Sign in

You're signed outSign in or to get full access.

PB

PUMA BIOTECHNOLOGY, INC. (PBYI)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 total revenue was $46.0M (+5.0% y/y) and GAAP EPS was $0.06, with non-GAAP adjusted EPS of $0.10; management highlighted “better than expected net income” and guided to continued profitability for FY25 .
  • Revenue and EPS exceeded Wall Street consensus: revenue $46.0M vs $44.6M, EPS $0.10 vs -$0.02; demand strength offset seasonal inventory drawdown and higher gross-to-net, producing a headline beat on both metrics (values retrieved from S&P Global).
  • FY2025 guidance maintained: net product revenue $192–$198M, royalties $20–$24M, net income $23–$28M, gross-to-net 20.5%–21.5%; Q2 net product revenue guided to $48–$50M and net income $4–$6M .
  • Call focus: inventory normalization (-$4.7M), dose-escalation adoption (~72%), stronger SD channel demand, Medicare Part D redesign tailwinds, and alisertib program updates with protocol amendment to increase dosing in SCLC .
  • Near-term stock catalysts: revenue/EPS beats vs consensus, inventory normalization into Q2, Medicare tailwinds, additional alisertib interim data in H2 2025, and partnership expansion (Er-Kim distribution) .

What Went Well and What Went Wrong

  • What Went Well

    • Revenue and EPS beat consensus; non-GAAP EPS $0.10 vs -$0.02 consensus; revenue $46.0M vs $44.6M (values retrieved from S&P Global). CEO: “We are pleased to report better than expected net income” .
    • Commercial execution: ~72% dose-escalation starts supporting persistence/compliance; SD channel demand up ~4% q/q and ~14% y/y .
    • Clinical momentum: encouraging neratinib + T-DXd signals (PRs across HER2-altered tumors; pancreatic regression observed) and alisertib programs enrolling ahead of expectations; Phase II portion opened March 2025 .

  • What Went Wrong

    • Seasonal inventory drawdown reduced net product revenue by ~$4.7M and bottles by ~251; TRx down ~9% q/q and demand down ~6% q/q .
    • Gross-to-net headwind: Q1 gross-to-net ~20.8% vs 18.2% in Q4, dampening net revenue conversion .
    • China royalties softer near term due to regulatory transitions; Q1 royalty revenue $2.9M vs $4.7M in Q4 .

Financial Results

Headline Financials (GAAP)

MetricQ3 2024Q4 2024Q1 2025
Total Revenue ($USD Millions)$80.5 $59.1 $46.0
Net Product Revenue ($USD Millions)$56.1 $54.4 $43.1
Royalty Revenue ($USD Millions)$24.4 $4.7 $2.9
Cost of Sales ($USD Millions)$29.1 $13.9 $10.6
Total Operating Costs & Expenses ($USD Millions)$58.4 $45.7 $42.0
Net Income ($USD Millions)$20.3 $19.3 $3.0
GAAP Diluted EPS ($)$0.41 $0.39 $0.06
Non-GAAP Adjusted Diluted EPS ($)$0.45 $0.43 $0.10

Segment Revenue Breakdown

SegmentQ3 2024Q4 2024Q1 2025
Net Product Revenue ($USD Millions)$56.1 $54.4 $43.1
Royalty Revenue ($USD Millions)$24.4 $4.7 $2.9

KPIs

KPIQ3 2024Q4 2024Q1 2025
Ex‑Factory Bottles Sold—2,964 2,338
Inventory Change (Bottles)—+204 -251
Inventory Change ($)—+$3.7M -$4.7M
Gross‑to‑Net Adjustment (%)—18.2% 20.8%
% Patients Starting at Reduced Dose—74% 72%
TRx Change (q/q, y/y)——-9% q/q; -3% y/y
Demand Change (q/q, y/y)——-6% q/q; +2% y/y
SD Channel Demand Change——+4% q/q; +14% y/y

Margins and Profitability

MetricQ3 2024Q4 2024Q1 2025
Gross Profit Margin %76.44%*76.44%*77.06%*
EBIT Margin %22.62%*22.62%*8.66%*
Net Income Margin %32.68%*32.68%*6.46%*
Cash from Operations ($USD Millions)—$15.6 $3.6

*Values retrieved from S&P Global.

Actuals vs Consensus (Q1 2025)

MetricConsensusActualBeat/Miss
Revenue ($USD Millions)$44.6*$46.0 Bold beat
Primary EPS ($)-$0.02*$0.10*Bold beat

*Values retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net Product Revenue ($USD Millions)Q2 2025N/A$48–$50 New
Royalty Revenue ($USD Millions)Q2 2025N/A$2–$3 New
Net Income ($USD Millions)Q2 2025N/A$4–$6 New
Gross‑to‑Net (%)Q2 2025N/A20%–21.5% New
Net Product Revenue ($USD Millions)FY 2025$192–$198 $192–$198 Maintained
Royalty Revenue ($USD Millions)FY 2025$20–$24 $20–$24 Maintained
Net Income ($USD Millions)FY 2025$23–$28 $23–$28 Maintained
Gross‑to‑Net (%)FY 202520.5%–21.5% 20.5%–21.5% Maintained
Net Product Revenue ($USD Millions)Q1 2025$41–$43 Actual $43.1 Achieved (top end)
Royalty Revenue ($USD Millions)Q1 2025$1.5–$2.5 Actual $2.9 Above
Net Income ($USD Millions)Q1 2025$(2)–$0 Actual $3.0 Above
Gross‑to‑Net (%)Q1 202522.5%–23.5% Actual ~20.8% Better

