Liquidia Corporation (NASDAQ:LQDA) Q2 2023 Earnings Call Transcript

Now, having said that, I think if there’s intolerance and as we hear in particular with PH-ILD for Tyvaso and Tyvaso DPI, for example, those patients I think would be readily accepting of a DPI formulation that perhaps may be more tolerable and more titratable. So, it’s not that we won’t go after the switches. I think that our initial push will be in the de novo patient market, which is an — which example — I would say look, there’s lots of patients treated. I think users reporting over 6,000 on therapy at this point seems to be about a 50-50 split between the nebulized and the DPI formulations roughly speaking. And I think the other opportunity here I probably should have mentioned is, once we establish the use and efficacy of YUTREPIA, for example in PAH, we will then go after its prostacyclin our first choice because we think it’s probably a better option because it’s gentler to take and is now readily titratable in the YUTREPIA format and could displace oral prostacyclins including Orenitram and UPTRAVI.

Thanks for the question, Serge. Operator, next question please.

Operator: Thank you. And our next question coming from the line of Kambiz Yazdi with Jefferies. Your line is open.

Kambiz Yazdi: Hi, team. How should we think about OpEx moving forward with the YUTREPIA open-label study and then eventually the L606 Phase 3? Thank you.

Roger Jeffs: Yeah. That’s a great question. I’ll ask our CFO, Mike Kaseta, please.

Mike Kaseta: Yeah. Good morning, Kambiz. Thanks for the question. So, as I said earlier, we ended Q2 with about $88 million in cash. We feel very confident in our ability to get through key events in 2024, which includes onboarding our extended Salesforce in Q4 of 2023. When we get the green light to move ahead, we will — to launch YUTREPIA, we will be ready to do that and hit the ground running on day one. So, very confident there. As it relates to L606, as I mentioned, we made a $10 million upfront payment to Pharmosa. We would expect that the vast majority of development expenses will happen as we move 2024, really specific backend of 2024. And then, after those years as the Phase 3 progresses. So, in the end, we’re very confident with where we are [Technical Difficulty] when given the clarity to do so.

Roger Jeffs: Thank you, Mike. Thanks for the question, Kambiz. Operator, next question please.

Operator: Thank you. [Operator Instructions] And our next question coming from the line of Matt Kaplan with Ladenburg Thalmann. Your line is open.

Matthew Kaplan: Hi. Good morning, guys. Thanks for taking the question. I guess, can you comment a little bit more on why you’re confident in being successful at the CAFC in the United PTAB appeal?

Roger Jeffs: Yeah. Matt, could you repeat the question? You broke up a little bit there.

Matthew Kaplan: Yeah. Can you comment a little bit more on why you’re confident in being successful at the CAFC and the United PTAB appeal?

Roger Jeffs: Sure. I think Rusty addressed some of that in his prepared remarks. But Rusty, if you would maybe emphasize some additional points if you could.

Rusty Schundler: Sure. The standard, Matt, has to do with the burden or the standard as to when the Court of Appeals for the Federal Circuit will overturn decision of the PTAB. It typically is the situation where there’s been clear error, especially where you’re dealing mostly with factual findings of the PTAB, as is the case here. So, again, it’s looking at the specifics of the holding, and sort of our view that the holding is sensible and supported by substantial evidence. And then that high bar of what United would have to show as clear error in order to overturn the lower court decision or the PTAB decision in this case.

Matthew Kaplan: Okay. Okay. That’s helpful. And then, just going back to a follow-up on L606. Can you talk a little bit about the potential development timeline there? And is manufacturing a rate living step to potential filing for approval?