Insmed Incorporated’s Fourth-Quarter and Full-Year 2024 Financial Results and Business Update
Insmed Incorporated, a biopharmaceutical company focused on delivering first- and best-in-class therapies for serious diseases, recently reported its financial results for the fourth quarter and full year ended December 31, 2024. The company also provided an update on its ongoing clinical trials and regulatory milestones.
Financial Performance
The company reported total revenue of $104.4 million for the fourth quarter and $363.7 million for the full year 2024, representing a 19% annual growth rate and surpassing the upper end of the full-year 2024 guidance range. This strong financial performance was driven by the continued growth of ARIKAYCE® (amikacin liposome inhalation suspension), which generated $328.3 million in revenue for the full year 2024.
ARIKAYCE
ARIKAYCE is a treatment for nontuberculous mycobacterial (NTM) lung disease, a serious and chronic infection that affects the lungs. The drug’s revenue growth can be attributed to its increasing market penetration and expanding patient base. The company ended 2024 with approximately $1.4 billion of cash, cash equivalents, and marketable securities, providing a strong financial position to support future growth.
Clinical Trials and Regulatory Milestones
Insmed also announced several clinical trial and regulatory milestones. The New Drug Application (NDA) for brensocatib, an investigational therapy for patients with bronchiectasis, has been accepted by the U.S. Food and Drug Administration (FDA) and granted priority review. The PDUFA target action date is August 12, 2025. Additionally, the Phase 2b study of TPIP (treprostinil palmitil inhalation powder) in patients with pulmonary arterial hypertension (PAH), the Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), and the Phase 3 ENCORE study of ARIKAYCE are all on track for topline data in mid-2025, end of 2025, and first quarter of 2026, respectively.
Impact on Patients and the World
The strong financial performance and clinical progress of Insmed’s portfolio of therapies have significant implications for patients and the world. For patients with NTM lung disease, the continued growth of ARIKAYCE means that more patients will have access to a potentially life-changing treatment. The acceptance of the NDA for brensocatib by the FDA and its potential approval could provide a new treatment option for patients with bronchiectasis, a chronic lung condition that can cause persistent coughing, breathlessness, and recurrent lung infections. Successful outcomes from the ongoing clinical trials could lead to new treatments for PAH, CRSwNP, and NTM lung disease, further transforming the lives of patients suffering from these serious conditions.
Conclusion
Insmed Incorporated’s strong financial performance and clinical progress demonstrate the company’s commitment to delivering first- and best-in-class therapies for patients facing serious diseases. The acceptance of the NDA for brensocatib by the FDA and its potential approval, along with the successful completion of ongoing clinical trials, could lead to new treatment options for patients with bronchiectasis, PAH, CRSwNP, and NTM lung disease. The company’s financial position, with approximately $1.4 billion of cash, cash equivalents, and marketable securities, provides a strong foundation for continued growth and innovation.
- Insmed Incorporated reported strong financial performance in Q4 and FY2024, with ARIKAYCE driving revenue growth
- NDA for brensocatib accepted by FDA with a PDUFA target action date of August 12, 2025
- Ongoing clinical trials for TPIP, brensocatib, and ARIKAYCE are on track for topline data in mid-2025, end of 2025, and first quarter of 2026, respectively
- Strong financial position with approximately $1.4 billion of cash, cash equivalents, and marketable securities
- Potential new treatment options for patients with bronchiectasis, PAH, CRSwNP, and NTM lung disease
