Sign in
KP

Kiniksa Pharmaceuticals International, plc (KNSA)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue was $137.8M, up 75% YoY in ARCALYST net product revenue and 14% QoQ, driven by a meaningful increase in active commercial patients, ~300 new prescribers, longer average treatment duration (30 months), and a bolus of Medicare Part D patients moving from free goods to paid therapy; 2025 ARCALYST revenue guidance was raised to $590–$605M from $560–$580M .
  • Gross margin expanded sequentially as COGS scaled below revenue; EBIT turned positive to $13.3M (9.6% margin) vs losses in Q4/Q3, with net income of $8.5M vs a $17.7M loss in Q1 2024 .
  • Against S&P Global consensus, revenue beat (Actual $137.8M vs $131.7M*) but EPS missed (Actual $0.11 vs $0.28*), reflecting higher operating and collaboration expenses tied to collaboration profit and a $7.0M tax provision in the quarter . Values marked with * retrieved from S&P Global.
  • Strategic catalysts: guidance raise, continued prescriber breadth/depth growth, and KPL-387 Phase 2/3 initiation mid-2025 with Phase 2 data expected 2H26; tariff risk to gross margin viewed as immaterial if applied to Samsung Biologics supply (Regeneron U.S. supply unaffected) .

What Went Well and What Went Wrong

  • What Went Well

    • Raised 2025 ARCALYST net sales guidance to $590–$605M after strong Q1 execution: “we are increasing our expected 2025 ARCALYST net sales to between $590 and $605 million from our previous guidance of between $560 and $580 million” (CEO) .
    • Commercial drivers outperformed typical Q1 headwinds: ~300 new prescribers, total prescribers since launch >3,150, average total duration rose to ~30 months from ~27 months; payer approval >90% (Q&A) .
    • Profitability inflected: EBIT of $13.3M and net income $8.5M; cash increased to $268.3M (+~$25M net cash flow) .

  • What Went Wrong

    • EPS missed S&P Global consensus despite a revenue beat (Actual $0.11 vs $0.28*), as operating costs and collaboration expenses scaled with profit and tax provision was $7.0M . Values marked with * retrieved from S&P Global.
    • Collaboration expenses more than doubled YoY to $43.8M, reflecting ARCALYST collaboration profitability, tempering EPS leverage .
    • Medicare Part D impact was a one-time Q1 bolus; management flagged uncertainties around continued enrollment and potential opt-outs in coming months .

Financial Results

  • Quarterly results vs prior periods
MetricQ3 2024Q4 2024Q1 2025
Total Revenue ($M)$112.2 $122.5 $137.8
Net Product Revenue ARCALYST ($M)$112.2 $122.5 $137.8
License & Collaboration Revenue ($M)$0.0 $0.0 $0.0
Cost of Goods Sold ($M)$20.1 $17.9 $17.9
Gross Margin % (calc)82.1% (112.214−20.109)/112.214 85.4% (122.536−17.896)/122.536 87.0% (137.785−17.868)/137.785
Total Operating Expenses ($M)$121.9 $141.8 $124.5
Collaboration Expenses ($M)$29.3 $48.2 $43.8
Income (Loss) from Operations ($M)$(9.7) $(19.3) $13.3
Net Income (Loss) ($M)$(12.7) $(8.9) $8.5
Diluted EPS ($)$(0.18) $(0.12) $0.11
Cash, Cash Equivalents & ST Inv. ($M)$223.8 $243.6 $268.3
  • Actual vs S&P Global consensus (Q1 2025)
MetricConsensusActualSurprise
Revenue ($M)$131.7*$137.8 +$6.1M (+4.6%)*
Diluted EPS ($)$0.28*$0.11 −$0.17*

Values marked with * retrieved from S&P Global.

  • KPIs and commercial drivers
KPIQ3 2024Q4 2024Q1 2025
Total prescribers since launch~2,550 >2,850 >3,150
Repeat prescribers (2+ patients)~640 —~820; ~50% of new Rx from repeat prescribers
Avg total duration of therapy~27 months ~27 months ~30 months
Avg initial treatment period——~17 months (median ~12)
Payer approval rate (completed cases)>90% —>90%
Gross-to-net (%)9.8% YTD through Q3 —10.7% (vs 13.5% in Q1’24)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ARCALYST Net Product RevenueFY 2025$560–$580M (2/25/25) $590–$605M (4/29/25) Raised
Cash FlowFY 2025Cash flow positive on an annual basis Cash flow positive on an annual basis Maintained
Gross Margin (Tariffs commentary)FY 2025+—Tariff impact expected immaterial; limited to cost of drug substance if Samsung supply; U.S. Regeneron-made supply unaffected Informational

