Belite Bio, Inc (BLTE) 2026 Q1 法說會逐字稿

Ladies and gentlemen, thank you for joining us and welcome to the Belite Bio first-quarter 2026 earnings call. (Operator Instructions)

各位女士、先生，感謝各位加入，歡迎參加 Belite Bio 2026 年第一季財報電話會議。(接線員指示)

I will now hand the conference over to Julie Fallon. Please go ahead.

現在我將把會議交給 Julie Fallon。請開始。

Good afternoon, everyone. Thank you for joining us. On the call today are Dr. Tom Lin, Chairman and CEO of Belite Bio; Dr. Hendrik Scholl, Chief Medical Officer; Dr. Nathan Mata, Chief Scientific Officer; and Hao-Yuan Chuang, Chief Financial Officer.

各位下午好。感謝各位加入我們今天的電話會議。今天與會者包括 Belite Bio 董事長兼執行長 Tom Lin 醫師；首席醫療長 Hendrik Scholl 醫師；首席科學長 Nathan Mata 醫師；以及財務長莊皓元。

Before we begin, let me point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. We encourage you to consult the risk factors discussed in our SEC filings for additional detail.

在開始之前，我先提醒各位，我們將發表前瞻性陳述，這些陳述係基於我們目前的預期與信念。此類陳述存在若干風險與不確定性，實際結果可能出現重大差異。我們建議各位參閱我們向美國證券交易委員會（SEC）提交文件中所討論的風險因素，以取得更多細節。

Additionally, today, we will be discussing certain non-GAAP financial measures. Reconciliations to the most directly comparable GAAP measures are provided in the press release we issued today.

此外，今天我們也將討論若干非 GAAP 財務衡量指標。與最直接可比的 GAAP 指標之調節表，已載於我們今日發布的新聞稿中。

And now I'll turn the call over to Dr. Lin.

接下來我將把電話交給 Lin 醫師。

Thank you, Julie. Good afternoon. Thank you for joining our first quarter 2026 financial results and updates. We have made exciting progress so far this year. We have received our Phase III clinical study report in Q1, and without delay in April, we initiated our NDA rolling submission to the FDA for Stargardt disease.

謝謝你，Julie。各位下午好。感謝各位參加我們 2026 年第一季財務結果與最新進展說明。今年至今我們已取得令人振奮的進展。我們在第一季收到第三期臨床研究報告，並於四月毫不延遲地啟動針對 Stargardt 病的 NDA 向 FDA 分段（rolling）送件。

We are on track to complete the submission by the second quarter of this year. As we approach the completion of the rolling submission, we're also preparing for our commercial launch. We have filed our commercial leadership positions and continue to build up our teams in sales, market access, and medical affairs.

我們預計可如期在今年第二季完成送件。在接近完成分段送件之際，我們也正為商業上市做準備。我們已完成商業領導職位的招募，並持續擴編銷售、市場准入與醫藥事務團隊。

We're also building out our commercial infrastructure as well as engaging with the retinal community to raise awareness of Stargardt disease. We are focused on preparing for a strong launch and looking forward to sharing more on our commercial planning in the future. In line with that commitment to bring Tinlarebant to patients around the world, this past quarter, we also announced that we have completed enrollment in our Phase II/III DRAGON II clinical trial, evaluating Tinlarebant to Stargardt disease.

我們也正在建置商業化基礎設施，並與視網膜領域社群互動，以提升對 Stargardt 病的認知。我們專注於為強勁上市做好準備，並期待未來分享更多商業規劃內容。為了實現將 Tinlarebant 帶給全球患者的承諾，本季我們也宣布已完成第二/三期 DRAGON II 臨床試驗的受試者入組，該試驗評估 Tinlarebant 用於 Stargardt 病。

This trial enrolled 73 adolescents and adult subjects age 12 to 20 years from Japan, United States, and UK. This is a registration-enabling study to pursue approval in Japan. This is shaping up to be a pivotal year for Belite as we begin our transition to a commercial-stage company. We look forward to providing further updates on our work bringing therapies for retinal degenerative diseases and significant unmet medical needs.

