Welcoming the Liquidia team, Roger Jeffs, the Chief Executive Officer, and Michael Kaseta, the CFO and COO. I will turn it over to them for opening remarks. Thank you, Amy. Always a pleasure to be here at Jefferies with you, and I'd also like to acknowledge that Jason Adair, our Chief Business Officer, is here in the audience, can answer some questions after this fireside chat. Maybe just to start off, it's been a really remarkable year. It was at this conference last year that we announced the official launch of YUTREPIA into the PAH and PH-ILD space, and I think by all measures, it's been a transcendent early phase of launch. Just in the initial period, we've garnered 25% share. We've achieved over a half a billion dollars in revenue run rate, and we feel very confident in our articulation that we should, in 2027, exceed at least $1 billion in annualized revenue. Really, we're just starting. I think the way we're going to invest in the programs is across four verticals. One, we're going to continue to invest in YUTREPIA's launch and success. Part of that will be augmenting our sales team, which we've already done. We've gone from 48 reps to 64. Those reps are in training and will be in the field in the coming months, and we think they'll obviously port significant value as we look to increase the reach and breadth of those sales calls. We're also clinically going to invest in YUTREPIA's success. We're going to do multiple phase IV-type studies where we look to transition patients directly from TYVASO and TYVASO DPI, and also do directed transitions from oral therapies, which is a $2 billion market, as you may know. Finally, we're doing a study in concert with WINREVAIR to show that there's synergy there, and that we can de-intensify the parenteral class of compounds and improve patient care on YUTREPIA as a much gentler way to give prostacyclin therapy. Really excited about what we're doing there. I think the next vertical is we're going to invest in L606. I'm happy to announce today that we've put our first patient into the L606 phase III registrational study. Nice. The sites, not only are they initiated in screening, but they're enrolling patients, and we're very pleased about what our clinical team has done in that regard. I think the next thing that we'll do beyond L606 is we'll begin in 2026, 2027, in the future years, looking at the new and next large indications that could accrue and accrete significant value to Liquidia. This would include IPF studies, PPF studies, PH-COPD studies, and then our Raynaud's study as well. Looking to massively increase the total addressable market going from what already is anywhere from a $7 billion-$8 billion opportunity in PAH and PH-ILD alone to adding incremental $4 billion-$5 billion market opportunities across the indications that I just mentioned. Finally, we're going to do this with financial discipline, as Mike will talk to you, no doubt, during the Q&A. We're looking to not only grow top line, but bottom line, and improve on our profitability, which we achieved in one of our first few full quarters of launch, and so looking to grow profitability. The beauty of that is that we can then independently fund and grow our company without having to access the capital markets and be dependent on that dilution. Awesome. Well, very exciting progress. Maybe before we get into the launch, I just want to take a step back and help us visualize the total opportunity for YUTREPIA. Because you've laid out a pretty helpful framework for PAH and PH-ILD, but now you're running all these expansion trials. When we think about what indications where YUTREPIA could be used, and are you thinking about maybe looking across all the respiratory and vascular diseases where PH is a component, or are you thinking about maybe looking at where treprostinil in any form or prostacyclin is used on or off label as potential indications that you could potentially go into? Yeah. The nice thing, there's already validation for the next indication. If you look, United Therapeutics had success in IPF, so they've already shown in two replicate studies that they have a confirmatory result on improving FVC. Our view is that that's an approvable set of studies, which is good for the field, and I think good for us. It gives us an opportunity, one, to develop data with YUTREPIA to show that the things that happen in PAH and PH-ILD, like good tolerability, better dosing, better outcome, also port to the IPF population. Remember, a lot of those patients with IPF likely have some underlying PH. To your point, where PH is prevalent in IPF, there's probably a 50% or greater prevalence of PH. We think that's somewhat low-hanging fruit mechanistically and validated. We're going to launch when we go, and then we'll do registrational studies with L606, but those will be phase III. We already know that we need a dose titration schedule in IPF, just as we have shown is needed in PAH and PH-ILD. That will be the first one. I think PPF is another opportunity. It's a broader subset of IPF. PH-COPD is another massive multi-billion dollar market opportunity where we can launch into a phase III program. Again, that would be with L606. Raynaud's, we're going to do some phase II work because that's a distal digital vasculopathy, but again, addresses the mechanistic benefit of a prostacyclin, not PH, but a vasculopathy. Also undertreated and underserved, and we think there's massive opportunity there. A lot to do. We're going to focus initially on maximizing the success value of YUTREPIA, moving L606 along, as we said we are doing. What we're doing now is