Q1 2026 Belite Bio Inc Earnings Call

May 20, 2026

Speaker #1: Ladies and gentlemen, thank you for joining us, and welcome to the BELITE BIO first quarter 2026 earnings call. After today's prepared remarks, we will host a question-and-answer session.

Operator: Ladies and gentlemen, thank you for joining us and welcome to the Belite Bio Q1 2026 Earnings Call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please raise your hand. I will now hand the conference over to Julie Fallon. Please go ahead.

Speaker #1: If you would like to ask a question, please raise your hand. If you have dialed into today's call, please press star 9 to raise your hand, and star 6 to unmute.

Speaker #1: I will now hand the conference over to Julie Fallon. Please go ahead.

Speaker #2: Good afternoon, everyone. Thank you for joining us. On the call today are Dr. Tom Lin, Chairman and CEO of BELITE BIO; Dr. Hendrick Scholl, Chief Medical Officer; Dr. Nathan Matta, Chief Scientific Officer; and Hao-Yuan Chuang, Chief Financial Officer.

Julie Fallon: Good afternoon, everyone. Thank you for joining us. On the call today are Dr. Tom Lin, Chairman and Chief Executive Officer of Belite Bio, Dr. Hendrik P. N. Scholl, Chief Medical Officer, Dr. Nathan Mata, Chief Scientific Officer, and Hao-Yuan Chuang, Chief Financial Officer. Before we begin, let me point out that we will be making forward-looking statements that are based on our current expectations and beliefs.

Julie Fallon: Good afternoon, everyone. Thank you for joining us. On the call today are Dr. Tom Lin, Chairman and Chief Executive Officer of Belite Bio, Dr. Hendrik Scholl, Chief Medical Officer, Dr. Nathan Mata, Chief Scientific Officer, and Hao-Yuan Chuang, Chief Financial Officer. Before we begin, let me point out that we will be making forward-looking statements that are based on our current expectations and beliefs.

Speaker #2: 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.

Julie Fallon: 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. 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. Now I'll turn the call over to Dr. Lin. Dr. Lin?

Speaker #2: We encourage you to consult the risk factors discussed in our SEC filings for additional detail. 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.

Speaker #2: And now I'll turn the call over to Dr. Lin. Dr. Lin?

Speaker #3: 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.

Tom Lin: Thank you, Julie. Good afternoon. Thank you for joining our Q1 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. Without delay, in April, we initiated our NDA rolling submission to the FDA for Stargardt disease. We're on track to complete the submission by Q2 of this year. As we approach the completion of the rolling submission, we're also preparing for our commercial launch. We have hired all commercial leadership positions and continue to build out our teams in sales, market access, and medical affairs. 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.

Speaker #3: We have received our Phase 3 clinical study report in Q1, and without delay, in April, we initiated our NDA rolling submission to the FDA for STARGUARDS disease.

Speaker #3: 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 are also preparing for our commercial launch.

Tom Lin: As we approach the completion of the rolling submission, we're also preparing for our commercial launch. We have hired all commercial leadership positions and continue to build out our teams in sales, market access, and medical affairs. 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.

Speaker #3: We have hired all commercial leadership positions and continue to build out our teams in Sales, Market Access, and Medical Affairs. We are also building out our commercial infrastructure.

Speaker #3: As well as engaging with the retinal community to raise awareness of STARGUARDS disease. We are focused on preparing for a strong launch, and looking forward to sharing more on our commercial planning in the future.

Speaker #3: In line with that commitment to bring Teneb into patients around the world, this past quarter we also announced that we have completed enrollment in our Phase 2/3 Dragon 2 clinical trial, evaluating Teneb in STARGUARDS disease.

Tom Lin: 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 in Stargardt disease. This trial enrolled 73 adolescents and adult subjects aged 12 to 20 years from Japan, US, 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 world-leading therapies for retinal degenerate disease and second-tier unmet medical needs. I'll now turn over the presentation to Hao-Yuan to discuss the financials. Hao-Yuan?

Speaker #3: This trial enrolled 73 adolescent and adult subjects, aged 12 to 20 years, from Japan, the United States, and the UK. This is a registration-enabling study to pursue approval in Japan.

Tom Lin: 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 world-leading therapies for retinal degenerate disease and second-tier unmet medical needs. I'll now turn over the presentation to Hao-Yuan to discuss the financials. Hao-Yuan?

Speaker #3: 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 disease and second-hand eye medical needs.