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
Inventory dynamicsQ3/Q4 noted seasonal inventory build; higher China shipments impacted cost of sales .Seasonal drawdown (~$4.7M; -251 bottles) weighed on revenue; expect normalization .Normalizing into Q2
Gross‑to‑netQ4 gross‑to‑net 18.2%; FY25 outlook 20.5%–21.5% .Q1 gross‑to‑net ~20.8%; FY guide reaffirmed .Slightly higher but stable
Demand/SD channelStronger SD demand emerging .SD demand +4% q/q, +14% y/y; focus on SD/GPO and 340B .Improving
Dose escalation/patient supportContinued adoption as persistence lever .~72% starts at reduced dose; new patient resource to boost persistence .Sustained high adoption
Medicare Part D redesignN/A in prior PRs.Lower co‑pays in ’25/’26; rising Medicare share; less free goods .Positive tailwind
China royalties/partnersHeavy Q3 royalty revenue; China shipments timing .Lower royalties near term due to regulatory transitions; Er‑Kim distribution expansion .Near‑term soft, expanding ROW
R&D execution (alisertib)Initiated ALISCA‑Breast1; ALISCA‑Lung1 ongoing .Breast1 enrolling ahead of expectations; Lung1 dose increase to 60mg planned .Progressing
Clinical data (neratinib + T‑DXd)H1 2025 interim data anticipated .Phase I signals incl. pancreatic regression; Phase II opened March 2025 .Constructive

Management Commentary

  • CEO on profitability: “We are pleased to report better than expected net income for the first quarter of 2025.”
  • CEO on pipeline milestones: Interim data from ALISCA‑Breast1 and ALISCA‑Lung1 expected in H2 2025 .
  • CCO on demand mix: “In Q1 of 2025… about 67%… SP channel and… 33%… SD channel… stronger growth in the SD channel… increased GPO sales and increasing 340B purchasing.”
  • CFO on gross‑to‑net and guidance: “Our gross to net adjustment in Q1 2025 was about 20.8%… FY 2025… gross to net… 20.5%–21.5%… net income… $23M to $28M.”
  • CEO on capital discipline: “We… recognize fiscal responsibility… continue to maintain positive net income… and… reduce expenses if needed to achieve this.”

Q&A Highlights

  • Alisertib dosing and timelines: Protocol amendment to increase dose (50→60mg) in SCLC; still aiming for interim data later in 2025 .
  • Neratinib + T‑DXd activity: Mechanistic rationale for enhanced activity; early efficacy signals across tumor types including pancreatic; more data likely in 2026 .
  • Medicare Part D redesign: Lower co‑pays in 2025/2026 boosting Medicare mix and reducing free goods burden; net positive for access/persistence .
  • IP/manufacturing for alisertib: Licensed from Takeda; manufacturing currently mostly in U.S.; not yet at commercial scale .

Estimates Context

  • Q1 2025 results vs consensus: Revenue $46.0M vs $44.6M; Primary EPS $0.10 vs -$0.02 — significant beat on both (values retrieved from S&P Global).
  • FY2025 consensus EPS $0.55 and revenue $221.5M; company guidance implies continued profitability with gross‑to‑net stability; potential upward estimate revisions if demand and SD mix strengthen (values retrieved from S&P Global).

Key Takeaways for Investors

  • Revenue/EPS beat driven by resilient demand and opex control despite seasonal inventory drawdown; non-GAAP EPS outperformance is a near-term positive .
  • Gross‑to‑net trending within guided 20.5%–21.5% band; Q1 at ~20.8% indicates disciplined discounting dynamics .
  • Commercial levers—dose escalation (~72%), SD channel expansion, and Medicare redesign—support persistence and mix, potentially improving net revenue conversion into Q2 .
  • China royalty softness is transitory per management; ROW expansion (Er‑Kim) adds optionality to ex‑U.S. revenue over time .
  • Pipeline catalysts: ALISCA‑Breast1 and ALISCA‑Lung1 interim data in H2 2025; neratinib + T‑DXd Phase II progression following promising Phase I signals .
  • FY25 guidance maintained; Q2 guide ($48–$50M net product revenue; $4–$6M net income) sets a bar for sequential rebound as inventories normalize .
  • Near-term trading lens: focus on Q2 demand normalization, SD channel strength, and any updates on Medicare impacts; medium-term thesis hinges on maintaining profitability and delivering clinical catalysts .

References: Press release and 8‑K Q1 2025 ; Q1 2025 earnings call transcript ; Prior quarter press releases ; AACR clinical data PR ; Er‑Kim distribution PR .