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Puma Biotechnology (PBYI)
NASDAQ:PBYI
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Puma Biotechnology (PBYI) AI Stock Analysis

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PBYI

Puma Biotechnology

(NASDAQ:PBYI)

Rating:69Neutral
Price Target:
Puma Biotechnology's overall stock score reflects its financial improvements, technical momentum, and attractive valuation. However, the company's challenges with revenue consistency and leverage, combined with mixed earnings call insights, temper the outlook. Long-term prospects may depend on successful execution of strategic initiatives and stabilization of revenue.
Positive Factors
Financial Performance
Puma reported net income, reflecting profitability in the financial results.
Product Demand
Puma anticipates a rebound in Nerlynx demand, expecting an increase in product revenue.
Negative Factors
Product Confidence
There is a lack of confidence in alisertib, and the recommendation remains at Hold.
Revenue Guidance
Significant accelerations in product and royalty revenue are needed in Q4 to support the full year guidance.

Puma Biotechnology (PBYI) vs. SPDR S&P 500 ETF (SPY)

Puma Biotechnology Business Overview & Revenue Model

Company DescriptionPuma 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.
How the Company Makes MoneyPuma Biotechnology generates revenue primarily through the sales of its flagship product, NERLYNX. The company earns money by selling this prescription drug to wholesalers, specialty pharmacies, and distributors, who then supply it to healthcare providers and patients. Additionally, Puma may receive milestone payments and royalties from licensing agreements or partnerships with other pharmaceutical companies interested in marketing NERLYNX in regions outside the United States. These collaborations can significantly contribute to the company's earnings by expanding its market reach and leveraging the distribution and marketing capabilities of its partners.

Puma Biotechnology Earnings Call Summary

Earnings Call Date:Aug 07, 2025
(Q2-2025)
|
% Change Since: 59.57%|
Next Earnings Date:Oct 30, 2025
Earnings Call Sentiment Neutral
The earnings call highlighted solid revenue growth and positive net income, with successful enrollment in clinical trials and increased marketing reach. However, the decrease in new prescriptions and enrollments, along with challenges in China, present areas of concern.
Q2-2025 Updates
Positive Updates
Revenue Growth
Total revenue for Q2 2025 was $52.3 million, with net product revenue from NERLYNX sales at $49.2 million, up from $43.1 million in Q1 2025 and $44.4 million in Q2 2024.
Increased NERLYNX Sales
NERLYNX ex-factory bottle sales were 2,608 in Q2 2025, a 12% increase quarter-over-quarter and a 4% increase year-over-year.
Positive Net Income
Reported GAAP net income of $5.9 million or $0.12 per share in Q2 2025, up from $3 million or $0.06 per share in Q1 2025.
Enrollment in Clinical Trials Ahead of Expectations
The ALISCA-Breast trial is enrolling faster than anticipated with 62 patients enrolled and 10 additional in screening.
Increased Marketing Reach
Year-to-date, reached 99.7% of oncologists through nonpersonal promotion, with new strategies to engage physicians.
Negative Updates
Decrease in New Prescriptions
New prescriptions were down approximately 3% compared to Q1 2025.
Lower R&D Efficacy Data
Lower pharmacokinetic data in the ALISCA-Lung1 study suggests a need to increase the dose of alisertib from 50 mg to 60 mg.
Decrease in Enrollments
Enrollments decreased by about 9% quarter-over-quarter and declined about 11% year-over-year.
Challenges in China
Fewer shipments expected to China due to regulatory transitions.
Company Guidance
During the second quarter of 2025, Puma Biotechnology reported total revenue of $52.3 million, with net product revenue from NERLYNX sales amounting to $49.2 million, marking an increase from $43.1 million in Q1 2025 and $44.4 million in Q2 2024. The company also recorded royalty revenue of $3.2 million, an increase from $2.9 million in Q1 2025. NERLYNX ex-factory bottle sales totaled 2,608, showing a 12% increase quarter-over-quarter and a 4% increase year-over-year, despite a 72-bottle inventory decrease. New prescriptions fell by approximately 3% compared to Q1 2025, whereas total prescriptions increased by roughly 3%. Puma's net income for the quarter stood at $5.9 million or $0.12 per share on a GAAP basis and $7.5 million or $0.15 per share on a non-GAAP basis, with a gross-to-net adjustment remaining at 20.8%. The company anticipates a full-year 2025 net NERLYNX product revenue between $192 million and $198 million, maintaining a focus on expanding NERLYNX utilization and engaging with healthcare providers.

