YUTREPIA (treprostinil) inhalation powder

Search documents
Liquidia Corp (LQDA) Earnings Call Presentation
2025-05-28 07:59
Product & Approval - YUTREPIA (treprostinil) inhalation powder has received FDA approval [1,3] - YUTREPIA offers a new choice to treat PAH & PH-ILD [11] - The WAC price for a 28-day supply is $24,360, at parity with Tyvaso DPI® [23] Clinical Data & Dosing - YUTREPIA enables a wide range of dosing for both naïve and transition patients [16] - In the INSPIRE study, cough was observed in 27% of transitioning patients and 55% of naïve patients [17] - In the ASCENT study, the median dosing at Week 8 was 132.5 mcg [20] Market & Commercialization - The company is targeting 6,500 physicians treating PH, ILD, or both [27] - The commercial team is fully mobilized and will start detailing today [26] - The field force includes 60 commercial team members, 10 medical science liaisons, field reimbursement specialists, 140 specialty centers and 650 community accounts [27] Patient Support - The company offers full patient support services, including a voucher program, co-pay program, bridge program, and patient assistance program [24]
Liquidia Corporation Reports First Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-05-08 10:30
Core Viewpoint - Liquidia Corporation is focused on the potential commercialization of YUTREPIA, an inhalation powder for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), with an FDA decision expected by May 24, 2025 [2][3][8]. Corporate Updates - The FDA accepted Liquidia's New Drug Application (NDA) resubmission for YUTREPIA, setting a PDUFA goal date of May 24, 2025, coinciding with the expiration of regulatory exclusivity for Tyvaso DPI [3][8]. - A U.S. District Court dismissed a cross-claim from United Therapeutics challenging the NDA amendment for YUTREPIA, allowing Liquidia to proceed without legal hindrance [4][8]. - Liquidia completed enrollment of Cohort A in the ASCENT study, with over 50 patients, showing promising results in dosing and tolerability [5][8]. Financial Position - Liquidia entered into a sixth amendment with HealthCare Royalty, allowing for up to an additional $100 million in financing to support the development of YUTREPIA and other clinical trials [6][8]. - As of March 31, 2025, cash and cash equivalents were $169.8 million, a decrease from $176.5 million at the end of 2024 [7][8]. - Revenue for Q1 2025 was $3.1 million, a slight increase from $3.0 million in Q1 2024, primarily from a promotion agreement with Sandoz [9][8]. Expenses and Losses - Research and development expenses decreased by 31% to $7.0 million in Q1 2025, down from $10.1 million in Q1 2024, due to a shift in focus towards commercialization [11][8]. - General and administrative expenses rose by 48% to $30.1 million in Q1 2025, attributed to increased personnel costs and legal fees [12][8]. - The 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 [14][8].