olivLaw · US equity research
Puma Biotechnology, Inc. PBYI
Pharmaceutical Preparations · SIC 2834 · Vertical: Pharmaceutical Preparations (SIC 2834)
Puma Biotechnology is a biopharmaceutical company in Los Angeles that sells NERLYNX, an oral HER2 inhibitor used in HER2-positive breast cancer, and is developing alisertib, a selective Aurora Kinase A inhibitor. In the second quarter of 2026 total revenue was 56.5 million USD, and the company raised its full-year revenue guidance to 224–231 million USD, keeping the sales trend of NERLYNX at the centre of attention.
At the close of 04 Nov 2026, Puma Biotechnology, Inc. (PBYI) stock was 10.69 USD (+4.60% on the day), with market capitalisation 551.8 m USD, P/E 20.5 on diluted EPS of 0.52 USD over the last 12 months, beta 0.77, 52-week range 4.73–11.26 USD. Latest reported quarter (Q2 2026): revenue of 56.5 m USD (+7.8% YoY), net income of 8.2 m USD (+39.9% YoY), diluted EPS 0.16 USD.
Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.
Price history
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Technical reading
- RSI (14)
- 56.7
- strong (55–70)
- Bollinger (20, 2)
- 9.75 – 11.23
- in the upper half of the band · %B 0.63 · band width 14.1%
- SMA 50 / 200
- 9.88 / 7.97
- uptrend (price > SMA50 > SMA200)
- MACD (12, 26, 9)
- 0.20 / 0.26
- MACD below signal
Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).
Performance
| Company | S&P 500 | vs S&P 500 | Vertical median | |
|---|---|---|---|---|
| 1 month | +10.5% | −2.0% | +12.5 pp | — |
| 3 months | +33.8% | −2.2% | +36.0 pp | — |
| 6 months | +43.5% | +4.3% | +39.2 pp | — |
| Year to date | +79.7% | +10.6% | +69.1 pp | — |
| 1 year | +118.2% | +10.5% | +107.7 pp | +16.6% |
| 3 years | +284.5% | +73.7% | +210.9 pp | +16.8% |
| 5 years | +166.6% | +61.7% | +104.9 pp | — |
Price returns, dividends excluded.
Quarterly results
Latest quarter: Q2 2026 · 30 Jun 2026
Quarterly margins
Quarterly statements · USD
| Fiscal year | Q3 '24 | Q4 '24 | Q1 '25 | Q2 '25 | Q3 '25 | Q4 '25 | Q1 '26 | Q2 '26 |
|---|---|---|---|---|---|---|---|---|
| Revenue | 80.5 m | 59.1 m | 46.0 m | 52.4 m | 54.5 m | 75.5 m | 44.8 m | 56.5 m |
| Cost of revenue | 29.1 m | 13.9 m | 10.6 m | 12.3 m | 12.2 m | 23.1 m | 10.4 m | 12.5 m |
| SG&A | 16.8 m | 16.6 m | 17.6 m | 18.0 m | 16.8 m | 18.4 m | 18.4 m | 17.5 m |
| Operating income | 22.1 m | 13.4 m | 4.0 m | 6.6 m | 9.6 m | 17.1 m | -3.8 m | 7.6 m |
| Depreciation & amortisation | 2.9 m ≈ | 2.8 m | 2.8 m | 2.8 m ≈ | 2.7 m ≈ | 2.7 m | 2.6 m | 2.5 m ≈ |
| Interest expense | 3.1 m | 2.6 m | 2.2 m | 1.8 m | 1.5 m | 1.1 m | 731.0 k | 180.0 k |
| Pre-tax income | 20.6 m | 12.2 m | 3.3 m | 6.2 m | 9.2 m | 17.1 m | -3.4 m | 8.2 m |
| Income tax | 291.0 k | -7.1 m | — | — | — | — | — | — |
| Net income | 20.3 m | 19.3 m | 3.0 m | 5.9 m | 8.8 m | 13.4 m | -3.8 m | 8.2 m |
| Diluted EPS | 0.41 | 0.39 ≈ | 0.06 | 0.12 | 0.17 | 0.26 ≈ | -0.07 | 0.16 |
| Operating cash flow | 11.0 m ≈ | 15.6 m | 3.6 m | 14.1 m ≈ | 9.7 m ≈ | 14.4 m | 15.4 m | 1.6 m ≈ |
| Capex | 20.0 k ≈ | 16.0 k | 61.0 k | 20.0 k ≈ | 26.0 k ≈ | -36.0 k | 0 | 0 ≈ |
≈ derived quarter (cumulative difference / share-days average)
E/P over time
E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.
