Belite Bio (NASDAQ:BLTE) held its first-quarter earnings conference call on Wednesday. Below is the complete transcript from the call.
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The full earnings call is available at https://events.q4inc.com/attendee/135456520
Summary
Belite Bio Inc reported a significant increase in R&D and SG&A expenses for Q1 2026, driven by clinical trial spending and team expansion, leading to a non-GAAP net loss of $13.7 million.
The company initiated its NDA rolling submission to the FDA for Stargardt’s Disease and aims to complete this by Q2 2026, with commercial launch preparations underway.
Belite Bio has completed enrollment for its Phase 2/3 Dragon 2 clinical trial in Japan, positioning itself for a pivotal year as it transitions to a commercial-stage company.
Belite Bio ended Q1 2026 with a strong cash position of $799 million, providing ample capital to support its strategic goals, including FDA submissions and commercialization efforts.
Management emphasized the company’s focus on expanding its commercial infrastructure and engaging with the retinal community to ensure a successful launch of its therapies.
Full Transcript
OPERATOR
Ladies and Gentlemen, thank you for joining us and welcome to the Belite Bio Inc 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.
Julie Fallon
Good afternoon everyone. Thank you for joining us. On the call today are Dr. Tom Lin, Chairman and CEO of Belite Bio Inc, Dr. Hendrik Scholl, Chief Medical Officer, Dr. Nathan Mata, Chief Scientific Officer and Haoyong Zhong, 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 issue today. And now I’ll turn the call over to Dr. Lin. Dr. Lin, thank you.
Tom Lin
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 Stargardt’s 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 their commitment to bring Tinlarabanch to patients around the world this past quarter we also announced that we have completed enrollment in our Phase 23 Dragon 2 clinical trial evaluating Tinlarabanch in Stargardt’s Disease. This trial enrolled 73 adolescents and adult subjects aged 12 to 20 years old 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 disease and certain unmet medical needs. I’ll now turn over the presentation to Haoyan to discuss the financials.
Haoyong Zhong (Chief Financial Officer)
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 APR and drug product manufacturing expenses and higher consultant and professional service fee. On a non GAAP base excluding share based compensation expenses, R and 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 and 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 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. 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 SGA, our balance sheet remains very strong. Specifically with proceed from ESOP and Warren 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 give us ample capital to execute on our goals, including finalizing our NDA application, preparing for the commercialization in Stargardt’s disease and completing our ongoing clinical trials. With that, I’ll now turn the call back to the operator for Q and A Operator.
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 9 to raise your hand. Star 6 to unmute. Please stand by as we compile the Q and A roster. And your first question comes from the line of Judah Frommer with Morgan Stanley. Your line is open. Please go ahead.
Judah Frommer
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 read-out 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 that is confirmatory and how could that play into timelines? Thank you.
Tom Lin
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 interim 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, I think you mean Dragon 2 or Dragon 2. Yes, Dragon 2. Sorry, sorry about that. So we don’t believe that the Dragon 2 data would be applicable to 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. But the Dragon 2 is mostly for Japanese regulatory requirements. I hope that answers some questions. Yeah, no, that’s great.
Judah Frommer
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 salesforce team could be here? Just given how concentrated the patient population is and where they’re seen by centers of excellence. Thank you.
Haoyong Zhong (Chief Financial Officer)
How you are probably better to answer this. Yeah, well, you know, we do expect that we’re going to have two teams. One for the diagnostic promotion team 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 they 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, you know, database of Stargardt’s disease patient confirmed with genetic testing. We’re doing a lot of survey right now. We do expect to get the market update about what we know what we’re going to be doing hoping 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, you know, treatment and continue to be follow up with their physicians. So we’ll be focused on the retina specialist community communities, 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.
Judah Frommer
Great, thank you.
OPERATOR
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.
Mark Goodman
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 Geographic Atrophy indication ends up looking really, really strong. Thanks, Mark. So for ga. So right now we are focused on getting the FDA approval for Stargardt’s disease. We are aiming for the interim for Geographic Atrophy 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 an answer 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 sense of that, right? I mean, yes. So we’re aiming for end of the year, but it all depends on the coordination and getting, getting ready with the CEOs. And also it’s a much, much more, bigger data than the starless disease. So logistically wise I think it’s a bit more complicated, but we aim for it. Yeah. And then just back on Stargard, what’s the timeline for Japan again?
Tom Lin
How is that? 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. Got it. Thank you. So we’re looking on track for that as well.
Mark Goodman
Thank you.
OPERATOR
And your next question comes from the line of Steve Seedhouse with Cantor. Your line is open. Please go ahead.
Steve Seedhouse
Great, thanks. And thanks for the color on the, the commercial preparations in the U.S. 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, you know, launch strategy, partnering strategy if relevant. Would love your current thinking on the ex US opportunity.
Tom Lin
Sure, sure. 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 rest of the world will be consistent with that FDA filing. So the timeline will be based on what the responses 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.
Steve Seedhouse
Okay, terrific. And I just want to follow up on the Geographic Atrophy 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?
Tom Lin
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. Okay, thank you very much. And Steve, if I can make 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’s. But you know, like Tom Lin said, some of these will be data driven and we did recognize that, you know, Stargardt’s 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. Thank you.
OPERATOR
And your next question comes from the line of Greg Svanoveg with Mizuho. Your line is open. Please go ahead.
Greg Svanoveg
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 is of Tinlarabanch right now with the prescribing community and whether once you get to a place of launch, how much education will be needed? Thanks.
Tom Lin
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.
Andrew Stasiak
Andrew, you want to go ahead first? I can start? Certainly. So I mean the IID 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 Inc and Tinlarabanch. 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 retinal specialists that have in depth knowledge about 10 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, forthcoming treatment for Stargardt’s disease. But yes, we are actively pursuing that.
Greg Svanoveg
Sorry, so that was a lot of questions. So what was the second of the question regarding the pricing and all that?
Haoyong Zhong (Chief Financial Officer)
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. Got it. Hal, did you 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 unmet need being the first treatment for Stargardt’s. 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, you know, the average open drug price in the US around 350,000. That’s a fair kind of reference price, maybe up to 500,000. That will be the range that you 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 assumptions. Okay, thank you.
OPERATOR
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 9 to raise your hand, 6 to unmute. Your next question comes from the line of I. Chen with H.C. wainwright. Your line is open. Please go ahead.
I. Chen
Thank you for taking my questions. Assuming that you get at 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 could you reasonably expect to receive the tularoban treatment in 2027? Thank you.
Tom Lin
You want to carry all of this question? Yes, yes. So thank you. Yi. Well this is a small molecule drug so the manufacturing is not that complicated and you know, 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 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 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.
I. Chen
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?
Haoyong Zhong (Chief Financial Officer)
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 like 30 team members. Now we’re now close to somewhere like 90. So we are expanding the team fast and also doing all these activities that we talk 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. 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’s disease easily in the US you probably look forward to 300 million and our existing pipeline. As we talked about before, we expect the budget will be about 150 million for the 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 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 Stargardt’s disease patients as fast, as broad as we can.
Tom Lin
Got it. Thank you. Thank you.
Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company’s SEC filings and official press releases. Corporate participants’ and analysts’ statements reflect their views as of the date of this call and are subject to change without notice.
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