having meetings around the world with thought leaders to say what is the best study criteria that we need to enrich the population for success for PH-COPD. We'll probably just replicate the IPF studies that were done. Raynaud's we're going to do a phase II study to look to see if on thermal imaging, can we improve the digital blood flow that would be required to improve that indication. A lot on our plate, all the mechanistically validated and most of which we can go right into a registration pathway. High near-term and mid-term value. Excellent. Super helpful. I think you've cited some registry data that's coming, I believe it was UCLA, that's showing around 50%- 70% of IPF patients or, sorry, ILD patients have some sort of PH component. Does that mean that a portion of IPF patients are actually PH-ILD and you would be able to address them even without violating United Therapeutics orphan drug exclusivity? Yeah, I think again, if they do well there, I think that's fine. If they start 10,000 patients, I think eventually the product profile that YUTREPIA reports would be advantageous to those patients, and as those patients fail those other alternative therapies, we would then pick them up, even in an off-label standpoint, potentially. I also do think, your point is correct. There is a significant degree of underlying pulmonary hypertension that we could assess by either echocardiography or formal right heart catheterizations to get them on-label for PH-ILD, and we could then promote to that patient. We'll be careful about not violating any regulatory rules around off-label promotion. I do think those patients will understand the attractiveness of YUTREPIA compared to the existing other products. Awesome. If we were to put a number to the potential undiagnosed PH-ILD patients, would it be, not 40,000- 60,000, maybe 100,000+? I think, again, these are broad estimates, and I think people are still trying to sort of triangulate to a better number. What you're saying is not unreasonable. Excellent. Moving on, launch. You've put out some fantastic numbers last quarter. I think the one point that you said was really interesting is you're seeing a deepening of prescriptions in existing providers, right? Can you give us some color on what that's being driven by? Is there kind of a formulary component where maybe you're put at a more favorable formulary status, or are you seeing this in PAH and PH-ILD, or is this kind of more of a familiarity where doctors are originally trying out YUTREPIA, seeing a benefit and, kind of either switching or prescribing more patients given the profile? Yeah. Essentially, it's product profile that's driving our success. I'll turn it over to Mike so you can hear his voice today as well. I think the product profile speaks for itself. What people want is the best-tolerated therapy that can then, because it's well-tolerated, can be dosed more effectively to drive a better outcome. When these patients come looking for a new therapy because they're short of breath and symptomatic, so they want a quick resolution to those problems. That's the value that we bring because the tolerability of the PRINT-enabled YUTREPIA is so good. I don't know, Mike, if you want to talk about formulary status and other things. Yeah. Thanks, Roger. Since launch, our goal was always to make sure the patients had a choice, if they wanted to choose YUTREPIA, and we've achieved that goal here in the early part of launch where for the vast majority, we are at parity. Patients will have that choice, and ultimately, we've seen that in performance in the field. You look at the launch metrics that we've shown through the end of April, we've had 4,500 prescriptions have been written. There was a slight acceleration from February to April, and where I think we're most excited is both on the breadth and the depth. If you just look at doctors who have prescribed YUTREPIA to five or more patients, that number of physicians has increased by 25% since the end of February. We're also, as Roger said, expanding our sales force. That expansion, which will increase our targets from approximately 6,500 doctors to over 8,000 doctors. There is a tremendous amount of white space in PH-ILD. That's where we're going to put the focus on the new sales force to get deeper into the community, to educate doctors, identify patients, and then ultimately put it in the doctor's hands to either prescribe to these patients or to refer them to the larger centers, which we feel we have a stranglehold at this point. Excellent. Well, Mike, to your point, there was a slight acceleration, right? Can you update us? Because you're talking about a $1 billion plus by 2027. That implies a consistency of NRx. Can you update us on the most recent trajectory? As we think about kind of where growth from here is sustained by, is there still headroom in the academic sites, or are you seeing a potential that once these sales force are trained and ready to go, you can actually see an increase from the community sites for PH-ILD as well? From a trajectory point of view, we gave data as of the end of April. We still feel very confident with where we are. As you mentioned, the billion-dollar target in 2027, nothing crazy has to happen. If we stay on the same trajectory that we're on, which we're very confident in, we feel that that is very attainable. I think the important thing to note as well is that billion dollars in 2027 is, to Roger's point about maintaining financial discipline and whatnot, we believe that we can approach or even exceed an operating margin of 50% while also being in the clinic in