Liquidia Corporation (NASDAQ:LQDA) Q4 2022 Earnings Call Transcript

Rajeev Saggar: Yes. So in particular, with PH-ILD, because of the inherent limitations with cost in general, we are — we understand that, there’s a certain number of patients in this population that tend to have efficiency, when exposed to a higher resistance to inhaler. And so it’s done — if this is done improperly that potentially can cause the patient to have additional cough and limitations when they’re exposed to certain types of dry powder inhalers.

Roger Jeffs: Okay. Thank you, Rajeev. So, I think the importance now of our own — in patients with PH-ILD, because it could be possible that not only the tolerability, but the rate of titration and that the patient — that would be a little bit different with hypertensions. But given the profile of our product, we’re well positioned to test that in the next . Operator, next question, please.

Operator: Thank you. One moment please for our next question. Our next question will come from Serge Belanger of Needham. Your line is open.

Serge Belanger: Hi. Good morning. I guess, just one question. I think Roger, you’ve highlighted over the last few quarters how YUTREPIA and YUTREPIA inhaler is a low resistance DPI inhaler and highlighted some of the benefits there. Maybe just talk about what are the benefits and how that inhaler differentiates the product from a TYVASO DPI? Thank you.

Roger Jeffs: Yes, that’s a great question. And I’ll team up again with Rajeev to answer this question. But I think a lot of our answer is going to be predicated on the fact that it’s formulation-driven. It’s actually the Print formulation product that allows the use of resistance device. Rajeev you can speak to kind of how the formulation leaves that combination that benefit uniquely ports.

Rajeev Saggar: Great, question. I think to highlight what Roger just noted, the innovative technology for these drug particles that require almost no agglomeration. And what that means is that YUTREPIA does not have to overcome such barriers. The PRINT powder has already — riding to its own. The particles have already been sized, positively deep in the lung. And a low resistance inhaler device is obviously the most suitable perfection for our PRINT technology. And by already — by optimizing the size and shape of these drug particles, the PRINT eventually enables a more ideal dry powder experience across a broad range of historic flow rates. And this is what effectively, the simplest — is probably one of the key reasons that, there’s growing excitement to bring YUTREPIA into the market into PH-ILD patients.

Roger Jeffs: Thank you, Rajeev. So I think, again, it’s the formulation that is given the ability to use would be differentiated to delivery platform, without need to agglomerate which we reached the higher resistance device, take capacity to do that, and we think that then can be technically certain limitation there have — leading entry into the market. Operator, next question, please.

Operator: Thank you. One moment for the next question. Our next question will come from Julian Harrison of BTIG. Your line is open.

Julian Harrison: Hi. Good morning. Thank you for taking my question. I’m wondering, if sotatercept has any bearing on the DPI treprostinil market opportunity in your mind?

Roger Jeffs: Yes. Great question, Julian. And again, I’ll tag team with Rajeev. So I think, first, let’s just say, it’s an exciting time in pulmonary hypertension, new mechanisms, new , new fits, on to triple is impressive. And I think there’s generally growing excitement including our own around with these new modalities. I’ve been in this field for 30-plus years and every time treatment has come in, there’s been a previous methodologies or treatments. It’s never ever been performed out to this therapy period. And I see this sotatercept as add-on to other therapies, the best benefit is in prostacyclin. In those patients, the prostacyclin dose was held steady because they were testing the test patients. And I think it would be exciting now to see what happened with YUTREPIA and sotatercept in combination wherever it could also be titrated the patients specifically.

So again, a lot of excitement, I think, it really changed the with YUTREPIA. We still think the will be the first choice changing option. We can capture a significant share of a market which has plenty of opportunity for building another drug, but obviously, other inhaler upon . We’re excited about process in my belief it will be they’re the only drug that can be titrated to effect. And given that, it’s so likely that will be approval. Rajeev, I don’t know if you have anything to add to that?

Rajeev Saggar: Yes, Julian, Roger said it excellently. I’ll just add, remember one of the key issues here is also focused on not only pulmonary arterial hypertension, but also specifically pulmonary hypertension associated with interstitial lung disease, where sotatercept has yet not just shown a benefit. And so we’ll all — the entirety of both populations will be important and we’re to have driven or . Thank you.

Roger Jeffs : Yes. Great efforts. Julian, thank you. Operator, next question, please.

Operator: Thank you. One moment for our next question. Our next question will come from Matt Kaplan of Ladenburg Thalmann. Your line is open.

Matt Kaplan: Thank you and good morning. Just a couple of questions, on following up on the PH-ILD opportunity. I guess, one, could you tell us a little bit about the approval pathway for PH-ILD? And then secondly, with your planned open-label study, what are some of the end points you’re going to look at there? And is there an opportunity to showcase a potential improvement in efficacy due to the titratability?

Roger Jeffs : Yes. Thanks, Matt. Good to hear. So I’ll talk about pathway. So as we’ve said before, we’ve confirmed with the FDA in writing no additional studies are required for approval for PH-ILD patients. Having said that, obviously, we can’t seek approval in the market exclusivity expired in for that market post that date. So that’s the path some of kind of how we provided approval will depend on the resolution of the legal case and when we get approval for pulmonary arterial hypertension and move our tenant of approval to full approval. But in general, those are the parameters that are gating for PH-ILD. And maybe, Rajeev, if you could speak a little bit we have there.

Rajeev Saggar: Matt, , so, first of all, as we just discussed on this call, this will be a study specifically in PH-ILD. So in that regard, one of the major focus is to really understand the tolerability of the YUTREPIA in patient population. Remember, this is about range of patients with different types of heterogeneous disease. So really highlighting the experience in that broad range population, and see if there’s any particular population that stands out with the best response. The second thing is that we’re going to be focusing titratability. We know that if conditions keep certain breadth equivalent to taking to have a better response. We want to see if; number one, we can absolutely reach those levels and more importantly, exceed those levels in a tolerable fashion.

This will translate into several data that we can acquire, including typical data points such as improved walk capacity or a six-minute walk distance. We can also look at various effects, not only on the right ventricle itself, using non-invasive parameters but also changes in scoring of the actual fibrosis again, using non-invasive imaging . So more to come on that as the final protocol.

Roger Jeffs : Thank you, Rajeev.

Matt Kaplan: Thank you. That’s very helpful. And then

Roger Jeffs : One moment.