Puma Biotechnology, Inc. Stock price
Is Puma Biotechnology, Inc. a Top Scorer Stock based on the Dividend, High-Growth-Investing or Leverman Strategy?
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Key metrics
📘 Market Capitalization
📈 What is it?
Market capitalization shows how much a company is currently worth on the stock market.
🧮 How is it calculated?
🏛️ Why is it important?
It helps classify companies by size (Large, Mid, Small Cap) and indicates their market presence and relative stability.
🧮 Calculation
🎯 What does this mean for investors?
- Large-cap companies tend to be more stable, often pay dividends, but may grow more slowly.
- Smaller firms may offer higher growth potential but come with more volatility.
- Market capitalization is a useful indicator of company size — but not a measure of whether a stock is undervalued or overvalued.
📘 Enterprise Value (EV)
📈 What is it?
Enterprise Value represents the total cost to acquire a company — including its debt and excluding its cash reserves.
🧮 How is it calculated?
(= Market Cap + Net Debt)
🏛️ Why is it important?
EV gives a more complete picture of a company's value than market cap alone and is used in key valuation ratios like EV/FCF or EV/Sales.
🧮 Calculation
🎯 What does this mean for investors?
- Enterprise Value shows the true cost of buying a company, including all financial obligations.
- It is more accurate than just looking at market cap, especially when comparing companies with different levels of debt or cash.
- Professional investors prefer EV-based multiples because they better reflect the company’s full financial footprint.
📘 Net Debt
📈 What is it?
Net Debt shows how much debt remains after subtracting a company’s available cash reserves.
🧮 How is it calculated?
🏛️ Why is it important?
It indicates how dependent a company is on borrowed money and how easily it can service its debt in the short term.
🧮 Calculation
🎯 What does this mean for investors?
- Low or negative net debt signals financial strength and flexibility.
- Companies with strong cash positions are better positioned in crises.
- High net debt increases financial risk — especially in environments with rising interest rates or economic downturns.
📘 Cash
📈 What is it?
Cash represents all liquid assets a company can access immediately — including cash, bank deposits, and short-term investments.
🧮 How is it calculated?
🏛️ Why is it important?
It reflects a company’s financial flexibility and resilience — enabling investments, buybacks, or buffer in downturns.
🧮 Calculation
🎯 What does this mean for investors?
- A strong cash position means greater room for maneuver and crisis resistance.
- Cash-rich companies can invest, pay down debt, or repurchase shares.
- But excess idle cash might indicate a lack of growth opportunities.
📘 Shares Outstanding
📈 What is it?
Shares outstanding represent the total number of a company’s shares currently held by investors — excluding treasury stock.
🧮 How is it calculated?
🏛️ Why is it important?
It’s the basis for key metrics like Earnings Per Share (EPS), Market Capitalization, or the Price/Earnings ratio (P/E).
🧮 Calculation
🎯 What does this mean for investors?
- Fewer shares in circulation typically increase earnings per share — making each share more valuable.
- Share buybacks reduce the number of shares and boost per-share metrics.
- Issuing new shares does the opposite — diluting shareholder value and lowering per-share figures.
📘 Price-to-Earnings Ratio (P/E)
📈 What is it?
The P/E ratio shows how many times a company's earnings per share are reflected in its current share price — in other words, how "expensive" the stock appears relative to its profits.
🧮 How is it calculated?
🏛️ Why is it important?
The P/E ratio is one of the most widely used valuation metrics. It helps investors assess whether a stock appears cheap or expensive compared to its earnings power.
🧮 Calculation
📊 P/E (TTM) = Based on earnings from the last 12 months (Trailing Twelve Months):🎯 What does this mean for investors?
- A low P/E may indicate undervaluation — or signal underlying issues.
- A high P/E may reflect strong growth expectations — or an overvalued stock.
📘 Price-to-Sales Ratio (P/S)
📈 What is it?
The P/S ratio shows how much investors are paying for $1 of the company’s revenue – regardless of profitability.
🧮 How is it calculated?
🏛️ Why is it important?
P/S is especially useful for evaluating growth companies or businesses not yet profitable. It reflects how the market values the company’s sales.
🧮 Calculation
Market Cap = $527.04m | Revenue (TTM) = $231.24m
Market Cap = $527.04m | Estimated Revenue = $226.44m
🎯 What does this mean for investors?
- A low P/S may indicate undervaluation — or low profitability.
- A high P/S can reflect strong growth expectations — or excessive optimism.
- Especially helpful when evaluating companies where profits are low, volatile, or negative.
📘 Enterprise Value to Sales (EV/Sales)
📈 What is it?
EV/Sales shows how much investors are paying for $1 of revenue — considering not just equity, but also debt and cash. It’s the capital structure–adjusted version of the P/S ratio.
🧮 How is it calculated?
🏛️ Why is it important?
It’s ideal for comparing companies with different levels of debt. It reflects a company's true cost relative to its revenue.
🧮 Calculation
Enterprise Value = $433.14m | Revenue (TTM) = $231.24m
Enterprise Value = $433.14m | Forward Revenue = $226.44m
🎯 What does this mean for investors?
- EV/Sales allows for capital structure–neutral company comparisons.
- A lower ratio may indicate undervaluation; a higher one may signal strong growth expectations or overvaluation.
- Especially helpful when evaluating high-growth companies with low or negative earnings.
📘 Enterprise Value to Free Cash Flow (EV/FCF) | ex SBC
📈 What is it?
EV/FCF compares a company’s enterprise value with its free cash flow. The metric therefore shows the multiple of current free cash flow at which a company is valued. EV/FCF ex SBC additionally accounts for stock-based compensation (SBC). While SBC does not represent a direct cash outflow, issuing shares as compensation can dilute existing shareholders. Therefore, SBC is deducted from free cash flow in this adjusted version.
🧮 How is it calculated?
EV/FCF ex SBC = Enterprise Value ÷ (Free Cash Flow (TTM) − SBC)
🏛️ Why is it important?
EV/FCF provides a valuation based on free cash flow and therefore complements earnings-based valuation metrics such as the P/E ratio. The ex SBC version additionally accounts for the economic impact of stock-based compensation and provides a more conservative view from a shareholder perspective.
🧮 Calculation
🎯 What does this mean for investors?
- A low EV/FCF means that enterprise value is low relative to current free cash flow. The reasons should always be considered in the context of the company and its industry.
- A high EV/FCF means that enterprise value is high relative to current free cash flow. This can, for example, reflect high growth expectations or temporarily weak cash generation.
- When SBC is positive and adjusted free cash flow remains positive, EV/FCF ex SBC is generally higher than the standard EV/FCF.
- The metric is particularly useful for companies with relatively stable and predictable cash flows.
- If free cash flow is negative or very low, EV/FCF has limited usefulness and should not be interpreted like a standard valuation multiple.
📘 Price-to-Book Ratio (P/B)
📈 What is it?
The P/B ratio compares a company’s market value to its book value — showing how much investors are paying for each dollar of net assets.
🧮 How is it calculated?
🏛️ Why is it important?
P/B is commonly used for asset-heavy industries like banks or industrials. It helps assess whether a stock is trading above or below its net asset value.
🧮 Calculation
🎯 What does this mean for investors?
- A P/B below 1 may signal undervaluation — or weak profitability.
- A P/B above 1 implies the market expects future value creation (e.g., brand, IP, growth).
- Best used for companies with tangible assets and strong balance sheets.
📘 Equity Ratio
📈 What is it?
The equity ratio indicates what portion of a company’s total assets is financed by shareholders’ equity – in other words, how much it relies on its own capital.
🧮 How is it calculated?
🏛️ Why is it important?
A high equity ratio reflects financial strength and stability, especially during downturns. It’s a key indicator of a company’s solvency and long-term risk profile.
🧮 Calculation
🎯 What does this mean for investors?
- Companies with high equity ratios are generally more resilient and less dependent on external debt.
- Low equity ratios can signal higher risk or aggressive financial strategies.
- Important: Always assess the equity ratio in combination with the return on equity (ROE). This shows not just how stable the company is – but also how efficiently it uses shareholder capital.
📘 Return on Equity (ROE)
📈 What is it?
Return on equity (ROE) shows how efficiently a company uses its shareholders’ equity to generate profit. In other words: how much net income is earned per dollar of equity.
🧮 How is it calculated?
🏛️ Why is it important?
ROE is a core profitability metric. It helps investors understand whether a company delivers attractive returns on the capital provided by its shareholders.
🧮 Calculation
🎯 What does this mean for investors?
- A high ROE indicates that the company is using its capital efficiently and profitably.
- It’s especially meaningful for capital-intensive businesses or firms with high equity bases.
- Important: A very high ROE can also result from high debt levels – always interpret it alongside the equity ratio to assess financial health.
📘 Return on Capital Employed (ROCE)
📈 What is it?
ROCE measures how efficiently a company generates profits from its total capital – including both equity and interest-bearing debt.
🧮 How is it calculated?
It evaluates the return on all capital employed, regardless of how it’s financed.
🏛️ Why is it important?
ROCE is ideal for comparing companies with different financing structures. It shows how well management uses capital to create value for both shareholders and creditors.
🧮 Calculation
🎯 What does this mean for investors?
- A high ROCE means the company uses its capital efficiently – regardless of whether it's funded by debt or equity.
- The higher the ROCE compared to peers, the more value the company creates with its invested capital.
- Especially relevant for capital-intensive sectors like industrials, energy, or infrastructure.
📘 Return on Invested Capital (ROIC)
📈 What is it?
ROIC measures how efficiently a company generates returns from the capital invested in its core operations – regardless of whether the capital comes from equity or debt.
🧮 How is it calculated?
- NOPAT = Net Operating Profit After Taxes
- Invested Capital = Operating assets minus non-interest-bearing liabilities
🏛️ Why is it important?
ROIC is one of the most accurate indicators of capital efficiency. Unlike return on equity, it is not distorted by leverage and shows how much value is created for all capital providers.
🧮 Calculation
🎯 What does this mean for investors?
- A high ROIC shows how effectively a company uses the capital that is truly invested in its core operations.
- Unlike ROCE, ROIC focuses only on the capital that is actively used to run the business – and that requires a return (i.e. interest-bearing).
- Especially useful when comparing companies with large amounts of excess cash or non-interest-bearing liabilities – giving a more realistic picture of capital efficiency.
📘 Leverage Ratio (Debt-to-Equity)
📈 What is it?
The leverage ratio indicates how much a company relies on interest-bearing debt (such as loans and bonds) relative to its shareholders’ equity.
🧮 How is it calculated?
🏛️ Why is it important?
This ratio helps assess a company’s financial structure and risk profile. High leverage can enhance returns – but also increases exposure to interest rate changes and financial stress.
🧮 Calculation
🎯 What does this mean for investors?
- A low leverage ratio signals financial strength and independence.
- A higher ratio can improve returns in good times but increases risk during downturns or rising interest rate periods.
- 👉 Always interpret in the context of industry, capital intensity, and interest rate environment.
📘 SBC | in % Revenue
📈 What is it?
SBC (Stock-Based Compensation) refers to equity-based compensation granted by a company to its employees and executives. The percentage shows SBC relative to revenue.
🧮 How is it calculated?
SBC as % of Revenue = (SBC ÷ Revenue) × 100
🏛️ Why is it important?
Stock-based compensation is a real cost factor for shareholders. It can increase the number of shares outstanding and therefore dilute existing shareholders. The percentage of revenue shows how heavily a company relies on equity-based compensation and how significant this form of compensation is relative to the size of the business.
🧮 Calculation
🎯 What does this mean for investors?
- A lower figure is generally positive: Stock-based compensation is relatively small compared with the company's revenue.
- A high figure can indicate greater reliance on stock-based compensation and a higher potential risk of dilution. However, it is also important to consider whether the company offsets dilution through share buybacks.
- The trend over time should also be considered. A high but declining percentage presents a different picture from a persistently high or increasing percentage.
- A single-digit SBC-to-revenue ratio is not unusual among many growth-oriented and technology companies.
📘 SBC as % of FCF
📈 What is it?
SBC (Stock-Based Compensation) refers to equity-based compensation granted by a company to its employees and executives. The percentage shows SBC relative to free cash flow (FCF).
🧮 How is it calculated?
SBC as % of FCF = (SBC ÷ Free Cash Flow) × 100
🏛️ Why is it important?
Stock-based compensation is a real cost factor for shareholders. It can increase the number of shares outstanding and therefore dilute existing shareholders. The percentage of free cash flow shows how significant SBC is relative to the cash generated by the company. Since SBC is non-cash compensation, it is typically not deducted as a cash outflow when calculating FCF.
🧮 Calculation
🎯 What does this mean for investors?
- A lower value is generally favorable. Stock-based compensation is relatively small compared with the company's cash generation.
- A high value means that SBC represents a significant portion of the company's reported free cash flow, even though SBC itself is non-cash.
- The higher the value, the more significant SBC can be as an economic cost to shareholders, particularly when it results in share dilution.
📘 SBC Growth 1Y
📈 What is it?
SBC Growth 1Y shows how much a company's stock-based compensation has changed compared to the previous year.
🧮 How is it calculated?
🏛️ Why is it important?
SBC Growth shows whether stock-based compensation is becoming more or less significant for shareholders. If SBC increases significantly, it can lead to greater shareholder dilution over time. At the same time, SBC is a non-cash expense that reduces earnings on the income statement but is added back in the cash flow statement.
🧮 Calculation
🎯 What does this mean for investors?
- A high positive value is generally negative, as rising SBC can increase the burden on shareholders, particularly through potential dilution.
- What matters is whether the development of SBC is sustainable over the long term. Some level of SBC is common among many growth and technology companies.
📘 Share Count Growth 1Y
📈 What is it?
Share Count Growth 1Y shows how much the number of shares outstanding has increased or decreased over a one-year period.
🧮 How is it calculated?
🏛️ Why is it important?
The number of shares determines how many shares the company's earnings and assets are distributed across. If the share count decreases, existing shareholders' relative ownership increases. If it increases, existing shareholders are diluted. The metric therefore makes dilution and share buybacks directly visible.
🧮 Calculation
🎯 What does this mean for investors?
- A negative value is generally positive, as the number of shares outstanding is decreasing.
- A positive value indicates dilution of existing shareholders.
- A declining share count is not automatically positive: It also matters at what price the shares are repurchased and how the buybacks are financed.
📘 Shareholder Yield
📈 What is it?
Shareholder Yield measures how much capital a company returns to shareholders or uses to reduce debt relative to its market capitalization. It goes beyond dividend yield by also including share buybacks and debt reduction.
🧮 How is it calculated?
🏛️ Why is it important?
Dividend yield only tells part of the story. Companies can also return capital through share buybacks, while reducing debt can strengthen the balance sheet. Shareholder Yield combines all three components into one metric, giving investors a broader view of how a company uses its capital.
🧮 Calculation
🎯 What does this mean for investors?
- A higher Shareholder Yield generally indicates more capital being returned to shareholders or used to reduce debt.
- The mix matters: dividends, buybacks, and debt reduction can affect shareholders in different ways.
- Share buybacks are most beneficial when shares are repurchased at attractive valuations.
- Investors should also consider whether dividends, buybacks, and debt reduction are sustainable over time.
📘 Revenue
📈 What is it?
Revenue shows how much a company earns in total from selling its products and services – the gross income before any costs are deducted.
🧮 How is it calculated?
🏛️ Why is it important?
Revenue is one of the key figures to assess a company’s size, market position, and growth potential.
🧮 Calculation
🎯 What does this mean for investors?
- Growing revenue indicates rising demand and can be an early signal of future earnings growth.
- Comparing actual and expected revenue reveals trends in the market environment and analyst sentiment.
- Note: Strong revenue alone isn’t enough – margins and profitability matter just as much.
📘 EBITDA
📈 What is it?
EBITDA stands for “Earnings Before Interest, Taxes, Depreciation, and Amortization.” It reflects a company’s operating profit before the effects of financing, taxes, and accounting depreciation.
🧮 How is it calculated?
🏛️ Why is it important?
EBITDA is widely used to evaluate a company’s operating performance – especially across capital-intensive sectors or international comparisons.
🧮 Calculation
🎯 What does this mean for investors?
- A high or growing EBITDA indicates strong operational profitability – independent of taxes, interest, or accounting methods.
- It’s especially useful for comparing companies across sectors or geographies.
- Important: EBITDA is not a net income figure – it excludes key costs like depreciation and interest.
📘 EBIT
📈 What is it?
EBIT stands for “Earnings Before Interest and Taxes.” It reflects a company’s operating profit after depreciation, but before interest and tax expenses.
🧮 How is it calculated?
🏛️ Why is it important?
EBIT is a core profitability metric that shows how well the company performs in its main business operations – independent of capital structure and tax environment.
🧮 Calculation
🎯 What does this mean for investors?
- A high EBIT indicates strong profitability from the company’s core business – before financial and tax effects.
- It allows better comparison between companies with different debt levels or tax structures.
- Compared to EBITDA, EBIT already accounts for depreciation and reflects capital intensity more clearly.
📘 Net Income
📈 What is it?
Net income is the company’s total profit – the amount left after all expenses, taxes, interest, and depreciation have been deducted.
🧮 How is it calculated?
🏛️ Why is it important?
Net income is the most comprehensive measure of a company’s profitability – showing how much actual profit remains after all business and financing costs.
🧮 Calculation
🎯 What does this mean for investors?
- Growing net income indicates that the company is managing all of its costs efficiently.
