Belite Bio, Inc (BLTE) Earnings Call Transcript & Summary

Good afternoon, and thanks for being with us today. With us on this call are Dr. Tom Lin, Belite Bio's Chairman and CEO, Dr. Hendrik Scholl, our Chief Medical Officer, Dr. Nathan Mata, Chief Scientific Officer, and Hao-Yuan Chuang, Chief Financial Officer. Before we get started, I want to note that forward-looking statements will be made during this call, and those are based on what we currently expect and believe. Such statements carry certain risks and uncertainties, and actual results could differ materially. We'd encourage you to review the risk factors described in our SEC filings for more detail. Also, certain non-GAAP financial measures will be discussed today. Reconciliations to the most directly comparable GAAP measures appear in the press release issued today. I'll now hand the call over to Dr. Lin. Dr. Lin?

Appreciate that, Julie. Hello, everyone, and good afternoon — thanks for joining our call covering third quarter 2026 financial results and the corporate update. This year has brought major change to Belite Bio, and on the regulatory front we are proceeding at a fast pace as we strive to bring tinlarebant to patients; in August we were delighted to announce that the FDA accepted our NDA for tinlarebant with priority review and a PDUFA date of February 12, 2027. The FDA has further informed us that no advisory committee meeting will be convened to discuss the NDA for tinlarebant in Stargardt disease. Since we filed our U.S. Regarding the NDA, we've submitted a JNDA in Japan as well, under the Sakigake designation, which provides for accelerated review. Should it gain approval, this would become the first Sakigake-designated pharmaceutical for an ophthalmology disease in Japan. In addition, we have submitted a marketing authorization application to regulators in the U.K., Switzerland, and Singapore via the Access Consortium framework. Our international rollout strategy will be thoughtful and measured, but these filings mark a significant step toward the objective of bringing tinlarebant to Stargardt patients around the world. Separately, we recently shared that our stock has moved up from the Nasdaq Capital Market to the Nasdaq Global Select Market — the top tier among Nasdaq's three market levels. Moving up to the Nasdaq Global Select Market shows we meet that exchange's tougher rules on finances and liquidity, and it also signals the strides we've made in fortifying our balance sheet and raising our visibility in the capital markets. This milestone makes us very proud, especially as we keep striving to deliver value to shareholders. While we advance on the regulatory side, we're simultaneously pushing our commercial strategy forward and striving to secure the best possible patient access to tinlarebant through early talks with payers and pharmacy benefit managers. We’ve already started building those key partnerships so we can help ensure wide access if approval comes through. We’ll share more updates as we get closer to our PDUFA date, and I’m confident we can pull off a fast launch and quickly start getting this medicine to patients. Now I’ll hand things over to Hao-Yuan for the financial discussion. Hao?

Thanks, Tom. It has been a solid year up to this point, and from a financial standpoint we've executed well as we get ready for what could be our first product launch. Let me walk through our financial statements. In the third quarter of 2026, R&D expenses came in at $15.5 million, versus $10.3 million in 2025. The quarter's rise in R&D expenses was mainly due to higher API manufacturing and DP manufacturing expenses, consulting fees, and sponsorship fundings. On a non-GAAP basis, which excludes share-based compensation expenses, R&D expenses for the third quarter were $14.7 million, compared with $8 million in 2025. SG&A expenses in Q3 totaled $21.4 million, versus $12.7 million in 2025. The quarter's increase in SG&A expenses was primarily driven by higher professional service fee. On a non-GAAP basis, SG&A expenses for the third quarter were $16.3 million, compared with $2.1 million in 2025. GAAP net loss for the third quarter was $30.3 million, versus $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 with $8.8 million in 2025. We finished the quarter with $774 million in cash equivalents, and U.S. Treasury bills, compared with $780 million in Q2 2026. All in all, our balance sheet is still strong, and we are extremely well-funded. Going forward, we believe our current cash runway is enough to support the potential commercialization of tinlarebant, subject to regulatory approval, and to keep advancing our pipelines. With that, I'll hand the call back to the operator for Q&A. Operator?

Great. Thanks a lot for taking my question. Given that PHOENIX enrolled patients who had smaller lesions, how are you thinking about earlier intervention as something that helps you stand out in the GA market? Thanks.

Thank you. Thanks, Maxwell. Hendrik, I believe you're the best person to respond to this.

