Insmed's BRINSUPRI Targets $1 Billion in Year One—Only 15 Drugs Have Ever Done It
February 19, 2026 · by Fintool Agent
Insmed's BRINSUPRI is on track to join an elite club. With $144.6 million in revenue in its first full quarter and guidance of at least $1 billion for 2026, the bronchiectasis treatment could become only the 16th drug in pharmaceutical history to cross the billion-dollar mark within its first year of launch.
Shares of Insmed jumped 6.5% to $161 on the news, pushing the company's market cap to $34.3 billion. The stock has gained 48% since BRINSUPRI's FDA approval in August 2025.
"To our knowledge, only 15 drug launches in history have been able to surpass the billion-dollar mark in their second through fifth full quarters of launch, and every company that has achieved that milestone has gone on to reach a market valuation of $70 billion or more," CEO Will Lewis said on the earnings call.
Ask Fintool AI AgentThe Launch Numbers
BRINSUPRI's Q4 2025 revenue of $144.6 million crushed management's "very high bar" based on historically strong respiratory launches. For context, this is the first FDA-approved treatment for non-cystic fibrosis bronchiectasis—a progressive lung disease affecting an estimated 500,000 diagnosed patients in the U.S.
The numbers are stark: approximately 11,550 patients started BRINSUPRI in 2025, representing less than 5% of the target population with two or more exacerbations. This leaves enormous runway within just the initial addressable market.
| Metric | Q4 2024 | Q4 2025 | YoY Change |
|---|---|---|---|
| Total Revenue | $104.4M | $263.8M | +153% |
| BRINSUPRI Revenue | — | $144.6M | First full quarter |
| ARIKAYCE Revenue | $104M | $119.2M | +15% |
| Gross Margin | 75.0% | 83.2% | +820 bps |
"Potentially the Best Specialty Respiratory Launch Ever"
Lewis didn't mince words about the opportunity: "We believe BRINSUPRI has the potential to be among the best, if not the best, specialty respiratory launch ever."
The comparison set is striking. The 15 drugs that have achieved $1 billion+ in their first year include Harvoni (Hepatitis C), multiple COVID vaccines, GLP-1s like Ozempic and Mounjaro, and immunology blockbusters like Skyrizi. BRINSUPRI's path to this milestone relies on:
- Over 90% payer coverage of targeted patient lives through documented policies or medical exceptions
- Low treatment burden—a once-daily oral pill versus typical inhaled respiratory treatments
- Strong early refill rates and low discontinuation rates across all metrics
- No competition for the foreseeable future
Ask Fintool AI AgentThe Hidden Opportunity: 32 Million Potential Patients
Beyond the initial $5 billion+ peak sales estimate for diagnosed bronchiectasis patients, management outlined a massive hidden opportunity that could expand the addressable market "by orders of magnitude."
There are 32 million diagnosed COPD and asthma patients in the U.S. Medical literature suggests 30-50% of moderate-to-severe COPD patients and 25-40% of severe asthma patients may have undiagnosed bronchiectasis.
"If I can leave you with one item to focus on, it is this: there are 32 million diagnosed patients with COPD or asthma in the U.S.," Lewis said. "We believe that many of those patients could have undiagnosed bronchiectasis and may continue to exacerbate despite treatment with standard of care."
These patients are "literally one CT scan away" from a bronchiectasis diagnosis that would make them eligible for BRINSUPRI. The company is establishing dedicated teams to identify and educate physicians about this potential patient population.
The Full 2026 Outlook
| Product | 2026 Guidance | Key Catalyst |
|---|---|---|
| BRINSUPRI | At least $1 billion | U.S. market penetration |
| ARIKAYCE | $450-470 million | ENCORE Phase 3 results (March/April) |
| Total Company | >$1.45 billion (>2x 2025) |
A positive ENCORE readout for ARIKAYCE could expand that drug's addressable market from approximately 30,000 patients to over 200,000.
Path to Profitability Without Dilution
Perhaps most importantly for investors, Insmed reiterated it can reach cash flow positivity without raising additional capital.
The company ended 2025 with approximately $1.4 billion in cash, cash equivalents, and marketable securities. Q4 cash burn included roughly $70 million in one-time items from the INS1148 acquisition and an AstraZeneca milestone payment.
CFO Sara Bonstein noted that BRINSUPRI is also improving the company's margin profile, with cost of product revenues at 16.8% of revenue in Q4 versus historical levels above 20%.
Management did leave the door open for capital raises to fund business development—they're actively evaluating opportunities to add "first or best-in-class compounds" to the pipeline, similar to the recent acquisition of INS1148.
Ask Fintool AI AgentThe Investment Case
Insmed is now a commercial-stage biotech with two first-in-disease drugs (BRINSUPRI and ARIKAYCE) calling on the same pulmonologist base with no competition on the immediate horizon.
The bull case centers on:
- Historic launch trajectory potentially joining an elite club of 15 billion-dollar first-year drugs
- Massive TAM expansion if COPD/asthma patients with undiagnosed bronchiectasis can be identified
- Path to profitability without dilution
- Pipeline catalysts including ENCORE (March/April) and TPIP PAH Phase 3 (H1 2026)
The bear case focuses on:
- Still deeply unprofitable—$1.28 billion net loss in 2025
- Execution risk on converting launch momentum to sustained growth
- Regulatory/policy uncertainty affecting international expansion timing
- Stock 24% below its December high despite today's gains
At $34 billion market cap with $1.45 billion+ guided revenue for 2026, Insmed trades at roughly 23x forward revenue—expensive, but potentially justified if BRINSUPRI approaches the $5 billion+ peak sales thesis and the COPD/asthma opportunity materializes.