本試驗自日本、美國與英國納入 73 名 12 至 20 歲的青少年與成人受試者。這是一項具備註冊申請支援性的研究，用以推進在日本的核准。隨著我們開始轉型為商業化階段公司，這一年對 Belite 而言正逐步成為關鍵的一年。我們期待就推進視網膜退化性疾病與重大未被滿足醫療需求之療法的工作，提供更多更新。

I will now turn over the presentation to Hao-Yuan to discuss the financials. Hao-Yuan?

接下來我將把簡報交給皓元，請他說明財務狀況。皓元？

Thank you, Tom. In Q1 2026, our R&D expenses were $15.7 million compared to $9.4 million in Q1 2025. The increase was mainly driven by higher spending on the DRAGON II trial, increased API and drug product manufacturing expenses and higher consultant and professional service fee. On a non-GAAP basis, excluding share-based compensation expenses, R&D expenses in Q1 2026 were $13.8 million compared to $7.4 million in Q1 2025. SG&A expenses in Q1 2026 were $17 million compared to $6.1 million in Q1 2025.

謝謝你，Tom。2026 年第一季，我們的研發費用為 1,570 萬美元，較 2025 年第一季的 940 萬美元增加。增加主要來自 DRAGON II 試驗支出提高、API 與製劑生產費用增加，以及顧問與專業服務費上升。以非 GAAP 口徑（排除股份基礎給付費用）計算，2026 年第一季研發費用為 1,380 萬美元，較 2025 年第一季的 740 萬美元增加。2026 年第一季的銷售、一般及行政（SG&A）費用為 1,700 萬美元，較 2025 年第一季的 610 萬美元增加。

The increase in SG&A expenses were primarily due to increase in share-based compensation expenses, professional service fees, and wages and salaries resulting from our team expansion. On a non-GAAP basis, excluding share-based compensation expenses, the SG&A expenses in Q1 2026 were $5.7 million compared to $1.5 million in Q1 2025. GAAP net loss for the quarter was $26.9 million compared to $14.3 million in the same period last year.

SG&A 費用增加主要由股份基礎給付費用增加、專業服務費上升，以及因團隊擴編導致的薪資與工資增加所致。以非 GAAP 口徑（排除股份基礎給付費用）計算，2026 年第一季 SG&A 費用為 570 萬美元，較 2025 年第一季的 150 萬美元增加。本季 GAAP 淨損為 2,690 萬美元，較去年同期的 1,430 萬美元增加。

On a non-GAAP basis, excluding share-based compensation expenses, Net loss was $13.7 million in Q1 2026 compared to $7.6 million in Q1 2025. Despite the increased investment in R&D and SG&A, our balance sheet remains very strong.

以非 GAAP 口徑（排除股份基礎給付費用）計算，2026 年第一季淨損為 1,370 萬美元，較 2025 年第一季的 760 萬美元增加。儘管我們加大研發與 SG&A 的投入，我們的資產負債表仍然非常強健。

Specifically, we proceed from ESOP and warrant exercise. We ended Q1 with $799 million in cash, cash equivalent and US treasury bills. A higher balance than at the end of 2025. This strong cash position gives us ample capital to execute on our goals, including finalizing our NDA application, preparing for the commercialization in Stargardt disease, and completing our ongoing clinical trials.

具體而言，我們有來自員工持股計畫（ESOP）及認股權證行使的款項入帳。第一季末，我們持有 7.99 億美元的現金、約當現金及美國國庫券。該餘額高於 2025 年底。這項強勁的現金部位為我們執行目標提供充足資本，包括完成 NDA 申請、為 Stargardt 病的商業化做準備，以及完成目前進行中的臨床試驗。

With that, I'll now turn the call back to the operator for Q&A. Operator?

接下來我把電話交回接線員進行問答。接線員？

We will now begin the question-and-answer session. (Operator Instructions)

我們現在開始問答環節。(接線員指示)

Judah Frommer, Morgan Stanley.

Morgan Stanley 的 Judah Frommer。

Yeah. Hi, guys. Thanks for taking the question and congrats on all the progress here.

