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Clearside Biomedical (CLSD)
NASDAQ:CLSD
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Clearside Biomedical
(NASDAQ:CLSD)
46Neutral
Positive Factors
Clinical Trial Results
The ODYSSEY trial of CLS-AX in wet AMD reported positive topline results and met both primary and secondary endpoints.
FDA Approval
FDA has approved the proposed Phase 3 program for CLS-AX in wAMD.
Negative Factors
Funding Concerns
The company needs to secure funding or a partnership to conduct the Phase 3 program for CLS-AX.
Clearside Biomedical (CLSD) vs. S&P 500 (SPY)
Market Cap
$67.48M
Dividend YieldN/A
Average Volume (3M)245.56K
Price to Earnings (P/E)―
Beta (1Y)1.82
Revenue Growth248.39%
EPS Growth26.05%
CountryUS
Employees30
SectorHealthcare
Sector Strength77
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.45
Shares Outstanding75,843,506
10 Day Avg. Volume251,876
30 Day Avg. Volume245,561
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)8.76
Price to Cash Flow (P/CF)-2.90
P/FCF Ratio0.00
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$5.75Price Target Upside546.07% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering4
Clearside Biomedical Business Overview & Revenue Model
Company DescriptionClearside Biomedical, Inc. (CLSD) is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of serious back-of-the-eye diseases. The company's proprietary SCS Microinjector is designed to deliver therapeutics to the suprachoroidal space, addressing unmet medical needs in ophthalmology. Clearside's pipeline includes multiple product candidates targeting diseases such as uveitis, retinal vein occlusion, and diabetic macular edema.
How the Company Makes MoneyClearside Biomedical primarily generates revenue through collaboration and licensing agreements with other pharmaceutical companies. The company partners with larger entities to co-develop and commercialize its proprietary drug delivery platform and therapeutic candidates. Additionally, Clearside may receive milestone payments and royalties from its partners upon successful development, regulatory approval, and commercialization of its therapies. The company's ability to establish and maintain strategic partnerships is crucial to its revenue generation as it continues to advance its pipeline and expand its reach in the ophthalmology market.
Clearside Biomedical Financial Statement Overview
Summary
Clearside Biomedical is facing financial challenges with declining revenues and negative profitability. The balance sheet shows negative equity, indicating a financially unstable position. Operating and free cash flows are negative, suggesting cash management issues despite efficient cash flow handling.Income Statement
Clearside Biomedical showed a declining revenue trend with a TTM revenue of $7.7M compared to $8.2M last year. The gross profit margin is high at 99.4%, but the company faces significant operational challenges with negative EBIT and EBITDA margins, reflecting ongoing losses. The net profit margin is also negative, highlighting profitability issues.40
Negative
Balance Sheet
The balance sheet reveals a weak financial position with negative stockholders' equity of -$34.8M, indicating liabilities exceed assets, which poses a risk. The debt-to-equity ratio is not applicable due to negative equity, and the negative return on equity further underscores profitability challenges.30
Negative
Cash Flow
Operating and free cash flows are negative, indicating cash outflows. However, operating cash flow to net income ratio is somewhat stable, suggesting efficient cash management despite losses. The free cash flow growth rate is a concern, showing negative trends.45
Neutral
| Breakdown | |||||
| TTM | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 | Dec 2019 |
|---|---|---|---|---|---|
| Income Statement | Total Revenue | ||||
| 7.70M | 8.23M | 1.33M | 29.57M | 7.89M | 2.17M | Gross Profit |
| 7.66M | 7.87M | 1.12M | 29.40M | 7.89M | 2.17M | EBIT |
| -24.65M | -24.84M | -30.28M | -627.00K | -17.93M | -30.30M | EBITDA |
| -22.23M | -23.06M | -29.46M | -449.00K | -17.93M | -30.09M | Net Income Common Stockholders |
| -31.88M | -32.48M | -34.07M | 376.00K | -18.03M | -30.56M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | ||||
| 40.88M | 28.92M | 48.26M | 30.44M | 17.29M | 22.59M | Total Assets |
| 44.12M | 34.02M | 51.30M | 42.90M | 19.32M | 26.78M | Total Debt |
| 9.97M | 43.00M | 1.28M | 675.00K | 1.98M | 6.41M | Net Debt |
| 1.93M | 14.08M | -46.97M | -29.76M | -15.31M | -16.19M | Total Liabilities |
| 20.50M | 49.93M | 40.70M | 4.93M | 10.56M | 15.62M | Stockholders Equity |
| 23.62M | -15.91M | 10.61M | 37.98M | 8.76M | 11.16M |
| Cash Flow | Free Cash Flow | ||||
| -19.60M | -19.91M | -13.61M | -10.73M | -13.18M | -27.09M | Operating Cash Flow |
| -18.95M | -18.14M | -13.37M | -10.73M | -13.12M | -27.07M | Investing Cash Flow |
| -10.06M | -1.78M | -246.00K | 0.00 | -55.00K | 32.92M | Financing Cash Flow |
| 14.10M | 414.00K | 31.33M | 23.78M | 7.87M | 8.70M |
Clearside Biomedical Technical Analysis
Neutral
0.89
Price Trends
0.95
Negative
1.00
Negative
1.09
Negative
Market Momentum
-0.03
Positive
46.97
Neutral
45.30
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CLSD, the sentiment is Neutral. The current price of 0.89 is below the 20-day moving average (MA) of 0.91, below the 50-day MA of 0.95, and below the 200-day MA of 1.09, indicating a bearish trend. The MACD of -0.03 indicates Positive momentum. The RSI at 46.97 is Neutral, neither overbought nor oversold. The STOCH value of 45.30 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for CLSD.
