Liquidia Corporation

Good morning and welcome everyone to the Lakedia Corporation full year 2020 financial results and corporate update conference call. My name is Victor and I'll 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. Instruction 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 now like to remind everyone that this conference call is being recorded. I will now hand the conference over to Jason Adair, Vice President, Corporate Development and Strategy.

Thank you, Victor. It's my pleasure to welcome everyone to today's conference call to discuss our full year financial results for 2020 and to 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 www.liquidia.com. I would now like to turn the call over to our Chief Executive Officer, Damian Dagoa, for our prepared remarks, after which he'll open the call for your questions.

Thank you, Jason, and good morning, everyone. We hope you and your families remain healthy. I'm excited to speak with you today on my first earnings call for Liquidia. I began with Liquidia in mid-December. As you might expect, the last three months have been busy as we position Liquidia for the future. But before we jump into the full corporate update and review of 2020 financials, I would like to take a moment to introduce a few of the new members of the management team. Joining me on the call today are Mike Cassetta, our Chief Financial Officer, who joined in November. Scott Mumaw, our Senior Vice President of Commercial, who joined as part of the RareGen merger, also in November. And Dr. Tushar Shah, our Chief Medical Officer and Head of R&D, who joined in May. The rest of the management team includes Rob Lippe, our Chief Operations Officer, who has helped scale print technology over the last six years. Jason Adair, who you've met and continues to lead business development and investor relations. And lastly, I'm pleased to announce that effective next week, Rusty Schundler will join Liquidia as Senior Vice President and General Counsel. Rusty has served as General Counsel at PBM Capital Group, where he and I worked together for more than five years. What can you expect from our leadership team? We will operate with a sense of urgency. We will be decisive and results oriented. We will be financially disciplined and efficient. We will focus on value creating objectives. We will be entrepreneurial and approach growth as an investor and manager. As a newly assembled management team, our initial thoughts on the company are as follows. our inhaled dry powder formulation of tryprosinol is a great product with very good market potential. Patient benefits are clear. We recognize that we have work to do to achieve final approval, including one, responding to the complete response letter issued by the FDA last November, two, preparing for a prior approval inspection by the FDA, and three, achieving a successful outcome in Hatch vaccine litigation brought by United Therapeutics. We know what we have to do and are executing on those plans. We also have an attractive commercial product, prosto injection, that we promote in partnership with Sandoz. This AP-rated generic formulation of remodulin offers the same active and inactive ingredients with the same patient and physician services, but at a lower cost to the healthcare system. The parenteral delivery of toprosinol remains a sizable market, and we see opportunity to increase utilization of our product. We have a unique, innovative platform in print technology. There is clear advantage in inhaled therapies, but also applications that have been explored in vaccines, antivirals, implants, topicals, and biologics. We are actively considering new internal R&D product candidates that can either leverage our expertise in pulmonary hypertension or the value of prints. we will discuss more about the R&D pipeline as things evolve. We have an asset in 865 to control post-operative pain that we feel is best positioned with a strategic partner, which I will address in a few minutes. And we need to look for value-creating opportunities both from our R&D and business development. This team will strive to provide balanced and transparent insights into the actions and decisions of the company. For the time being, Liquidia is a small company, and the impact of many events are magnified. We understand these details can be important to investors, but need to be managed with due sensitivity, such as around active litigation, competitive intel related to troprosomal injection, and details of regulatory interactions. So, with the future in mind, I'd like to summarize some of the key activities from 2020 and the recent past. First, we have evolved the company from a clinical stage to one with commercial presence in PAH. Having closed the rare-gen merger transaction in November, there have been no interruptions to commercial support of Sandoz's first-to-file generic troposynol injection. Despite the current limitation to IV administration only, demand for troposynol injection remains consistent and strong even as new generics have entered and commercial activities have been limited due to COVID. We continue to see increasing potential for generic utilization as payers consider adoption and physicians become more familiar. Importantly, we now have a PAH-focused sales force that establishes the initial commercial infrastructure needed to launch 861. Prior to restructuring at Liquidia Corporation, much of our activity last year was tied to the FDA's review of 861. In January, the company submitted an NDA for the first product enabled by our proprietary print technology and the first dry powder inhaled to prostanel. We remain confident in our abilities to address the items efficiently and bring 861 to the market as soon as possible. To that end, we expect to submit our formal response to CRL in the middle of the year. This project timeline has been informed by our Type A meeting with the FDA in January. As previously announced, the items that led to the CRL were related to the need for additional information and clarification of CMC data and device biocompatibility. that CRL did not require any additional studies in areas of toxicology, pharmacology, or clinical exposure to patients. We're fully prepared to host the FDA for an on-site inspection at Liquidia and our manufacturing partners after our response has been submitted. While the 861 team works on the CRL response, the new management team has extended our cash runway by making financially disciplined choices to operate until 861 can be approved. Specifically, Over the last three months, we have implemented changes that will reduce our net cash expenses in 2021 by more than 40% when compared to spending in 2020. Mike will outline some of the components of those savings. As a result of these quick decisions, the company is well positioned to drive value through key events in 2021 and 2022, beyond the projected expiration of the regulatory stay in October 2022. To that point, we continue to progress the hatch waxing litigation brought by United Therapeutics and our concurrent IPR efforts at the U.S. Patent Office. We believe the patents being asserted are not infringed nor valid. We are confident in our arguments to be made in court, but will not be commenting in detail on these ongoing proceedings. Anticipating commercial success, Liquidia has strengthened its intellectual property and competitive position with the issuance of the 494 patent, which expires in 2037. Enabled by the print formulation and clinical evidence of 861, claims of this patent were first allowed last August and relate to methods of treating pulmonary hypertension, not just pulmonary arterial hypertension, with doses between approximately 100 micrograms to approximately 300 micrograms of dry powder tricostinol. Specifically, more than 75% of patients enrolled in our pivotal and extension studies have received 861 doses of 100 micrograms or more. we believe those dose levels may be translating to a patient benefit over time, having treated more than 75 patients for longer than two years. With regard to 865, as stated in earlier filing, we're advancing conversations with external collaborators about continued development. To ensure we achieve our near-term financial objectives, as well as provide 865 with the highest chances of success, we feel it is important to collaborate with partners already working in the field of pain management We look forward to updating you on these efforts in future calls, though to be clear, investment in 865 has been paused until these business discussions conclude. At this time, I'll turn the call over to Mike to review our full year financial summaries.