Good morning, ladies and gentlemen. My name is Deborah, and I will be your conference operator today. I would like to welcome everyone to the Liquidia conference call to discuss a regulatory update. At this time, 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 the 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 conference over to Jason Adair, Vice President, Corporate Development and Strategy. Thank you and good morning, everyone. Before we begin, I'd like to remind you that today's call will include forward-looking statements pursuant to the Private Securities Litigation Reform Act of 1995 relating to, among other things, our expectations concerning next steps in the regulatory review and potential approval of YUTREPIA. Such statements represent management's judgment as of today and may involve significant risks and uncertainties that could cause actual results to differ materially from expected results. Please refer to our press release this morning and the annual filings with the SEC, which are available with the SEC at sec.gov or from Liquidia's website at liquidia.com for information concerning risk factors that could cause such differences and otherwise affect the company. Joining us from Liquidia on today's call are Chief Executive Officer Damian deGoa, Chief Financial Officer Mike Kaseta, and Chief Medical Officer Tushar Shah, as well as other members of senior management who may be called upon to answer questions at the end of our prepared remarks. With that said, I'd like to hand the call over to Damian. Thanks, Jason. What an exciting time for the company. The FDA's tentative approval for YUTREPIA, formerly known as LIQ861, is a major milestone in our company's continuing evolution to positively impact the lives of patients. Before I speak to the product and next steps, I would like to recognize the tremendous effort by the professional, collaborative, and dedicated team here at Liquidia and thank all who participated in our clinical trials. We successfully navigated the FDA regulatory process. We regrouped after last year's CRL and submitted a comprehensive, timely response. We resubmitted the NDA a month earlier than originally planned and more importantly, addressed all FDA information requests. We successfully completed our first pre-approval inspection with no observation. This was the first time our facility and our proprietary PRINT technology was formally inspected, and the outcome was exceptional. Not only have we demonstrated that YUTREPIA is ready for commercial production according to FDA's requirements, but we also validated our PRINT technology as an innovative drug formulation and manufacturing platform. To our knowledge, no other company in the world has the ability to engineer and manufacture discrete drug particles with a precise size, shape, and chemical co-composition at a commercial scale. It's humbling to think that technology which started in the labs of the University of North Carolina in 2004 has evolved to meet the stringent requirements of the FDA to enable effective, safe, and convenient medicines at a commercial scale. This is maybe a good time to thank the investors and equity alumni who contributed or supported us along the way. Lastly, we achieved these results while managing through the constraints and stress created by the global pandemic. At no time was this team deterred, and at every turn they demonstrated a resiliency and resolve to achieving this milestone today. This high-performance culture will serve us well as we prepare to commercialize YUTREPIA in the future. Now turning towards YUTREPIA. YUTREPIA treprostinil inhalation powder is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability in adult patients with a New York Heart Association NYHA functional Class two to three symptoms. We will not be discussing the approved package insert in detail at this time because it's not yet a marketed drug. However, we can point out some key pieces. The label reads as we expected and is consistent with the program discussed with the agency from the start. Though we recognize and intend to pursue additional indications for YUTREPIA, we are pleased to receive the PAH indication. YUTREPIA has a clean label with no black box warnings, no contraindication, and clear links to Tyvaso's label as the reference lists the drug in our 505(b)(2) regulatory process. The dosing and administration of YUTREPIA will be consistent with what has been studied and published. Our INSPIRE trial demonstrated we can safely administer dry powder treprostinil to patients both naive to treprostinil, as well as those transitioning from Tyvaso. We demonstrated in our PK study that a single capsule of 79.5 micrograms of YUTREPIA is comparable to nine breaths of Tyvaso. Additionally, with no maximum tolerated dose established, we are confident that the safety profile enables titration of dosing to levels higher than the target maintenance dose of Tyvaso. This attribute may become especially important to help address disease progression in PAH and as we consider new indications to pursue where higher levels of inhaled treprostinil may provide the greatest benefit. YUTREPIA offers convenience and ease of use as compared to today's nebulized version. The device used