News Releases

-ARIKAYCE Preliminary Unaudited U.S. Net Product Sales Approximately $9.2 Million for the Fourth Quarter of 2018-

—Seasoned Pharmaceutical Executive Elizabeth McKee Anderson Appointed as New Director—

—Quarter Highlighted by U.S. FDA Approval of ARIKAYCE® (amikacin liposome inhalation suspension), Followed by Immediate Launch—

New Patent Adds 7 ½ Years of Market Exclusivity in Japan

Commercial availability expected in early Q4 2018

As previously reported, study met primary endpoint of culture conversion (p<0.0001)

Advisory committee supports surrogate endpoint of sputum culture conversion

PDUFA (Prescription Drug User Fee Act) Action Date for ALIS (Amikacin Liposome Inhalation Suspension) Set for September 28, 2018

Meeting planned for August 7, 2018

Data support the benefit of treating patients with a combination of ALIS (Amikacin Liposome Inhalation Suspension) and guideline-based therapy (GBT) for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC)

PDUFA Action Date Set for September 28, 2018

Submitted NDA to FDA for Amikacin Liposome Inhalation Suspension (ALIS) in NTM lung disease caused by MAC; anticipates priority review

ALIS previously designated as an orphan drug, breakthrough therapy and Qualified Infectious Disease Product (QIDP)

On track to file NDA before the end of March and anticipate a priority review