Business
MannKind Corporation Reports First Quarter 2025 Financial Results and Provides Business Update
Conference call to provide corporate updates today at 9:00 am ET 1Q 2025 revenues of $78M, +18% v. 1Q 20241Q 2025 net income of $13M, + 24% v. 1Q 20241Q 2025
About this update from Mannkind Corporation
[{"type":"text","content":"Conference call to provide corporate updates today at 9:00 am ET 1Q 2025 revenues of $78M, +18% v. 1Q 20241Q 2025 net income of $13M, + 24% v. 1Q 20241Q 2025 non-GAAP net income of $22M, +43% v. 1Q 2024Advanced pipeline: Expect to submit sBLA for Afrezza® in pediatric patients in mid-2025MNKD-101: NTM global Phase 3 trial enrollment on track for interim analysisMNKD-201: Expect to continue to next phase of global development in 2H 2025 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the first quarter 2025 and provided a business update. “The first quarter was marked by strong year-over-year NRx growth in Afrezza, substantial Tyvaso DPI-related revenues and continued progress in our Phase 3 trial of MNKD-101 (clofazimine inhalation suspension) in NTM lung disease,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “We expect to file for approval of Afrezza in the pediatric population this summer and to continue developing our MNKD-201 (nintedanib DPI) program in IPF.” 1Q 2025 Business Update and Upcoming Milestones Afrezza INHALE-1 Pediatric Phase 3 clinical trial Met with the FDA to obtain guidance on a supplemental Biologics License Application (sBLA) for the pediatric population expected to be filed in mid-2025Topline results from the full study pediatric data set with the safety extension expected in 2Q 2025 Clofazimine Inhalation Suspension (MNKD-101) Phase 3 global clinical trial (ICON-1) 85% of anticipated sites have been activated in five countries (U.S., Japan, Australia, South Korea, Taiwan)55 patients randomized in four countries (U.S., Japan, Australia, South Korea)Expect to meet the interim enrollment target of 100 patients by YE 2025 Nintedanib DPI (MNKD-201) Planning to advance into the next phase of global development in 2H 2025 Endocrine Business Unit Afrezza INHALE-3 Phase 4 30-week data published in two articles in Diabetes Technology & TherapeuticsLabel application to update initial Afrezza conversion dose submitted to FDA; currently under reviewAfrezza performance 1Q 2025 compared to 1Q 2024: 20% NRx growth; 14% TRx growth Corporate and Financial Cash, cash equivalents and investments as of March 31, 2025 totaled $198 millionMajority of revenue and future pipeline programs are d...