MannKind (MNKD) Oppenheimer 36th Annual Healthcare Life Sciences Conference summary

Financial performance and outlook

• Reported nearly $350 million in total revenues for 2025, a 46% annual growth rate, with projections above $450 million in 2026 driven by Afrezza pediatric expansion, auto-injector approval, and Tyvaso DPI royalties.

• Significant free cash flow expected from Tyvaso DPI royalties, with $700 million to $1 billion projected over several years.

• Recent stock volatility attributed to investor reaction to UT's soft mist inhaler update, not to core business fundamentals.

• Company remains fully funded for ongoing clinical programs and is focused on deploying cash flow for growth investments.

• Digital marketing and patient activation strategies are being evaluated to support future launches.

Pipeline and clinical development

• MNKD-201 (Nintedanib DPI) phase 1 trial initiated in December, with rapid enrollment; phase 2 to begin early Q2, focusing on tolerability and early efficacy in IPF patients.

• Phase 1 aims to demonstrate safety of dry powder in IPF, with data expected in the second half of the year; phase 2 will assess efficacy over 12 weeks with a 6-month rollover.

• If early efficacy is observed, asset will progress to phase 3; company is optimistic about blockbuster potential due to improved tolerability over oral Nintedanib.

• INHALE-1ST trial for Afrezza targets pediatric type 1 diabetes patients post-discharge, aiming to eliminate long-term mealtime injections.

• Introduction of a 2-unit cartridge and BluHale tracking device under evaluation to improve titration and patient confidence.

Product strategy and market expansion

• FUROSCIX positioned for growth in heart failure and chronic kidney disease, with focus on hospital and nephrology segments.

• Expansion of key account management and integration with diabetes reps to drive adoption in hospitals and nephrology clinics.

• Ready flow auto-injector seen as a major catalyst, simplifying administration and potentially expanding market reach.

• Ongoing assessment of new market segments, including nursing homes and hospitals, for FUROSCIX auto-injector.

• Pediatric approval for Afrezza expected to open new market, with low current awareness among pediatric endocrinologists.