Belite Bio (BLTE) Q3 2026 Earnings Call Transcript

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DATE

Thursday, Nov. 12, 2026

CALL PARTICIPANTS

• Chairman and Chief Executive Officer - Yu-Hsin Lin
• Chief Medical Officer - Hendrik Scholl
• Chief Scientific Officer - Nathan Mata
• Chief Financial Officer - Hao-Yuan Chuang

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TAKEAWAYS

• GAAP Research and Development Expenses -- $15.5 million, reflecting increases in active pharmaceutical ingredient manufacturing, drug product manufacturing, and consulting fees.
• Non-GAAP Research and Development Expenses -- $14.7 million, excluding share-based compensation of $773,000, compared to $8 million in the prior year.
• GAAP Selling, General, and Administrative Expenses -- $21.4 million, primarily driven by higher professional service fees.
• Non-GAAP Selling, General, and Administrative Expenses -- $16.3 million, excluding share-based compensation of $5.2 million, compared to $2.1 million in the prior year.
• GAAP Net Loss -- $30.3 million for the third quarter, compared to $21.7 million in 2025.
• Non-GAAP Net Loss -- $24.3 million, excluding share-based compensation expenses, compared to $8.8 million in the prior year.
• Cash, Cash Equivalents, and U.S. Treasury Bills -- $774 million as of Sept. 30, 2026, representing a slight decrease from $780 million at the end of the second quarter.
• Other Income -- $6.7 million, driven by interest income from bank deposits and U.S. Treasury securities.
• DRAGON Trial Primary Efficacy -- 35.7% reduction in the growth rate of retinal lesions compared with placebo, as measured by fundus autofluorescence imaging.
• Secondary Endpoint qAF Marker -- 2% decrease in quantitative autofluorescence from baseline at month 25 for the treatment group, versus a 20% increase for the placebo group.
• PHOENIX Trial Enrollment -- 530 subjects completed enrollment in the global Phase 3 trial for geographic atrophy.
• DRAGON II Trial Enrollment -- 73 subjects completed target enrollment, including 15 Japanese subjects, for the Phase 2/3 study in adolescent Stargardt disease patients.
• U.S. Stargardt Disease Patient Population -- 53,000 total diagnosed patients identified through company market research.
• Genetically Tested U.S. Patients -- 10,000 patients, representing approximately 50% of a more engaged patient subgroup.
• Japan Stargardt Disease Patient Population -- 10,000 patients estimated by the prevalence rate in the region.
• PDUFA Target Action Date -- Feb. 12, 2027, assigned by the FDA for the New Drug Application of Tinlarebant in Stargardt disease.
• DRAGON Trial Subject Count -- 104 subjects aged 12 to 20 years old were randomized in the pivotal Phase 3 trial.
• Nine-Month R&D Expenses -- $49.4 million, primarily attributable to a royalty payment for a milestone achieved in the second quarter and increased manufacturing costs.

SUMMARY

Belite Bio, Inc (NASDAQ:BLTE) reported significant regulatory milestones and clinical progress as it advances toward the potential commercialization of Tinlarebant for Stargardt disease. Management noted the FDA's acceptance of its New Drug Application for priority review and the filing of a J-NDA in Japan under the Sakigake designation. The company also expanded its global footprint by submitting marketing authorization applications in the United Kingdom, Switzerland, and Singapore through the Access Consortium framework. To support these initiatives, the company uplisted its securities to the NASDAQ Global Select Market and completed several clinical trial enrollments while maintaining a cash position of $774 million.

• Management reported that the FDA will not convene an advisory committee meeting to discuss the New Drug Application for Tinlarebant in Stargardt disease.
• The company has established a fully functional commercial team in Japan and expects to market Tinlarebant directly in that territory, according to CEO Yu-Hsin Lin.
• Chief Medical Officer Hendrik Scholl stated that a pediatric study for children under 12 years old is scheduled to begin at Moorfields Eye Hospital in the fourth quarter of 2026.
• Management indicated that an interim analysis for the Phase 3 PHOENIX trial in geographic atrophy will be deferred until after the Feb. 12, 2027, PDUFA date for Stargardt disease.
• The company launched a dedicated Stargardt disease website in Japanese and English to support prelaunch disease education and patient identification.
• CFO Hao-Yuan Chuang stated that the current cash runway is sufficient to support the potential commercialization of Tinlarebant and the continued advancement of the clinical pipeline.

