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Insmed 8-K Report, Financial Results (Oct 29, 2026)

Reports
Earnings & Results·Exhibits & Filings
Filing Date
Filed October 29, 2026
Period End
October 29, 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 · Sep ’18Sep ’18
  2. Leadership change8-K · Jun ’21Jun ’21
  3. Leadership change8-K · May ’25May ’25

Summary

Summary of the 8-K filed October 29, 2026. Cited figures are marked; the original filing is the authoritative source.

Insmed Incorporated reported third-quarter 2026 financial results on October 29, 2026, with total company revenues of $524.4 milliona, up from $142.3 million in the third quarter of 2025.

BRINSUPRI generated $400.1 millionb in revenue, which the company describes as 29% growth over the second quarter of 2026, driven by strong growth in the U.S. market. ARIKAYCE revenues were $124.4 million, reflecting 9% growth over the third quarter of 2025, primarily driven by international markets. The net loss narrowed to $100.3 million, or $0.46 per share, compared with a net loss of $370.0 million, or $1.75 per share, in the prior-year quarter.

The company raised the low end of its full-year 2026 revenue guidance. BRINSUPRI guidance is now $1.35 billion to $1.4 billionc, up from $1.25 billion to $1.4 billion, and ARIKAYCE guidance is $460 million to $470 million, up from $450 million to $470 million. Operating expenses rose year over year, with research and development expenses of $270.0 million and SG&A expenses of $253.0 million, reflecting BRINSUPRI commercialization and TPIP clinical development.

As of September 30, 2026, cash, cash equivalents, and marketable securities totaled approximately $1.1 billiond. Management stated it continues to believe cash flow positivity in 2027 can be achieved without additional capital, while expecting increased investment in clinical programs and Japan commercial infrastructure in the fourth quarter of 2026.

Other developments include the FDA's acceptance of the ARIKAYCE sNDA for MAC lung disease with Priority Review and a PDUFA target action date of January 28, 2027, and the launch of BRINSUPRI Tablets 25 mg in Japan following MHLW approval in August 2026. The company also enrolled more than 35% of patients in the Phase 3 PALM-ILD study of TPIP.

Key Highlights

  1. Total company revenues of $524.4 million in Q3 2026 versus $142.3 million in Q3 2025.
  2. BRINSUPRI revenues of $400.1 million in Q3 2026, reflecting 29% growth over Q2 2026, driven by strong U.S. growth.
  3. ARIKAYCE revenues of $124.4 million in Q3 2026, reflecting 9% growth over Q3 2025, primarily driven by international markets (21% international growth).
  4. Full-year 2026 BRINSUPRI revenue guidance raised to $1.35 billion to $1.4 billion from $1.25 billion to $1.4 billion; ARIKAYCE guidance raised to $460 million to $470 million from $450 million to $470 million.
  5. Net loss of $100.3 million, or $0.46 per share, in Q3 2026, compared with a net loss of $370.0 million, or $1.75 per share, in Q3 2025.
  6. Cash, cash equivalents, and marketable securities of approximately $1.1 billion as of September 30, 2026; management continues to expect cash flow positivity in 2027 without additional capital.
  7. FDA accepted the ARIKAYCE sNDA for MAC lung disease with Priority Review; PDUFA target action date is January 28, 2027.

Frequently Asked Questions

  1. How did BRINSUPRI perform in the third quarter of 2026?

    BRINSUPRI generated $400.1 million in revenue in Q3 2026, compared with $28.1 million in Q3 2025, and grew 29% over the second quarter of 2026. The company attributed the growth to strong performance in the U.S. market, and it raised full-year 2026 BRINSUPRI revenue guidance to $1.35 billion to $1.4 billion.

  2. Why did the company raise its ARIKAYCE and BRINSUPRI guidance?

    Management said BRINSUPRI's U.S. launch continues to exceed expectations and ARIKAYCE continues to grow, which supported raising the low end of full-year 2026 revenue guidance for both products. The company noted that BRINSUPRI guidance does not contemplate meaningful revenue contribution from Japan in 2026, and ARIKAYCE guidance does not contemplate a potential label expansion in the U.S. and Japan.

  3. What are the company's main cost drivers this quarter?

    Research and development expenses were $270.0 million in Q3 2026, up from $186.4 million, due to higher manufacturing costs and clinical development spending primarily for TPIP. SG&A expenses were $253.0 million, up from $186.4 million, driven by professional fees and compensation tied to BRINSUPRI commercial activities.

  4. What regulatory milestones are upcoming for ARIKAYCE?

    The FDA accepted the sNDA for ARIKAYCE in MAC lung disease with Priority Review and set a PDUFA target action date of January 28, 2027. Insmed also plans to submit Phase 3 ENCORE data to Japan's PMDA in the fourth quarter of 2026 to support a potential label expansion.

  5. What is the company's cash position and outlook?

    As of September 30, 2026, Insmed had approximately $1.1 billion in cash, cash equivalents, and marketable securities. The company said it continues to believe cash flow positivity in 2027 can be achieved without additional capital, while expecting increased investment in clinical programs and Japan commercial infrastructure in the fourth quarter of 2026.