Belite Bio's Q3 2025 Earnings Call: Contradictions in Regulatory Timelines, Commercialization Plans, SG&A Forecasts, and PHOENIX Trial Strategy

Guidance:

• Plan to submit regulatory applications across regions in H1 2026, using a consistent data package.
• PHOENIX interim analysis planned (~H2 2026) with a sample-size reestimation/promising‑zone design like DRAGON.
• Prioritize FDA/US and Japan for initial submissions; open to partnerships for other regions.
• Commercial prep: U.S. sales force ~20 initially, ramp to ~40; estimated U.S. commercialization cost ≈ $200M.
• Cash position: $275.6M on hand after $140M financing, with potential additional $165M from warrant exercise.

Business Commentary:

* Clinical Trial Milestones: - Belite Bio completed enrollment in the Phase III PHOENIX trial with 530 subjects and the Phase III DRAGON trial for Stargardt's disease, anticipating final data by the end of November. - - The progress in these trials is crucial for the development of Tinlarebant and potentially expanding its market authorization globally.

• Regulatory Approvals and Feedback:
• China's NMPA and the U.K.'s MHRA agreed to accept applications for priority review and conditional marketing authorization based on DRAGON's interim analysis results.

• Positive feedback from regulatory authorities indicates a strong foundation for global submissions and potential approvals.

• Funding and Financial Position:

• Belite Bio secured $140 million in funding through a registered direct offering and private placement, with potential for an additional $165 million through warrant exercise.

• This investment strengthens the company's financial position, providing sufficient funding to support clinical trials and commercialization.

• Research and Development (R&D) Expenses:

• R&D expenses increased to $10.3 million from $6.8 million in the previous year, primarily due to expenses related to the DRAGON and PHOENIX trials.

• The rise in expenses reflects an investment in the development of potential new products and therapies.

• General and Administrative (G&A) Expenses:

• G&A expenses rose to $12.7 million from $2.9 million in the same period last year, largely due to share-based compensation expenses.
• The increase in G&A expenses is attributed to the expansion of the team in preparation for commercialization and related share-based compensation costs.
  

  Sentiment Analysis:

  Overall Tone: Positive

  • Management emphasized completed Phase III enrollments, DRAGON final top-line data due 'by end of this month', NMPA agreed to accept NDA for priority review and MHRA accepted a conditional marketing application, completed $140M financing and reported $275.6M cash; management described the balance sheet as 'strong' and 'well positioned' to fund trials and commercialization.

Q&A:

• Question from Yi Chen (H.C. Wainwright & Co): 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?
  Response: Not yet; plan to submit in first half of 2026 to maintain a consistent data package across agencies.

• Question from Yi Chen (H.C. Wainwright & Co): Got it. and can you also provide us with the current amount of shares outstanding after the most recent announcement.
  Response: CFO indicated total outstanding shares are approximately 35 million (per recent S-3).

• Question from Bruce Jackson (The Benchmark Company): Following up on the last question about the international submissions. When do you think you might be submitting the application in Japan?
  Response: Still discussing required modules with Japan; timeline tentatively first half of 2026, prioritization pending final data with FDA as a top priority.

• Question from Bruce Jackson (The Benchmark Company): Are you going to have an interim analysis [for PHOENIX] that is structured similar to the DRAGON trial, testing for futility or adequacy of sample size?
  Response: Yes; interim analysis planned (~H2 2026) and will likely be a sample‑size reestimation using a promising‑zone approach like DRAGON.

• Question from Bruce Jackson (The Benchmark Company): The SG&A levels have been moving around with milestone payments. What should we assume as the baseline level for SG&A going forward?
  Response: Hard to estimate baseline SG&A due to commercialization hiring and large, valuation‑sensitive share‑based compensation (ESOP) affecting reported expenses.

• Question from Michael Okunewitch (Maxim Group): What steps are you taking now to prepare for a potential approval and launch? And how are you prioritizing different regions since the DRAGON trial should serve several geographies?
  Response: Focusing on U.S. given market size, applying in multiple regions (including Japan), and open to partnerships for other regions; targeting markets they can handle internally first.

• Question from Michael Okunewitch (Maxim Group): Do you have a sense of how large of a sales force you would need for the U.S.?
  Response: Plan to start with ~20 sales reps and potentially scale to ~40.

