Release Date: November 13, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Liquidia Corp (NASDAQ:LQDA) has a clear path to seeking final approval for Reia, with potential approval as early as May 2025.
• The company has successfully expanded its relationship with Hermosa, securing rights for L 606 in the EU and other territories outside North America.
• Liquidia Corp (NASDAQ:LQDA) has strengthened its balance sheet with approximately $100 million raised through several financing transactions.
• The clinical progress of Reia and L 606 is promising, with positive preliminary data from the Ascent study showing good tolerability and titratability.
• The company has a well-prepared sales force with significant experience in rare diseases, ready to launch Reia upon FDA approval.

Negative Points

• The final approval of Reia is currently delayed due to the FDA's decision to grant exclusivity to a competitor, which Liquidia is challenging in court.
• Research and development expenses have increased significantly, up 60% from the previous year, impacting the company's financials.
• General and administrative expenses have nearly doubled, primarily due to increased personnel and legal fees.
• The company faces ongoing litigation challenges, including a lawsuit against the FDA and a patent dispute with United Therapeutics.
• The timeline for the L 606 pivotal study has been pushed to the first half of 2025 due to the integration of a new nebulizer device.

Q & A Highlights

• Warning! GuruFocus has detected 5 Warning Signs with LQDA.

Q: Regarding the summary judgment hearing in December, how soon could a decision be delivered, and what are the possible outcomes? A: (Rusty, General Counsel) It's hard to predict the timing for a judge's decision as there is no set timeline. The possible outcomes include upholding the decision, overruling it, or remanding it back to the FDA for further consideration.

Q: What is the expectation for data disclosure from the Ascent trial? A: (Rajeev, Chief Medical Officer) We plan to disclose data at a congress in the first half of 2025. The data will highlight the differentiated value of Yutrepia, particularly in terms of dose, clinical outcomes, and treatment persistence.

Q: Should we expect any coverage access issues when launching Yutrepia? A: (Mike, CFO) We have been engaging with payers since receiving tentative approval in 2021 and are confident in obtaining access close to the launch.

Q: Can you provide a timeline for the development and enrollment of L606, given its global nature? A: (Roger, CEO) We plan to initiate the trial in the first half of 2025, with enrollment expected to take 18-24 months. The entire process, from start to finish, could take about four years, but we aim to expedite this due to the unmet need for PH-ILD patients.

Q: How robust is your supply of the DPI inhaler for the launch? A: (Mike, CFO) We have been manufacturing commercial supply since early 2022 and are prepared for a successful launch with sufficient supply upon the expiration of United's marketing exclusivity.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.