eight to 10 studies that Roger talked about. We feel that we're really a unique company for the stage of where we're at, that we can generate significant value while also increasing the TAM, increasing our product profile, and increasing YUTREPIA sales. We're very excited for where we're heading. We are just executing to the plan and feel that we stay on the same trajectory. Our opportunity to grow will continue. If you just look at the TAM in PAH, we're still just scratching the surface. It's a $3 billion opportunity in prostacyclins, and given the dosing flexibility that YUTREPIA has, we feel that we will fit patients, whether they are oral patients, inhaled patients, or even parenteral patients based on this. As Roger said, the studies we're going to do around selexipag transitions and also parenteral transitions alongside WINREVAIR will only improve that. These doctors are looking for data. We did that with the ASCENT data in PH-ILD, which really helped us in the trajectory of our launch. We think these additional studies are only going to support that further. Excellent. Maybe if we were to focus on the community. What is the current paradigm in these community PH-ILD patients? Are most of these doctors referring to an academic site? In terms of if you were to segment the market in terms of what community sites would be more willing to treat with an inhaled treprostinil itself, what metrics would you look at? Is it people who are prescribing antifibrotics? Is it people who've had some experience with prostacyclins? Yeah. In PH-ILD, 75% of our patients are new to prostacyclins or de novo, 25% are switchers. Some of the business, the switchers, is coming from experienced centers who are already treating. I think, with two companies now driving awareness in the space, that's good for both companies. It's a rising tide phenomenon. I think if you look over the last several quarters, the market's grown 5% quarter-over-quarter, which we'd all enjoy that to continue. I think we're driving a lot of that growth through the messaging about YUTREPIA and its benefits, and I think obviously we're capturing a large proportion of the NRx share. There's no way you get to 25% share if 75% of your business is new to prostacyclins, unless you're capturing a large majority of the NRx share. I think it's just our sales team and our medical affairs team getting into the community centers, either teaching them about PH and the difficulty to get ports to these patients. You have to remember, if you have ILD and then you have PH as a component of your ILD, your three-year survival is about 35%. Your five-year survival is about 14%. It's a horrific diagnosis. The more we can sort of lean on that and then tell them that now there is a product that can address this pathobiology and improve, hopefully, the patient's outcome, then I think the use will get more common. Now, your point is they may refer because they may say, "Well, now that they're a more complicated patient with PH and not just a lung disease, I'm going to refer them to a major PH center." Some of that will happen, and that's fine because we'll be there to capture them in the major referral centers where we have, I think, an anchoring position in terms of being the inhaled prostacyclin of first choice. Either way, for us, it's just education at this point, and the market will come. We saw this in PH 30 years ago when I first started doing this. Everybody thought it was a small market opportunity, and look at it today. Yeah. Awesome. Moving on to the litigation. One, there's been a couple of updates. Number one, you have decided to expand your sales force to just target PH-ILD. Number two, I see you guys post a new job posting almost every week, so there's got to be some confidence that you have in this drug staying on the market, right? Can you go over your base case still? Has there been any communication with Judge Andrews, or are you getting more comfortable from a timeline perspective? If there's no decision, you almost have 4,000 patients on treatment now that it's unlikely that you trouble give. Well, first, if you find a job you like, let me know, and I'll get you an interview. Mike, maybe you want to talk about the label? Yeah. Amy, I think for us, we've been confident from day one. We've invested into this opportunity. As you said, we're filling out an organization. We're expanding our manufacturing capacity of YUTREPIA. We're going to almost triple our capacity by building a new facility in North Carolina. As you said, we're adding sales reps. We believe in the facts of the case. We are confident that we should win this case, and we are investing as if we will to show that confidence. We do not have any communication with Judge Andrews. All we can focus on is the commercial execution of YUTREPIA at this point, developing L606, and getting all of those other studies into the clinic. That is our focus. All I'll say is while we are absolutely confident, we will be prepared for any situation and any scenario that plays out, and we'll be able to react quickly. The base case is that we feel that we should win, and patients will benefit most by that. Awesome. Amarin, Hikma versus Amarin, that decision is coming, I think, in the next month or so. Can you explain to us why this is not a skinny label case, and then what the read-across would be? I think the read-across is simple. As part of post-trial briefing, United Therapeutics cited the Amarin Hikma case as part of their reasons why they should win the case. That case has now been brought to the Supreme Court. We have no idea why we're still