MannKind (MNKD) Morgan Stanley 22nd Annual Global Healthcare Conference summary

Company evolution and strategic focus

• Transitioned from a broad development portfolio to a focused orphan lung disease strategy since 2019, leveraging a unique inhaled technology platform.

• Partnership with United Therapeutics led to the approval and success of Tyvaso DPI for pulmonary hypertension, with over 5,000 patients now using the product.

• Technosphere platform, based on FDKP excipient, enables deep lung drug delivery and supports multiple FDA-approved and pipeline products.

• Manufacturing capacity has been scaled up in Danbury, CT, to support current and future indications, with readiness for significant market expansion.

• Recent acquisition of a Boston R&D site enhances capacity for new product development and higher drug load formulations.

Pipeline progress and clinical development

• MNKD-101 (inhaled clofazimine) is in phase III for nontuberculous mycobacteria, with a global trial across 100 sites and innovative dosing design to reduce patient burden.

• MNKD-201 (inhaled nintedanib) is in phase I for idiopathic pulmonary fibrosis (IPF), aiming for similar efficacy but improved tolerability over oral formulations.

• Both programs are considered de-risked due to known molecules and defined targets, with rapid development timelines anticipated.

• Additional assets, including Pulmozyme for cystic fibrosis and an ALK-5 inhibitor, are under evaluation for advancement.

• Multiple data readouts and regulatory milestones are expected in the next 12 months, including pediatric and global expansion data for Afrezza.

Endocrine business and Afrezza

• Endocrine segment, including Afrezza and V-Go, generates nearly $80 million in annual revenue, supporting infrastructure for broader launches.

• INHALE-3 trial data showed Afrezza can help more patients achieve glycemic goals compared to standard of care, with further pediatric data expected soon.

• Efforts are underway to position Afrezza as a standard option in diabetes care, with focus on payer access and guideline inclusion.

• Pediatric trial (INHALE-1) aims to support a label update, with results anticipated to drive long-term growth.

• Global expansion plans for Afrezza include launches in India and potential filings in Europe and Japan.