- It directly influences valuation metrics like P/E ratio and the company’s dividend capacity.
- Over time, net income trends reveal how resilient and profitable the business model really is.
📘 Free Cash Flow (FCF) | ex SBC
📈 What is it?
Free cash flow shows how much cash remains after a company has covered its operating and capital expenditures. FCF ex SBC additionally deducts stock-based compensation (SBC) to adjust the cash flow for the effect of non-cash SBC.
🧮 How is it calculated?
Free Cash Flow ex SBC = Operating Cash Flow − SBC − Capital Expenditures (CAPEX)
🏛️ Why is it important?
FCF reflects a company’s actual financial strength – independent of reported accounting earnings. It shows how much flexibility a company has for dividends, share buybacks, or debt reduction. FCF ex SBC also deducts stock-based compensation and shows how much cash generation remains after SBC.
🧮 Calculation
🎯 What does this mean for investors?
- High free cash flow indicates that a company has strong financial strength – independent of reported earnings.
- It is often a solid basis for sustainable dividends and share buybacks.
- Declining FCF can be a warning sign, even if reported earnings remain stable.
📘 Revenue Growth
📈 What is it?
Revenue growth shows how much a company’s sales have changed compared to the previous year – both on a trailing basis (TTM) and based on forward projections.
🧮 How is it calculated?
Forward = (Expected revenue ÷ Revenue in prior year − 1) × 100
Forward growth is based on analyst estimates for the current fiscal year.
🏛️ Why is it important?
Rising revenue signals growing demand, business expansion, and market share gains – especially important for growth-oriented companies.
🧮 Calculation
🎯 What does this mean for investors?
- Growth is the engine of long-term value creation – especially in tech and growth sectors.
- What matters is not just current growth, but its sustainability.
- Forward projections reflect whether analysts expect continued momentum – or a slowdown.
📘 EBITDA Growth
📈 What is it?
EBITDA growth shows how much a company’s operating profit (before interest, taxes, depreciation, and amortization) has increased or decreased compared to the previous year.
🧮 How is it calculated?
Forward = (Expected EBITDA ÷ EBITDA from prior year − 1) × 100
The forward estimate is based on analyst projections for the current fiscal year.
🏛️ Why is it important?
Growing EBITDA indicates improving operational profitability – regardless of financing or accounting effects.
🧮 Calculation
🎯 What does this mean for investors?
- Strong EBITDA growth signals operational efficiency and scalability – especially during growth phases.
- EBITDA growth can be an early indicator of margin and earnings expansion – but should be assessed alongside revenue and EBIT.
📘 EBIT Growth
📈 What is it?
EBIT growth shows how much a company’s operating profit (after depreciation, but before interest and taxes) has increased compared to the previous year.
🧮 How is it calculated?
Forward = (Expected EBIT ÷ EBIT from prior year − 1) × 100
The forward estimate is based on analyst projections for the current fiscal year.
🏛️ Why is it important?
EBIT growth is a direct indicator of a company’s business performance – taking into account capital intensity through depreciation.
🧮 Calculation
🎯 What does this mean for investors?
- Rising EBIT signals improving operating profitability – even after accounting for depreciation.
- It’s especially important for evaluating companies with significant capital expenditures.
- Combined with revenue and EBITDA growth, EBIT growth provides a well-rounded view of operational progress.
📘 Net Income Growth
📈 What is it?
Net income growth shows how much a company’s bottom-line profit has increased or decreased compared to the previous year – both on a trailing basis (TTM) and based on analyst projections.
🧮 How is it calculated?
Forward = (Expected net income ÷ Net income from prior year − 1) × 100
The forward estimate reflects analysts’ expectations for the current fiscal year.
🏛️ Why is it important?
Net income is the ultimate measure of profitability. Growing net income signals stronger efficiency, cost control, and sustainable earnings power.
🧮 Calculation
🎯 What does this mean for investors?
- Stronger net income boosts valuation, dividend potential, and investor confidence.
- If profits stall while revenue grows, it may signal margin pressure.
📘 Free Cash Flow Growth
📈 What is it?
Free cash flow (FCF) growth shows how a company’s available cash – after covering operating expenses and capital expenditures – has changed compared to the previous year.
🧮 How is it calculated?
🏛️ Why is it important?
Free cash flow reflects real financial strength. Growing FCF indicates more flexibility for dividends, share buybacks, and reinvestment.
🧮 Calculation
🎯 What does this mean for investors?
- Declining FCF may point to rising investments, increasing costs, or weaker operating performance.
- Especially for dividend investors, FCF growth is critical – since dividends are paid from actual available cash.
- A negative trend isn't always bad, but it deserves closer attention.
📘 Gross Margin
📈 What is it?
Gross margin shows how much of a company’s revenue remains after deducting the direct costs of goods sold (like materials and production). It represents the company’s “raw profit” before fixed costs, taxes, and interest.
🧮 How is it calculated?
Or simply: Gross Margin = Gross Profit ÷ Revenue × 100
🏛️ Why is it important?
Gross margin indicates how efficiently a company can produce or procure what it sells. It is a key measure of product-level profitability and pricing power.
🧮 Calculation
🎯 What does this mean for investors?
- A high gross margin suggests strong pricing power and efficient production.
- Falling margins may signal rising input costs or competitive pressure.
- Compared to peers, gross margin offers insights into the quality of a business model.
📘 EBITDA Margin
📈 What is it?
The EBITDA margin shows how much of a company’s revenue remains as operating profit before interest, taxes, depreciation, and amortization.It reflects operating efficiency without being distorted by financing or accounting factors.
🧮 How is it calculated?
🏛️ Why is it important?
The EBITDA margin reveals how much operating income a company generates per dollar of revenue – independent of capital structure and tax effects.
🧮 Calculation
🎯 What does this mean for investors?
- A high EBITDA margin reflects strong core profitability – before accounting distortions.
- It allows for effective comparisons across companies and sectors.
- A stable or growing margin signals efficient cost control and business scalability.
📘 EBIT Margin
📈 What is it?
The EBIT margin shows what percentage of revenue remains as operating profit after depreciation but before interest and taxes.
🧮 How is it calculated?
🏛️ Why is it important?
The EBIT margin reflects a company’s core profitability while accounting for capital intensity (e.g. machinery, infrastructure). It’s especially useful for comparing businesses with different levels of depreciation.
🧮 Calculation
🎯 What does this mean for investors?
- A high EBIT margin shows that the company remains efficient even after factoring in depreciation.
- It’s especially relevant for capital-intensive industries.
- Stable or rising EBIT margins over time are a strong indicator of pricing power and business quality.
📘 Net Margin
📈 What is it?
Net margin shows how much of a company’s revenue remains as bottom-line profit after deducting all costs, interest, taxes, and depreciation.
🧮 How is it calculated?
🏛️ Why is it important?
Net margin reflects a company’s overall efficiency – across operations, financing, and taxation. It shows how much actual profit is generated from each dollar of revenue.
🧮 Calculation
🎯 What does this mean for investors?
- A high net margin means the company is not only strong operationally but also manages financing and taxes efficiently.
- Peer comparisons reveal business quality and competitiveness.
- Declining margins despite revenue growth can be a red flag for rising costs or inefficiencies.
📘 Free Cash Flow Margin | ex SBC
📈 What is it?
The Free Cash Flow Margin shows how much free cash flow a company generates relative to its revenue. In simplified terms, free cash flow is calculated as operating cash flow minus capital expenditures. The Free Cash Flow Margin ex SBC additionally accounts for stock-based compensation (SBC). While SBC does not represent a direct cash outflow, issuing shares as compensation can dilute existing shareholders. Therefore, SBC is deducted from free cash flow in this adjusted metric.
🧮 How is it calculated?
Free Cash Flow Margin ex SBC = (Free Cash Flow − SBC) ÷ Revenue × 100
🏛️ Why is it important?
The Free Cash Flow Margin shows how efficiently a company converts its revenue into free cash flow. Strong free cash flow can provide financial flexibility for dividends, share buybacks, debt repayment, or further investments. The ex SBC version additionally accounts for the economic impact of stock-based compensation and therefore provides a more conservative view of cash generation from a shareholder perspective.
🧮 Calculation
🎯 What does this mean for investors?
- A high Free Cash Flow Margin shows that a company converts a high proportion of its revenue into free cash flow.
- This can provide greater financial flexibility for dividends, share buybacks, debt repayment, or investments.
- The Free Cash Flow Margin ex SBC additionally accounts for potential shareholder dilution from stock-based compensation.
- The long-term trend is particularly important. Declining margins can, for example, result from higher investments, changes in working capital, or weaker operating performance.
📘 Earnings per share (EPS)
📈 What is it?
Earnings per Share (EPS) shows how much profit is attributable to a single share – and is one of the most important metrics for evaluating a company's performance.
🧮 How is it calculated?
The diluted share count reflects potential new shares that could be issued through options, convertible bonds, or other rights.
🏛️ Why is it important?
EPS is the basis for many key valuation metrics like P/E ratio, PEG ratio, or payout ratio. It enables comparisons of profitability across companies, regardless of their size.
🧮 Calculation
🎯 What does this mean for investors?
- EPS captures per-share profitability and is especially useful for comparisons over time or with analyst estimates.
- Rising EPS may signal consistent growth or share buybacks.
- Important: Always use diluted EPS for more realistic valuations – especially in companies with stock-based compensation.
📘 Free cash flow per share (FCF per share)
📈 What is it?
Free Cash Flow per Share shows how much free cash flow a company generates per outstanding share – after investments, but before dividends or debt repayments.
🧮 How is it calculated?
Free cash flow is calculated as operating cash flow minus capital expenditures (CapEx).
🏛️ Why is it important?
FCF per Share reveals how much real cash is available per share – useful for dividends, buybacks, or reducing debt. Unlike net income, free cash flow is harder to manipulate and often seen as a more reliable metric.
🧮 Calculation
🎯 What does this mean for investors?
- High FCF per share signals strong financial flexibility.
- It shows how much capital the company can effectively reinvest or return to shareholders.
- Particularly relevant for dividend payers and capital-efficient businesses.
📘 Short interest
📈 What is it?
Short interest indicates how many shares of a company are currently sold short – that is, borrowed and sold by investors who expect the price to decline.
🧮 How is it calculated?
It reflects the percentage of a company’s shares that are being shorted relative to the total shares available.
🏛️ Why is it important?
Short interest serves as a sentiment indicator: A high value may signal skepticism or bearish expectations – but also increases the potential for a short squeeze if prices rise unexpectedly.
🧮 Calculation
🎯 What does this mean for investors?
- Low short interest usually indicates market confidence in the company.
- High short interest can be a warning sign – or an opportunity if sentiment shifts.
- Especially relevant in volatile markets or ahead of key earnings releases.
📘 Employees
📈 What is it?
The employee count shows how many people a company employs worldwide – offering insights into its size, structure, and business model.
🧮 How is it calculated?
🏛️ Why is it important?
It helps assess operational scale, labor intensity, and cost structure. Combined with revenue and profit, it enables key metrics like revenue per employee or productivity.
🧮 Calculation
🎯 What does this mean for investors?
- A high headcount can signal operational complexity – but also significant growth capacity.
- Revenue per employee is a key indicator of efficiency.
- Especially useful for comparing tech, industrial, or service-heavy companies.
📘 Revenue per employee
📈 What is it?
Revenue per employee indicates how much revenue a company generates on average per employee – a key measure of efficiency and productivity.
🧮 How is it calculated?
The employee count is typically taken from the most recent annual report.
🏛️ Why is it important?
This metric helps compare business models – especially between labor-intensive and technology-driven companies. A high value suggests automation, operational efficiency, or strong value creation per head.
🧮 Calculation
🎯 What does this mean for investors?
- A high revenue per employee indicates a scalable and margin-strong business model.
- A low figure may reflect labor-intensive operations or lower value-add.
- Especially helpful when comparing tech companies to industrial or service sectors.
Puma Biotechnology, Inc. Stock Analysis
Analyst Opinions
6 Analysts have issued a Puma Biotechnology, Inc. forecast:
Analyst Opinions
6 Analysts have issued a Puma Biotechnology, Inc. forecast:
Puma Biotechnology, Inc. Events
Upcoming Event
Past Events
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AUG
6
Q2 2026 Earnings Call
3 months ago
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MAY
7
Q1 2026 Earnings Call
6 months ago
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FEB
26
Q4 2025 Earnings Call
8 months ago
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NOV
6
Q3 2025 Earnings Call
12 months ago
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StocksGuide Free
Puma Biotechnology, Inc. — Q2 2026 Earnings Call
1. Management Discussion
Good afternoon. My name is Darryl, and I will be your conference call operator today. [Operator Instructions] As a reminder, this call is being recorded. I would now like to turn the conference call over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. You may begin your conference.
Thank you, Darryl. Good afternoon, and welcome to Puma's conference call to discuss our earnings results for the second quarter of 2026. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of Puma Biotechnology; Maximo Nougues, Chief Financial Officer; Heather Blaber, Senior Vice President of Marketing; and Roger Storms, Senior Vice President of Sales.
After the close today, Puma issued a news release detailing earnings results for the second quarter of 2026. That news release, the slides that Roger will refer to and a webcast of this call are accessible via the homepage and Investors section of our website at pumabiotechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days. Today's conference call will include statements about Puma's future expectations, plans and prospects that constitute forward-looking statements for purposes of federal securities laws.
Such statements are subject to risks and uncertainties, and actual events and results may differ from those expressed in these forward-looking statements. For a full discussion of these risks and uncertainties, please review our periodic and current reports filed with the SEC from time to time, including our annual report on Form 10-K for the year ended December 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this live conference call, August 6, 2026.
Puma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law. During today's call, we may refer to certain non-GAAP financial measures that involve adjustments to our GAAP figures. We believe these non-GAAP metrics may be useful to investors as a supplement to, but not a substitute for, our GAAP financial measures. Please refer to our second quarter 2026 earnings release for a reconciliation of our GAAP to non-GAAP results. I will now turn the call over to Alan.
Thank you, Mariann, and thank you all for joining our call today. Today, Puma reported total revenue for the second quarter of 2026 of $56.5 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales as well as royalties from our sublicensees. Product revenue net was $53.6 million in the second quarter of 2026, an increase from $42 million reported in Q1 of 2026 and $49.2 million reported in Q2 of 2025. As a reminder to investors, Puma's reported NERLYNX sales includes both U.S. net sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex-U.S. partners.
Product revenue for the second quarter of 2026 included approximately $1.3 million (sic) [ $1 million ] of inventory drawdown at our specialty pharmacies and specialty distributors. Royalty revenue was $2.9 million in the second quarter of 2026 compared to $2.8 million in Q1 2026 and $3.2 million in Q2 of 2025. We reported 2,929 bottles of NERLYNX sold in the second quarter of 2026 compared to 2,328 bottles sold in Q1 of '26. In Q2 2026, we estimate that inventory decreased by 57 bottles. In Q2 2026, new prescriptions were down approximately 6% compared to Q1 2026, and total prescriptions were up approximately 7% compared to Q1 2026.
Roger will provide further details in his comments and slides. I will now provide updates from Puma's ongoing Phase II trials of alisertib in small cell lung cancer and HER2-negative ER-positive breast cancer, also referred to as ALISCA-Lung1 and ALISCA-Breast1. Heather Blaber and Roger Storms will add additional color on NERLYNX commercial activities. Maximo Nougues will follow with highlights of the key components of our financial statements for the second quarter of 2026.
As investors are aware, Puma has 2 ongoing Phase II trials of our investigational drug, alisertib, ALISCA-Breast1, which is a Phase II trial of alisertib in combination with endocrine therapy in patients with HER2-negative hormone receptor positive, recurrent or metastatic breast cancer; and ALISCA-Lung1, a Phase II study looking at the efficacy of alisertib monotherapy in patients with small cell lung cancer. As a reminder, the ALISCA-Breast1 trial investigates alisertib in combination with endocrine treatment consisting of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen in patients with HER2-negative hormone receptor positive recurrent or metastatic breast cancer.
Patients must be chemotherapy naive in the recurrent or metastatic setting, have had previous treatment with a CDK4/6 inhibitor and have received at least 2 prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial. Patients were initially being dosed with alisertib given at either 30 milligrams, 40 milligrams or 50 milligrams twice daily BID on days 1 to 3, 8 to 10 and 15 to 17 on a 28-day cycle in combination with endocrine therapy at the -- of the investigator's choice. Patients must not have been previously treated with the endocrine treatment in the metastatic setting that will be given in combination with alisertib in the trial.
Interim data from this trial was presented on the company's first quarter conference call. As discussed during that presentation, the company believes that the data obtained to date from ALISCA-Breast1 is providing a preliminary indication of potentially better activity in patients with biomarkers where the Aurora kinase pathway plays a role. Based on the feedback that we have received from breast cancer key opinion leaders on this interim data, the trial has been amended such that now we are only continuing enrollment in the 40-milligram and 50-milligram dose groups.
That amendment to the protocol has been submitted to the FDA and the EU authorities and is being submitted to the IRBs as well. We are hoping to begin enrollment under that amended protocol in Q3. We will also be updating interim data from the ALISCA-Lung1 trial, including longer-term patient follow-up in the fourth quarter of this year. With respect to the ALISCA-Lung1 study, as investors are aware, Puma has an ongoing Phase II trial of our investigational drug alisertib, to investigate the efficacy of alisertib monotherapy in patients with small cell lung cancer. Interim data from this trial was presented on the company's first quarter earnings call.
