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MannKind (MNKD) investor relations material
MannKind Jefferies London Healthcare Conference 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Product pipeline and clinical development
Initiated a phase IB trial for nintedanib in the U.S. to support FDA requirements for phase III; INFLOW 2 phase II will run ex-U.S. as a bridge to phase III dosing.
FUROSCIX, an on-body furosemide infuser, targets a $10B+ heart failure market; nephrology indication added in Q2, now 15% of Q3 sales.
Expanded sales force for FUROSCIX, with 80 reps by late 2024, driving 93% YoY revenue growth and over 61,000 doses dispensed.
Nintedanib DPI leverages Technosphere technology for deep lung delivery; phase I trial in IPF patients to support U.S. regulatory pathway.
INFLOW 2 phase II study to enroll 210-220 patients ex-U.S., with 12-week placebo period and extension phase; aims to refine phase III target population.
Market opportunity and growth drivers
FUROSCIX addresses high hospitalization costs for heart failure, with new U.S. physician penalties (AMC) incentivizing reduced readmissions.
Hospital segment expansion and national contracts are key to increasing FUROSCIX adoption; targeting 5,000-7,000 cardiologists and nephrologists.
Product enhancements include an autoinjector to improve patient experience and adherence.
Bumetanide product in development using FDKP technology for IV-like experience and flexible dosing.
Tyvaso DPI collaboration with United Therapeutics generated $59M in Q3 revenue, up 15% YoY, with higher dose launches driving growth.
Diabetes and endocrinology portfolio
AFREZZA, FDA-approved for over 10 years, has over 75 trials supporting safety and efficacy; new data shows strong postprandial control.
Pediatric market is a key growth area, with potential for 10% market share translating to $150M in net revenue; trial with JDRF and top U.S. centers underway.
New two-unit cartridge and BluHale device with CGM integration aim to improve titration and real-time insulin management.
Gestational diabetes trial progressing, with initial safety data positive and further enrollment ongoing.
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