 NORSE 8 臨床試驗也取得了良好進展，如果成功，將作為向 FDA 重新提交 BLA 的基礎，我們預計將在 2025 年第一季進行。稍後會詳細介紹。

Focusing on the European Union and the United Kingdom. We're very pleased with the decisions from both regulatory bodies and believe this is a culmination of all the hard work our colleagues and partners have been striving to achieve these past several years. I think it also speaks to and validates the data we have generated, the clinical studies we have conducted, and the CMC work we have completed.

重點關注歐盟和英國。我們對兩個監管機構的決定感到非常滿意，並相信這是我們的同事和合作夥伴過去幾年努力的成果。我認為它也說明並驗證了我們產生的數據、我們進行的臨床研究以及我們完成的 CMC 工作。

We are going to do everything we can to bring this important drug to as many patients as possible in these two territories, which combined represent the second largest market for wet AMD in the world.

我們將盡一切努力將這種重要的藥物帶給這兩個地區盡可能多的患者，這兩個地區合計代表了全球第二大濕性 AMD 市場。

Now turning to commercialization. We're continuing with market access work and inventory planning for Germany and the UK and expected product availability in those markets in the first half of calendar 2025. Additionally, we are continuing discussions with organizations that have established EU infrastructure, and we'll continue to evaluate potential partners in the EU.

現在轉向商業化。我們正在繼續進行德國和英國的市場准入工作和庫存規劃，預計將於 2025 年上半年在這些市場上提供產品。此外，我們正在繼續與已建立歐盟基礎設施的組織進行討論，並將繼續評估歐盟的潛在合作夥伴。

Turning to the US. We continue to make progress on our NORSE EIGHT study, a three-month non-inferiority study with an eight-week efficacy endpoint. NORSE EIGHT is progressing as planned, and we currently have 359 -- that's 359 of the planned 400 subjects enrolled. We continue to expect to complete enrollment before the end of the third quarter.

轉向美國。我們的 NORSE EIGHT 研究持續取得進展，這是一項為期三個月的非劣效性研究，具有八週的療效終點。NORSE EIGHT 正在按計劃進行，目前我們有 359 名受試者——這是計劃註冊的 400 名受試者中的 359 名。我們仍然預計在第三季末之前完成註冊。

Top line results from NORSE EIGHT are expected in the fourth quarter of this year, and if positive, should provide sufficient clinical data to resubmit our BLA with the US FDA in the first calendar quarter 2025. In addition, we've completed our planned Type C and Type D meetings with the FDA and believe we have addressed the open CMC items that were received in the CRL.

NORSE EIGHT 的主要結果預計將在今年第四季度公佈，如果呈陽性，應提供足夠的臨床數據，以便在 2025 年第一季向美國 FDA 重新提交我們的 BLA。此外，我們已經完成了計劃與 FDA 舉行的 C 型和 D 型會議，並相信我們已經解決了 CRL 中收到的開放 CMC 項目。

And now it's my pleasure to turn the call over to Larry Kenyon, our Chief Financial Officer. Larry?

現在我很高興將電話轉給我們的財務長拉里·凱尼恩 (Larry Kenyon)。拉里？

Thank you, Russ. Good morning, everyone. During the most recent quarter, we saw a further reduction in the balance of our outstanding convertible notes. Additional conversions of the note into common stock have continued in July, and the outstanding balance is approximately $30.3 million as of today. On the remaining balance, another $5.5 million is convertible at $7 per share, with the remaining balance convertible at $40 per share.

謝謝你，拉斯。大家早安。在最近一個季度，我們發現未償還可轉換票據餘額會進一步減少。7 月份，該票據繼續轉換為普通股，截至目前，未償餘額約為 3,030 萬美元。剩餘餘額中，另外 550 萬美元可以每股 7 美元的價格兌換，其餘餘額可以每股 40 美元的價格兌換。

Our June 30, 2024 cash position of $32 million when combined with the expected $107 million of proceeds from the full exercise of warrants to purchase shares of common stock, subject to meeting the requirements for calling these warrants, should be sufficient to support our operations through calendar 2025.

截至2024 年6 月30 日，我們的現金部位為3,200 萬美元，加上充分行使認股權證購買普通股的預期收益1.07 億美元（在滿足認購這些認股權證的要求的前提下），應足以支援我們的營運2025 年日曆。

Moving on to our financial results for the third fiscal quarter of 2024. I can report that we saw a reduction in adjusted net loss from fiscal quarter two of 2024.