Today's P/E sits at the 86 percentile of its own 14-quarter history (min 3.5, median 10.2, max 33.3; quarters with earnings only).
Fiscal years
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|---|
| Revenue | 251.0 m | 272.3 m | 225.1 m | 253.2 m | 228.0 m | 235.6 m | 230.5 m | 228.4 m |
| Revenue YoY | +806.6% | +8.5% | −17.3% | +12.5% | −9.9% | +3.3% | −2.2% | −0.9% |
| Net income | -113.6 m | -75.6 m | -60.0 m | -29.1 m | 2.0 k | 21.6 m | 30.3 m | 31.1 m |
| Net income YoY | unavailable | unavailable | unavailable | unavailable | unavailable | +1,079,450.0% | +40.2% | +2.8% |
| Diluted EPS | unavailable | -75,595.00 | -1.52 | -0.72 | 0.00 | 0.45 | 0.62 | 0.61 |
| Diluted EPS YoY | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | +37.8% | −1.6% |
| net % | -45.3% | -27.8% | -26.7% | -11.5% | 0.0% | 9.2% | 13.1% | 13.6% |
| Free cash flow | -24.5 m | 22.1 m | 727.0 k | 20.7 m | -15.8 m | 26.9 m | 38.9 m | 41.7 m |
Reported results vs expectations
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Balance sheet & financial health
Fiscal year 2025 · 31 Dec 2025
- Cash
- 29.6 m USD
- Financial debt
- 22.5 m USD
- Net debt
- -7.1 m USD
- Equity
- 130.3 m USD
- Total assets
- 216.3 m USD
- Debt / equity
- 0.17x
- Current ratio
- 2.00x
- ROE
- 28.0%
- ROA
- 14.5%
- FCF margin
- 18.3%
Financial statements (source on every figure)
Revenue and net income (USD)
Margins
Income statement · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Revenue | 225.1 m | 253.2 m | 228.0 m | 235.6 m | 230.5 m | 228.4 m | SEC (XBRL)· 26 Feb 2026verified |
| Cost of revenue | 39.4 m | 63.7 m | 55.1 m | 62.7 m | 64.4 m | 58.2 m | SEC (XBRL)· 26 Feb 2026verified |
| Gross profit | 185.7 m ≈ | 189.5 m ≈ | 172.9 m ≈ | 173.0 m ≈ | 166.1 m ≈ | 170.2 m ≈ | SEC (XBRL)· 26 Feb 2026derived |
| Research & development | 97.7 m | 71.9 m | — | — | — | — | SEC (XBRL)· 03 Mar 2022verified |
| SG&A | 118.5 m | 116.3 m | 90.0 m | 89.9 m | 80.2 m | 70.8 m | SEC (XBRL)· 26 Feb 2026verified |
| Operating income | -30.4 m | 1.3 m | 23.7 m | 32.6 m | 31.0 m | 37.3 m | SEC (XBRL)· 26 Feb 2026verified |
| Depreciation & amortisation | 10.0 m | 11.3 m | 9.8 m | 11.5 m | 11.5 m | 10.9 m | SEC (XBRL)· 26 Feb 2026verified |
| EBITDA | -20.4 m ≈ | 12.6 m ≈ | 33.6 m ≈ | 44.2 m ≈ | 42.5 m ≈ | 48.2 m ≈ | SEC (XBRL)· 26 Feb 2026derived |
| Interest expense | 14.0 m | 12.8 m | 11.6 m | 13.3 m | 12.5 m | 6.6 m | SEC (XBRL)· 26 Feb 2026verified |
| Pre-tax income | -59.8 m | -28.8 m | 457.0 k | 22.7 m | 24.1 m | 35.8 m | SEC (XBRL)· 26 Feb 2026verified |
| Income tax | 207.0 k | 324.0 k | 455.0 k | 1.1 m | -6.2 m | 4.7 m | SEC (XBRL)· 26 Feb 2026verified |
| Net income | -60.0 m | -29.1 m | 2.0 k | 21.6 m | 30.3 m | 31.1 m | SEC (XBRL)· 26 Feb 2026verified |
| Diluted EPS | -1.52 | -0.72 | 0.00 | 0.45 | 0.62 | 0.61 | SEC (XBRL)· 26 Feb 2026verified |
| Weighted average diluted shares | 39.6 m | 40.6 m | 44.9 m | 47.6 m | 49.1 m | 50.7 m | SEC (XBRL)· 26 Feb 2026verified |
≈ computed by olivLaw from the reported lines of the same year: Revenue − Cost of revenue; Operating income + Depreciation & amortisation.
