Insmed Raises 2026 Revenue Outlook Floor as BRINSUPRI Sales Reach $400 Million

Insmed Incorporated (NASDAQ: INSM) raised the lower end of its 2026 revenue guidance for both commercial products after BRINSUPRI generated $400.1 million in third-quarter revenue, up 29% sequentially, and ARIKAYCE sales increased 9% year over year to $124.4 million.

The biopharmaceutical company reported total revenue of $524.4 million for the three months ended September 30, 2026, compared with $142.3 million a year earlier. The expanding revenue base and a lower cost-of-product-revenue ratio helped narrow Insmed’s operating loss to $89.4 million from $366.0 million in the prior-year quarter, even as the company increased investment in commercialization and clinical development.

BRINSUPRI drives guidance increase

Insmed now expects full-year BRINSUPRI revenue of $1.35 billion to $1.4 billion, compared with its previous range of $1.25 billion to $1.4 billion. The forecast does not assume a meaningful contribution from Japan during 2026.

BRINSUPRI’s third-quarter gross-to-net deductions were within the company’s annual guidance range of the mid-20% to high-20% area. Insmed said the medicine reached blockbuster status during its first four full quarters following launch.

The company has also launched BRINSUPRI in Japan, where it is the only approved medicine for patients with non-cystic fibrosis bronchiectasis. Insmed estimates that about 150,000 patients in Japan are currently diagnosed with the disease and expects Japan to be the primary source of BRINSUPRI’s international revenue.

To build longer-term evidence for the treatment, Insmed is supporting two observational initiatives. A three-year, open-label collaboration with the European Multi-centre Bronchiectasis Audit and Research Collaboration is expected to include as many as 3,000 patients across six countries. A separate two-year U.S. study at 13 sites plans to enroll up to 1,000 patients to assess exacerbations, safety, quality of life, lung function and other outcomes.

ARIKAYCE sales grow as regulatory decisions approach

ARIKAYCE generated $75.5 million in U.S. revenue, up 2% from the third quarter of 2025, while international revenue rose 21% to $48.9 million. Worldwide sales totaled $124.4 million.

Insmed increased its full-year ARIKAYCE forecast to $460 million to $470 million from $450 million to $470 million, leaving the upper end unchanged. The guidance excludes any 2026 contribution from a potential label expansion in the United States or Japan. Gross-to-net deductions remained within the anticipated low-20% to mid-20% range.

The U.S. Food and Drug Administration granted priority review to Insmed’s supplemental application for a broader ARIKAYCE indication, with a target action date of January 28, 2027. The company also intends to submit supporting data to Japan’s Pharmaceuticals and Medical Devices Agency in the fourth quarter of 2026. Subject to approval, Insmed expects to launch ARIKAYCE under an expanded label covering all patients with Mycobacterium avium complex lung disease in both markets during the first half of 2027.

Higher investment accompanies narrower operating loss

Cost of product revenue, excluding intangible-asset amortization, was $78.2 million, or 14.9% of revenue, compared with $29.4 million, or 20.6%, a year earlier. Insmed attributed the lower percentage to BRINSUPRI’s contribution.

Research and development expense increased to $270.0 million from $186.4 million, while selling, general and administrative expense rose to $253.0 million from $186.4 million. The increases reflected spending on the BRINSUPRI launch and development of the clinical pipeline. Total operating expenses were $613.8 million, up from $508.3 million.

Insmed ended September with approximately $1.1 billion in cash, cash equivalents and marketable securities. Management continues to believe the company can reach cash-flow positivity in 2027 without additional capital, assuming no material expansion of its expense base through business development. The company expects investment in clinical programs and its Japanese commercial infrastructure to increase in the fourth quarter, including anticipated milestone payments totaling $50 million to AstraZeneca.

Clinical pipeline advances

Insmed said four Phase 3 studies of treprostinil palmitil inhalation powder, or TPIP, remain on track. One study is more than 35% enrolled and is targeting completion of enrollment in the first half of 2028. Other studies have enrolled their first patient, opened an initial site ahead of planned enrollment, or are expected to begin in the first half of 2027.

The company is also preparing for several earlier-stage milestones in 2027. Subject to positive Phase 1 results, Insmed expects to advance INS1033 into a Phase 2 rheumatoid arthritis study. It also plans to begin a Phase 2 program for INS1148 in idiopathic pulmonary fibrosis and report initial data from Phase 1 gene-therapy studies involving INS1201 and INS1202.

Execution remains subject to commercial, regulatory and clinical risks. Insmed identified potential setbacks in product adoption and reimbursement, manufacturing capacity, trial enrollment, safety or efficacy findings, regulatory approvals and expanded indications. The company also cited its history of operating losses, financing obligations, dependence on third parties and the possibility that it may not achieve or sustain profitability.