to administer YUTREPIA is very small. It's only palm sized with a long and proven track record of use with other commercially available inhaled products. YUTREPIA provides simple portability, easy setup and administration, as well as minimal cleaning, lowering the burden of treatment from nebulized therapy. YUTREPIA can easily be stored without the need of special handling or refrigeration. A single dose, day's dose of YUTREPIA can easily be carried in a pocket. With convenience, we believe that patient compliance into inhaled therapy will increase. Our quality of life data from INSPIRE suggests a strong preference for YUTREPIA over Tyvaso, which is further demonstrated by the fact that Liquidia is still treating patients today, more than three years after we started our clinical trials. Based on this combination of attributes, we believe that YUTREPIA will quickly become the preferred inhaled formulation of treprostinil when it can be introduced into the marketplace. We believe that YUTREPIA may broadly benefit PAH patients across the stages of disease, including earlier use of prostacyclins and later use of inhaled prostacyclins. Local delivery helps to minimize the systemic toxicities, especially those caused by oral prostacyclins. Comparable convenience and local delivery will play well as an alternative to oral treatments. YUTREPIA can quickly achieve targeted therapeutic levels in treprostinil-naive patients, as shown in the INSPIRE and extension studies. By expanding the inhaled dose range of treprostinil in a dosage-friendly manner, it is conceivable that patients may remain on inhaled treatment longer, delaying the use of infusion pumps and achieving a big win for quality of life for patients. As we know with the prostacyclin class, exposure drives efficacy. Parenterals have shown the greatest benefit, however, they must be dosed 24/7 by an external infusion pump, which presents its own risk, burdens, and impacts quality of life. Not only have we continued to treat patients more than three years after starting therapy in our clinical trials, but we've also observed doses in our trial as high as 238.5 micrograms four times per day. The same clinical data that supports our label has also enabled an issued patent that protects the use of inhaled dry powder treprostinil at doses between 100 and 300 micrograms. This may become especially important as we consider the current and growing market opportunity in treatments above 100 micrograms of treprostinil. YUTREPIA's preferred product profile was enabled by our proprietary PRINT technology. By controlling the precise size, shape, and aerosolization of the dry powder particles, we can enhance the delivery of drugs to the deep lung. We took the Goldilocks approach to the particle size. Not too big, not too small, just right. Building on decades of knowledge related to the inhaled dry powders, our formulation was designed to ensure that fewer drug particles are caught in the upper airway and more dispersed efficiently to the deep lung. We were inspired by nature. The trefoil shape of each YUTREPIA particle resembles a particular type of pollen. We believe that today's positive decision on YUTREPIA also helps validate PRINT technology, demonstrating the ability to create ideal formulations for local drug delivery to treat local diseases of the lung. We feel well positioned to pursue the increasing interest in inhaled treatments in pulmonary hypertension and beyond. While there are clear demonstrated benefits in inhaled therapies using PRINT has many other applications that have been previously explored and may be considered in the future. The market opportunity for inhaled treprostinil is significant and growing due to the advent of dry powder inhalers and new indications. In 2020, United Therapeutics reported that its inhaled treprostinil achieved sales of more than $480 million in PAH, and projections are being made that this may achieve sales of greater than $1 billion in the coming years. Dry powder inhalers like YUTREPIA are expected to expand the use of inhaled treprostinil as patients seek a quick switch option from oral or nebulized treatments and hope to delay transition to more invasive parenteral administration, increasing the time patients use inhaled therapy. Dry powder inhalers also represent an approachable option for patients with other forms of pulmonary disease where prostacyclins show promise. We will consider the best path to expand in new indications. Before Liquidia can realize this future market potential, we have to address what is next. Tentative approval is notification that an NDA meets the requirements for approval under the Federal Food, Drug, and Cosmetic Act, but cannot be market authorized because of an outstanding patent issue, Hatch issue. As we have reported previously, United Therapeutics is asserting infringement of three patents listed in the Orange Book for Tyvaso, the reference listed drug in our 505(b)(2) NDA submission. The FDA initiated a regulatory stay on final approval of YUTREPIA, which expires in October 2022, unless the litigation is resolved earlier. Infringement of these patents is being decided through a Hatch-Waxman litigation process, with a trial scheduled for late March 2022. While we