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Belite Bio, Inc. ADR (BLTE)
NASDAQ:BLTE
US Market

Belite Bio, Inc. ADR (BLTE) AI Stock Analysis

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Belite Bio, Inc. ADR

(NASDAQ:BLTE)

41Neutral
Belite Bio, Inc.'s overall stock score reflects substantial financial challenges, with persistent losses and negative cash flows. Although the earnings call highlighted progress in clinical trials and a stable cash position, the technical analysis and valuation metrics remain weak, contributing to a lower overall score.
Positive Factors
Clinical Trials
The Phase 3 DRAGON study has shown positive interim results in Stargardt Disease, supporting the analyst's Buy rating.
Regulatory Progress
Tinlarebant holds multiple designations, including Fast Track and Orphan Drug, which could facilitate its market entry as the first FDA-approved treatment for STGD1.
Negative Factors
Financial Performance
Despite a market cap of ~$2.5B, there are concerns about whether Belite can sustain its recent strong performance.

Belite Bio, Inc. ADR (BLTE) vs. S&P 500 (SPY)

Belite Bio, Inc. ADR Business Overview & Revenue Model

Company DescriptionBelite Bio, Inc, a clinical-stage biopharmaceutical drug development company, engages in the research and development of novel therapeutics targeting atrophic age-related macular degeneration and autosomal recessive stargardt diseases. Its lead product candidate is LBS-008, an oral once-a-day treatment that can reduce and maintain the delivery of vitamin A to the eye to reduce the accumulation of toxic vitamin A by-products in ocular tissue that is in phase 3 clinical trial. The company is also developing LBS-009, an anti-retinol binding protein 4 oral therapy targeting liver disease, including non-alcoholic fatty liver disease, nonalcoholic steatohepatitis, and type 2 diabetes, which is in the preclinical development phase. Belite Bio, Inc was founded in 2016 and is based in San Diego, California. Belite Bio, Inc operates as a subsidiary of Lin Bioscience International Ltd.
How the Company Makes MoneyBelite Bio, Inc. primarily makes money through the development and eventual commercialization of its proprietary drug candidates. As a clinical-stage company, it currently relies on funding from investors, partnerships, and potential licensing agreements to support its research and development activities. A significant portion of its future revenue is expected to come from successful clinical trials leading to the regulatory approval and marketing of its key product, LBS-008, targeting retinal degeneration diseases. Additionally, strategic partnerships and collaborations with other pharmaceutical companies could provide milestone payments and royalties, contributing to its revenue streams as its products progress through various development stages.

Belite Bio, Inc. ADR Financial Statement Overview

Summary
Belite Bio, Inc. faces significant financial challenges, with persistent lack of revenue and increasing losses impacting its income statement. Although there have been improvements in equity levels, the company's balance sheet reflects past high leverage and current reliance on financing activities. The cash flow statement highlights ongoing operational cash deficits, stressing the importance of achieving revenue growth and effective cash management.
Income Statement
10
Very Negative
The company has consistently reported zero revenue, indicating no commercial products or services generating income. Net income is negative, worsening from -$12.48 million in 2022 to -$31.63 million in 2023, reflecting increasing losses. EBIT and EBITDA margins are negative, emphasizing operational challenges and a lack of profitability.
Balance Sheet
30
Negative
The company has a positive stockholders' equity at $90.43 million in 2023, indicating an improvement from negative equity in 2021. However, the debt-to-equity ratio is relatively low due to reduced total debt, suggesting limited leverage but also highlighting past reliance on external financing. The equity ratio shows a reasonable level of capitalization.
Cash Flow
20
Very Negative
Free cash flow is negative and deteriorating, with a significant drop from -$11.85 million in 2022 to -$29.9 million in 2023. Operating cash flow is also negative, indicating cash outflows from core operations. Despite substantial financing cash inflows, the cash flow situation remains weak, emphasizing cash burn issues.
Breakdown
TTMDec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
0.000.000.000.000.00
Gross Profit
0.00-399.00K-198.00K-30.00K-17.00K
EBIT
-8.56M-31.67M-12.82M-9.80M-5.74M
EBITDA
-8.53M-31.53M-12.43M-9.64M-5.71M
Net Income Common Stockholders
-8.31M-31.63M-12.47M-9.79M-5.75M
Balance SheetCash, Cash Equivalents and Short-Term Investments
6.40M88.16M42.09M17.34M25.62M
Total Assets
6.44M94.64M44.27M18.35M25.74M
Total Debt
0.00886.00K866.00K31.81M31.81M
Net Debt
-6.40M-87.27M-41.22M14.46M6.19M
Total Liabilities
8.19M4.21M2.77M33.44M32.78M
Stockholders Equity
-1.76M90.43M41.50M-15.09M-7.04M
Cash FlowFree Cash Flow
-1.89M-29.90M-11.85M-7.55M-4.46M
Operating Cash Flow
-1.87M-29.84M-11.46M-7.47M-4.44M
Investing Cash Flow
-18.50K-63.00K-394.00K-56.00K-20.00K
Financing Cash Flow
-203.75K75.96M36.96M-583.00K28.06M

