Yahoo Finance Liquidia Corp (LQDA) Q1 2024 Earnings Call Transcript Highlights: A Detailed Review of ...
Revenue: $3 million in Q1 2024, down from $4.5 million in Q1 2023.
Cost of Revenue: Increased to $1.5 million in Q1 2024 from $0.7 million in Q1 2023.
Research and Development Expenses: $10.1 million in Q1 2024, up from $5.3 million in Q1 2023.
General and Administrative Expenses: $20.2 million in Q1 2024, significantly higher than $7.8 million in Q1 2023.
Net Loss: $40.9 million in Q1 2024, compared to a net loss of $11.7 million in Q1 2023.
Earnings Per Share (EPS): Net loss of $0.54 per basic and diluted share in Q1 2024, versus a net loss of $0.18 per share in Q1 2023.
Cash Position: Ended Q1 2024 with $157.9 million in cash.
Release Date: May 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
Liquidia Corp (NASDAQ:LQDA) is poised to launch YUTREPIA, a promising product for PAH and PH-ILD, into a rapidly growing market with potential peak sales eclipsing $3 billion.
YUTREPIA has shown high patient preference and satisfaction in clinical trials, with 100% of patients preferring it over Tyvaso after four months.
The company has a strong financial position with $157.9 million cash on hand, ensuring sufficient resources to achieve corporate objectives.
Liquidia Corp (NASDAQ:LQDA) has received positive feedback from the FDA with no additional clinical data required for adding the PH-ILD indication to YUTREPIA.
The company has robust commercial preparations in place, with commercial inventories ready and a fully engaged sales team prepared for immediate launch post-approval.
Negative Points
Revenue in Q1 2024 was down to $3 million from $4.5 million in Q1 2023, primarily due to lower sales quantities and unfavorable growth-to-net rebate adjustments.
Cost of revenue and general and administrative expenses have significantly increased, contributing to a net loss of $40.9 million in Q1 2024.
There are ongoing legal challenges from United Therapeutics seeking to stop the launch of YUTREPIA for PH-ILD, although they currently do not impact the FDA's ability to approve the drug.
The FDA has not yet issued a final action on the amended NDA for YUTREPIA, causing uncertainty about the approval timeline.
Despite the potential market growth, there is still significant competition and market penetration challenges that Liquidia Corp (NASDAQ:LQDA) must navigate to achieve projected sales targets.
Q & A Highlights
Q: Hey, guys. Thanks for taking my question. I guess just on last week's filing to dismiss by both UTHR and the FDA. How quickly do you think -- you have a sense of how quickly Judge Bates may move here? This seems like maybe the one new variable here. If FDA is being asked to give three days' notice, they don't want to give three days' notice, they want this dismissed. I'm just kind of curious how to put this in proper context. A: Roger Jeffs, CEO of Liquidia Corp, responded by addressing the second part of the question first, emphasizing the differentiation of YUTREPIA based on its pillars of tolerability, titratability, durability, and usability, dictated by the PRINT formulation. He highlighted that YUTREPIA allows for a highly tolerable therapy that is readily titratable, which will be reflected in the label related to the exposures seen in clinical work. Jeffs also noted that YUTREPIA aims to become the best-in-class and first-in-choice prostacyclin, competing with inhaled treprostinil and oral therapies like Orenitram and Uptravi. Russell Schundler, General Counsel, added that the timing of the judge's decision on the motion to dismiss is uncertain, and it could lead to a hearing or a ruling based on the briefs.
Q: Hi. Good morning. Thanks for taking my questions. I guess the first one, Roger, you mentioned targeting the oral treprostinil market. If you can just maybe elaborate on that in terms of the market opportunity, and I think, this would be another differentiated aspect of YUTREPIA, because I don't think your competitor has positioned their DPI product for that segment. A: Roger Jeffs explained that YUTREPIA aims to cannibalize the oral prostacyclin market, which includes therapies like Orenitram and Uptravi, due to its superior titratability and fewer off-target effects. He mentioned that YUTREPIA's ability to offer a more flexible and durable treatment option positions it well to capture a significant portion of the oral market, which has not been targeted by competitors due to their existing product lines. Michael Kaseta, CFO, discussed the payer landscape, expressing confidence in achieving payer coverage post-approval to ensure patient access to YUTREPIA.
Q: Hi, guys. Can you hear me? A: Julian Harrison, Analyst at BTIG, asked about the potential factors the FDA might be waiting on to make an approval decision and inquired about the status of manufacturing inspections. Roger Jeffs directed Rusty Schundler to respond to the legal aspects and Michael Kaseta to address the manufacturing queries. Schundler reiterated that there are no legal impediments to FDA approval, and Kaseta confirmed that all necessary pre-approval inspections have been completed and that the company is ready to launch immediately upon receiving FDA approval.
Q: Good morning, team. Thank you for sharing some of the ASCENT data to-date. So I guess my question on that open-label study is kind of what titration schemes are you looking to assess? And then as a second question, in terms of that overall projected $3 billion inhaled nebulized treprostinil market -- sorry, inhaled treprostinil market, what do you see the split between the different indications in that market and is that also kind of including some cannibalization of the oral treprostinil market? Thank you. A: Roger Jeffs responded by outlining the market opportunity for YUTREPIA, projecting it could eclipse $3 billion, with significant growth potential in both the PH-ILD and oral prostacyclin markets. He emphasized the underpenetration of the PH-ILD market and YUTREPIA's potential to significantly impact the oral market due to its superior dosing flexibility. Rajeev Saggar, CMO, discussed the ASCENT trial's focus on demonstrating the titratability and tolerability of YUTREPIA in PH-ILD patients, aiming to establish a strong dosing recommendation that exceeds current therapies.
Q: Hi. Good morning, guys. Thanks for taking the questions. Just in terms of your commercial prep and readiness, how soon after approval will you launch the drug? Thanks. A: Michael Kaseta addressed the company's readiness for the commercial launch of YUTREPIA, stating that the sales force and commercial inventory are prepared to initiate distribution within days following FDA approval. He highlighted the company's proactive engagement with payers and the readiness to provide immediate access to YUTREPIA post-approval.
Q: Okay. Thanks. And I know we're all focused and waiting for YUTREPIA's approval, but thinking out a little bit into the future, can you tell us a little bit more about 606 and L606 and what role and position you think that will play in terms of the inhaled precaution market? A: Roger Jeffs discussed the future potential of L606, a product designed to improve upon the dosing regimen of YUTREPIA by reducing the frequency of administration. He explained that L606 aims to dominate the inhaled treprostinil market by offering a twice-a-day dosing schedule that maintains therapeutic levels throughout the night, potentially improving patient outcomes and adherence.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
