Puma Biotechnology, Inc.
- Open
- 8.94
- Day high
- 9.20
- Day low
- 8.92
- Prev close
- 9.06
- Volume
- 243K
- Mkt cap
- $470M
- P/E (TTM)
- 17.0
- EPS (TTM)
- $0.54
- P/B
- 3.4
- P/S
- 2.0
- Yield
- —
- Per share
- —
- ▼Insiders net selling -$1.1M over the last 3 months (0 open-market buys, 8 sales)
- 🏛Institutions reducing (13F)
Puma Biotechnology, Inc. (PBYI) is a Healthcare company listed on NASDAQ. The stock is up 78% over the past year. Over the trailing 3 months, insiders filed 0 open-market buys and 8 sales (SEC Form 4).
Puma Biotechnology, Inc. (PBYI) financials & analyst ratings
Fundamentals (TTM)
Source: exchange market data + company filings. Figures are trailing-twelve-month or as most recently reported. For informational purposes only — not investment advice.
PBYI earnings date, history & EPS estimates
| Report date | EPS est | EPS actual | Surprise | Revenue | Rev. surprise |
|---|---|---|---|---|---|
| Aug 6, 2026 | $0.04 | $0.19 | +375.0% | $57M | +6.6% |
| May 7, 2026 | $-0.13 | $-0.04 | +69.2% | $45M | +6.7% |
| Nov 6, 2025 | $0.09 | $0.21 | +133.3% | $54M | -21.7% |
| Aug 7, 2025 | $0.11 | $0.15 | +36.4% | $52M | +3.1% |
| May 8, 2025 | $0.02 | $0.10 | +400.0% | $46M | -12.0% |
| Feb 27, 2025 | $0.10 | $0.43 | +330.0% | $59M | +10.0% |
| Nov 7, 2024 | $0.35 | $0.41 | +17.1% | $81M | +53.3% |
| Aug 1, 2024 | $-0.10 | $-0.05 | +50.0% | $47M | +4.4% |
| May 2, 2024 | $-0.16 | $-0.05 | +68.8% | $44M | +4.9% |
| Feb 29, 2024 | $0.30 | $0.26 | -13.3% | $72M | -1.6% |
| Nov 2, 2023 | $0.08 | $0.12 | +50.0% | $56M | -23.2% |
| Aug 3, 2023 | $0.07 | $0.10 | +42.9% | $55M | +3.7% |
PBYI insider trading activity (SEC Form 4)
| Date | Insider | Type | Shares | Price |
|---|---|---|---|---|
| Jul 8, 2026 | NOUGUES MAXIMO Fofficer: Chief Financial Officer | Sell | 9,386 | $8.26 |
| Jul 8, 2026 | HUNT DOUGLAS Mofficer: See Remarks | Sell | 8,460 | $8.26 |
| Jul 8, 2026 | AUERBACH ALAN Hdirector, 10 percent owner, officer: President and CEO | Sell | 44,058 | $8.26 |
| Jun 15, 2026 | Senderowicz Adriandirector | Sell | 27,000 | $7.20 |
| Jun 15, 2026 | MILLER MICHAEL PATRICKdirector | Grant | 27,000 | — |
| Jun 15, 2026 | Stuglik Brian Mdirector | Grant | 27,000 | — |
| Jun 15, 2026 | MOYES JAY Mdirector | Sell | 22,000 | $7.22 |
| Jun 15, 2026 | WILSON TROY EDWARDdirector | Grant | 27,000 | — |
| Jun 15, 2026 | Dorval Allisondirector | Sell | 11,610 | $7.20 |
| Jun 15, 2026 | Dorval Allisondirector | Grant | 27,000 | — |
| Jun 15, 2026 | WILSON TROY EDWARDdirector | Sell | 10,800 | $7.20 |
| Jun 15, 2026 | Senderowicz Adriandirector | Grant | 27,000 | — |
| Jun 15, 2026 | Cesano Alessandradirector | Grant | 27,000 | — |
| Jun 15, 2026 | Stuglik Brian Mdirector | Sell | 8,100 | $7.20 |
| Jun 15, 2026 | MOYES JAY Mdirector | Grant | 27,000 | — |
Source: PBYI SEC Form 4 filings, latest Jul 8, 2026. For informational purposes only — not investment advice.
