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Dec 31, 2020
Insmed Q4 2020 Earnings Report
Insmed reported financial results for the fourth quarter and full year 2020 and provided a business update.
Key Takeaways
Insmed's total revenue for the fourth quarter ended December 31, 2020 was $41.4 million, compared to total revenue of $45.7 million for the fourth quarter of 2019. The company reported a GAAP net loss of $102.2 million, or $1.00 per share, compared to a GAAP net loss of $53.0 million, or $0.59 per share, for the fourth quarter of 2019. As of December 31, 2020, Insmed had cash and cash equivalents of $532.8 million.
ARIKAYCE EU launch progresses, with product now available and reimbursed in Germany and the Netherlands.
Frontline clinical trial program of ARIKAYCE in NTM lung disease caused by MAC initiated in Q4 2020.
Phase 3 ASPEN study of Brensocatib in Bronchiectasis initiated in Q4 2020.
Topline results from Phase 1 study of Treprostinil Palmitil Inhalation Powder (TPIP) support continued development with once-daily dosing.
Insmed
Insmed
Forward Guidance
Insmed plans to invest in key activities in 2021, including U.S. commercialization of ARIKAYCE, clinical trial activities for ARIKAYCE, brensocatib, and TPIP, and launch activities for ARIKAYCE in initial European countries and potential launch activities for ARIKAYCE in Japan.
Positive Outlook
- U.S. commercialization of ARIKAYCE
- Advancement of ARIKAYCE frontline clinical trial program (ARISE and ENCORE)
- Advancement of Phase 3 ASPEN study of brensocatib in patients with bronchiectasis
- Advancement of clinical development of TPIP
- Advancement of earlier-stage research pipeline
Challenges Ahead
- Failure to obtain regulatory approvals for ARIKAYCE outside the U.S. or Europe.
- Failure to successfully commercialize ARIKAYCE in the U.S. or Europe.
- Risk that brensocatib does not prove effective or safe for patients in ongoing and future clinical studies.
- Risk that TPIP does not prove to be effective or safe for patients in ongoing and future clinical studies.
- Uncertainties in the degree of market acceptance of ARIKAYCE.