是的。各位好。謝謝讓我提問，也恭喜你們取得這些進展。

On DRAGON II, what confidence do you have based on communication with FDA that readout will not be necessary for an approval decision in the US. And then I guess on the flip side of that, if FDA does imply that they would like to see DRAGON II results, what are the chances that, that is confirmatory? And how could that play into timelines? Thank you.

關於 DRAGON II，基於你們與 FDA 的溝通，你們對於在美國核准決策不需要等待讀出結果有多大信心？反過來說，如果 FDA 暗示希望看到 DRAGON II 的結果，那麼該結果作為確認性證據（confirmatory）的可能性有多大？這會如何影響時程？謝謝。

Thanks, Judah. So that's a great question. So we had several meetings with the FDA, including a meeting with the FDA to discuss the strong positive data at interim analysis. And it's the FDA's recommendation that we complete the DRAGON II study at two years with a possible path to one single-study approval based on the robustness of our data. And obviously --

謝謝你，Judah。這是個很好的問題。我們與 FDA 開過數次會議，包括就期中分析的強勁正向數據與 FDA 討論的會議。FDA 的建議是我們將 DRAGON II 研究完成至兩年，並且基於我們數據的穩健性，可能存在以單一研究取得核准的途徑。而且顯然--

I think you mean DRAGON I or DRAGON II?

你指的是 DRAGON I 還是 DRAGON II？

Yes, DRAGON I, So we don't believe that the DRAGON II data would be applicable to our FDA filings. But even if there's a slight chance of that happening, we could always have the DRAGON II data available, at least the interim part of that to serve as a confirmatory evidence. But the DRAGON II is mostly for Japan regulatory requirements. I hope that answers your questions.

是的，DRAGON I。所以我們不認為 DRAGON II 的數據會適用於我們向 FDA 的申報。但即使有一點點可能發生，我們也可以隨時提供 DRAGON II 的數據，至少提供其期中部分，作為確認性證據。不過 DRAGON II 主要是為了符合日本的法規要求。希望這回答了你的問題。

That's great. And then just maybe touching on building out the commercial infrastructure. What are your latest thoughts on how targeted the commercial team or the field sales force team could be here just given how concentrated the patient population is and where they're seen by centers of excellence? Thank you.

很好。另外想再談一下商業化基礎設施的建置。考量患者族群相當集中，且多在卓越中心就診，你們目前對於商業團隊或外勤銷售團隊需要多「精準聚焦」的最新看法是什麼？謝謝。

Hao, do you want to probably better to answer this?

Hao，你想要可能更好地回答這個問題嗎？

Yeah. Well, we do expect that we're going to have twoteams, one for the diagnostic promotion to bring more disease awareness and awareness to genetic testing to make sure that it is an easy kind of reach-out for the patient to be diagnosed and get that testing confirmed. And we also have another team more focused on promoting the drug. In total, we're thinking about 30 to maybe 40 total team members for that regard. We do know that there are many retina specialists that already have a database of Stargardt disease patients confirmed with genetic testing. We're doing a lot of survey right now.

是的。嗯，我們確實預期會有兩個團隊：一個負責診斷推廣，以提升疾病認知與基因檢測的認知，確保病患能夠容易地被觸及、獲得診斷並完成檢測確認。另外我們也有另一個團隊更專注於藥物推廣。整體而言，我們預計相關團隊總人數約30到40人。我們也知道，許多視網膜專科醫師已經擁有一個以基因檢測確認的Stargardt病患資料庫。我們目前正在進行大量的調查。

We do expect to give the market an update about what we know, what we're going to be doing hopefully in September. So you have a better idea about the whole plan and what is already confirmed out there. But long story short, we do see that there are many patients are very incentivized to this treatment and continue to be follow-up with their physicians.

我們預期會在9月左右向市場更新我們所掌握的資訊，以及我們希望將採取的行動。讓你對整體計畫以及目前外部已確認的情況有更清楚的了解。但簡而言之，我們確實看到有許多病患對這項治療有很高的動機，並持續與其醫師進行追蹤。

So we'll be focused on the retina specialist committee -- community, the patient advocacy group to better understand the needs, and also, of course, the general ophthalmologists and probably the low-vision optometrist community as well.

