Puma Biotechnology, Inc. (PBYI) Earnings

Management highlights

### Commercial Operations for Nearlink - 2,929 ex-factory bottles of Nearlink were sold in Q2 2026, a 26% quarter-over-quarter increase and 12% year-over-year increase. Distribution channel inventory decreased by 57 bottles in Q2 2026, following a 439-bottle inventory decrease in Q1 2026. - U.S. domestic demand for Nearlink reached 2,896 bottles in Q2 2026, an 8% quarter-over-quarter increase and 11% year-over-year increase. The specialty distributor channel saw 12% quarter-over-quarter demand growth and 32% year-over-year demand growth, driven by increased GPO segment sales and 340B purchasing. - Total prescriptions grew 7% quarter-over-quarter and 3% year-over-year, while new patient starts declined 6% quarter-over-quarter but grew 8% year-over-year. 73% of new patients start Nearlink at a reduced dose, with dose escalation supported by patient education resources to improve therapy compliance. - Nearlink was launched in Thailand in Q1 2026, with international partner activities continuing to progress. ### Clinical Development of Alacertib - For the ALISCA Breast 1 phase 2 trial (Alacertib + endocrine therapy for HER2-negative ER-positive recurrent/metastatic breast cancer), interim data showed preliminary promising activity in patients with aurora kinase pathway biomarkers. The trial protocol was amended to only enroll patients in the 40mg and 50mg twice daily dose groups, with regulatory submissions completed and enrollment under the amended protocol expected to start in Q3 2026. Updated interim data with longer follow-up will be released in Q4 2026. - For the ALISCA Lung 1 phase 2 trial (Alacertib monotherapy for small cell lung cancer), interim data also showed preliminary promising activity in biomarker-selected patients. Dosing has been escalated to 70mg twice daily, with 92 total patients enrolled to date (36 at 60mg BID, 4 at 70mg BID). Additional interim data for ALISCA Lung 1 is expected in 2027. - The ALISCA Lung 2 phase 2 trial (Alacertib + Paclitaxel for small cell lung cancer) is expected to start enrollment in Q3 2026, with initial data expected in 2027. ### Corporate Strategy & Financial Operations - PUMA continues to evaluate potential in-licensing and acquisition targets for commercial and development-stage assets to diversify its pipeline and leverage existing R&D, regulatory, and commercial infrastructure. - PUMA paid off its final outstanding loan principal in Q2 2026 and is now completely debt-free. As of June 30 2026, the company held $93.9 million in cash, cash equivalents, and marketable securities. - The company reported GAAP net income of $8.2 million ($0.16 per diluted share) in Q2 2026, compared to a GAAP net loss of $3.8 million ($0.07 per diluted share) in Q1 2026. Non-GAAP net income (adjusted for stock-based compensation) was $10.1 million in Q2 2026.

Guidance

- Full year 2026 Nearlink net product revenue guidance is upwardly revised to $205-$209 million, from the prior guidance range of $202-$206 million. Full year 2026 royalty revenue guidance is slightly downwardly revised to $19-$22 million, from the prior range of $20-$23 million. - Full year 2026 net income guidance is upwardly revised to $17-$20 million, from the prior range of $16-$19 million. The guidance does not include any potential adjustment to deferred tax asset valuation allowances. - Full year 2026 gross-to-net adjustment is expected to be between 26.5% and 27.5%. No license revenue is expected in 2026. - Q3 2026 Nearlink net product revenue is guided to $54-$56 million, royalty revenue to $2-$3 million, and gross-to-net adjustment to 26-27%. Q3 2026 net income is expected to be between $2 million and $2.5 million. - For full year 2026, SG&A expenses are expected to increase 1-2% year-over-year, while R&D expenses are expected to increase 34-37% year-over-year, driven by ongoing Alacertib clinical trial progress.

Segment performance

PUMA Biotechnology has one primary commercial product segment: Nearlink. For Q2 2026, Nearlink net product revenue totaled $53.6 million, representing 94.9% of the company's total Q2 2026 revenue of $56.5 million. This marks a 27.6% increase from Q1 2026 Nearlink revenue of $42 million, and a 8.9% increase from Q2 2025 Nearlink revenue of $49.2 million. Royalty revenue from sub-licensees, the second segment, totaled $2.9 million in Q2 2026, making up 5.1% of total Q2 2026 revenue. Royalty revenue was flat quarter-over-quarter compared to Q1 2026, and down 9.4% year-over-year compared to Q2 2025 royalty revenue of $3.2 million. In Q2 2026, 61% of Nearlink channel volume went through the specialty pharmacy channel, and 39% went through the specialty distributor/in-office dispensing channel.

Risks & headwinds

- A royalty rate reduction under PUMA's Chinese sublicense agreement will trigger when generic Nearlink market share in China reaches a specified threshold. This threshold could be reached as early as late 2026 or 2027, and the timing cannot be predicted with certainty. - Evolving and unpredictable global trade policies and tariffs could impact product costs, though management currently does not expect tariffs to have a material impact on operations, as manufacturing product cost only accounts for a mid-to-high single-digit percentage of total cost of goods sold. - Clinical trial results to date are preliminary, and actual efficacy and safety outcomes may differ from preliminary indications, which could impact plans for future phase 3 development. - Any potential business development transaction carries inherent execution and integration risks, and there is no guarantee that attractive targets will be identified or completed on favorable terms. - Adjustments to deferred tax asset valuation allowances may be required, which could impact full year net income, though the size and timing of any adjustment is undetermined at present.

Analyst Q&A

• Q: What is the expected R&D spending trajectory for 2027 and beyond as Alacertib trials ramp up, and can PUMA afford to run phase 3 trials for both Alacertib indications? /

  A: Management confirms that PUMA, now debt-free and cash flow positive, has the capacity to run phase 3 trials for both the breast cancer and small cell lung cancer indications of Alacertib if preliminary data continues to support advancement. Trials will likely be staggered sequentially rather than launched simultaneously to maintain the company's commitment to positive net income, with the first phase 3 trial expected to start as early as 2027 if data holds.

• Q: What types of business development opportunities is PUMA targeting for potential in-licensing or acquisition? /

  A: PUMA is actively evaluating both commercial-stage and development-stage oncology assets, with no restrictions on technology modality or tumor type. The company prioritizes assets that can fit into its existing infrastructure to generate additional cash flow for shareholders and improve outcomes for cancer patients. For commercial assets, PUMA has demonstrated ability to cut costs and drive cash generation, while for development assets, the company looks for unique assets where it can add clinical development value.