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PBYI 
Puma Biotechnology Inc (PBYI)
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Upturn Advisory Summary
12/09/2025: PBYI (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
2 Analysts rated it
Very few follow this stock; limited insights, higher-risk early investing.
1 Year Target Price $3.5
1 Year Target Price $3.5
| 0 | Strong Buy |
| 0 | Buy |
| 1 | Hold |
| 1 | Sell |
| 0 | Strong Sell |
Analysis of Past Performance
Type Stock | Historic Profit -18.57% | Avg. Invested days 32 | Today’s Advisory PASS |
Upturn Star Rating | Upturn Advisory Performance  1.0 | Stock Returns Performance  1.0 |
| Profits based on simulation | Last Close 12/09/2025 |
Key Highlights
Company Size Small-Cap Stock | Market Capitalization 278.16M USD | Price to earnings Ratio 7.46 | 1Y Target Price 3.5 |
Price to earnings Ratio 7.46 | 1Y Target Price 3.5 | ||
Volume (30-day avg) 2 | Beta 1.16 | 52 Weeks Range 2.58 - 6.12 | Updated Date 12/9/2025 |
52 Weeks Range 2.58 - 6.12 | Updated Date 12/9/2025 | ||
Dividends yield (FY) - | Basic EPS (TTM) 0.74 |
Analyzing Revenue: Products, Geography and Growth
Revenue by Products
Product revenue - Year on Year
Earnings Date
Report Date - | When - | Estimate - | Actual - |
Profitability
Profit Margin 17.44% | Operating Margin (TTM) 17.57% |
Management Effectiveness
Return on Assets (TTM) 9.9% | Return on Equity (TTM) 39.69% |
Valuation
Trailing PE 7.46 | Forward PE 3.46 | Enterprise Value 224822910 | Price to Sales(TTM) 1.31 |
Enterprise Value 224822910 | Price to Sales(TTM) 1.31 | ||
Enterprise Value to Revenue 1.06 | Enterprise Value to EBITDA 4.48 | Shares Outstanding 50391107 | Shares Floating 38613194 |
Shares Outstanding 50391107 | Shares Floating 38613194 | ||
Percent Insiders 15.39 | Percent Institutions 71.09 |
Upturn AI SWOT
Puma Biotechnology Inc
Company Overview
History and Background
Puma Biotechnology, Inc. was founded in 2010 by Alan H. Auerbach. The company is a biopharmaceutical company that focuses on the development and commercialization of innovative oncology drugs. A significant milestone was the acquisition of the Nerlynx (neratinib) program from Wyeth in 2011. Nerlynx was subsequently approved by the U.S. Food and Drug Administration (FDA) in 2017 for the extended adjuvant treatment of patients with early-stage HER2-overexpressed/amplified breast cancer, and has since expanded its indications.
Core Business Areas
- Oncology Drug Development and Commercialization: Puma Biotechnology's core business revolves around the development, manufacturing, and commercialization of therapeutics for cancer. The company identifies promising drug candidates, conducts clinical trials, and seeks regulatory approval to bring these treatments to market.
Leadership and Structure
Puma Biotechnology, Inc. is led by a management team with extensive experience in the pharmaceutical industry. Alan H. Auerbach serves as the Chief Executive Officer and President. The company operates with a lean structure, outsourcing certain functions such as manufacturing to third parties. The Board of Directors oversees the strategic direction of the company.
Top Products and Market Share
Key Offerings
- Nerlynx (neratinib): Nerlynx is a tyrosine kinase inhibitor used for the extended adjuvant treatment of adult patients with a history of early-stage HER2-positive breast cancer, after completing treatment with trastuzumab-based adjuvant therapy. Competitors in the HER2-positive breast cancer space include drugs like Kadcyla (ado-trastuzumab emtansine) by Genentech/Roche, and Perjeta (pertuzumab) by Genentech/Roche. Market share for Nerlynx is specific to its indication within the broader HER2+ breast cancer market. Precise market share figures are proprietary and subject to change based on sales data and competitive pressures. Revenue generated by Nerlynx is the primary driver of Puma Biotechnology's financial performance.
Market Dynamics
Industry Overview
Puma Biotechnology operates within the highly competitive and rapidly evolving biopharmaceutical industry, specifically focusing on oncology. The industry is characterized by significant R&D investment, stringent regulatory processes, and a constant drive for innovation to address unmet medical needs in cancer treatment. Key trends include targeted therapies, immunotherapies, and personalized medicine.
Positioning
Puma Biotechnology is positioned as a focused oncology company with a key product, Nerlynx, targeting a specific segment of breast cancer. Its competitive advantage lies in its established product, specialized knowledge in HER2-positive breast cancer, and its ability to navigate the complexities of drug development and commercialization in a niche market.