Balance sheet · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Cash | 85.3 m | 63.1 m | 76.2 m | 84.6 m | 69.2 m | 29.6 m | SEC (XBRL)· 26 Feb 2026verified |
| Receivables | 25.5 m | 32.5 m | 40.4 m | 47.8 m | 32.0 m | 53.7 m | SEC (XBRL)· 26 Feb 2026verified |
| Inventories | 3.5 m | 7.1 m | 4.5 m | 7.1 m | 8.7 m | 5.5 m | SEC (XBRL)· 26 Feb 2026verified |
| Current assets | 146.1 m | 140.0 m | 134.3 m | 156.2 m | 147.7 m | 162.7 m | SEC (XBRL)· 26 Feb 2026verified |
| Property, plant & equipment, net | 2.5 m | 1.8 m | 1.1 m | 855.0 k | 515.0 k | 187.0 k | SEC (XBRL)· 26 Feb 2026verified |
| Intangibles (excl. goodwill) | 74.1 m | 66.1 m | 70.6 m | 60.9 m | 51.1 m | 41.4 m | SEC (XBRL)· 26 Feb 2026verified |
| Total assets | 244.2 m | 226.6 m | 222.1 m | 230.5 m | 213.3 m | 216.3 m | SEC (XBRL)· 26 Feb 2026verified |
| Accounts payable | 12.1 m | 11.2 m | 6.4 m | 6.9 m | 5.5 m | 5.1 m | SEC (XBRL)· 26 Feb 2026verified |
| Short-term debt | 14.3 m | 0 | 0 | 34.0 m | 45.3 m | 22.5 m | SEC (XBRL)· 26 Feb 2026verified |
| Long-term debt | 84.0 m | 97.1 m | 98.3 m | 65.7 m | 21.7 m | 0 | SEC (XBRL)· 26 Feb 2026verified |
| Current liabilities | 114.3 m | 109.6 m | 77.5 m | 99.4 m | 96.1 m | 81.3 m | SEC (XBRL)· 26 Feb 2026verified |
| Total liabilities | 250.2 m | 229.0 m | 200.5 m | 177.1 m | 121.2 m | 86.0 m | SEC (XBRL)· 26 Feb 2026verified |
| Equity | -6.0 m † | -2.4 m † | 21.6 m † | 53.4 m † | 92.1 m † | 130.3 m † | SEC (XBRL)· 26 Feb 2026verified |
† equity attributable to the parent's shareholders: in these years the issuer no longer reports the total including non-controlling interests.
Cash flow · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Operating cash flow | 773.0 k | 20.7 m | -15.8 m | 27.0 m | 38.9 m | 41.8 m | SEC (XBRL)· 26 Feb 2026verified |
| Capex | 46.0 k | 0 | 0 | 140.0 k | 56.0 k | 71.0 k | SEC (XBRL)· 26 Feb 2026verified |
| Free cash flow | 727.0 k ≈ | 20.7 m ≈ | -15.8 m ≈ | 26.9 m ≈ | 38.9 m ≈ | 41.7 m ≈ | SEC (XBRL)· 26 Feb 2026derived |
| Investing cash flow | 33.4 m | -10.9 m | 7.1 m | -19.1 m | -20.4 m | -36.2 m | SEC (XBRL)· 26 Feb 2026verified |
| Financing cash flow | -9.9 m | -31.9 m | 12.2 m | 0 | -33.8 m | -45.2 m | SEC (XBRL)· 26 Feb 2026verified |
≈ computed by olivLaw from the reported lines of the same year: Operating cash flow − Capex.