Yes, glad to address that. The criteria for inclusion in our PHOENIX trial cover a variety of lesion sizes, and that range would also take in smaller lesions. Should we see a particularly positive impact on smaller lesions, that will become clear once the trial results come in. You are right that going after bisretinoid accumulation in the RPE may well be something that protects RPE and photoreceptors at an early point, and may well deliver a strongly positive treatment effect in earlier stages of disease, whereas geographic atrophy already represents a late stage of AMD.

Excellent, thanks.

Are you able to hear me at this point?

Yes, I’m able to hear you.

Hello? All right, good. Apologies — I'm on the road and can't view the screen. Thanks for the news on the AdCom. Assuming it's more probable that the product gets approved on schedule, with a February PDUFA in view, could you tell us what your submission plans are for ex-U.S. geographies, and what timelines might look like for a first approval in your first country there? On GA, have you spoken with FDA at all about precisely what they'd expect to see in an interim analysis? Thank you.

Starting with GA, we've had limited communication with the FDA concerning the GA study. For now, we want to keep the FDA focused on our Stargardt NDA submission. That, I think, is the most important thing for us at present. As for filings with regulatory authorities around the world, at this point it's the FDA followed by the Japan PMDA, and of course the U.K., Switzerland, and Singapore consortium. That's the submission picture as it stands. We're planning for others to roll out, but there's a limit to how many regulatory reviews we can take on; it's a great deal of work, and we don't want to shoulder too much, since we remain focused on the U.S. FDA, and that's the most important approval.

We do recognize, though, that Stargardt disease patients urgently need therapies, so we are doing everything possible in an effort to get this treatment to patients around the world as quickly as we can.

If I could add something about the interim analysis, right now we intend to run one, though the design hasn't been confirmed yet, since our attention has been on getting ready commercially for Stargardt. Once we've confirmed it, we'll share further details.

Great, thanks. I just want to get confirmation on something first, since it's a question that comes up a lot and keeps coming. Has your mid-cycle review meeting with the FDA taken place yet, and overall, how would you say the dialogue with FDA has been going regarding the tinlarebant review?

Yes. Yes is the answer, we've already had our mid-cycle review; it's been remarkably smooth up to now, though we don't want to speculate too much, and for the time being we're staying neutral.

All right, great, thank you. I wanted to ask about Japan. What kinds of steps has the company taken in preparation for commercialization in Japan, which I suppose might be possible next year? Perhaps you could speak a bit about the Stargardt market in Japan compared with the U.S.

Hao, would you like to take this question?

Right, yes. We're aware that, based on prevalence rates in Japan, roughly 10,000 people there have Stargardt disease. A Japan team has been assembled and is prepared to launch in that market. A disease website has also gone live in Japanese, within Japan. Certain disease education efforts of the pre-approval, compliant variety are underway at present. So yes, that team is carrying out the same work the U.S. team is doing to prepare for commercialization.

Regarding the regulatory side, my view is that the PMDA has been moving at a remarkably quick pace. Things have gone very smoothly up to this point, but once again, we prefer to stay neutral and would rather not speculate too much.

Great, thank you. So then as a final point, I was wondering whether you could give us an update on whether there are still plans this year to begin the study in younger children. My understanding was that it was meant to kick off in the U.K. first, and I just wanted an update on that trial in children under 12.

Yes, absolutely. Hendrik, would you like to give an update?

Sure, glad to answer that. One additional IRB review was required, and it came back positive roughly 3 or 4 weeks ago, as I recall. So that PIP study, the pediatric study at Moorfields Eye Hospital, will definitely get underway this quarter, meaning before the year is out.

Great, thanks a lot.

Does that work? So what label are you anticipating, given the interactions you've had with the FDA? My second question: where do you believe consensus sits on pricing at the moment, and what's your thinking there? And third, did I understand you right? For Japan, the plan is to go it alone, build infrastructure there, and sell it yourselves. Thank you.

Yes. On the Japan question, yes, we've already assembled a team. That team in Japan is fully functional, and our expectation is to market the drug ourselves in Japan. What was the second question? Sorry.

Regarding interactions with the FDA, what do you anticipate the label will look like?

Up to this point, no conversation about the label has taken place. I believe that, as things stand, with the questions the FDA raised, everything continues to stay on the path we anticipate. Once more, there isn't much I can disclose at this moment, but we prefer to remain neutral. Naturally, should additional information become available for us to disclose, we will do so at a time when we have a better Once the picture becomes clearer, we can then talk about it openly.