接下來是 2024 年第三財季的財務表現。我可以報告說，與 2024 年第二財季相比，我們的調整後淨虧損有所減少。

R&D expenses decreased during the current fiscal quarter versus Q2 of this year after we completed the majority of the NORSE EIGHT initiation activities in fiscal Q1. Previously, we had reported that we estimated a total cost of $30 million to complete NORSE EIGHT, with most of these expenses to be incurred during the first three calendar quarters of 2024. We have not changed our estimates for NORSE EIGHT and expect that overall R&D expenses will continue to run at these levels for the next quarter.

在我們在第一財季完成了大部分 NORSE EIGHT 啟動活動後，本季的研發費用比今年第二季有所下降。此前，我們曾報道稱，我們估計完成 NORSE EIGHT 的總成本為 3000 萬美元，其中大部分費用將在 2024 年前三個日曆季度發生。我們沒有改變對 NORSE 8 的預測，並預計下季整體研發費用將繼續保持在這些水準。

Fiscal Q3 G&A expenses increased compared to fiscal Q2, as we did incur prelaunch expenses for Europe in the most recent quarter.

第三財季的一般管理費用與第二財季相比有所增加，因為我們在最近一個季度確實在歐洲產生了預啟動費用。

I will now turn the call back over to the operator for the Q&A portion.

我現在將把電話轉回給接線員進行問答部分。

(Operator Instructions) Julian Harrison, BTIG.

（操作員說明）Julian Harrison，BTIG。

First, just on enrollment in NORSE EIGHT, are you able to provide any more granular details with regards to how far along you are? I understand completion is still on track for later in the third quarter -- calendar quarter of this year. But any more details there you could share at this point?

首先，關於 NORSE EIGHT 的註冊，您能否提供更多關於您目前進展的詳細資訊？據我所知，預計將在第三季晚些時候（今年的日曆季度）完成。但現在可以分享更多細節嗎？

Yes. I think it's worth noting, Julian, that in this five minutes, we've got dozens of people that are in screening. And of course, we track that screening rate to see how many of those convert to actual enrollments. And we believe that right now, we've got enough in screening to take us to 380 patients on top of -- and of course, today or yesterday, we were at 359. So we continue to see a good level of screening and expect that to continue so that we can comfortably finish enrollment before the end of the third quarter.

是的。朱利安，我認為值得注意的是，在這五分鐘內，我們有數十人正在接受篩檢。當然，我們會追蹤篩選率，看看其中有多少轉化為實際入學率。我們相信，現在我們已經有足夠的篩檢能力，可以篩選 380 名患者——當然，今天或昨天，我們已經篩選了 359 名患者。因此，我們繼續看到良好的篩選水平，並期望這種情況能夠持續下去，以便我們能夠在第三季末之前輕鬆完成註冊。

Excellent. Very helpful. And then when enrollment completion is confirmed in NORSE EIGHT, does it become easier to guide to specifically when you expect BLA resubmission? I understand your updated guidance for 1Q '25. But does it become easier to be more precise in that guidance once enrollment completions confirmed?

出色的。非常有幫助。然後，當 NORSE EIGHT 確認註冊完成時，是否會更容易具體指導您何時期望重新提交 BLA？我了解您對 25 年第一季的更新指引。但是，一旦確認完成註冊，指導就變得更容易更準確嗎？

Yes, yes, because I think there is the amount of time between the last patient treated and when their last visit is scheduled is known. And the amount of time to lock and clean the database is predictable. So yes, we will be in a better position to nail that down once we know when enrollment completion has occurred.

是的，是的，因為我認為最後一位接受治療的患者和安排最後一次就診的時間之間有一段時間是已知的。鎖定和清理資料庫的時間是可以預測的。所以，是的，一旦我們知道註冊何時完成，我們將能夠更好地確定這一點。

Will Hidell, Brookline Capital Markets.

威爾希德爾，布魯克林資本市場。

Quick question about the UK process with NICE. I know I think they're going to have a tech assessment delivered by maybe December. Is there any updates on that process?

關於英國 NICE 流程的快速問題。我知道我認為他們可能會在 12 月之前進行技術評估。該流程有任何更新嗎？

I think the -- really the only update we have is that we believe we put together a well-informed dossier to NICE, and we're going through the process with them. They've accepted our application. And so we're going through that process, and we'll know later in the year, just exactly what that looks like in terms of the type of pricing that we'll be utilizing in that market.

