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INSMED Inc (INSM)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 revenue of $107.4M grew 18.9% year over year and beat Wall Street consensus ($104.3M), while EPS of -$1.70 missed consensus (-$1.32); strength came from ARIKAYCE across all regions, with record U.S. revenue and outsized growth in Japan and Europe . Revenue consensus and EPS consensus shown below are from S&P Global estimates.*
  • Management reiterated FY2025 global ARIKAYCE revenue guidance of $405–$425M and highlighted strong capital (~$1.9B cash and marketable securities) to support brensocatib’s imminent U.S. launch post-PDUFA (Aug 12) and TPIP Phase 3 initiations .
  • Key operational drivers: brensocatib launch readiness (expanded salesforce, patient support “inLighten”), TPIP Phase 2b PAH topline that exceeded expectations (largest PVR reduction vs placebo in a well-controlled trial), and BiRCh CRSsNP progressing with no safety signals .
  • Immediate stock reaction: pre-market dip of ~2.9% as revenue beat was offset by a larger-than-expected EPS loss despite favorable pipeline/catalyst setup .

What Went Well and What Went Wrong

  • What Went Well

    • ARIKAYCE revenue hit $107.4M (+18.9% YoY), driven by U.S. $68.7M (+7.7%), Japan $30.7M (+45.3%), Europe/ROW $8.1M (+48.3%); CFO called it the “highest quarterly revenue ever achieved in the U.S.” .
    • TPIP Phase 2b in PAH met primary and all secondary endpoints, with the company describing topline results that “surpassed our expectations” and planning Phase 3 starts (PH-ILD 2H25, PAH early 2026) .
    • Brensocatib launch readiness: expanded salesforce >10 months pre-approval; strong physician intent; patient support program inLighten deployed; Will Lewis: “our ambition here and our preparation is for this to be a strong launch” .

  • What Went Wrong

    • EPS missed consensus as SG&A rose to $154.8M and R&D to $177.2M with commercialization and pipeline investments (headcount, professional fees) ahead of the brensocatib launch .
    • Cost of product revenues increased to $28.1M (26.1% of revenue) alongside volume growth, slightly pressuring gross margin vs prior year .
    • Ongoing net loss of $321.7M reflects the investment cycle; CFO reminded that revenue booking from new launches lags approval by weeks, tempering near-term contribution tracking .

Financial Results

Headline vs. Estimates (Q2 2025)

MetricActual Q2 2025Consensus (S&P Global)Surprise
Revenue ($USD Millions)$107.415 $104.312*+$3.103
EPS ($)-$1.70 -$1.316*-$0.384

Values marked with * were retrieved from S&P Global.

Sequential Performance

MetricQ4 2024Q1 2025Q2 2025
Revenue ($USD Millions)$104.4 $92.8 $107.4
Net Loss ($USD Millions)$235.5 $256.6 $321.7
EPS ($)-$1.32 -$1.42 -$1.70
Cost of Product Revenues ($USD Millions)$26.2 $21.3 $28.1
R&D ($USD Millions)$179.7 $152.6 $177.2
SG&A ($USD Millions)$142.5 $147.5 $154.8

Year-over-Year Snapshot (Q2)

MetricQ2 2024Q2 2025
Revenue ($USD Millions)$90.3 $107.4
EPS ($)-$1.94 -$1.70

ARIKAYCE Regional Revenue

Region ($USD Millions)Q4 2024Q1 2025Q2 2025
U.S.$67.8 $64.3 $68.7
Japan$30.7 $22.1 $30.7
Europe & Rest of World$5.9 $6.5 $8.1
Total$104.4 $92.8 $107.4

Key KPIs

KPIQ4 2024Q1 2025Q2 2025
U.S. ARIKAYCE Gross-to-Net (%)n/a~20% guidance (high-teens to low-twenties) ~20% guidance (high-teens to low-twenties)
Cash, Cash Equivalents & Marketable Securities ($USD Billions)~$1.4 ~$1.2 ~$1.9
Weighted Avg. Shares (Millions)179.0 180.9 189.3

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ARIKAYCE Global Revenue ($USD Millions)FY 2025$405–$425 (Q4 2024, Q1 2025) $405–$425 (Q2 2025) Maintained
U.S. ARIKAYCE Gross-to-Net (%)FY 2025High-teens to low-twenties (Q1 2025) High-teens to low-twenties (Q2 CFO slide) Maintained
Cash Burn Trend2H 2025 onwardn/aExpect decrease with U.S. brensocatib launch (pending approval) New qualitative

