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Liquidia Liquidia Reports Third Quarter 2021 Financial Results and Provides Corporate Update November 3 , 2021 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 ( UTC ) being asserted in related Hatch - Waxman litigation . In August 2021 , the U.S. Patent Trial and Appeal Board ( PTAB ) instituted an IPR against U.S. Patent No. 10,716,793 ( 793 patent ) owned by UTC . In its decision , the PTAB stated that Liquidia had demonstrated a reasonable likelihood of prevailing in its assertion that all of the claims of the ' 793 patent are unpatentable as obvious over the combination of certain prior art cited by Liquidia in its petition to the PTAB . A final written decision determining the validity of the challenged claims of the ' 793 patent is expected within 12 months from institution . More recently in October 2021 , the PTAB ruled in Liquidia's favor in the IPR proceeding against U.S. Patent No. 9,604,901 ( ' 901 patent ) . In its ruling , the PTAB found that seven of the nine claims were unpatentable . Only the narrower dependent claims 6 and 7 remain , both of which require actual storage at ambient temperature of treprostinil sodium . The ' 901 and ' 793 patents , along with U.S. Patent No. 9,593,066 ( ' 066 patent ) , are the subject of Hatch - Waxman litigation filed by UTC in June 2020 . The trial is expected in March 2022 in U.S. District Court for the District of Delaware . As a result of this litigation , the FDA is automatically precluded from fully approving the LIQ861 NDA until October 2022 absent an earlier judgment unfavorable to United Therapeutics by the court or other settlement . Third Quarter 2021 Financial Results Cash totaled $ 64.1 million and $ 65.3 million as of September 30 , 2021 , and December 30 , 2020 , respectively . Revenue of $ 3.2 million was recognized for the three months ended September 30 , 2021 , as compared to no revenue for the three months ended September 30 , 2020. Revenue recognized during 2021 related primarily to the promotion agreement with Sandoz Inc. , after the acquisition of Liquidia PAH in November 2020 . Cost of revenue was $ 0.9 million for the three months ended September 30 , 2021 , compared to no cost of revenue for the three months ended September 30 , 2020. Cost of revenue recognized during 2021 related to the promotion agreement as noted above . Research and development expenses were $ 4.5 million for the three months ended September 30 , 2021 , compared with $ 7.7 million for the three months ended September 30 , 2020 , a decrease of $ 3.2 million or 41.4 % . The decrease primarily related to lower expenses from the LIQ861 clinical program as well as lower employee and consulting expenses . General and administrative expenses were $ 4.9 million for the three months ended September 30 , 2021 , compared with $ 7.2 million for the three months ended September 30 , 2020. The decrease of $ 2.3 million or 31.7 % was primarily due to $ 2.9 million lower consulting expenses and professional fees associated with corporate activities offset by a $ 0.6 million increase in legal fees related to the ongoing LIQ861 - related litigation . Net loss for the quarter ended September 30 , 2021 , was $ 7.3 million , or $ 0.14 per basic and diluted share , compared to a net loss of $ 15.0 million , or $ 0.40 per basic and diluted share , for the quarter ended September 30 , 2020 . RemodulinⓇ ( treprostinil ) is a registered trademark of United Therapeutics Corporation . About LIQ861 LIQ861 is an investigational inhaled dry powder formulation of treprostinil designed using Liquidia's PRINT® technology with the goal of enhancing