As discussed during the presentation, the company believes that the data obtained to date from ALISCA-Lung1 is providing a preliminary indication of potentially better activity in patients with the biomarkers where the Aurora kinase pathway is playing a role. As was also discussed on that call, the company previously amended the trial to increase the dose from 50 milligrams BID to 60 milligrams BID. Dosing of the trial was further increased to 70 milligrams BID, and the company is currently enrolling patients at the 70-milligram BID level.
There are currently 92 patients in the trial with 36 of the patients enrolled at the 60-milligram BID dose and 4 patients enrolled at the 70-milligram dose. As was also mentioned on the recent earnings call, Puma also plans to initiate a second trial of alisertib in small cell lung cancer, ALISCA-Lung2, where the drug will be given in combination with paclitaxel similar to the Phase II randomized trial that was previously published in the Journal of Thoracic Oncology. The company anticipates that enrollment in the ALISCA-Lung2 trial will start in Q3, and the company will provide investors with further information on this trial in the future.
The company anticipates that we will have additional interim data from ALISCA-Lung1 and the initial data for ALISCA-Lung2 in 2027. As mentioned on prior earnings calls and in response to investor questions, Puma continues to evaluate several commercial stage and development stage drugs to potentially in-license or acquire that would allow the company to diversify itself and leverage Puma's existing R&D, regulatory and commercial infrastructure. The company will keep investors updated on this as it progresses. I will now turn the call over to Heather Blaber for an update on our marketing initiatives. Roger Storms will follow with a review of our commercial performance during the quarter.
Thanks, Alan. I appreciate the opportunity to share some additional insights into our marketing strategy. The marketing team is focused on continued awareness of both clinical data for NERLYNX as well as reinforcing the continued unmet need in HER2-positive early-stage breast cancer after adjuvant therapy. We continue to invest in market research to help us understand and validate the most effective ways to communicate our data with health care professionals through both personal and nonpersonal promotion.
Our strategy is focused on increasing awareness of our dual indication in HER2-positive breast cancer. We believe NERLYNX plays an important role in the early stage by reducing the risk of recurrence and in the metastatic setting by helping protect against progression. Not only do physicians who have experience with NERLYNX continue to identify appropriate patients that could benefit from additional therapy post-adjuvant treatment, but we continue to adopt new prescribers year-over-year who recognize the unmet need in HER2-positive early-stage breast cancer and how NERLYNX may help their patients reduce their risk of recurrence.
In summary, we are excited and committed to engage with more oncologists and support their patients diagnosed with HER2-positive breast cancer in both the early and metastatic setting. I will now turn the call over to Roger Storms to provide an overview on the commercial performance for the second quarter.
Thank you, Heather, and thanks to everyone for joining our second quarter earnings call. Before I move into the commercial review, just a reminder that I'll be making forward-looking statements. The sales team remains focused on increasing the use of NERLYNX with a main focus on patients at higher risk of recurrence. They are also dedicated to enhancing clinical education and engagement through nonpersonal promotional efforts as well as utilizing patient resources to support persistence and compliance during NERLYNX therapy.
Let me now transition to some of the commercial slides where I'll provide some additional specifics around performance. Slide 3 is an illustration of our distribution model, which is broken out into the specialty pharmacy channel and the specialty distributor or in-office dispensing channel. Regarding the overall distribution of our business, in Q2 2026, about 61% of our business was purchased through the SP channel, and the remaining 39% was purchased through the SD channel. We continue to see stronger growth in the SD channel driven by 2 main factors: increased sales in the group purchasing organizations, or GPO segment and increasing 340B purchasing.
Turning to Slide 4. NERLYNX net product revenue in Q2 2026 was $53.6 million, an increase from the $42 million we reported in Q1 2026 and the $49.2 million we reported in Q2 of 2025. As a reminder to investors, Puma's reported NERLYNX sales include both U.S. net sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex-U.S. partners. Please note that in Q2 2026, we reported minimal product supply revenue to our international partners versus about $100,000 in Q1 of 2026. I will provide some more details around inventory changes, and Maximo will provide some additional specifics around gross to net expenses during his update.
In Q2 2026, we estimate that inventory decreased by about $1 million. As a comparator, we estimate that inventory decreased by about $7.9 million in Q1 of 2026. Slide 5 shows Q2 2026 ex-factory bottle sales and also provides both a year-over-year and a quarter-over-quarter comparison. As a reminder, ex-factory bottles include sales to our SP and SD channels. In Q2 2026, NERLYNX ex-factory bottle sales were 2,929, which represents an approximate 26% increase quarter-over-quarter and 12% increase year-over-year. Let me specifically call out the inventory changes from a bottle perspective. In Q2 2026, we estimate that inventory decreased by 57 bottles.
As a comparator, we estimate that inventory decreased by 439 bottles in Q1 of 2026 and decreased by 85 bottles in Q2 of 2025. Slide 6 highlights our commercial demand for the quarter. In Q2 2026, U.S. demand was 2,986 bottles, which represents an approximate 8% increase quarter-over-quarter and 11% increase year-over-year. As mentioned earlier, we have seen stronger growth in the SD channel where we saw demand grow by about 12% quarter-over-quarter and 32% year-over-year. The year-over-year and quarter-over-quarter increases are a direct result of continued emphasis put on executional excellence and increased field accountability.
Our Q2 2026 call activity increased 18% year-over-year and 2% quarter-over-quarter, and total prescriptions or TRx increased by 7% quarter-over-quarter and 3% year-over-year. Enrollments in the quarter grew 1% quarter-over-quarter and 12% year-over-year. Commercial new patient starts in the quarter declined 6% quarter-over-quarter and grew 8% year-over-year. Continued messaging and adoption of dose escalation remains an important commercial priority, and 73% of patients started NERLYNX at a reduced dose.
We believe dose escalation, coupled with patient education resources will give patients better support throughout their NERLYNX therapy and ultimately help them reduce the risk of recurrence. Slide 7 highlights the strategic collaborations we formed across the globe. Most recently, in Q1 2026, NERLYNX was launched in Thailand, also in the extended adjuvant setting. We really appreciate the excellent work being done by our partners around the world and look forward to supporting their continued success moving forward.
I'll close by sharing my sincere appreciation for the entire Puma team and their steadfast commitment to supporting patients and families affected by breast cancer. This disease is truly devastating. And while meaningful progress has been made, we know there is still important work ahead and even more we can accomplish together. I will now turn the call over to Maximo for a review of our financial results.
Thanks, Roger. I will begin with a brief summary of our financial results for the second quarter of 2026. Please note that I will make comparisons to Q1 2026, which we believe is a better indication of our progress as a commercial company and year-over-year comparisons. For more information, I recommend that you refer to our second quarter 2026 10-Q, which will be filed today and includes our consolidated financial statements.
For the second quarter of 2026, we reported net income based on GAAP of $8.2 million or $0.16 per diluted share. This compares to a net loss in Q1 2026 of $3.8 million or $0.07 per share. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $10.1 million or $0.20 per basic share and $0.19 per diluted share for the second quarter of 2026. Gross revenue from NERLYNX sales was $74.3 million in Q2 2026 and $57.5 million in Q1 2026. As Alan mentioned, net product revenue from NERLYNX sales was $53.6 million, an increase from the $42 million reported in Q1 2026 and the $49.2 million reported in Q2 2025.
As a reminder to investors, Puma reported NERLYNX sales include both U.S. net sales of NERLYNX and product supply revenue of NERLYNX to Puma ex-U.S. partners. Please note that in Q2 2026, we reported product supply revenue to our international partners of around $23,000. Therefore, U.S. net sales of NERLYNX in Q2 2026 were $53.6 million versus $41.9 million in Q1 2026. The increase in net product revenue in Q2 2026 versus Q1 2026 was driven by higher demand, inventory decrease in Q2 of about $1.3 million (sic) [ $1 million ] versus inventory decrease of $7.9 million in Q1 2026, offset by a higher gross to net in Q2.
Royalty revenue totaled $2.9 million in the second quarter of 2026 compared to $2.9 million in Q1 2026. Our gross to net adjustment in Q2 2026 was about 27.9% and 27% in Q1 2026. The high gross to net adjustment was driven by higher Medicaid share. Cost of sales for Q2 2026 was $12.5 million and includes $2.4 million for the amortization of intangible assets related to our neratinib license. Cost of sales for Q1 2026 was $10.4 million. Going forward, we will continue to recognize amortization of milestones to the license or about $2.4 million per quarter as cost of sales.
For fiscal year 2026, Puma anticipates that net NERLYNX product revenue will be in the range of $205 million to $209 million, higher than our prior guidance of $202 million to $206 million. We also anticipate that our gross to net adjustment for the full year 2026 will be between 26.5% and 27.5%. In addition, for fiscal year 2026, we anticipate receiving royalties from our partners around the world in the range of $19 million to $22 million, slightly lower than our prior guidance of $20 million to $23 million. Under our sublicense agreement covering China, the royalty rate payable to us is subject to reduction when the market share of generic versions of NERLYNX in China reaches a specific threshold.
We are unable to predict with certainty when this threshold will be reached. However, we believe it is possible that the threshold could be reached, triggering the royalty rate reduction in late 2026 or in 2027. We don't expect any license revenue in 2026. We also expect that net income for the full year will be in the range of $17 million to $20 million, also higher than our prior guidance of $16 million to $19 million. The current guidance does not include any potential release of any additional tax asset valuation allowance in our net income estimate.
The company is reviewing its deferred tax assets as part of its ongoing tax valuation analysis and has not yet determined whether any adjustment will be required or if so, the potential timing or size of such an adjustment. We will continue to keep investors updated on this as it progresses. At this time, we do not believe that the tariffs imposed or proposed to be imposed by the United States, particularly with other countries, will have a material impact on our product costs or results of operations. However, shift in trade policies in the United States and other countries have been rapidly evolving and are difficult to predict.
As a point of reference, our manufacturing product cost accounts for a mid- to high single-digit percentage of our total cost of goods sold. We anticipate that for Q3 2026, NERLYNX product revenue net will be in the range of $54 million to $56 million. We expect Q3 royalty revenues will be in the share in the range of $2 million to $3 million and no license revenue. We further estimate that the gross to net adjustment in Q3 2026 will be approximately 26% to 27%. Puma anticipates a Q3 net income between $2 million and $2.5 million.
SG&A expenses were $17.5 million in the second quarter of 2026 compared to $18.4 million in the first quarter of 2026. SG&A expenses included noncash charges for stock-based compensation of $1.2 million for Q2 2026 and $1.1 million for Q1 2026. Research and development expenses were $18.9 million in the second quarter of 2026 and $19.8 million in Q1 2026. R&D expenses included noncash charges for stock-based compensation of $0.8 million (sic) [ $0.7 million ] in Q2 2026 and $0.8 million in Q1 2026. On the expense side, Puma anticipates higher total operating expenses in 2026 compared to 2025.
More specifically, we anticipate SG&A expenses to increase by 1% to 2% and R&D expenses to increase by 34% to 37% year-over-year. The higher increase in R&D is driven by the progress of our clinical trials. In the second quarter of 2026, Puma reported cash burn of approximately $9.7 million. This compares to cash burn of approximately $4 million in Q1. Please note that during Q2 2026, we made our final quarterly principal loan payment of $11.1 million related to our obligation with Athyrium. As a result, Puma now is debt-free.
At June 30, 2026, we had approximately $93.9 million in cash, cash equivalents and marketable securities versus $97.5 million at year-end 2025. Our accounts receivable balance was $34.1 million. Our accounts receivable terms range between 10 and 68 days, while our days sales outstandings are about 44 days. We estimate that as of June 30, 2026, our distribution network maintained approximately 3 weeks of inventory. Overall, we continue to deploy our financial resources to focus on the commercialization of NERLYNX, the development of alisertib and controlling our expenses.
Thanks, Maximo. On past earnings calls, we have stressed that Puma's senior management in cooperation with the Board of Directors continues to remain focused on NERLYNX sales trends and recognizes its fiscal responsibility to shareholders to continue to maintain a positive net income. We believe that this focus has contributed to our commercial execution thus far in 2026.
According to our current projections, 2026 will mark the second year-over-year demand increase for NERLYNX in the United States and the first time in the history of the launch of NERLYNX in the United States that we have seen 2 positive consecutive year-over-year increases in demand. We are pleased to report this demand-driven increase in NERLYNX sales in the second quarter of 2026, and we believe that the positive net income that the company is guiding to for full year 2026 has resulted from both this increased demand as well as the continued financial discipline across the company over the last few years.
The company remains committed to continuing to achieve this positive net income and we will continue to reduce expenses if needed to achieve this. We look forward to updating investors on this in the future. There continues to remain a significant unmet need for patients battling breast cancer, lung cancer and other solid tumors. We at Puma are committed and passionate about finding more effective ways at helping these patients during their journey, and we will continue to strive to achieve that goal. This concludes today's presentation. We will now turn the floor back to the operator for Q&A. Operator?
[Operator Instructions] Our first questions come from the line of Marc Frahm with TD Cowen.
2. Question Answer
On the strong quarter and kind of recent commercial performance. But maybe looking a little further beyond the formal guidance. You have a couple of trials ongoing and another one going to start up. Can you maybe speak to, Alan, what the kind of R&D spend trajectory looks like maybe beyond just kind of Q3 and more into, as we look into '27 as some of those trials are a little more fully up and running.
So in terms of the R&D in '27, '28, '29, we've gotten this question from investors before, which is, let's say you want to do the Phase III trials of both alisertib in ER-positive breast cancer and in small cell lung cancer. Can you do that? And the answer to that is according to our current projections, yes. We probably have to stagger them. So like start one before the other type of thing, but it is completely achievable, and that's what we're looking to do.
We think that with the -- thankfully now, we're a debt-free company. So we're cash flow positive. Obviously, thinking investing that in alisertib is a good thing for the shareholders. It's a very, very interesting drug. We're very pleased with the data. And assuming the data continues to hold up, we're very eager to start Phase III trials. And I think that we have the ability to do that, hopefully, knock on wood next year. And I think that's where we're heading. So I think there's no reason we can't run both of them. Like I said, we are committed to maintaining positive net income. So if we have to stagger the trials, then we can stagger them.
Okay. That's helpful. And then also in your prepared remarks, you mentioned continuing to evaluate BD opportunities. Can you speak a little bit more as to kind of what would be of interest? I mean, should we look at alisertib as very much the model in terms of stage? Or would you be willing to take on maybe either a little bit more of an upfront or your maybe a little bit earlier stage projects?
Yes. So from a BD perspective, we look at commercial assets, and we look at development stage ones. On the commercial side, I think that we've shown a strong ability to obviously cut costs, generate cash from a commercial asset. And if there's ones out there where we feel like we could fit it into the existing organization and continue to do that for shareholders, add on additional sales, build additional cash, I think that would be something very wise to do for the shareholders.
On the development stage side, obviously, there's a lot of drugs being developed right now in the oncology space. If there's something where we feel that it's a unique asset and something where we believe that we can contribute to shareholder value by bringing it in and developing it clinically, we're happy to look at that. We're not technology agnostic, if you will, like we just only look at small molecule or something like that. We're happy to look at anything -- any other technologies.
And I guess the same thing would be true on the commercial side as well. Is it just something in breast or lung cancer? Again, happy to look at things that are outside of that if we feel that we can, #1, most importantly, help cancer patients. And #2, by helping cancer patients benefit the shareholders.
This concludes our question-and-answer session. I would now like to turn the conference back to Mariann for closing remarks.
Thank you all for joining us today. As a reminder, this call may be accessed via replay of the webcast at pumabiotechnology.com beginning later today. Have a good evening.
Ladies and gentlemen, thank you for participating in today's conference call. This concludes our program. Everyone, have a great day. You may now disconnect.
Puma Biotechnology, Inc. — Q2 2026 Earnings Call
Puma Biotechnology, Inc. — Q1 2026 Earnings Call
1. Management Discussion
Good afternoon. My name is John, and I will be your conference call operator today. [Operator Instructions] As a reminder, this call is being recorded.
And I would now like to turn the conference call over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. Thank you. You may begin your conference.
Thank you, John. Good afternoon, and welcome to Puma's conference call to discuss our results for the first quarter of 2026. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of Puma Biotechnology; Maximo Nougues, Chief Financial Officer; Heather Blaber, Senior Vice President of Marketing; and Roger Storms, Senior Vice President of Sales.
After the close today, Puma issued a news release detailing results for the first quarter of 2026. That news release, the slides that Alan and Roger will refer to and a webcast of this call are accessible via the homepage and Investors sections of our website at pumabiotechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days.
Today's conference call will include statements about Puma's future expectations, plans and prospects that constitute forward-looking statements for purposes of federal securities laws. Such statements are subject to risks and uncertainties, and actual events and results may differ from those expressed in these forward-looking statements. For a full discussion of these risks and uncertainties, please review our periodic and current reports filed with the SEC from time to time, including our annual report on Form 10-K for the year ended December 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this live conference call, May 7, 2026. Puma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law.
During today's call, we may refer to certain non-GAAP financial measures that involve adjustments to our GAAP figures. We believe these non-GAAP metrics may be useful to investors as a supplement to, but not a substitute for, our GAAP financial measures. Please refer to our first quarter 2026 release for a reconciliation of our GAAP to non-GAAP results.
I will now turn the call over to Alan.