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
Brensocatib regulatory/launchNDA accepted; Priority Review; no AdCom; launch prep [29 (press)]PDUFA Aug 12; “strong launch” ambition; inLighten support live Steady progress; high confidence
TPIP programPAH Phase 2b enrollment complete; PH-ILD imaging data Phase 2b PAH topline exceeded expectations; PH-ILD Phase 3 2H25; PAH Phase 3 early 2026 Positive inflection
ARIKAYCE performanceFY2024 +19% YoY; Q1 +22.9% Q2 +18.9% YoY; record U.S. quarter Sustained double-digit growth
Supply chain/tariffsSingle-digit million annual impact; minimized exposure Not emphasized De-emphasized
R&D execution (Brensocatib/ARIKAYCE)BiRCh fully enrolled; ENCORE on track H1’26 BiRCh safety review: no signals; CEDAR >50% enrollment; ENCORE timeline reiterated On track
Capital & balance sheet~$1.4B YE’24; ~$1.2B Q1’25 ~$1.9B Q2’25; $823.1M equity raise; converts redeemed Strengthened

Management Commentary

  • “Insmed is now ‘three for three’ in terms of positive clinical trial results for our late-stage assets… we await the widely anticipated FDA approval and launch of brensocatib in bronchiectasis” — Will Lewis, CEO .
  • “Brensocatib’s U.S. launch is uniquely positioned for success; trained & deployed our expanded salesforce >10 months pre-approval; ~90% of surveyed physicians intend to prescribe to patients with ≥2 PEs” — COO reflections .
  • “ARIKAYCE continues to grow double-digits… highest quarterly revenue ever achieved in the U.S… On track to achieve 2025 ARIKAYCE revenue guidance” — CFO .

Q&A Highlights

  • Patient journey/access: inLighten patient support is fully deployed to ease payer navigation and script-to-fill funnel; payer interactions supportive of access processes .
  • Launch timing for revenue recognition: CFO reminded revenue booking typically begins weeks after approval (analogous to ARIKAYCE), guiding near-term projections .
  • Brensocatib follow-on indications: BiRCh safety committee found no safety signal; CEDAR HS futility analysis expected in Q1 2026; next-gen DPP1 work advancing .
  • TPIP: Confidence reinforced by Phase 2b PVR/6MWD benefits; Phase 3 designs targeted to start on disclosed timelines .

Estimates Context

  • Q2 2025 actual revenue beat consensus ($107.415M vs $104.312M), while EPS missed (-$1.70 vs -$1.316). The revenue upside was driven by broader ARIKAYCE strength (Japan/Europe outperformance), whereas the EPS miss reflected elevated SG&A and R&D tied to brensocatib launch readiness and pipeline progress . Consensus values shown are from S&P Global.*
  • Post-quarter catalysts should prompt upward revisions to medium-term revenue (brensocatib approval announced Aug 12, available by prescription), with near-term EPS drag potentially easing as revenue ramps and cash burn decreases per CFO commentary .

Values marked with * were retrieved from S&P Global.

Key Takeaways for Investors

  • ARIKAYCE remains a durable growth engine (+18.9% YoY in Q2) with geographic breadth; guidance maintained at $405–$425M for FY2025 .
  • Brensocatib’s U.S. approval (Aug 12) unlocks a new growth leg; expect initial booking lag then acceleration, supported by prepared field force and patient support infrastructure .
  • TPIP’s Phase 2b results de-risk the program; watch for PH-ILD Phase 3 start in 2H 2025 and PAH Phase 3 in early 2026 as potential pipeline value drivers .
  • Near-term EPS pressure stems from strategic spend; cash of ~$1.9B provides runway through multiple catalysts, with CFO signaling cash burn to decline as brensocatib revenue ramps .
  • Estimate resets likely: revenue raised for ARIKAYCE near-term and brensocatib medium-term; EPS paths should improve with launch scaling and operating leverage.*
  • Monitor: ENCORE Phase 3 readout (ARIKAYCE label expansion; H1 2026), BiRCh CRSsNP topline by YE 2025, HS CEDAR futility analysis Q1 2026 .
  • Tactical: Post-approval pullbacks tied to EPS misses may offer entry ahead of brensocatib ramp and TPIP Phase 3 initiations; watch payer access and script conversion metrics cited by management .
Notes:
- Consensus/estimates marked * are from S&P Global.