Puma Biotechnology Financial Statement Overview

Summary
Puma Biotechnology's financial performance shows improvements with a positive net income and enhanced cash flow management. However, challenges persist with revenue fluctuations and high leverage, which weigh on the overall financial stability.
Income Statement
65
Positive
Puma Biotechnology's income statement shows moderate performance with a consistent gross profit margin of around 72% over the years. However, the revenue has shown fluctuations, with a recent decline from 2023 to 2024. Net income has improved significantly, transitioning from negative figures in previous years to a positive $30.28 million in 2024. EBIT and EBITDA margins have improved, indicating better operational efficiency, but the overall revenue growth remains a concern.
Balance Sheet
55
Neutral
The balance sheet reflects improvement in stockholders' equity, rising to $92.13 million in 2024 from negative figures in previous years. The debt-to-equity ratio has improved due to increased equity, although it still indicates a leveraged position. The equity ratio has stabilized, reflecting better asset management, but the high total liabilities continue to pose a risk.
Cash Flow
70
Positive
Cash flow analysis shows strong growth in free cash flow, which increased significantly in 2024. Operating cash flow to net income ratio indicates efficient cash management, and free cash flow to net income ratio is favorable. The company has managed capital expenditures well, contributing to improved free cash flow, though past fluctuations in cash flow need monitoring.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue238.06M230.47M235.64M228.00M253.20M225.10M
Gross Profit172.19M166.06M172.96M172.90M189.50M185.70M
EBITDA63.29M48.08M47.52M20.97M-5.40M-38.54M
Net Income48.45M30.28M21.59M2.00K-29.10M-60.00M
Balance Sheet
Total Assets194.92M213.33M230.53M222.06M226.59M244.22M
Cash, Cash Equivalents and Short-Term Investments96.02M100.97M95.94M81.07M82.11M93.39M
Total Debt38.36M74.08M111.49M114.28M116.64M120.95M
Total Liabilities90.20M121.21M177.09M200.45M229.03M250.17M
Stockholders Equity104.72M92.13M53.44M21.60M-2.40M-6.00M
Cash Flow
Free Cash Flow44.22M38.86M14.37M-22.80M20.70M-19.25M
Operating Cash Flow44.34M38.92M27.01M-15.80M20.70M800.00K
Investing Cash Flow-11.78M-20.44M-19.13M7.10M-10.90M23.30M
Financing Cash Flow-45.05M-33.85M0.0012.20M-31.90M100.00K

Puma Biotechnology Technical Analysis

Technical Analysis Sentiment
Positive
Last Price5.25
Price Trends
50DMA
3.74
Positive
100DMA
3.45
Positive
200DMA
3.26
Positive
Market Momentum
MACD
0.51
Negative
RSI
70.44
Negative
STOCH
58.01
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For PBYI, the sentiment is Positive. The current price of 5.25 is above the 20-day moving average (MA) of 4.21, above the 50-day MA of 3.74, and above the 200-day MA of 3.26, indicating a bullish trend. The MACD of 0.51 indicates Negative momentum. The RSI at 70.44 is Negative, neither overbought nor oversold. The STOCH value of 58.01 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for PBYI.

Puma Biotechnology Risk Analysis

Puma Biotechnology disclosed 58 risk factors in its most recent earnings report. Puma Biotechnology reported the most risks in the "Legal & Regulatory" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Puma Biotechnology Peers Comparison

Overall Rating
UnderperformOutperform
Sector (62)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
69
Neutral
$264.45M5.3663.24%8.63%429.84%
62
Neutral
€1.89B22.1712.16%2.05%7.83%13.92%
60
Neutral
$372.15M-30.00%-100.00%-266.37%
56
Neutral
$473.04M2152.93%
54
Neutral
$767.70M-76.09%-42.84%-17.32%
46
Neutral
$140.84M-97.49%-100.00%62.82%
39
Underperform
$119.99M-43.02%48.80%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
PBYI
Puma Biotechnology
5.25
2.60
98.11%
TARA
Protara Therapeutics
3.11
1.01
48.10%
FULC
Fulcrum Therapeutics
6.88
-2.86
-29.36%
TNGX
Tango Therapeutics
6.90
-5.03
-42.16%
IKT
Inhibikase Therapeutics
1.89
0.44
30.34%
NBTX
Nanobiotix
10.09
4.80
90.74%
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: May 01, 2025