Speaker #3: I'll now turn over the presentation to Hao-Yuan to discuss the financials. Hao-Yuan?

Speaker #4: 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 2 trial, increased API and drug product manufacturing expenses, and higher consultant and professional service fees.

Hao-Yuan Chuang: 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. The increase in SG&A expenses were primarily due to increase in share-based compensation expenses, professional service fees, and wage 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.

Speaker #4: 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.

Speaker #4: The increase in SG&A expenses was primarily due to increase in share-based compensation expenses, professional service fees, and wage and salaries resulting from our team expansion.

Hao-Yuan Chuang: The increase in SG&A expenses were primarily due to increase in share-based compensation expenses, professional service fees, and wage 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.

Speaker #4: On a non-GAAP basis, excluding share-based compensation expenses, 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.

Hao-Yuan Chuang: GAAP net loss for the quarter was $26.9 million, compared to $14.3 million in the same period last year. 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. Specifically, with proceeds from ESOP and warrant exercise, we ended Q1 with $799 million in cash equivalents, 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. With that, I'll now turn the call back to the operator for Q&A. Operator?

Speaker #4: 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.

Speaker #4: Specifically, we proceed from ESOP and Warren exercise. We ended Q1 with $799 million in cash, cash equivalents, and US Treasury bills—a higher balance than at the end of 2025.

Hao-Yuan Chuang: Specifically, with proceeds from ESOP and warrant exercise, we ended Q1 with $799 million in cash equivalents, 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. With that, I'll now turn the call back to the operator for Q&A. Operator?

Speaker #4: This strong cash position gives us ample capital to execute on our goals, including finalizing our NDA application, preparing for commercialization in STARGUARD disease, and completing our ongoing clinical trials.

Speaker #4: With that, I'll now turn the call back to the operator for Q&A. Operator?

Speaker #3: We will now begin the question-and-answer session. If you would like to ask a question, please raise your hand now. If you have dialed into today's call, please press *9 to raise your hand, and *6 to unmute.

Operator: We will now begin the question and answer session. If you would like to ask a question, please raise your hand now. If you have dialed into today's call, please press star nine to raise your hand, star six to unmute. Please stand by as we compile the Q&A roster. Your first question comes from the line of Judah Frommer with Morgan Stanley. Your line is open. Please go ahead.

Speaker #3: Please stand by as we compile the Q&A roster. Your first question comes from the line of Judah Frommer with Morgan Stanley. Your line is open.

Speaker #3: Please go ahead.

Speaker #5: Yeah. Hi guys, thanks for taking the question, and congrats on all the progress here. On Dragon 2, what confidence do you have, based on communication with the FDA, that a readout will not be necessary for an approval decision in the U.S.?

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

Speaker #5: And then I guess, on the flip side of that, if FDA does imply that they would like to see Dragon 2 results, what are the chances that that is confirmatory, and how could that play into timelines?

Speaker #5: Thank you.

Speaker #3: Thanks. Thanks, Judah. So that's a great, great question. So we had several meetings with the FDA, including a meeting with the FDA to discuss the study, and two recommendations that we complete the DRAGON 2 years, with a possible path to one single study approval based on the robustness of our data.

Tom Lin: Thanks, Judah. That's a great question. We had several meetings with the FDA, including a meeting with the FDA to discuss the strong positive data at interim analysis. It's the FDA's recommendation that we complete the DRAGON II study at 2 years with a possible path to one single study approval based on the robustness of our data.

Speaker #3: And obviously.

Judah Frommer: Sorry, Tom, I think you mean DRAGON I, not DRAGON II.

Speaker #5: I think you mean Dragon 1, not Dragon 2.

Tom Lin: Yes. DRAGON I, sorry about that. We don't believe that the DRAGON II data would be applicable to our FDA filings. 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 the confirmatory evidence. The DRAGON II is mostly for Japan regulatory requirements.

Speaker #3: Yes, Dragon 1. Sorry. Sorry about that. So we don't believe that the Dragon 2 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 2 data available, at least the interim part of that, to serve as a confirmatory evidence.

Speaker #3: But the Dragon 2 is mostly for Japan regulatory requirements. I hope that answers your questions.

Judah Frommer: Okay.

Tom Lin: I hope I answered your questions.

Speaker #5: Yeah. No, that's great. And then just maybe touching on building on the commercial infrastructure, what are your latest thoughts on how targeted the commercial team or the field sales force team could be here?