Thank you, Mariann, and thank you all for joining our call today. Today, Puma reported total revenue for the first quarter of 2026 of $44.8 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales as well as royalties from our sublicensees. Product revenue net was $42 million in the first quarter of 2026, a decline from $59.9 million reported in Q4 2025 and $43.1 million reported in Q1 2025.
As a reminder to investors, Puma's reported NERLYNX sales includes both U.S. net sales and product supply revenues of NERLYNX to Puma's ex-U.S. partners. Product revenue for the first quarter of 2026 was impacted by approximately $7.9 million of inventory drawdown at our specialty pharmacies and specialty distributors. Royalty revenue was $2.8 million in the first quarter of 2026 compared to $15.6 million in Q4 2025 and $2.9 million in Q1 of 2025. As noted in our last call, royalty revenue in 2025 -- in Q4 2025 was driven by the shipment of -- to our partner in China.
We reported 2,328 bottles of NERLYNX sold in the first quarter of 2026 compared to 3,298 bottles sold in Q4 2025. In Q1 2026, we estimate that inventory decreased by 439 bottles. In Q1 2026, new prescriptions were up approximately 25% compared to Q4 2025 and total prescriptions were down approximately 4% compared to Q4 2025. Roger will provide further details in his comments and slides.
I will now present the interim data from Puma's ongoing Phase II trials of alisertib in small cell lung cancer and HER2-negative ER-positive breast cancer, also referred to as the ALISCA-Lung1 and ALISCA-Breast1 trials.
Heather Blaber and Roger Storms will add additional color on NERLYNX commercial activity. Maximo Nougues will follow with highlights of the key components of our financial statements for the fourth quarter of 2025.
We now move to the ALISCA-Lung1 interim presentation. As a reminder, in clinical trials to date, alisertib has shown single-agent activity and activity in combination with other cancer drugs in the treatment of many different types of cancers, including hormone receptor-positive breast cancer, triple-negative breast cancer, small cell lung cancer and head and neck cancer. The drug has also shown activity in previous clinical trials in peripheral T-cell lymphoma and non-Hodgkin's lymphoma.
Takeda's previous clinical development program with alisertib was extensive. And due to this, there is a large well-characterized clinical safety database with over 1,300 patients who were treated across 22 company-sponsored trials.
From a preclinical perspective, it has been shown that aurora kinase A and c-Myc upregulate each other, which suggests the existence of a positive feedback loop. c-Myc upregulates the cyclin complex, which leads to cell proliferation. So by inhibiting aurora kinase A with alisertib, it also inhibits c-Myc, which decreases cell proliferation. Additionally, preclinical data has shown that alisertib inhibited growth of cells with c-Myc overexpression and in xenograft models that expressed high levels of c-Myc, tumor growth was inhibited.
Puma's Phase II trial, ALISCA-Lung1, which is also referred to as study PUMA-ALI-4201, was designed to enroll up to 60 patients with small cell lung cancer who had received prior treatment with a platinum-based chemotherapy and immunotherapy. The trial enrolls both second-line and third-line patients. Patients must provide tissue-based biopsies so that biomarkers can be analyzed. Alisertib was initially dosed at 50 milligrams BID on days 1 to 7 of a 21-day cycle. As investors are aware, the trial was then amended to increase the dose to 60-milligram BID, and the company is now in the process of increasing the dose to 70 milligrams BID.
The primary endpoint of the trial is to determine whether any biomarker correlates with alisertib response with endpoints of overall response rate, duration of response, disease control rate, progression-free survival and overall survival. The secondary endpoints include investigator-assessed efficacy and survival. Mandatory G-CSF prophylaxis is also given in the trial in an effort to reduce the neutropenia that was shown to be dose-limiting in the previous clinical trials with alisertib.
Slide 6 shows the baseline characteristics for the 52 patients treated at 50 milligrams BID and the 27 patients treated at 60-milligram BID that are included in this interim analysis.
Slide 7 shows the summary of the prior treatments the patients received prior to entering the study. Of note, all of these patients were treated in either the second line or third line in this trial.
To first discuss the safety in the trial. In previous clinical trials of alisertib, the treatment-emergent adverse events seen were those characteristic of a cell cycle inhibitor with neutropenia being the main AE seen in the highest percentage. In this trial, the all-grade neutropenia was 19.2% in the 50-milligram arm and 22% in the 60-milligram arm.
Slide 10 shows the rates of grade 3 and 4 AEs seen in the trial. Of note, the grade 3 or higher neutropenia rate was 13.5% in the 50-milligram arm and 11.1% in the 60-milligram arm.
Slide 11 compares the Grade 3 and Grade 4 AE rates seen in the ALISCA-Lung1 trial to those that were seen in the previous Phase II trial of alisertib monotherapy in small cell lung cancer referred to as study C14007. C14007 was previously published in Lancet Oncology in 2010. As a reminder, in C14007, G-CSF prophylaxis was not mandated, while ALISCA-Lung1 requires mandatory prophylactic G-CSF. As can be seen on the slide, the use of prophylactic G-CSF appeared to reduce the rates of Grade 3 or higher neutropenia compared to what was seen in the previous trial.
We next move to the efficacy seen in the trial. As you can see in Slide 13, in the 52 patients in ALISCA-Lung1 that were treated at 50 milligrams, we have seen 4 ((sic) [ 6 ]) patients or 11.5% with a best response of a partial response and 18 patients or 34.6% with stable disease. The median PFS for the 50-milligram arm was 1.7 months. In the first 15 patients in the 60-milligram arm, we have seen 1 patient or 6.7% with the best response of a partial response and 7 patients or 46.7% with stable disease. The median PFS for the 60-milligram arm is currently 4.2 months.
Slide 14 shows the Kaplan-Meier curve for PFS between the 50-milligram and 60-milligram arm of the trial. As previously stated, the median PFS for the 60-milligram arm is currently 4.2 months. However, we caution it is still early, and we await additional patient numbers and additional follow-up.
We will now move to the biomarkers in the trial. Slide 16 presents the Kaplan-Meier curve for the patients according to c-Myc H-score. c-Myc H-score is a semi-quantitative immunohistochemical assessment that measures the intensity and percentage of tumor cells staining for the c-Myc protein, typically ranging from 0 to 300. High c-Myc H-scores are believed to be associated with poor prognosis and lower overall survival in various cancers. As you can see on Slide 16, for the combined doses of 50 milligrams and 60 milligrams, patients with c-Myc H-score of between 0 and 100 had a median PFS of 1.68 versus a PFS of 4.17 for the patients with a c-Myc H-score of between 101 and 300. This would suggest that alisertib has better activity in cancers with a higher amount of c-Myc activity.
Slide 17 presents the c-Myc -- presents the KM curve for the 50-milligram and 60-milligram dose separately for the patients according to c-Myc H-score. As you can see on the slide, for the 50-milligram dose, patients with H-score of between 0 and 100 had a median PFS of 1.68 months versus a PFS of 2.83 months for the patients with a c-myc H-score of between 101 and 300. While for the 60-milligram dose, patients with H-score of between 0 and 100 had a median PFS of 1.41 months, while the median PFS has not yet been reached for the patients with c-Myc H-score of 101 to 300. We believe that these slides are suggesting that alisertib has greater activity in tumors with higher c-Myc H-score and hence more c-Myc activity, which we believe is due to the inhibition of the aurora kinase pathway by alisertib.
Slide 18 presents the KM curve for the patients according to percent of tumor cells that are c-Myc positive. As you can see on Slide 18, for the combined doses of 50-milligram and 60-milligram, for tumors having between 0 and 10% of the cells c-Myc positive, there's a median PFS of 1.68 months versus a PFS of 2.83 months for the patients with tumors having between 11% and 100% of the cells c-Myc positive.
Slide 19 presents the KM curve for the 50-milligram and 60-milligram doses separately for the patients according to the percent of tumor cells that are c-Myc positive. As you can see on the slide, for the 50-milligram dose, patients with tumors having between 0% and 10% of the cells c-Myc positive had a median PFS of 1.68 months versus a PFS of 2.73 months for patients with tumors having between 11% and 100% of the tumor cells c-Myc positive. While for the 60-milligram dose, between 0% and 10% of c-Myc positive had a median PFS that has not been reached versus a PFS of 4.17 months for the patients with between 11% to 100% of the tumor cells c-Myc positive. We believe that these slides are suggesting that alisertib has greater activity in the tumors where a higher percentage of the cells are c-Myc positive, which we again believe is due to the inhibition of the aurora kinase pathway by alisertib.
We believe that the initial clinical data with alisertib in small cell lung cancer are demonstrating that alisertib is showing better activity in patients where c-Myc is playing a role in driving the tumor, which is indicative of tumors where aurora kinase A is activated. There are currently 32 patients enrolled in the 60-milligram arm of the trial. Based on this preliminary safety seen at this dose, we are continuing to dose escalate to 70 milligrams, and we hope to begin enrollment of the 70-milligram cohort in the second half of 2026. We believe that the data generated thus far in ALISCA-Lung1 is showing that alisertib monotherapy is showing a PFS at higher doses and in certain biomarker-directed populations that is as good or slightly better than the PFS for currently approved drugs in this space.
As discussed previously, we are hopeful that with increasing doses of alisertib monotherapy ALISCA-Lung1, we can achieve higher concentrations of alisertib in these biomarker-defined populations and potentially open up the opportunity for a Phase III design that tests alisertib monotherapy in a randomized trial.
As investors are aware, alisertib was previously tested in a randomized Phase II trial of paclitaxel plus alisertib versus paclitaxel plus placebo where PFS and OS benefit was seen in patients with tumors with biomarkers that appear to indicate that the aurora kinase A pathway was activated. Based on this data and the data from ALISCA-Lung1, Puma will be looking to a dual approach for the development of alisertib in small cell lung cancer.
Therefore, in addition to the monotherapy dose escalation approach in ALISCA-Lung1, Puma will also be looking to initiate ALISCA-Lung2, which will investigate the efficacy of alisertib given in combination with paclitaxel using mandatory G-CSF prophylaxis. We are hoping to initiate this trial in the second half of 2026.
We are pleased with the interim data from ALISCA-Lung1, and we believe it is showing an improved tolerability profile for alisertib monotherapy and improved efficacy with dose escalation as well as improved efficacy in a biomarker-directed population that is indicative of the aurora kinase pathway activation. We anticipate additional interim efficacy data from ALISCA-Lung1 in the second half of 2026 or the first half of 2027.
I will now move to the ALISCA-Breast1 interim presentation. As a reminder, and as previously stated, in clinical trials to date, alisertib has shown single-agent activity and activity in combination with other cancer drugs in the treatment of many different types of cancer, including hormone receptor-positive breast cancer, triple-negative breast cancer, small cell lung cancer and head and neck cancer. There's also a large well-characterized clinical safety database with over 1,300 patients who were treated across 22 company-sponsored trials. As previously stated, from a preclinical perspective, it has been shown that aurora kinase A and c-Myc upregulate each other, which suggests the existence of a positive feedback loop. Preclinical data has shown that alisertib inhibited growth of cells with c-Myc overexpression and in xenograft models that expressed higher levels of c-Myc, tumor growth was inhibited.
Puma's Phase II ALISCA-Breast1, also referred to as study, PUMA-ALI-1201, investigates alisertib in combination with endocrine treatment consisting of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen in patients with HER2-negative hormone receptor positive recurrent or metastatic breast cancer. Patients must be chemotherapy naive in the recurrent or metastatic setting and have had previous treatment with a CDK4/6 inhibitor and have received at least 2 prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial. Patients were dosed with alisertib given at either 30 milligrams, 40 milligrams or 50 milligrams BID on days 1 to 3, 8 to 10 and 15 to 17 on a 28-day cycle in combination with the endocrine therapy of investigator's choice. Patients must not have been previously treated with the endocrine treatment in the metastatic setting that will be given in combination with alisertib in the trial.
The primary endpoints include objective response rates, duration of response, disease control and progression-free survival. As a secondary objective, the company is evaluating each of these efficacy endpoints within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better efficacy, which might give the company the potential to focus the future clinical development of alisertib in combination with endocrine therapy for patients with HER2-negative hormone receptor-positive breast cancer in these biomarker-specific populations.
Slide 25 shows the baseline characteristics for the 164 patients included in this interim analysis. As the slide shows, the majority of these patients were treated in the third line or later setting. First, discuss the safety in the trial. As previously mentioned, in previous clinical trials of alisertib, the treatment-emergent adverse events seen were those characteristic of a cell cycle inhibitor with neutropenia being the AE seen in the highest percentage.
Slide 27 shows the rates of Grade 3 or 4 AEs seen in the trial. Of note, the grade 3 or higher neutropenia rate was 8% in the 30-milligram arm, 10.2% in the 40-milligram arm and 26.9% in the 50-milligram arm. It is important for investors to note that prophylactic G-CSF was not given in the study. Slide 27 also compares the Grade 3 or 4 AE rates seen in the ALISCA-Breast1 trial to those that were seen in the previously published Phase II of alisertib in HER2-negative ER-positive breast cancer that was published in JAMA Oncology in 2020, referred to as study TBCRC041. As can be seen in the slide, the rates of Grade 3 or higher neutropenia appear to be lower in the ALISCA-Breast1
trials compared to what was seen in TBCRC041.
To next move to the efficacy seen in the trial. Slide 29 shows the summary of clinical benefit for the patients with at least 1 post-baseline scan or who ended treatment or died before they got a scan. As you can see in the slide, the best response was 5% in the 30-milligram arm, 20% in the 40-milligram arm and 18.4% in the 50-milligram arm.
Slide 30 shows the Kaplan-Meier curve for PFS in the trial. As is seen in the slide, the median PFS of the 30-milligram arm is currently 2.04 months. The median PFS of the 40-milligram arm is 5.45 months and the median PFS of the 50-milligram arm is currently 5.59 months.
We will now move to the biomarkers in the trial. Slide 32 presents the KM curve for all the patients in the trial according to c-Myc copy number, also referred to as c-Myc copy number gain. As you can see on the slide, for all of the patients in the trial for which there are tissue results, patients with c-Myc copy number of greater than 2 had a median PFS of 7.29 months versus a median PFS of 2.0 months for the patients with a c-Myc copy number equal to 2.
Slide 33 presents the KM curve for all of the patients for which there are tissue results according to percent of tumor cells that are c-Myc positive. As you can see on the slide, for the patients with between 0 and 10% of the cells c-Myc positive. The median PFS was 3.06 months versus a PFS of 5.62 months for the patients with between 11% and 100% of the cells c-Myc positive.
Slide 34 presents the KM curve for the 50-milligram and 40-milligram doses separately for the patients according to percent of tumor cells that are c-Myc positive. As you can see on the slide, for the 40-milligram dose, patients with between 0% and 10% of the cells c-Myc positive had a median PFS of 3.9 months versus a PFS of 5.75 months for the patients with between 11% and 100% of the tumor cells c-Myc positive. For the 50-milligram dose for patients with between 0% and 10% of the cells c-Myc positive, there was a median PFS of 3.58 months versus a PFS of 9.3 months for the patients with between 11% and 100% of the tumor cells c-Myc positive.
Similar to the data from ALISCA-Lung1, we believe that these slides are suggesting that in patients with alisertib has greater efficacy in ALISCA-Breast1 in tumors where a higher percent of the tumor cells are c-Myc positive, and hence, a greater degree of c-Myc activation. Preclinically, it's been shown that alisertib inhibits c-Myc positive cells. So we believe that this increased efficacy is due to the mechanism of action of alisertib and the inhibition of the aurora kinase pathway.
Slide 35 presents the KM curve for all the patients according to ESR1 mutation status. As is seen on the slide, for patients at all 3 dose groups who are ESR1 mutated as measured by ctDNA, a median PFS of 5.62 months was seen versus a PFS of 3.58 months for the people who are ESR1 wild type as measured by ctDNA. For patients at all 3 dose groups who are ESR1 mutated as measured by tissue, a median PFS of 7.23 months was seen versus a PFS of 3.71 months for patients who are ESR1 wild-type as measured by tissue. It is important for investors to remember that these patients are being treated in the third-line setting.
So these patients have already received treatment with a selective endocrine receptor degrader or SERD. Since enrollment of this trial was done, while the newer oral SERDs have either been FDA approved or in later stages of clinical development, many of the patients in the ALISCA-Breast1 trial have been previously treated with the new oral SERDs. More specifically, approximately 58% of the ESR1 mutated patients in the trial were previously treated with oral SERDs, including camizestrant, elacestrant, giredestrant, imlunestrant or palazestrant.
Slide 36 presents the KM curve for the 50-milligram and 40-milligram dose groups separately for patients according to ESR1 mutation status as measured by ctDNA. For patients in the 40-milligram group who were ESR1 mutated as measured by ctDNA, a median PFS of 3.7 months was seen versus a PFS of 5.75 months for the patients who are ESR1 wild type as measured by ctDNA. For patients at the 50-milligram group who were ESR1 mutated as measured by ctDNA, a median PFS of 9.3 months was seen versus a PFS of 2.76 months for the patients who were ESR1 wild-type as measured by ctDNA.
Slide 37 presents the KM curve for the 50-milligram and 60-milligram ((sic) [ 40-milligram ]) dose separately for patients who are ESR1 -- according to ESR1 mutation status as measured by tissue. For the patients at the 40-milligram group who were ESR1 mutated as measured by tissue, a median PFS of 4.86 months was seen versus a PFS of 4.04 months for the patients who were ESR1 wild type as measured by tissue. For the patients at the 50-milligram group who were ESR1 mutated and measured by tissue, a median PFS has not yet been reached versus a PFS of 3.58 months for patients who were ESR1 wild-type as measured by tissue.
