Insmed Reports $606M in 2025 Revenue as Sales Jump 67% YoY

Insmed Incorporated (NASDAQ:INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today provided an update on the Company's commercial and clinical programs and its outlook for 2026. These updates will be discussed as part of the Company's presentation at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 12, 2026, at 3:00 p.m. PT (6:00 p.m. ET).

"2025 was a landmark year for the patients we serve, our company, and our people, during which we demonstrated what's possible when breakthrough science meets steadfast execution. Our strong BRINSUPRI launch and encouraging TPIP readout in PAH reinforced both the clinical potential of our growing portfolio and the remarkable discipline of our teams," said Will Lewis, Chair and Chief Executive Officer of Insmed. "As monumental as this past year was, the road ahead is poised to be even more exciting. With numerous upcoming clinical and commercial catalysts across our designated therapeutic areas — Respiratory, Immunology & Inflammation, and Neuro & Other Rare — we believe that the next 18 months could accelerate our trajectory even further and bring us closer to helping more patients living with serious diseases."

Preliminary Full-Year 2025 Global Net Product Revenues (Unaudited)

The following table summarizes Insmed's preliminary unaudited financial revenues expected for full-year 2025 and revenue growth across all commercial regions:

These preliminary unaudited results are subject to adjustment. Insmed will report its final and complete fourth-quarter and full-year 2025 financial results in February 2026. The actual results could be materially different from these preliminary unaudited financial results.

As of year-end 2025, approximately 4,000 medical professionals had prescribed BRINSUPRI, with approximately 9,000 new patients starting therapy during the fourth quarter of 2025 alone.

Progress and Anticipated Milestones by Therapeutic Area:

Respiratory

BRINSUPRI

• In November 2025, the European Commission approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months. Insmed plans to launch BRINSUPRI in the European Union (EU) in the first half of 2026.
• Insmed anticipates commercial launches in the United Kingdom and Japan in 2026, pending approval in each territory.

ARIKAYCE

• Insmed anticipates 2026 global ARIKAYCE revenues to be between $450 million and $470 million.
• The Company anticipates the topline readout of the Phase 3 ENCORE trial in March or April of 2026 in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease who have not started antibiotics.
• Pending successful results from the ENCORE trial, Insmed plans to submit a supplementary new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in all patients with MAC lung disease in the U.S. in the second half of 2026.

TPIP

• Insmed initiated PALM-ILD, a Phase 3 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), in the fourth quarter of 2025.
• Insmed plans to initiate a Phase 3 study of TPIP in patients with pulmonary arterial hypertension (PAH) in early 2026.
• The Company expects to report data from the open-label extension (OLE) of its Phase 2b study of TPIP in PAH in the second half of 2026.
• The Company anticipates initiating additional Phase 3 studies of TPIP in progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF) in the second half of 2026.

INS1148

• In December 2025, Insmed acquired INS1148, a Phase 2-ready monoclonal antibody targeting a specific isoform of Stem Cell Factor 248 (SCF248). The Company plans to advance Phase 2 development programs for INS1148 initially in interstitial lung disease and moderate-to-severe asthma.

Immunology and Inflammation

Brensocatib

• In October 2025, Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS). Insmed anticipates reporting topline data from CEDAR in the second quarter of 2026.

INS1033

• Insmed's second dipeptidyl peptidase 1 (DPP1) inhibitor, INS1033, is currently advancing toward the clinic in rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), with an IND filing expected in 2026.

Neuro & Other Rare

INS1201

• Insmed is currently enrolling cohorts 2 and 3 in the Phase 1 ASCEND clinical study of INS1201, an intrathecally-delivered gene therapy for patients with Duchenne muscular dystrophy (DMD).

INS1202

• In December 2025, the Company opened the first clinical site for the Phase 1 ARMOR study of INS1202, an intrathecally-delivered gene therapy for patients with Amyotrophic Lateral Sclerosis (ALS).

INS1203

• Insmed's third gene therapy candidate, INS1203, targeting Stargardt disease, is currently advancing toward the clinic, with an IND filing expected in 2026.

Pre-Clinical Programs

• Insmed's research efforts include more than 30 identified pre-clinical programs in development, all of which have the potential to become first-in-class or best-in-class therapies for the indications being pursued.
• The Company anticipates submitting an average of one to two INDs per year from its pre-clinical research programs.
• Insmed continues to anticipate that the totality of its pre-clinical research programs will comprise less than 20% of overall expenditures.