Computed indicators
Growth
Profitability
Returns
Balance sheet
Liquidity
Cash
Efficiency
Market and valuation
1 indicators that do not apply to the sector.
Valuation
olivLaw classification
Score: 75 / 100
A scoring methodology on indicators and valuation, not investment advice.
score >= 65 · margin_of_safety >= 0.15 · agreement in ['high', 'medium']
Closing price
04 Nov 2026Source: olivLaw, closing series
Market cap: 551.8 m USD
Key indicators
Coverage and freshness
Score by group
- Balance sheet93
- Growth0
- Valuation76
- Quality85
Estimated value range
The combined range = the median of the valid methods' low, central and high values; it is not a probability interval and does not cover every result. Envelope of all methods: 7.11 – 20.30 USD.
Valuation assumptions are editorial choices, not measured; beta is not measured.
Method ranges (USD per share)
— — Mid · ▏ Price
Valuation methods
- DCF (discounted cash flow)10.85 – 16.05 (Mid 12.88)WACC 9.3% · starting FCFF 44.1 m USD · terminal value share of EV 72%The WACC × g sensitivity gives the method's bounds; these are not probabilities.Reverse DCF: starting growth implied by the price (fading linearly to terminal growth, everything else fixed): -8.2%
- Peers: EV/EBITDA9.95 – 18.56 (Mid 13.70)4 companies used · median multiple 16.4x · quartiles 11.7x – 22.5xBHC, TEVA, VRTX, VTRS
- Peers: P/E7.11 – 20.30 (Mid 11.69)15 companies used · median multiple 22.5x · quartiles 13.7x – 39.0xABBV, ABT, ALNY, ANAB, BMY, JNJ, LLY, PFE, QTTB, REGN, RPRX, TGTX, UTHR, VRTX, ZTS
- Dividend discount (DDM)unavailable · the company pays no dividend: a dividend model needs an explicit initiation assumption
Classification (SIC) comparables group by industry code, not by economic activity; the direct group is an editorial selection by activity. Members' multiples are on their own trailing twelve months, at their own latest close.
Assumptions (illustrative, editorial)
- Risk-free rate
- 4.3%
- Equity risk premium
- 5.0%
- Beta (default)
- 1.00
- Cost of equity
- 9.3%
- Terminal growth
- 2.5%
Factor scorecard
Attractive profile · Score 75/100
| Factor | Value | Score | Weight used |
|---|---|---|---|
| ROIC · Quality | 26.3% | 92 (vs peers) | 13% |
| Net margin · Quality | 11.6% | 59 (vs peers) | 8% |
| FCF conversion · Quality | 154.0% | 100 (on a fixed band) | 8% |
| Revenue CAGR 3Y · Growth | 0.0% | 0 (on a fixed band) | 10% |
| EPS CAGR 3Y · Growth | unavailable | unavailable | — |
| Net debt / EBITDA · Balance sheet | -0.9x | 86 (vs peers) | 13% |
| Interest coverage · Balance sheet | 8.6x | 100 (on a fixed band) | 8% |
| Current ratio · Balance sheet | 2.9x | 100 (on a fixed band) | 5% |
| P/E (TTM) · Valuation | 20.5x | 72 (vs peers) | 13% |
| EV/EBITDA · Valuation | 12.6x | 67 (vs peers) | 13% |
| FCF yield · Valuation | 7.5% | 93 (on a fixed band) | 10% |
| Shareholder yield (distributions) · Returns | unavailable | unavailable | — |
| Payout ratio (FCF) · Returns | unavailable | unavailable | — |
Factors without a value were dropped; the remaining weights were renormalised.
Score groups
- Balance sheet93/100 · 3/3 factors with a value
- Growth· partial0/100 · 1/2 factors with a value
- Quality85/100 · 3/3 factors with a value
- Returns· partialunavailable · 0/2 factors with a value
- Valuation76/100 · 3/3 factors with a value
A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.