INDUSTRY GLOSSARY

• ABCA4: A gene that provides instructions for making a protein that helps transport substances in and out of photoreceptor cells.
• Access Consortium: A collaborative framework among regulatory authorities in Australia, Canada, Singapore, Switzerland, and the United Kingdom.
• Bisretinoids: Fluorescent by-products of the visual cycle that accumulate as toxic deposits in the retina.
• DDAF: Definitely decreased autofluorescence, an imaging measurement used to quantify retinal lesion size and growth.
• Geographic Atrophy (GA): An advanced form of dry age-related macular degeneration characterized by the progressive loss of retinal tissue.
• PDUFA: The Prescription Drug User Fee Act, which sets deadlines for the FDA to complete its review of drug applications.
• qAF: Quantitative autofluorescence, a specialized imaging technique used to measure the accumulation of toxic bisretinoids in the eye.
• RBP4: Retinol binding protein 4, the primary carrier protein responsible for transporting vitamin A from the liver to the retina.
• RPE: Retinal pigment epithelium, the cell layer that nourishes and supports retinal visual cells.
• Sakigake Designation: A Japanese regulatory pathway designed to expedite the development and review of innovative medicines.
• Stargardt disease type 1 (STGD1): An inherited macular dystrophy caused by mutations in the ABCA4 gene leading to central vision loss.
• Tinlarebant (LBS-008): An oral, once-daily investigational drug designed to reduce the accumulation of toxins in the retina.

Full Conference Call Transcript

Operator: Ladies and gentlemen, thank you for joining us, and welcome to the Belite Bio Third Quarter 2026 Earnings Call. [Operator Instructions] I will now hand the conference over to Julie Fallon. Please go ahead.

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

Yu-Hsin Lin: Thank you, Julie. Good afternoon, everyone. Thank you for joining our third quarter 2026 financial results and corporate update call. This has been a transformative year for Belite Bio, and we are rapidly progressing on the regulatory front as we work to bring Tinlarebant to patients. We were very excited to report in August that the FDA accepted our NDA for Tinlarebant for priority review and a PDUFA date of February 12, 2027. The FDA has also informed us that it will not convene an advisory committee meeting to discuss the NDA for Tinlarebant in Stargardt disease. Since our U.S. NDA submission, we have also submitted a J-NDA in Japan under Sakigake Designation for accelerated review.

If approved, this will be the first Stargardt pharmaceutical product for ophthalmology disease in Japan. We have also submitted a marketing authorization application to the regulatory authorities in the U.K., Switzerland, and Singapore via the Access Consortium framework. While we will be thoughtful and measured in our international rollout strategy, these regulatory submissions are an important step toward a goal of making Tinlarebant available to Stargardt patients worldwide. On another note, we have recently announced that our stock has been uplisted from the NASDAQ Capital Market to the NASDAQ Global Select Market. This is the highest of the 3 NASDAQ market tiers.

The uplisting reflects the company's compliance with the NASDAQ Global Select Market, more stringent financial and liquidity standards as well as our continued progress in strengthening our financial profile and capital market presence. We are very proud of this achievement as we look to continually drive value for shareholders. As we make progress on the regulatory front, we are also continuing to build on our commercial plans and working to ensure optimal patient access to Tinlarebant by engaging early with payers and pharmacy benefits managers. We have already begun forging these important relationships to help us support broad coverage following potential approval.

We look forward to providing further updates as we come down to our PDUFA date, and I am confident in our ability to execute a quick launch and rapidly begin -- bringing this medicine to patients. I'll now turn the presentation over to Hao-Yuan to discuss the financials. Hao?