Judah Frommer: Yeah, no, that's great. 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.

Speaker #5: Just given how concentrated the patient population is and where they're seen by centers of excellence. Thank you.

Speaker #3: How else do you want to probably better to answer this?

Tom Lin: Hao, you are probably better to answer this.

Speaker #5: Yeah. Well, we do expect that we're going to have two teams. One, for the diagnostic promotion. To bring more disease awareness and awareness to genetic testing to make sure that it's an easy kind of reach out for the patient.

Hao-Yuan Chuang: Well, we do expect that we're going to have 2 teams. One for the diagnostic promotion, to bring more disease awareness and awareness to genetic testing, to make sure that it's an easy reach out for the patient to be diagnosed and get that testing confirmed. Then also have another team more focused on promoting the drug. In total, we're thinking about 30 to 40 total team members for that regard. We do know that there are many retinal specialists that already have a database of Stargardt disease patient confirmed with genetic testing. We're doing a lot of surveys right now. We do expect to get the market an update about what we know, what we're going to be doing, hopefully in September. You have a better idea about the whole plan and what is already confirmed out there.

Speaker #5: To be diagnosed and get the testing confirmed, and 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.

Speaker #5: We do know that they are many retina specialists that already have database of STARGARD disease patient confirmed with genetic testing. We're doing a lot of survey right now.

Hao-Yuan Chuang: We do know that there are many retinal specialists that already have a database of Stargardt disease patient confirmed with genetic testing. We're doing a lot of surveys right now. We do expect to get the market an update about what we know, what we're going to be doing, hopefully in September. You have a better idea about the whole plan and what is already confirmed out there.

Speaker #5: We do expect to get 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.

Speaker #5: But long story short, we do see that many patients are very incentivized by this treatment and continue to be followed up with their physicians.

Hao-Yuan Chuang: Long story short, we do see that there are many patients are very incentivized to this treatment. Continue to be follow up with their physicians. We'll be focused on the retina specialist community, the patient advocacy group, the general ophthalmologists, and probably the low vision optometrists community as well.

Speaker #5: So we'll be focused on the retina specialist committee, communities, the patient advocacy group to better understand the needs and also of course the general ophthalmologists and probably the low vision optometrists community as well.

Speaker #5: Great. Thank you.

Judah Frommer: Great. Thank you.

Speaker #3: And your next question comes from the line of Mark Goodman with Lerank. Your line is open. Please go ahead. A reminder that you may need to unmute locally.

Operator: Your next question comes from the line of Marc Goodman with Leerink. Your line is open. Please go ahead. A reminder that you may need to unmute locally.

Speaker #5: Hey, guys. How are you? Geographic atrophy—could 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?

Marc Goodman: Hey, guys. How are you? Geographic Atrophy, could 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?

Speaker #3: Thanks, Mark. So for G8, right now we're focused on getting the FDA approval for Stargardt disease. We are aiming for the interim for G8 around the end of the year.

Tom Lin: Thanks, Marc. For GA, right now we're 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. If it's a strong positive data, then it's a good problem to have. At this time, we don't know what the data looks like, so we haven't given it much thought in terms of strategy anyway. I don't think I have answer for you now. Probably near the time when we have the interim, we probably have a better idea.

Speaker #3: Right now, we don't know what the data is going to be like. And if it's strong positive data, then it's a good problem to have.

Speaker #3: But at this time, we don't know what the data looks like, so we haven't given it much thought in terms of strategy anyway. So I don't think I've answered for you now.

Speaker #3: Probably near the time when we have the interim, we probably have a better idea.

Speaker #5: Right. Okay. So you will have a sense of that, right? I mean.

Marc Goodman: Right. Okay. You will have a sense of that, right?

Speaker #3: Yes, so we're aiming for the end of the year, but it all depends on the coordination and getting the data ready with the COs and all that.

Tom Lin: We're aiming for end of the year, it all depends on the coordination and getting the data ready with the CROs and all that. It's a much, much more bigger data than the Stargardt disease. Logistic-wise, I think it's a bit more complicated, but we aim for end of the year.

Speaker #3: So it’s a much, much bigger data set than the Stargardt disease. So, logistics-wise, I think it’s a bit more complicated, but we aim for end of the year.

Speaker #5: Yeah, and then just back on STARGARD, what's the timeline for Japan again? How is that coming up?