因此我們將聚焦於視網膜專科醫師委員會——社群、病患倡議團體，以更好地了解需求；當然也包括一般眼科醫師，以及可能也包括低視力驗光師社群。

Great. Thank you.

很好。謝謝你。

Marc Goodman, Leerink.

Marc Goodman，Leerink。

Hey, guys. How are you? Geographic atrophy, can you just talk about how you're thinking about this right now, and timing of the interim, and what happens if the GA indication ends up looking really, really strong?

嗨，各位。你們好嗎？關於地理性萎縮（GA），你能談談你們目前是如何看待的、期中分析的時間點，以及如果GA適應症最後看起來非常、非常強勁，會發生什麼嗎？

Thanks, Marc. So for GA, right now, we are focused on getting the FDA approval for Stargardt disease. We are aiming for the interim for GA around end of the year. Right now, we don't know what's the data going to be like. And if it's a strong-positive data, then it's a good problem to have. But at this time, we don't know what the data looks like. So we haven't given that much thought in terms of strategy anyway. So I don't think I'll answer for you now, probably nearer the time when we have the interim, we probably have a better idea.

謝謝你，Marc。所以就GA而言，目前我們專注於取得Stargardt疾病的FDA核准。我們的目標是GA的期中分析大約在年底。目前我們不知道數據會是什麼樣子。如果是強烈的正向數據，那會是個「好問題」。但此時此刻，我們還不知道數據長什麼樣。因此在策略方面我們也還沒有投入太多思考。所以我現在可能無法回答你；等到更接近期中分析時，我們可能會有更清楚的想法。

Right. Okay. So you will have a sense of that, right? I mean --

了解。好。所以你們會對此有個概念，對吧？我的意思是--

I mean -- Yes, so we're aiming for end of the year, but it all depends on the coordination and getting the data ready with the CROs. It's a much, much more bigger data than the Stargardt disease. So logistic-wise, I think it's a bit more complicated, but we are aiming for the end of the year.

我的意思是——是的，我們的目標是年底，但一切取決於與CRO的協調以及把數據準備好。這是一個比Stargardt疾病大得多、得多的數據集。所以在物流層面我認為會更複雜一些，但我們仍以年底為目標。

Yes. And then just back on Stargardt, what's the time line for Japan again? How --

是的。然後回到Stargardt，日本的時間表再提醒一次是什麼？怎麼--

I think Japan, given that we have Sakigake Designation, the Pioneer designation, I think the approval -- the PMDA is aiming for approval within three months of the FDA approval.

我想日本方面，鑑於我們有Sakigake指定與Pioneer指定，我認為核准——PMDA的目標是在FDA核准後三個月內完成核准。

Got it. Thank you.

了解了。謝謝。

So we're looking on track for that as well.

所以我們在那方面也看起來是按計畫進行。

Thank you.

謝謝。

Steve Seedhouse, Cantor.

Steve Seedhouse，Cantor。

And thanks for the color on the commercial preparations in the US. I actually just wanted to ask about on the other side, ex-US, particularly in Europe, how you're thinking about filing time line, launch strategy, partnering strategy, if relevant. Would love your current thinking on the ex-US opportunity.

謝謝你們提供美國商業化準備的細節。我其實想問的是另一端，也就是美國以外，特別是歐洲，你們如何思考申請送件的時間表、上市策略、以及（如適用）合作夥伴策略。很想聽聽你們目前對美國以外機會的看法。

Sure, sure. So again, right now, we are focusing on the FDA approval. So within the submission time line, the six months will be period. We are expecting to have some questions from the FDA. So we don't want to overstretch ourselves and file in different jurisdictions while we're focusing on the FDA. So our filing strategy is that the FDA forms the basis of our submission and rest of the world will be consistent with the FDA filing. So the time line will be based on what the responses from the FDA. So at this point, again, the time line, we'll need to update you on that. So the FDA will serve as our priority.

