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Puma Biotechnology Inc (PBYI)

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Upturn Advisory Summary
12/26/2025: PBYI (1-star) is currently NOT-A-BUY. Pass it for now.
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 | Stock Returns Performance |
Key Highlights
Company Size Small-Cap Stock | Market Capitalization 310.41M USD | Price to earnings Ratio 8.32 | 1Y Target Price 3.5 |
Price to earnings Ratio 8.32 | 1Y Target Price 3.5 | ||
Volume (30-day avg) 2 | Beta 1.16 | 52 Weeks Range 2.58 - 6.22 | Updated Date 12/28/2025 |
52 Weeks Range 2.58 - 6.22 | Updated Date 12/28/2025 | ||
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 8.32 | Forward PE 3.46 | Enterprise Value 257073219 | Price to Sales(TTM) 1.46 |
Enterprise Value 257073219 | Price to Sales(TTM) 1.46 | ||
Enterprise Value to Revenue 1.21 | Enterprise Value to EBITDA 5.13 | Shares Outstanding 50391107 | Shares Floating 38615713 |
Shares Outstanding 50391107 | Shares Floating 38615713 | ||
Percent Insiders 15.39 | Percent Institutions 71.42 |
Upturn AI SWOT
Puma Biotechnology Inc

Company Overview
History and Background
Puma Biotechnology Inc. was founded in 2010. The company's primary focus is the development and commercialization of cancer therapeutics. A significant milestone was the acquisition of the rights to neratinib from Pfizer in 2011. Neratinib is a tyrosine kinase inhibitor used in the treatment of HER2-positive breast cancer. The company has since been dedicated to advancing the development and regulatory approval of this drug.
Core Business Areas
- Oncology Therapeutics Development: Puma Biotechnology's core business revolves around the research, development, and commercialization of novel treatments for cancer. Their primary focus is on small molecule targeted therapies.
Leadership and Structure
Puma Biotechnology Inc. is led by Alan H. Auerbach, its founder, CEO, and Chairman of the Board. The company operates with a lean management team focused on clinical development, regulatory affairs, and commercialization of its lead product.
Top Products and Market Share
Key Offerings
- Nerlynx (neratinib): Nerlynx is a prescription medicine used to treat certain types of early-stage HER2-positive breast cancer in adults. It is an oral, irreversible tyrosine kinase inhibitor that targets HER2, HER3, and HER4. Competitors in the HER2-positive breast cancer space include drugs like Kadcyla (T-DM1), Enhertu (trastuzumab deruxtecan), and Tykerb (lapatinib). Market share data for specific drugs within this niche indication can be proprietary and fluctuate; however, Nerlynx has carved out a segment for extended adjuvant treatment following trastuzumab-based therapy. Revenue generated from Nerlynx is the primary source of the company's income.
Market Dynamics
Industry Overview
The oncology therapeutics market is characterized by high R&D costs, long development timelines, stringent regulatory requirements, and significant unmet medical needs. It is a highly competitive and innovative sector with a focus on targeted therapies and immunotherapies.
Positioning
Puma Biotechnology is positioned as a niche player in the HER2-positive breast cancer market, focusing on a specific treatment paradigm for early-stage disease. Its competitive advantage lies in the established efficacy and safety profile of Nerlynx in its approved indication and its ongoing research into potential new uses.
Total Addressable Market (TAM)
The TAM for HER2-positive breast cancer treatments is substantial, with millions of new cases diagnosed globally each year. Puma Biotechnology's TAM is specifically defined by the patient population eligible for extended adjuvant therapy after standard HER2-targeted treatment. The company is well-positioned to capture a significant portion of this specific segment.
Upturn SWOT Analysis
Strengths
- Approved and marketed product (Nerlynx) with established efficacy.
- Focused therapeutic area with a clear patient population.
- Experienced management team with expertise in drug development and commercialization.
Weaknesses
- High reliance on a single product for revenue.
- Limited pipeline beyond Nerlynx.
- Potential for pricing pressures and competition from newer therapies.
Opportunities
- Expansion of Nerlynx's indication into other cancer types.
- Geographic expansion and increased market penetration.
- Development of combination therapies with Nerlynx.
Threats
- Emergence of more effective or convenient treatments.
- Patent expirations and generic competition.
- Changes in healthcare reimbursement policies.
- Regulatory hurdles for any new indications.
Competitors and Market Share
Key Competitors
- Roche (OTCQX: RHHBY)
- Seagen Inc. (NASDAQ: SGEN) - acquired by Pfizer
- Daiichi Sankyo Company, Limited (OTCPK: DSNKY)
Competitive Landscape
Puma Biotechnology faces competition from larger pharmaceutical companies with extensive portfolios and resources in oncology. Its advantage lies in its specialized focus on HER2-positive breast cancer and the established clinical profile of Nerlynx. However, competitors often have broader drug pipelines and greater market access.
Growth Trajectory and Initiatives
Historical Growth: Puma Biotechnology's historical growth has been tied to the successful development and commercialization of Nerlynx. Post-launch, revenue growth has been driven by increasing adoption and market penetration in its approved indication.
Future Projections: Future projections are often based on analyst estimates, which consider factors like expected sales growth of Nerlynx, potential label expansions, and competitive landscape evolution. These projections are subject to change based on market dynamics and company performance.
Recent Initiatives: Recent initiatives likely focus on expanding the use of Nerlynx through clinical trials in different patient populations or earlier lines of therapy, and efforts to optimize commercial strategies for broader market reach.
Summary
Puma Biotechnology Inc. is a specialized oncology company with a single, approved product, Nerlynx, for HER2-positive breast cancer. Its strength lies in its focused expertise and established market position within this niche. However, a heavy reliance on one drug and a limited pipeline present significant risks. Future growth hinges on expanding Nerlynx's applications and navigating a highly competitive landscape with evolving treatment paradigms. The company needs to actively explore pipeline diversification to ensure long-term sustainability.
Similar Stocks
Sources and Disclaimers
Data Sources:
- Company's SEC Filings (10-K, 10-Q)
- Financial News and Analysis Platforms (e.g., Bloomberg, Refinitiv, Yahoo Finance)
- Industry Research Reports
Disclaimers:
This analysis is based on publicly available information and is for informational purposes only. It does not constitute financial advice. Market share and financial data can change rapidly. Investors should conduct their own due diligence before making any investment decisions.
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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