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Insmed 8-K Report, Regulation FD Disclosure (Jan 9, 2026)

Reports
Regulation FD·Exhibits & Filings
Filing Date
Filed January 9, 2026
Period End
January 9, 2026
Security
INSM
In the record · 2016–202610-K1110-Q338-K134

INSM filed 11 annual reports (10-K), 33 quarterly reports (10-Q) and 134 current reports (8-K) between 2016 and 2026.

  1. Material agreement8-K · Jan ’18Jan ’18
  2. Leadership change8-K · May ’20May ’20
  3. Material agreement8-K · Oct ’22Oct ’22
  4. Leadership change8-K · Oct ’26Oct ’26

01—Abstract

Summary

Summary of the 8-K filed January 9, 2026. Cited figures are marked; the original filing is the authoritative source.

Insmed Incorporated (Nasdaq: INSM) furnished an 8-K on January 9, 2026 under Item 7.01 (Regulation FD) containing a press release and slide presentation for its appearance at the 44th Annual J.P.

Morgan Healthcare Conference on January 12, 2026. The company reported preliminary, unaudited full-year 2025 total revenues of approximately $606.4 milliona (U.S. $453.0 million, international $153.5 million), up from $363.7 million in 2024. ARIKAYCE generated approximately $433.8 million globally in 2025, exceeding the upper end of its guidance range, while BRINSUPRI, launched in the U.S., generated approximately $172.7 million for full-year 2025, including approximately $144.6 million in the fourth quarter, its first full quarter of launch.

Final fourth-quarter and full-year 2025 results are to be reported in February 2026, and the company cautioned the preliminary figures could differ materially. Looking ahead, Insmed guided 2026 global ARIKAYCE revenues to between $450 millionb and $470 million.

Key anticipated catalysts include topline data from the Phase 3 ENCORE study of ARIKAYCE in March or April 2026, with a planned supplemental NDA in the second half of 2026 if results are positive; topline data from the Phase 2b CEDAR study of brensocatib in hidradenitis suppurativa in the second quarter of 2026; and the initiation of additional Phase 3 TPIP studies in PAH, PPF, and IPF. The company also noted that BRINSUPRI's results do not yet reflect final contracting and access dynamics, with management expecting out-of-pocket reset effects in the first quarter of 2026 and rebating to increase as payor contracts are finalized.

02—Key points

Key Highlights

  1. Preliminary unaudited 2025 total revenues of approximately $606.4 million, up from $363.7 million in 2024 (U.S. $453.0 million; international $153.5 million)
  2. ARIKAYCE full-year 2025 global revenues of approximately $433.8 million, exceeding the upper end of guidance; 2026 guidance set at $450 million to $470 million
  3. BRINSUPRI launched in the U.S. with approximately $172.7 million in full-year 2025 revenue, including approximately $144.6 million in Q4 2025; approximately 4,000 prescribers and approximately 9,000 new patient starts in Q4
  4. Management noted inventory stocking accounted for approximately 9% of Q4 BRINSUPRI revenues and expects out-of-pocket reset dynamics in Q1 2026 and increased rebating as payor contracts are finalized
  5. Upcoming catalysts include ENCORE Phase 3 ARIKAYCE topline data (March or April 2026) and CEDAR Phase 2b brensocatib HS topline data (Q2 2026)
  6. BRINSUPRI approved in the EU with a launch planned in the first half of 2026; UK and Japan launches anticipated in 2026 pending approval
  7. Phase 3 PALM-ILD study of TPIP initiated in Q4 2025; additional Phase 3 studies in PAH, PPF, and IPF planned for 2026, with final 2025 results to be reported in February 2026

03—Questions

Frequently Asked Questions

  1. How much revenue did Insmed generate in 2025?

    Insmed preliminarily reported unaudited total 2025 revenues of approximately $606.4 million, compared with $363.7 million in 2024. ARIKAYCE contributed approximately $433.8 million and BRINSUPRI approximately $172.7 million. These figures are preliminary and subject to adjustment, with final results to be reported in February 2026.

  2. What is the 2026 revenue guidance for ARIKAYCE?

    Insmed expects global ARIKAYCE revenues of between $450 million and $470 million in 2026. The guidance does not include potential revenue from an expanded label, which would depend on successful ENCORE trial results and FDA approval.

  3. What are the key clinical catalysts for Insmed in 2026?

    The company expects topline ENCORE Phase 3 data for ARIKAYCE in March or April 2026 and topline CEDAR Phase 2b data for brensocatib in hidradenitis suppurativa in the second quarter of 2026. It also plans additional Phase 3 TPIP initiations and an ARIKAYCE sNDA in the second half of 2026 if ENCORE is successful.

  4. What challenges could affect BRINSUPRI's launch?

    Management said the early results do not yet reflect final contracting and access dynamics. It expects out-of-pocket reset effects in Q1 2026 and increased rebating and stricter access criteria as payor contracts are finalized in 2026. Inventory stocking also accounted for approximately 9% of Q4 2025 revenues.

04—Continue

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