Marc Goodman: Yeah. Then just back on Stargardt, what's the timeline for Japan again? How is that looking now?

Tom Lin: I think Japan, given that we have Sakigake designation, the pioneer designation, I think the PMDA is aiming for approval within 3 months of the FDA approval.

Speaker #3: 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.

Speaker #5: Got it. Thank you.

Marc Goodman: Got it. Thank you.

Speaker #3: So, looking on track for that as well.

Tom Lin: We're looking on track for that as well.

Speaker #5: Thank you.

Marc Goodman: Thank you.

Speaker #3: And your next question comes from the line of Steve Seedhouse with Cantor. Your line is open. Please go ahead.

Operator: Your next question comes from the line of Steve Seedhouse with Cantor. Your line is open. Please go ahead.

Speaker #6: Great, thanks. 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—sort of how you're thinking about filing timeline, launch strategy, and partnering strategy, if relevant.

Steve Seedhouse: Great. Thanks, 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 timeline, launch strategy, partnering strategy, if relevant. Would love your current thinking on the ex-US opportunity.

Speaker #6: Would love your current thinking on the ex-US opportunity.

Speaker #3: Sure, sure. So again, right now we are focusing on the FDA approval. Within the submission timeline—the six-month review period—we are expecting to have some questions from the FDA.

Tom Lin: Sure. Again, right now we are focusing on the FDA approval. Within the submission timeline, the 6-month review period, we are expecting to have some questions from the FDA. We don't want to overstretch ourselves and file in different jurisdictions while we're focusing on the FDA. Our filing strategy is that the FDA forms the basis of our submissions, and rest of the world will be consistent with that FDA filing. The timeline will be based on what the responses from the FDA. At this point, again, the timeline, we'll need to update you on that. The FDA will serve as our priority.

Speaker #3: 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 the rest of the world will be consistent with that FDA filing.

Speaker #3: So the timeline will be based on what the responses from the FDA are. So at this point, again, the timeline—we will need to update you on that.

Speaker #3: So the FDA will serve as our priority.

Speaker #6: I'll be terrific. And I just want to follow up on the GA analysis around year-end as well. Is this the type of situation where you would share data in any scenario, resize the study, or stop the study either for efficacy or futility?

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

Speaker #6: Can you just talk about maybe just some of the possible scenarios or that analysis?

Speaker #3: So, this is just assuming—what I think the possible scenario is, is probably resizing the study. So, the data will show us what the sample size is going to be after that interim.

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

Speaker #3: So again, this will be a data-driven decision and strategy.

Speaker #6: Okay. Thank you very much.

Steve Seedhouse: Okay. Thank you very much.

Speaker #5: And Steve, if I can may additional comment, we're definitely trying everything that we can do to try to bring this treatment to all the patients around the world.

Hao-Yuan Chuang: 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. 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.

Speaker #5: 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.

Speaker #5: But we'll continue to monitor all the other developments and definitely try to bring the treatment to all the patients as soon as we can.

Steve Seedhouse: Thank you.

Speaker #6: Thank you.

Speaker #3: And your next question comes from the line of Greg Svanovich with Mizuho. Your line is open. Please go ahead.

Operator: Your next question comes from the line of Graig Suvannavejh with Mizuho. Your line is open. Please go ahead.

Speaker #5: Hey, it's Greg. Thanks so much for taking my questions. Congrats on the progress. I had two questions, if I could. One, it's been some time now since you've had the data in hand.

Graig Suvannavejh: Hey, it's Graig. Thanks so much for taking my questions. Congrats on the progress. I had 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? Second, fully appreciating that you are ramping up your pre-commercial activities, can you give a sense of what the level of awareness is of Tinlarebant right now with the prescribing community and whether, once you get to a place of launch, how much education will be needed? Thanks.

Speaker #5: 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?

Speaker #5: 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 is of TinLara bans right now with the prescribing community, and whether once you get to a place of launch, how much education will be needed?

Graig Suvannavejh: Second, fully appreciating that you are ramping up your pre-commercial activities, can you give a sense of what the level of awareness is of Tinlarebant right now with the prescribing community and whether, once you get to a place of launch, how much education will be needed? Thanks.

Speaker #5: Thanks.

Speaker #3: So, I'll ask Hendrik to discuss the data part that you mentioned. And then, Hao, maybe you want to comment on the commercial side of this question?

Tom Lin: 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?

Speaker #5: Sure. Hendrik, do you want to go ahead first?