See the full PBYI insider & 13F page →Puma Biotechnology, Inc. company profile
Overview
Puma Biotechnology, Inc. (NASDAQ:PBYI) is a Los Angeles-based biopharmaceutical company founded in 2010 that focuses on developing and commercializing innovative cancer treatments. The company went public in 2012 and has established itself as a specialized oncology company with a primary focus on HER2-positive breast cancer therapies. Puma's flagship product is NERLYNX (neratinib), an oral medication approved for treating early-stage and advanced HER2-positive breast cancer patients. The company has built a global presence through licensing partnerships and continues to expand its pipeline through clinical development programs and potential in-licensing opportunities.
Business
Puma Biotechnology operates in the oncology therapeutics sector, specifically focusing on targeted cancer treatments. The company's core business revolves around developing and commercializing drugs that target specific molecular pathways in cancer cells, particularly those involving the HER2 protein. The company's primary product is NERLYNX (neratinib), an oral tyrosine kinase inhibitor that blocks multiple members of the HER family of receptors. HER2 is a protein that promotes cell growth and is overexpressed in approximately 20-25% of breast cancers, making these tumors more aggressive. NERLYNX works by irreversibly binding to and blocking these receptors, preventing cancer cells from receiving growth signals. The drug is approved for extended adjuvant treatment (additional therapy after initial treatment) of early-stage HER2-positive breast cancer patients and for advanced or metastatic HER2-positive breast cancer when used in combination with capecitabine. Puma's pipeline also includes alisertib, an aurora kinase inhibitor in-licensed from Takeda in 2022. Aurora kinases are enzymes critical for cell division, and their inhibition can prevent cancer cells from dividing properly. Alisertib is currently being evaluated in Phase 2 trials for small cell lung cancer and hormone receptor-positive breast cancer. The company generates revenue from two primary sources: approximately 85-90% from direct product sales of NERLYNX in the United States, and 10-15% from royalty payments received from international licensing partners who commercialize neratinib in their respective territories including China, Europe, and other global markets.
Revenue model
Puma Biotechnology operates a hybrid business model combining direct commercialization with licensing partnerships. The company generates revenue through direct product sales of NERLYNX in the United States, where it maintains its own commercial infrastructure including sales representatives and market access teams. Product revenue accounts for approximately 85-90% of total revenue, with net sales of around $190-200 million annually from NERLYNX. The company also earns royalty revenue from licensing agreements with international partners who have rights to commercialize neratinib in specific geographic regions. These partnerships with companies like Specialised Therapeutics Asia, CANbridge BIOMED, Pierre Fabre, and others generate royalty payments typically ranging from $20-30 million annually, though this can be lumpy depending on partner shipment timing. Puma's paying customers are primarily specialty pharmacies and distributors who serve oncology patients, with approximately 67% of sales flowing through specialty pharmacy channels and 33% through specialty distributors. The ultimate end-users are cancer patients, with payer mix consisting of roughly 65% commercial insurance, 25% government programs (Medicare/Medicaid), and 10% uninsured or other payment sources. Several factors significantly impact Puma's margins and profitability. Positive margin drivers include the company's ability to implement annual price increases (typically 5-7%), improved patient persistence through dose escalation strategies, and expanding global market access through new regulatory approvals. The company benefits from relatively high gross margins typical of specialty pharmaceuticals, with gross-to-net adjustments around 17-18%. Margin pressures come from increasing rebates and discounts to payers, particularly as Medicare Part D redesign affects patient access, competitive pressure in the HER2-positive breast cancer space from newer therapies, and the need to maintain field sales forces and medical affairs teams. Patent expiration risk for neratinib also creates long-term margin pressure, while clinical development costs for pipeline assets like alisertib represent ongoing investment requirements that impact near-term profitability.
