Liquidia Corp(US:LQDA)2019-08-08 23:01Financial Data and Key Metrics Changes - Revenues for Q2 2019 were $8.1 million, a significant increase from $1 million in Q2 2018, primarily due to the recognition of previously deferred revenue related to the GSK collaboration [16][18] - Cost of sales increased to $0.8 million in Q2 2019 from $0.1 million in Q2 2018, reflecting sub-licensing fees associated with the GSK agreement [17] - R&D expenses rose to $10.7 million in Q2 2019 from $5.9 million in the prior year, driven by ongoing clinical costs related to LIQ861 [17] - General and administrative expenses were $2.4 million in Q2 2019, up from $2 million in Q2 2018, mainly due to employee-related expenses [18] - The net loss narrowed to $5.9 million in Q2 2019 from $6.3 million in Q2 2018, attributed to the recognition of $8.1 million in deferred revenue [18][19] - Cash at the end of Q2 2019 was $52.1 million, with 18.6 million shares outstanding [19] Business Line Data and Key Metrics Changes - LIQ861, an inhaled dry powder formulation of treprostinil, has shown a favorable safety and tolerability profile, with over 90% of patients remaining on therapy at the two-month mark [10][12] - LIQ865, a PRINT formulation of bupivacaine for postoperative pain, is on track for Phase 2 studies in the first half of 2020 [14] Market Data and Key Metrics Changes - The company has amended its agreement with GSK to pursue additional inhaled products using PRINT technology, expanding its pipeline opportunities [12][13] Company Strategy and Development Direction - The company aims to submit the NDA for LIQ861 by the end of 2019 and release additional longitudinal data from the INSPIRE trial in Q4 2019 [20][21] - The focus is on leveraging PRINT technology to build a robust portfolio of innovative programs, with an emphasis on inhaled therapies [21][55] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the therapeutic benefits of LIQ861 and the positive feedback from the PAH community [11][21] - The company is exploring various financing options to extend its cash runway beyond Q2 2020 [33][58] Other Important Information - The company is actively assessing partnership opportunities for ex-U.S. strategies and is open to various funding alternatives [42][58] Q&A Session Summary Question: What is the evolution of the PK human landscape for LIQ861? - Management indicated optimism about LIQ861's potential to replace and expand the inhaled therapy market, leveraging the convenience of a dry powder inhaler [25] Question: What additional 861 INSPIRE trial data will be available in Q4? - Management confirmed that longitudinal data will include adverse event data and secondary endpoints, consistent with previous reports [32] Question: What is the cash runway for the company? - The company has cash into the second quarter of 2020 and is exploring various financing options to extend its runway [33] Question: Has the pre-NDA meeting with the FDA been completed? - Management plans to schedule the pre-NDA meeting in early Q4, setting the stage for NDA filing by the end of the year [40] Question: What are the strategies for additional pipeline programs? - The company aims to build on its existing expertise and capabilities in inhaled therapies, focusing on differentiated molecules and sustained release capabilities [55]