Belite Bio, Inc. ADR Technical Analysis

Technical Analysis Sentiment
Negative
Last Price56.40
Price Trends
50DMA
60.85
Negative
100DMA
61.29
Negative
200DMA
58.31
Negative
Market Momentum
MACD
-1.97
Positive
RSI
35.99
Neutral
STOCH
55.55
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For BLTE, the sentiment is Negative. The current price of 56.4 is below the 20-day moving average (MA) of 60.68, below the 50-day MA of 60.85, and below the 200-day MA of 58.31, indicating a bearish trend. The MACD of -1.97 indicates Positive momentum. The RSI at 35.99 is Neutral, neither overbought nor oversold. The STOCH value of 55.55 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for BLTE.

Belite Bio, Inc. ADR Risk Analysis

Belite Bio, Inc. ADR disclosed 115 risk factors in its most recent earnings report. Belite Bio, Inc. ADR reported the most risks in the “Finance & Corporate” category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Belite Bio, Inc. ADR Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
54
Neutral
$2.05B-54.83%948.62%33.12%
51
Neutral
$2.21B-61.89%32.00%-6.86%
51
Neutral
$5.19B3.13-40.94%2.95%17.94%2.00%
47
Neutral
$1.70B-43.94%-83.18%-144.95%
46
Neutral
$1.79B-61.35%
45
Neutral
$1.85B-37.40%-100.00%-144.79%
41
Neutral
$1.82B-30.60%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
BLTE
Belite Bio, Inc. ADR
54.69
20.21
58.61%
DNLI
Denali Therapeutics
13.15
-2.84
-17.76%
BEAM
Beam Therapeutics
18.24
-5.86
-24.32%
TARS
Tarsus Pharmaceuticals
48.51
16.22
50.23%
NAMS
NewAmsterdam Pharma Company
16.26
-3.97
-19.62%
RXRX
Recursion Pharmaceuticals
5.41
-2.19
-28.82%

Belite Bio, Inc. ADR Earnings Call Summary

Earnings Call Date: Mar 17, 2025 | % Change Since: -16.37% | Next Earnings Date: May 7, 2025
Earnings Call Sentiment Neutral
The earnings call presented both positive and negative aspects. Significant advancements and regulatory designations for Tinlarebant, along with strong clinical trial enrollment and financial stability, were highlighted as major achievements. However, increased expenses, net loss, adverse events in trials, and high dropout rates were notable challenges. Despite the challenges, the overall sentiment was cautiously optimistic due to strong progress in clinical trials and financial stability.
Highlights
Tinlarebant's Significant Advancements
Tinlarebant has been granted Rare Pediatric Disease and Fast Track designations in the U.S., Pioneer Drug designation in Japan, and Orphan Drug designation in the U.S., Europe, and Japan. The Phase 3 DRAGON trial interim analysis recommended proceeding without modifications, indicating promising efficacy.
Clinical Trial Enrollment Success
The DRAGON 2 trial has enrolled 11 of the targeted 60 subjects, and the PHOENIX trial for GA has over 400 subjects enrolled, with plans to increase to 500 due to good progress.
Financial Stability
Belite Bio ended 2024 with $31.7 million in cash and $113.5 million in investments, and raised $15 million in a direct offering, maintaining a full year's cash runway.
Lowlights
Increased Expenses and Net Loss
R&D expenses increased to $29.9 million from $28.8 million in 2023, G&A expenses rose to $10.1 million from $6.8 million, and net loss increased to $36.1 million from $31.6 million.
Adverse Events in DRAGON 1 Trial
Treatment-emergent adverse events included xanthopsia and delayed dark adaptation, with a 9.6% withdrawal rate, though deemed mild and transient.
High Dropout Rate in GA Trial
The PHOENIX trial for GA has a dropout rate of approximately 20%, which is common in elderly populations but still notable.
Company Guidance
During Belite Bio's fourth quarter and full year 2024 earnings call, significant guidance was provided regarding the progress of their flagship drug, Tinlarebant, for treating Stargardt disease and geographic atrophy (GA). The company is conducting two studies for Stargardt disease: the Phase 3 DRAGON trial with 104 subjects and the Phase 2/3 DRAGON 2 trial targeting approximately 60 subjects. The Data Safety Monitoring Board (DSMB) recommended the DRAGON trial proceed without modifications and suggested regulatory review for drug approval, indicating promising interim results. For GA, the global Phase 3 PHOENIX trial has enrolled over 400 subjects and plans to increase to 500, reflecting strong enrollment progress. Financial metrics highlighted included R&D expenses of $29.9 million and a net loss of $36.1 million in 2024. The company ended the year with $31.7 million in cash and $113.5 million in investments, and they raised $15 million in February 2025, ensuring a full-year cash runway.
Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.