Memo
PUMA BIOTECHNOLOGY, INC. (PBYI). Latest full fiscal year: 2025; data up to 2026-06-30.
Figures computed from the financial statements: revenue 228.4 m USD in 2025; YoY growth -0.9%; net margin 11.6%; ROE 22.0%; net debt/EBITDA -0.9x.
The estimated value range is 9.95–18.56 USD per share (median of 3 methods, agreement: high); assumptions are illustrative. Against the central value of 12.88 USD, the price of 10.69 USD leaves a potential of 20.5% (value / price − 1) and a margin of safety of 17.0% (1 − price / value). The range is the median of the methods' low, central and high values, not a probability interval.
olivLaw score 75/100, methodological classification: attractive profile (score, margin of safety and method agreement together; not a judgement of the right price). Groups assessed only in part: growth, returns. Not investment advice.
Text generated deterministically from the figures shown; no language model. Not investment advice.
What supports the thesis
- ROIC: 26.3%
- FCF conversion: 154.0%
- Net debt / EBITDA: -0.9x
- Interest coverage: 8.6x
- Current ratio: 2.9x
- P/E (TTM): 20.5x
- FCF yield: 7.5%
What contradicts it
- Revenue CAGR 3Y: 0.0%
Not assessed (insufficient data or a ratio without meaning): EPS CAGR 3Y, Shareholder yield (distributions), Payout ratio (FCF).
Versus the vertical median
Pharmaceutical Preparations (SIC 2834) · same industry (4-digit SIC) · compared with 39 companies
Multiples and returns vs the median
Price rebased to 100 (monthly, 5 years)
Companies in the vertical
| Market cap | P/E | ROE | Net margin | Revenue YoY | 1A / 3A | |
|---|---|---|---|---|---|---|
| LLYEli Lilly And Company | 1,325.9 bn | 45.7 | 86.1% | 31.9% | +44.7% | +31% / +138% |
| JNJJohnson & Johnson | 640.8 bn | 40.4 | 20.0% | 16.2% | +6.0% | +29% / +72% |
| ONCBeone Medicines Ltd. | 524.7 bn | 817.5 | 14.7% | 10.7% | +40.2% | +4% / +90% |
| ABBVAbbVie Inc. | 505.5 bn | 49.2 | — | 15.7% | +8.6% | +26% / +101% |
| MRKMerck & Co., Inc. | 356.9 bn | 115.6 | 7.0% | 4.8% | +1.3% | +38% / +41% |
| ABTAbbott Laboratories | 190.6 bn | 30.6 | 12.4% | 13.9% | +5.7% | −15% / +5% |
| PFEPfizer Inc | 171.0 bn | 42.7 | 4.4% | 6.3% | −1.6% | +17% / −2% |
| VRTXVertex Pharmaceuticals Inc | 134.6 bn | 34.2 | 20.8% | 30.7% | +8.9% | +22% / +50% |
| BMYBristol-Myers Squibb Company | 126.1 bn | 13.7 | 44.1% | 18.5% | −0.2% | +25% / +25% |
| TEVATeva Pharmaceutical Industries Limited | 48.9 bn | 97.6 | 6.6% | 3.6% | +4.3% | +56% / +327% |
| ZTSZoetis Inc. | 34.3 bn | 13.7 | 64.4% | 27.5% | +2.3% | −35% / −53% |
| ROIVRoivant Sciences Ltd. | 26.0 bn | — | -6.2% | -3,535.0% | −71.6% | +73% / +277% |
| UTHRUnited Therapeutics Corporation | 25.8 bn | 21.5 | 19.3% | 41.6% | +10.6% | +24% / +151% |
| RPRXRoyalty Pharma plc | 25.8 bn | 37.6 | 8.5% | 32.1% | +5.1% | +66% / +145% |
| INSMInsmed Inc | 22.9 bn | — | -72.5% | -39.9% | +66.7% | −50% / +317% |
| VTRSViatris Inc. | 21.7 bn | — | -23.6% | -23.9% | −3.0% | +77% / +106% |
| ALNYAlnylam Pharmaceuticals, Inc. | 21.4 bn | 8.1 | 126.6% | 52.8% | +65.2% | −65% / −5% |
| TGTXTg Therapeutics, Inc. | 9.4 bn | 22.5 | 100.3% | 55.2% | +87.3% | +85% / +381% |
| BLRXBioLineRx Ltd | 4.9 bn | — | -12.8% | -171.7% | −95.9% | −46% / −97% |
| BHCBausch Health Companies Inc. | 3.1 bn | — | — | -7.6% | +6.7% | +31% / +17% |
| ANABAnaptysbio, Inc. | 1.4 bn | 11.5 | — | 82.4% | +157.0% | +71% / +404% |
