Liquidia (LQDA) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Product pipeline and launch plans

• YUTREPIA, using PRINT technology, received FDA tentative approval and is set for launch in May 2025, targeting both PAH and PH-ILD markets.

• PH-ILD market is estimated at over 60,000 patients, with potential market size of $2–4 billion; YUTREPIA would be the second approved product.

• YUTREPIA aims to compete with Tyvaso, offering advantages in particle size, deep lung deposition, and a low-resistance inhalation device.

• Full sales force onboarded since Q4 2023, building relationships with key physicians to ensure readiness for launch.

• L606, a sustained-release treprostinil, is advancing to a global pivotal trial, with regulatory alignment in the US and EU.

Legal and regulatory developments

• FDA granted Tyvaso DPI three-year exclusivity, delaying YUTREPIA’s launch; litigation is ongoing, with a court hearing set for December 2024.

• 327 patent litigation trial is scheduled for June 2025; company is confident in prevailing and does not see it as a barrier to launch.

• 793 patent was invalidated; Supreme Court decision on certiorari expected in October 2024, with no further litigation if denied.

• Company is prepared to launch at risk if necessary, evaluating the landscape upon full approval.

Financial position and strategy

• Raised $100 million through a mix of royalty facility and equity, extending cash runway into 2026.

• Confident in reaching profitability within three to four quarters post-launch, even while supporting a global Phase III trial.

• Pricing strategy focuses on patient access and payer relationships, aiming for no patient disadvantage.