Record Quarterly and Annual Revenue
Q4 2025 total revenue of $112 million, up 46% year-over-year; full-year 2025 total revenue of $349 million, up 22% year-over-year. Management reported a 5-year CAGR of ~46% to nearly $350M and a stated path to a >$450M revenue run-rate in 2026.
Furoscix Rapid Growth After Acquisition
Furoscix Q4 net sales $23.3 million (management) representing 91% year-over-year growth; full-year 2025 net sales $70.4 million. The team shipped nearly as many units in Q4 as in all of 2024, expanded the sales force from ~80 to ~160 reps, and projects a 2026 CVR range of $110–$120 million.
Afrezza Commercial Momentum and Regulatory Progress
Afrezza Q4 U.S. net sales ~$22–23 million (management/CFO figures) representing ~22–25% year-over-year growth; full-year global net sales ~$74.6–75 million (16% YoY growth per CFO). First commercial shipment to Cipla (India) completed. FDA label change approved clarifying starting bolus dose; dose trial showed a 58% reduction in 2-hour postprandial glucose excursions with the higher Afrezza dose. Pediatric indication accepted with PDUFA date May 29, 2026.
Tyvaso DPI Revenue and Royalty Predictability
Q4 royalty revenue $34 million, up 24% YoY; full-year royalty revenue $128 million, up 25% YoY. Management expects over $350 million in royalties over the next 36 months and highlighted a revised supply agreement providing multi-year minimum orders (CFO: manufacturing revenues ~ $100M in 2025; expectation of similar levels for next 2 years and an approximate $50M annual floor in later committed years). Net royalty economics reported at ~9% post-transaction, providing predictable cash flow.
Completed Strategic Acquisition and Commercial Infrastructure Build
Acquisition of scPharmaceuticals (Furoscix) completed in Q4 2025; integration cited as smooth. Company doubled sales rep footprint (~80 to ~160), deployed key account managers for hospital pull-through, activated endocrine team to cover nephrology, and increased marketing spend in support of ReadyFlow Autoinjector and Furoscix growth.
Non-GAAP Profitability and Improved Full-Year Results
Q4 2025 non-GAAP adjusted net income of $1.5 million (GAAP net loss $15.9M); full-year 2025 non-GAAP adjusted net income $59.5 million and GAAP net income $5.9 million, reflecting improved profitability on an adjusted basis despite acquisition-related and noncash amortization impacts.
Multiple Upcoming Regulatory and Clinical Milestones
Key near-term catalysts include Afrezza pediatric PDUFA (May 29, 2026) and Furoscix ReadyFlow Autoinjector PDUFA (July 26, 2026). Clinical program MNKD-201 (Nintedanib DPI) advancing: U.S. Phase Ib enrolling with top-line data expected H2 2026 and global Phase II initiation expected next quarter.
Afrezza Pediatric Market Opportunity Signals
New market research: ~50% of HCPs cite eliminating mealtime injections as primary adoption driver; ~66% of pediatric endocrinologists likely to prescribe; ~25% would consider using Afrezza in newly diagnosed type 1 patients. Management estimates pediatric share potential of 23–37%, noting every 10% share historically equates to ~ $150M in net revenue opportunity.