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1. Company Snapshot

1.a. Company Description

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's drug candidates include PB272 neratinib (oral) for the patients with early stage HER2-overexpressed/amplified breast cancer; PB272 (neratinib, oral) for the use of neratinib in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer; PB272 (neratinib, oral) for HER2 mutation-positive solid tumors.It has a license agreement with Pfizer, Inc.; and sub-license agreement with Specialised Therapeutics Asia Pte Ltd., CANbridge BIOMED Limited, 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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1.b. Last Insights on PBYI

Positive drivers behind Puma Biotechnology's recent performance include its strong Q4 earnings and revenue beat, with EPS of $0.43 per share, surpassing estimates of $0.14 per share. The company's sole-marketed drug, Nerlynx, exceeded management's expectations in Q3, and the acquisition of alisertib holds promise. Additionally, the company issued fresh financial guidance for 2025, indicating confidence in its future performance.

1.c. Company Highlights

2. Puma Biotechnology's Q3 2025 Earnings: A Closer Look

Puma Biotechnology reported total revenue of $54.5 million for the third quarter of 2025, with product revenue net of $51.9 million, a 5% increase from $49.2 million in Q2 2025. The company's net income was $8.8 million, or $0.18 per basic share and $0.17 per diluted share, compared to net income of $5.9 million, or $0.12 per share, in Q2 2025. On a non-GAAP basis, net income was $10.5 million, or $0.21 per basic and diluted share, beating analyst estimates of $0.09. The gross to net adjustment was 25.9% in Q3 2025, driven by a higher Medicare rebate and Medicaid share.

Publication Date: Nov -25

📋 Highlights
  • NERLYNX U.S. Sales Growth: U.S. net sales rose 6% YoY to $51.8 million in Q3 2025.
  • Product Revenue Decline: Net product revenue fell 7% YoY to $51.9 million, despite a 5% QoQ increase.
  • Inventory Build-Up: Inventory increased by 172 bottles in Q3, reversing a 85-bottle decline in Q2.
  • Alisertib Trial Progress: ALISCA-Breast1 trial is enrolling 98 patients, with interim analysis expected in H1 2026.
  • Net Profit Growth: Net income rose to $8.8 million ($0.18/share) in Q3 2025, up from $5.9 million in Q2 2025.

Revenue Growth and NERLYNX Sales

U.S. net sales of NERLYNX were $51.8 million in Q3 2025, a 6% increase from $48.8 million in Q3 2024. The company sold 2,949 bottles of NERLYNX in Q3 2025, an 8% increase from Q3 2024. Royalty revenue was $2.6 million, down from $3.2 million in Q2 2025 and $24.4 million in Q3 2024. Puma anticipates net NERLYNX product revenue of $198-200 million for fiscal year 2025, with a gross to net adjustment of 23-23.5%.

Operating Expenses and Cash Position

SG&A expenses were $16.8 million in Q3 2025, down from $18 million in Q2 2025, while R&D expenses were $15.9 million, up from $15.5 million in Q2 2025. Puma anticipates flat to slightly higher total operating expenses in 2025, with SG&A expenses decreasing by 7-10% and R&D expenses increasing by 20-25%. As of September 30, 2025, Puma had $94 million in cash, cash equivalents, and marketable securities, and made a principal loan payment of $11.1 million, reducing its outstanding debt to $33 million.

Valuation and Future Outlook

With a P/E Ratio of 6.78 and an ROE of 36.14%, Puma Biotechnology's valuation appears reasonable. The company's commitment to achieving positive net income and reducing expenses if needed is evident. Analysts estimate next year's revenue growth at -0.7%. Puma's debt is expected to be paid off by mid-next year, potentially allowing for a pivotal Phase III trial without going negative. The company's cash position and expected cash flow generation will be crucial in determining its ability to invest in new opportunities or return value to shareholders.

3. NewsRoom

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Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)

Dec -02

Source: businesswire.com

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IRWD vs. PBYI: Which Small-Cap Biotech Stock Is the Better Pick?