• Question from Michael Okunewitch (Maxim Group): Given the additional $125M raised and strong cash, do you anticipate current cash is sufficient for commercial preparation and launch of Tinlarebant?
  Response: Estimate roughly $200M to commercialize Stargardt in the U.S.; current financing structure and potential warrant proceeds make funding potentially sufficient, but it's an estimate.

• Question from Marc Goodman (Leerink Partners): Can you confirm the U.K. asked for the same interim information sent to the FDA that got breakthrough designation — did everyone get the same information?
  Response: Yes; the same dataset was presented to each agency, though formats differed (in‑person for NMPA, online for U.K.).

Contradiction Point 1

Regulatory Submission Timeline

It directly impacts regulatory timelines and approval expectations for the company's key drug candidate, potentially influencing market strategy and investor expectations.

Have you submitted applications to regulatory agencies in China and the UK? If not, when do you plan to? - Yi Chen(H.C. Wainwright & Co, LLC, Research Division)

2025Q3: We have not submitted applications yet. We plan to submit in the first half of 2026, once we have consistent data packages across all regulatory agencies. - Yu-Hsin Lin(CEO)

Is the FDA discussion on DRAGON trial interim data progressing? Could this lead to an NDA filing? What DRAGON II data is needed for an NDA filing? - Boris Peaker(Titan Partners)

2025Q2: Once final data is submitted, there will possibly be a single study approval based on robust statistical significance. - Yu-Hsin Lin(CEO)

Contradiction Point 2

Commercialization and Sales Force Expansion

It involves the company's plans for commercialization, including the size of the sales force, which directly impacts the company's ability to capture market share.

What steps are you taking to prepare for potential launch approval, and how are you prioritizing regions? - Michael Okunewitch(Maxim Group LLC, Research Division)

2025Q3: Our focus is on the U.S., with potential cooperation and partnerships for other regions. We are preparing for U.S. launch with a sales force of about 20-40 people. - Hao-Yuan Chuang(CFO)

What is the FDA's current stance on using single pivotal trials for full approval, and what size commercial team would be required? - Michael Okunewitch(Maxim Group LLC, Research Division)

2025Q2: Our current cash burn estimate does not include full commercialization costs, which we are in the process of building. - Yu-Hsin Lin(CEO)

Contradiction Point 3

SG&A Expenses Outlook

It involves changes in financial forecasts, specifically regarding SG&A expenses, which are critical indicators for investors.

What is the expected baseline for SG&A expenses moving forward? - Bruce Jackson(The Benchmark Company, LLC, Research Division)

2025Q3: It's difficult to estimate a baseline level currently, due to preparations for commercialization, ESOP, and valuation factors. - Hao-Yuan Chuang(CFO)

What are the key SG&A line items in this year's guide? - Steve Pandick(B. Riley Securities)

2025Q1: The SG&A is $27.5 million. SG&A expenses for Q2 are expected to be approximately $35 million, resulting in full-year 2025 guidance of $98 million. - Hao-Yuan Chuang(CFO)

Contradiction Point 4

Interim Analysis for PHOENIX Trial

It directly impacts the clinical trial progress and data interpretation, which could influence regulatory and market strategy.

Will you conduct an interim analysis for the PHOENIX trial similar to the DRAGON trial? - Bruce Jackson(The Benchmark Company, LLC, Research Division)

2025Q3: Yes, we plan an interim analysis for next year. It will likely involve a sample size reestimation as we did for DRAGON, looking for efficacy trends within a specific time frame. - Yu-Hsin Lin(CEO), Nathan L. Mata(CMO)

What are the efficacy and safety goalposts for the Phase 3 data? - Jennifer Kim(Cantor)

2025Q1: The Phase 3 data is powered to detect a 35% treatment effect. - Tom Lin(CEO), Nathan Mata(CMO)

Contradiction Point 5

Submission Priority and Timeline

It involves the prioritization of submission to regulatory agencies in different regions, which could impact the company's strategic focus and global expansion plans.

When do you expect to submit the application in Japan? - Bruce Jackson(The Benchmark Company, LLC, Research Division)

2025Q3: We are still in discussions with Japan regarding submission modules. The expected timeline is the first half, but we haven't prioritized which countries will be submitted first. - Yu-Hsin Lin(CEO)

What is the current status of the regulatory process for the DRAGON data? - Michael Okunewitch(Maxim Group LLC, Research Division)

2024Q4: Once we get the breakthrough designation, we will prioritize the submission to the FDA and expect to start the FDA submission process in 2024. - Tom Lin(CEO)