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Belite Bio, Inc. ADR (BLTE)
:BLTE
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Belite Bio, Inc. ADR
(NASDAQ:BLTE)
43Neutral
Positive Factors
Clinical Trial Progress
The P3 pivotal DRAGON study has passed its DSMB review, maintaining its sample size of N=104 subjects, placing the study on track for completion.
Financial Health
The company raised $15M in a direct offering, adding to its cash reserves.
Regulatory Approvals
The DSMB recommended submission of the DRAGON data for further regulatory review for drug approval, which could suggest a strong signal of efficacy according to management and could potentially be the basis for an accelerated approval for tinlarebant.
Negative Factors
Clinical Trial Uncertainty
The P3 PHOENIX study in geographic atrophy has enrolled 406 subjects to date, with plans for an interim analysis, which introduces uncertainty until results are disclosed.
Market Valuation
BLTE shares have risen significantly, with a market cap of ~$2.5B, indicating strong recent performance but also potential overvaluation concerns.
Belite Bio, Inc. ADR (BLTE) vs. S&P 500 (SPY)
Market Cap
$1.94B
Dividend YieldN/A
Average Volume (3M)34.39K
Price to Earnings (P/E)―
Beta (1Y)0.75
Revenue GrowthN/A
EPS Growth4.80%
CountryUS
Employees25
SectorHealthcare
Sector Strength60
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.32
Shares Outstanding32,281,760
10 Day Avg. Volume26,429
30 Day Avg. Volume34,393
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)0.00
Price to Cash Flow (P/CF)0.00
P/FCF Ratio0.00
Enterprise Value/Market Cap0.68
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-3.33K
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$96.67Price Target Upside54.67% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering4
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 primarily makes money by developing and commercializing pharmaceutical products. The company generates revenue through strategic partnerships and collaborations with other pharmaceutical companies and research institutions, where it may receive upfront payments, milestone payments, and royalties on sales of successfully developed drugs. Additionally, Belite Bio may seek funding through grants and government programs to support its research and development activities, which are critical to advancing its product candidates through clinical trials and towards market approval.
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
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.10
Very Negative
Balance Sheet
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.30
Negative
Cash Flow
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.20
Very Negative
| Breakdown | |||
| Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|
| Income Statement | Total Revenue | ||
| 0.00 | 0.00 | 0.00 | 0.00 | Gross Profit |
| -399.00K | -198.00K | -30.00K | -17.00K | EBIT |
| -31.67M | -12.82M | -9.80M | -5.74M | EBITDA |
| -31.53M | -12.43M | -9.64M | -5.71M | Net Income Common Stockholders |
| -31.63M | -12.47M | -9.79M | -5.75M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | ||
| 88.16M | 42.09M | 17.34M | 25.62M | Total Assets |
| 94.64M | 44.27M | 18.35M | 25.74M | Total Debt |
| 886.00K | 866.00K | 31.81M | 31.81M | Net Debt |
| -87.27M | -41.22M | 14.46M | 6.19M | Total Liabilities |
| 4.21M | 2.77M | 33.44M | 32.78M | Stockholders Equity |
| 90.43M | 41.50M | -15.09M | -7.04M |
| Cash Flow | Free Cash Flow | ||
| -29.90M | -11.85M | -7.55M | -4.46M | Operating Cash Flow |
| -29.84M | -11.46M | -7.47M | -4.44M | Investing Cash Flow |
| -63.00K | -394.00K | -56.00K | -20.00K | Financing Cash Flow |
| 75.96M | 36.96M | -583.00K | 28.06M |
Belite Bio, Inc. ADR Technical Analysis
Positive
62.50
Price Trends
61.80
Negative
60.45
Positive
58.99
Positive
Market Momentum
0.19
Negative
51.57
Neutral
81.11
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For BLTE, the sentiment is Positive. The current price of 62.5 is above the 20-day moving average (MA) of 58.87, above the 50-day MA of 61.80, and above the 200-day MA of 58.99, indicating a neutral trend. The MACD of 0.19 indicates Negative momentum. The RSI at 51.57 is Neutral, neither overbought nor oversold. The STOCH value of 81.11 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive 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 (52)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
54 Neutral | $1.99B | ― | -33.98% | ― | 449.03% | 42.86% | |
52 Neutral | $1.69B | ― | -86.10% | ― | 29.32% | -11.00% | |
52 Neutral | $5.24B | 3.76 | -41.88% | 2.85% | 17.01% | 0.78% | |
51 Neutral | $2.13B | ― | -61.35% | ― | ― | ― | |
45 Neutral | $2.39B | ― | -37.40% | ― | -100.00% | -144.79% | |
43 Neutral | $1.94B | ― | -30.60% | ― | ― | 4.80% | |
40 Underperform | $2.04B | ― | -38.04% | ― | -82.38% | -164.76% |
* Healthcare Sector Average
Performance Comparison
BLTE
Belite Bio, Inc. ADR
61.11
18.31
42.78%
DNLI
Denali Therapeutics
13.97
-4.93
-26.08%
BEAM
Beam Therapeutics
15.99
-6.25
-28.10%
TARS
Tarsus Pharmaceuticals
46.45
9.10
24.36%
NAMS
NewAmsterdam Pharma Company
19.00
-2.79
-12.80%
RXRX
Recursion Pharmaceuticals
4.16
-4.43
-51.57%
Belite Bio, Inc. ADR Earnings Call Summary
Earnings Call Date:Mar 17, 2025
(Q4-2024)
| % Change Since: -7.33%|
Next Earnings Date:May 14, 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.Q4-2024 Updates
Positive Updates
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.
Negative Updates
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.