Slide 38 presents the KM curve for all the patients according to PIK3CA mutation status. As is seen on the slide, for patients at all 3 dose groups who are PIK3CA mutated as measured by ctDNA, a median PFS of 2.1 months was seen versus a PFS of 5.45 months for patients who are PIK3CA wild-type as measured by ctDNA. For the patients at all 3 dose groups who are PIK3CA mutated as measured by tissue, a median PFS of 3.71 months was seen versus a PFS of 4.86 months for patients who are PIK3CA wild-type as measured by tissue.
Slide 39 shows the KM curve for the 50-milligram and 40-milligram dose separately for patients according to PIK3CA mutation status as measured by ctDNA. For patients at the 40-milligram group who were PIK3CA mutated as measured by ctDNA, a median PFS of 3.71 months was seen versus PFS of 5.65 for patients who are PIK3CA wild-type as measured by ctDNA. For patients at the 50-milligram group who were PIK3CA mutated as measured by ctDNA, a median PFS of 3.58 months was seen versus a PFS that has not yet been reached for patients who are PIK3CA wild-type as measured by ctDNA. Based on the efficacy seen in the patients who were ESR1 mutated and PIK3CA wild type, the company conducted a subset analysis to specifically focus on these 2 subgroups.
Slide 40 presents the KM curve for patients who are PIK3CA wild-type according to ESR1 mutation status. As is seen on the slide, for patients at all 3 dose groups who are PIK3CA wild-type and who had an ESR1 mutation as measured by ctDNA, a median PFS has not yet been reached versus a PFS of 3.48 months for patients who are PIK3CA wild-type and ESR1 wild-type as measured by ctDNA. For patients at all 3 dose groups who are PIK3CA wild-type and who had an ESR1 mutation as measured by tissue, a median PFS has not been reached versus a PFS of 2.79 months for patients who are PIK3CA wild-type and ESR1 wild type as measured by tissue.
Slide 41 presents the KM curve according to 50-milligram and 40-milligram doses separately for the patients who are PIK3CA wild-type according to ESR1 mutation status as measured by ctDNA. For PIK3CA wild-type patients at the 40-milligram group who were ESR1 mutated as measured by ctDNA, a median PFS of 4.86 months was seen versus a PFS of 5.75 months for the patients who were ESR1 wild-type as measured by ctDNA. For PIK3CA wild-type patients at the 50-milligram group who were ESR1 mutated, the median PFS has not been reached versus a median PFS of 2.14 months in the patients who were ESR1 wild-type as measured by ctDNA. We are very pleased to see that at the 50-milligram dose group for the patients who were PIK3CA wild-type and ESR1 mutant, no patient has yet progressed, although we caution these numbers here are small and further patient follow-up is needed.
Slide 42 presents the KM curve for the 50-milligram and 40-milligram dose separately for patients who are PIK3CA wild-type according to ESR1 mutation status as measured by tissue. For PIK3CA wild-type patients at the 40-milligram group who were ESR1 mutated as measured by tissue, a median PFS of 7.23 months was seen versus a PFS of 3.98 months for the patients who were ESR1 wild type as measured by tissue. For PIK3CA wild-type patients at 50 milligrams who were ESR1 mutated, the median PFS has not been reached versus a median PFS of 2.14 months in the patients who were ESR1 wild-type as measured by tissue. Again, we are very pleased to see that the 50-milligram dose group for the patients who are PIK3CA wild-type and ESR1 mutant, no patient has yet progressed, although we caution these numbers here are small and further patient follow-up is needed.
As we've shown in the earlier slides, c-Myc appeared to play a role in the activity of alisertib in HER2-negative ER-positive breast cancer. And more specifically, the analysis on Slides 33 and 34 showed that alisertib had better activity in patients with a higher percent of their cells being c-Myc positive. This analysis also showed that patients with between 11% to 100% of their cells being c-Myc positive showed the best activity with alisertib. We, therefore, conducted an analysis to see whether or not c-Myc had any correlation with the activity of alisertib that we are seeing in the PIK3CA wild-type patients, the ESR1 mutated patients or the patients who are both PIK3CA wild-type and ESR1 mutated.
On Slide 43, we present the data that shows the percent of c-Myc positive cells for PIK3CA wild-type ESR1 mutated and patients who are both PIK3CA wild-type and ESR1 mutated. The left-hand side of the slide presents the patients whose mutation status was determined by tissue. The right-hand side of the slide shows the patients whose mutation status was by ctDNA. As you can see on the slide, patients who are PIK3CA wild-type patients who are ESR1 mutated and patients who are both PIK3CA wild-type and ESR1 mutated appear to show an increase in the median percent of c-Myc positive cells. This is seen in both the patients where the mutation status is determined by ctDNA and in tissue. It is also seen in this analysis that a high percent of the patients who are PIK3CA wild-type who are ESR1 mutant and who are both PIK3CA wild-type and ESR1 mutant have between 11% to 100% of their cells being c-Myc positive, which is again where the best activity of alisertib has been shown to occur.
We believe this analysis is suggesting that better activity being seen with alisertib in the patients who are PIK3CA wild-type, ESR1 mutated or both PIK3CA wild-type and ESR1 mutated may be due to this increased c-Myc activity as it appears to be showing that c-Myc is playing a role in driving the tumor in these subgroups of patients, which is suggestive of tumors with the aurora kinase A is activated and hence, where alisertib's mechanism of action may be playing a role.
When Puma licensed alisertib, it had stated that the goal was to enroll ALISCA-Breast1 in order to perform a biomarker analysis to better understand which biomarker subgroups had the best activity and then amend the trial to focus on a more biomarker-focused population. Based on the interim data from ALISCA-Breast1, the company is going to be expanding the enrollment in the trial to obtain more data on the biomarker-focused cohorts with a focus in the patients who are PIK3CA wild-type, ESR1 mutant or both.
The company anticipates that this will occur in the second half of 2026. The company also plans to present updated data on the ALISCA-Breast1 trial in the second half of 2026. Similar to the data from ALISCA-Lung1, we believe that the data generated thus far in ALISCA-Breast1 is showing that alisertib in combination with endocrine therapy appears to be active in the third-line setting and more specifically in patients who are PIK3CA wild-type, ESR1 mutant or both PIK3CA wild-type and ESR1 mutant. Similar to ALISCA-Lung1, the activity of alisertib in the trial appears to be driven by c-Myc. To our knowledge, we are not aware of any drugs that have shown this level of activity in these subgroups of patients in the third line, which we believe differentiates the drug from others in development. We believe that this activity is attributable to biomarkers that are indicative of aurora kinase pathway activation, which we believe is in line with the mechanism of action of alisertib.
As we've mentioned on prior earnings calls and in response to investor questions, Puma continues to evaluate several commercial stage and development-stage drugs to potentially in-license and acquire that would allow the company to diversify itself and leverage Puma's existing R&D, regulatory or commercial infrastructure. The company will keep investors updated on this as it progresses. I will now turn the call over to Heather Blaber for an update on our marketing initiatives. Roger Storms will follow with a review of our commercial performance during the quarter.
Thanks, Alan. I appreciate the opportunity to share some additional insights into our marketing strategy. The marketing team is focused on continued awareness of both clinical data for NERLYNX as well as reinforcing the continued unmet need in HER2-positive early-stage breast cancer after adjuvant therapy. We continue to invest in market research to help us understand and validate the most effective ways to communicate our data with health care professionals through both personal and nonpersonal promotion. Our strategy is focused on increasing awareness of our dual indication in HER2-positive breast cancer. We believe NERLYNX plays an important role in the early stage by reducing the risk of recurrence and in the metastatic setting by helping protect against progression. Not only do physicians who have experience with NERLYNX continue to identify appropriate patients that could benefit from additional therapy post adjuvant treatment, but we continue to adopt new prescribers year-over-year who recognize the unmet need in HER2-positive early-stage breast cancer and how NERLYNX can help their patients.
In summary, we are excited and committed about the potential to engage with more oncologists and support their patients diagnosed with HER2-positive breast cancer in both the early and metastatic setting.
I will now turn the call over to Roger Storms to provide an overview on the commercial performance for the first quarter.
Thank you, Heather, and thanks to everyone for joining our first quarter earnings call. But before I move into the commercial review, just a reminder that I'll be making forward-looking statements. The sales team remains focused on expanding overall HCP reach and frequency with a strong emphasis on driving engagement when treatment decisions are being made. Q1 2026 call activity increased 44% year-over-year and 14% quarter-over-quarter. The year-over-year and quarter-over-quarter increases are a direct result of continued emphasis put on executional excellence and increased field accountability. The commercial team continues to prioritize increasing use of NERLYNX with a main focus on patients at higher risk of recurrence. They are also dedicated to enhancing clinical education and engagement through nonpersonal promotional efforts as well as utilizing patient resources to support persistence and compliance during NERLYNX therapy.
Let me now transition to some of the commercial slides where I'll provide some additional specifics around performance. Slide 3 is an illustration of our distribution model, which is broken out into the specialty pharmacy channel and the specialty distributor or in-office dispensing channel. Regarding the overall distribution of our business, in Q1 2026, about 58% of our business was purchased through the SP channel and the remaining 42% was purchased through the SD channel. We continue to see stronger growth in the SD channel, driven mainly by increased sales in the group purchasing organizations or GPO segment.
Turning to Slide 4. NERLYNX net product revenue in Q1 '26 was $42 million, which represents a decrease of $17.9 million from the $59.9 million we reported in Q4 2025 and a decrease of $1.1 million from the $43.1 million we reported in Q1 of 2025. As a reminder to investors, Puma's reported NERLYNX sales include both U.S. net sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex-U.S. partners. Please note that in Q1 of 2025, we reported product supply revenue to our international partners of approximately $400,000 versus the $150,000 in Q1 of 2026. Therefore, U.S. net sales of NERLYNX in Q1 2026 were $41.8 million versus the $42.7 million in Q1 of 2025.
I'll provide some more details around inventory changes, and Maximo will provide some additional specifics around gross to net expenses during his update.
In Q1 2026, we estimate that inventory decreased by about $7.9 million. As a comparator, we estimate that inventory increased by about $5.7 million in Q4 of 2025.
Slide 5 shows Q1 2026 ex-factory bottle sales and also provides both a year-over-year and quarter-over-quarter comparison. In Q1 2026, NERLYNX ex-factory bottle sales were 2,328, which represents an approximate 29% decrease quarter-over-quarter while remaining essentially flat at 0.4% year-over-year.
Let me specifically call out the inventory changes from a bottle perspective. In Q1 2026, we estimate that inventory decreased by about 439 bottles. As a comparator, we estimate that inventory increased by 343 bottles in Q4 of 2025 and decreased by 251 bottles in Q1 of 2025.
Let me take a moment to provide some additional metrics regarding our first quarter performance. In Q1 2026, we saw enrollments increase by about 10% quarter-over-quarter and about 1% year-over-year. Commercial new patient starts or NRxs were even stronger, increasing by about 25% quarter-over-quarter and about 11% year-over-year. Turning to total prescriptions or TRx, we saw TRx decline about 4% quarter-over-quarter and about 1% year-over-year.
Finally, let me share some specifics around commercial demand overall. In Q1 2026, we saw demand decrease by about 6% quarter-over-quarter, but increased by about 7% year-over-year. As mentioned, these dynamics are strongly influenced by SD patterns. In Q1 2026, we saw SD demand decrease by about 9% quarter-over-quarter due to Q4 buy-ins while continuing to show strong growth year-over-year at about 28%.
Slide 6 highlights the quarterly adoption of dose escalation since the launch of NERLYNX. In Q1 2026, approximately 78% of patients started NERLYNX at a reduced dose. This is higher compared to the 75% we reported in Q4 of 2025.
Continued messaging and -- continued messaging and adoption of dose escalation remains an important commercial priority. We believe dose escalation, coupled with patient education resources will give patients better support throughout their NERLYNX therapy and ultimately help to reduce the risk of recurrence.
Slide 7 highlights the strategic collaborations we formed across the globe. Most recently, in Q1 2026, NERLYNX was launched in Thailand, also in the extended adjuvant setting. We really appreciate the excellent work being done by our partners around the world and look forward to supporting their continued success moving forward.
I'll close by sharing my sincere appreciation for the entire Puma team and their steadfast commitment to supporting patients and families affected by breast cancer. This disease is truly devastating. And while meaningful progress has been made, we know there's still important work ahead and even more we can accomplish together.
I will now turn the call over to Maximo for a review of our financial results.
Thanks, Roger. I will begin with a brief summary of our financial results for the first quarter of 2026. Please note that I will make comparisons to Q4 2025, which we believe is a better indication of our progress as a commercial company than year-over-year comparisons. For more information, I recommend that you refer to our first quarter 2026 10-Q, which will be filed today and includes our consolidated financial statements.
For the first quarter of 2026, we reported a net loss based on GAAP of $3.8 million or $0.07 per share. This compares to net income in Q4 2025 of $13.4 million or $0.27 per basic share and $0.26 per diluted share. the fourth quarter of 2025 included a net change in valuation allowance that unfavorably impacted net income by $3.2 million. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported a net loss of $1.9 million or $0.04 per share for the first quarter of 2026. Gross revenue from NERLYNX sales was $57.5 million in Q1 2026 and $82.9 million in Q4 2025. As Alan mentioned it, net product revenue from NERLYNX sales was $42 million, a decrease from the $59.9 million reported in Q4 2025 and the $43.1 million reported in Q1 2025. A reminder to investors, Puma reported NERLYNX sales include both U.S. net sales of NERLYNX and product supply revenues of NERLYNX to Puma ex-U.S. partners.
Please note that in Q1 2026, we reported product supply revenue to our international partners of about $0.1 million. Therefore, U.S. net sales of NERLYNX in Q1 2026 were $41.9 million versus $55.2 million in Q4 2025. The decrease in Q1 2026 versus Q4 2025 was driven by lower demand, inventory reduction in Q1 of about $7.9 million versus inventory increase of $5.7 million in Q4 2025. Royalty revenue totaled $2.8 million in the first quarter of 2026 compared to $15.6 million in Q4 2025. The decline in royalty revenue reflects a large Q4 2025 shipment to our partner in China.
Our gross to net adjustment in Q1 2026 was about 27% and 27.8% in Q4 2025. The lower gross to net adjustment was driven mostly by lower government chargebacks. Cost of sales for Q1 2026 was $10.4 million and includes $2.4 million for the amortization of intangible assets related to our neratinib license. Cost of sales for Q4 2025 was $23.2 million. Going forward, we will continue to recognize amortization of milestones to the licensor of about $2.4 million per quarter as cost of sales.
For fiscal year 2026, Puma anticipates that net NERLYNX product revenue will be in the range of $202 million to $206 million, higher than our prior guidance of $194 million to $198 million. We also anticipate that our gross to net adjustment for the full year 2026 will be between 26.5% and 27.5%, significantly higher than 2025 as we expect higher government chargebacks and Medicare and Medicaid share to maintain the levels we saw in the last 2 quarters of 2025.
In addition, for fiscal year 2025 (sic) [ 2026 ]), we anticipate receiving royalties from our partners around the world in the range of $20 million to $23 million. We don't expect any license revenue in 2025 ((sic) [ 2026 ]). We also expect that net income for the full year will be in the range of $16 million to $19 million, also higher than our prior guidance of $10 million to $13 million. Current guidance does not include any potential release of any additional tax asset valuation allowance in our net income estimate. The company is reviewing its deferred tax assets as part of its ongoing tax valuation analysis has not yet determined whether any adjustments would be required, if so, the potential timing or size of such an adjustment. We will continue to keep investors updated on this as it progresses.
This time, we do not believe that tariffs imposed or proposed to be imposed by the United States, particularly with other countries, will have a material impact on our product cost or cost or results of operations. However, shifts in the trade policies in the United States and other countries have been rapidly evolving and are difficult to predict. As a point of reference, our manufacturing product cost accounts for a mid- to high single-digit percentage of our total cost of goods sold.
We anticipate that for Q2 2026, NERLYNX product revenue will be in the range of $50 million to $52 million. We expect Q2 royalties revenues will be in the range of $2 million to $3 million and no license revenue. We further estimate that the gross to net adjustment in Q2 2026 will be approximately 27% to 28%. Puma anticipates a Q2 net income between $2 million and $4 million. SG&A expenses were $18.4 million in the first quarter of 2026, unchanged from the fourth quarter of 2025. SG&A expenses include noncash charges for stock-based compensation of $1.1 million for Q1 2026 and $1 million in Q4 2025. Research and development expenses were $19.8 million in the first quarter of 2026 and $16.8 million in Q4 2025. R&D expenses included noncash charges for stock-based compensation of $0.8 million in Q1 2026 and $0.7 million in Q4 2025.
On the expense side, Puma anticipates higher total operating expenses in 2026 compared to 2025. More specifically, we anticipate SG&A expenses to increase by 1% to 2% and R&D expenses to increase by 34% to 37% year-over-year. The higher R&D expense -- the higher increase in R&D expense is driven by the progress of our clinical trials. In the first quarter of 2026, Puma reported cash burn of approximately $4 million. This compares to cash burn of approximately $3.1 million in Q4.
