Belite Bio, Inc (BLTE) Q1 2026 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for joining us, welcome to the Belite Bio first Quarter 26 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. If you have dialed in to today's call, please press 9 to raise your hand. And 6 to unmute. I will now hand the conference over to Julie Fallon. Please go ahead.

Good afternoon, everyone. Thank you for joining us. On the call today are doctor Tom Lin, chairman and CEO of Belite Bio, Doctor. Hendrik Scholl, Chief Medical Officer Doctor. Nathan L. 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. These statements are subject to certain risks and uncertainties, and actual results may differ materially. 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. And now I will turn the call over to Doctor. Lin. Doctor Lin?

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. Have received our Phase 3 clinical study report in Q1 without delay in April we initiated our NDA rolling submission to the FDA for Stargardt disease. 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. We have hired all commercial leadership positions and continue to build out our teams in sales, market access, and medical affairs, 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, 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 2/3 Dragon 2 clinical trial evaluating Tinlarebant for Stargardt disease. This trial enrolled 73 adolescents and adult subjects aged 12 to 20 years or 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. I will now turn the presentation over to Hao-Yuan to discuss the financials. Hao-Yuan?

Thank you, Tom. In Q1 26, our R&D expenses were 15.7 million compared to 9.4 million in Q1 25. The increase was mainly driven by higher spending on the Dragon 2 trial, increased APR and drug product manufacturing expenses, and higher consultant and professional service fees. On a non-GAAP basis, excluding share based compensation expenses, R&D expenses in Q1 26, were 13.8 million compared to 7.4 million in Q1 25. SG&A expenses in Q1 26 were 17 million compared to $6.1 million in Q1 25. The increase in SG&A expenses was primarily due to an increase in share-based compensation expenses, professional service fees, wages, and salaries resulting from our team expansion. On a non-GAAP basis, excluding share based compensation expenses, the SG&A expenses in Q1 26 were 5.7 million compared to $1.5 million in Q1 25. 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 26 compared to 7.6 million in Q1 25. Despite the increased investment in R&D and SG and A, our balance sheet remains very strong. Specifically, with proceeds from ESOP and warrant exercise, We ended Q1 with $799 million in cash equivalent, and U. S. Treasury bills. A higher balance than at the end of 25. 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 will now turn the call back to the operator for Q and A. 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 in to today's call, please press 9 to raise your hand. 6 to unmute. Please standby as we compile the Q&A roster. And your first question comes from the line of Judah Frommer with Morgan Stanley. Your line is open. Please go ahead.

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 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 2 results, what are the chances that it is confirmatory? And how could that play into time lines? Thank you. Thanks.

Thanks, Judah. So that is a great question. So we had several meetings with the FDA including a meeting with the FDA to discuss the strong positive data interim analysis. And it is the FDA's recommendation that we complete the Dragon 2 study at 2 years with a possible path to 1 single study approval based on the robustness of our data. And obviously, I think you mean Dragon 1, not Dragon 2. Yes. Dragon 1. Sorry. Sorry about that. So we do not believe that the Dragon 2 data would be applicable to our FDA filings. But even if there is 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. But Dragon 2 is mostly for Japan regulatory requirements. I hope that answers your question. Yes, that is great. And then just maybe touching on building out the commercial infrastructure. What are your latest thoughts on how targeted the, the commercial team or the field salesforce team could be here, just given how concentrated the patient population is and where they are seen by centers of excellence. Thank you. How about you? it is probably better to answer this. Yeah.

Well, we do expect that we are going to have 2 teams. 1 for the diagnostic promotion to bring more disease awareness and awareness to genetic testing to make sure that is an easy kind of reach out for the patient to be diagnosed and get that testing confirmed. And we will also have another team more focused on, you know, promoting the drug. In total, we are thinking about, you know, 30 to maybe 40 total team members for that regard. We do know that there are many retina specialists that already have, you know, a database of Stargardt disease patients confirmed with genetic testing. We are doing a lot of surveys right now. We do expect to get the market an update about what we know, what we are going to be doing, hopefully, in September. So, you know, you will have a better idea about the whole plan and what has already come from out there. But long story short, we do see that there are many patients are very incentivized to this treatment, and continue to be followed up with their physicians. So we will be focused on, you know, the retina specialist communities, the patient advocacy group to better understand the needs and also, of course, the general ophthalmologist and probably the low vision of optometrist community as well. Great. Thank you.

And 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.

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

Thanks, Marc. So for GA, so 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 do not know what the data is going to be like. And if it is a strong positive data, then it is a good problem to have. But at this time, we do not know what the data looks like, so we have not given it much thought in terms of strategy. So I do not think I have answered for you now, probably near the time when we have it, we will probably have a better idea.

Right. Okay. So you will have a sense of that. Right?

I mean Yes. So we are aiming for end of the year, but it all depends on the coordination and getting the data ready with the CROs and OSO. it is a much, much more bigger data than the Stargardt disease. So I think I think it is a bit more complicated, but we aim for end of the year. Yeah.

