Insmed (INSM) Investor presentation summary

Commercial performance

• FY26 Brinsupri revenue guidance raised to $1.35B-$1.4B from $1.25B-$1.4B; gross-to-net mid-20s to high-20s unchanged; excludes meaningful Japan revenue.

• FY26 ARIKAYCE revenue guidance raised to $460M-$470M from $450M-$470M; gross-to-net low-20s to mid-20s unchanged; excludes potential U.S. and Japan label expansion.

• Q3 2026 ARIKAYCE revenue was $124.4M worldwide (+9% YoY), including $75.5M in the U.S. (+2%) and $48.9M internationally (+21%).

• Brinsupri generated $400.1M in unaudited Q3 2026 revenue and reached blockbuster status in its first four full launch quarters.

Brinsupri opportunity

• FDA-approved 10 mg and 25 mg tablets for adults and adolescents 12+ with NCFB; label has no minimum prior-exacerbation requirement and notes statistically significant FEV₁ benefits for 25 mg.

• Japan launch began with favorable pricing; an estimated 150K patients are diagnosed with NCFB, and Japan is expected to be the primary international revenue driver.

• BEST-BE and EMBARC studies will assess real-world effectiveness, safety and longer-term disease outcomes; plans include up to 1,000 patients across 13 U.S. sites and up to 3,000 patients across six countries.

• The bronchiectasis opportunity could potentially reach more than 1M patients across the U.S., EU5 and Japan, including diagnosed and undiagnosed populations.

ARIKAYCE and MAC lung disease

• In Phase 3 ENCORE, ARIKAYCE plus multidrug therapy improved respiratory symptom score by 3.11 points versus comparator at Month 13 (p=0.0299); the Month 15 difference was 4.80 points (p=0.0015, nominal).

• ENCORE culture conversion at Month 13 was 82.4% vs. 55.6% (p<0.0001); durable conversion at Month 15 was 76.2% vs. 47.6% (p<0.0001).

• More than 90% of participants completed ENCORE in both arms; the safety profile was consistent with known therapy profiles, with no new or unexpected signals.

• FDA granted priority review to the ARIKAYCE supplemental application, with a January 28, 2027 target action date; expanded-label launches in the U.S. and Japan are targeted for 1H 2027 if approved.