Insmed — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total company revenues for the third quarter of 2026 were $524.4 million, a 268% increase compared to $142.3 million in the same period of 2025.
• Year-to-date (nine months ended September 30, 2026) total revenues were $1,255.9 million, a 267% increase compared to $342.6 million in 2025.
• BRINSUPRI revenues were $400.1 million for the third quarter of 2026, reflecting a 29% growth over the second quarter of 2026; year-to-date revenues were $917.1 million.
• ARIKAYCE revenues were $124.4 million for the third quarter of 2026, a 9% increase compared to $114.3 million in the third quarter of 2025; year-to-date revenues were $338.8 million, an 8% increase.
• Cost of product revenues (excluding amortization) was $78.2 million for the third quarter of 2026, compared to $29.4 million in 2025.
• Research and development expenses were $270.0 million for the third quarter of 2026, compared to $186.4 million in 2025.
• Selling, general and administrative expenses were $253.0 million for the third quarter of 2026, compared to $186.4 million in 2025.
• Net loss for the third quarter of 2026 was $100.3 million ($0.46 per share), compared to a net loss of $370.0 million ($1.75 per share) in 2025.
• As of September 30, 2026, cash, cash equivalents, and marketable securities totaled approximately $1.1 billion.
• Long-term debt was $544.9 million as of September 30, 2026, compared to $541.0 million as of December 31, 2025.

Guidance and Future Outlook:

• Full-year 2026 revenue guidance for BRINSUPRI was raised to $1.35 billion to $1.4 billion (previously $1.25 billion to $1.4 billion).
• Full-year 2026 revenue guidance for ARIKAYCE was raised to $460 million to $470 million (previously $450 million to $470 million).
• The company anticipates peak revenues of more than $7 billion for BRINSUPRI, more than $6 billion for TPIP, and more than $1 billion for ARIKAYCE.
• The company anticipates submitting an average of one to two INDs per year from pre-clinical research programs.
• Pre-clinical research programs are anticipated to comprise less than 20% of overall expenditures.
• The company plans to initiate a Phase 3 study of TPIP in patients with idiopathic pulmonary fibrosis (IPF) in the first half of 2027.

Business Segments and Product Lines:

• BRINSUPRI global revenue grew 29% in the third quarter of 2026 compared to the second quarter of 2026, driven by strong U.S. market growth.
• In October 2026, Insmed launched BRINSUPRI Tablets 25 mg in Japan for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adults and pediatric patients 12 years and older.
• ARIKAYCE global revenue grew 9% in the third quarter of 2026 compared to the third quarter of 2025, primarily driven by strong growth in international markets.
• In September 2026, the FDA accepted the sNDA for ARIKAYCE for the treatment of MAC lung disease as part of a combination antibacterial drug regimen, granting Priority Review with a target action date of January 28, 2027.
• Insmed plans to submit data from the Phase 3 ENCORE study to Japan's PMDA in the fourth quarter of 2026 to support potential ARIKAYCE label expansion to all patients with MAC lung disease.
• TPIP Phase 3 PALM-ILD study enrollment has exceeded 35% of patients, with completion expected in the first half of 2028.
• The first patient was enrolled in the Phase 3 PALM-PAH study in July 2026.
• The Phase 3 PALM-PPF study was initiated in September 2026.
• Phase 2 development for INS1148 continues, initially targeting IPF.
• Active enrollment for the Phase 1 study of INS1033 in rheumatoid arthritis began in September 2026.
• Phase 1 ASCEND study enrollment for INS1201 (DMD) was completed.
• Phase 1 ARMOR study enrollment for INS1202 (ALS) continues.

Market and Competitive Landscape:

• BRINSUPRI is the first and only MHLW-approved treatment for NCFB in Japan.
• ARIKAYCE is in its ninth year on the market.
• The company presented five abstracts from its respiratory therapeutic area at the European Respiratory Society (ERS) Congress 2026 in September 2026.
• Data across the respiratory portfolio was presented at the American College of Chest Physicians (CHEST) 2026 Annual Meeting and IDWeek 2026 in October 2026.

Risks and Challenges:

• ARIKAYCE carries a boxed warning for increased risk of respiratory adverse reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease.
• BRINSUPRI is associated with dermatologic adverse reactions (rash, dry skin, hyperkeratosis) and gingival/periodontal adverse reactions.
• Forward-looking statements involve risks including failure to successfully commercialize products, maintain regulatory approvals, or obtain full approval for ARIKAYCE.
• Risks include potential inability to obtain adequate reimbursement, failure to enroll sufficient patients in clinical trials, and development of unexpected safety or efficacy concerns.
• The company faces risks related to its senior secured loan and royalty financing agreements, including compliance with covenants.
• Potential risks include intellectual property disputes, cybersecurity attacks, and deterioration in general economic conditions.

Management Commentary and Tone:

• Will Lewis, Chair and CEO, stated the third quarter was defined by "commercial momentum, regulatory achievements, and advancement across our diversified pipeline."
• Management noted BRINSUPRI's U.S. launch continues to exceed expectations and ARIKAYCE continues to grow.
• The company expressed pleasure regarding regulatory approval and launch of BRINSUPRI in Japan and the FDA's acceptance of the sNDA for ARIKAYCE.
• Management emphasized a continued focus on delivering meaningful innovation and improving lives for patients with serious diseases.

Other Key Points:

• In October 2026, Insmed appointed Paul Hudson (former CEO of Sanofi and Novartis Pharmaceuticals) and Utpal Koppikar (current CFO of Verily Health) to its Board of Directors.
• The company plans to continue investing in 2026 to accelerate BRINSUPRI commercial efforts in the U.S. and Japan, strengthen ARIKAYCE commercial efforts, and advance clinical development programs for TPIP, INS1148, INS1201, INS1202, and INS1033.
• A conference call regarding these results was scheduled for October 29, 2026, at 8:00 a.m. Eastern Time.