Puma Biotechnology Inc. (NASDAQ: PBYI) Q2 2025 Earnings | 08/08/2025

11 days ago

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Earnings Calls

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Summary of Puma Biotechnology Q2 2025 Earnings Call

Date: August 8, 2025
Participants:

LaTonya (Conference Call Operator)
Marianne Ohanison (Senior Director, Investor Relations)
Alan (Chief Medical Officer)
Heather Blaber (SVP, Marketing)
Roger Storms (SVP, Sales)
Maximo Noguez (CFO)

Key Highlights:

1. Financial Performance (Q2 2025):

Total Revenue: $52.3M (up from Q1 2025: $46M, Q2 2024: $47.1M)
- Product Revenue (Nerlynx): $49.2M (up from $43.1M in Q1 2025, $44.4M in Q2 2024)
- Royalty Revenue: $3.2M (up from $2.9M in Q1 2025, $2.7M in Q2 2024)
Net Income (GAAP): $5.9M ($0.12/share) vs. $3M in Q1 2025
Non-GAAP Net Income: $7.5M ($0.15/share)
Cash Position: $96M (down from $101M at year-end 2024)

2. Nerlynx Commercial Performance:

Bottles Sold: 2,608 (up 12% QoQ, 4% YoY)
Demand Growth: +4% QoQ, +2% YoY
Distribution: 63% specialty pharmacy, 37% specialty distributor (SD channel growing due to 340B & GPO purchasing)
Dose Escalation: 71% of patients started on reduced dose (improving persistence/compliance)

3. Clinical Development Updates:

ALISCA Breast-1 Trial (HER2-, HR+ metastatic breast cancer):
- 62 patients enrolled, 10 in screening (ahead of expectations).
- Interim data expected late 2025.
ALISCA Lung-1 Trial (Small Cell Lung Cancer – biomarker-driven):
- 52 patients enrolled, dose increased from 50mg to 60mg BID to improve PK.
- Interim data expected late 2025.

4. Marketing & Sales Strategy:

Focus on high-risk HER2+ early breast cancer patients to reduce recurrence.
New patient education resources to improve compliance.
Increased HCP engagement (calls up 16% YoY, 24% QoQ).

5. Financial Guidance (2025):

Nerlynx Revenue: $192M–$198M
Royalties: $20M–$24M (lower due to regulatory delays in China)
Net Income Forecast: $23M–$28M
Q3 2025 Expectations:
- Nerlynx Revenue: $46M–$48M
- Royalties: $2M–$3M
- Net Income: $2M–$4M

6. Future Outlook:

Profitability Focus: Committed to maintaining positive net income.
Strategic Acquisitions: Evaluating in-licensing opportunities but prioritizing financial discipline.
Clinical Milestones: Interim data from ALISCA trials in late 2025 will guide future development.

Closing Remarks:
Puma remains committed to addressing unmet needs in breast and lung cancer while maintaining financial stability. The company looks forward to updating investors on clinical progress and commercial execution in upcoming quarters.

About this video

Puma Biotechnology reported its second-quarter 2025 financial results, showcasing a return to profitability with strong top-line growth and effective expense control. Total revenue reached $52.4 million, up approximately 11.3% year-over-year, slightly surpassing analyst expectations. The growth was primarily driven by net product revenue from NERLYNX, Puma’s oral HER2-positive breast cancer treatment, which rose 10.8% to $49.2 million, fueled by improved demand, expanded patient education efforts, and new distribution agreements in Eastern Europe and Central Asia. The company reported GAAP net income of $5.9 million, a significant turnaround from a net loss of $4.5 million in Q2 2024. On a non-GAAP basis, adjusted net income was $7.5 million, or $0.15 per basic and diluted share, beating consensus estimates. Expense discipline played a key role, with selling, general, and administrative costs declining 28% due to reduced legal expenses, while research and development expenses increased 14% to $15.5 million to support ongoing Phase II trials for alisertib in breast and lung cancer. Operational highlights included strategic expansion of NERLYNX’s global reach through new partnerships and enhanced commercial execution targeting high-risk patients, alongside continued progress in the clinical pipeline with expected interim alisertib data in Q4 2025. The company emphasized prudent financial management with strong cash flow and debt reduction, ending the quarter with $96 million in cash and equivalents. Management reaffirmed full-year 2025 guidance, targeting total GAAP revenue between $212 million and $222 million, and net income of $23 million to $28 million. Risks remain related to competitive pressures on NERLYNX, regulatory shifts affecting royalty revenue, and continued investment needs for clinical development. About Inside Ticker: Inside Ticker delivers timely, in-depth financial news and earnings analysis to empower investors with actionable insights on global companies across sectors. For comprehensive video analysis and real-time updates, visit https://www.insideticker.com/. #PumaBiotechnology #PBYI #Q22025 #Earnings #FinancialResults #RevenueGrowth #NetIncome #EPS #NERLYNX #BreastCancer #Alisertib #ClinicalTrials #Pharmaceuticals #Biotech #CancerTherapies #DrugDevelopment #CommercialLaunch #ProductRevenue #ExpenseControl #R&DInvestment #GlobalExpansion #PatientEducation #LegalExpenseReduction #NonGAAP #InvestorUpdates #PipelineProgress #NASDAQ #HealthcareInnovation #InsideTicker

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