Clearside Biomedical Risk Analysis
Clearside Biomedical disclosed 69 risk factors in its most recent earnings report. Clearside Biomedical 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
Clearside Biomedical Peers Comparison
Overall Rating
UnderperformOutperform
Sector (49)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
54 Neutral | $1.23B | ― | -95.21% | ― | 9.03% | -25.00% | |
54 Neutral | $7.69B | ― | -80.35% | ― | ― | -10.89% | |
49 Neutral | $6.86B | 0.03 | -54.79% | 2.48% | 24.62% | -2.84% | |
48 Neutral | $448.11M | ― | -43.42% | ― | -5.97% | -25.87% | |
46 Neutral | $67.48M | ― | 91.63% | ― | 248.39% | 26.05% | |
44 Neutral | $412.59M | ― | -58.54% | ― | ― | -47.28% | |
42 Neutral | $39.90M | ― | -430.96% | ― | ― | 70.70% |
* Healthcare Sector Average
Performance Comparison
CLSD
Clearside Biomedical
0.89
-0.67
-42.95%
EYPT
EyePoint Pharmaceuticals
6.52
-14.78
-69.39%
MDGL
Madrigal Pharmaceuticals
348.35
65.12
22.99%
ALDX
Aldeyra Therapeutics
6.91
4.13
148.56%
OCUL
Ocular Therapeutix
7.72
-1.72
-18.22%
KALA
Kala Pharmaceuticals
6.55
-1.15
-14.94%
Clearside Biomedical Earnings Call Summary
Earnings Call Date: Nov 12, 2024 | % Change Since: -19.82% | Next Earnings Date: Mar 27, 2025
Earnings Call Sentiment Positive
The earnings call highlighted significant progress in clinical trials, strategic partnerships, and financial stability. The positive results from the ODYSSEY trial and strategic collaborations provide a strong foundation for future developments. However, there are uncertainties related to the Phase III plans and geographic atrophy research timeline.Highlights
Positive ODYSSEY Phase IIb Results
The ODYSSEY trial showed positive results for CLS-AX in treating wet AMD, demonstrating efficacy, safety, and potential for reduced treatment burden. The trial showed a 84% reduction in injection frequency, with most patients not requiring additional treatment for up to 6 months.
Strategic Collaborations and Partnerships
Clearside has strategic collaborations with Arctic Vision, REGENXBIO, and others, expanding the reach and validation of their suprachoroidal platform. Notably, Arctic Vision's collaboration with Santen Pharmaceuticals and REGENXBIO's partnership with AbbVie to advance gene therapy.
Expansion into Geographic Atrophy
Research is underway to explore treatments for geographic atrophy, a market valued at over $20 billion. Two approaches are being evaluated: improving choroidal perfusion and moderating inflammatory cells.
Financial Stability
As of September 30, 2024, Clearside had approximately $23.6 million in cash and cash equivalents, sufficient to fund operations into the third quarter of 2025.
Leadership and Structural Enhancements
Key personnel changes, including Tony Gibney as Chair of the Board and expanded responsibilities for Victor Chong, strengthen Clearside's leadership team.
Lowlights
Pending Phase III Plans
While the Phase III plans for CLS-AX are progressing, they remain under development with uncertainties regarding final design and costs. The end-of-Phase II meeting with the FDA is expected in early 2025.
No Immediate Geographic Atrophy IND Timeline
Although there are significant efforts in geographic atrophy research, there is no specific timeline for an IND submission, indicating that the program is still in exploratory stages.
Company Guidance
During the Clearside Biomedical Q3 2024 earnings call, the management provided comprehensive guidance on the company's progress and future plans. They highlighted the positive outcomes from the ODYSSEY Phase IIb clinical trial for CLS-AX in wet AMD, which demonstrated a favorable safety profile, stable best corrected visual acuity, and a significant reduction in treatment frequency by 84% with dosing flexibility between 3 to 6 months. The management anticipates starting two Phase III trials in the second half of 2025, with plans to discuss trial specifics in an end-of-Phase II meeting with the FDA early in 2025. Financially, the company reported cash and cash equivalents of approximately $23.6 million as of September 30, 2024, which is expected to support operations into Q3 2025, including preparations for the Phase III program and geographic atrophy research. Additionally, they discussed the strategic importance of their suprachoroidal platform, emphasizing its potential to address a $20 billion market in geographic atrophy and ongoing collaborations with partners like Arctic Vision and REGENXBIO.Clearside Biomedical Corporate Events
Product-Related AnnouncementsBusiness Operations and Strategy
Clearside Biomedical Highlights Advancements in Drug Delivery
Positive
Dec 12, 2024
Clearside Biomedical has updated its corporate presentation to highlight its advancements in drug delivery through the suprachoroidal space (SCS) platform, a method proven to enhance safety and efficacy in treating retinal disorders. This update underscores Clearside’s strategic positioning in the biopharmaceutical market, emphasizing its successful commercialization of XIPERE and ongoing developments in its pipeline, which target multi-billion dollar markets like wet AMD. The company’s robust intellectual property portfolio and collaborative efforts with global partners further solidify its competitive stance and potential for growth in ocular therapeutics.
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.