當然、當然。所以同樣地，目前我們專注於FDA核准。在送件時程內，會有六個月的期間。我們預期會收到FDA的一些問題。因此在我們專注於FDA的同時，我們不希望把資源拉得太分散、同時在不同司法管轄區送件。所以我們的送件策略是：以FDA的申請作為我們送件的基礎，其他國家/地區將與FDA送件保持一致。因此時間表將取決於FDA的回覆情況。所以在這個時間點，我們仍需要之後再向各位更新時間表。因此FDA將是我們的優先事項。

Okay. Terrific. And I just want to follow up on the GA analysis around year-end as well. Is this a type of situation where you would share data in any scenario, resize the study, stop the study either for efficacy or futility? Like can you just talk about maybe just some of the possible scenarios for that analysis?

好的。太好了。我也想追問一下年底左右的GA分析。這是否屬於那種在任何情境下你們都會分享數據、調整（縮放）試驗規模、或因有效性或無效性而停止試驗的情況？你能談談那次分析可能出現的一些情境嗎？

So, this is just assuming what I think the possible scenario is probably resizing the study. So the data will show us what the sample size is going to be after that interim. So again, this will be a data-driven decision and strategy.

所以，這只是基於我認為可能的情境，可能會是調整試驗規模。數據會告訴我們在那次期中分析之後樣本數需要是多少。因此同樣地，這將是一個以數據驅動的決策與策略。

Okay, thank you very much.

好的，非常感謝。

And Steve, if I can make an additional comment. We definitely are trying everything that we can do to try to bring this treatment to all the patients around the world, both on GA and Stargardt. But like Tom said, some of these will be data-driven, and we did recognize that Stargardt disease in the US will be our first focus, but we're continuing to monitor all the other development and definitely try to bring the treatment to all the patients as soon as we can.

Steve，如果我可以再補充一句。我們確實正在盡一切所能，嘗試把這項治療帶給全球所有病患，無論是GA或Stargardt。但如Tom所說，其中一些將以數據為依據；我們也認知到在美國的Stargardt疾病將是我們的第一個重點，但我們會持續監測其他所有進展，並確實會盡快把治療帶給所有病患。

Thank you.

謝謝。

Graig Suvannavejh, Mizuho.

Graig Suvannavejh，Mizuho。

Hey, it's Graig. Thanks so much for taking my questions. Congrats on the progress. I have two questions, if I could. One, it's been some time now since you've had the data in hand. Have you done any additional testing market research-wise with payers in terms of potential pricing bands that would be acceptable? What are your latest thoughts on potential pricing? And then second, fully appreciating that you are ramping up your pre-commercial activities. Can you give a sense of what the level of awareness of Tinlarebant right now within the prescribing community? And whether once you get to a place of launch, how much education will be needed? Thanks.

嗨，我是Graig。非常感謝你們回答我的問題。恭喜進展順利。如果可以的話我有兩個問題。第一，你們拿到數據已經有一段時間了。在市場研究方面，你們是否針對付款方做了任何額外測試，以了解可接受的潛在定價區間？你們對潛在定價最新的想法是什麼？第二，充分理解你們正在加速推進上市前活動。你們能否說明一下目前在處方醫師社群中，對Tinlarebant的認知程度大概如何？以及一旦進入上市階段，需要多少教育推廣？謝謝。

So I'll ask Hendrik to discuss on the data part that you mentioned. And then Hao, maybe you want to comment on the commercial side of this question?

那我會請Hendrik就你提到的數據部分來說明。然後Hao，或許你也可以就這個問題的商業面向發表看法？

Sure. Hendrik, do you want to go ahead first?

好的。Hendrik，你要不要先開始？

I can start, certainly. So I mean, the IRD and retina specialist community is a very well-defined community that meets regularly at ARVO, ASRS, and the American Academy meeting. People know about Belite Bio and Tinlarebant. We can certainly improve on that because our interviews with retinal specialists have shown that they are enthusiastic about the prospect of a first treatment ever for this so far untreatable disease, plus the convenience of this being an oral treatment.

