Insmed Q4 2019 Earnings Report
Key Takeaways
Insmed reported a transformative year in 2019, marked by the first full year of the ARIKAYCE U.S. launch and advancements in the global infrastructure. The company also announced positive top-line Phase 2 data for INS1007 in non-cystic fibrosis bronchiectasis.
Total revenue for ARIKAYCE was $45.7 million for the fourth quarter of 2019 and $136.5 million for the full year 2019.
The company anticipates a potential launch of ARIKAYCE in Germany by the end of 2020, followed shortly thereafter by the UK.
Insmed plans to file for approval of ARIKAYCE in Japan in the first quarter of 2020.
Phase 2 WILLOW study of INS1007 in patients with Non-Cystic Fibrosis Bronchiectasis Achieves Primary and Key Secondary Endpoint
Insmed
Insmed
Forward Guidance
Insmed expects full-year 2020 revenues for ARIKAYCE to be in the range of $180 million to $220 million.
Positive Outlook
- The Company plans to advance INS1007 into a Phase 3 program in patients with bronchiectasis.
- The Company plans to invest in the development of a PRO for NTM lung disease as well as the initiation of a study to validate the PRO and, in parallel, a confirmatory clinical study of ARIKAYCE
- The Company plans to advance INS1009 and our earlier-stage research pipeline
- The company expects adjusted operating expenses to be in the range of $340 million to $360 million for 2020.
- Pending the approval of our marketing authorization application in Europe, Insmed anticipates a potential launch of ARIKAYCE in Germany by the end of 2020, followed shortly thereafter by the UK.