5/12/2022

speaker
Howard
Conference Operator

Good morning, and welcome, everyone, to the Liquidia Corporation First Quarter 2022 Financial Results and Corporate Update Conference Call. My name is Howard, and I will be your conference operator today. Currently, all participants are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. Instructions will be provided at that time for you to queue up for questions. If anyone has any difficulties hearing the conference, please press star then zero for operator assistance at any time. I would like to remind everyone that this conference call is being recorded. I will now hand the call over to Jason Adair, Senior Vice President, Corporate Development and Strategy.

speaker
Jason Adair
Senior Vice President, Corporate Development and Strategy

Thank you, Howard. It is my pleasure to welcome everyone to today's conference call. Before we begin, I would like to remind everyone that today's call will contain forward-looking statements based on current expectations. Such statements may involve risks and uncertainties that may cause actual results to differ materially from these stated expectations. For further information on the company's risk factors, please see Liquidia's filings with the Security and Exchange Commission at www.icc.gov or on Liquidia's website at liquidia.com. Joining the call today are Chief Executive Officer Roger Jeff, Chief Financial Officer Mike Cassetta, General Counsel Rusty Schundler, and other members of Liquidia's management. I would now like to turn the call over to Roger for prepared remarks, after which he will open up the call for your questions.

speaker
Roger Jeff
Chief Executive Officer

Thank you, Jason, and good morning, everyone. The first quarter of this year reinforced everything that I believed to be true when I moved into the CEO role in January. Our products are needed, our team is dedicated and focused, and our confidence is high. We are focused on things in our control, first and foremost, of which is commercializing our products and building a path towards profitability. We remain encouraged by increasing payer support for troposanil injection, along with concurrent increasing demand. Large national and regional payers have been reviewing and now enacting generic mandates for parenteral troposanil. We are aware that additional payers are expected to implement mandates in the second half of 2022 and into 2023, reflecting acknowledgement that there is no perceived difference in quality, efficacy, safety, or patient support services with our troposyl injection versus the brancic remodulin. These payers see great potential benefit to reduce costs on a drug that was first introduced nearly 20 years ago. At the end of the first quarter, we argued the merits of our case in district court with respect to Hatch-Waxman litigation that was initiated nearly two years ago by United Therapeutics. We've been eager to reach this point in the proceedings, if only so that our full positions and evidence both as to non-infringement and invalidity of the asserted patents could become publicly known and accessible. We will continue to advance our position to the fullest extent post trial proceedings and related patent office actions. Next up is the inter-parties review or IPR against the 793 patent with oral arguments to be presented tomorrow to the Patent Trials Appeal Board or PTAT. Consistent with past earning calls, we do not intend to summarize our arguments against the patents being litigated To those who are interested, you can find much more information in the public domain through the court's PACER system, now that the trial has concluded, or through the PTABS docket system. What we will say is that liquidity remains confident. The path to launching your Trepia is on the visible horizon. We will update investors when decisions are rendered and continue to ask for your patience, as it will likely be September or October before we have definitive information. Regardless, we are not waiting to plan for success. During the first four months of this year, we fortified the balance sheet and enabled an operating plan for long-term value. Under Mike Cassetta's leadership, we have created a financing plan that allows us to optimize the path towards potential profitability. The combination of restructured debt, targeted equity in financing, and increasing sales of proprosenol injection provides us the flexibility required to navigate some uncertainty without reliance on any one form of capital. We will continue to tightly manage expenses in a disciplined manner while also playing to win, which more than the $100 million in cash allows. More specifically, we will continue preparations to rapidly launch Utrepia pending FDA approval and build commercial inventories accordingly. We will build on the 280 plus patient years of exposure with Utrepia by initiating new clinical trials in HUGA III patients, among others. We will advance development of our next-generation eutrapia pipeline, looking to improve on the product profile and dosing regimen. And we will monitor the external landscape for programs that might leverage our expertise and presence in the cardiopulmonary community. I'm personally excited to build on the foundation created by the team who welcomed me in January, and I'm humbled by the drive and determination of the company as a whole to get new treatment options to patients who eagerly need and await them. While our eyes are on the future, it is also important to recognize the great quarter we have had so far this year. With that, Mike, would you please highlight a few points from our financial statements?

Disclaimer

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