Belite Bio, Inc (NASDAQ:BLTE) Q3 2025 Earnings Call Transcript

Belite Bio, Inc (NASDAQ:BLTE) Q3 2025 Earnings Call Transcript November 10, 2025

Belite Bio, Inc misses on earnings expectations. Reported EPS is $-0.65 EPS, expectations were $-0.53.

Operator: Ladies and gentlemen, thank you for joining us, and welcome to the Belite Bio Third Quarter 2025 Earnings Call. [Operator Instructions]. I will now hand the call 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; 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. And now I’ll turn the call over to Dr. Lin. Dr. Lin?

Yu-Hsin Lin: Thank you for joining today’s call to discuss our third quarter 2025 financial results. I’d like to start immediately by highlighting our recent progress. For GA, we completed the enrollment of the Phase III PHOENIX trial with 530 subjects. For Stargardt’s disease, we have completed the Phase III DRAGON trial, and we now look forward to reporting the final top line data by end of this month. The DRAGON II trial have enrolled approximately 35 subjects of our targeted enrollment of approximately 60 subjects, including 10 Japanese subjects. The data from Japanese subjects is intended to expedite a new drug application in Japan. We have been in close communications with Japan’s PMDA and Sakigake-designated concierge to ensure that our JNDA is submitted as one of the first countries for market authorization.

We also recently received positive feedback from regulatory authorities. Specifically, China’s NMPA agreed to accept NDA for priority review based on the interim analysis results from the Phase III DRAGON trial. Additionally, the U.K.’s MHRA agreed to accept conditional marketing authorization application also based on DRAGON’s interim analysis results. With the consistent feedback from major regulatory agencies across the world, we are encouraged that the DRAGON trial provides a strong foundation for global submissions and potential approvals. Lastly, we have completed a $50 million registered direct offering and an upsized $125 million private placement with leading health care investors with the potential for an additional $165 million upon full warrant exercise.

This investment puts us in a very good position to advance and prepare for Tinlarebant’s commercialization. I’ll now turn over the presentation to Hao-Yuan. Hao-Yuan?

Hao-Yuan Chuang: Thank you, Tom. For Q3 2025, we had R&D expenses of $10.3 million compared to $6.8 million for the same period last year. The increase was mainly due to expenses related to the DRAGON trial and the PHOENIX trial, partially offsetting by the Australian R&D tax incentive program. It was also due to an increase in share-based compensation expenses. Regarding G&A expenses, we had G&A expenses of $12.7 million compared to $2.9 million for the same period last year. The increase was primarily driven by an increase in share-based compensation expenses from the new grant of equity incentive plan this year, which has become higher as our share price and exercise price increased. Overall, we had a net loss of $21.7 million compared to a net loss of $8.7 million for the same period last year.

It is important to note that, as I said, the majority of our expense increase came from the share-based compensation, which was about $12.9 million and was not cash related. Our total operating cash outflow for the third quarter was approximately $9.3 million, similar to $8.6 million in the second quarter. Moving to the balance sheet. As Tom shared, we were pleased to complete a registered direct offering and a significant pipe with gross proceeds of total $140 million with potential for up to additional $165 million of our full warrant exercise. With that, at the end of Q3, we had $275.6 million in cash, liquidity from time deposit and U.S. treasury bills. We have made significant progress toward our key milestone year-to-date. We sincerely appreciate the continued trust and support from our shareholders.

Our balance sheet remains strong and is expected to provide sufficient funding to support our clinical trials and preparation for commercialization. We are well positioned to achieve our future objectives. With that, I’ll turn the call back to the operator for Q&A. Operator?

Q&A Session

Operator: [Operator Instructions]. Your first question comes from the line of Yi Chen with H.C. Wainwright.

Yi Chen: So can you tell us whether you have submitted the application to the regulatory agency in China and U.K.? And if not, when do you plan to do so?

Yu-Hsin Lin: No, we have not. We plan to submit our first half next year. As you can see, there’s a couple of regulatory agencies that has given us the green light to submit, whether it be based on interim analysis or waiting for the final report for the DRAGON study to come out. We want to maintain the consistent data package across all regulatory agencies. And therefore, the time line for that will be first half of 2026.

Yi Chen: Got it. and can you also provide us with the current amount of shares outstanding after the most recent announcement.

Yu-Hsin Lin: Hao-Yuan, this probably a question for you.

Hao-Yuan Chuang: Yes, I think somewhere like the total outstanding shares, I think list on the recent S3. I think somewhere like $35 million.

Operator: Your next question comes from the line of Bruce Jackson with Benchmark.

