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Upturn AI SWOT - About
OTLK 
OUTLOOK THERAPEUTICS INC (OTLK)
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Upturn Advisory Summary
11/03/2025: 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 $6.25
1 Year Target Price $6.25
| 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 11/03/2025 |
Key Highlights
Company Size Small-Cap Stock | Market Capitalization 57.75M USD | Price to earnings Ratio - | 1Y Target Price 6.25 |
Price to earnings Ratio - | 1Y Target Price 6.25 | ||
Volume (30-day avg) 6 | Beta 0.57 | 52 Weeks Range 0.79 - 6.98 | Updated Date 11/3/2025 |
52 Weeks Range 0.79 - 6.98 | Updated Date 11/3/2025 | ||
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 73325787 | Price to Sales(TTM) 38.36 |
Enterprise Value 73325787 | Price to Sales(TTM) 38.36 | ||
Enterprise Value to Revenue 48.71 | Enterprise Value to EBITDA -4.13 | Shares Outstanding 44419529 | Shares Floating 29085463 |
Shares Outstanding 44419529 | Shares Floating 29085463 | ||
Percent Insiders 36.39 | Percent Institutions 13.6 |
Upturn AI SWOT
OUTLOOK THERAPEUTICS INC
Company Overview
History and Background
Outlook Therapeutics, Inc. is a late clinical-stage biopharmaceutical company founded in 2003. It focuses on developing and commercializing ONS-5010, an ophthalmic formulation of bevacizumab for various retinal diseases.
Core Business Areas
- Ophthalmic Therapeutics Development: Development of ONS-5010, an ophthalmic formulation of bevacizumab for retinal diseases, primarily wet AMD.
Leadership and Structure
The leadership team consists of Russel Trenary (CEO), C. Russell Trenary III, and others. The company follows a typical biotech organizational structure with departments focused on research, clinical development, regulatory affairs, and commercial planning.
Top Products and Market Share
Key Offerings
- ONS-5010 (Lytenava): ONS-5010 is an ophthalmic formulation of bevacizumab. Currently awaiting FDA approval to treat wet age-related macular degeneration (wet AMD). Competitors include Eylea (aflibercept) from Regeneron, Lucentis (ranibizumab) from Roche/Genentech, and Beovu (brolucizumab) from Novartis.
Market Dynamics
Industry Overview
The ophthalmic therapeutics market is experiencing growth driven by an aging population and increasing prevalence of retinal diseases like wet AMD, diabetic retinopathy, and retinal vein occlusion.
Positioning
Outlook Therapeutics aims to capture market share in the wet AMD treatment space by offering an on-label bevacizumab formulation, potentially at a competitive price compared to existing branded treatments.
Total Addressable Market (TAM)
The global wet AMD market is estimated to be several billion dollars annually. Outlook Therapeutics is positioned to address a portion of this TAM, particularly the segments where bevacizumab is currently used off-label.
Upturn SWOT Analysis
Strengths
- Potential first FDA-approved on-label bevacizumab for wet AMD
- Competitive pricing strategy
- Addresses a significant unmet need in off-label bevacizumab use
Weaknesses
- Reliance on single product (ONS-5010)
- Subject to FDA approval risk
- Limited commercial infrastructure compared to larger competitors
- Past CRL from FDA
Opportunities
- Expansion into other retinal disease indications
- Partnerships for commercialization and distribution
- Penetration of the global wet AMD market
Threats
- Competition from established anti-VEGF therapies
- Potential delays or rejection by regulatory agencies
- Biosimilar competition if ONS-5010 is approved
Competitors and Market Share
Key Competitors
- REGN
- NVS
- ROG
Competitive Landscape
Outlook Therapeutics' main advantage is ONS-5010 being a potential on-label bevacizumab. Disadvantages are the lack of revenue stream until product approval and strong competition from the competitors who have market share now. The market share values in Market Share Comparison will change if OTLK gets FDA approval.
Growth Trajectory and Initiatives
Historical Growth: Historical growth is characterized by clinical development progress and fundraising activities.
Future Projections: Future growth is dependent on successful FDA approval and commercialization of ONS-5010.
Recent Initiatives: Focus on resubmitting BLA for ONS-5010 following CRL, and preparing for potential commercial launch.
Summary
Outlook Therapeutics is a high-risk, high-reward biopharmaceutical company focused on securing FDA approval for ONS-5010. Its success hinges on navigating regulatory hurdles and effectively competing with established players in the wet AMD market. The recent CRL posed a significant setback, and resubmission success is critical. The company needs to effectively manage its cash burn and commercialize. Watch out for competition and regulatory approval.
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Sources and Disclaimers
Data Sources:
- Company SEC Filings
- Analyst Reports
- Company Website
Disclaimers:
This analysis is for informational purposes only and does not constitute investment advice. Investing in biopharmaceutical companies involves significant risk, including the risk of loss of principal.
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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