Liquidia (LQDA) 2024 Wells Fargo Healthcare Conference summary

Technology and product development

• PRINT technology enables uniform particle size for deep lung deposition, supporting efficacy in PAH and PH-ILD.

• Yutrepia received tentative FDA approval for both PAH and PH-ILD, with a planned launch in Q2 2025.

• L606, a twice-daily inhaled treprostinil with a liposomal formulation, is set to enter a global phase 3 trial by year-end.

• ASCENT trial is the first prospective DPI study in PH-ILD, aiming for full enrollment by year-end to support launch data.

• Generic treprostinil remains a strategic annuity, supporting relationships with payers and physicians.

Market opportunity and strategy

• PAH is a well-established market, with inhaled treprostinil as standard care; oral agents have significant side effects.

• PH-ILD market is underpenetrated, estimated at 60,000 patients, with potential for multi-billion dollar growth.

• Education and diagnosis are key to expanding PH-ILD market reach; both companies will drive awareness.

• Differentiation focuses on delivery, device, and dose, with PRINT technology enabling higher titration and ease of use.

• Sales force of 50 was onboarded in late 2023, focusing on both PAH centers and community physicians.

Regulatory and legal landscape

• Tentative FDA approval for Yutrepia in both indications; full launch gated by Tyvaso DPI’s exclusivity expiring May 2025.

• Litigation ongoing with FDA and United Therapeutics; summary judgment hearing set for December, but base case remains Q2 2025 launch.

• No 30-month stay applies to the '327 patent; trial set for June 2025, not expected to impede approval.

• Confident in maintaining both PAH and PH-ILD indications on the label at launch.

• Commercial supply is secured and ready for launch, with manufacturing at full capacity.