Liquidia Corp Q4 FY2024 earnings call

• Strategic imperatives for 2025 include seeking final approval and launching YUTREPIA in PAH and PH-ILD, advancing YUTREPIA's clinical profile, building commercial/m medical prowess, and advancing L606.
• YUTREPIA progress: No legal barriers to FDA final approval after May 23, 2025; plan to submit final approval request in coming weeks.
• ASCENT trial: On track to complete enrollment with 50+ patients; early efficacy data shows 26.4m improvement in 6-minute walk test for first 20 patients.
• Commercial readiness: Built a best-in-class commercial enterprise ready for YUTREPIA launch.
• L606: Sustained release liposomal formulation of treprostinil with favorable PK profile, Phase III ready.

Revenue for the year ended December 31, 2024 was $14 million, down from $17.5 million in 2023, primarily due to lower sales quantities of treprostinil injections. Cost of revenue in 2024 was $5.9 million vs $2.9 million in 2023. Research and development expenses were $47.8 million in 2024 vs $43.2 million in 2023, driven by activities related to L606 and YUTREPIA. General and administrative expenses were $81.6 million in 2024 vs $44.7 million in 2023, attributable to increased personnel, legal, and commercial expenses.

• Plan to launch YUTREPIA post-exclusivity in May 2025, with final approval request submitted in coming weeks.
• Optimistic about reaching profitability with $100M additional financing from HealthCare Royalty Partners if YUTREPIA launches successfully.
• Continue advancing L606 and YUTREPIA Phase 4 studies.

Forward-looking statements subject to known and unknown risks/uncertainties, including clinical trial outcomes, regulatory approvals, market acceptance of YUTREPIA, and competition. Detailed risk factors available in SEC filings.

Q: Julian Harrison asked about the timeline to convert YUTREPIA's tentative approvals to full approvals.

A: Roger Jeffs stated they plan to request final approval in the coming weeks, aiming for around May 23, 2025.

Q: Julian Harrison inquired about L606 physician feedback and INSPIRE trial initiation.

A: Rajeev Saggar said twice-daily dosing is a game-changer for patients, and the INSPIRE trial is set to initiate by year-end.

Q: Bhavan Patel asked about YUTREPIA's market penetration strategy and label differences.

A: Roger Jeffs noted the label differs in dose titration table; Scott Moomaw discussed commercial approach to centers and communities.

Q: Serge Belanger asked about commercial and Medicare coverage for YUTREPIA.

A: Scott Moomaw said Medicare is the largest payer, and they've been working closely with payers for access.

Q: Ryan Deschner asked about key readouts for the ASCENT study.

A: Rajeev Saggar discussed the 26.4m walk test improvement and data to be shared at the ATS conference.

Q: Cory Jubinville asked about ASCENT sample size and dose response.

A: Rajeev Saggar discussed dose response and plan for a transition study from TYVASO patients.

Q: Greg Harrison asked about cash runway and pricing.

A: Michael Kaseta discussed cash runway with new financing and noted pricing strategy balances patient access and value.