waiting for a decision, and nobody knows, frankly. There is direct relation by virtue of the fact that it was included in the post-trial brief. Whether the judge is waiting for that, whether he's not, we do not know. We're not focused or fixated on it, but at the end of the day, we're preparing. We feel it should come any day now. Granted, we've been saying that since last September, but we do expect a decision any day. It could be impacted by the Supreme Court. The expectation is that if it does relate to that Supreme Court case, the expectation is that that opinion should come down by the end of June or early July, and we'll be prepared for whatever outcome is put before us. Awesome. Super clear. Let's move on to L606. I think one thing that people are underappreciating is that because L606 is a 505(b)(2), you've gone to the FDA, you aligned on just running a PH-ILD trial, and that would be sufficient for both PAH and PH-ILD approval. Whereas, your competitor TPIP will have to run a PAH trial and a PH-ILD trial separately in an environment where WINREVAIR is standard of care. Can you go over the hurdles of running a PAH trial on top of WINREVAIR? I think, again, WINREVAIR is going to use a lot of the capacity or reserve that the patients have to improve, so you're going to have to escalate or have an incremental benefit above and beyond when used in combination. WINREVAIR is here to stay. It's a staple of therapy now. I think you cannot do a study in PAH without doing it as an addition to WINREVAIR. I think they will try to do some of that work ex-U.S., where WINREVAIR might not be available to short-circuit that a little bit, but it will add an incremental level of work and difficulty in showing success. For us, though, for L606, like I said, we've begun enrolling. We're very excited about that product profile. It's by far the best-tolerated prostacyclin that we've seen to date, bar none. We had at one year only 14% drug-related cough. That's orders of magnitude lower than what you typically see, even with YUTREPIA. Now, YUTREPIA has cough, but it's mild. Here with L606, we had cough at very low frequency rates, and it was mild. That's the good news. We had nobody drop out of the study due to drug-related cough. What we've seen, and we've had patients out more than one year, is that we can get peak and trough benefit that are the same to each other, which is what you want to do with an extended or sustained release formulation. We've measured at peak and trough, and we can maintain the benefit over the 24-hour dosing interval. The way to think about how simple that is, when you brush your teeth, you take L606, either in the morning or at night. It doesn't have to be with you in the day because there's enough freedom during the in-between interval to not require to carry the drug around. We're going to use a modern, portable mesh nebulizer. We have portability, but when people have this argument with themselves around once a day versus twice a day, it's kind of meaningless, frankly. I think what you really want to concern yourself with is how well-tolerated is the drug so that you can do what YUTREPIA does. You can dose to benefit and do it to improve the disease and outcome of these patients who are severely ill. Awesome. Then in terms of timelines to market, I think both companies have put up the primary completion dates. I think TPIP is around half a year in terms of primary completion date earlier than you guys. I know these are all tentative holds. Can you talk about the benefits of already knowing these sites, running phase II trials, and the potential to accelerate and timelines? How do you think your timelines to enter the market will be relative to TPIP? Again, we don't have to debate if they're going to be six months faster or not. I think we're both on a similar timeline is what I would suggest. The fact that they have to do two studies maybe puts a little bit more of an arduous task for them. As you said, where our real skill set at Liquidia that's unrecognized is our development expertise. It's where I've spent my whole career. I think we can get these global centers up and running. We have the best thought leaders in the world as our steering committee. We have Rajeev Saggar, our Chief Medical Officer, who's a former KOL himself, who's leveraging his own relationships. I'm confident we will be very competitive in our rate of enrollment, but we will not do that at the expense of quality. Right. You can go fast, but be dumb about letting patients in that shouldn't be in. Fast isn't the key. Fast and good is the key. We'll be rigorous about making sure we've trained the centers exquisitely on what we want from a patient profile. We'll be diligent in training them on what we need from a data standard so that when we get the data, it's registerable and approvable data without any disagreement. Again, rough estimate, Amy, I think 2.5 years to enroll it. It's about 350 patients. Yes, we'll try to improve on that. It's a six-month study, we've got to run the patients out through the six-month observation window. Three months to analyze and file, 10 months to approval. You can quickly get yourself to four years or so. Yeah. We think sometime in 2029, we'll have a readout. Awesome. As you look across the competitive landscape, I know your competitor's been making some comments about soft mist, once daily ralinepag, and I think there was another company that had patch data out recently. Of course, I think Roivant has upcoming data in ILD. Are you seeing any mechanisms or approaches that you think is particularly differentiated? How do