Liquidia Corporation Q2 FY2025 earnings call

• YUTREPIA launched for PAH and PH-ILD treatment, with over 900 unique patient prescriptions and over 550 patient starts in the 11 weeks since approval. The script-to-start conversion rate in the first 6 weeks was 75%.
• Clinical team analyzing ASCENT study data with 54 PH-ILD patients, showing favorable tolerability with only 18.5% discontinuing at week 16 with no serious or drug-related adverse events including cough.
• Financials: Cash and cash equivalents over $173 million; R&D expenses expected to increase in coming quarters; SG&A expenses to remain flat excluding noncash and variable costs; expanding manufacturing space in North Carolina to support growth, potentially tripling production capacity.

In the second quarter, Liquidia Corporation generated $8.8 million in revenue. Of this, $6.5 million came from YUTREPIA product sales, which began shipping in June. The additional $2.3 million in service revenue related to the ongoing promotion agreement of treprostinil injection with Sandoz.

• Anticipate increases in quarterly R&D expenses as ongoing label studies continue and pivotal study of L-606 is initiated.
• SG&A expenses after excluding noncash and variable costs associated with treprostinil should remain flat over the next few quarters.
• Plan to host R&D Day in fall to provide update on open-label L-606 study, including data for patients on L-606 for up to a year.

• Potential litigation risks, such as the 327 patent litigation; post-trial briefing complete but outcome uncertain.
• Market access challenges initially with new-to-market blocks and non-formulary positioning, though efforts are underway to expand market access.

Q: Implications of United's trial result for L-606?

A: If United is successful, they may have orphan protection for a period, and Liquidia will develop L-606 for the indication, potentially benefiting from the market once orphan exclusivity expires.