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INSMED Inc (INSM)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 marked Insmed’s first quarter with two commercial products: total product revenues rose 52% year over year to $142.3M, driven by ARIKAYCE strength and the initial U.S. BRINSUPRI launch .
  • ARIKAYCE revenue was $114.3M (+22% YoY), and management raised full-year 2025 global ARIKAYCE guidance to $420–$430M from $405–$425M; this was a key positive catalyst .
  • BRINSUPRI generated $28.1M in its first partial quarter, with breadth of adoption (≈2,550 patients started; ≈1,700 prescribers) but with ~40% of Q3 sales from inventory stocking; expect Q4 to better reflect underlying demand dynamics .
  • EPS of -$1.75 missed Wall Street consensus (-$1.33*) while revenue of $142.3M beat consensus ($115.5M*), with mix effects and higher SG&A/R&D from launch and pipeline investment; consensus values via S&P Global* .
  • Near-term catalysts: continued BRINSUPRI U.S. launch normalization, EMA decision and EU launch (EC approval granted Nov 18, 2025), and advancing TPIP Phase 3 initiations; these should drive estimate revisions and sentiment .

What Went Well and What Went Wrong

  • What Went Well

    • ARIKAYCE delivered record quarterly revenue across U.S. and international regions (+22% YoY) and guidance was raised to $420–$430M for FY25 .
    • BRINSUPRI’s launch showed broad early adoption: ≈2,550 patients started, ≈1,700 physicians wrote ≥1 script; early market access approvals were broad across Medicare and commercial payers .
    • Strategic pipeline momentum: positive CHMP opinion in October (later culminating in EC approval) for BRINSUPRI in EU; Phase 3 TPIP program alignment with FDA and DMC support; multiple Phase 2/3 readouts slated in 2026 .

  • What Went Wrong

    • EPS missed consensus as SG&A ($186.4M) and R&D ($186.4M) grew materially with BRINSUPRI launch resourcing and clinical development; net loss widened to $370.0M .
    • Brensocatib Q3 revenue included ~40% inventory stocking, limiting visibility into underlying demand; management cautioned that Q4 will be more informative .
    • Continued expense pressure from change in fair value of deferred/contingent consideration ($104.7M) and elevated operating expenses ($508.3M), tempering near-term profitability trajectory .

Financial Results

Quarterly headline metrics vs prior periods and estimates

MetricQ1 2025Q2 2025Q3 2025
Total Product Revenues ($USD Millions) – Actual$92.8 $107.4 $142.3
Total Product Revenues ($USD Millions) – Consensus$91.2*$104.3*$115.5*
Diluted EPS ($) – Actual-$1.42 -$1.70 -$1.75
Diluted EPS ($) – Consensus-$1.337*-$1.316*-$1.333*

Values with asterisk retrieved from S&P Global.

Margins and operating expenses

MetricQ1 2025Q2 2025Q3 2025
Cost of Product Revenues ($USD Millions)$21.3 $28.1 $29.4
Cost of Product Revenues as % of Revenues22.9% 26.1% (calc from $28.1/$107.4) 20.6%
R&D ($USD Millions)$152.6 $177.2 $186.4
SG&A ($USD Millions)$147.5 $154.8 $186.4
Change in Fair Value of Deferred/Contingent Consideration ($USD Millions)$18.3 $59.0 $104.7

Segment and regional revenue breakdown

Segment/Region ($USD Millions)Q1 2025Q2 2025Q3 2025
ARIKAYCE – U.S.$64.3 $68.7 $74.0
ARIKAYCE – International$28.6 (22.1+6.5) $38.8 (30.7+8.1) $40.3
ARIKAYCE – Total$92.8 $107.4 $114.3
BRINSUPRI – U.S.$0.0$0.0$28.1
Total Company Revenues$92.8 $107.4 $142.3

KPIs (launch and commercial execution)

KPIQ1 2025Q2 2025Q3 2025
BRINSUPRI patients started (approx.)N/AN/A~2,550
BRINSUPRI prescribers with ≥1 script (approx.)N/AN/A~1,700
BRINSUPRI net sales ($USD Millions)N/AN/A$28.1
Inventory stocking contribution to BRINSUPRI salesN/AN/A~40%

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ARIKAYCE Global RevenueFY 2025$405–$425M (reiterated in Q1 & Q2) $420–$430M Raised

