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PUMA BIOTECHNOLOGY, INC. (PBYI)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 delivered a clean top- and bottom-line beat vs S&P Global consensus and a full-year guidance raise: revenue $54.5M vs $51.0M est., Primary EPS $0.21 vs $0.05 est.; management lifted FY25 net product revenue, total revenue and net income ranges while tightening gross-to-net assumptions . Results beat consensus values from S&P Global*.
  • Mix shift explains the YoY revenue decline despite U.S. strength: total revenue fell 32% YoY on sharply lower China-related royalty/product supply, but U.S. NERLYNX net sales rose to $51.8M (+6% YoY) with bottles up 8% YoY; QoQ momentum also solid with net product revenue up ~$2.7M .
  • Gross-to-net rose to 25.9% (from 20.8% in Q2) on higher Medicare rebates (IRA) and Medicaid share; nevertheless, Q3 GAAP diluted EPS was $0.17 and non-GAAP adjusted EPS $0.21, aided by U.S. demand and inventory build ($3.1M) .
  • 2025 outlook raised: FY25 net product revenue to $198–$200M (from $192–$198M), total revenue $220–$223M (from $212–$222M), and net income $27–$29M (from $23–$28M); Q4 revenue guidance $67–$70M with royalties $13–$14M (driven by a partner shipment), and net income $9–$11M .
  • Clinical catalysts in 1H26: interim readouts from ALISCA-Breast1 and additional interim data from ALISCA-Lung1; enrollment and a protocol dose escalation to 60mg BID (potential 70mg) underpin progress; management reiterates commitment to remaining profitable while advancing alisertib .

What Went Well and What Went Wrong

What Went Well

  • U.S. commercial execution: U.S. net sales reached ~$51.8M in Q3 vs ~$48.8M a year ago, with NERLYNX bottles up 13% QoQ and 8% YoY; management highlighted increased demand and salesforce execution with QoQ increases in calls and SD channel strength .
  • Guidance raised across key FY metrics: FY25 net product revenue, total revenue, and net income all moved higher, with Q4 royalty lift tied to a large partner shipment; gross-to-net full-year range updated to 23–23.5% .
  • Profitability sustained with stronger cash position and deleveraging: Q3 GAAP net income $8.8M; cash, cash equivalents and marketable securities $94.4M at 9/30; principal debt declining (current portion ~$33.7M) as company moves toward being debt-free mid-2026 per discussion of amortization schedule impacts on cash flow .

Management quote: “We are very happy to report the continuation of our positive earnings trend, which is driven by increased demand for NERLYNX” .

What Went Wrong

  • YoY revenue pressure from ex-U.S. mix: total revenue fell to $54.5M vs $80.5M in Q3’24 on significantly lower royalty/product supply revenue tied to China/regulatory transitions and higher gross-to-net .
  • Gross-to-net headwind: Q3 gross-to-net rose to ~25.9% vs 20.8% in Q2, driven by higher-than-expected Medicare rebate (IRA) and higher Medicaid mix, partially muting stronger U.S. demand .
  • Royalty revenue softness: Q3 royalties were $2.6M vs $24.4M in Q3’24; management continues to guide FY25 royalties below 2024 given fewer China shipments through regulatory transitions .

Financial Results

Core P&L vs Prior Periods

MetricQ3 2024Q2 2025Q3 2025
Total Revenue ($M)$80.5 $52.4 $54.5
Net Product Revenue ($M)$56.1 $49.2 $51.9
Royalty Revenue ($M)$24.4 $3.2 $2.6
GAAP Net Income ($M)$20.3 $5.9 $8.8
GAAP Diluted EPS ($)$0.41 $0.12 $0.17
Non-GAAP Adjusted Diluted EPS ($)$0.45 $0.15 $0.21
Cost of Sales ($M)$29.1 $12.3 $12.2
Gross Margin % (calc)63.9% (80.5–29.1)/80.5 76.5% (52.4–12.3)/52.4 77.6% (54.5–12.2)/54.5

Segment/Revenue Mix Detail

Revenue Component ($M)Q3 2024Q2 2025Q3 2025
Net Product Revenue$56.1 $49.2 $51.9
Royalty Revenue$24.4 $3.2 $2.6
Total Revenue$80.5 $52.4 $54.5

Operating Expense Profile

OpEx ($M)Q3 2024Q2 2025Q3 2025
SG&A$16.8 $18.0 $16.8
R&D$12.5 $15.5 $15.9
Total OpEx$58.4 $45.8 $44.9

KPIs and Commercial Metrics

KPIQ2 2025Q3 2025
U.S. NERLYNX Net Sales ($M)$—~$51.8
Ex-Factory Bottles Sold2,608 2,949
Inventory Change ($)(~$1.3M) +$3.1M
Inventory Change (Bottles)(72) +172
Gross-to-Net Adjustment20.8% ~25.9%

Consensus vs Actual (Q3 2025)

MetricS&P Global ConsensusActual
Revenue ($M)$51.0* [GetEstimates]$54.5
Primary EPS ($)$0.05* [GetEstimates]$0.21 (Primary EPS actual via SPGI)* [GetEstimates]

Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net Product RevenueFY 2025$192–$198M $198–$200M Raised
Royalty RevenueFY 2025$20–$24M $22–$23M Tightened/Higher Mid
Total RevenueFY 2025$212–$222M $220–$223M Raised
Net IncomeFY 2025$23–$28M $27–$29M Raised
Gross-to-NetFY 202521.5%–22.0% 23%–23.5% Raised
Net Product RevenueQ4 2025N/A$54–$56M New
Royalty RevenueQ4 2025N/A$13–$14M New
Total RevenueQ4 2025N/A$67–$70M New
Net IncomeQ4 2025N/A$9–$11M New
Gross-to-NetQ4 2025N/A24%–25% New

Note: Q4 guidance includes ~$4.5M of product sales to a global partner; U.S. net revenue expected at $50–$52M . Guidance excludes any potential tax valuation allowance changes .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2 2025)Current Period (Q3 2025)Trend
U.S. Demand/Commercial ExecutionQ2: Demand +4% QoQ; call activity +24% QoQ; SD channel growth; dose escalation starts ~71% . Q1: Better-than-expected net income, focus on execution .Bottles +13% QoQ/+8% YoY; demand +3% QoQ/+3% YoY; call activity +17% QoQ/+22% YoY; dose escalation starts ~77% .Improving execution and adherence support.
Gross-to-Net/IRA ImpactQ2 GtN ~20.8%; FY25 raised to 21.5–22.0% on higher government chargebacks .Q3 GtN ~25.9% on higher Medicare rebates (IRA) and Medicaid share; FY25 23–23.5% .Headwind intensifies, embedded in guidance.
Ex-U.S./China RoyaltiesQ2: FY25 royalties guided $20–$24M (below 2024) due to fewer China shipments .Q3: Royalties $2.6M; FY25 $22–$23M; Q4 step-up to $13–$14M with partner shipment .Near-term Q4 recovery, still lower vs 2024.
Inventory DynamicsQ2: Distributor inventory drawdown ~$1.3M; (72) bottles .Q3: Inventory build ~$3.1M; +172 bottles .Tailwind in Q3; normalizes into Q4 mix.
Alisertib R&D ExecutionQ2: Enrollment ahead of plan; Lung dose-escalation to 60mg BID; interim updates ‘late 2025’ .Q3: Breast1 98 pts enrolled; formal interim H1’26; Lung1 61 pts (9 at 60mg), potential 70mg BID; interim H1’26 .Enrollment ahead; dose optimization ongoing.
Profitability Focus/CapitalQ2: Maintain profitability; principal payments reduce debt; ~$96M cash .Q3: Maintain profitability; debt ~$33M current; $94.4M liquidity; path to being debt-free supports cash flow .Strengthening balance sheet/FCF leverage.
Tariffs/MacroQ2: No material tariff impact; COGS mid-high single-digit % manufacturing cost .Q3: Same view reiterated .Stable.

Management Commentary

  • “2025 will mark the first year-over-year demand increase for NERLYNX in the United States since 2018 and we are very pleased with our commercial execution” — Alan H. Auerbach, CEO .
  • “Our gross-to-net adjustment in Q3 2025 was about 25.9%… driven mostly by a higher than expected Medicare rebate… and higher Medicaid share” — Maximo F. Nougues, CFO .
  • “We anticipate… interim data from ALISCA-Breast1… and additional interim data from ALISCA-Lung1 in H1 2026” — Alan H. Auerbach .

Q&A Highlights

  • Thresholds for advancing alisertib: Company will gauge Breast1 against TBCRC41 and expects PFS (and likely OS) benefits vs endocrine alone in biomarker-selected populations; in SCLC, seeks PFS and OS benefits consistent with prior biomarker subgroup signals; will stagger indications to remain profitable .
  • Profitability vs pivotal spend: Management aims to fund a manageable-size pivotal program through NERLYNX cash flows while staying net-income positive; debt amortization roll-off improves cash generation mid next year .
  • Q4 color: Guidance embeds ~$4.5M of partner product sales; U.S. net revenue $50–$52M; royalties $13–$14M; GtN 24–25% .

Estimates Context

  • Beat vs S&P Global: Revenue $54.5M vs $51.0M est. (+6.8%); Primary EPS $0.21 vs $0.05 est. (large beat). Drivers: stronger U.S. demand, inventory build (~$3.1M), and higher bottles sold; partially offset by higher gross-to-net . Consensus and Primary EPS values from S&P Global*.
  • Implications: Street models likely move up on FY revenue/NI raises and Q4 royalty step-up; GtN trajectories (IRA/Medicaid) may push mix assumptions higher.

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Clear revenue/EPS beat and raised FY25 guidance — the combination often supports positive revisions and sentiment; watch Q4 execution given partner shipment dynamics .
  • U.S. NERLYNX demand momentum is real (bottles, SD channel, dose-escalation adoption), offsetting ex-U.S. headwinds; sustainability into 2026 is the key debate .
  • Gross-to-net is a rising structural headwind (IRA/Medicaid); management has embedded higher rates into FY25, reducing negative surprise risk but capping upside leverage .
  • Balance sheet de-risking via steady amortization supports staying profitable while funding alisertib; debt reduction should improve FCF in 2026 .
  • 1H26 clinical readouts (Breast1 and Lung1) are the next major stock catalysts; biomarker-enriched signals and dose optimization (60mg→70mg BID) could shape pivotal design and partnering optionality .
  • Near-term trading setup: Q4 revenue/royalty cadence and any interim clinical disclosures could move shares; guidance implies a strong Q4 print (royalties $13–$14M) .
  • Medium-term: Monitor U.S. script trends, GtN trajectory, China normalization, and alisertib biomarker efficacy to underwrite durable profitability and pipeline value .