Liquidia (LQDA) Stifel 2024 Healthcare Conference summary

Regulatory and legal updates

• Yutrepia received tentative FDA approval for PAH and PH-ILD, with a potential launch by May 2025 pending exclusivity expiration and ongoing legal proceedings.

• A lawsuit challenges the FDA's grant of three-year marketing exclusivity to a competitor, with a summary judgment hearing set for December and possible earlier launch if favorable.

• Patent litigation over the '327 patent is scheduled for June 2025; management is confident in their position and open to launching at risk if no valid patent blocks approval.

Commercial and launch preparations

• Commercial manufacturing of Yutrepia has been ongoing since 2021, with launch readiness maintained.

• Strong payer relationships and a focus on access aim to ensure broad patient and physician uptake at launch.

• Yutrepia will be reimbursed as a Medicare Part D product, not requiring a J-code.

• Pricing strategy is designed to maximize launch trajectory and market share, with specifics undisclosed.

Product differentiation and clinical data

• Yutrepia's value proposition centers on delivery, device, and dose, leveraging PRINT technology for deep lung deposition and higher titratable doses.

• The ASCENT trial in PH-ILD is over a third enrolled, targeting 60 patients, with safety as the primary endpoint and interim data showing higher achievable doses.

• INSPIRE study in PAH demonstrated high patient satisfaction and ability to reach high doses, supporting no need for additional PAH studies.