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Insmed Reports Fourth-Quarter and Full-Year 2024 Financial Results and Provides Business Update

In This Article:

—ARIKAYCE® (amikacin liposome inhalation suspension) Total Revenue of $104.4 Million for Fourth-Quarter and $363.7 Million for Full-Year 2024, Reflecting 19% Annual Growth and Exceeding the Upper End of Full-Year 2024 Guidance Range—

—Company Reiterates 2025 Global ARIKAYCE Revenue Guidance of $405 Million to $425 Million, Reflecting Double-Digit Growth Compared to 2024—

—NDA for Brensocatib in Patients with Bronchiectasis Accepted by FDA and Granted Priority Review with a PDUFA Target Action Date of August 12, 2025—

—Phase 2b Study of TPIP in Patients with PAH, Phase 2b BiRCh Study of Brensocatib in Patients with CRSsNP, and Phase 3 ENCORE Study of ARIKAYCE Remain on Track for Topline Data in Mid-2025, End of 2025, and First Quarter of 2026, Respectively—

—Company Ends 2024 with Approximately $1.4 Billion of Cash, Cash Equivalents, and Marketable Securities—

BRIDGEWATER, N.J., Feb. 20, 2025 /PRNewswire/ -- 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 reported financial results for the fourth quarter and full year ended December 31, 2024 and provided a business update.

"As we report on the most important year in Insmed's history, we feel we are in a rare position in our industry, with extraordinary opportunities ahead. Our success across all areas of the business in 2024—most notably the delivery of positive data from the landmark Phase 3 ASPEN study of brensocatib in bronchiectasis—has positioned us to potentially reach many more patients suffering from serious diseases, and resulted in significant value creation," said Will Lewis, Chair and Chief Executive Officer of Insmed. "In 2025, we look forward to delivering the highly anticipated U.S. launch of brensocatib, pending FDA approval, and we are delighted to be one step closer to achieving that goal with the FDA's acceptance of our NDA with Priority Review. Simultaneously, we expect to continue to advance our robust mid- to late-stage pipeline while generating double-digit worldwide revenue growth for ARIKAYCE. We believe that Insmed's strong balance sheet and unique company culture will enable us to deliver on behalf of patients in need."

Recent Progress and Anticipated Milestones by Program:

ARIKAYCE

  • ARIKAYCE global revenue grew 19% in 2024 compared to 2023, reflecting continued strong growth in the U.S., Japan, and Europe.

  • In the fourth quarter of 2024, the Company completed enrollment in the Phase 3 ENCORE study for patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease who had not started antibiotics. Total enrollment in the study was 425 patients.

  • The Company continues to anticipate a topline readout for ENCORE in the first quarter of 2026, with the submission of a supplementary new drug application (sNDA) to the FDA for ARIKAYCE in all patients with MAC lung disease in the U.S. expected later in 2026.