我認為，我們唯一的更新是，我們相信我們向 NICE 匯總了一份消息靈通的檔案，我們正在與他們一起完成這個過程。他們已經接受了我們的申請。因此，我們正在經歷這個過程，我們將在今年稍後知道我們將在該市場使用的定價類型。

Tim Chiang, Capital One.

蔣添明，第一資本。

Russell, could you just talk a little bit about what came out of the type C and D meetings that you had with the FDA? I noticed the timing of the filings extended to 1Q of next year. So I just -- is there any correlation between your discussions with the FDA and the pushout in the filing?

Russell，您能簡單談談您與 FDA 舉行的 C 型和 D 型會議的結果嗎？我注意到申請的時間延長到了明年第一季。所以我只是 - 你們與 FDA 的討論與文件中的拒絕之間有任何關聯嗎？

None. Really the timing of the filing is really associated with our prediction on completion of enrollment. It's solely focused on that. The -- after we had the first Type A meeting with FDA, they encouraged us, aside from having discussions around what the additional clinical trial design would look like, they also encouraged us during that meeting to come back and meet with them during the course of the trial to talk to their CMC group around what the questions that they had in there.

沒有任何。實際上，提交的時間確實與我們對註冊完成的預測有關。它只專注於此。在我們與 FDA 舉行第一次 A 類會議之後，他們除了討論額外的臨床試驗設計是什麼樣子之外，還鼓勵我們在會議期間回來與他們會面。問題。

So we took them up on that offer. And so I think we would characterize our discussions with FDA as -- have been very positive. And I think we've now reviewed with FDA every single question that they had on the CMC list. And so we're happy to say we've completed those meetings. And we'll continue to finish up some of the work, but we're really at a point where we're just going to publishing on answers to those CMC questions. So we're quite satisfied with how that turned out.

所以我們接受了他們的提議。因此，我認為我們與 FDA 的討論是非常積極的。我認為我們現在已經與 FDA 審查了 CMC 清單上的每一個問題。因此，我們很高興地說我們已經完成了這些會議。我們將繼續完成一些工作，但我們確實正處於這樣的階段：我們將發布這些 CMC 問題的答案。所以我們對結果非常滿意。

Douglas Tsao, H.C. Wainwright.

雪兒 (Douglas Tsao)溫賴特。

Just curious, so in terms of the timing of the BLA filing has been noted, you're sort of now guiding to the first quarter versus the fourth quarter. Just curious exactly what led to that? And my guess is maybe patient enrollment is a little behind where you expected? And was that the result of just the pace of patients coming in? Or just did you not quite get as many sites up and running as quickly as you maybe anticipated?

只是好奇，所以就 BLA 備案的時間而言，您現在正在指導第一季與第四季。只是好奇究竟是什麼原因導致了這一點？我的猜測是，患者入組人數可能比您預期的要少一些？這僅僅是患者就診速度的結果嗎？或者只是您沒有像您預期的那樣快速建立和運行盡可能多的網站？

Yes. Thanks, Doug. Yes, I think for us to be able to hit that end of year enrollment timing -- or to be able to resubmit the BLA by the end of the year, we would have had to finish enrollment by the end of July.

是的。謝謝，道格。是的，我認為，為了讓我們能夠趕上年底的註冊時間，或者能夠在年底之前重新提交 BLA，我們必須在 7 月底之前完成註冊。

Our current enrollment pace is about two times faster than the industry average. Most people talk about in the industry that it takes a patient per doctor per site to -- that that's what should be predicted. And so if that were the case, then it would have taken us all the way to the end of the year to enroll. Instead, we're going to finish enrollment by the end of the third quarter.

我們目前的招生速度大約是行業平均的兩倍。大多數人在業界談論的是，每個站點需要一名醫生一名患者才能完成——這是應該預測的。如果是這樣的話，那麼我們就需要一直到年底才能入學。相反，我們將在第三季末完成註冊。

So I think it was just a really aggressive goal that we're almost going to hit. But it's going to -- but I think it does -- because we did not hit end of July, it puts us into the beginning of next year in terms of BLA submission.

所以我認為這是一個我們即將實現的非常激進的目標。但它將會——但我認為確實如此——因為我們沒有在 7 月底到來，所以就 BLA 提交而言，這使我們進入了明年初。

Okay. Great. And in terms of the European launch, I'm just curious what kind of investments are you making in terms of inventory than for the European launch? And is that going to potentially provide supply for the US launch as well?

好的。偉大的。至於在歐洲的推出，我只是好奇你們在庫存方面比在歐洲推出方面進行了哪些投資？這是否也可能為美國的發射提供供應？

Yes, it could. We actually went into -- we had some inventory ready for August 29 of last year when we expected approval from FDA. So that inventory is still sitting there, and it's going to be available for sale in the European area and/or in the United States.

