Executive Summary

Q2 2025 delivered total revenue of $52.4M and GAAP diluted EPS of $0.12, with non-GAAP adjusted EPS of $0.15; both revenue and EPS improved year over year on higher NERLYNX demand and lower operating costs .
Against Wall Street consensus, revenue modestly beat ($52.44M actual vs $52.00M estimate*) and EPS beat ($0.15 actual vs $0.096 estimate*) on stronger mix and disciplined expenses; estimate depth thin (1 contributor each)*. Values retrieved from S&P Global.
FY 2025 guidance largely maintained (Net Product Revenue $192–$198M; Royalty $20–$24M; Net Income $23–$28M), but gross-to-net raised to 21.5–22.0% (prior 20.5–21.5%), implying heavier discounts/chargebacks .
Near-term catalysts: Q3 2025 guide ($48–$51M total revenue; $2–$4M net income; gross-to-net 22.5–23.5%) and interim alisertib data in Q4 2025 for breast and small cell lung trials; management reiterated profitability focus and fiscal discipline .

What Went Well and What Went Wrong

What Went Well

Demand-driven growth: Net product revenue rose to $49.2M (+11% YoY), with total revenue $52.4M (+11% YoY); management highlighted “growth in revenues… driven by NERLYNX demand” .
Operating discipline: Total operating costs fell YoY to $45.8M (from $49.3M), enabling GAAP net income of $5.9M and non-GAAP adjusted net income of $7.5M .
Commercial execution: Ex-factory bottle sales increased to 2,608 (+12% QoQ; +4% YoY) with stronger SD channel growth; dose-escalation adoption remained high at ~71% supporting compliance .

What Went Wrong

Gross-to-net pressure: FY 2025 gross-to-net raised to 21.5–22.0% (from 20.5–21.5%) and Q3 guided to 22.5–23.5%, reflecting higher government chargebacks and discounts .
China royalties softer/lumpy: FY 2025 royalties expected lower than 2024 due to regulatory transitions; shipments to China to be “lumpy” near-term, reducing royalty revenue visibility .
Q2 mix headwinds: Cost of sales rose to $12.3M (+$1.6M YoY) and inventory drawdown (~$1.3M, 72 bottles) muted top line leverage; management noted inventory movements and higher royalty expense/product costs .

Financial Results

Core P&L vs prior periods and estimates (GAAP unless noted)

Metric	Q4 2024	Q1 2025	Q2 2025
Total Revenue ($USD Millions)	$59.1	$46.0	$52.4
Net Product Revenue ($USD Millions)	$54.4	$43.1	$49.2
Royalty Revenue ($USD Millions)	$4.7	$2.9	$3.2
Cost of Sales ($USD Millions)	$13.9	$10.6	$12.3
GAAP Net Income ($USD Millions)	$19.3	$3.0	$5.9
GAAP Diluted EPS ($USD)	$0.39	$0.06	$0.12
Non-GAAP Adjusted EPS ($USD)	$0.43	$0.10	$0.15
Net Income Margin (%)	32.6% (19.3/59.1)	6.5% (3.0/46.0)	11.3% (5.9/52.4)
Gross Profit Margin (%)	76.5% ((52.4-12.3)/52.4)	76.9% ((46.0-10.6)/46.0)	76.5% ((52.4-12.3)/52.4)

Consensus vs Actual (Q2 2025)

Metric	Consensus	Actual
Revenue ($USD)	$52.000M*	$52.436M*
Primary EPS ($USD)	$0.096*	$0.15*
# of Estimates (Revenue / EPS)	1* / 1*	—

Values retrieved from S&P Global.
Note: Actuals reflect “Primary EPS” per S&P Global dataset; company-reported GAAP diluted EPS was $0.12 .

Segment/Revenue Mix

Revenue Component ($USD Millions)	Q4 2024	Q1 2025	Q2 2025
Net Product Revenue	$54.4	$43.1	$49.2
Royalty Revenue	$4.7	$2.9	$3.2
Total Revenue	$59.1	$46.0	$52.4

KPIs and Operating Metrics

KPI	Q4 2024	Q1 2025	Q2 2025
NERLYNX Bottles Sold (ex-factory)	2,964	2,338	2,608
Inventory Change (Bottles)	+205	−251	−72
Inventory Change ($USD)	+$3.7M	−$4.7M	−$1.3M
New Rx (QoQ)	−7%	+6%	−3%
Total Rx (QoQ)	+4%	−9%	+3%
Demand (QoQ / YoY)	+3% QoQ; ~flat YoY	−6% QoQ; +2% YoY	+4% QoQ; +2% YoY
Channel Mix (SP / SD)	75% / 25%	67% / 33%	63% / 37%
Dose Escalation Adoption	74% start reduced dose	72%	~71%
Gross-to-Net Adjustment	18.2%	20.8%	20.8%

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Net Product Revenue	FY 2025	$192–$198M	$192–$198M	Maintained
Royalty Revenue	FY 2025	$20–$24M	$20–$24M	Maintained
Total Revenue	FY 2025	$212–$222M	$212–$222M	Maintained
Net Income	FY 2025	$23–$28M	$23–$28M	Maintained
Gross-to-Net	FY 2025	20.5%–21.5%	21.5%–22.0%	Raised
SG&A Expense (YoY)	FY 2025	−5% to −10%	−5% to −10%	Maintained
R&D Expense (YoY)	FY 2025	+10% to +15%	+20% to +25%	Raised
Net Product Revenue	Q3 2025	—	$46–$48M	New
Royalty Revenue	Q3 2025	—	$2–$3M	New
Total Revenue	Q3 2025	—	$48–$51M	New
Net Income	Q3 2025	—	$2–$4M	New
Gross-to-Net	Q3 2025	—	22.5%–23.5%	New