Nov -27

Source: zacks.com

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Puma Biotechnology: Step By Step In Making A Transition

Nov -10

Source: seekingalpha.com

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Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)

Nov -07

Source: businesswire.com

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Puma Biotechnology, Inc. (PBYI) Q3 2025 Earnings Call Transcript

Nov -07

Source: seekingalpha.com

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PBYI's Q3 Earnings & Revenues Beat Estimates, 2025 Sales View Raised

Nov -07

Source: zacks.com

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Puma Biotech (PBYI) Q3 Earnings and Revenues Top Estimates

Nov -07

Source: zacks.com

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Puma Biotechnology Reports Third Quarter 2025 Financial Results

Nov -06

Source: businesswire.com

4. Business Breakdown

4.a. Revenues by Country

4.b. Revenues by Segment

5. Expected revenues mid-term growth (9.33%)

6. Segments

Cancer Care Products

Expected Growth: 9.33%

Puma Biotechnology's Cancer Care Products segment growth of 9.33% is driven by increasing adoption of Nerlynx, a HER2-positive breast cancer treatment, and expanding label indications. Strong sales momentum in the US and Europe, coupled with growing demand for targeted therapies, contribute to the segment's growth. Additionally, investments in R&D and strategic partnerships enhance the company's product pipeline and market presence.

7. Detailed Products

Nerlynx

Nerlynx (neratinib) is an oral tablet used to treat adult patients with early-stage HER2-positive breast cancer, following trastuzumab-based adjuvant therapy.

8. Puma Biotechnology, Inc.'s Porter Forces

Forces Ranking

Threat Of Substitutes

Puma Biotechnology, Inc. operates in a niche market with limited substitutes, but the threat of substitutes is still present due to the ongoing research and development in the biotechnology industry.

Bargaining Power Of Customers

Puma Biotechnology, Inc. has a diverse customer base, which reduces the bargaining power of individual customers. Additionally, the company's products are specialized, making it difficult for customers to switch to alternative suppliers.

Bargaining Power Of Suppliers

Puma Biotechnology, Inc. relies on a few key suppliers for raw materials and services, which gives them some bargaining power. However, the company's strong relationships with its suppliers and its ability to negotiate contracts mitigate this risk.

Threat Of New Entrants

The biotechnology industry has high barriers to entry, including significant research and development costs, regulatory hurdles, and the need for specialized expertise. This makes it difficult for new entrants to compete with established companies like Puma Biotechnology, Inc.

Intensity Of Rivalry

The biotechnology industry is highly competitive, with many established companies competing for market share. Puma Biotechnology, Inc. faces intense competition from companies with similar products and technologies, which can lead to pricing pressure and reduced market share.

9. SWOT Analysis

Strength

Weaknesses

Opportunities

Threats

10. Capital Structure

10.a. Balance Sheet

10.b. Weighted Average Cost of capital

Value
Debt Weight 66.15%
Debt Cost 10.41%
Equity Weight 33.85%
Equity Cost 10.41%
WACC 10.41%
Leverage 195.46%

11. Quality Control: Puma Biotechnology, Inc. passed 4 out of 9 key points

12.a Historical Valuation

12.b Price/Earnings Ratio

12.c Margin Valuation

12.d Peers Valuation

Peers Group Analysis

Stock-Card
Puma Biotechnology

A-Score: 5.6/10

Value: 7.4

Growth: 6.1

Quality: 8.7

Yield: 0.0

Momentum: 9.5

Volatility: 2.0

1-Year Total Return ->

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Stock-Card
Harmony Biosciences

A-Score: 5.2/10

Value: 7.0

Growth: 9.4

Quality: 9.0

Yield: 0.0

Momentum: 1.5

Volatility: 4.3

1-Year Total Return ->

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Stock-Card
iTeos Therapeutics

A-Score: 4.6/10

Value: 7.8

Growth: 3.6

Quality: 6.2

Yield: 0.0

Momentum: 6.0

Volatility: 4.3

1-Year Total Return ->

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Stock-Card
Amylyx Pharmaceuticals

A-Score: 4.3/10

Value: 8.2

Growth: 3.6

Quality: 7.2

Yield: 0.0

Momentum: 5.0

Volatility: 1.7

1-Year Total Return ->

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Stock-Card
Ardelyx

A-Score: 3.8/10

Value: 6.8

Growth: 6.2

Quality: 4.7

Yield: 0.0

Momentum: 3.0

Volatility: 2.0

1-Year Total Return ->

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Stock-Card
Applied Therapeutics

A-Score: 2.8/10

Value: 6.2

Growth: 6.9

Quality: 3.3

Yield: 0.0

Momentum: 0.0

Volatility: 0.3

1-Year Total Return ->

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Peers Metrics

12.e Scoring Insights

12.f DCF BETA

Parameters

Short Term Growth

Short term Time

Long-Term Growth

WACC

Target Price

5.3$

Current Price

5.3$

Potential

-0.00%

Expected Cash-Flows