Release Date: August 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Liquidia Corp (LQDA, Financial) is actively preparing for the potential launch of YUTREPIA, with commercial teams ready to distribute upon FDA approval.
- The ASCENT study of YUTREPIA in PH-ILD patients is progressing well, with positive preliminary feedback from physicians.
- The company has received favorable scientific advice from the European Medicines Agency for its L606 trial design, aligning with FDA feedback.
- Liquidia Corp (LQDA) ended the second quarter of 2024 with a strong cash position of $133 million, supporting its corporate objectives.
- The market opportunity for inhaled treprostinil is significant, with potential growth from a $1.5 billion run rate to over $3 billion.
Negative Points
- Revenue for the second quarter of 2024 decreased to $3.7 million from $4.8 million in the same quarter of 2023, primarily due to lower sales quantities.
- The company reported a net loss of $27.9 million for the second quarter of 2024, compared to a net loss of $23.5 million in the previous year.
- General and administrative expenses increased significantly to $20 million in Q2 2024, up from $9.2 million in Q2 2023, driven by personnel and legal expenses.
- There are ongoing uncertainties regarding the FDA's decision on the YUTREPIA NDA, with no specific timeline provided for approval.
- The company faces legal challenges, including ongoing litigation related to YUTREPIA, which could impact future operations and financial performance.
Q & A Highlights
Q: Can you explain why higher inhaled treprostinil exposure is beneficial for PAH and PH-ILD?
A: Roger Jeffs, CEO, explained that prostacyclins allow for continuous titration to effect, which is crucial for progressive diseases like PAH and PH-ILD. YUTREPIA offers the benefits of parenteral and oral products with fewer systemic side effects, allowing for higher dosing flexibility and effectiveness. Rajeev Saggar, CMO, added that higher doses have shown improved outcomes in clinical observations, making YUTREPIA a potentially best-in-class treatment.
Q: When can we expect comprehensive data from the ASCENT trial, and what key questions will it address?
A: Rajeev Saggar, CMO, stated that the ASCENT trial focuses on safety, tolerability, and exploratory efficacy of YUTREPIA in PH-ILD patients. The study aims to demonstrate durability and optimal dosing. Preliminary data will be presented at upcoming conferences, with full results expected by year-end and publication in 2025.
Q: What are the next steps in the UT case against the FDA, and how might it affect the YUTREPIA NDA decision?
A: Rusty Schundler, General Counsel, mentioned that the court could either hold an oral argument or rule on the briefs regarding the motion to dismiss. The company cannot comment on FDA communications, but they remain focused on obtaining approval for YUTREPIA.
Q: Can you provide details on the L606 registrational study and the ASCENT study's progress?
A: Rajeev Saggar, CMO, noted that the L606 study will start by year-end, focusing on 6-minute walk distance as the primary endpoint. The ASCENT study has tripled its sites and aims to complete by year-end, with 15 patients expected by month-end.
Q: How does the company plan to manage cash burn, and are there plans to respond to United's citizens' petition?
A: Mike Kaseta, CFO, stated that Liquidia has $133 million in cash and is confident in its financial position to support key objectives. Rusty Schundler, General Counsel, added that they do not plan to publicly respond to the citizens' petition, focusing instead on direct communications with the FDA.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
