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Karyopharm Therapeutics Inc. (KPTI)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 total revenue was $30.0M, down 9% year over year, driven by a $5.0M atypical increase in product return reserve tied to expired 80 mg/100 mg XPOVIO units; demand grew 5% YoY and royalty revenue rose 57% to $1.7M .
  • The Phase 3 SENTRY trial in JAKi‑naïve myelofibrosis passed the pre‑specified futility analysis and is ~80% enrolled; completion of target enrollment is expected in June/July 2025, with top‑line results late 2025/early 2026 .
  • 2025 guidance was reaffirmed: total revenue $140–$155M and U.S. XPOVIO net product revenue $115–$130M; management now expects to track to the lower end given Q1 returns .
  • Cash, cash equivalents, restricted cash and investments fell to $70.3M (from $109.1M at year‑end); company is exploring alternatives to extend cash runway (base case funds operations into early Q1 2026; into early Q4 2025 after factoring October 2025 converts and liquidity covenant) .
  • Near‑term catalysts: SENTRY enrollment completion (June/July), initial SENTRY‑2 data in 1H 2025, and myelofibrosis Phase 3 readout late 2025/early 2026—key stock drivers alongside resolution of financing runway .

What Went Well and What Went Wrong

What Went Well

  • SENTRY Phase 3 passed futility and continues unchanged; ~80% enrollment with plan to complete June/July 2025: “continues as planned without modifications” .
  • Commercial demand resilience: XPOVIO demand +5% YoY; strong community and academic usage; royalty revenue +57% reflecting expanding ex‑U.S. footprint .
  • Strategic clarity and confidence: management highlighted additive/synergistic potential of selinexor + ruxolitinib and a U.S. peak MF opportunity up to ~$1B: “commercial opportunity in myelofibrosis is transformational… peak revenue potential… up to approximately $1 billion” .

What Went Wrong

  • Revenue pressure from atypical returns: U.S. net product revenue fell to $21.1M (from $26.0M YoY) due to a $5.0M product return reserve increase on expired higher‑dose units; gross‑to‑net elevated versus 2024 .
  • Higher interest expense year over year ($11.0M vs $5.9M) tied to 2024 debt issuance; cash balance declined to $70.3M, increasing financing sensitivity .
  • SENTRY enrollment slightly slower than anticipated in early 2025, pushing completion into June/July; management acknowledged pacing versus initial curves .

Financial Results

Revenue, EPS, Margins vs Prior Periods and Estimates

MetricQ3 2024Q4 2024Q1 2025
Revenue Actual ($USD)$38.783M $30.542M $30.015M
Revenue Consensus ($USD)$37.924M*$35.674M*$35.122M*
Primary EPS Actual ($)-3.90*-3.60*-2.77
Primary EPS Consensus ($)-4.425*-4.05*-4.282*
Net Income Margin %-82.70%*-100.78%*-78.17%*

Values with asterisks retrieved from S&P Global.

Notes:

  • Company disclosed that Q1 2025 per‑share amounts are adjusted for the 1‑for‑15 reverse split effective Feb 25, 2025; prior quarter press releases present pre‑split per‑share figures .
  • Q1 results: revenue missed consensus (returns‑driven), EPS beat (loss narrower), aided by $19.8M other income from non‑cash fair value remeasurements .

Revenue Breakdown

MetricQ3 2024Q4 2024Q1 2025
Net Product Revenue ($USD)$29.516M $29.252M $21.054M
License & Other Revenue ($USD)$9.267M $1.290M $8.961M
Total Revenue ($USD)$38.783M $30.542M $30.015M

Operating Metrics

MetricQ3 2024Q4 2024Q1 2025
Total Operating Expenses ($USD)$65.066M $61.823M $63.271M
R&D Expense ($USD)$36.134M $33.302M $34.618M
SG&A Expense ($USD)$27.632M $27.190M $27.352M
Interest Expense ($USD)$11.385M $11.204M $10.994M
Other Income ($USD)$3.792M $10.114M $19.824M

KPIs

KPIQ3 2024Q4 2024Q1 2025
Gross-to-Net (XPOVIO)31% 33.3% 45% (Q1) vs 29.3% Q1’24
Cash, Cash Equivalents & Investments ($USD)$133.9M $109.1M $70.3M

