10-K annual report · filed Feb 19, 2026

Insmed Incorporated (INSM) FY2025 10-K Annual Report

Short answer

Insmed Incorporated (INSM) filed its fiscal 2025 10-K annual report with the SEC on Feb 19, 2026. It reported revenue of $606M (+66.7% year over year) and net income of −$1.3B.

  • Top risk flagged: FDA accelerated approval of ARIKAYCE contingent on successful ENCORE confirmatory trial with 425 patients enrolled as of Q4 2024

FY2025 key financial metrics · XBRL

Revenue
$606M
+66.7% YoY
Net income
−$1.3B
−39.7% YoY
Operating margin
-205.6%
+35.9 pp YoY
EPS (diluted)
−$6.42
−15.3% YoY
ROE
-172.8%
+147.4 pp YoY
Operating cash flow
−$935M
−36.7% YoY

Source: XBRL data from the Insmed Incorporated (INSM) FY2025 10-K on SEC EDGAR. USD.

Insmed Incorporated FY2025 10-K analysis

AI summary of each section, grounded in the filing text

Business Overview

  • Core business model: Development and commercialization of specialty pharmaceuticals focusing on respiratory diseases, including key marketed products ARIKAYCE and BRINSUPRI
  • New product emphasis: BRINSUPRI launch in August 2025 generated $172.7M US sales in 2025, contributing to 66.7% overall revenue growth to $606.4M
  • Strategic shift: Accelerated commercial readiness and significant investment in BRINSUPRI’s US launch, plus acquisition of INS1148 for $40M in 2025, expanding pipeline
  • Notable quantitative metrics: R&D expenses rose 28.9% to $771.1M, SG&A increased 52.1% to $701.2M, driven by headcount growth and commercial activities for BRINSUPRI
  • Unique fact: Completed two large equity offerings in 2024 and 2025, raising net proceeds of $713.2M and $823.3M respectively, bolstering cash reserves to support operations

Management Discussion & Analysis

  • Respiratory therapeutic area is the only commercial segment with two approved products: ARIKAYCE and BRINSUPRI
  • No cash flow, buybacks, dividends, or capex details mentioned
  • Forward-looking: portfolio focused on Respiratory, Inflammation & Immunology, Neuro & Rare diseases, with ongoing clinical and pre-clinical programs spanning advanced modalities

Risk Factors

  • FDA accelerated approval of ARIKAYCE contingent on successful ENCORE confirmatory trial with 425 patients enrolled as of Q4 2024
  • Exposure to inflation affecting suppliers, service providers, and partners across US, Europe, Japan, and global operations
  • Dependence on Lamira device regulatory approval in each market for ARIKAYCE commercialization limits product sales capability
  • Competitive market risks amid reliance on market acceptance against alternatives amid safety concerns like US boxed warning on ARIKAYCE
  • Outstanding term loan and royalty financing arrangement may limit financial flexibility and increase risk of shareholder dilution

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