是的，可以。事實上，我們在去年 8 月 29 日準備了一些庫存，當時我們預計會獲得 FDA 的批准。因此，庫存仍然存在，並將在歐洲地區和/或美國出售。

And I think one of the nice things about having built that inventory is we're continuing to be able to extend the shelf life of that product. So I think by the end of the year, we're expecting to have between 30 and 36 months of dating on that product. So I think that's kind of the work that's being done on inventory right now is really just tracking stability and extending shelf life.

我認為建立庫存的好處之一是我們能夠繼續延長該產品的保質期。所以我認為到今年年底，我們預計該產品的約會時間將在 30 到 36 個月之間。所以我認為現在在庫存方面所做的工作實際上只是追蹤穩定性和延長保質期。

Daniil Gataulin, Chardan.

丹尼爾·加陶林，查丹。

Congrats on all the progress. I have a quick one. [The medical] approval in the EU and the UK, how does the off-label use dynamics change there between now and launch and before after launch? And as a follow-up, what are the current assumptions or checklist items on your list for the commercial launch in Europe in the first half?

祝賀所有的進展。我有一個快速的。歐盟和英國的[醫療]批准，從現在到上市之前以及上市之後，標籤外使用動態有何變化？作為後續行動，您對上半年在歐洲進行商業發布的當前假設或清單項目是什麼？

Yes. So the -- in terms of off-label use, the situation in Europe is really different market by market. There are some markets where off-label use is close to zero because it's not allowed. And in those markets, people are following the law, and they're not repackaging or compounding.

是的。因此，就標籤外使用而言，歐洲的情況確實因市場而異。在某些市場，標籤外使用接近零，因為這是不允許的。在這些市場中，人們遵守法律，他們不會重新包裝或混合。

In other markets, it's also unlawful, but it's tolerated for now. And I think the thing that we hear from doctors is and from payers is that they like having a source of bevacizumab available. It's the only molecule of its kind. And so they'll turn a blind eye for a little bit of time, at least on offering off-label products.

在其他市場，這也是非法的，但目前是可以容忍的。我認為我們從醫生和付款人那裡聽到的是，他們喜歡擁有可用的貝伐單抗來源。它是同類中唯一的分子。因此，他們會在一段時間內視而不見，至少在提供標籤外產品方面是如此。

So I think once we are approved, I think the market research and the customer conversations that we've had indicate that doctors and payers, they get it. They understand that the standards that we have to live to and the standards that we have lived to in our -- with the product that was used in our clinical trial, are different for that bevacizumab that we have versus the bevacizumab that was originally developed and designed to treat oncology and be delivered through a drip IV.

因此，我認為一旦我們獲得批准，我認為市場研究和客戶對話表明醫生和付款人都會明白。他們明白，我們必須遵守的標準以及我們在臨床試驗中使用的產品中所遵循的標準，對於我們現有的貝伐單抗與最初開發的貝伐單抗是不同的，旨在治療腫瘤並透過靜脈注射輸送。

So those standards for oncology don't need ophthalmic standards for things like utter lack of particulates. They don't meet the -- they're not -- they don't have the same requirements for pH levels. They don't have the same requirements for endotox levels. They don't have the same requirements for approved packaging for use in ophthalmology and validation that the vial or syringe that the oncologic version comes from meet ophthalmic standards.

因此，這些腫瘤學標準不需要像完全不含顆粒物這樣的眼科標準。他們沒有滿足——他們沒有——他們對pH值水平沒有相同的要求。他們對內毒素水平的要求不同。他們對用於眼科的批准包裝和驗證腫瘤版本所使用的小瓶或註射器是否滿足眼科標準沒有相同的要求。

So there are a whole host of things that that off-label bevacizumab don't provide the payer and the customer compared to an ophthalmic approved version of bevacizumab. So we think that we'll be in a great position to go in. In those markets where it takes a while for the off-label to go away, we think we can compete with them based on quality, based on clinical data and ophthalmology based on meeting all the GMP standards.

因此，與眼科批准的貝伐單抗版本相比，標籤外貝伐單抗無法為付款人和客戶提供很多東西。所以我們認為我們將處於進入的有利位置。在那些超適應症需要一段時間才能消失的市場中，我們認為我們可以在品質、臨床數據和眼科方面與他們競爭，並滿足所有 GMP 標準。

And based upon having the right amount of drug protein concentration, vial by vial, syringe by syringe that is never validated from a product that comes out of the repackaging effort. So I think the right product profile, the right level of quality and the right price point will put us in a position where we'll be a very able competitor against off-label bevacizumab. But it's a little different market, market by market.