Hao-Yuan Chuang: Sure. Hendrik, you want to go ahead first?

Speaker #4: I can start. Certainly. So, I mean, the IAD and retina specialist community is a very well-defined community that meets regularly at ARVO, ASRS, and the American Academy meeting.

Hendrik P. N. Scholl: I can start, certainly. The IRD and retinal specialist community is a very well-defined community that meets regularly at ARVO, ASRS, and the American Academy of Ophthalmology 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. We know that the rate of retinal 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, and we will be at The Retina Society meeting in Los Angeles in September.

Hendrik Scholl: I can start, certainly. The IRD and retinal specialist community is a very well-defined community that meets regularly at ARVO, ASRS, and the American Academy of Ophthalmology 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.

Speaker #4: People know about Belite Bio and TinLara bans. You can certainly improve on that, because our interviews with retina specialists have shown that they are enthusiastic about the prospect of a first treatment ever for this so-far untreatable disease.

Speaker #4: Plus, the convenience of this being an oral treatment. But we know that the rate of retina specialists that have in-depth knowledge about TinLara band and the DRAGON trial needs to be improved.

Hendrik Scholl: We know that the rate of retinal 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, and we will be at The Retina Society meeting in Los Angeles in September.

Speaker #4: 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.

Speaker #4: In September, we will be at the American Academy meeting in October. And we have presentations at all of those meetings. So this will be a major opportunity to educate the community about this forthcoming treatment for Stargardt disease.

Hendrik P. N. Scholl: We will be at the American Academy of Ophthalmology meeting in October, and we have presentations at all of those meetings. This will be major opportunities to educate the community about this forthcoming treatment for Stargardt disease. Yes, we are actively pursuing that.

Hendrik Scholl: We will be at the American Academy of Ophthalmology meeting in October, and we have presentations at all of those meetings. This will be major opportunities to educate the community about this forthcoming treatment for Stargardt disease. Yes, we are actively pursuing that.

Speaker #4: But yes, we are actively pursuing that.

Speaker #3: Sorry. So, there was a long question. What was the second half of the question regarding the pricing and all that?

Tom Lin: Sorry, that was the last question. What was the second half of the question regarding the pricing and all that?

Speaker #5: Yeah, I just wanted to get a sense of whether you, now that you've had the Phase 3 data in hand, have been able to do any additional payer market research in terms of how you're thinking about pricing.

Graig Suvannavejh: 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.

Speaker #3: Oh, got it. How did you get that?

Tom Lin: Oh, got it. Hao, did you get that?

Speaker #5: Yeah, yeah, I did. So, yeah, correct. We have done several pricing projects so far. So far, the payers have been super supportive of the price range that we're thinking about.

Hao-Yuan Chuang: Yeah, I did. Yeah, correct. We have done several pricing projects so far. Far, the payers have 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. I think we appreciate the payers have been showing a lot of support on this. It's still too early to really set the price. 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 kind of reference price. Maybe up to $500,000. That would be the range that you'll consider to compare with some of analog out there. We haven't really set the price. It's still early.

Speaker #5: And they definitely recognize the strong amount of need being the first treatment for Stargardt. So I think we appreciate the payers have been showing a lot of support on this.

Speaker #5: And it's still too early to really set the price. But I think we talk about, if people want to know maybe a reference price, we think that the average often drop price in the US is around $350,000.

Hao-Yuan Chuang: 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 kind of reference price. Maybe up to $500,000. That would be the range that you'll consider to compare with some of analog out there. We haven't really set the price. It's still early.

Speaker #5: That's a fair kind of reference price—maybe up to $500,000. That would be the range that you would consider, compared with some of the analogs out there.

Speaker #5: 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.

Hao-Yuan Chuang: We do see that this is a range that should be a fair assumption.

Speaker #4: Okay. Thank you.

Graig Suvannavejh: Okay, thank you.

Speaker #3: And just a reminder that if you would like to ask a question, you can use the raise hand function. Or, if you have dialed into today's call, you can press star 9 (*) to raise your hand, and star 6 (*) to unmute.

Speaker #3: Your next question comes from the line of E. Chen with HC Wainwright. Your line is open. Please go ahead.

Operator: Your next question comes from the line of Yi Chen with H.C. Wainwright. Your line is open. Please go ahead.

Speaker #6: Thank you for taking my questions. Assuming that you get the 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 you could reasonably expect to receive the TinLara band treatment in 2027?