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
BRINSUPRI U.S. launch and accessPreparing for frictionless launch; payer engagement underway PDUFA Aug 12; readiness for immediate launch; access planning Broad early prescribing, high approvals; EMR inclusion; establishing standardized PA criteria; caution on early “honeymoon” access Expanding breadth; access formalization may slow approvals
ARIKAYCE performance & label expansionStrong double-digit growth; ENCORE on track H1’26 Record growth; ENCORE on track H1’26 Record U.S./Intl revenue; guidance raised; ENCORE progressing Strengthening; potential blockbuster on label expansion
EU/Global BRINSUPRI regulatoryEU/UK filings accepted EU/UK accepted; Japan filing planned H2’25 CHMP positive opinion in Oct; EC approval on Nov 18 Approvals achieved; EU launch early 2026
TPIP program (PAH/PH-ILD/PPF/IPF)Phase 2b topline expected June 2025 Phase 2b PAH positive; Phase 3 PH-ILD 2H’25; PAH early 2026 DMC/End-of-Phase-2 alignment; registrational program plans; Phase 3 initiations 4Q25/2026 Advancing toward pivotal
Macro/tariffs/manufacturingTariff impact assessed (single-digit $mm); expanding U.S. manufacturing N/AN/A (focus on launch dynamics)Stable; low direct impact reiterated earlier
R&D execution (BiRCh, CEDAR)BiRCh enrollment complete; CEDAR enrolling BiRCh topline by YE’25; CEDAR interim futility planned Q1’26 BiRCh topline early Jan’26; CEDAR fully enrolled; topline 1H’26 On schedule; timelines clarified

Management Commentary

  • CEO on BRINSUPRI launch positioning: “Our ambition is to place Brensupri in the conversation with some of the strongest respiratory launches the industry has ever seen, including Dupixent, Fasenra, Tezspire, and Ofev” .
  • COO on early adoption breadth and access: “As of the end of September, approximately 2,550 new patients had started treatment…about 1,700 physicians had written at least one script…vast majority of prescriptions have been approved for coverage” .
  • CFO on guidance and capital: “We are raising our 2025 full year global ARIKAYCE net revenue guidance to $420 to $430 million…At approximately $1.7 billion in cash, cash equivalents, and marketable securities…well capitalized” .
  • CEO on EU pricing strategy: “It’s our practice…to match the list price in the US with Europe and Japan…ultimate net price…often negotiations…with payors” .
  • CEO on inventory dynamics: “These results reflect the impact of necessary inventory stock in the channel, which accounted for approximately 40% of Brensupri revenue this quarter…do not anticipate a significant contribution…in the fourth quarter” .

Q&A Highlights

  • Payer criteria and “frictionless” access: Management targets clear, minimally burdensome PA criteria (e.g., ≥2 exacerbations, confirmed diagnosis), willing to offer modest discounting; cautions that once criteria are enforced, access may slow from “honeymoon” levels .
  • Prescriber behavior and dosing: Majority of prescriptions at 25 mg, with some physicians starting at 10 mg and titrating; depth of prescribing expected to build as patient feedback emerges .
  • Seasonality and reauthorization: Moderate holiday-related slows in physician visits; watching Medicare deductible reset in early 2026 and any reauthorization impacts .
  • EU pricing and prescriber mix: EU list price intended to match U.S.; breadth includes Centers of Excellence and community prescribers, with focus shifting to depth over coming quarters .
  • HS and CRSsNP clinical endpoints: CEDAR will report 16-week topline (AN count primary; HiSCR as secondary), full 52-week data to inform Phase 3; BIRCH powered at alpha 0.10 to detect meaningful sTSS improvements .

Estimates Context

  • Q3 2025: Revenue $142.3M vs consensus $115.5M* → beat; EPS -$1.75 vs -$1.33* → miss .
  • Q2 2025: Revenue $107.4M vs $104.3M* → beat; EPS -$1.70 vs -$1.32* → miss .
  • Q1 2025: Revenue $92.8M vs $91.2M* → beat; EPS -$1.42 vs -$1.34* → beat .

Values with asterisk retrieved from S&P Global.

Key Takeaways for Investors

  • ARIKAYCE continues to outperform with record revenue and raised FY25 guidance; this supports upward estimate revisions and strengthens the medium-term cash flow trajectory ahead of potential label expansion (ENCORE H1’26) .
  • BRINSUPRI’s U.S. launch showed strong breadth but Q3 included ~40% stocking; monitor Q4 for underlying demand, depth of prescribing, and finalized payer criteria effects on approval rates and time-to-fill .
  • Near-term regulatory catalysts are favorable: CHMP positive opinion (Oct), EC approval (Nov 18) enabling early 2026 EU launch; UK/Japan decisions expected in 2026, expanding market reach .
  • Pipeline de-risks TPIP with DMC endorsement and FDA EoP2 alignment; expect Phase 3 initiations in PH-ILD (Q4’25) and PAH (early 2026), plus PPF/IPF studies in 2H’26—broadening multi-indication optionality .
  • Expense intensity remains elevated (SG&A and R&D) due to launch and pipeline investments; while gross margin benefits from BRINSUPRI, operating losses persist—watch cash burn moderation as revenues scale .
  • Trading implications: Expect post-call estimate revisions (top-line higher, EPS lower near term), with stock likely sensitive to Q4 BRINSUPRI normalization, EU launch timelines, and ongoing payer dynamics .
  • Medium-term thesis: Multi-asset revenue growth (ARIKAYCE, BRINSUPRI, TPIP) with expanding geographies/indications provides diversified drivers; execution on clinical readouts and market access will be key to sustaining re-rating .