Liquidia Corporation

Good morning and welcome everyone to the Liquidia Corporation Full Year 2021 Financial Results and Corporate Update Conference Call. My name is Josh 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 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.

Thank you, Josh. It's my pleasure to welcome everyone to today's call to discuss our full year results for 2021 and provide a business update. Before we begin, I'd 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 Securities and Exchange Commission at www.sec.gov or on Liquidia's website at liquidia.com. Joining the call today are Chief Executive Officer Roger Jeffs, Chief Financial Officer Mike Cassetta, Senior Vice President and General Counsel, Rusty Schundler, and other members of Liquidia Management. I would now like to turn the call over to Roger for our prepared remarks, after which he will open the call for your questions. Roger?

Thank you, Jason, and good morning, everyone. It's a pleasure to be speaking with you today. 2021 was a banner year for Liquidia, a year that focused on optimizing the company's core initiatives as we begin to focus our full efforts towards the launch of Utrepia at the end of this year. 2021 included multiple major accomplishments. Some highlights are, firstly, in November, we received tentative approval of Utrepia with labeling. We view the labeling as highly favorable as it includes description of use in both patients switching from Tyveso as well as prostacyclin-naive patients with no new safety issues identified. We are excited to bring this portable, titratable, and durable therapy to patients, some of whom have been using Utrepia for more than three years It doses approximately three times that of Tyveso's therapeutic dose. This therapeutic profile represents a potential game changer for PAH patients and positions Eutrefia to become the prostacycline of first choice. Secondly, in April, we expanded the use of troposinol injection into the subcutaneous market. As a result, we more than doubled the number of patients on troposinol injection with approximately 500 patients on therapy today based on specialty pharmacy reporting. Approximately 400 unique prescribers have switched patients from brand to generic, including approximately 150 unique prescribers since our sub-Q launch in April of 21. We expect to see continued demand growth as new generic mandates from payers are increasingly being issued from large payers that cover tens of millions of lives. Thirdly, we also have significantly advanced our ongoing litigation with United Therapeutics, including a final written decision in the IPR for the 901 patents that found seven of the nine claims unpatentable. In addition, based on United Therapeutics' stipulation of liquidity as non-infringement of the remaining two claims of the 901 patent, that patent will no longer be part of the Hatch-Waxman trial, which is scheduled for the end of this month. An IPR was also instituted for the 793 patent with a PTAF stating that liquidity had demonstrated a reasonable likelihood of prevailing in its assertion that all of the claims of the 793 patent are unpatentable as obvious over the combination of certain IRR. And while last Friday's summary judgment decision did not go as we hoped, it is important to note that the issue before the court in summary judgment was not the same issue that will be before the court at trial. Judge Hall specifically noted that she would not comment in on the validity of the asserted claims in the 901 and 066 patents or the likelihood that the Delaware court may find the claims invalid based on the same reasoning that led the PTAB previously to invalidate United Therapeutics' 393 patent. In fact, given that Judge Hall's recommendation was based solely on technicalities that applied only to our collateral estoppel arguments and not on the substance of arguments regarding the scope of the 066 and 901 patents, We are, if anything, more confident than before in our positions of invalidity and non-infringement that will be presented at trial. And finally, we strengthen our balance sheet through business optimization initiatives and the refinancing of our credit facility with SVB, providing funding through key legal milestones in the early launch phase of EUTREPIA, as Mike Cassetta will now describe in more detail for you. Mike, over to you.