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Belite Bio, Inc. ADR (BLTE)
NASDAQ:BLTE
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Belite Bio, Inc. ADR
(NASDAQ:BLTE)
Rating:43Neutral
Price Target:―
Positive Factors
Clinical Efficacy
Tinlarebant demonstrated promising efficacy in the open-label Phase 2 study with about 50% slowing of the atrophic lesion growth compared to matched controls.
Market Potential
Tinlarebant is differentiated from other geographic atrophy treatments as it is a once-daily oral tablet targeting earlier stages of dry AMD, offering a unique treatment approach.
Regulatory Progress
The FDA granted Breakthrough Therapy designation to tinlarebant for the treatment of Stargardt disease based on interim data from the ongoing Phase 3 DRAGON trial.
Negative Factors
Clinical Development Risk
The next major catalysts for the shares are enrollment of the DRAGON II study and completion of the DRAGON study by year-end 2025.
Regulatory Uncertainty
The DRAGON trial is on track to be completed, potentially leading to a regulatory submission in Japan, indicating progress in the development and potential approval of tinlarebant.
Belite Bio, Inc. ADR (BLTE) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$2.02B
Dividend YieldN/A
Average Volume (3M)58.97K
Price to Earnings (P/E)―
Beta (1Y)0.72
Revenue GrowthN/A
EPS Growth4.80%
CountryUS
Employees25
SectorHealthcare
Sector Strength44
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.45
Shares Outstanding32,281,760
10 Day Avg. Volume86,930
30 Day Avg. Volume58,966
Financial Highlights & Ratios
PEG Ratio3.15
Price to Book (P/B)12.93
Price to Sales (P/S)0.00
P/FCF Ratio0.00
Enterprise Value/Market Cap1.02
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/Ebitda-14.77
Forecast
1Y Price Target
$93.75Price Target Upside53.71% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering5
Belite Bio, Inc. ADR Business Overview & Revenue Model
Company DescriptionBelite Bio, Inc. ADR (BLTE) is a clinical-stage biopharmaceutical company focused on discovering and developing novel therapeutics to address significant unmet medical needs in the fields of ophthalmology and metabolic diseases. The company is engaged in developing innovative treatments aimed at improving patient outcomes, particularly in the areas of retinal degenerative diseases such as Stargardt disease and dry age-related macular degeneration.
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 Earnings Call Summary
Earnings Call Date:May 14, 2025
(Q1-2025)
| % Change Since: 0.16%|
Next Earnings Date:Aug 06, 2025
Earnings Call Sentiment Positive
The earnings call presented a generally positive outlook for Belite Bio, with significant progress in clinical trials for Tinlarebant and a robust financial position. However, increased operating expenses and pending regulatory details introduce some uncertainty.Q1-2025 Updates
Positive Updates
Promising Clinical Progress for Tinlarebant
The Phase 3 DRAGON trial for Tinlarebant showed promising interim results with the DSMB recommending submission for further regulatory review. The trial is on track for completion by the end of the year.
Strong Financial Position
Belite Bio reported a cash increase of $12.3 million for the quarter, leaving the company with $157.4 million in cash and equivalents. The company expects a full year cash runway to complete all current clinical trials.
Phase 3 PHOENIX Trial Advancements
The PHOENIX trial for geographic atrophy has enrolled 464 subjects with a total target of 500. Enrollment is expected to be completed in Q3 2025.
Low Withdrawal Rates in Clinical Trials
DRAGON trial showed less than a 10% overall withdrawal rate, and the PHOENIX trial's dropout rate is approximately 20%, which is lower than comparables.
Negative Updates
Increased Net Loss
Net loss for the quarter was $14.3 million, up from $7.9 million in the same period last year, primarily due to increased R&D and G&A expenses.
Regulatory Uncertainty
Pending meetings with the FDA and other regulatory agencies could impact the development plan for Stargardt disease, and potential changes in drug pricing policy under President Trump could pose challenges.
Increased Operating Expenses
Operating expenses are anticipated to rise throughout 2025 due to milestones in clinical trials, potentially impacting financial projections.