我可以先開始，當然。我的意思是，IRD與視網膜專科醫師社群是一個界定非常清楚的社群，會定期在ARVO、ASRS以及美國眼科學會年會聚會。大家都知道Belite Bio以及Tinlarebant。我們當然可以在這方面做得更好，因為我們對視網膜專科醫師的訪談顯示，他們對於這個迄今無法治療的疾病能有史上第一個治療方案的前景感到非常振奮，再加上這是一種口服治療的便利性。

But we know that the rate of retina specialists that have in-depth knowledge about Tinlarebant and the DRAGON trial needs to be improved. We clearly know that. We will be present at the American Society of Retina Specialists Meeting in Montreal in July. We will be at the Retina Society Meeting in Los Angeles in September.

但我們也知道，對Tinlarebant以及DRAGON試驗具有深入了解的視網膜專科醫師比例需要提升。我們很清楚這一點。我們將於7月在蒙特婁舉行的美國視網膜專科醫師學會年會（American Society of Retina Specialists Meeting）出席。我們也會在9月於洛杉磯舉行的視網膜學會年會（Retina Society Meeting）出席。

We will be at the American Academy Meeting in October, and we have presentations at all of those meetings. So this will be major opportunities to educate the community about this forthcoming treatment for Stargardt disease. But yes, we are actively pursuing that.

我們也會在10月參加美國眼科學會年會（American Academy Meeting），而且在上述所有會議上我們都有發表。因此，這些將是向社群宣導這項即將到來的Stargardt病治療方案的重大機會。是的，我們正在積極推進這件事。

That was the last question. So what was the second half of the question regarding the pricing and all that?

那是最後一個問題。所以問題的後半段是關於定價之類的是嗎？

Yeah. I just wanted to get a sense of whether you -- now that you've had the Phase III data in hand, whether you've been able to do any additional payer market research in terms of how you're thinking about pricing?

對。我只是想了解一下，現在你們已經拿到第三期數據之後，是否已經就定價思考做了任何額外的付款方市場研究？

Got it. Hao, did you get that?

了解。Hao，你有聽到這個問題嗎？

So yeah, Graig, we have done several pricing projects so far. So far, the payers has been super supportive of the price range that we're thinking about. And they definitely recognize the strong unmet need being the first treatment for Stargardt. So I think we appreciate the payers has been showing a lot of support on this. And it's still too early to really set the price.

是的，Graig，我們目前已經做了幾個定價專案。到目前為止，付款方對我們所考量的價格區間非常支持。他們也確實認同作為Stargardt病的第一個治療方案所代表的強烈未被滿足需求。所以我們很感謝付款方在這方面展現出很大的支持。而且現在要真正訂出價格仍然太早。

But I think we talk about if people want to know maybe a reference price, we think that the average orphan drug price in the US around $350,000. That's a fair reference price. Maybe up to $500,000, that will be the range that you'll consider compared with some of the analog out there. But we haven't really set the price. It's still early, but we do see that this is a range that should be a fair assumption.

但我想，如果大家想知道一個可能的參考價格，我們認為美國孤兒藥的平均價格大約在35萬美元左右。這是一個合理的參考價。也許到50萬美元，這會是你們在與市面上一些類似產品比較後會考慮的區間。但我們還沒有真正訂價。現在仍然偏早，但我們確實看到這個區間應該是一個合理的假設。

Okay, thank you.

好的，謝謝。

(Operator Instructions)

（接線員指示）

Yi Chen, HC Wainwright.

Yi Chen，HC Wainwright。

Thank you for taking my questions. Assuming that you get FDA approval in early 2027, can you tell us how quickly you can launch the drug, whether your manufacturing facility is in alignment with that timing? And more importantly, can you provide us with a rough estimate as to how many patients could you reasonably expect to receive the Tinlarebant treatment in 2027? Thank you.

謝謝讓我提問。假設你們在2027年初獲得FDA核准，能否告訴我們你們能多快推出這款藥物，你們的製造設施是否與該時程相符？更重要的是，你們能否提供一個粗略估計：在2027年，合理而言會有多少名患者可望接受Tinlarebant治療？謝謝。

Hao, you want to take this question too?

