Belite Bio, Inc (BLTE) Earnings Call Transcript
November 12, 2026
Earnings Call Speaker Segments
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.
Good afternoon. Thank you for joining us today. On the call are Dr. Tom Lin, Chairman and CEO of Blite 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 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, everyone. Thank you for joining our third quarter 2026 Financial Results and Corporate Update Call. This has been a transformative year for Bilte Bio. and we are rapidly progressing on the regulatory front as we work to bring to neobank to patients. We were very excited to report in August that the FDA accepted our NDA for Tetra with priority review and a PDUFA date of February 12, 2027. The FDA has also informed us that it will not convene and advisory committee meeting to discuss the NDA for tenement in Stages disease. Since our U.S. NDA submission, we have also submitted a JNDA in Japan under Saudi target designation for accelerated review. If approved, this will be the first Sakigake pharmaceutical product for ophthalmology disease in Japan. We have also submitted a marketing authorization application to the regulatory authorities, either U.K., Switzerland and Singapore via the excess consortium framework. While we will be so full and measured in our international rollout strategy, these regulatory submissions are an important step toward a goal of making Tenant available to start up 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. And this is the highest of the 3 NASDAQ market tiers. The uplisting reflects the company's compliance with the NASDAQ Global Select markets, 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 tenement by engaging early with payers and pharmacy benefit 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 particular date. and I am confident in our ability to execute a quick launch and rapidly begin bringing this medicine to patients. I will now turn the presentation over to Hain to discuss the financials. Hal?
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 statement. 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 an increase in API manufacturing and DP manufacturing expenses, consulting fees and sponsorship ones. 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 was $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 of 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 Telaria 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 Instructions] And your first question comes from the line of Maxwell Skor with Morgan Stanley.
Since Phoenix enrolled patients with smaller lesions, how do you think about earlier intervention as a way to stand out in the GA market.
Thanks, Mike. Hendrik, I think you are the best closer to answer this.
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 base retina 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 latest stage of AMD.
And your next question comes from Tazeen Ahmad with Bank of America..
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 out of 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 the FDA on what exactly they would want to see on an interim analysis?
So first on the GA, we haven't had much communication with the FDA regarding a study. So far, it's -- we want to keep the FDA focused on our Stargard NDA submission. I think that's a motioning for us right now. In terms of submissions for regulatory authorities worldwide. Right now, with the FDA and then the Japan NDA 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 grow 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 overload -- take on too much work as we are still focused on the U.S. FDA and that's the most important approval.
Yes. But we definitely recognize there is an urgent need for therapeutics for start disease. So we're doing everything we can to try to bring the treatment to the patient worldwide as soon as we can.
And if I may add to the interim analysis. So at this time, we plan to conduct an interim analysis, but we have not confirmed the design as we have been focusing on the Star got commercial preparedness. So we will share more information once we confirm.
And your next question comes from the line of Steve Seedhouse with Cantor.
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 Tinleravan review.
Yes. So the answer is, yes, we had our mid-cycle review already. has been incredibly smooth so far, but we don't want to overspeculate and we may win true for now.
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 Stargard market in Japan by comparison to the U.S.
Hao, you want to answer this question?
Sure, sure, sure. Yes. So we do know that there's about 10,000 stratification by the preference rate in Japan. And we have built a Japan team that is ready to launch in Japan. They are the disease website also launched in Japanese in Japan. And there's some sort of the disease education activity, pre-approval kind of compliance that we're working on right now. the team is doing it the same as what the U.S. team is doing to get commercialization ready.
So on the regular part, I think the PMDA, the pace of PBA is incredibly fast. It has been very smooth so far. But again, we want to remain neutral and 1 of stake. Very good.
And then just lastly, I was hoping you could provide an update on 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. And I just wanted to get an update on that study in children under 12.
Yes, of course, Henrik. but we want to stay neutral. And then, of course, if there's more information that we could review then we'll do that when we have a bit better -- why the information becomes more clear that we cannot discuss this openly.
Right. But just to be clear, your expectation and our hope was always that you get a broad label from the beginning, right?
At this moment, yes, that's what our expectation is. But we don't want to, again, over speculate too much at this moment.
And then maybe, Mark, if I can add here. So I mean this was discussed before, and there's a clear understanding at the FDA that this is genetically caused disease due to this function of ABCA4, and that is -- 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 and treatment response. So that's a scientific risk on, but I think it's important to understand here that disease progression and growth profiles are quite homogeneous across all agents.
And then the other question was just what's the consensus view right now on pricing out there?
Well, I cannot say we did 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 STADA disease. Everybody recognized Agadi's a rare progressive vision driving disease with no treatment. So we believe that being a potential first-in-class reagent, we expect the pricing to reflect the rare disease profile, clinical benefit and unmet need. and benchmarking with other rare otology and pediatric other therapies. Yes. So we still think that the real pricing is still the guidance that we can provide.
And your next question comes from Whitney Ijem with Canaccord.
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 that relative to your kind of initial target docs or centers?
Hendrik, do you want to answer this question?
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 the U.S. numbers would be roughly 10,000 compared to total population, 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 5,000 patients out there, this subgroup would be more readily available because there would totally be under regular care. The second question, how concentrated are these patients? So it's still an IRD an inherent retinal disease. It's still monogenic, it comes with genetic testing. So these patients are typically being seen by IRD specialists but also a retinal specialists, not so much by general ophthalmologists, but they would be referred from general ophthalmologists to retinal specialists and/or IRD specialists. So there is a concentration of patients in large 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 retina 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 those general ophthalmologists and retinal specialists that do not necessarily work in large sentence.
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.
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 building and happy to perform genetic testing on their patients.
Japan will be fairly quickly, we believe, to catch up on those testing because they work as a national health care system. So once our 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 lease announced. which we know is on the way.
And your next question comes from the line of Graig Suvannavejh with Mizuho.
Congrats on the progress. I know you had commented on a mid-cycle review. Can you comment maybe on your -- if a late cycle review meeting has happened and maybe in connection or related to that. Can you comment on preapproval 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?
Yes. So we already have a date scheduled for late cycle review, but I think that's as much as we can say for now.
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.
Yes. So right now, all our team that's involved in the NDA submission process, the scientific team -- the same side will be the team that's going to coordinate and organize that GA interim interim analysis. So we don't want to take away the bandwidth. We remain that Stargard study is still the most important -- the stockout approval is still the most important milestone for this company. And so we were only going to get on the GA interim assets once we have the February PDUFA date completed and then we can move on to a GA analysis.
And we have a follow-up question from Tazeen Ahmed with Bank of America. This concludes today's call. Thank you for attending. You may now disconnect.
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