Hao-Yuan Chuang: Thank you, Tom. We have had a strong year so far and have executed well financially as we prepare for our first potential product launch. Let me recap our financial statements. For the third quarter of 2026, our R&D expenses were $15.5 million compared to $10.3 million in 2025. The increase in R&D expenses in the quarter was primarily attributable to increases in API manufacturing and DP manufacturing expenses, consulting fees, and sponsorship funding. On a non-GAAP basis, excluding share-based compensation expenses, R&D expenses in the third quarter was $14.7 million compared to $8 million in 2025. SG&A expenses in Q3 were $21.4 million compared to $12.7 million in 2025.

The increase in SG&A expenses in the quarter was primarily attributable to an increase in professional service fee. On a non-GAAP basis, SG&A expenses for the third quarter were $16.3 million compared to $2.1 million in 2025. GAAP net loss in the third quarter was $30.3 million compared to $21.7 million in 2025. On a non-GAAP basis, excluding share-based compensation, we reported a non-GAAP net loss of $24.3 million for the third quarter compared to $8.8 million in 2025. We ended the quarter with $774 million in cash, cash equivalents and U.S. Treasury bills compared to $780 million in Q2 2026. Overall, our balance sheet remains strong, and we are extremely well funded.

Looking ahead, we believe our current cash runway is sufficient to support the potential commercialization of Tinlarebant, subject to regulatory approval and to continue advancing our pipeline. With that, I'll now turn the call back to the operator for Q&A. Operator?

Operator: [Operator Instructions] And your first question comes from the line of Maxwell Skor with Morgan Stanley.

Maxwell Skor: Since PHOENIX enrolled patients with smaller lesions, how do you think about earlier intervention as a way to stand out in the GA market?

Yu-Hsin Lin: Thank you. Thanks, Maxwell. Hendrik, I think you are the best person to answer this.

Hendrik Scholl: Yes, I'm happy to take that question. So the inclusion criteria of our PHOENIX trial include a range of lesion sizes that would also cover smaller lesions. And if we find specifically positive effect on smaller lesions that would become obvious when the trial results are available. It is correct that targeting bisretinoid accumulation in the RPE could indeed be something that preserves and photoreceptors early on and could indeed have a very positive treatment effect in earlier disease stages while geographic atrophy is already a late disease stage of AMD.

Operator: And your next question comes from Tazeen Ahmad with Bank of America.

Tazeen Ahmad: Okay. Great. Sorry, I'm traveling, and I can't see the screen. So thanks for the update about the AdCom. Making the assumption that it's more likely that the product does get approved on time looking at a February PDUFA, can you talk to us about what your plans are for submission for ex U.S. geographies and possible time lines for the first approval in your first country there? And then for GA, have you had any discussions with FDA on what exactly they would want to see on an interim analysis?

Yu-Hsin Lin: So first on the GA, we haven't had much communication with the FDA regarding the GA study. So far, we want to keep the FDA focused on our Stargardt NDA submission. I think that's the most important thing for us right now. In terms of submissions for regulatory authorities worldwide, right now, it's the FDA and then the Japan PMDA and of course, the U.K., Switzerland and Singapore consortium. So that's the current submission so far. So we're planning for others to roll-out, but we can only take on so many regulatory reviews.

It's a lot of work, and we want to kind of don't want to take over -- take on too much work as we are still focused on the U.S. FDA that's the most important approval.

Hao-Yuan Chuang: Yes. But we definitely recognize there is an urgent need for therapies for the Stargardt disease. So we're doing everything we can to try to bring the treatment to the patient worldwide as soon as we can.

Hendrik Scholl: If I may add to the interim analysis at this time, we plan to conduct the interim analysis, but we have not confirmed the design as we have been focusing on the Stargardt commercial preparedness. So we will share more information once we confirm.

Operator: And your next question comes from the line of Steve Seedhouse with Cantor.

Steven Seedhouse: I just wanted to confirm first because it's a question we get a lot and keep getting. Have you had your mid-cycle review meeting with the FDA? And generally, how do you feel the dialogue with FDA has been going with respect to the Tinlarebant review?