you see YUTREPIA fitting into some of those competitive approaches? Yeah. Roivant's soluble guanylate cyclase stimulator is a different mechanism. It would be used in combination. Even if they had success, which I hope they do, that would not harm us in any way. For the competitive like soft mist inhalers or ralinepag DPI, we have no concern about those being competitive. If you look at soft mist inhaler, you're just giving a nebulized formulation, which is like TYVASO, just with a different device. You're going to get the same result. There's nothing changed in the formulation that would drive a different result. ralinepag orally is the most toxic oral prostacyclin we've seen. If you look at adverse events, particularly to the gut, they're higher than anybody else's in terms of frequency. To suggest that you could then put it in a dry powder formulation and use the MannKind backbone that they're using currently for TYVASO DPI and get a different result would be highly aspirational and probably not achievable. We don't really spend any time worrying about those. Those are also years away. They're not going to impede on YUTREPIA, we don't believe, in any way. While they're trying to do that, we're doing L606. We're raising the bar to a different standard that they then have to meet. I think we're going to be the chased. We've set the bar, and everybody else is going to have to try to match us, particularly not only with YUTREPIA, but very quickly with L606. Awesome. I guess, just a broad question. Mike, you were talking about the operating leverage that you could have. Roger, you talked about all the new indications that you're going for, and a lot of them have overlapping prescriber bases, right? As you think about the operating leverage you could build and then kind of the competitive moat that you're building in vascular and respiratory conditions, can you tell us I don't think people appreciate it. Can you tell us about this competitive moat and what the hurdle for other newer companies coming in would be? Well, first for PRINT, that would be very hard to intercede with what we're doing. Nobody else does it, well, can make the uniform particles the way we do. There's some trade secret know-how there as well that would be unknown to people trying to replicate or clone that technology. We also have patents that go out into the late 2030s. I think with L606, we searched the world for a next-generation sustained release moiety, and Jason found L606 through Pharmosa, and there's really nothing else out there. Trust me, we've looked. We feel that we're years ahead of everybody else. Even if in a year, somebody comes up with something else, they've got to do all of the groundwork that we As you've just heard, we're already into phase III registration studies. We're going to be significantly ahead of anybody if anybody else comes up with a next-gen product that has some greater PK exposure. I don't know, Mike, if you want to talk about moats from an operational standpoint, but I think the fact that we are so profitable so early. Maybe you can talk about what we'll port in the future. We really can control our own destiny quite fluidly. I think what's important to understand is I think we obviously know what we have with YUTREPIA and what we have with L606. A lot of similar companies in our situation would potentially have to be sequencing trials, need to raise capital to do that. As I said earlier, we feel that if we're a billion-dollar product next year, we could have an operating margin of 50%, or approaching or even exceeding 50%, all while having all 8-10 of these trials in the clinic, three of which would be registrational studies. I think the time that it will take us to get to goal is so much less than what other similar companies would encounter, given our financial discipline, given the success of YUTREPIA and what we believe will be a product that will be of blockbuster status very soon. Awesome. We can leverage our infrastructure. Excellent. The sales force for all these other indications, we just have to augment that for these additional ones, but they would be bolt-on. Awesome. Maybe last question. You had over $200 million in cash and cash equivalents at the end of Q1. You're going to be generating more fresh cash flow, right? As you think about how you're spending that cash over time, I know you're investing in L606 and additional indications, but beyond that, would you consider BD at some point? If so, what type of targets would you be looking at? Well, I think there are going to be other people trying to get into these arenas because they're so attractive. I think what we've shown with not only our clinical acumen, but now our commercial acumen, is that people would have to decide is that something they want to actually commercialize themselves, or we could put it into our sales bag. I think over time, we will look to grow Liquidia and add on things that are synergistic, particularly as you noted in the pulmonary space or cardiopulmonary space. We have enough on our plate that the opportunity value to add something in would have to be really, really handsome. Otherwise, why do it? Because another part of what we're trying to focus on is financial discipline. We constantly look at BD. Jason's tireless in bringing things to us. There's a lot of people that want to partner with Liquidia now, and that won't change. We'll only get more attractive as a partner for other people. We'll look, but I think the bar is very high. Excellent. Well, thank you so much. Thank you to the Liquidia team. Thank you everyone for being here. Thank you.