Insmed (INSM) Q4 2025 earnings review
BRINSUPRI Launch Ignites Hyper-Growth; $1B+ Target Set for 2026
Insmed delivered a transformative quarter driven by the U.S. launch of BRINSUPRI, which generated $144.6M in Q4 revenue—significantly accelerating from the $28.1M partial-quarter sales in Q3. Total Q4 revenue surged 153% YoY to $263.8M. While the company posted a net loss of $328.5M due to heavy commercial and R&D investment, the narrative has firmly shifted to top-line execution. Management issued aggressive FY26 guidance, projecting BRINSUPRI sales to exceed $1 billion in its first full year, positioning the drug as a rapid blockbuster. With $1.4B in cash, the balance sheet supports this aggressive ramp.
🐂 Bull Case
BRINSUPRI generated $144.6M in Q4, crushing the Q3 run rate. The FY26 guidance of >$1B suggests this is one of the most successful specialty respiratory launches in history, validating the heavy SG&A investment.
Far from being cannibalized or neglected, the legacy asset ARIKAYCE grew 14% YoY in Q4 and 19% in FY25, exceeding guidance. It provides a $450M+ stable revenue floor while BRINSUPRI ramps.
🐻 Bear Case
The company burned through significant capital, posting a $1.28B net loss for FY25. Operating expenses in Q4 alone were $583M against $263M in revenue. Profitability remains distant despite top-line hyper-growth.
The >$1B FY26 guidance sets an extremely high bar. Any hiccups in payer reimbursement dynamics, patient compliance, or the European rollout could lead to a painful valuation reset.
⚖️ Verdict: 🟢🟢
Bullish. The revenue acceleration is undeniable. Insmed has successfully transitioned from a single-product company to a high-growth commercial execution story. The $1B+ guidance for BRINSUPRI signals immense confidence in underlying demand.
Key Themes
BRINSUPRI: From Launch to Blockbuster
BRINSUPRI is capitalizing on the bronchiectasis unmet need faster than anticipated. Q4 sales of $144.6M signal massive uptake. Management's confidence is reflected in the FY26 guidance of >$1 billion, which implies a quarterly run rate averaging $250M+, a massive step up from current levels. The company noted broad prescriber adoption and is now focused on deepening usage.
ARIKAYCE Outperformance
Legacy asset ARIKAYCE continues to outperform, growing 19% in FY25 to $433.8M, beating the upper end of guidance ($420-430M). International markets are driving this, with Q4 International revenue up 25% YoY compared to 8% in the U.S. This provides critical cash flow diversity.
Expense Explosion
Success is expensive. Q4 SG&A surged to $212.5M (up from $142.5M in 24Q4) and R&D hit $254.9M (up from $179.7M). Total operating expenses for Q4 were $583.6M, more than double the revenue. While the cash balance is strong ($1.4B), the path to breakeven requires revenue to triple from current levels to cover this cost base.
Pipeline Velocity: TPIP & ENCORE
The pipeline remains a major value driver. 2026 is rich with catalysts: TPIP (PAH) Phase 3 initiating H1 2026, ARIKAYCE ENCORE (label expansion) topline data in March/April 2026, and Brensocatib CEDAR (HS) data in Q2 2026. The TPIP program specifically received Orphan Drug Designation in Jan 2026, de-risking the regulatory path.
Other KPIs
Strong. Cash, equivalents, and marketable securities stand at $1.4B. This provides a runway for the intense commercial ramp of BRINSUPRI and the initiation of multiple Phase 3 trials for TPIP, though heavy burn persists ($328M net loss in Q4).
Improving. Cost of product revenues (excluding amortization) was $44.2M on $263.8M revenue. This implies a gross margin of ~83%, an improvement driven by BRINSUPRI's lower manufacturing cost profile compared to ARIKAYCE.
Up 42% YoY. Driven by the acquisition of INS1148 and scaling up clinical activities for TPIP and brensocatib lifecycle management. This level of spend indicates aggressive reinvestment rather than profit optimization.
Guidance
Accelerating. This is the first specific annual guidance for the new launch. It implies a massive ramp from the $172.7M realized in partial-year 2025. If achieved, this confirms the 'blockbuster' thesis.
Stable/Growth. Implies YoY growth of 4% to 8% off the FY25 base of $433.8M. This represents a deceleration from the 19% growth seen in FY25, likely due to saturation in core markets, but remains a solid cash generator.
Accelerating. Compared to FY25 total revenue of $606.4M, this guidance implies ~140% YoY growth for the total company, driven almost entirely by the BRINSUPRI ramp.
Key Questions
Gross-to-Net Dynamics
With BRINSUPRI scaling rapidly, how are gross-to-net adjustments trending compared to the initial launch phase? Are we seeing pressure from payer contracting as volumes increase?
EU Launch Cadence
With European approval secured in Nov 2025, how should we model the revenue ramp in the EU/UK for 2026 compared to the U.S. trajectory? Are reimbursement discussions delaying significant contribution until H2?
Path to Profitability
Despite >$1.4B in projected revenue for 2026, the current expense run-rate ($2.3B annualized based on Q4) suggests continued losses. When does management anticipate the operating leverage will turn the company cash flow positive?