Business
Liquidia Reports Third Quarter 2021 Financial Results and Provides Corporate Update
- Increased adoption of generic Treprostinil Injection by patients, physicians and payers- Completed on-site pre-approval inspections by FDA of two U.S.
About this update from Liquidia Corporation
[{"type":"text","content":"- Increased adoption of generic Treprostinil Injection by patients, physicians and payers- Completed on-site pre-approval inspections by FDA of two U.S. manufacturing facilities- Anticipate FDA action on LIQ861 near PDUFA goal date of November 7, 2021 MORRISVILLE, N.C., Nov. 03, 2021 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (“Liquidia” or the “Company”) today reported financial results for the quarter and nine-months ended September 30, 2021. Damian deGoa, Liquidia’s Chief Executive Officer, said: “We had another productive quarter. Sales performance of Treprostinil Injection was ahead of target. The initial uptake has been very positive as patients continue to transition to, or start on, Treprostinil Injection with clear support from payers and healthcare providers. We also had positive developments in our ongoing litigation with United Therapeutics. We look forward to hearing from the FDA in the coming days about the potential tentative approval of LIQ861.” Corporate Updates Increased adoption of generic Treprostinil Injection by patients, physicians and payers. During the third quarter, unit sales of Treprostinil Injection increased across intravenous and subcutaneous routes of administration, more than doubling the number of patients being treated as compared to the number of patients prior to the launch of the subcutaneous route of administration in late May of 2021. Revenue was impacted by a reduction in the contractual profit split percentage earned pursuant to the Promotion Agreement between Liquidia PAH and Sandoz as a result of achievement of pre-determined cumulative sales thresholds. As a result, the increase in unit sales did not result in a corresponding increase in revenue reflected on the income statement on a quarter-over-quarter basis. Completed on-site pre-approval inspections by FDA of two U.S. manufacturing facilities in advance of LIQ861 PDUFA goal date. As part of the FDA review of LIQ861, the FDA conducted two prior-approval inspections, one at the Company’s Morrisville, NC facility and the other at the facility of a third-party provider of encapsulation and packaging services for LIQ861. These pre-approval inspections were completed in August 2021 and October 2021, respectively. Successfully advanced inter partes review (IPR) proceedings against two patents owned by United Therapeutics (UT...