Insmed Incorporated (NASDAQ: INSM) has reported its financial results for the fourth quarter and full year ended December 31, 2024. The company's ARIKAYCE® (amikacin liposome inhalation suspension) total revenue was $104.4 million for the fourth quarter and $363.7 million for the full year 2024, representing a 19% annual growth and exceeding the upper end of the full-year 2024 guidance range.
Arikayce's global revenue grew 19% in 2024 compared to 2023, reflecting continued strong growth in the U.S., Japan, and Europe. In the U.S., Arikayce revenue was $67.8 million for the fourth quarter of 2024, a 16.4% increase from the same period in 2023, and $254.8 million for the full year 2024, a 13.7% increase from 2023. In Japan, Arikayce revenue was $30.7 million for the fourth quarter of 2024, a 46.6% increase from 2023, and $87.7 million for the full year 2024, a 33.4% increase from 2023. In Europe and the rest of the world, Arikayce revenue was $5.9 million for the fourth quarter of 2024, a 32.5% increase from 2023, and $21.2 million for the full year 2024, a 38.8% increase from 2023.
Insmed ended 2024 with approximately $1.4 billion of cash, cash equivalents, and marketable securities. The company reiterates its 2025 global Arikayce revenue guidance of $405 million to $425 million, reflecting double-digit growth compared to 2024.
The company's NDA for brensocatib in patients with bronchiectasis was accepted by the FDA and granted priority review with a PDUFA target action date of August 12, 2025. Additionally, the Phase 2b study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH) completed enrollment in December 2024, with 102 patients randomized. Insmed anticipates topline data from the study in the middle of 2025.
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 program and expects the totality of its pre-clinical research programs will comprise less than 20% of overall expenditure.
In the fourth quarter of 2024, Insmed reported a net loss of $235.5 million, or $1.32 per share, compared to a net loss of $186.1 million, or $1.28 per share, for the fourth quarter of 2023. For the full year 2024, Insmed reported a net loss of $913.8 million, or $5.57 per share, compared to a net loss of $749.6 million, or $5.34 per share, for the full year 2023. As of December 31, 2024, Insmed had cash, cash equivalents, and marketable securities totaling approximately $1.4 billion.
Insmed plans to continue to invest in the commercialization and expansion of Arikayce globally, the commercial launch of brensocatib in the U.S., if approved, with advancement of regulatory submissions in the EU, UK, and Japan, and the advancement of clinical trial programs for brensocatib, among other key activities in 2025. The market has reacted to these announcements by moving the company's shares -0.2% to a price of $83.68. If you want to know more, read the company's complete 8-K report here.
