Liquidia (LQDA) Status Update summary

Regulatory and Product Approval

• YUTREPIA received final FDA approval for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), marking a significant milestone for patients.

• The product leverages proprietary PRINT technology for precise drug particle engineering, enabling deep lung delivery and improved usability via a low-resistance dry powder inhaler.

• YUTREPIA is the first product approved using PRINT, offering rapid dose escalation and flexible dosing across four strengths for both naïve and transitioning patients.

Clinical Differentiation and Data

• Robust clinical data from the INSPIRE and ASCENT studies support broad dosing flexibility, safe titration, and strong tolerability in both PAH and PH-ILD patients.

• ASCENT study showed PH-ILD patients achieved high median doses with no meaningful increase in cough, and no dose-dependent adverse events.

• Most common adverse reactions were cough, headache, throat irritation, and dizziness, consistent with known side effects of nebulized treprostinil.

• The label allows for flexible dosing frequency and timing, accommodating patient needs and activities.

Commercial Launch and Strategy

• The commercial team is fully mobilized, targeting 6,500 physicians and 140 specialty centers, with nationwide detailing and product availability expected within 14 days.

• Initial focus targets both specialty centers and community practices, aiming to reach newly diagnosed and unsatisfied patients.

• Pricing is set at $24,362 for a 28-day supply, at parity with Tyvaso DPI, with flat pricing across capsule strengths.

• Patient access programs include copay assistance, free vouchers, and bridge programs to ensure affordability.