Belite Bio, Inc Q2 FY2026 Earnings Call

Ladies and gentlemen, thank you for joining us and welcome to the Beelite Bio first quarter 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. If you have dialed into today's call, please press star nine to raise your hand and star six 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 Dr. Tom Lin, Chairman and CEO of BeLiveBio, Dr. Hendrick Scholl, Chief Medical Officer, Dr. Nathan Mata, Chief Scientific Officer, and Haoyang Zhang, 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. 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. And now I'll turn the call over to Dr. Lin. Dr. 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. 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 Stargardt's 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. We're also building out our commercial infrastructure, as well as engaging with the retinal community to raise awareness of star disease. We're 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 Tenebent 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 10-11 in Stardust 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 Belight as we begin our transition to a commercial stage company. We look forward to providing further updates on our work bringing therapies for retinal degenerate disease and significant medical needs. I'll now turn over the presentation to Hao Yen to discuss the financials.

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 base, 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 the non-GAAP base, excluding share-based compensation expenses, the SG&A expenses in Q1-2026 were $5.7 million compared to $1.5 million in Q1-2025. Gap net loss for the quarter was $26.9 million, compared to $14.3 million in the same period last year. On a non-gap basis, excluding share base 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 a proceed from ESOP and Warren exercise, we ended Q1 with $799 million in cash, cash equipment, and U.S. 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 Starga disease, and completing our ongoing clinical trials. With that, I'll now turn the call back to the operator for Q&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 star nine to raise your hand, star six to unmute. Please stand by 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, you know, what confidence do you have based on communication with FDA that that readout will not be necessary for an approval decision in the U.S.? And then I guess on the flip side of that, if FDA does imply that they would like to see Dragon 2 results, you know, what are the chances that that is confirmatory and how could that play into timelines? Thank you.

Thanks. Thanks, Gita. So that's a great, great question. So we had several meetings with the FDA, including a meeting with the FDA to discuss the strong positive data in term analysis. And it's the FDA's recommendation that we complete the Dragon 2 study at two years with a possible path to one single study approval based on the robustness of our data.

And obviously, you mean Dragon 1, no Dragon 2.

Yes, Dragon 1. Sorry. Sorry about that. So we don't believe that the DRAGON2 data would be applicable to FDA filings. But even if there's a slight chance of that happening, we could always have the DRAGON2 data available, at least the interim part of that to serve as a confirmatory evidence. But the DRAGON2 is mostly for Japan regulatory requirements. I hope that answers your questions.

Yeah, no, that's great. And then just maybe touching on building out the commercial infrastructure, you know, what are your latest thoughts on how targeted the commercial team or the field Salesforce team could be here, just given how concentrated the patient population is and where they're seen by centers of excellence? Thank you.

How have you got better to answer this?

Yeah, well, you know, 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 to be diagnosed and get that testing confirmed. And they also have another team more focused on, you know, promoting the drug. In total, we're thinking about, you know, 30 to maybe 40 total team members for that regard. We do know that, you know, there are many retina specialists that already have, you know, a database of STAGA DC patients confirmed with genetic testing. We're doing a long survey 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. So, you know, 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 follow up with their physicians. So we'll be focused on the retina specialist community, the patient advocacy group to better understand the needs, and also, of course, the general ophthalmologist and probably the low vision optometrist community as well.

Great. Thank you. And your next question comes from the line of Mark Goodman with Lee Rink. Your line is open. Please go ahead. A reminder that you may need to unmute locally.

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?

Thanks, Mark. So for GA, so right now we're focused on getting the FDA approval for Stardust 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 it much thought in terms of strategy anyway so I don't think I've answered for you now probably near the near the time when we have the interim we probably have a better idea right okay so you will have a a sense of that right i mean yes so we're aiming for end of the year but it all depends on um the coordination and getting getting the data ready with the cls and all so it's a much much more bigger data um than um the starglass disease so uh logistic wise i think i think it's a bit more complicated but we Yeah.

And then just back on StarGuard, what's the timeline for Japan again?

I think Japan, given that we have Sagigake destination, the Pioneer destination, I think the approval, the PMDA is aiming for approval within three months of the FDA approval. Got it. Thank you. So we're 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 U.S. I actually just wanted to ask about, on the other side, ex-U.S., particularly in Europe, But sort of how you're thinking about filing timeline, you know, launch strategy, partnering strategy, if relevant, would love your current thinking on the ex-US opportunity.

So again, right now we are focusing on the FDA approval. So within the submission timeline, the six-month review 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 the rest of the world will be consistent with that FDA filing. So the timeline will be based on what the response is from the FDA. So at this point, again, the timeline will need to update you on that. So the FDA will serve as our priority.

Okay, 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, resized the study, stop the study, either for efficacy or futility? Can you just talk about maybe just some of the possible scenarios?

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.

So again, this will be a data-driven decision and strategy. okay thank you very much and steve if i can make a additional comment you know we definitely are trying everything that we can do uh to try to bring this treatment to all the patients around the world uh both on g and staga um but you know like tom said uh some of these will be data driven and we did recognize that you know uh staga disease in the u.s 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.

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

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. Have you done any additional testing market research wise with payers in terms of potential pricing bans 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 Tin Larabent right now with the prescribing community and whether once you get to a place of launch, how much education will be needed.

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

Hendrik, you want to go ahead first?

I can start. Certainly. So, I mean, the IRD and retinal specialist community is a very well-defined community that meets regularly at ARVO, ASRS and the American Academy meeting. People know about Abilite Bio and Antin Laraband. He 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 retinal specialists that have in-depth knowledge about Tim Laraband 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 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 Stalker disease. But yes, we are actively pursuing that.

Sorry, so that was a lot of questions. So what was the second of the question regarding the pricing and all that?

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

Oh, got it. How did he get that?

Yeah, yeah, I did. So, yeah, 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're thinking about, and they definitely recognize the strong met need being the first treatment for stock. So I think we appreciate the payers has been showing a lot of support on this. And, you know, it's 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 the average open drop price in the U.S. around $350,000, that's a fair kind of reference price. maybe up to, you know, $500,000. That would be the range that, you know, you'll consider to compare with some of the analog out there. But we haven't really set the price. It's still early. But we do see that, you know, this is a range that should be a fair assumption.

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 into today's call, you can press star nine to raise your hand, star six to unmute. Your next question comes from the line of E. Chen with H.C. Wainwright. Your line is open. Please go ahead. 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 telarabam treatment in 2027?

Oh, you want to carry on with this question as well? Yeah, yeah.

So thank you. Well, this is a small molecule drug. So the manufacturing is not that complicated and packaging, delivering are 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. Yeah, 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, you know, all this potential database and doing all the surveys and, you know, all the so-called medical affairs tasks 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 upper expenses to continuously increase as you approach the FDA decision?

Oh, yeah. Well, it's a fair scenario as you get ready for launch. There's a huge team expansion. And 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, you know, doing all these activities that we talk about. So we don't expect that, you know, it's going to go up too much. But, you know, it's a fair assumption that, you know, it will go up while we go toward commercialization. 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, you know, like I said in the presentation, you know, we're sitting on close to $800 million cash. So we're in a very, very comfortable cash position. To launch stock up in the U.S., you probably look forward, you know, probably $300 million U.S. dollar. And our existing pipeline, as we talked about before, we expect the budget will be about $150 million for, you know, next three 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, you know, 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.

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.