will not comment in detail about the ongoing litigation, we remain confident in our positions. We've been encouraged by the recent wins issued by the U.S. Patent Office through the inter partes review proceedings. Last month, PTAB issued a final written decision that seven of the nine claims in the 901 patent were unpatentable, with only the narrower dependent claims six and seven remaining. This was a great outcome. In August, the PTAB also instituted an IPR with respect to the 793 patent, stating that Liquidia 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 prior art. We think this is a strong signal. We will continue to vigorously pursue our right to bring the innovation and benefits of YUTREPIA to market as soon as possible. We continue to operate with financial discipline and an emphasis on execution. We ended the third quarter with $64 million in cash. We are in a strong financial position to be able to take this through the end of the regulatory stay while preparing for commercial launch. Our Treprostinil Injection sales have been good. We more than doubled the number of patients on the treatment in the last four months since introducing the subcutaneous cartridge. With the increase in unit sales, we triggered a step down in profit split with Sandoz from 80%- 50% earlier than expected. We know that Treprostinil Injection will continue to grow as more payers mandate generic first programs. It's a great offering. In essence, it is a therapeutically equivalent product provided with the same services at a lower cost. This is a big win for the healthcare system, patients, and healthcare providers. At this time, we would like to open the call up to your questions related to YUTREPIA or the earnings that we filed last Wednesday. If you would like to ask a question, please press star one on your telephone keypad. Again, that is star one to ask a question. We'll pause for a moment to compile the Q&A roster. Your first question comes from the line of Chris Howerton with Jefferies. Hey, everybody. Thank you so much for taking the questions, and obviously, congratulations on the tentative approval. So for me, the couple questions would be, you know, as you move towards eventual commercialization, you know, hopefully next year, what would be kind of the CMC scale that may or may not be required and what kind of unit volume you'd be looking to have at launch would be one question. The second question I would have would be, you know, now that you have a product that has been approved using the PRINT® Technology, have you considered additional expansion of that technology to inhaled products or other potential therapeutic areas or, you know, I guess any evolved thinking you have around there? Third, if I may, you know, I don't know that you'll be able to, but to the extent that you can, help us understand what the expectations might be for the existing business with the injectable treprostinil, either by volume or revenue, moving forward. Thank you. Thanks, Chris. Let me try to address each of those. In relation to the CMC scale and unit volume, we have plenty of capacity within our infrastructure to meet the demands of the commercial launch, and it would be our expectation to build obviously above our forecasted level, probably somewhere in the 25%-50% above our expectations just to have safety stock. We're prepared to do that starting in probably around Q2 of next year. In regards to the expansion of PRINT, we continue to look at opportunities. I think because we've demonstrated that there's clear benefits in the inhaled side, that's kind of where we start. That's kind of the center of the bull's-eye. But as you probably have known, as you followed our stock for a long time or the company, I should say, you know, there's been a lot of things that have been experimented with in the past, including biologics and topicals and implants, et cetera. I think there's a lot of opportunity of things that we could look at that have been experimented with in PRINT. But we'll definitely be, you know, kind of focused on the inhaled side of things to start. In relation to expectations of treprostinil injection, I think, you know, we're excited. Like I said, it's been on target with what our expectations were. We think, again, as more payers move towards generic mandates because they see the clear benefits and the fact that there's no trade down in benefits to the patients, we just think that that's gonna continue to climb. We'll talk internally about what we plan to do for next year, but I don't think that we're gonna release guidance on Treprostinil Injection itself. We're gonna continue to execute and demonstrate, you know, how our commercial efforts will, you know, fare in the field. You know, we can talk to the market about that as we kind of get more time under our belt. Okay. All right. Well, that's excellent. Again, congratulations, and I appreciate the answers. Thanks. Thanks, Damian. Your next question comes from the line of Serge Belanger with Needham & Company. Hi, good morning, and congratulations on the YUTREPIA approval. A couple questions. First on the actual approval, is the label finalized with a tentative approval, and are there any post-approval commitments that you can talk about? Secondly, have