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Kiniksa Pharmaceuticals International, plc (KNSA)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 delivered strong topline growth with ARCALYST net product revenue of $180.9M (+61% YoY, +15% QoQ), prompting a second guidance raise this year to $670–$675M for FY25; however, diluted EPS of $0.23 fell below consensus while revenue beat materially .
  • Versus S&P Global consensus, revenue beat by ~$13.5M (+8.1%), while EPS missed by ~$0.14 (−37.3%); management attributed higher collaboration expense to stronger collaboration profit on higher sales, pressuring EPS despite positive operating leverage .
  • Commercial KPIs improved: prescribers surpassed 3,825 (+350+ new in Q3), average total therapy duration increased to ~32 months, and Q3 was the highest new prescriber quarter since launch—underscoring expanding breadth and durability of adoption .
  • Pipeline momentum: KPL‑387 received FDA Orphan Drug Designation (pericarditis) and remains on track for Phase 2 dose‑focusing data in 2H26, supporting a broader IL‑1α/β inhibition franchise narrative and potential future penetration gains .

What Went Well and What Went Wrong

  • What Went Well

    • Record commercial execution: ARCALYST revenue rose to $180.9M (+$24M QoQ; +$68.6M YoY), driven by higher active patients, prescriber breadth (>3,825 total; >350 new in Q3), and longer therapy duration (~32 months) .
    • Guidance raised again: FY25 ARCALYST net sales increased to $670–$675M (from $625–$640M), reflecting sustained trajectory even as management factors normal year‑end dynamics .
    • Cash strengthening alongside growth: Cash, equivalents, and ST investments rose by ~$44M QoQ to $352.1M with no debt, and management reiterated annual cash‑flow positivity under the current plan .
    • Quote: “We’ve raised our full‑year net sales guidance to between $670 million to $675 million… we expect to continue to grow ARCALYST revenue.” – Sanj K. Patel, CEO .

  • What Went Wrong

    • EPS below Street: Diluted EPS ($0.23) missed consensus despite revenue beat; collaboration expense rose with collaboration profit, limiting EPS leverage .
    • Operating expenses accelerated: Total OpEx increased to $156.8M (vs. $136.6M in Q2 and $121.9M in Q3’24), including higher collaboration expenses tied to stronger sales .
    • Modeling headwind items: Growth‑to‑net trended down YTD to 8.9% (from 9.5% YTD in Q2), and the tax rate and collaboration expense ran higher than some Street models (management pointed to sales strength and jurisdictional mix) .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Total Revenue ($M)$112.214 $137.785 $156.797 $180.855
Net Income ($M)$(12.693) $8.539 $17.832 $18.435
Diluted EPS ($)$(0.18) $0.11 $0.23 $0.23
Total Operating Expenses ($M)$121.872 $124.513 $136.637 $156.834
Cost of Goods Sold ($M)$20.109 $17.868 $18.603 $20.257
Collaboration Expenses ($M)$29.307 $43.790 $52.418 $63.307
R&D ($M)$26.057 $19.325 $18.753 $24.166
SG&A ($M)$46.399 $43.530 $46.863 $49.104
Cash & ST Investments ($M, period end)$223.780 $268.340 $307.782 $352.102

Vs Estimates (S&P Global consensus)

MetricActualConsensus*Surprise*Surprise %*
Revenue ($M)$180.855 $167.358*+$13.497*+8.1%*
Diluted/Primary EPS ($)$0.23 $0.3667*−$0.1367*−37.3%*

Values marked with * retrieved from S&P Global.

KPIs and Operational Metrics

KPIQ3 2024Q1 2025Q2 2025Q3 2025
Prescribers since launch>2,550 >3,150 >3,475 >3,825
New prescribers in quarter——>325 >350
Avg total therapy duration (months)~27 ~30 ~30 ~32
Penetration (2+ recurrences)——~15% —
Payer approval rate——>90% (resonance/field) —
Growth‑to‑net (YTD)——9.5% (YTD) 8.9% (YTD)

Notes: “—” indicates not disclosed in that period.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ARCALYST Net Product RevenueFY 2025$625–$640M (7/29/25) $670–$675M (10/28/25) Raised
Cash flow (company plan)FY 2025Cash‑flow positive annually Cash‑flow positive annually Maintained