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
Prescriber breadth/depthQ3: +250 new prescribers; ~2,550 total; ~640 repeat prescribers . Q4: continued growth; commercialization investments ongoing .~300 new prescribers; >3,150 total; ~820 repeat prescribers, ~50% of new Rx from repeat prescribers .Accelerating breadth and depth.
Duration of therapyAvg total duration 27 months .Avg total duration 30 months; initial period ~17 months (median ~12) .Extending duration supports revenue durability.
Medicare Part D dynamicsNot a driver in Q3; normal gross-to-net seasonality noted .One-time bolus of Medicare patients switching to paid therapy; improves affordability; creates uncertainty on opt-outs/grace period .Positive Q1 tailwind; trajectory uncertain.
Gross-to-netYTD Q3: 9.8% .Q1’25: 10.7% (vs 13.5% Q1’24); mix shift due to Medicare bolus (fewer co-pay eligible) .Lower vs Q1’24; roughly in line with ~10% full-year history .
KPL-387 (monthly IL‑1R1 mAb)Q4: announced; monthly SC dosing potential; Phase 2/3 mid-2025; data 2H26 .On track to initiate Phase 2/3 mid-2025; data 2H26; design details forthcoming .Execution on timelines; strategic extension of leadership.
Manufacturing/tariffsTech transfer costs noted; no 2024 license revenue in Q4 .Transfer to Samsung Biologics; tariff impact expected immaterial; Regeneron U.S. supply unaffected .Risk monitored; minimal impact expected.
Disease awarenessLaunch of Life DisRPted with Henrik Lundqvist and Carly Pearce .Continued campaign; Carly Pearce partnership amplified (4/30) .Sustained investment in awareness funnel.
Portfolio focusQ4: Discontinue abiprubart in Sjögren’s; prioritize CV .Continued focus on CV; KPL-1161 IND-enabling activities .Streamlined R&D spend into IL‑1 portfolio.

Management Commentary

  • “As a result of strong first quarter performance, we are increasing our expected 2025 ARCALYST net sales to between $590 and $605 million from our previous guidance of between $560 and $580 million.” — Sanj K. Patel, CEO .
  • “Q1 is typically a very challenging quarter … however, these were outweighed by 3 key drivers … ~300 new prescribers … total duration of therapy increased … and federal changes to Medicare Part D … led to a onetime bolus of patients who converted to paid therapy.” — Ross Moat, CCO .
  • “ARCALYST collaboration profit grew a significant 118% year-over-year to $87.6 million in the first quarter … We ended the first quarter with a cash balance of $268.3 million, representing approximately $25 million of net cash flow.” — Mark Ragosa, CFO .
  • “We expect any tariff on Samsung supply to be limited … which would have an immaterial impact on ARCALYST cost of goods sold and gross margin.” — Mark Ragosa, CFO .

Q&A Highlights

  • Duration and adherence: Avg initial treatment period ~17 months (median ~12); total duration ~30 months; payer approvals >90%; patient willingness to stay on therapy remains high .
  • Prescribing patterns: ~15% of patients treated at first recurrence; ~85% at 2+ recurrences, reflecting broad label utilization and earlier use for some physicians .
  • Gross-to-net: Q1’25 10.7% vs 13.5% in Q1’24 due to Medicare bolus changing co-pay eligibility mix; historical full-year around ~10% (not guidance) .
  • Medicare Part D: Q1 bolus largely historical PAP patients; uncertainties include 2-month grace period, opt-outs, and first-time co-pays; future quarter impact uncertain .
  • R&D spend baseline: Q4’24 included $19M abiprubart raw materials charge; on an apples-to-apples basis R&D ex one-time items was roughly flat; KPL-387 Phase 2/3 to initiate mid-2025 .

Estimates Context

  • Q1 2025 vs S&P Global consensus: Revenue beat (Actual $137.8M vs $131.7M*), EPS missed (Actual $0.11 vs $0.28*); number of estimates: Revenue (6*), EPS (4*) . Values marked with * retrieved from S&P Global.
  • Implication: Street likely raises revenue/ARPU/volume assumptions (prescriber adds, duration) but trims EPS on higher collaboration expense scaling with profit and tax provision visibility .

Key Takeaways for Investors

  • Commercial momentum intact: prescriber breadth/depth and multi‑year duration expanded; Q1 overcame seasonal headwinds and delivered a revenue beat, supporting a guidance raise .
  • Profitability inflection: EBIT and net income positive; sequential gross margin expansion; collaboration expenses scale with profit and temper EPS vs revenue upside .
  • Medicare Part D bolus boosted Q1; durability of this tailwind is uncertain due to new program dynamics—watch Q2 conversion/retention trends and gross‑to‑net mix .
  • Pipeline catalyst: KPL‑387 Phase 2/3 start mid‑2025; monthly liquid SC dosing could defend/expand leadership and address patient preference; Phase 2 data 2H26 .
  • Manufacturing/tariffs: Transfer to Samsung Biologics progressing; tariff exposure to drug substance seen as immaterial; U.S. Regeneron supply insulated—gross margin risk limited .
  • Near-term setup: Narrative likely centers on sustained patient adds, duration, repeat prescribers, and Medicare dynamics; medium term on KPL‑387 execution and maintaining ARCALYST growth .
  • Watchlist: Q2 patient flow-through post-bolus, collaboration expense elasticity to profit, and any updates to centers of excellence/awareness campaigns supporting funnel growth .

Additional Relevant Press Releases (Q1 period)

  • 4/30: Carly Pearce joins “Life DisRPted” disease awareness campaign to drive earlier diagnosis and treatment discussions, augmenting funnel-building efforts .
  • 4/24: Q1 results call logistics (pre-announcement) .