Hao，你也要回答這個問題嗎？

Yes. So, thank you, Lin. Well, this is a small-molecule drug. So, the manufacturing is not that complicated, and the packaging, delivering are all relatively easy compared with most of the other drugs. So we do expect that we should be fairly quickly be able to launch right upon the approval. We are getting all the supply chain and the manufacturing ready right now.

是的。謝謝你，Lin。這是一款小分子藥物。因此製造並不那麼複雜，包裝與配送相較於多數其他藥物也都相對容易。所以我們預期在獲批後應該能相當快速地立即上市。我們目前正在把供應鏈與製造端都準備就緒。

Yes, the -- in terms of the number of patients at the first year, I think like I said earlier, we would like to do more survey and maybe get the market a good throughout kind of a survey and numbers probably in September on the Commercial Day event. So we're doing everything we can to try to find all this potential database and doing all the surveys and all the so-called Medical Affairs task to make sure we warm up the community. But I think we cannot provide a specific guidance on today's call yet.

是的——至於第一年的患者人數，我想如我先前所說，我們希望做更多調查，並且可能在9月的商業日（Commercial Day）活動上，對市場做一個更全面的調查並提供一些數字。因此我們正在盡一切努力，嘗試找出所有潛在資料庫並進行各種調查，以及所謂的醫學事務（Medical Affairs）工作，以確保我們能讓社群提前暖身。但我想我們今天的電話會議上還無法提供具體指引。

Thanks. And a quick question on the operating expenses. I noticed the first quarter numbers are meaningfully higher compared to fourth quarter last year. Shall we expect that the operating expenses to continuously increase as you approach the FDA decision?

謝謝。另外快速問一下營運費用。我注意到第一季的數字相較於去年第四季明顯更高。隨著你們接近FDA決策，我們是否應預期營運費用會持續增加？

Yeah. Well, it's a fair scenario as you get ready for launch. There's huge team expansion. And we -- last year, we were somewhere close to like 30 team members now. We're now close to somewhere like 90, right? So we are expanding the team fast and also do all this activity that we talked about. So we don't expect that expense will go up too much, but it's a fair assumption that it will go up while we go towards commercialization.

是的。當你們為上市做準備時，這是合理的情境。團隊會大幅擴編。而且——去年我們大概接近30名團隊成員，現在呢？我們現在接近大約90人，對吧？所以我們正在快速擴編團隊，也在進行我們剛才談到的各項活動。因此我們不預期費用會上升太多，但在邁向商業化的過程中，費用上升是一個合理的假設。

And compared to last quarter, that's really not a fair assumption because that was when we just started some of the preparation work. But like I said in the presentation, we're sitting on close to $800 million cash. So we're in a very, very comfortable cash position. To launch Stargardt disease in the US, we probably look forward probably USD 300 million.

而且與上一季相比，那其實不是一個公平的比較，因為那時我們才剛開始一些準備工作。但如我在簡報中所說，我們手上有接近8億美元的現金。所以我們的現金部位非常、非常充裕。要在美國推出Stargardt病的產品，我們大概預期需要約3億美元。

And our existing pipeline, as we talked about before, we expect the budget will be about $150 million for next 3 years. So in total, we're talking about $450 million at most of the budget, while we're sitting on $800 million. So, we think we are very comfortable on cash. And this is going to be a good investment to be made to make sure that we get all the awareness out there and try to help the patient as fast, as broad as we can.

而我們現有的研發管線，如同先前所談，我們預期未來3年的預算大約是1.5億美元。所以合計來看，我們談的是最多約4.5億美元的預算，而我們手上有8億美元。因此，我們認為現金非常充裕。而這將是一項值得投入的投資，以確保我們能把相關認知推廣出去，並盡可能快速、盡可能廣泛地幫助患者。

Got it. Thank you.

了解。謝謝。

Thank you.

謝謝。

There are no further questions at this time. This concludes today's call. Thank you for attending. You may now disconnect.

目前沒有其他問題。今天的電話會議到此結束。感謝各位參與。您現在可以掛線。