| KURAKura Oncology, Inc. | 677.0 m | — | -167.7% | -384.3% | +25.2% | −37% / −21% |
| DMACDiaMedica Therapeutics Inc. | 580.8 m | — | -114.6% | — | unavailable | +25% / +341% |
| PBYIPuma Biotechnology, Inc. | 551.8 m | 20.5 | 22.0% | 11.6% | −0.9% | +118% / +285% |
| PHATPhathom Pharmaceuticals, Inc. | 461.7 m | — | — | -30.2% | +216.9% | −64% / −19% |
1- and 3-year price returns: for PBYI from daily closes (the same as the performance table), for the other companies from month-end closes.
olivLaw engine forecast
The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.
The engine has no published run for this company yet.
Valuation scenarios (editable assumptions)
Illustrative scenarios
Illustrative: not forecasts and without probabilities. Each case is one coherent set of assumptions, computed on today's figures.
Estimated price (USD)
| Estimated price | Bear | Base | Bull |
|---|---|---|---|
| 1 years | 6.00 Total return -44% · Per year -44% | 10.64 Total return -0% · Per year -0% | 16.05 Total return 50% · Per year 50% |
| 3 years | 5.32 Total return -50% · Per year -21% | 10.65 Total return -0% · Per year -0% | 17.72 Total return 66% · Per year 18% |
| 5 years | 4.71 Total return -56% · Per year -15% | 10.66 Total return -0% · Per year -0% | 19.55 Total return 83% · Per year 13% |
- Exit P/E± 2.66
- Net margin± 1.86
- Annual revenue growth± 1.60
- Annual dilution± 0.16
AI analysis
AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.
In brief
Puma Biotechnology is a biopharmaceutical company in Los Angeles that sells NERLYNX, an oral HER2 inhibitor used in HER2-positive breast cancer, and is developing alisertib, a selective Aurora Kinase A inhibitor. In the second quarter of 2026 total revenue was 56.5 million USD 3, and the company raised its full-year revenue guidance to 224–231 million USD 3, keeping the sales trend of NERLYNX at the centre of attention.
SWOT
Strengths
Weaknesses
Opportunities
Risks
- Dependence on a single producthigh
All product revenue depends on NERLYNX, so any fall in demand would have a direct effect on the company 1.
- Profitability riskhigh
The company cannot assure that it will keep reporting net income in coming years, especially if development costs rise 13.
- China royalty reductionmedium
If the generic share in China reaches the contractual threshold, the royalty rate could fall, reducing sub-licence income 2.
- Financing needsmedium
If revenues fail to materialise the company could need additional capital, which could dilute existing shareholders 1.
- Efficacy and side effectsmedium
Severe diarrhoea and perceived limited efficacy could restrict physician and patient adoption of NERLYNX 1.
Investment thesis
What would need to be true (bull case)
- If demand for NERLYNX keeps growing the company could reach its raised 2026 guidance and strengthen its profit 3.
- Success of alisertib in a new indication could add a second revenue pillar, with potential milestone payments 1.
- Debt repayment and the international sub-licence network could give the company more flexibility 32.
What to watch
- Delivery of the 2026 revenue and net income guidancenext 10-Q
- Evolution of the China royalty and the generic thresholdlate 2026 / 2027
- Enrolment start in ALISCA-Lung2 and results of ALISCA-Breast1Q3 2026 / Q4 2026
- R&D spending relative to revenuenext 10-K
Products, market & competition
AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.
