Liquidia Corp Q1 FY2025 earnings call

• Upcoming PDUFA goal date for YUTREPIA on May 24, 2025.
• District Court dismissed United Therapeutics’ cross-claim, with dismissal without prejudice.
• ASCENT study Cohort A fully enrolled with over 50 PH-ILD patients, interim data shows favorable dosing and tolerability.
• Go-to-market preparedness with 50 sales reps and medical affairs team with PH experience.
• Prepared patient support services for YUTREPIA launch.
• Product availability within 2-3 weeks of potential approval.
• Strong payer relationships for broad access.

Revenue for the 3 months ended March 31, 2025 was $3.1 million, compared to $3 million in the same period in 2024. Cost of revenue was $1.5 million for both periods. Research and development expenses were $7 million in 2025 vs $10.1 million in 2024, a decrease of $3.1 million. General and administrative expenses were $30.1 million in 2025 vs $20.2 million in 2024, an increase of $9.9 million. Net loss for Q1 2025 was $38.4 million, or $0.45 per share, compared to a net loss of $30.1 million, or $0.40 per share, in Q1 2024.

• Preparations for YUTREPIA's potential launch are ongoing across multiple strategic areas.
• Data from the ASCENT study to be presented at the American Thoracic Society’s International Conference in San Francisco on May 20th.
• Anticipation of launching YUTREPIA and providing a potential best-in-class therapy for PAH and PH-ILD patients.

• United Therapeutics could potentially repurpose or rephrase their argument in the future despite the dismissal being without prejudice.
• Legal challenges from United Therapeutics remain a potential risk, though currently no active injunction efforts to prevent YUTREPIA's approval or launch.

Q: Do you believe United has any injunctive value left on the cross-claim that was dismissed last week? Also curious if you had any reaction to the dismissal without prejudice versus with prejudice?

A: Currently no active proceeding to enjoin FDA approval or launch. Dismissal was without prejudice, meaning United can try to repurpose the argument but face standing issues.

Q: Thoughts on forward-looking transition studies and update on L606?

A: Transition study for PH-ILD patients transitioning from Tyvaso to YUTREPIA; L606 is a liposomal sustained release formulation of treprostinil, global study with over 300 patients to be initiated by year-end.

Q: Patient perspective on switching to dry powder formulation and how ASCENT data helps?

A: YUTREPIA is differentiated with better tolerability, higher doses achievable, and portability; ASCENT study shows patients can tolerate well, get to high doses quickly, benefiting patient experience.

Q: Details on prescriber support team activities and patient bridging programs?

A: Prescriber support team has over a decade of treprostinil experience; patient support program details to be shared post-May approval; focus on new patient starts first.

Q: Early flavor of ATS data presentations and timing of full 48-week ASCENT data?

A: Presenting three posters at ATS on ASCENT study, including baseline demographics, tolerability, exercise tolerability, and transition from parental therapy; full 48-week data details under embargo but excited to showcase at ATS near potential approval.