Bruce Jackson: Following up on the last question about the international submissions. When do you think you might be submitting the application in Japan?

Yu-Hsin Lin: Actually, we are still in discussion with Japan on how the — basically the different modules that we need to submit with Japan. We’re still going through this with Japan. So the expected time line will be first half. But given that we have several countries that we need to prioritize, we still haven’t had a — we still need to wait until the data comes out and then prioritize which countries will be submitted first. Certainly, Japan is up there. But having 3, 4 countries submitted at once, we definitely wouldn’t have the bandwidth to handle all those submissions and getting questions from regulatory agencies across several regions. So we still haven’t had the list of where to prioritize first, but certainly FDA is one of the first authorities that we need to submit first. So yes. So I don’t know if that answers your question, but at this point, we’ve got several that we had a green light to submit, including Japan.

Bruce Jackson: Yes. Okay. Then turning over to the PHOENIX trial. Are you going to have an interim analysis that is structured in a way that was similar to the DRAGON trial. So we’re going to be testing for either futility or for adequacy of the sample size?

Yu-Hsin Lin: Yes, we do. So at this point, we have an interim analysis planned for next year, probably around second half next year. But regarding the — how we’re going to go about that, I probably will refer to Nathan. Do you have a better idea on the structure of the interim analysis?

Nathan L. Mata: Very likely, it will be a sample size reestimation as we did for DRAGON. Same sort of scenario where we set up a conditional window specifically refer to as a promising zone to look for efficacy trends within that window to determine whether or not we can supplement the sample size with additional subjects.

Bruce Jackson: Okay. Super. Then last question for me. The SG&A levels have been moving around a little bit with all the milestone payments. What should we be assuming as kind of like the baseline level for SG&A expenses going forward?

Yu-Hsin Lin: Hao?

Hao-Yuan Chuang: Well, Bruce, that’s a good one, but it’s also a little bit hard to estimate at this point of time. As you can see, we are starting to prepare for commercialization. So we’re expanding the team now. So we don’t have a clear — and also many of that will involve some ESOP as well. And ESOP has become a big moving factor based on the share price on the actual expenses being recognized on the income statement. So we have a better understanding about the cash flow. But for the income statement itself, the G&A, it’s a little bit hard to estimate a correct number given it was so much related to the valuation of the ESOP.

Operator: [Operator Instructions]. Your next question comes from the line of Michael Okunewitch with Maxim.

Michael Okunewitch: I just wanted to ask a couple of questions on your commercial preparations. In particular, what steps are you taking right now to prepare for a potential approval and launch? And then how are you prioritizing different regions since the DRAGON trial should serve for several different geographies?

Yu-Hsin Lin: Sure. Hao, do you want to give more details on this?

Hao-Yuan Chuang: Sure, sure. Well, apparently U.S. is the focus given the potential size, but we are applying for NDA in all the regions. Probably U.S. or some smaller single market such as Japan will be relatively easy for us to focus on. And we remain open to seek cooperation and partnership for all the other regions. Yes. But for now, I think we’re targeting on those markets that we think will be easier to take the handle by ourselves.

Michael Okunewitch: And do you have a sense of how large of a sales force you would need for the U.S.?

Yu-Hsin Lin: Sure. We probably will start with 20 people and then maybe up to 40 people.

Michael Okunewitch: And then one last for me, and I’ll hop back into the queue. Just given that you have raised this additional $125 million and you have a pretty strong cash position, are you anticipating that your current cash should be sufficient for the commercial preparation and launch of Tinlarebant?

Yu-Hsin Lin: Well, that’s a good question. So we estimate it could be probably about $200 million to commercialize Stargardt in the U.S. That’s how we designed the recent transaction with additional cash coming from the warrant. So potentially, yes, we think we should have enough. But of course, that is just estimation.

Operator: [Operator Instructions]. Your next question comes from the line of Marc Goodman with Leerink.

Marc Goodman: Yes. Can you confirm the U.K. basically ask for the same interim information that you sent to the U.S. FDA that got you the breakthrough designation. I mean is all of this the same exact information and in China as well, did they get anything different? Everybody got the same information?

Yu-Hsin Lin: Yes. So everyone will present the same information. I’ll let Hendrik answer those questions since he presented to them. Hendrik.?

Hendrik Scholl: Yes. Thank you, Tom. Yes, Marc, this was the same set of information. The type of presentation was different. It was an in-person presentation in Beijing to the NMPA, including a large panel of experts from China. While for the U.K., as an example, this was an online meeting with the agency. But the data set that was the basis for the presentation and the discussion was exactly the same.

Operator: There are no further questions at this time. This concludes today’s call. Thank you for attending. You may now disconnect.