Liquidia Corporation

Good morning and welcome everyone to the Liquidity of Corporation second quarter 2021 financial results and corporate update conference call. My name is Angie and I will be your conference operator today. Currently, all participants are in 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 difficulty hearing the conference, please press star zero for an operator to assist you at any time. I would like to remind everyone that today's conference call is being recorded. I would now like to hand the conference over to Jason Adair, Vice President, Corporate Development and Strategy. Please go ahead, sir.

Thank you, Angie. It's my pleasure to welcome everyone to today's conference call to discuss our second quarter financial results for 2021 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 liquidia.com. I would now like to turn the call over to Chief Executive Officer Damian Ngoa for a prepared remark after which he will open up the call for your questions.

Thank you, Jason, and good morning, everyone. I'm joined today by Mike Cassetta, our Chief Financial Officer, and several members of our management team who may help address questions later in the call. My comments today will be brief and consistent with the release issued earlier today. What I can confidently say is that in the seven months since I assumed this role of CEO, we have delivered on every objective we set forth. We immediately addressed and increased the financial stability of the company, focusing it on value-creating activity. We increased the value of our proprostanil injection product by securing the FDA clearance and launch of the RG3 ML medication cartridge that enables the delivery of proprostanil injection by subcutaneous route of administration. and more than doubles the addressable market for that product. We promptly resubmitted the NDA for LIQ861, now with a PDUFA day action in November. And we continue to engage in multiple work streams to defend our legal right to provide choice and options for patients to receive proxenol therapy in a convenient, easy-to-use dry powder inhaler. Despite some minor setbacks along the way last year, we have shown perseverance. We were not deterred when restrictions imposed by other companies limited access to the cartridges needed by patients using the CAD-MS3 pump. Instead, working with our manufacturing partner and through our litigation against Smith Medical and United Therapeutics, we launched the RG-3ML medication cartridge earlier this year. We went above and beyond and solved the device problem in order to allow greater patient access to the troposomal injection medication. It's important to remember that archiprostal injection is AP-rated and therapeutically equivalent to remodulin, with the same active and inactive ingredients, same dosage strength, same dosage forms, the same Smith's medical pumps, with the same services and support for patients and healthcare providers at a lower cost. It's also worth noting that we are partners with Sandoz Novartis, one of the largest pharma companies in the world, and all the resources and expertise that they have to bear. Even though our product is a generic, we treat the commercialization efforts more like a brand. We have a national field sales force of experienced PAH sales reps that are calling on prescribers, and we recently hired a VP of market access to work with PEARS to complement Sandoz's efforts. We have confirmed that the available supply of pumps is more than adequate to serve the subcutaneous patient population. Though it's a bit early to assess the full impact of our launch, we are highly encouraged and I look forward to updating you during our next earnings call on the response to this new choice. Concurrent with the launch of the subcutaneous cartridge, our in-house team promptly resubmitted the NDA for 861 ahead of schedule. The FDA has since confirmed that the resubmission was complete and considered a Class 2 response, setting a PDUFA goal date of November 7, 2021. We feel confident that the data submitted clarifies and directly addresses the CMC related items identified by the agency last year. We also feel well prepared to support the FDA's pre-approval inspections with one currently ongoing at our North Carolina facility. Needless to say, it's an exciting time in the company's evolution and we look forward to a positive outcome with the agency with the goal of receiving tentative approval in the fall. As we work to support the FDA's ability to grant tentative approval, Our ultimate success will be tied to the resolution of Hatch Waxman litigation brought by United Therapeutics. While we cannot disclose the details of our legal strategies and arguments, we can remind you that the FDA's 30-month regulatory stay, which expires in October 2022, is directly tied to patents covering a process of making troposynol, a compound that has been manufactured at commercial scale for decades. We will provide updates in the future as they are deemed material, But for the time being, we remain confident in our arguments of non-infringement and invalidity that we have pursued in the Hatch-Waxman litigation and the corresponding IPR proceedings with the United States Patent and Trademark Office. Lastly, with a long-term path in mind, we took the additional steps in the second quarter to ensure stable financial footing. We maintained a sense of discipline in each financial decision, and we built a prioritized operating plan to provide the capital needed to achieve our near-term goals of launching 861. We have taken these steps with the fervent belief that Liquidia's products serve the best interests of the patient community who we are committed to support. At this time, I will turn the call over to Mike to review our second quarter financial summaries.