Yu-Hsin Lin: Yes. So the answer is, yes, we had our mid-cycle review already. It has been incredibly smooth so far, but we don't want to overspeculate and we remain neutral for now.

Steven Seedhouse: Okay. Great. And I wanted to ask about Japan. What steps have you taken as a company to prepare for commercialization in Japan, I guess, which could be possible next year? And maybe you could talk a little bit about the Stargardt market in Japan by comparison to the U.S.

Yu-Hsin Lin: Hao, do you want to answer this question?

Hao-Yuan Chuang: Sure, sure, sure. Yes. So we do know that there's about 10,000 Stargardt disease patients by the prevalence rate in Japan. And we have built a Japan team that is ready to launch in Japan. Our disease website also launched in Japanese in Japan. And there's some of the disease education activity, preapproval kind of compliance that we're working on right now. So yes, the team is doing the same as what the U.S. team is doing to get the commercialization ready.

Yu-Hsin Lin: So on the regulatory part, I think the PMDA -- the pace of PMDA is incredibly fast. It has been very smooth so far. But again, we want to remain neutral and don't want to overspeculate.

Steven Seedhouse: Very good. And then just lastly, I was hoping you could provide an update on -- if there are plans still this year to start the study in younger children. I think that was intended to start in the U.K. initially. I just wanted to get an update on that study in children under 12.

Yu-Hsin Lin: Yes, of course. Hendrik?

Hendrik Scholl: Happy to take the question. So we needed one extra IRB review that came back positive, I believe, 4 or 3 weeks ago. So we will definitely start this PIP study, this pediatric study at Moorfields Eye Hospital in this quarter, so before the end of the year.

Operator: And your next question comes from the line of Marc Goodman with Leerink.

Marc Goodman: So based on your FDA interactions, what are you expecting the label to look like? Second question is, what do you think right now consensus is for pricing? And how do you think about that? And then third, did I hear you correctly, Japan, the plan is to go it alone in Japan and build an infrastructure there and sell it yourself?

Yu-Hsin Lin: Yes. So the question regarding Japan, yes, we already built a team. It's a fully functional team in Japan, and we expect to market the drug in Japan ourselves. What was the second question, sorry?

Marc Goodman: FDA interactions, what do you expect the label to look like?

Yu-Hsin Lin: So far, we haven't had a discussion on the label yet. But I think right now, given the questions that were asked from the FDA, I think everything is still remain on the path that we expect. Again, there's -- I can't reveal too much at this moment, but we want to stay neutral. And then, of course, if there's more information that we could reveal, then we'll do this at -- when we have a better -- once the information is more clear, then we can discuss this openly.

Marc Goodman: Right. But just to be clear, your expectation and hope was always that you get a broad-label from the beginning, right?

Yu-Hsin Lin: At this moment, yes, that's what our expectation is, but we don't want to, again, overspeculate too much at this moment.

Marc Goodman: That's fair.

Hendrik Scholl: Maybe, Marc, if I can add here. So I mean, this was discussed before, and there's a clear understanding at the FDA that this is a genetically caused disease due to dysfunction of ABCA4, and that is true for all patients regardless of disease onset or age. So it's also true, and this was shown in the ProgStar study, that lesion growth profiles are not dramatically different between adolescent and adult patients. And there's also no evidence to suggest that there would be a difference between the 2 patient populations in treatment response. So that's a scientific response, but I think it's important to understand there that disease progression and growth profiles are quite homogeneous across all ages.

Marc Goodman: And then the other question was just what's the consensus view right now on pricing out there?

Hao-Yuan Chuang: Well, Marc, I cannot say we get a consensus out there for everyone. But we have disclosed that. We have done several payers survey and the payers all seems to be very supportive and recognize the strong unmet need of Stargardt disease. Everybody recognize Stargardt is a rare, progressive, vision-threatening disease with no treatment. So we believe that being a potential first-in-class treatment, we expect the pricing to reflect the rare disease profile, clinical benefit and the unmet need and benchmarking with other rare ophthalmology and pediatric orphan therapies. Yes. So we still think that the rare disease pricing is still the guidance that we can provide.

