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EX - 99.1 2 brhc10027348_ex99-1.htm EXHIBIT 99.1 insmed Exhibit 99.1 Insmed Reports Second Quarter 2021 Financial Results and Provides Business Update -ARIKAYCE® ( amikacin liposome inhalation suspension ) Now Launched in Japan ; Available in Three Major Territories- -Continuing to Progress ARIKAYCE , Brensocatib , and Treprostinil Palmitil Inhalation Powder ( TPIP ) Clinical Development Programs― -ARIKAYCE Total Revenue of $ 45.4 Million for the Second Quarter 2021- BRIDGEWATER , N.J. , August 5 , 2021 / PRNewswire / — Insmed Incorporated ( Nasdaq : INSM ) , a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases , today reported financial results for the second quarter ended June 30 , 2021 and provided a business update . “ Insmed made meaningful progress in the second quarter of 2021 , with important achievements across our four pillars — ARIKAYCE , brensocatib , TPIP , and translational medicine , ” commented Will Lewis , Chair and Chief Executive Officer of Insmed . “ With the launch of ARIKAYCE just last month in Japan , the largest market for refractory MAC lung disease that we are pursuing , we're thrilled that our lead product is now available in three major territories . We continue to enroll patients in both the Phase 3 ASPEN study of brensocatib in patients with bronchiectasis and the ARIKAYCE frontline clinical trial program in patients with NTM lung disease in line with expectations , and we are advancing TPIP to Phase 2 development in both PAH and PH - ILD . As we carry forward learnings from the past year and a half in navigating the pandemic , we have great confidence in our ability to execute on our commercial and clinical activities around the world . " Recent Corporate Developments & Program Highlights ARIKAYCE • ARIKAYCE launched in Japan in July of 2021 , following its approval by the Ministry of Health , Labour , and Welfare in March of 2021 for the treatment of patients with nontuberculous mycobacterial ( NTM ) lung disease caused by Mycobacterium avium complex ( MAC ) who did not sufficiently respond to prior treatment with a multidrug regimen . ARIKAYCE has been priced in Japan in line with list prices in the U.S. and Europe . Insmed continues to advance the European launch of ARIKAYCE following its approval by the European Commission in October of 2020 for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have cystic fibrosis ( CF ) . Consideration should be given to official guidance on the appropriate use of antibacterial agents . Enrollment continues in the post - approval confirmatory frontline clinical trial program of ARIKAYCE in patients with NTM lung disease caused by MAC . The program consists of ARISE , an interventional study designed to validate a patient - reported outcome ( PRO ) tool in MAC lung disease , and ENCORE , a pivotal trial designed to establish , using the PRO tool validated in the ARISE trial , the clinical benefits and evaluate the safety of ARIKAYCE in patients with newly diagnosed MAC lung disease . 1