Liquidia Corp(LQDA) - 2021 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company recognized revenue of $3.1 million for Q2 2021, compared to no revenue in Q2 2020, as the acquisition of RareGen was completed in November 2020 [20] - Research and Development expenses decreased to $4.6 million in Q2 2021 from $8.5 million in Q2 2020, a reduction of approximately 46% [21] - General administrative expenses were $4.4 million in Q2 2021, down from $5.2 million in the same quarter of the previous year, a decrease of roughly 15% [22] - The net loss for Q2 2021 was $6.5 million or $0.13 per share, compared to a net loss of $13.9 million or $0.49 per share in Q2 2020 [23] - Cash at the end of Q2 2021 was $67.9 million, an increase from $65.3 million at the end of 2020 [24] Business Line Data and Key Metrics Changes - The launch of the RG 3ml Medication Cartridge for Treprostinil Injection has more than doubled the addressable market for the product [6] - The company has seen positive uptake and patient conversions for the generic Treprostinil Injection since its launch in June 2021 [31] Market Data and Key Metrics Changes - There is strong payer engagement and interest in increasing the utilization of generic Treprostinil, indicating a positive market response [31] Company Strategy and Development Direction - The company aims to optimize Treprostinil Injection sales, achieve tentative approval for LIQ861, and resolve the Hatch-Waxman Litigation to launch LIQ861 in 2022 [26] - The company is treating the commercialization of its generic product similarly to a brand, with a dedicated sales force and a VP of Market Access to work with payers [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver on its objectives and emphasized the importance of financial stability and disciplined spending [5][17] - The company is optimistic about receiving tentative approval for LIQ861 and is prepared for FDA inspections [14] Other Important Information - The FDA has set a PDUFA date of November 7, 2021, for the resubmission of the NDA for LIQ861 [13] - The company is involved in ongoing litigation with United Therapeutics, which is critical for its future product offerings [15][16] Q&A Session Summary Question: What is the split this quarter between IV and subcutaneous generic Treprostinil sales? - The company is not disclosing the split at this time but noted that the launch has gone well with positive uptake and patient conversions [30] Question: Can you provide additional details on the claims construction? - The judges ruled on three terms, with two terms given their plain and ordinary meaning and one term ruled in favor of the company [32] Question: What regulatory steps are needed to achieve approval for ILD indication? - The company intends to pursue the ILD indication after the expiration of United Therapeutics' data exclusivity in March 2024 [34] Question: Is there additional contracting required for patient access to the subcutaneous product? - Currently, all patients have access to the generic Treprostinil without additional contracting [38] Question: Have you reached the profit split threshold with Sandoz? - The threshold has not been met yet, but it is anticipated to be reached by the end of Q3 or beginning of Q4 [39]