Please note that during Q1 2026, we made our eighth quarterly principal loan payment of $11.1 million related to our obligation with Ethereum. Furthermore, after quarter end, we made our final payment to Ethereum and as a result, Puma is now debt-free. On March 31, 2026, we had approximately $101.5 million in cash, cash equivalents and marketable securities versus about $97.5 million at year-end 2025. Our accounts receivable balance was $26.3 million. Our accounts receivables terms range between 10 and 68 days, while our days sales outstandings are about 46 days. We estimate that as of March 31, 2026, our distribution network maintained approximately 3 weeks of inventory. Overall, we continue to deploy our financial resources to focus on the commercial NERLYNX [indiscernible] controlling our expenses.
Thanks, Maximo. On past earnings calls, we have stressed that Puma's senior management in cooperation with the Board of Directors continues to remain focused on NERLYNX sales trends and recognizes its fiscal responsibility to shareholders to continue to maintain positive net income. We believe that this focus has contributed to our commercial execution in a positive way as according to our current projections, 2026 will mark the second year-over-year demand increase for NERLYNX in the United States and the first time in the history of the launch of NERLYNX in the U.S. that we have seen 2 positive consecutive year-over-year increases in demand. We are pleased to report this demand-driven growth in NERLYNX sales in the first quarter of 2026 which has been driven by better-than-expected enrollments and better-than-expected new patient starts as well as strong increases in sales to our specialty distributors.
In addition, we believe that the positive net income that the company is guiding to for full year 2026 has resulted from the continued financial discipline across the company over the last few years. The company remains committed to continuing to achieve this positive net income, and we'll continue to reduce expenses if needed in order to achieve this. We look forward to updating investors on this in the future. There continues to remain a significant unmet need for patients battling breast cancer, lung cancer and other solid tumors. We at Puma are committed and passionate about finding more effective ways and helping these patients during their journey, and we will continue to strive to achieve that goal. This concludes today's presentation.
We will now turn the floor back to the operator for Q&A. Operator?
[Operator Instructions]
And the first question comes from the line of Salvatore Caruso with TD Cowen.
2. Question Answer
Congrats on the data. I'm looking forward to more mature data sets. This is on behalf of Marc Frahm at TD Cowen. Two quick questions. The first one, given the emerging signal in c-Myc positive patients in both lung and breast that you presented today, how are you thinking about incorporating c-Myc biology going forward into future trial designs? Do you see, like, for example, in your registrational strategy, it evolving to some sort of biomarker enriched program with maybe a more narrow patient selection? And then I'll ask my second one after.
Yes, this is Alan. So you're absolutely right. We are seeing a much better signal in the patients where there's a signal of c-Myc positivity, if you will, using that in a broad sense. In small cell lung, you don't have the benefit of a lot of the kind of predetermined disease-driven categories like you do in ER-positive breast. So that likely may require some form of a c-Myc positive. Now is that going to be like a c-Myc positive, which includes copy number or percent of cells. I think we need a little more data to say that. I think we're hopeful that as we increase dose, we may get in the overall population, we may continue to see that signal in c-Myc. But in the overall population, we may see it as well.
So we may be able to go for something a little more general. But I think likely that would -- if we went for a biomarker focused in small cell lung, it would be something that's probably going to be inclusive of a number of different categories of c-Myc positivity, if you will. Now in ER-positive breast, HER2-negative ER-positive breast, we've got a very interesting situation because you're absolutely right, it is a c-Myc driven signal. But for whatever reason, we're seeing an enrichment of that signal in the patients who are ESR1 mutated and PIK3CA or PIK3CA wild-type or both, right?
So if I remember this correctly, ESR1 wild type is probably 50% to 60% of the patients. I'm sorry, PIK3CA wild-type is probably 50% to 60% of the patients. ESR1 mutated is about 40% to 50%. So that's quite a big number. Now if we look at the patients that are in the both category, which is where we're seeing, especially at the 50-milligram dose, really compelling activity with no patients having progressed, then that's about 20% of the patients there. So it's a 40,000 patient population. If that 8,000 patient population is the one that we focus on, I'm totally okay with that. It could be a fantastic benefit.
So I think for right now, it looks like in ER-positive breast, we have the benefit of just having enrichment of c-Myc in categories where the disease is -- it's already being -- the biomarker, if you will, is already being determined. They already know post-CDK4/6 standard of care is to do either tissue-based or ctDNA or both to see are you PIK3CA wild-type, PIK3CA mutated, are you ESR1 wild type or ESR1 mutated. So we kind of have the benefit of that already being done for us. So I think in ER-positive breast, that's probably the path we're going down. Obviously, we got to get more data, but I think that's kind of the initial thoughts on that.
Awesome. That helps a lot. And just, like, a quick second question. Looking ahead to the next updates in both programs, can you maybe help ballpark for us what specific outcomes would give you guys confidence to advance or keep progressing these programs or advance to the next stage of development?
Yes. So in terms of investing in the next stage of development, we're all systems go on both. At this juncture, I don't see any data that would tell us we're not continuing this into Phase III. I think the question is just what's the design? And as you referenced in your earlier question, what's the exact patient population to focus on. So I think what we're looking for is going to be more patient numbers and then more duration.
This concludes our question-and-answer session. And I would like to turn the conference back over to Mariann for any closing remarks.
Thank you all for joining us today. As a reminder, this call may be accessed via replay of the webcast at pumabiotechnology.com beginning later today. Have a good evening.
Thank you, ladies and gentlemen. Thank you for participating in today's conference call. This concludes our program. Everyone, have a great day, and you may now disconnect.
Puma Biotechnology, Inc. — Q1 2026 Earnings Call
Puma Biotechnology, Inc. — Q4 2025 Earnings Call
1. Management Discussion
Good morning -- good afternoon, ladies and gentlemen. My name is Sherry, and I will be your conference call operator today. [Operator Instructions] As a reminder, this call is being recorded.
I would now like to turn the conference over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. You may begin your conference.
Thank you, Sherry. Good afternoon, and welcome to Puma's conference call to discuss our earnings results for the fourth quarter and full-year 2025.
Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of Puma Biotechnology; Maximo Nougues, Chief Financial Officer; Heather Blaber, Senior Vice President of Marketing; and Roger Storms, Senior Vice President of Sales.
After the close today, Puma issued a news release detailing earnings results for fourth quarter 2025. That news release, the slides that Roger will refer to and a webcast of this call are accessible via the homepage and Investors sections of our website at pumabiotechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days.
Today's conference call will include statements about Puma's future expectations, plans and prospects that constitute forward-looking statements for purposes of federal securities law. Such statements are subject to risks and uncertainties, and actual events and results may differ from those expressed in these forward-looking statements. For a full discussion of these risks and uncertainties, please review our periodic and current reports filed with the SEC from time to time, including our Annual Report on Form 10-K for the year ended December 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this live conference call, February 26, 2026. Puma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law.
During today's call, we may refer to certain non-GAAP financial measures that involve adjustments to our GAAP figures. We believe these non-GAAP metrics may be useful to investors as a supplement to, but not a substitute for our GAAP financial measures. Please refer to our fourth quarter 2025 earnings release for a reconciliation of our GAAP to non-GAAP results.
I will now turn the call over to Alan.
Thank you, Mariann, and thank you all for joining our call today.
PUMA reported total revenue for the fourth quarter of 2025 of $75.5 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales as well as royalties from our sub-licensees. Product revenue net was $59.9 million in the fourth quarter of 2025, an increase from the $51.9 million reported in Q3 2025 and an increase from the $54.4 million reported in Q4 2024. As a reminder to investors, Puma's reported NERLYNX sales include both U.S. net sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex-U.S. partners.
Product revenue for the fourth quarter of 2025 was impacted by approximately $5.7 million of inventory build at our specialty pharmacies and specialty distributors. Royalty revenue was $15.6 million in the fourth quarter of 2025 compared to $2.6 million in Q3 2025 and $4.7 million in Q4 2024. We reported 3,298 bottles of NERLYNX sold in the fourth quarter of 2025, an increase of 349 from the 2,949 bottles sold in Q3 2025.
In Q4 2025, we estimate that inventory increased by approximately 343 bottles. In Q4 2025, new prescriptions were down approximately 11.4% compared to Q3 2025 and total prescriptions were up approximately 1.4% compared to Q3 2025. Roger will provide additional details in his comments and slides.
I will now provide a clinical review of the quarter, and then Heather Blaber and Roger Storms will add additional color on NERLYNX commercial activities. Maximo Nougues will follow with highlights of the key components of our financial statements for the fourth quarter of 2025. And as investors are aware, Puma currently has 2 ongoing Phase II trials of alisertib. One is the ALISCA-Breast1 trial, a Phase II trial of alisertib in combination with endocrine treatment in patients with HER2-negative, hormone receptor positive recurrent or metastatic breast cancer; and number two, ALISCA-Lung1, a Phase II trial looking at the efficacy of alisertib monotherapy in patients with small cell lung cancer.
As a reminder, the ALISCA-Breast1 trial investigates alisertib in combination with endocrine treatment, consisting of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen in patients with HER2-negative, hormone receptor positive recurrent or metastatic breast cancer. Patients must be chemotherapy naive in the recurrent or metastatic setting, have had prior treatment with a CDK4/6 inhibitor and received at least 2 prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial.
Patients are being dosed with alisertib at either 30, 40 or 50 milligrams twice daily BID on days 1 to 3, 8 to 10 and 15 to 17 on a 28-day cycle in combination with the endocrine therapy of the investigator's choice. Patients must not have been previously treated with the endocrine treatment in the metastatic setting that will be given in combination with alisertib in the trial. The primary endpoint for the trial includes objective response rate, duration of response, disease control rate and progression-free survival.
As a secondary objective, the company will be evaluating each of these efficacy endpoints within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better activity as has been seen in pre-clinical and clinical studies in other cancers, including breast and small cell lung cancer. Depending on the outcome of the data, the company will then look to focus the future clinical development of alisertib in combination with endocrine therapy for patients with HER2-negative, hormone receptor-positive breast cancer in these biomarker-specific patient population or in the broader population of interest.
The trial was initiated in late November 2024. There are currently 35 sites in the U.S. and 18 sites in Europe that have been activated for the trial, and the trial is enrolling ahead of expectations. The trial was originally designed to enroll 150 patients and was originally anticipated to achieve full enrollment in December 2026. As we have previously reported, enrollment in the trial has occurred faster than expected, and we, therefore, reached 150 patients enrolled in February 2026. There are currently 164 patients enrolled in the trial and 15 additional patients in screening. Screening in the study is now closed.
We anticipate that the interim data from this trial will be available in Q2 of 2026. Per the study protocol, the interim safety and efficacy analysis will be done after approximately 75 patients have been randomized and have completed at least 2 tumor assessments or have documented disease progression or death. With respect to ALISCA-Lung1, as investors are aware, Puma has ongoing Phase II of our investigational drug, alisertib, to investigate the efficacy of alisertib monotherapy in patients with small cell lung cancer and to specifically look at the efficacy of the drug in patients with biomarkers where the Aurora Kinase pathway plays a role.
The goal is to correlate the efficacy in these biomarker subgroups in the ALISCA-Lung1 study to the efficacy that was previously seen in the biomarker subgroups from the randomized trial of paclitaxel plus alisertib versus paclitaxel plus placebo that was published in the Journal of Thoracic Oncology in 2020. In that randomized trial, a progression-free survival benefit and overall survival benefit was seen in patients with biomarkers that correlate with Aurora Kinase pathway.
If the efficacy and biomarker data are comparable from the 2 studies, the company would look to engage the FDA to discuss the regulatory path further. As discussed on the recent earnings call, the company believes that the data obtained to date in the ALISCA-Lung1 study is providing a preliminary indication of potentially better activity in patients with biomarkers where the Aurora Kinase pathway plays a role.
The most recent analysis of pharmacokinetic data from ALISCA-Lung1 suggests that we are seeing lower PK of alisertib in the ALISCA-Lung1 trial compared to the previous Phase II study of alisertib monotherapy in small cell lung cancer patients that was published in Lancet Oncology. The company amended the protocol for the trial to increase the dose of alisertib from 50-milligram BID to 60-milligram BID, which the company believes will increase the PK of the drug to levels closer to what was seen in the prior Phase II.
The company is currently enrolling patients at the 60-milligram dose. There are currently 79 patients enrolled in the trial, with 27 of these enrolled at the 60-milligram BID dose and additional 3 patients in screening. Based on a preliminary review of the data from the 60-milligram cohort, the company believes that the safety of the 60-milligram dose is acceptable, and the company is in the process of submitting a protocol amendment to the FDA to increase the dose to 70 milligrams in the trial.
Separately, Puma also plans to initiate a second trial of alisertib in small cell lung cancer, where the drug will be given in combination with paclitaxel, similar to the previously mentioned trial that was published in the Journal of Thoracic Oncology. The company will provide investors with further information on this trial in the future. The company anticipates that it will have additional interim data from the ALISCA-Lung1 study in the second quarter of 2026. As per the trial protocol, this interim analysis will include safety and efficacy data from approximately 60 patients that have been enrolled in the trial and have completed at least 2 tumor assessments or have documented disease progression or death.
As mentioned on prior earnings calls and in response to investor questions, Puma continues to evaluate several drugs to potentially in-license or acquire that would allow the company to diversify itself and leverage the company's existing R&D, regulatory and commercial infrastructure. The company will keep investors updated on this as it progresses.
I will now turn the call over to Heather Blaber for an update on our marketing initiatives. Roger Storms will follow with a review of our commercial performance during the quarter.
Thanks, Alan.
I appreciate the opportunity to share some additional insights into our marketing strategy. The marketing team is focused on creating awareness of both clinical data for NERLYNX, as well as reinforcing the continued unmet need in HER2-positive early-stage breast cancer after adjuvant therapy. We continue to invest in market research to help us better understand and validate the most effective ways to communicate this data with health care professionals through both personal and non-personal promotion.
Our strategy is focused on increasing awareness of our dual-indication in HER2-positive breast cancer. We believe NERLYNX plays an important role in the early stage by reducing the risk of recurrence and in the metastatic setting by helping protect against progression. Not only do physicians who have experience with NERLYNX continue to identify appropriate patients, but we continue to adopt new prescribers year-over-year who recognize the unmet need and how NERLYNX can help their patients.
In summary, we are excited about the potential to engage with more oncologists and support their patients diagnosed with HER2-positive breast cancer.
I will now turn the call over to Roger Storms to provide an overview on the commercial performance for the fourth quarter.
Thank you, Heather, and thanks to everyone for joining our fourth quarter earnings call. Before I move into the commercial review, just a reminder that I'll be making forward-looking statements.
Sales team remains focused on expanding overall HCP reach and frequency, with a strong emphasis on driving engagements when treatment decisions are being made. Q4 2025 call activity increased 23% year-over-year and decreased 13% quarter-over-quarter. The year-over-year increase is a direct result of continued emphasis put on executional excellence and increased field accountability and the quarter-over-quarter decrease was due to increased number of vacant territories as well as fewer opportunities with HCPs due to the holidays in Q4. I expect call activity to continue to improve as we fill vacancies.
The commercial team continues to prioritize increasing the use of NERLYNX, with a main focus on patients at higher risk of recurrence. They are also dedicated to enhancing clinical education and engaging through non-personal promotional efforts as well as utilizing patient resources to support persistence and compliance during NERLYNX therapy.
Let me now transition to some of the commercial slides where I'll provide some additional specifics around performance. Slide 3 is an illustration of our distribution model, which is broken out into the specialty pharmacy channel and the specialty distributor or in-office dispensing channel. In regards to the overall distribution of our business, in Q4 2025, about 63% of our business was purchased through the SP channel and the remaining 37% was purchased through the SD channel. We continue to see stronger growth in the SD channel driven by 2 main factors: one, increased sales in the group purchasing organizations, or GPO segment; and two, increasing 340B purchasing.
Turning to Slide 4. NERLYNX net product revenue in Q4 2025 was $59.9 million, which represents an increase of $8 million from the $51.9 million we reported in Q3 2025 and an increase of $5.5 million from the $54.4 million we reported in Q4 of 2024. As a reminder to investors, Puma's reported NERLYNX sales include both U.S. net sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex-U.S. partners.
Please note that in Q4 2024, we reported product supply revenue to our international partners of about $840,000 versus the $4.7 million in Q4 of 2025. Therefore, U.S. net sales of NERLYNX in Q4 2025 were $55.2 million versus $53.5 million in Q4 of 2024. I will provide some more details around inventory changes, and Maximo will provide some additional specifics around gross to net expenses during his update. In Q4 2025, we estimate that inventory increased by about $5.7 million. As a comparator, we estimate that inventory increased by about $3.1 million in Q3 of 2025 and increased by about $3.7 million in Q4 of 2024.
Slide 5 shows Q4 2025 ex-factory bottle sales and also provides a year-over-year and quarter-over-quarter comparison. In Q4 2025, NERLYNX ex-factory bottle sales were 3,298, which represents an approximate 12% increase quarter-over-quarter and an 11% increase year-over-year. Inventory declined for the first 2 quarters, but increased in Q3 of 2025 and Q4 of 2025.
Similar to the prior slide, let me specifically call out the inventory changes from a bottle perspective. In Q4 2025, we estimate that inventory increased by 343 bottles. As a comparator, we estimate that inventory increased by 182 bottles in Q3 of 2025 and increased by 205 bottles in Q4 of 2024.
Let me take a moment to provide some additional metrics regarding our fourth quarter performance. In Q4, we saw enrollments declined by about 5% quarter-over-quarter and declined by about 3% year-over-year. New patient starts or NRxs followed a similar pattern, declining approximately 11% quarter-over-quarter and declining about 6% year-over-year.
