Liquidia (LQDA) Jefferies 2024 Global Healthcare Conference summary

Regulatory and legal update

• YUTREPIA has tentative FDA approval for PAH and is awaiting final approval for both PAH and PH-ILD, with no current legal barriers to launch.

• A recent preliminary injunction request by a competitor was denied, with the judge citing doubts about patent validity and public interest in YUTREPIA's launch.

• The main remaining step is final FDA approval, with a related patent trial set for June 2025.

• The company is confident that recent legal rulings will positively influence related regulatory cases.

Product positioning and market opportunity

• YUTREPIA is positioned as a first-choice prostacyclin due to its tolerability, titratability, portability, and ease of use.

• The inhaled treprostinil market has grown significantly, especially after PH-ILD indication expansion, with a current split of 60/40 between nebulized and DPI forms.

• INSPIRE study data shows high patient satisfaction for both naive and transition patients.

• The company is ready for immediate commercialization, with product manufactured and a trained sales force in place.

Clinical development and data

• The ASCEND open-label study in PH-ILD is ongoing, with enrollment expected to complete by year-end and interim data showing high titratability and tolerability.

• Additional data from ASCEND will be presented at upcoming congresses, including safety and early efficacy results.

• YUTREPIA has over six years of long-term extension data in PAH patients, supporting its safety and efficacy profile.