Liquidia Corp Q3 FY2024 earnings call

• Progress towards YUTREPIA approval: Critical wins include FDA confirming amended NDA for PH-ILD, legal resolution of 3 patents initially asserted by United Therapeutics, and nearing final approval by May 2025 or earlier.
• Clinical progress: ASCENT study evaluating YUTREPIA in PH-ILD has doubled clinical sites, with enrollment on track to complete in Q1 2025; L606's RESPIRE study in PH-ILD to start in first half of 2025, with focus on sustained-release liposomal treprostinil suspension.
• Partnerships: Expanded relationship with Pharmosa for L606, including EU and other territories, and secured rights to next-generation nebulizers for L606.
• Balance sheet: Strengthened with $100 million raised in September, ending Q3 2024 with $204.4 million cash on hand.

In the third quarter of 2024, Liquidia Corporation reported revenue of $4.4 million, compared to $3.7 million in the same quarter of 2023. Cost of revenue was $1.7 million in 2024 versus $0.6 million in 2023. Research and development expenses were $11.9 million in 2024, up from $7.4 million in 2023. General and administrative expenses were $20.2 million in 2024, compared to $10.6 million in 2023. The net loss for the three months ended September 30, 2024, was $23.2 million, or $0.30 per basic and diluted share, compared to a net loss of $15.8 million, or $0.24 per basic and diluted share, in the same period of 2023.

• Anticipate final approval of YUTREPIA for PAH and PH-ILD by May 2025 or earlier.
• Plan to initiate L606's placebo-controlled global Phase III study (RESPIRE) in PH-ILD in the first half of 2025.
• Confidence in balance sheet to support corporate objectives, including YUTREPIA launch preparation.

• Legal risks related to FDA clinical investigation exclusivity lawsuit, with uncertainty around timing and outcome of December 2024 summary judgment hearing.
• Ongoing patent litigation with United Therapeutics regarding the '327 patent, with trial scheduled for June 2025 and uncertainty around its impact on YUTREPIA's launch for PH-ILD.
• Uncertainties in regulatory decisions that could impact the timing of YUTREPIA's final approval and L606's development timeline.

Q: Regarding the summary judgment hearing in December, what is the expected timing of a decision and the range of possible outcomes?

A: Rusty Schundler stated it's hard to predict timing of the judge's decision, and possible outcomes include upholding the FDA's decision, overruling it, or remanding back to the FDA for further consideration.

Q: Thoughts on coverage access for YUTREPIA launch?

A: Michael Kaseta mentioned they've been engaging with payers and are confident in obtaining access close to launch.

Q: L606's pivotal study plan for PH-ILD next year, how similar is the design to the INCREASE study?

A: Rajeev Saggar noted the open-label study for L606 provided safety/tolerability confidence, and the trial design uses INCREASE as a replicable framework, focusing on 6-minute walk distance and patient outcomes.

Q: How would a favorable FDA lawsuit ruling expedite timelines?

A: Rusty Schundler said it's highly dependent on the timing and nature of the decision, but the exclusivity for TYVASO DPI ends in May 2025 regardless.

Q: Sales force sizing for YUTREPIA launch?

A: Scott Moomaw stated the sales team is experienced in rare disease, sized to cover the entire market including PH centers, community treaters, and ILD prescribers, with around 6,000-7,000 targets.