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Upturn AI SWOT - About
OTLK 
OUTLOOK THERAPEUTICS INC (OTLK)
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Upturn Advisory Summary
09/17/2025: OTLK (1-star) is currently NOT-A-BUY. Pass it for now.
Upturn Star Rating
Not Recommended Performance
These Stocks/ETFs, based on Upturn Advisory, consistently fall short of market performance, signaling caution before investing.
Number of Analysts
6 Analysts rated it
Limited analyst coverage, niche firm, research info may be scarce.
1 Year Target Price $8.25
1 Year Target Price $8.25
| 4 | Strong Buy |
| 1 | Buy |
| 1 | Hold |
| 0 | Sell |
| 0 | Strong Sell |
Analysis of Past Performance
Type Stock | Historic Profit -78.1% | Avg. Invested days 31 | Today’s Advisory PASS |
Upturn Star Rating | Upturn Advisory Performance  2.0 | Stock Returns Performance  1.0 |
| Profits based on simulation | Last Close 09/17/2025 |
Key Highlights
Company Size Small-Cap Stock | Market Capitalization 47.97M USD | Price to earnings Ratio - | 1Y Target Price 8.25 |
Price to earnings Ratio - | 1Y Target Price 8.25 | ||
Volume (30-day avg) 6 | Beta 0.49 | 52 Weeks Range 0.79 - 6.98 | Updated Date 09/17/2025 |
52 Weeks Range 0.79 - 6.98 | Updated Date 09/17/2025 | ||
Dividends yield (FY) - | Basic EPS (TTM) -0.84 |
Earnings Date
Report Date - | When - | Estimate - | Actual - |
Profitability
Profit Margin - | Operating Margin (TTM) -1046.2% |
Management Effectiveness
Return on Assets (TTM) -130.65% | Return on Equity (TTM) -3.65% |
Valuation
Trailing PE - | Forward PE 2.85 | Enterprise Value 72437396 | Price to Sales(TTM) 31.87 |
Enterprise Value 72437396 | Price to Sales(TTM) 31.87 | ||
Enterprise Value to Revenue 48.12 | Enterprise Value to EBITDA -4.13 | Shares Outstanding 44419500 | Shares Floating 25057945 |
Shares Outstanding 44419500 | Shares Floating 25057945 | ||
Percent Insiders 36.39 | Percent Institutions 20.54 |
Upturn AI SWOT
OUTLOOK THERAPEUTICS INC
Company Overview
History and Background
Outlook Therapeutics, Inc. is a late clinical-stage biopharmaceutical company working to develop and commercialize on label ophthalmic formulations of bevacizumab for various ophthalmic indications. The company was founded in 2003 and has focused on developing ONS-5010, its lead product candidate.
Core Business Areas
- Ophthalmic Biopharmaceuticals: Focuses on the development and commercialization of ophthalmic formulations of bevacizumab for the treatment of retinal diseases.
Leadership and Structure
Outlook Therapeutics is led by a management team with experience in the pharmaceutical industry. The organizational structure includes departments responsible for research and development, clinical trials, regulatory affairs, and commercialization.
Top Products and Market Share
Key Offerings
- ONS-5010 (Lytenava): ONS-5010 (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab under development for the treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases. Outlook Therapeutics is focused on obtaining FDA approval for ONS-5010. The main competitor is off-label bevacizumab (Avastin) used intravitreally, as well as approved therapies such as aflibercept (Eylea) and ranibizumab (Lucentis).
Market Dynamics
Industry Overview
The ophthalmic pharmaceutical industry is characterized by significant growth due to an aging population and increasing prevalence of retinal diseases such as wet AMD, diabetic macular edema (DME), and retinal vein occlusion (RVO).
Positioning
Outlook Therapeutics aims to gain market share by offering an on-label, FDA-approved bevacizumab formulation, potentially addressing safety and quality concerns associated with off-label use. It is positioned to compete with existing VEGF inhibitors.
Total Addressable Market (TAM)
The total addressable market for wet AMD treatment is estimated to be several billion dollars globally. Outlook Therapeutics aims to capture a portion of this market with ONS-5010, once approved.
Upturn SWOT Analysis
Strengths
- Potential first FDA-approved on-label bevacizumab for ophthalmic use
- Targeting a large and growing market
- Focus on a specific therapeutic area (retinal diseases)
Weaknesses
- Reliance on a single product candidate (ONS-5010)
- History of CRL from FDA
- Currently not generating revenue
- Dependence on raising capital to fund operations
Opportunities
- Expansion to other ophthalmic indications (DME, RVO)
- Partnerships for commercialization
- Potential for higher pricing compared to off-label bevacizumab
- Positive clinical trial results.
Threats
- Competition from established VEGF inhibitors (Eylea, Lucentis)
- Regulatory hurdles and potential delays in FDA approval
- Generic competition if ONS-5010's market exclusivity is limited
- Off-label bevacizumab usage continuing to be a cheaper treatment alternative
Competitors and Market Share
Key Competitors
- REGN
- SNY
- NVS
Competitive Landscape
Outlook Therapeutics' advantage lies in its potential to offer the first FDA-approved on-label bevacizumab formulation for ophthalmic use. However, it faces strong competition from established VEGF inhibitors like Eylea (REGN) and Lucentis (NVS), as well as off-label Avastin.
Growth Trajectory and Initiatives
Historical Growth: Historical growth is reflected in the advancement of ONS-5010 through clinical trials.
Future Projections: Future growth depends on the successful FDA approval and commercialization of ONS-5010.
Recent Initiatives: Recent initiatives include completing clinical trials and preparing for potential commercial launch.
Summary
Outlook Therapeutics is a high-risk, high-reward biopharmaceutical company focused on developing an on-label ophthalmic formulation of bevacizumab. The company's future depends heavily on the successful FDA approval and subsequent commercialization of ONS-5010. Currently, the company faces the risk of failure as evidenced by the recent CRL. The company has large competitors with market share that will provide a challenge to compete against.
Peer Comparison
Sources and Disclaimers
Data Sources:
- Company Website
- SEC Filings
- Analyst Reports
- ClinicalTrials.gov
Disclaimers:
This analysis is for informational purposes only and does not constitute investment advice. The information provided is based on publicly available data and analyst estimates, which are subject to change. The company's future performance is subject to various risks and uncertainties.
AI Summarization is directionally correct and might not be accurate.
Summarized information shown could be a few years old and not current.
Fundamental Rating based on AI could be based on old data.
AI-generated summaries may have inaccuracies (hallucinations). Please verify the information before taking action.
About OUTLOOK THERAPEUTICS INC
Exchange NASDAQ | Headquaters Iselin, NJ, United States | ||
IPO Launch date 2016-05-13 | President, CEO & Director Mr. Robert Charles Jahr | ||
Sector Healthcare | Industry Biotechnology | Full time employees 23 | |
Full time employees 23 | |||
Outlook Therapeutics, Inc., operates as a clinical-stage biopharmaceutical company, focuses on developing and commercializing monoclonal antibodies for ophthalmic indications. Its lead product candidate is ONS-5010, an ophthalmic bevacizumab product formulation of bevacizumab product candidate that is in Phase-III clinical trial for the treatment of wet age-related macular degeneration and other retina diseases. Outlook Therapeutics, Inc. has collaboration agreements with Cencora. The company was formerly known as Oncobiologics, Inc. and changed its name to Outlook Therapeutics, Inc. in November 2018. Outlook Therapeutics, Inc. was incorporated in 2010 and is headquartered in Iselin, New Jersey.
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