Earnings Call Themes & Trends

TopicQ1 2025 (Prev-2)Q2 2025 (Prev-1)Q3 2025 (Current)Trend
IL‑1 adoption / SoC shiftGrowing duration (~30m) and adoption Real‑world data, second‑line after NSAIDs/colchicine; awareness campaigns Continued earlier use (20% at first recurrence), expanding active patients Strengthening
Prescriber breadth & AI/digital—AI‑driven targeting; strong new prescribers Highest new prescriber quarter since launch; >350 new; AI and digital marketing emphasis Accelerating
Duration & restarts—Avg total duration ~30m; strong compliance Avg total duration ~32m; ~45% restart after initial stop; 99.5% event reduction with continued treatment (literature) Improving durability
Medicare Part D / IRA—Q1 bolus from IRA; persistence maintained Not emphasizedLapping Q1 effect
Guidelines——ACC concise guidance (Aug) supports IL‑1 pathway; used in promotion Positive reinforcement
KPL‑387 developmentOn track initiate mid‑25; 2H26 Ph2 data Recruiting; 2H26 Ph2 data ODD granted; 2H26 Ph2 data; monthly dose focus Positive progress
Tariffs / supply chainMonitoring tariffs; Samsung transfer; immaterial GM impact expected ——Stable risk disclosure

Management Commentary

  • “We’ve raised our full‑year net sales guidance to between $670 million to $675 million… we expect to continue to grow ARCALYST revenue.” – Sanj K. Patel, CEO .
  • “New patient enrollments grew by their highest level in a quarter since launch… prescriber count… more than 3,825… ~28% have written for two or more patients.” – Ross Moat, CCO .
  • “ARCALYST collaboration profit grew… 118% YoY to $126.6M… we continue to expect our current operating plan to remain cash flow positive on an annual basis.” – Mark Ragosa, CFO .
  • “Continued treatment without interruption resulted in a 99.5% reduction in event rates post‑treatment/on treatment compared to pre‑treatment.” – John Paolini, CMO .
  • “ACC concise clinical guidance… positions IL‑1 pathway inhibition as second line after NSAIDs and colchicine… we’ve incorporated it within promotional materials.” – John Paolini / Ross Moat .

Q&A Highlights

  • Duration, satisfaction, and restarts: Physicians treat to disease duration (median ~3 years) with strong efficacy; ~45% restart rate after initial discontinuation, with quick returns to control on re‑initiation .
  • Guidelines tailwind: August ACC concise guidance supports earlier use as steroid‑sparing second line; KNSA integrated into promotion, reinforcing paradigm shift .
  • Prescriber acquisition tactics: Record new prescribers driven by targeted field efforts, AI‑guided outreach, and digital marketing to match physician timing and patient flow .
  • Financial modeling: Growth‑to‑net YTD moved to 8.9% (vs 9.5% YTD in Q2); collaboration expense up in line with higher ARCALYST collaboration profit; tax consistent with jurisdictional mix .
  • KPL‑387 dose selection and competitive lens: Phase 2 is dose‑focusing around 300mg monthly SC; management emphasized dual IL‑1α/β blockade as mechanistically upstream vs inflammasome‑only approaches .

Estimates Context

  • Q3 revenue beat and EPS miss versus S&P Global consensus: revenue $180.9M vs $167.4M estimate (+8.1%), EPS $0.23 vs $0.3667 estimate (−$0.1367) . Values marked with * retrieved from S&P Global.
  • Street models may need higher FY25 revenue and collaboration expense/Tax line updates post guidance raise and Q3 mix; EPS trajectory sensitive to collaboration profit share dynamics .

Key Takeaways for Investors

  • Revenue outperformance with another guidance raise supports upward estimate revisions; watch for collaboration expense scaling with sales as a key EPS swing factor .
  • Commercial flywheel is strengthening (record new prescribers, longer duration), aided by ACC guidance and enhanced AI/digital execution—sustaining growth into 2026 .
  • EPS shortfall vs consensus highlights the importance of modeling collaboration expense and tax; gross profit drivers remain intact with robust demand .
  • Balance sheet is strengthening (cash to $352.1M, no debt), enabling continued pipeline and commercial investment without capital markets reliance .
  • KPL‑387 adds optionality: ODD and a monthly liquid autoinjector profile could expand IL‑1α/β penetration; Phase 2 dose‑focusing data in 2H26 is the next major clinical catalyst .
  • Near‑term watch items: Q4 seasonality (typical industry dynamics), growth‑to‑net trend, collaboration expense trajectory, and any competitive inflammasome data read‑throughs .
  • Medium‑term thesis: Continued penetration (still ~15% in multi‑recurrence cohort as of Q2) and earlier‑line adoption suggest a multi‑year runway, with pipeline potentially extending franchise durability .

Additional Source Highlights (Q3 2025)

  • Q3 2025 8‑K/Press release (Ex. 99.1): ARCALYST revenue $180.9M; FY25 guidance to $670–$675M; cash $352.1M; OpEx detail; net income $18.4M; duration ~32 months; prescribers >3,825 .
  • Q3 2025 Earnings call: details on collaboration profit, GTN, prescriber adds, ACC guidance use, restart dynamics, and KPL‑387 dose‑focusing .
  • Other relevant Q3 press release: FDA Orphan Drug Designation for KPL‑387 (pericarditis) .

S&P Global disclaimer: All values marked with an asterisk (*) are retrieved from S&P Global consensus data.