Turning to total prescriptions or TRxs. We saw TRx increase about 2% quarter-over-quarter and decline about 6% year-over-year. Finally, let me share some specifics around demand. In Q4 2025, we saw demand increase by about 7% quarter-over-quarter and about 7% year-over-year. As mentioned earlier, we have seen stronger demand growth in the SD channel, where we saw SD grow by about 17% quarter-over-quarter and about 46% year-over-year.
Slide 6 highlights the quarterly adoption of dose escalation since the launch of NERLYNX. In Q4 2025, approximately 75% of patients started NERLYNX at a reduced dose. This is lower compared to the 77% we reported in Q3 of 2025. Continued messaging and adoption of dose escalation remains an important commercial priority. Patients who start on NERLYNX utilizing dose escalation have better persistence and compliance. We believe dose escalation, coupled with patient education resources will give patients better support throughout their NERLYNX therapy and ultimately, help them reduce the risk of recurrence.
Slide 7 highlights the strategic collaborations we have formed across the globe. In Q4 of 2025, NERLYNX was launched in Algeria in the extended adjuvant setting. Most recently, in Q1 of 2026, NERLYNX was launched in Thailand also in the extended adjuvant setting. We really appreciate the excellent work being done by our partners around the world and look forward to supporting their continued success moving forward.
I'll close by sharing my sincere appreciation for the entire Puma team and their steadfast commitment to supporting patients and families affected by breast cancer. This disease is truly devastating. And while meaningful progress has been made, we know there is still important work ahead and even more we can accomplish together.
I will now turn the call over to Maximo for a review of our financial results.
Thanks, Roger.
I will begin with a brief summary of our financial results for the fourth quarter of 2025. Please note that I will make comparisons to Q3 2025, which we believe is a better indication of our progress as a commercial company and year-over-year comparisons. For more information, I recommend that you refer to our 2025 10-K, which will be filed today and includes our consolidated financial statements.
For the fourth quarter of 2025, we reported net income based on GAAP of $13.4 million, or $0.20 (sic) [ $0.27 ] per share -- basic share and $0.26 per diluted share. This compares to net income in Q3 2025 of $8.8 million, or $0.18 per basic share and $0.17 per diluted share. The fourth quarter of 2025 included a net change in valuation allowance that unfavorably impacted net income by $3.2 million.
On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $15.1 million, or $0.30 per basic share and $0.29 per diluted share for the fourth quarter of 2025. Gross revenue from NERLYNX sales was $82.9 million in Q4 2025 and $70 million in Q3 2025. As Alan mentioned, net product revenue from NERLYNX sales was $59.9 million, an increase from the $51.9 million reported in Q3 2025 and an increase versus the $54.4 million reported in Q4 2024.
As a reminder to investors, Puma's reported NERLYNX sales include both U.S. net sales of NERLYNX and product supply revenue of NERLYNX to Puma's ex-U.S. partners. Please note that in Q4 2025, we reported product supply revenue to our international partners of about $4.7 million. Therefore, U.S. net sales of NERLYNX in Q4 2025 were $55.2 million versus $51.8 million in Q3 2025. The increase in Q4 2025 net revenue versus Q3 2025 was driven primarily by an increase in NERLYNX demand and inventory build of $5.7 million, offset by higher gross to net expense.
Royalty revenue totaled $15.6 million in the fourth quarter of 2025 compared to $2.6 million in Q3 2025. The increase in royalty was driven by the shipment to our partner in China. Our gross to net adjustment in Q4 2025 was about 27.8% and 25.9% in Q3 2025. The increase on gross to net was driven mostly by higher Medicare and Medicaid share and higher government chargebacks.
Cost of sales for Q4 2025 was $23.2 million and includes $2.4 million for the amortization of intangible assets related to our neratinib license. Cost of sales for Q3 2025 was $12.2 million. Going forward, we will continue to recognize amortization of milestones to the licensor about $2.4 million per quarter as cost of sales.
For fiscal year 2026, Puma anticipates that net NERLYNX product revenue will be in the range of $194 million to $198 million. We also anticipate that our gross to net adjustment for the full-year 2026 will be between 27.5% and 28.5%, significantly higher than 2025 as we expect high government chargebacks and Medicare and Medicaid share to maintain in the same levels we saw in the last quarters of 2025.
In addition, for fiscal year 2025, we anticipate receiving royalties from our partners around the world in the range of $20 million to $23 million. We don't expect any license revenue in 2025. We also expect that net income for the full year will be in the range of $10 million to $13 million. The current guidance does not include any potential release of any additional tax asset valuation allowance in our net income estimate. The company is reviewing its deferred tax assets as part of its ongoing tax valuation analysis and has not yet determined whether any adjustments will be required or if so, the potential timing or size of such an adjustment. We will continue to keep investors updated as it progresses.
At this time, we do not believe that tariffs imposed or proposed to be imposed by the United States, particularly with other countries, will have a material impact on our product cost or results of operations. However, shift in trade policies in the United States and other countries have been rapidly evolving and are difficult to predict. As a point of reference, our manufacturing product costs account for a mid- to high single-digit percentage of our total cost of goods sold.
We anticipate that for Q1 2026, NERLYNX product revenue, net, will be in the range of $36 million to $39 million. Please note that the Q1 net product revenue is usually the lowest quarter of the year as we often see inventory burn off from our distribution channel. We expect Q1 royalty revenue will be in the range of $2 million to $3 million and no license revenue. We further estimate that the gross to net adjustment in Q1 2026 will be approximately 29.5% to 30.5%. Puma anticipates a Q1 net loss of $8 million -- between -- sorry, between $8 million and $10 million.
SG&A expenses were $18.4 million in the fourth quarter of 2025 compared to $16.8 million in the third quarter. SG&A expenses included non-cash charges for stock-based compensation of $1 million for Q4 and $1.1 million for Q3 2025. Research and development expenses were $16.8 million in the fourth quarter of 2025 and $15.9 million in the third quarter. R&D expenses included non-cash charges for stock-based compensation of $0.7 million in the fourth quarter of 2025, unchanged from the third quarter.
On the expense side, Puma anticipates higher than operating expenses in 2026 compared to 2025. More specifically, we anticipate SG&A expenses to increase by 3% to 5%, and R&D expenses to increase by 30% to 35% year-over-year. The higher increase in R&D is driven by the progress of our clinical trials.
In the fourth quarter of 2025, Puma reported cash burn of approximately $3.1 million. This compares to cash burn of approximately $1.6 million in Q3. Please note that during Q4, we made our seventh quarterly principal loan payment of $11.1 million related to our obligation with Athyrium. As a result of this, our total outstanding principal debt balance decreased to approximately $22 million.
At December 31, 2025, we had approximately $97.5 million in cash, cash equivalents and marketable securities versus about $101 million at year-end in 2024. Our accounts receivables balance was $53.7 million. Our accounts receivable terms range between 10 and 68 days, while our days sales outstandings are about 48 days. We estimate that as of December 31, 2025, our distribution network maintained approximately 4.5 weeks of inventory. Overall, we continue to deploy our financial resources to focus on the commercialization of NERLYNX, the development of alisertib and controlling our expenses.
Thanks, Maximo.
On past earnings calls, we have stressed that Puma's senior management in cooperation with the Board of Directors continues to remain focused on NERLYNX sales trends and recognizes its fiscal responsibility to shareholders to continue to maintain positive net income. We are pleased to achieve positive net income for the full-year 2025, which marks the third consecutive year of profitability for the company.
We believe that the positive net income that the company is guiding to for the full-year 2026 is resulting from the continued financial discipline across the company over the last few years. The company remains committed to continuing to achieve this positive net income, and we'll continue to reduce expenses if needed to achieve this.
We look forward to updating investors on this in the future. There continues to remain a significant unmet need for patients battling breast cancer, lung cancer and other solid tumors. We at Puma are committed and passionate about finding more effective ways of helping these patients during their journey, and we will continue to strive to achieve that goal.
This concludes today's presentation. We will now turn the call back to the operator for Q&A.
[Operator Instructions] Our first question is from Salvatore Caruso with TD Cowen.
2. Question Answer
This is Salvatore Caruso on behalf of Marc Frahm over at TD Cowen. Great presentation. Just one quick question. Can you maybe speak to some of the dynamics around the inventory build this fourth quarter as well as how it relates to build in previous quarters? Is there any sort of overall trend that you're starting to see, and kind of what can we expect going forward?
So, Salvatore, this is Alan. We tend to always see an inventory build at the end of the quarter -- at the end of the year, especially in the fourth quarter. This has been since launch. A lot of the reason for that is that there's an assumption that you're going to take a price increase at the beginning of the year. So, we perceive the reason they're doing that is to get in on that to buy before you do the price increase.
Maximo, if you want to speak to a little more on the logistics there?
Yes. As Alan mentioned, we usually see that in Q4, and that's what we called out in terms of the increase that we saw in terms of the number of units and the net product sales in the U.S. We also -- when we provided guidance for Q1, we usually see a decrease or the burn off of that inventory. Thus, our Q1 guidance is usually on the lower end in terms of the quarter-by-quarter comparison.
Yes. So, Salvatore, what you usually see is the -- we see the -- and again, we're near 9 of launch here. So, we've got a lot of history. We saw the inventory burn off -- we see the inventory buildup in Q4, and it burns off in the first quarter.
This concludes our question-and-answer session. I would like to turn the conference back over to Mariann for closing remarks.
Thank you all for joining us today.
As a reminder, this call may be accessed via replay of the webcast at pumabiotechnology.com beginning later today. Have a good evening.
Thank you. This does conclude today's conference. You may disconnect at this time, and thank you for your participation.
Puma Biotechnology, Inc. — Q4 2025 Earnings Call
Puma Biotechnology, Inc. — Q3 2025 Earnings Call
1. Management Discussion
Good afternoon. My name is Julian, and I will be your conference call operator today. [Operator Instructions] as a reminder, this call is being recorded. I would now like to turn the conference call over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. Thank you. You may begin.
Thank you, Julian. Good afternoon, and welcome to Puma's conference call to discuss our earnings results for the third quarter of 2025. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of Puma Biotechnology; Maximo Nougues, Chief Financial Officer; Heather Blaber, Senior Vice President of Marketing; and Roger Storms, Senior Vice President of Sales. After the close today, Puma issued a news release detailing earnings results for third quarter 2025. That news release, the slides that Roger will refer to and a webcast of this call are accessible via the homepage and Investors section of our website at pumabiotechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days.
Today's conference call will include statements about Puma's future expectations, plans and prospects that constitute forward-looking statements for purposes of federal securities laws. Such statements are subject to risks and uncertainties, and actual events and results may differ from those expressed in these forward-looking statements. For a full discussion of these risks and uncertainties, please review our periodic and current reports filed with the SEC from time to time, including our annual report on Form 10-K for the year ended December 31, 2024.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this live conference call, November 6, 2025. Puma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law. During today's call, we may refer to certain non-GAAP financial measures that involve adjustments to our GAAP figures. We believe these non-GAAP metrics may be useful to investors as a supplement to, but not a substitute for, our GAAP financial measures. Please refer to our third quarter 2025 earnings release for a reconciliation of our GAAP to non-GAAP results. I will now turn the call over to Alan.
Thank you, Mariann , and thank you all for joining our call today. Today, Puma reported total revenue for the third quarter of 2025 of $54.5 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales as well as royalties from our sub-licensees. Product revenue net was $51.9 million in the third quarter of 2025, an increase from $49.2 million reported in Q2 2025 and a decrease from $56.1 million reported in Q3 2024.
As a reminder to investors, Puma reported NERLYNX sales includes both U.S. net sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex-U.S. partners. Please note that in Q3 2024, we reported product supply revenue to our international partners of about $7.4 million versus $0.1 million in Q3 2025. Therefore, U.S. net sales of NERLYNX in Q3 2025 were $51.8 million versus $48.8 million in Q3 2024.
Product revenue for the third quarter of 2025 was impacted by approximately $3.1 million of inventory build in our specialty pharmacies and specialty distributors. Royalty revenue was $2.6 million in the third quarter of 2025 compared to $3.2 million in Q2 2025 and $24.4 million in Q3 2024. Q3 2024 royalty revenue included sales to China by our offshore partner, Pierre Fab.
We reported 2,949 bottles of NERLYNX sold in the third quarter of 2025, an increase of 341 from the 2,608 bottles sold in Q2 2025. In Q3 2025, we estimate that inventory increased by 172 bottles. In Q3 2025, new prescriptions were down approximately 3% compared to Q2 2025 and total prescriptions were down approximately 1% compared to Q2 2025. Roger will provide further details in his comments and slides.
I will now provide a clinical review of the quarter, then Heather Blaber and Roger Storms will add additional color on NERLYNX commercial activities. Maximo Nougues will follow with highlights of the key components of our financial statements for the third quarter of 2025. As investors are aware, Puma currently has 2 ongoing Phase II trials of our investigational drug, alisertib, ALISCA-Breast1, which is a Phase II trial of alisertib in combination with endocrine treatment in patients with HER2-negative hormone receptor-positive breast cancer; and ALISCA-Lung1, a Phase II trial looking at the efficacy of alisertib monotherapy in patients with small cell lung cancer.
As a reminder, the ALISCA-Breast1 trial investigates alisertib in combination with endocrine treatment, which consists of either an anastrozole, exemestane, letrozole, fulvestrant or tamoxifen in patients with HER2-negative hormone receptor-positive metastatic breast cancer. Patients must be chemotherapy naive, have been previously treated with a CDK4/6 inhibitor and received at least 2 prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial.
Patients are being dosed with alisertib given at either 30 milligrams, 40 milligrams or 50 milligrams twice daily BID on days 1 to 3, 8 to 10 and 15 to 17 on a 28-day cycle in combination with the endocrine therapy and investigator choice. Patients must not have been previously treated with the endocrine treatment in the metastatic setting that will be given in combination with alisertib in the trial. The primary efficacy endpoints include objective response rate, duration of response, disease control rate and progression-free survival.
As a secondary objective, the company will be evaluating each of these efficacy biomarkers within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better efficacy and has been -- as has been seen in preclinical and clinical studies in other cancers, including breast cancer and small cell lung cancer. The company will then look to focus the future clinical development of alisertib in combination with endocrine therapy for patients with HER2-negative hormone receptor positive breast cancer with these biomarkers.
The trial was initiated in late November 2024. There are currently 34 sites in the U.S. and 18 sites in Europe that have been activated for the trial, and the trial is enrolling ahead of expectations. There are currently 98 patients enrolled in the trial and 14 additional patients in screening. Due to the faster-than-expected enrollment in the trial, the former interim analysis was triggered sooner than expected. We anticipate that the formal interim analysis will be completed in the first half of 2026 and look forward to sharing this with investors at that time. With respect to the ALISCA-Lung study -- the ALISCA-Lung is a Phase II study of our investigational drug alisertib to investigate the efficacy of alisertib monotherapy in patients with small cell lung cancer and to specifically look at the efficacy of the drug in patients with biomarkers where the aurora kinase pathway plays the role.
The goal is to correlate the efficacy in these biomarker subgroups in the ALISCA-Lung1 study to the efficacy that was previously seen in the biomarker subgroups from the randomized trial of paclitaxel plus alisertib versus paclitaxel plus placebo that was published in the Journal of Thoracic Oncology in 2020. In that randomized trial, a progression-free survival benefit and overall survival benefits were seen in patients with biomarkers, which correlate with the aurora kinase pathway.
If the efficacy and biomarker data are comparable from the 2 studies, the company would look to engage the FDA to discuss the regulatory path further. As discussed on the recent earnings call, the company believes the data obtained to date from the ALISCA-Lung1 is providing a preliminary indication of potentially better activity in patients with biomarkers where the aurora kinase plays a role. The most recent analysis of the PK data from the ALISCA-Lung suggests that we are seeing lower PK of alisertib in the ALISCA-1 study compared to the previous Phase II of alisertib monotherapy in small cell lung cancer patients that was published in Lancet Oncology.
The company has amended the protocol for the trial to increase the dose of alisertib from 50 milligrams BID to 60 milligrams BID, which the company believes will increase the PK of the drug to levels closer to what was seen in the prior Phase II. The company is currently enrolling patients at the 60-milligram dose -- 60-milligram BID dose. There are currently 61 patients in the trial with 9 of these patients enrolled at the 60-milligram BID dose and additional 2 patients in screening.
Assuming the safety at the 60-milligram dose is acceptable, the company plans to meet with the FDA in order to amend the protocol to continue to dose escalate to 70 milligrams BID. The company looks to have additional interim data from this trial in the first half of 2026. As mentioned on prior earnings calls and in response to investor questions, Puma continues to evaluate several drugs to potentially in-licensed or acquire that would allow the company to diversify itself and leverage Puma's existing R&D, regulatory and commercial infrastructure. The company will keep investors updated on this as it progresses. I will now turn the call over to Heather Blaber for an update on our marketing initiatives. Roger Storms will follow with a review of our commercial performance during the quarter.
Thank you, Alan. I appreciate the opportunity to share some additional insights into our marketing strategy. The marketing team is focused on creating awareness of both clinical messaging for NERLYNX as well as recently published data that demonstrate the continued need to reduce the risk of recurrence in HER2-positive early breast cancer after treatment with adjuvant therapy.
