Liquidia Q1 FY26 earnings call LQDA

YUTREPIA has demonstrated strong commercial momentum, leading the growth of the inhaled prostacyclin category in PAH and PH-ILD. In its third full quarter on the market, YUTREPIA achieved $129.9 million in net product sales, representing 44% sequential growth. The product has garnered approximately 4,500 unique patient prescriptions and started 3,750 patients on therapy since launch, with 980 physicians prescribing. The number of physicians prescribing to 5 or more patients grew 25% to 270 since February, indicating increasing depth of prescription and YUTREPIA becoming a foundational therapy.

Liquidia is actively broadening its clinical opportunities to expand the franchise value of its portfolio. This includes recruiting into Cohort B of the ASCENT study to transition inadequate responders from Tyvaso DPI to YUTREPIA, and actively screening patients for the pivotal Phase III RESPIRE study of L606 for PH-ILD. Additionally, the company is advancing clinical programs to explore YUTREPIA's role in other serious pulmonary and vascular diseases such as IPF, PPF, PH-COPD, and scleroderma associated Raynaud's phenomenon, with a PH-COPD study anticipated to begin in 2027.

The company has established a profitable, self-funded business in a short period, delivering its third consecutive quarter of profitability. Net income reached $52.9 million and non-GAAP adjusted EBITDA was $71.2 million in Q1 FY26. This financial strength allows Liquidia to reinvest profits into new manufacturing capacity, YUTREPIA and L606 clinical studies, and other growth initiatives, rather than relying on capital markets. Cash and cash equivalents grew to $222.8 million, reinforcing the ability to fund future priorities.

The PH-ILD market is seen as significantly underpenetrated, with a potential value well in excess of $2 billion to $3 billion on its own, contributing to a total PAH and PH-ILD market opportunity of $6 billion. Liquidia's strategy involves driving awareness among community pulmonologists, who often see ILD patients but may not actively screen for PH. The company is expanding its sales force to reach these physicians, educate them on PH-ILD, and encourage diagnosis or referral to specialized centers, leveraging recent data showing 50-75% of ILD patients have a PH component.

The company remains confident in its arguments regarding the 327 litigation concerning United Therapeutics' patents. While not directly comparable, the Hikma vs. Amarin case, which focuses on induced infringement and certain conduct, presents parallels that Liquidia believes could potentially favor its position. Management expressed bullishness on the outcome of the opinion when rendered, suggesting any read-through from Hikma would likely be positive for Liquidia.

YUTREPIA is experiencing a 'renaissance' in inhaled therapy, driven by its product profile which offers superior tolerability and allows for higher dosing, leading to better patient outcomes. Practitioners are increasingly switching patients from oral prostacyclins due to YUTREPIA's direct lung administration, minimized off-target systemic side effects, and ability to achieve higher therapeutic exposures. Studies are planned to facilitate transitions from oral prostacyclins and parenteral therapies, including those on sotatercept, to YUTREPIA.