The business
Puma Biotechnology builds its business on a single commercial product, NERLYNX (oral neratinib), approved in the United States for extended adjuvant treatment and for metastatic HER2-positive breast cancer with capecitabine 1. In the US the company uses its own direct specialty sales force of about 35 specialists at 31 December 2025 1 and 38 as of 30 June 2026 2. Outside the US NERLYNX is sold through sub-licensees, and approvals had been obtained in more than 40 countries at the end of 2025 1.
Financially, the company reported net income in 2023, 2024 and 2025 1, although it carried an accumulated deficit of over 1283.8 million USD at the end of 2025 1. In May 2026 it made the final payment under its 2021 note agreement, bringing outstanding debt to zero 3.
Segments
Royalty revenue
Royalty revenue comes from sales by sub-licensees in international territories and fell in 2025, mainly because of China 1. For 2026 the company expects royalty revenue of 19 to 22 million USD 3, and a reduction in the China royalty rate could be triggered if generic market share reaches the contractual threshold 2.
Market context
Breast cancer is the leading cause of cancer death among women worldwide, and up to 20% of tumours over-express the HER2 protein 1. The market for HER2-directed treatments is competitive, and the company estimates about 6,400 US patients with third-line HER2-positive metastatic breast cancer 1.
In small cell lung cancer alisertib could have a role if clinical results are confirmed, but the market remains at an early development stage for the company 12.
Trends
- Rising demand for NERLYNXtailwind
The company reports higher demand in the second quarter of 2026 versus the prior year and has raised its revenue and net income guidance 3. If this trend holds it could support sales of its single product.
- Pressure from the China royalty reductionheadwind
Royalty revenue fell in 2025 due to weaker sales in China 1, and the rate reduction may be triggered by generic competition 2. This could limit future royalty income.
- International expansion through sub-licencesmixed
NERLYNX is approved in over 60 countries outside the US 2, which opens additional revenue if sub-licensees meet their obligations and grow sales.
- Rising research costsheadwind
R&D expenses rose significantly in 2026 with clinical activity for alisertib 3, which could weigh on profit if revenues do not hold.
Competitive position
HER2-positive treatments include trastuzumab, pertuzumab, lapatinib, T-DM1, fam-trastuzumab deruxtecan and tucatinib, used alone or in combination 1. The company argues that the irreversible mechanism of neratinib may offer an advantage, but competition is intense.
In small cell lung cancer alisertib faces other drugs in development, and the company aims to differentiate through biomarker-selected populations 1.
- Trastuzumab and pertuzumab (anti-HER2 combinations)
Standard treatments for HER2-positive breast cancer used across disease stages 1.
- Fam-trastuzumab deruxtecan
Newer anti-HER2 therapy cited as an alternative in HER2-positive treatment 1.
- Tucatinib
HER2 inhibitor used in combinations for HER2-positive disease 1.
- Lapatinib
HER2 inhibitor given alone or in combination, cited as an existing option 1.
Links, dependencies and risks
Who the company is tied to, from its own SEC filings (customers, suppliers, production, partners, competitors, countries, regulation), from the 5 %+ holders' statements (13D/13G) and from what other companies say about it. Click a node for its evidence; on a listed company the graph moves to it.