And then just back on Stargardt, what is the timeline for Japan again?

Oh, I think Japan, given that we have Sakigake Designation, the Pioneer Designation, I think the approval, the PMDA is aiming for approval within 3 months of the FDA approval. Got it. Thank you. So we are looking on track for that as well. Thank you.

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

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 are thinking about filing timeline, you know, launch strategy, partnering strategy, if relevant, Would love your current thinking on the ex US opportunity.

Sure. Sure. So, again, right now, we are focusing on the FDA approval. So within the submission timeline, this 6-month review period we are expecting, you know, to have some questions from the FDA, so we do not wanna overstretch ourselves and file in different jurisdictions while we are 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 that f FDA filing. So the timeline will be based on what the responses from the FDA. So at this point, again, the timeline, we will need to update you on that. So the FDA will serve as our priority. Okay. Terrific. And, I just wanna 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, like, can you just talk about maybe just some of the possible scenarios for analysis? So this is just assuming what I think the possible scenario is probably resizing the study So the data will show us, you know, the sample size is going to be after that interim. So again, this will be a data-driven decision and strategy.

Okay. Thank you very much.

And, Steve, if I can make an additional comment, you know, 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, you know, Stargardt disease in The US will be our first focus. But we will continue to monitor all the other development and definitely try to bring the treatment to all the patients as soon as we can. Thank you.

And your next question comes from the line of Greg Swanovic with Mizuho. Your line is open. Please go ahead.

Hey, it is Greg. Thanks so much for taking my questions. Congrats on progress. I had 2 questions, if I could. 1, it is been some time now since you have 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 precommercial 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.

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

Sure. Hendrik, you want to go ahead first? I can start certainly. I mean, the R&D and retina specialist community is a very well defined community that meets regularly at ARVO, ASRS, 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. 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 Retinal Specialists meeting in Montreal in July. We will be at the Retinal Society meeting in Los Angeles. In September, we will be at 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, we are actively pursuing that. Sorry.

So that was a long question. So what was the second half of the question regarding the pricing and all that? Yeah. I just wanted to get a sense of whether you, now that you have had the Phase 3 data in hand, whether you have been able to do any additional, payer market research in terms of how you are thinking about pricing? Oh, got it. Hao, did you get that?

Yeah, yeah, I did. So, yep. Greg, so we have done several pricing projects so far. You know, so far, the payers has been super supportive of the price range that we are 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 on this. And, you know, it is still too early. To really set the price. But, you know, I think we talk about you know, if people want to know maybe a reference price, we think that, you know, the average open drug price in The US $350 thousand. that is a fair kind of reference price. Maybe up to, you know, $500 thousand. That will be the range that, you know, you would consider compared with some of the analogs out there. But we have not really set the price. it is still early, but we do see that you know, this is a range that should be a fair assumptions.

Okay. Thank you.

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 in to today's call, you can press 9 to raise your hand. 6 to unmute. Your next question comes from the line of Yi Chen with HC Wainwright. Your line is open. Please go ahead.

Thank you for taking my questions. Assuming that you get FDA approval in early 27, can you tell us how quickly you can launch the drug, whether your manufacturing facility is in alignment with that timing, 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.

Hao, you want to carry all of this question as well?

Yes. Yes. So, Yi. Well, this is a small molecule drug. So the manufacturing is not that complicated. And 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 approval. We are, you know, getting all the supply chain and the manufacturing ready right now. In terms of the number of patients at the first year, I think, you know, like I said earlier, we would like to do more survey and maybe give the market a good, you know, thorough kind of survey and numbers probably in September. at a commercial day event. So we are doing everything we can to try to find, you know, all this potential database and doing all the surveys and, you know, all the so called medical affair task to make sure we warm up the community. But I think we cannot provide a specific guidance on today's call yet. 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 OpEx is expected to continuously increase as you approach the FDA decision.

Oh, yeah. Well, it is a fair, you know, scenario as you get ready for launch.

there is, you know, huge team expansion and we, you know, last year, we were somewhere close to, like, 30 team members now. We are now somewhere close to 90. Right? So we are expanding the team fast and also, you know, doing all these activity that we talk about. So we do not expect that, you know, expenses will go up too much but, you know, it is a fair assumption that, you know, it will go up while we go toward commercialization. And compared to last quarter, that is really not a fair assumption because that was when we just started some of the preparation work. But, you know, like I said, in the presentation, you know, we are sitting on close to $800 million in cash. So we are in a very, very comfortable cash position. To launch Stargardt in The US, you would probably look for probably $300 million. And our existing pipeline as we talk about before, we expect the budget will be about $150 million for, you know, next 3 years. In total, we are talking about $450 million at most for the budget. Well, we are sitting on $800 million. So we think we are very comfortable on cash, and you know, this is gonna be a good investment to be made to make sure that we get all the awareness out there, try to help the patients as fast and as broad as we can.

Got it. Thank you.

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