Total Addressable Market (TAM)
The Total Addressable Market for HER2-positive breast cancer therapies is substantial, comprising hundreds of thousands of patients globally. Puma Biotechnology is positioned to capture a significant portion of this market with Nerlynx, particularly in its approved extended adjuvant setting. The TAM is dynamic, influenced by new diagnoses, treatment guidelines, and the introduction of competing therapies.
Upturn SWOT Analysis
Strengths
- Established product (Nerlynx) with regulatory approval.
- Expertise in HER2-positive breast cancer.
- Focused business model on oncology.
- Experienced management team.
Weaknesses
- Reliance on a single primary product.
- Pipeline is relatively nascent beyond Nerlynx.
- Potential for market share erosion by newer therapies.
- Limited financial resources compared to larger pharmaceutical companies.
Opportunities
- Expansion of Nerlynx's indications through further clinical trials.
- Development of new oncology drug candidates.
- Potential for strategic partnerships or acquisitions.
- Growth in emerging markets.
Threats
- Competition from established and emerging oncology drugs.
- Regulatory hurdles and potential delays in drug approvals.
- Pricing pressures and reimbursement challenges.
- Patent expirations and generic competition in the long term.
Competitors and Market Share
Key Competitors
- Genentech/Roche (US Stock Symbol: RHHBY - ADR)
- Pfizer Inc. (US Stock Symbol: PFE)
- Bristol Myers Squibb Company (US Stock Symbol: BMY)
Competitive Landscape
Puma Biotechnology's competitive landscape is challenging, with major pharmaceutical players like Genentech/Roche, Pfizer, and Bristol Myers Squibb having established portfolios in oncology. Puma's advantage lies in its specific focus on Nerlynx within the HER2+ breast cancer niche. However, it faces competition from products with broader indications or different mechanisms of action. The company needs to continually demonstrate the value proposition and clinical superiority of Nerlynx to maintain and grow its market share.
Growth Trajectory and Initiatives
Historical Growth: Puma Biotechnology has experienced growth since the commercialization of Nerlynx. Revenue has increased as the product gains market traction and expands its patient base. However, the company's growth trajectory is also influenced by ongoing clinical development and the need to establish a broader product portfolio.
Future Projections: Future growth projections for Puma Biotechnology are largely dependent on the continued success of Nerlynx, including potential label expansions and improved market penetration. Analyst estimates will provide insights into anticipated revenue and earnings growth, but are subject to revision.
Recent Initiatives: Recent initiatives likely include ongoing clinical trials for Nerlynx in different cancer types or stages, efforts to optimize commercialization strategies, and potentially exploring early-stage pipeline assets.
Summary
Puma Biotechnology Inc. is a biopharmaceutical company with a strong focus on oncology, primarily driven by its product Nerlynx. While Nerlynx has established a presence in the HER2-positive breast cancer market, the company faces challenges due to its reliance on a single product and intense competition from larger pharmaceutical giants. Its future success hinges on expanding Nerlynx's indications, effectively managing commercialization, and potentially diversifying its pipeline to mitigate risks and ensure long-term sustainability.
Similar Stocks
Sources and Disclaimers
Data Sources:
- Company's SEC Filings (10-K, 10-Q)
- Financial News Outlets (e.g., Bloomberg, Reuters, Wall Street Journal)
- Industry Analysis Reports
- PubMed (for clinical trial information)
Disclaimers:
This analysis is based on publicly available information and is for informational purposes only. It does not constitute financial or investment advice. Investors should conduct their own due diligence and consult with a qualified financial advisor before making any investment decisions. Market share data and TAM figures are estimates and can vary significantly based on source and methodology. Competitor identification and market share are based on the primary therapeutic area and may not encompass all aspects of each company's operations.
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 Puma Biotechnology Inc
Exchange NASDAQ | Headquaters Los Angeles, CA, United States | ||
IPO Launch date 2012-04-24 | Founder, Chairman, President, CEO & Secretary Mr. Alan H. Auerbach | ||
Sector Healthcare | Industry Biotechnology | Full time employees 172 | |
Full time employees 172 | |||
Puma Biotechnology, Inc., a biopharmaceutical company, focuses on the development and commercialization of products to enhance cancer care in the United States and internationally. The company offers NERLYNX, an oral version of neratinib that is used to treat adult patients with early stage HER2-overexpressed/amplified breast cancer; and advanced or metastatic HER2-positive breast cancer when combined with capecitabine. It develops alisertib, a small molecule inhibitor of aurora kinase A for the treatment of hormone receptor positive breast cancer, triple negative breast cancer, small cell lung cancer, and head and neck cancer. The company sells its products through specialty pharmacy and distributor networks. It has license agreements with Pfizer Inc. for the development, manufacture, and commercialization of neratinib (oral), neratinib (intravenous), PB357, and related compounds, as well as sub-license agreements with Medison Pharma Ltd., Pint Pharma International SA, Knight Therapeutics, Inc., Pierre Fabre Medicament SAS, and Bixink Therapeutics Co., Ltd. The company was founded in 2010 and is headquartered in Los Angeles, California.
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