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News & filings
In the press
- TABEL Mașinile electrice, creștere masivă în România. Au cucerit o nouă redută pe piața de autoturisme noi, motorina a devenit irelevantă. Tesla Model 3 și Ford Puma luptă pentru primul locProfit.ro · 03 Nov 2026 · RO
- Ford Puma rămâne pe plus la şapte ani de la lansare, tras de versiunea electrică, în timp ce Duster şi Logan pierd o treime din vânzări în 10 luni. Mărcile chinezeşti urcă spre 20% din piaţăZiarul Financiar · 02 Nov 2026 · RO
- Atacuri masive cu drone, în porturile ucrainene de la Dunăre. Avioane F-16 și un IAR Puma, ridicate de la sol în RomâniaLibertatea.ro · 02 Nov 2026 · RO
- Ce va face România pentru ca viitorul Ford Puma să rămână în producţie la Craiova? Un pariu de peste 4 mld. euro pe an, într-o perioadă în care industria auto locală este în corziZiarul Financiar · 09 Oct 2026 · RO
- Bătălia pentru Dacia Striker s-a încheiat în favoarea Turciei. Urmează cea pentru viitorul Ford Puma, un pariu de peste 4 miliarde de euro anualZiarul Financiar · 08 Oct 2026 · RO
- Ford Otosan Craiova, avans puternic al producției. Mai multe mașini Puma au ieșit de pe bandă. Exporturile totale ale uzinei s-au majorat cu un sfertProfit.ro · 08 Oct 2026 · RO
- Puma Shen’s debut in Taipei mayoral election creates more than waves. But can it translate to votes?The Straits Times — Asia · 08 Oct 2026 · EN
- Puma, Fiesta sau Escort? Ford se întoarce în WRC cu un model complet nouProfit.ro · 01 Oct 2026 · RO
- Cine a adus creşterea pe piaţa auto în 2026: mărcile chinezeşti au adăugat 9.100 de maşini noi în nouă luni, în timp ce modelele made in România pierd teren. Doar Ford Puma, de la Craiova, rămâne pe loc - BusinessMagazinSurge — Google News · 01 Oct 2026 · RO
- Cine a adus creşterea pe piaţa auto în 2026: mărcile chinezeşti au adăugat 9.100 de maşini noi în nouă luni, în timp ce modelele made in România pierd teren. Doar Ford Puma, de la Craiova, rămâne pe locZiarul Financiar · 01 Oct 2026 · RO
- Drive test ZF: Ford Puma Gen-E 2026 - electrica de Craiova câştigă prin eficienţă, nu prin mărimea baterieiZiarul Financiar · 27 Sept 2026 · RO
- Puma’s Revolving Door Persists With Two More Executive Changes, With One Addition From NikeYahoo Finance — News · 22 Sept 2026 · EN
- Puma restructures European leadershipYahoo Finance — News · 22 Sept 2026 · EN
- Succes pentru Ford Puma și Dacia Duster. Urcă în topul celor mai vândute mașini din Europa, în segmentul B-SUVProfit.ro · 15 Sept 2026 · RO
- Ford Puma electric, produs la Craiova, presat de chinezi care au pus stăpânire pe 40% din piațăLibertatea.ro · 06 Sept 2026 · RO
- Ford Puma, singura electrică din România, prinsă la mijloc de chinezii care au acaparat deja 40% din piața de BEV din RomâniaProfit.ro · 06 Sept 2026 · RO
- Dronele rusești roiesc lângă frontiera cu România. MApN anunță că două avioane F-18 și un elicopter IAR 330 Puma SOCAT erau pregătite de decolareDefenseRomania.ro · 06 Sept 2026 · RO
- Două drone detectate în apropierea României: Au fost ridicate două F-18 și un elicopter IAR-330 Puma Socat, dar nu s-au detectat intrări neautorizate în spațiul aerianDefenseRomania.ro · 01 Sept 2026 · RO
- Alertă la graniță. Două F-18 și un elicopter IAR-330 PUMA SOCAT trimise în misiuneHotNews.ro · 01 Sept 2026 · RO
- Imagini de la BIAS 2026, cel mai aşteptat eveniment aerian al anului. Spectacol cu avioane F-16, IAR-330 Puma, Spartan şi HerculesAntena 3 CNN · 29 Aug 2026 · RO
SEC filings
- Quarterly report06 Aug 2026
- Current report06 Aug 2026Results of operations · Financial statements and exhibits
- Current report16 Jun 2026Shareholder vote
- Quarterly report07 May 2026
- Current report07 May 2026Results of operations · Financial statements and exhibits
- Proxy statement28 Apr 2026
- Annual report26 Feb 2026
- Current report26 Feb 2026Results of operations · Financial statements and exhibits
- Quarterly report06 Nov 2025
- Current report06 Nov 2025Results of operations · Financial statements and exhibits
Sources
- [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / Puma Biotechnology, Inc. · 26 Feb 2026
- [2] Form 10-Q, quarter ended 2026-06-30 · SEC / Puma Biotechnology, Inc. · 06 Aug 2026
- [3] Form 8-K, results release (exhibit 99.1) · SEC / Puma Biotechnology, Inc. · 06 Aug 2026
Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.