you had a chance to interact with the FDA about additional data that would be required to expand the label beyond PH? Lastly, just there's been a few positive developments with the IPR process and the CRL from United. Just curious how that changes your outlook for YUTREPIA and your level of pre-commercial launch activities. Thanks. Thanks, Serge. So in terms of the label, yeah, I mean, it is for PAH, as we kind of mentioned. We have not had a Type A meeting, if you will, with the FDA in regards to future expansions, as an example, PH-ILD. We've not had that, although we have had informal discussions with them of you know, what it would have taken in order for us to have considered that during this review cycle. We came to the conclusion that it was best if we prioritized and focused on getting PAH done at this time. As you know, Tyvaso was also granted an exclusivity that I believe started in March or April of this year and lasts for three years. We certainly have time to make sure that we do it right and efficiently to try to continue to expand YUTREPIA into new product offerings. We'll have to check on that. In relation to the IPR and CRL and how that changes our outlook for YUTREPIA, I think that obviously from our perspective, we're excited that we've now cleared this regulatory hurdle. I think this is, you know, especially given the fact that it's a new technology and new manufacturing and formulation that's never been done before, it's really exciting to, you know, again, bring it to the stringent FDA requirements that are on the market. With that said, as you noted, a competitor has a product that did receive a CRL. I guess what we've seen is that their expectations are at sometime by summer of next year or earlier. I think as you could imagine, my thoughts on that is, you know, that just compressed the amount of time that they would have a head start if they're able to successfully get to approval and, you know, by a significant amount of reduction. Therefore, I think, you know, probably one of the biggest impacts is that I believe that there will be a lot more Tyvaso transition patients that will be available to be for both parties to compete against, rather than if they had, say, a year head start. I think that gives us a significant opportunity for the Tyvaso transition patients. Again, assuming that they're successful in getting to a regulatory position like we are. Great. Thank you. Thanks, Serge. Your next question comes from the line of Andreas Argyrides with Wedbush. Good morning, guys, and congrats on the approval, or the tentative approval rather. Just a quick one on, I guess, you know, while you're waiting for full marketing approval, you know, what are your thoughts on seeking a partner? Do you believe that the resolution of the ongoing litigation is a gating factor? Maybe what are you looking for in a partner? Then, how are you thinking about the sales force that's you started putting one in place, and how are you kind of what are the early work that you're doing on the strategic plan for the launch, potential launch? Thanks. Thanks, Andreas. I think that in regards to seeking a partner, it's not our focus, it's not what we're aiming to do. I think as you rightly alluded to, we have a sales force that's in the field that's already calling on PAH doctors and ramping up for YUTREPIA launch should we get to full approval. We would be adding more people into the field. We feel very confident in our ability to commercialize this asset. This is kind of an area that we've got expertise. Our current sales force, everyone on the field has PAH experience of at least, I think on average, around seven years. Also led by Scott Moomaw, who's our head of commercial, who's got a tremendous amount of experience in this therapeutic area and category. We also have, you know, expertise and guidance that's involved at the board level in Roger Jeffs, who is a director for us and also has a tremendous amount of experience in the PAH market. We feel very confident in our ability to commercialize this and scale it. You know, we're continuing to take a financially disciplined and efficient means of getting there. We'll continue to use the current sales force to drive Treprostinil Injection sales. When or if we add more sales reps, we would expect that they would be able to carry both products in the bag, the Treprostinil Injection as well as YUTREPIA. Okay, great. Thanks, guys. I'll hop back in the queue. Congrats. Thanks. Again, if you'd like to ask a question, please press star one on your telephone keypad. We have no questions in queue. Thank you. We are obviously very excited about achieving tentative approval for the first dry powder inhaled treprostinil. We are proud how we executed as a company this year. We're in a really good spot. We are in a strong financial position. We have a great team. We have a strong legal position and feel confident about knocking down that last hurdle. We have the committed resolve to accomplish what we set out to do, addressing the unmet needs of PAH patients. We'd like to thank everyone that supported us along the way, and we'll continue to drive and execute. Thank you. This does conclude today's conference call. You may now disconnect your lines.