Guidance Changes

MetricPeriodPrevious Guidance (Q4 2024)Current Guidance (Q1 2025)Change
Total RevenueFY 2025$140–$155M $140–$155M Maintained; mgmt expects lower end due to Q1 returns
U.S. XPOVIO Net Product RevenueFY 2025$115–$130M $115–$130M Maintained; tracking to lower end
R&D + SG&A ExpensesFY 2025$240–$255M $240–$255M Maintained
Cash Runway (base case)ThroughInto Q1 2026 (base); Q4 2025 incl. converts & covenant Into early Q1 2026 (base); into early Q4 2025 incl. converts & covenant Maintained; company exploring runway extension

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024 and Q4 2024)Current Period (Q1 2025)Trend
Myelofibrosis SENTRY trialEndpoint changed to Abs‑TSS; strong Phase 1 combo signal; on track 2H25 readout Passed futility; ~80% enrolled; completion June/July; late 2025/early 2026 readout Confidence rising; operational progress
Demand & GTN3 consecutive QoQ demand growth; GTN ~31–33% Demand +5% YoY; GTN 45% in Q1 due to atypical returns; reversion expected Near‑term GTN spike; expected normalization
Endometrial cancer (EC‑042)Design modifications after FDA dialogue; focus on TP53 WT pMMR; top‑line mid‑2026 Enrollment steady; mid‑2026 timeline reiterated Steady execution; clarity on population
Financing/runwayCash $109.1M at YE; exploring financing/BD Cash $70.3M; “exploring various alternatives to extend cash runway” Heightened focus on capital
Competitive MM landscapeCommunity/academic positioning; pre/post T‑cell therapy role Resilience; community 60% of sales; continued usage pre/post T‑cell therapies Stable positioning amid competition

Management Commentary

  • CEO on MF strategy: “We are pleased that our Phase 3 SENTRY trial... has passed its pre‑specified futility analysis and continues as planned without modifications… the combination holds the potential to be a much needed, new standard of care” .
  • CFO on GTN spike: “Gross to net provisions for XPOVIO in the first quarter was 45%… We expect our gross to net provisions will return to historic levels starting in the second quarter” .
  • CMO on futility details: thresholds required “no worsening for the combination relative to ruxolitinib alone”; DSMB recommended continue as planned .
  • CEO on runway: “We are exploring various opportunities to extend our cash runway” while prioritizing MF and EC Phase 3s .

Q&A Highlights

  • Futility analysis scope and criteria: DSMB reviewed unblinded SVR35 and absolute TSS in first 61 patients over 24 weeks; recommended continuation without modifications .
  • TSS powering assumptions: company assumptions use ~4‑point delta, SD ~12, targeting >80% power on absolute TSS .
  • Enrollment pacing: slightly slower in early 2025 vs curves (MANIFEST/TRANSFORM benchmarks), driving June/July completion; screening robust .
  • Returns impact clarification: $5M high‑dose returns tied to 2021–2022 BOSTON launch; isolated to expiry window; expect reversion to historical returns .
  • Runway extension levers: BD/partnerships, debt extensions, equity as options; specifics not disclosed .
  • Guidance context: management expects delivery toward lower end of ranges given Q1 returns; demand growth and partner royalties supportive .

Estimates Context

  • Q1 2025 vs consensus: Revenue $30.015M vs $35.122M (miss); EPS -$2.77 vs -$4.282 (beat). Drivers: $5.0M returns (revenue headwind) and $19.824M other income from non‑cash remeasurements (EPS tailwind) .
  • Q4 2024: Revenue $30.542M vs $35.675M (miss); EPS -$3.60 vs -$4.05 (beat)*.
  • Q3 2024: Revenue $38.783M vs $37.924M (beat); EPS -$3.90 vs -$4.425 (beat)*.

Values with asterisks retrieved from S&P Global.

Key Takeaways for Investors

  • Revenue softness in Q1 was primarily non‑recurring (expiry‑driven high‑dose returns); management expects GTN normalization from Q2, implying cleaner P&L optics into 2H .
  • SENTRY passing futility materially reduces binary risk; June/July enrollment completion and late‑2025/early‑2026 top‑line are critical catalysts likely to drive sentiment .
  • Financing runway is the main overhang; active exploration of BD/financing suggests path to bridge into key readouts—monitor disclosures closely .
  • Commercial engine remains resilient amid MM competition; ex‑U.S. royalty growth supports diversified revenue base .
  • Guidance held but skewed to the low end; watch Q2/Q3 print for GTN reversion, demand trajectory, and cash burn pacing .
  • Scientific narrative in MF is strengthening (monotherapy signals on spleen, hemoglobin, cytokines); supports additive/synergistic thesis for ruxolitinib combo .
  • Near‑term trading set‑up hinges on MF enrollment completion PR and early SENTRY‑2 data, alongside any financing update; mid‑term thesis is binary on SENTRY top‑line.