Operator: And your next question comes from Whitney Ijem with Canaccord.

Whitney Ijem: Just first, I wanted to go back to some of the patient characterization you did in the U.S. I think you talked about 20,000 patients diagnosed and 50% genetically tested. Of the genetically tested folks, just curious what percent of those are kind of like actively under the care of an IRD specialist or a retina specialist. I know there had also been some discussion about, as patients get more comfortable with their disease, they kind of come in less frequently. So just curious how many are kind of actively in the system?

And is there any information you're willing to give at this point about how concentrated they are versus more dispersed just relative to your kind of initial target docs or centers?

Yu-Hsin Lin: Hendrik, do you want to answer this question?

Hendrik Scholl: Yes. Happy to take the question. It's complex. So to the first question, patients that have been genetically confirmed belong to the subgroup of all patients out there when we use numbers would be roughly 10,000 compared to total population of 53,000, and this represents a more engaged patient population, which was the reason in the beginning why they would undergo genetic confirmation. So I think this is important out of the 53,000 patients out there, this subgroup would be more readily available because they would typically be under regular care. The second question, how concentrated are these patients. So it's still an IRD, an inherited retinal disease. It's still monogenic. It comes to genetic testing.

So these patients are typically being seen by IRD specialists, but also retinal specialists, not so much by general ophthalmologists, but they would be referred from general ophthalmologists through retinal specialists and/or IRD specialists. So there's a concentration of patients in larger centers, large private practices and academic centers. But given that the disease is not so rare, there are also other patients out there that would need to be diagnosed and then treated by retinal specialists that are not necessarily in large practices and academic centers.

And we are -- our market research shows that we can find these patients and we can provide information to both general ophthalmologists and retinal specialists, they do not necessarily work in large centers.

Whitney Ijem: Got it. Very helpful. And then do you have similar numbers in terms of Japan in terms of the diagnosed patients and then percent genetically tested?

Hendrik Scholl: Yes, but maybe what we can say about Japan is we have a heavily engaged IRD specialist community. So it's a real pleasure to work with those academic centers in Japan. In Japan, the concentration that we just discussed is more significant than in the U.S. Those patients are almost exclusively seen in larger academic centers. And Japanese physicians are very much willing and happy to perform genetic testing on their patients.

Hao-Yuan Chuang: Japan will be fairly quick, we believe, to catch up on those testing because they work as a national health care system. So once testing is approved and reimbursed by the government, Japan is relatively concentrated on major hospitals for this kind of testing. And I think currently, they have 12, and they're adding that additionally. So we think that testing rate will easily be covered once the reimbursement by the government is announced, which we know is on the way.

Operator: And your next question comes from the line of Graig Suvannavejh with Mizuho.

Graig Suvannavejh: Congrats on the progress. I know you had commented on a mid-cycle review. Can you comment maybe on your -- if the late cycle review meeting has happened? And maybe in connection or related to that, can you comment on pre-approval inspection time lines, labeling discussion time lines? Just trying to figure out what is left from your perspective that still needs to be checked in terms of boxes.

Yu-Hsin Lin: Yes. So we already have a date for -- schedule for late cycle review, but I think that's as much as we can say for now.

Graig Suvannavejh: Okay. Great. Maybe then just a follow-up on the GA opportunity, which I don't think a lot of investors have given you much credit for just yet. But can you just remind us on the communication strategy around that data readout and timing?

Yu-Hsin Lin: Yes. So right now, all our team that's involved in the NDA submission process, the scientific team, the same scientific team will be the team that's going to coordinate and organize that GA interim analysis. So we don't want to take away the bandwidth. We maintain that Stargardt study is still the most important -- the Stargardt approval is still the most important milestone for this company. And so we were only going to get on the GA interim analysis once we have the February PDUFA date completed and then we can move on to the GA analysis.

Operator: And we have a follow-up question from Tazeen Ahmad with Bank of America. All right. This concludes today's call. Thank you for attending. You may now disconnect.

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