Belite Bio - Earnings Call - Q3 2025
November 10, 2025
Transcript
Operator (participant)
Ladies and gentlemen, thank you for joining us, and welcome to the Belite Bio Q3 2025 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 9 to raise your hand and star 6 to unmute. I will now hand the call over to Julie Fallon. Please go ahead.
Julie Fallon (Head of Investor Relations)
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. Now I'll turn the call over to Dr. Lin. Dr. Lin?
Tom Lin (Chairman and CEO)
Thank you for joining today's call to discuss our Q3 2025 financial results. I'd like to start immediately by highlighting our recent progress. For GA, we completed the enrollment of the phase 3 Phoenix trial with 530 subjects. For Stargardt disease, we have completed the phase 3 DRAGON trial, and we now look forward to reporting the final top-line data by the end of this month. The DRAGON II trial has enrolled approximately 35 subjects of our targeted enrollment of approximately 60 subjects, including 10 Japanese subjects. The data from our 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 3 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 healthcare investors, with the potential for an additional $165 million upon full bond exercise. These investments put us in a very good position to advance and prepare for the commercialization. I'll now turn over the presentation to Hao-Yuan. Hao-Yuan?
Hao-Yuan Chuang (CFO)
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 offset 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 expenses 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 Q3 was approximately $9.3 million, similar to $8.6 million in the Q2. Moving to the balance sheet, as Tom shared, we were pleased to complete a registered direct offering and a significant PIPE, with gross profit of total $140 million, with potential for up to an additional $165 million upon full board exercise. With that, at the end of Q3, we had $275.6 million in cash, liquidity from time deposit and US 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 objective. With that, I'll turn the call back to the operator for Q&A. Operator?
Operator (participant)
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 and star 6 to unmute. Please stand by while we compile the Q&A roster. Your first question comes from the line of Ye Chen with HC Wainwright. Your line is open. Please go ahead.
Ye Chen (Managing Director and Senior Healthcare Analyst)
Hello. Thank you for taking my questions. Can you tell us whether you have submitted the application to the regulatory agency in China and the U.K.? If not, when do you plan to do so?
Tom Lin (Chairman and CEO)
Oh, hi. No, we have not. We plan to submit the first half next year. As you can see, there's a couple of regulatory agencies that have given us the green light to submit, whether it be based on interim analysis or waiting for the final report for the DRAGON trial to come out. We want to maintain the consistent data package across all regulatory agencies. Therefore, the timeline for that will be the first half of 2026.
Ye Chen (Managing Director and Senior Healthcare Analyst)
Got it. Got it. Can you also provide us with the current amount of shares outstanding after the most recent?
Tom Lin (Chairman and CEO)
How? That's probably a question for you.
Hao-Yuan Chuang (CFO)
Yeah, yeah. I think it's somewhere like the total outstanding shares. I think it's listed on the recent F-3. I think it's somewhere like $35 million.
Ye Chen (Managing Director and Senior Healthcare Analyst)
$35 million. Okay. Got it. Thank you.
Tom Lin (Chairman and CEO)
Thanks. Thanks to you.
Operator (participant)
Your next question comes from the line of Bruce Jackson with Benchmark. Your line is open. Please go ahead.
Bruce Jackson (Senior Analyst)
Hi. Good afternoon, and thank you for taking my questions. Following up on the last question about the international submissions, when do you think you might be submitting the application in Japan?
Tom Lin (Chairman and CEO)
Actually, we are still in discussion with Japan on how basically the different modules that we need to submit with Japan. We're still going through this with Japan. The expected timeline will be the first half. 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. Having three or four 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. We still haven't had the list of where to prioritize first. Certainly, FDA is one of the first authorities that we need to submit first. Yeah. I don't know if that answers your question.
At this point, we got several that we had a green light to submit in Japan. Yeah.
Bruce Jackson (Senior Analyst)
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?
Tom Lin (Chairman and CEO)
Yes, we do. At this point, we have an interim analysis planned for next year, probably around the second half of next year. Regarding 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?
Ye Chen (Managing Director and Senior Healthcare Analyst)
Very likely it will be a sample size re-estimation as we did for DRAGON. Same sort of scenario where we set up a conditional window to strictly 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 (Senior Analyst)
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?
Tom Lin (Chairman and CEO)
How?
Hao-Yuan Chuang (CFO)
Bruce, that's a good one. It is also a little bit hard to estimate at this point in time. As you can see, we are starting to prepare for commercialization. We are expanding the team now. We do not have a clear—and also, you know, many of that will involve some ESOP as well. ESOP has become a big moving factor based on the share price on the actual expenses being recognized on the income statement. We have a better understanding about the cash flow. For the income statement itself, the G&A is a little bit hard to estimate a correct number, given it was so much related to the valuation of the ESOP.
Bruce Jackson (Senior Analyst)
Okay. Got it. Thank you.
Hao-Yuan Chuang (CFO)
Thank you.
Operator (participant)
As a reminder, if you would like to ask a question, please raise your hand. The raise hand button can be found in the center of the toolbar at the bottom of your screen on Zoom desktop and on the left side of the toolbar on Zoom mobile. If you have dialed into the call, please press star 9 to raise your hand and star 6 to unmute. Your next question comes from the line of Michael Okuniewicz with Maxim Group. Your line is open. Please go ahead.
Michael Okuniewicz (Analyst)
Hey, guys. Thank you so much for taking my questions today. 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? Then how are you prioritizing different regions since the DRAGON trial should serve for several different geographies?
Tom Lin (Chairman and CEO)
Sure. Hao-Yuan, you want to give more details on this?
Hao-Yuan Chuang (CFO)
Sure. Sure. Apparently, U.S. is the focus given the potential size. 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. We remain open to seek cooperation and partnership for all the other regions. Yeah. For now, I think we're targeting on those markets that we think will be easier to be handled by ourselves.
Michael Okuniewicz (Analyst)
Do you have a sense of how large of a sales force you would need for the US?
Hao-Yuan Chuang (CFO)
Sure. We probably will start with 20 people and then maybe up to 40 people.
Michael Okuniewicz (Analyst)
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?
Hao-Yuan Chuang (CFO)
That's a good question. We estimate it could be probably about $200 million to commercialize Saga in the U.S. That's how we designed the recent PIPE transaction with additional cash coming from the warrant. Potentially, yeah, we think we should have enough. Of course, that is just estimation.
Michael Okuniewicz (Analyst)
Thank you very much. Congratulations on all the progress.
Hao-Yuan Chuang (CFO)
Thank you.
Tom Lin (Chairman and CEO)
Thanks, Mike.
Operator (participant)
As a final reminder, 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 and star 6 to unmute. Your next question comes from the line of Mark Goodman with Leerink. Your line is open. Please go ahead.
Marc Goodman (Senior Research Analyst)
Yeah. Can you all confirm that the U.K. basically asked 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 China as well? Did they get anything different? Everybody got the same information?
Tom Lin (Chairman and CEO)
Yes. So everyone will present the same information. I'll let Hendrik answer this question since he presented to them. Hendrik?
Hendrik Scholl (Chief Medical Officer)
Yeah. Thank you, Tom. Yes, Mark. 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 dataset that was the basis for the presentation and the discussion was exactly the same.