Yi Chen: 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.

Speaker #6: Thank you.

Speaker #3: Oh, you want to carry on with this question as well?

Tom Lin: Hao, you want to carry on with this question as well?

Speaker #5: Yes, yeah. So, thank you. Well, this is a small molecule drug, so the manufacturing is not that complicated. And packaging and delivery are relatively easy compared with most of the other drugs.

Hao-Yuan Chuang: Yes. Well, thank you, Yi. This is a small molecule drug, so the manufacturing is not that complicated. The packaging, delivering, all relatively easy compared with most of the other drugs. We do expect that we should be fairly quickly be able to launch right upon approval. We are getting all the supply chain and the manufacturing ready right now. Yeah, in terms of the number of patients at the 1st year, I think, like I said earlier, we would like to do more survey and maybe get the market a good throughout survey and numbers probably in September on the commercial day event. We're doing everything we can to try to find all the potential database and doing all the surveys and all the so-called medical affair tasks to make sure we warn up the community.

Speaker #5: So, we do expect that we should be fairly quickly able to launch right upon approval. We are getting all the supply chain and the manufacturing ready right now.

Speaker #5: Yeah. In terms of the number of patients in the first year, I think, like I said earlier, we would like to do more surveys and maybe get the market a good, thorough kind of survey and numbers, probably in September on the commercial day event.

Hao-Yuan Chuang: Yeah, in terms of the number of patients at the 1st year, I think, like I said earlier, we would like to do more survey and maybe get the market a good throughout survey and numbers probably in September on the commercial day event. We're doing everything we can to try to find all the potential database and doing all the surveys and all the so-called medical affair tasks to make sure we warn up the community.

Speaker #5: 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 tasks to make sure we warm up the community.

Speaker #5: But I think we cannot provide specific guidance on today's call yet.

Hao-Yuan Chuang: I think we cannot provide a specific guidance on today's call yet.

Speaker #6: Thanks. And a quick question on the operating expenses. I noticed the first quarter numbers are meaningfully higher compared to the fourth quarter last year. Should we expect the operating expenses to continuously increase as you approach the FDA decision?

Yi Chen: Thanks. A quick question on the operating expenses. I noticed the Q1 numbers are meaningfully higher compared to Q4 last year. Shall we expect that the operating expenses to continuously increase as you approach the FDA decision?

Speaker #5: Oh, yeah. Well, it's a fair scenario as you get ready for launch. There's huge team expansion. And last year, we were somewhere close to 30 team members now.

Hao-Yuan Chuang: Oh, yeah. Well, it's a fair scenario as you get ready for launch. There's huge team expansion. Last year we were somewhere close to 30 team members now. We're now close to somewhere like 90, right? We are expanding the team fast and also doing all these activity that we talk about. We don't expect that expense will go up too much. It's a fair assumption that it will go up while we go towards commercialization. Compared to last quarter, that's really not a fair assumption because that was when we just started some of the preparation work. Like I said in the presentation, we're sitting on close to $800 million cash. We are in a very, very comfortable cash position. To launch Stargardt in the US, you probably look forward probably $300 million.

Speaker #5: We’re now close to somewhere like 90, right? So, we are expanding the team fast and also doing all these activities that we talked about.

Speaker #5: So, we don't expect that expense will go up too much, but it's a fair assumption that it will go up as we move towards commercialization.

Speaker #5: 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 in cash.

Hao-Yuan Chuang: Compared to last quarter, that's really not a fair assumption because that was when we just started some of the preparation work. Like I said in the presentation, we're sitting on close to $800 million cash. We are in a very, very comfortable cash position. To launch Stargardt in the US, you probably look forward probably $300 million.

Speaker #5: So we're in a very, very comfortable cash position. To launch STARGARD in the US, you probably look for probably $300 million US dollars. And our existing pipeline, as we talked about before, we expect the budget will be about $150 million for the next three years.

Hao-Yuan Chuang: Our existing pipeline, as we talked about before, we expect the budget will be about $150 million for next 3 years. In total, we're talking about $450 million at most of the budget, while we're sitting on $800 million. 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.

Speaker #5: 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.

Speaker #5: And this is going to be a good investment to make sure that we get all the awareness out there and try to help the patient as fast and as broad as we can.

Speaker #6: Got it. Thank you.

Yi Chen: Got it. Thank you.

Speaker #5: Thank you.

Hao-Yuan Chuang: Thank you.

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