Note: Outlook excludes any adjustments for tax valuation allowance .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4 2024, Q1 2025)	Current Period (Q2 2025)	Trend
R&D execution (alisertib)	Breast/Lung Phase II trials enrolling ahead of expectations; protocol amendments to enrich biomarkers; interim data later 2025	Breast: 62 pts enrolled; Lung: 52 pts; dose increased to 60mg BID; interim data targeted Q4 2025	Accelerating enrollment; dose optimization progressing
NERLYNX product performance	Q4 inventory build; dose-escalation benefits and persistence; distribution expansion	QoQ demand +4%; SD channel strength; dose-escalation ~71%; inventory drawdown	Improving demand QoQ; high dose-escalation adoption sustained
China royalties/International	Lumpy royalties; China shipments drove Q3/Q4 2024; expectation of lower 2025 royalties	Lower FY 2025 royalties as partner navigates regulatory transitions; lumpiness persists	Near-term headwind; long-term in-market demand intact
Gross-to-net/tariffs/macro	Gross-to-net ~18.2% in Q4; minimal IRA/Part D impact observed early	FY gross-to-net raised; Q3 gross-to-net 22.5–23.5%; tariffs not material	Discount/chargeback pressure higher; limited tariff impact
AI/tech in commercial ops	Piloting predictive analytics for sales prioritization	Continued emphasis on executional excellence/accountability in sales	Data-driven targeting ongoing
Regulatory/legal cost tailwinds	SG&A down YoY due to prior AstraZeneca litigation costs	SG&A down YoY; continued expense control	Sustained Opex discipline
NERLYNX + Enhertu (Phase I)	Interim data presented at AACR; RP2D set; more data likely 2026	Not a focus in Q2 call script; pipeline emphasis on alisertib	Stable; next disclosure later

Management Commentary

“We are pleased to report both the growth in revenues in the second quarter as well as the positive net income for the quarter… driven by NERLYNX demand… and progress in the clinical development of alisertib” — Alan H. Auerbach, CEO .
“Gross-to-net for full year 2025 will be between 21.5%–22.0%, higher than prior guidance due to an increase in government chargeback expenses” — Maximo F. Nougues, CFO .
“Q2 ex-factory bottle sales were 2,608… demand increased about 4% QoQ and 2% YoY; stronger growth in the SD channel… dose escalation adoption ~71%” — Roger Storms, SVP Sales .
“We anticipate interim alisertib data for breast and lung later in 2025; if efficacy aligns with biomarker-driven benefits (PFS/OS), we would engage FDA on regulatory path” — Alan H. Auerbach .

Q&A Highlights

Thresholds for advancing alisertib: Management articulated need for PFS (and likely OS) benefit aligned with prior biomarker subgroup signals to justify further development; otherwise remain selective to preserve profitability .
Disclosure venue/timing: Interim data likely via corporate update around November 2025; breast may push into 2026 if enrollment outpaces data maturity .
Portfolio strategy: Profitable profile enables self-funding; cautious on in-licensing to avoid jeopardizing net income .
Macro/policy: IRA/Medicare Part D redesign viewed as supportive with lower patient co-pays; no material tariff impacts anticipated .

Estimates Context

Q2 2025 actuals vs consensus: Revenue $52.44M actual vs $52.00M estimate*; Primary EPS $0.15 actual vs $0.096 estimate*; contributors: 1 each*; implies modest top-line beat and stronger EPS performance. Values retrieved from S&P Global.

Where estimates may need adjustment:

Gross-to-net upward revisions suggest modest pressure on net product revenue conversion; analysts may lift discount assumptions for H2 2025 .
Royalties trajectory lower/lumpy due to China regulatory transitions could trim FY 2025 royalty models .
Operating expenses: R&D spend guide raised (+20–25% YoY) on faster trial enrollment; modest EPS headwind offset by demand/pricing .

Key Takeaways for Investors

Demand improving QoQ with stronger SD channel and stable dose-escalation, supporting persistence and compliance; watch inventory movements for quarterly volatility .
FY guide intact but gross-to-net raised; near-term mix/discount dynamics likely cap upside on net product revenue conversion .
Royalties softer/lumpy in 2025 due to China transitions; in-market demand remains on track, but quarterly royalty variability persists .
Pipeline catalysts: Q4 2025 alisertib interim readouts (breast and SCLC) are key stock-moving events; management’s PFS/OS threshold provides a clear go/no-go bar .
Expense discipline continues (SG&A down YoY) while R&D ramps to support alisertib; profitability focus reiterated, reducing dilution risk and bolstering defensive profile .
Tactical setup: Q3 guide implies lower net income amid higher gross-to-net; trading near catalysts may hinge on biomarker-driven efficacy signals and channel mix strength .
Monitor Enhertu combo program timing (next disclosures likely 2026) and any in-licensing steps (management cautious to preserve profitability) .

PUMA BIOTECHNOLOGY, INC. (PBYI)·Q2 2025 Earnings Summary