並且基於具有適量的藥物蛋白質濃度，一個小瓶接著一個小瓶，一個注射器接著一個注射器，而這些藥物蛋白濃度從未經過重新包裝工作的產品的驗證。因此，我認為正確的產品概況、正確的品質水準和正確的價格點將使我們成為一個非常有能力對抗標籤外貝伐珠單抗的競爭對手。但每個市場都有所不同。

And in terms of the assumptions on the checklist for launch in the first half of '25.

就 25 年上半年啟動清單的假設而言。

Yes, it's really the whether we're hiring our own -- so basically, the work that we're engaged in right now is market access. So we're in hot pursuit of the health technology assessment groups. We're talking to NICE. We're talking to that same counterpart in Germany to establish with the payer community what it is that they're looking for in terms of pricing and availability. So the HTA work comes first. That market access work has to be done.

是的，這確實是我們是否僱用自己的問題——所以基本上，我們現在從事的工作是市場准入。因此，我們正在緊追衛生技術評估小組。我們正在與 NICE 交談。我們正在與德國的同行進行交談，以便與付款人社群確定他們在定價和可用性方面所尋求的是什麼。因此，HTA 工作是第一位的。市場准入工作必須完成。

In addition to that, we're going through the process of showing up at trade shows, conducting symposia with doctors and really doing some of the good communication that's required with the retina community to help them understand what the real difference is between an ophthalmic approved bevacizumab versus what they've had available to them today.

除此之外，我們正在經歷參加貿易展覽、與醫生舉行研討會以及與視網膜界進行一些必要的良好溝通的過程，以幫助他們了解眼科批准的產品之間的真正區別。他們目前可用的藥物的比較。

We love having those conversations. The doctors do have a preference for a regulatory approved ophthalmic version. All the market research points to that. So we're continuing to engage in all of that work.

我們喜歡進行這些對話。醫生確實更喜歡監管部門批准的眼科版本。所有的市場研究都顯示了這一點。因此，我們將繼續從事所有這些工作。

And then the final step will be, whether it's with a partner or whether it's our own would be to make the decision to put a sales force in a group of medical scientific liaisons, so-called MSLs on the ground, so that the appropriate conversations can take place with the customers.

然後最後一步是，無論是與合作夥伴還是我們自己的合作夥伴，都將決定將一支銷售隊伍放入一組醫學科學聯絡人（即所謂的現場 MSL）中，以便進行適當的對話可以與客戶一起進行。

At this time, I would like to turn the floor back over to Mr. Trenary for closing comments.

現在，我想把發言權交還給特雷納裡先生以供結束發言。

Great. Thank you so much. Well, look, we believe this is a really exciting time for Outlook Therapeutics. And the next few months have the potential to continue to transform the profile of our company.

偉大的。太感謝了。好吧，我們相信這對 Outlook Therapeutics 來說是一個非常令人興奮的時刻。接下來的幾個月有可能繼續改變我們公司的形象。

So to summarize what we've talked about today, in Europe, the second largest market for wet AMD, we received marketing authorization in the EU and the United Kingdom, and we're actively advancing market access initiatives, preparing product inventory and are in discussions with potential partners to launch in these key markets.

所以總結一下我們今天講的，在歐洲這個濕式AMD的第二大市場，我們在歐盟和英國獲得了營銷授權，我們正在積極推進市場准入舉措，準備產品庫存，並在與潛在合作夥伴討論在這些關鍵市場推出的產品。

In the US, we remain on track with enrollment for NORSE EIGHT and expect to report top line results this calendar year and resubmit our BLA early in first calendar quarter 2025. We look forward to continuing this progress and the opportunity to bring an enhanced level of care to the retina anti-VEGF space. Thanks so much for joining us today.

在美國，我們的 NORSE EIGHT 招生工作仍按計劃進行，預計將在本日曆年報告營收結果，並在 2025 年第一季初重新提交 BLA。我們期待著繼續這一進展，並有機會為視網膜抗 VEGF 領域帶來更高水準的照護。非常感謝您今天加入我們。

Ladies and gentlemen, this concludes today's event. You may disconnect your lines at this time or log off the webcast, and enjoy the rest of your day.

女士們、先生們，今天的活動到此結束。此時您可以斷開線路或退出網路廣播，然後享受剩下的一天。