Competitive moat
Puma Biotechnology operates in a competitive oncology market with limited sustainable competitive advantages. The company's primary moat is its regulatory approval and market position in the extended adjuvant HER2-positive breast cancer setting, where NERLYNX holds a specific indication that provides some protection from direct competition. The extended adjuvant indication represents a differentiated treatment approach, as patients receive NERLYNX after completing standard HER2-targeted therapy to further reduce recurrence risk. However, this moat is relatively narrow and vulnerable to several competitive threats. The HER2-positive breast cancer treatment landscape is rapidly evolving with newer, potentially more effective therapies entering the market. Companies like Roche/Genentech with trastuzumab deruxtecan (Enhertu) and other novel HER2-targeted agents pose significant competitive risks. These newer therapies may offer superior efficacy or tolerability profiles that could erode NERLYNX's market position. The company's intellectual property protection provides temporary competitive protection, but patent expiration represents a significant long-term risk. Puma's licensing partnerships create some geographic diversification, but these relationships are dependent on partner performance and commitment. Competitive disruption is likely to come from several sources: next-generation HER2-targeted therapies with improved efficacy or safety profiles, combination therapies that incorporate newer agents, and potential biosimilar competition following patent expiration. The company's relatively small size and limited R&D resources compared to larger pharmaceutical companies also constrain its ability to compete in developing next-generation therapies. Puma's attempt to diversify through alisertib development and potential in-licensing represents recognition of these competitive vulnerabilities, but success is uncertain and execution risk is high.
Risks & safety
Puma Biotechnology demonstrates a moderate margin of safety with stable cash generation but faces some structural financial challenges. **Overall Assessment:** The company maintains positive cash flow generation and reasonable liquidity, but operates with elevated debt levels and faces patent expiration risks. **Cash and Liquidity:** - Cash and short-term investments: $63.0 million (Q1 2025) - Positive operating cash flow: $3.6 million (Q1 2025), $38.9 million (FY 2024) - Free cash flow positive: $3.6 million (Q1 2025), $38.9 million (FY 2024) - Current ratio: 1.53x indicating adequate short-term liquidity **Debt and Solvency:** - Debt-to-equity ratio: 0.53x (improved from 0.80x in Q4 2024) - Total liabilities: $99.1 million vs. total assets: $196.2 million - No immediate solvency concerns but elevated leverage compared to cash-rich biotech peers **Valuation Metrics:** - Price-to-earnings ratio: 12.3x (Q1 2025) - reasonable for profitable biotech - EV/EBITDA: 8.5x - moderate valuation multiple - Price-to-book ratio: 1.51x - trading near book value - Graham number: 1.63 - suggests potential undervaluation **Other Considerations:** - Revenue concentration risk in single product (NERLYNX) - Patent expiration timeline creates long-term revenue cliff risk - Quarterly revenue volatility due to inventory fluctuations and royalty timing
Recent development
Over the past few years, Puma Biotechnology has undergone significant strategic evolution focused on pipeline diversification and operational optimization. The most significant development was the 2022 in-licensing of alisertib from Takeda, marking the company's first major expansion beyond neratinib. Alisertib, an aurora kinase inhibitor, represents Puma's attempt to build a broader oncology portfolio and reduce dependence on NERLYNX. The company has advanced alisertib through multiple clinical programs, launching two Phase 2 trials: ALISCA-Lung1 for small cell lung cancer and ALISCA-Breast1 for hormone receptor-positive, HER2-negative metastatic breast cancer. These trials represent Puma's strategy to target cancer types with high unmet medical need and specific biomarker profiles that may predict alisertib response. Simultaneously, Puma has been exploring combination therapy approaches with neratinib, initiating a Phase 1 trial combining neratinib with trastuzumab deruxtecan (Enhertu) for HER2-positive cancers. This represents recognition that combination approaches may be necessary to remain competitive in the evolving HER2-positive breast cancer landscape. On the commercial front, the company has implemented a focused commercial strategy emphasizing dose escalation to improve patient persistence and tolerability. Approximately 70-75% of patients now start NERLYNX at reduced doses, with gradual escalation to full dosing, which has improved treatment completion rates. The company has also expanded its global footprint through new regulatory approvals and launches in markets including Turkey, Saudi Arabia, Libya, and several African countries. Financial discipline has become a key strategic priority, with management committed to maintaining profitability while funding clinical development. The company has actively managed expenses and is exploring business development opportunities to in-license additional commercial-stage or late-stage development assets that could leverage its existing commercial infrastructure.
PBYI company profile · for informational purposes only — not investment advice.
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