Company Guidance
During the Belite Bio First Quarter 2025 Earnings Call, the company provided several key metrics and updates regarding their clinical trials and financial standing. In the Stargardt disease program, the Phase 3 DRAGON trial, involving 104 subjects, has moved forward successfully with the Data Safety Monitoring Board (DSMB) recommending no changes to the trial size and suggesting data submission for regulatory review. The DRAGON 2 trial has enrolled 16 out of a targeted 60 subjects. For geographic atrophy, the Phase 3 PHOENIX trial has enrolled 464 subjects out of a planned 500, with full enrollment expected by Q3 2025. Financially, the company reported R&D expenses of $9.4 million and G&A expenses of $6.1 million for Q1 2025, resulting in a net loss of $14.3 million. Despite the increased expenses, primarily due to share-based compensation, Belite Bio maintains a strong financial position with $157.4 million in cash and equivalents, ensuring a cash runway to complete current clinical trials.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 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | -449.00K | -399.00K | -198.00K | -30.00K | -17.00K |
| EBITDA | -35.67M | -31.53M | -12.43M | -9.64M | -5.71M |
| Net Income | -36.14M | -31.63M | -12.47M | -9.79M | -5.75M |
Balance Sheet | |||||
| Total Assets | 152.13M | 94.64M | 44.27M | 18.35M | 25.74M |
| Cash, Cash Equivalents and Short-Term Investments | 145.15M | 88.16M | 42.09M | 17.34M | 25.62M |
| Total Debt | 537.00K | 886.00K | 866.00K | 31.81M | 31.81M |
| Total Liabilities | 6.31M | 4.21M | 2.77M | 33.44M | 32.78M |
| Stockholders Equity | 145.82M | 90.43M | 41.50M | -15.09M | -7.04M |
Cash Flow | |||||
| Free Cash Flow | -29.39M | -29.90M | -11.85M | -7.55M | -4.46M |
| Operating Cash Flow | -29.23M | -29.84M | -11.46M | -7.47M | -4.44M |
| Investing Cash Flow | -110.57M | -63.00K | -394.00K | -56.00K | -20.00K |
| Financing Cash Flow | 83.59M | 75.96M | 36.96M | -583.00K | 28.06M |
Belite Bio, Inc. ADR Technical Analysis
Negative
60.99
Price Trends
61.82
Negative
61.81
Negative
62.28
Negative
Market Momentum
0.23
Negative
49.11
Neutral
43.77
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 60.99 is above the 20-day moving average (MA) of 60.59, below the 50-day MA of 61.82, and below the 200-day MA of 62.28, indicating a neutral trend. The MACD of 0.23 indicates Negative momentum. The RSI at 49.11 is Neutral, neither overbought nor oversold. The STOCH value of 43.77 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 (46)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
65 Neutral | $2.35B | ― | -31.51% | ― | ― | ― | |
56 Neutral | $1.97B | ― | -38.04% | ― | -82.38% | -164.76% | |
56 Neutral | $2.33B | ― | -86.10% | ― | 29.32% | -11.00% | |
49 Neutral | $1.75B | ― | -33.98% | ― | 449.03% | 42.86% | |
46 Neutral | C$197.02M | -3.33 | -23.14% | 2.65% | 20.75% | -0.36% | |
45 Neutral | $2.16B | ― | -35.21% | ― | -100.00% | -144.79% | |
43 Neutral | $2.02B | ― | -33.43% | ― | ― | 4.80% |
* Healthcare Sector Average
Performance Comparison
BLTE
Belite Bio, Inc. ADR
60.92
10.59
21.04%
DNLI
Denali Therapeutics
14.00
-7.46
-34.76%
BEAM
Beam Therapeutics
20.45
-5.49
-21.16%
TARS
Tarsus Pharmaceuticals
43.25
16.21
59.95%
NAMS
NewAmsterdam Pharma Company
22.20
3.30
17.46%
RXRX
Recursion Pharmaceuticals
5.84
-1.77
-23.26%
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
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.