We continue to invest in market research to help us better understand risk factors that put a patient at high risk of recurrence in HER2-positive early-stage breast cancer as well as Garner Insights on the NERLYNX clinical data in this patient population. Together with our marketing initiatives, our strategy is focused on increasing awareness of our broad indication of patients that are appropriate for treatment with NERLYNX. We have adjusted our strategy based on our learnings and revised both personal and nonpersonal messaging with the goal of engaging physicians on a broader set of patients where the risk of recurrence still remains high and where we believe NERLYNX can play an important role in helping to reduce the risk of recurrence in patients with early-stage HER2-positive breast cancer.
In addition to revising our messaging, we have a new resource to support patients throughout their recommended course of NERLYNX therapy. This educational resource is provided to patients on a monthly basis with the goal of improving patient adherence as they receive their refills. Lastly, year-to-date, we have reached 99.7% of oncologists through nonpersonal promotion and continue to expand our share of voice, working closely with the sales team to increase engagement with health care providers.
In summary, we are excited about our new marketing strategy and messaging, which we believe will continue to help educate and engage oncologists on the unmet need for those diagnosed with HER2-positive early breast cancer. I will now turn the call over to Roger Storms to provide an overview on the commercial performance for the third quarter.
Thank you, Heather, and thanks to everyone for joining our third quarter earnings call. Before I move into the commercial review, just a reminder that I'll be making forward-looking statements. The sales team remains focused on expanding overall HCP reach and frequency with a strong emphasis on driving engagement at key treatment decision points.
In Q3 2025, call activity increased 22% year-over-year and increased 17% quarter-over-quarter. This is a direct result of continued emphasis put on executional excellence and increased accountability with the existing sales team. I expect call activity to continue to improve as we fill vacancies. The commercial team continues to prioritize increasing use of NERLYNX with the main focus on patients at higher risk of recurrence.
They are also dedicated to enhancing clinical education and engagement through nonpersonal promotional efforts as well as utilizing patient resources to support persistence and compliance during NERLYNX therapy. Let me now transition to some of the commercial slides where I'll provide some additional specifics around performance. Slide 3 is an illustration of our distribution model, which is broken out into the specialty pharmacy channel and the specialty distributor or in-office dispensing channel.
In regards to overall distribution of our business, in Q3 2025, about 65% of our business was purchased through the SP channel and the remaining 35% was purchased through the SD channel. We are seeing some stronger growth in the SD channel driven by 2 main factors: one, increased sales in the group purchasing organization segment; and two, increased 340B purchasing.
Turning to Slide 4. NERLYNX net product revenue in Q3 2025 was $51.9 million, which represents an increase of $2.7 million from the $49.2 million we reported in Q2 2025 and a decrease of $4.2 million from the $56.1 million we reported in Q3 of 2024. As a reminder to investors, Puma's reported NERLYNX sales includes both U.S. sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex-U.S. partners.
Please note that in Q3 2024, we reported product supply revenue to our international partners of about $7.4 million versus the $0.1 million in Q3 of 2025. Therefore, U.S. net sales of NERLYNX in Q3 2025 were $51.8 million versus the $48.8 million in Q3 of 2024. I will provide some more details around inventory changes, and Maximo will provide some additional specifics around gross to net expenses during his update.
In Q3 of 2025, we estimate that inventory increased by about $3.1 million. As a comparator, we estimate that inventory decreased by about $1.3 million in Q2 of 2025 and increased by about $0.7 million in Q3 of 2024. Slide 5 shows Q3 2025 ex-factory bottle sales and also provides both a year-over-year and a quarter-over-quarter comparison. In Q3 2025, NERLYNX ex-factory bottle sales were 2,949, which represents an approximate 13% increase quarter-over-quarter and an 8% increase year-over-year.
Inventory declined for the first 2 quarters, but increased in Q3 of 2025. Similar to the prior slides, let me specifically call out the inventory changes from a bottle perspective. In Q3 2025, we estimate that inventory increased by 172 bottles. As a comparator, we estimate that inventory decreased by 85 bottles in Q2 of '25 and increased by 39 bottles in Q3 of 2024. Let me take a moment to provide some additional metrics regarding our second quarter performance. In Q3, we saw enrollments increase by about 6% quarter-over-quarter and decline about 6% year-over-year. New patient starts or NRx follow a similar pattern, increasing 3% quarter-over-quarter and declining about 1% year-over-year.
Turning to total prescriptions or TRx, -- we saw TRx decline about 1% quarter-over-quarter and decline about 4% year-over-year. Finally, let me share some specifics around demand. In Q3 2025, we saw demand increased by about 3% quarter-over-quarter and about 3% year-over-year. As mentioned earlier, we have seen stronger demand growth in the SD channel where we saw SD demand grow by about 11% quarter-over-quarter and about 25% year-over-year.
Slide 6 highlights the quarterly adoption of dose escalation since NERLYNX launch. In Q3 2025, approximately 77% of patients started NERLYNX at a reduced dose. This is higher compared to the 71% we reported in Q2 2025. Continued messaging and adoption of dose escalation remains an important commercial priority. Patients who are started on NERLYNX utilizing dose escalation have better persistence and compliance. We believe dose escalation, coupled with the new patient education resources will give patients better support throughout their NERLYNX therapy and ultimately help them reduce the risk of recurrence. Slide 7 highlights the strategic collaborations we formed across the globe. We really appreciate the excellent work being done by our partners around the world and look forward to supporting their continued success moving forward.
Let me close by expressing my heartfelt gratitude to the entire Puma team for their unwavering passion and dedication to supporting patients and families affected by breast cancer. This disease can be devastating, and we recognize there is still more work to do and more that can be done. I will now turn the call over to Maximo for a review of our financial results.
Thanks, Roger. I will begin with a brief summary of our financial results for the third quarter of 2025. Please note that I will make comparisons to Q2 2025, which we believe is a better indication of our progress as a commercial company than year-over-year comparisons. For more information, I recommend that you refer to our third quarter 2025 10-Q, which will be filed today and includes our consolidated financial statements. For the third quarter of 2025, we reported net income based on GAAP of $8.8 million or $0.18 per basic share and $0.17 per diluted share. This compares to net income in Q2 2025 of $5.9 million or $0.12 per share.
On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $10.5 million or $0.21 per basic and diluted share for the third quarter of 2025. Gross revenue from NERLYNX sales was $70 million in Q3 2025 and $62.1 million in Q2 2025. As Alan mentioned it, net product revenue from NERLYNX sales was $51.9 million, an increase from the $49.2 million reported in Q2 2025 and a decrease versus the $56.1 million reported in Q3 2024.
As a reminder to investors, Puma reported NERLYNX sales include both U.S. net sales of NERLYNX and product supply revenue of NERLYNX to Puma's ex-U.S. partners. Please note that in Q3 2024, we reported product supply revenue to our international partners of about $7.4 million versus $0.1 million in Q3 2025. Therefore, U.S. net sales of NERLYNX in Q3 2025 were $51.8 million versus $48.8 million in Q3 2024. The increase in Q3 2025 net revenue versus Q2 2025 was driven primarily by an increase in NERLYNX bottles sold in the U.S., inventory build of $3.1 million, offset by a higher gross to net expense. Inventory build by our distributors was approximately $3.1 million in Q3 versus drawdown of approximately $1.3 million in Q2 2025.
Royalty revenue totaled $2.6 million in the third quarter of 2025 compared to $3.2 million in Q2 2025. Our gross to net adjustment in Q3 2025 was about 25.9% and 20.8% in Q2 2025. The increase on gross to net was driven mostly by a higher-than-expected Medicare rebate driven by the Inflation Reduction Act implemented in Q4 of 2022 and higher Medicaid share.
Cost of sales for Q3 2025 was $12.2 million and includes $2.4 million for the amortization of intangible assets related to our neratinib license. Cost of sales for Q2 2025 was $12.3 million. Going forward, we will continue to recognize amortization of the milestones to the licensor about $2.4 million per quarter as cost of sales. For fiscal year 2025, Puma anticipates that net NERLYNX product revenue will be in the range of $198 million to $200 million, higher than our prior guidance.
We also anticipate that our gross to net adjustment for the full year 2025 will be between 23% and 23.5%. In addition, for fiscal year 2025, we anticipate receiving royalties from our partners around the world in the range of $22 million to $23 million, lower than 2024 due to the fewer shipments expected to China as our partner works through regulatory transitions during the first several quarters of 2025. We don't expect any license revenue in 2025. We also expect that net income for the full year will be in the range of $27 million to $29 million.
The current guidance does not include any potential release of any additional tax asset valuation allowance in our net income estimate. The company is reviewing its deferred tax assets as part of its ongoing tax valuation analysis and has not yet determined whether any adjustment will be required or if so, the potential timing or size of such an adjustment.
We will continue to keep investors updated on this as it progresses. At this time, we do not believe the tariffs imposed or proposed to be imposed by the United States, particularly with other countries, will have a material impact on our product cost or results of operations. However, shifts in trade policies in the United States and other countries have been rapidly evolving and are difficult to predict. As a point of reference, our manufacturing product cost accounts for a mid- to high single-digit percentage of our cost of goods sold. We anticipate that for Q4 2025, NERLYNX product revenue net will be in the range of $54 million to $56 million.
Please note that Q4 net product revenue guidance includes almost $4.5 million of product sales to one of our global partners as well as U.S. net revenue, which we will -- we expect to be in the range of $50 million to $52 million. The sales to our global partners will also contribute to the large royalty revenue we expect in Q4. We expect Q4 royalty revenue will be in the range of $13 million to $14 million and no license revenue.
We further estimate that the gross to net adjustment in Q4 2025 will be approximately 24% to 25%. Puma anticipates Q4 net income between $9 million and $11 million. SG&A expenses were $16.8 million in the third quarter of 2025 compared to $18 million in the second quarter. SG&A expenses included noncash charges for stock-based compensation of $1.1 million for Q3 and $1 million for Q2 2025.
Research and development expenses were $15.9 million in the third quarter of 2025 and $15.5 million in the second quarter. R&D expenses included noncash charges for stock-based compensation of $0.6 million in the third quarter of 2025, unchanged from the second quarter. On the expense side, Puma anticipates flat to slightly higher total operating expenses in 2025 compared to 2024.
More specifically, we anticipate SG&A expenses to decrease by 7% to 10% and R&D expenses to increase by 20% to 25% year-over-year. The higher increase in R&D is driven by faster enrollment in our clinical trials than previously expected. In the third quarter of 2025, Puma reported cash burn of approximately $1.6 million. This compares to cash burn of approximately $2.9 million in Q2.
Please note that during Q3, we made our sixth quarterly principal loan payment of $11.1 million related to our obligation with Athyrium. As a result of this, our total outstanding principal debt balance decreased to approximately $33 million. At September 30, 2025, we had approximately $94 million in cash, cash equivalents and marketable securities versus about $101 million at year-end 2024.
Our accounts receivables balance was $33.6 million. Our accounts receivable terms range between 10 and 68 days, while our days sales outstanding are about 50 days. We estimate that as of September 30, 2025, our distribution network maintained approximately 3.5 weeks of inventory. Overall, we continue to deploy our financial resources to focus on the commercialization of NERLYNX, the development of alisertib and controlling our expenses.
Thanks, Maximo. On past earnings calls, we have stressed that Puma's senior management in cooperation with the Board of Directors continues to remain focused on NERLYNX sales trends in 2025 and beyond and recognizes its fiscal responsibility to the shareholders to continue to maintain positive net income. We believe that this focus has contributed to our commercial execution in a positive way.
And according to our current projections, 2025 will mark the first year-over-year demand increase for NERLYNX in the United States since 2018. We are pleased to report this demand-driven growth in NERLYNX sales for the first 9 months of 2025. In addition, we believe that the positive net income that the company achieved in Q3 '25 and that the company is guiding to for the full year 2025 has resulted from the continued financial discipline across the company over the last few years. The company remains committed to continuing to achieve this positive net income, and we'll continue to reduce expenses if needed to achieve this. We look forward to updating investors on this in the future.
There continues to remain a significant unmet need for patients battling breast cancer, lung cancer and other solid tumors. We at Puma are committed and passionate about finding more effective ways of helping these patients during their journey, and we will continue to strive to achieve that goal. This concludes today's presentation. We will now turn the floor back to the operator for Q&A. Operator?
[Operator Instructions] And our first question comes from the line of Mark Frahm with TD Cowen.
2. Question Answer
Maybe just looking forward to the breast cancer interim. Just remind us what the kind of bar you're going to be kind of evaluating that with in terms of willingness to continue to spend on that indication, particularly in light to your comments in the prepared remarks of remaining committed to staying profitable.
Yes. Thanks, Marc. So there's been 2. This is going to be alisertib in combination with endocrine. You remember, there was a previous trial TBCRC41 of alisertib in combination with endocrine. And I think that's probably going to be the gauge we're looking for to see -- to compare it to those numbers. Right now, as you know, the standard of care for ER-positive HER2-negative breast cancer is first line, they get a CDK4/6 inhibitor.
Second line, depending on which mutation they have, they may get a targeted therapy or may get a different type of a combination therapy. Third line is still kind of a white space, if you will. And that's where we're focusing is in that third-line white space. So all these patients are kind of third-line endocrine, if you will. So obviously, what we would look for in terms of continued spend would really be, number one, how the efficacy compares to what we would typically expect to be standard of care in third line.
But then also assuming we're able to find a biomarker where it portends for or it predicts a better outcome to alisertib, that would obviously be quite compelling as well. So we've gotten asked that question in the past, which is, okay, you have both the breast and the lung. You want to remain profitable. As we've said in the past, and I will say again, we're happy to stagger the indications to control the burn so we can remain a profitable company.
Okay. That's helpful. But I guess the next steps could ultimately involve a larger pivotal program. Would that -- which I think would strain -- for any one of the indications might strain the ability to stay profitable. Would you be willing to go negative the data and go back to a loss if the data supports -- or does that require a partner?
Yes. So a couple of things to remember from that perspective, Marc. If you look at our guidance for our full year in terms of net income, remember, that includes us paying down our debt. The debt goes away mid next year, and we become a debt-free company. So you start to see cash flow generation occurring because of that. Now in terms of the pivotal Phase III that you would need, based on the other Phase IIIs I've seen in this space, I'm not anticipating this to be like a 1,000-patient trial or something.
So I think it would still be within a manageable number, especially given that you're not going to hit all those expenses at once, you're going to see it spaced out over time. I think it's still possible to be able to do a pivotal Phase III just based on the cash flow from NERLYNX and remaining committed to being net income positive.
With that, this does conclude today's question-and-answer session. I'd like to turn the conference back to Mariann for closing remarks.
Thank you for joining us today. As a reminder, this call may be accessed via replay at pumabiotechnology.com beginning later today. Have a good evening.
Thank you, ladies and gentlemen, thank you for participating in today's conference call. This concludes our program. Everyone, have a great day. You may now disconnect your lines.
Puma Biotechnology, Inc. — Q3 2025 Earnings Call
Financial data from Puma Biotechnology, Inc.
Revenue
Revenue is the sum of all sales generated by a company, e.g. for its products or services.
Revenue (TTM) metric explainedDirect Costs
Direct costs are the costs incurred directly in connection with the manufacture of the product or service.
Gross Profit
Gross Profit indicates how much of the revenue remains in the company after deducting direct production costs. If the percentage share of sales is calculated, this is referred to as the gross margin.
Gross Profit metric explainedSelling and Administrative Expenses
Selling, general and administrative expenses (SG&A) include all expenses for marketing and sales as well as the general administration of the company.
Research and Development Expense
Research and development costs (R&D) provide information on how much the company invests in the research and development of its products. The costs are particularly interesting as a percentage of revenue and in comparison to direct competitors.
EBITDA
EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization) is the company's earnings before interest, taxes, depreciation and amortization. The EBITDA margin is calculated as a percentage of sales.
Depreciation and Amortization
Depreciation represents reductions in the value of the company's assets (e.g. due to wear and tear on machinery).
EBIT (Operating Income)
EBIT (Earnings Before Interest and Taxes) is the company's profit before interest and taxes, also known as the operating income. The EBIT Margin is calculated as a percentage of sales at
.
Net Profit
Net Profit represents the profit or loss after deduction of all costs.
Net Profit metric explainedStocksGuide Premium
| Jun '26 |
+/-
%
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| Revenue | 231 231 |
3%
3%
100%
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| - Direct Costs | 58 58 |
12%
12%
25%
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| Gross Profit | 173 173 |
0%
0%
75%
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| - Selling and Administrative Expenses | 71 71 |
3%
3%
31%
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| - Research and Development Expense | 71 71 |
25%
25%
31%
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| EBITDA | 41 41 |
29%
29%
18%
|
|
| - Depreciation and Amortization | 10 10 |
7%
7%
5%
|
|
| EBIT (Operating Income) EBIT | 30 30 |
34%
34%
13%
|
|
| Net Profit | 27 27 |
45%
45%
12%
|
|
In millions USD.
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Puma Biotechnology, Inc. Stock News
Company Profile
Puma Biotechnology, Inc. is a development stage biopharmaceutical company. It acquires and develops innovative products for the treatment of various forms of cancer. The company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seek to further develop those drug candidates for commercial use. Puma Biotechnology was founded by Alan H. Auerbach on September 15, 2010 and is headquartered in Los Angeles, CA.
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| Head office | United States |
| CEO | Mr. Auerbach |
| Employees | 179 |
| Founded | 2010 |
| Website | www.pumabiotechnology.com |
