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

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Operator: And I see there are no further questions — and I see there are no further questions in the queue. I would now like to turn the conference back to Roger Jeffs for closing remarks.

Roger Jeffs : Maybe we can let Matt back in.

Jason Adair: Hey, Chris, Matt had one more question. Could you let him back in so he can ask it?

Operator: No problem. One moment please.

Matt Kaplan: Can you hear me?

Operator: Yes. Mr. Kaplan, you are now able to ask your next question.

Matt Kaplan: Yes. Great. Just a quick question. In terms of — with the moving parts associated with the Hatch-Waxman litigation and the PTAB decisions, what’s your current thoughts on the timing for full approval now?

Roger Jeffs: Yes. Great question. Maybe I’ll ask Rusty to opine on some of the — how he sees the timeline for the legal situation playing out?

Rusty Schundler : Sure. So thanks for the question, Matt. So we really have two separate opportunities to get clear of the patents at this point; the appeal of the Hatch-Waxman decision; and the appeal of the ‘793 IPR and both on different time lines. So first is the appeal of the Hatch-Waxman decision. As I noted earlier, briefing is now complete, and we’re just waiting on the court to set in oral argument dates. We think that date will be some time in the second quarter or third quarter of this year. And once oral argument has been held, we expect a decision could come in as quickly as a few days after oral argument or it could take a couple of months depending on whether we get some reaffirmance or not. And so if in that decision, the 066, the District Court’s decision regarding the 066 Patent is upheld, and if the 793 decision of the District Court is overturned, we would be able to proceed immediately to seek full approval after that.

So that would put it sometime in the second, third and fourth quarter this year. Alternatively, if that appeal results in the 066 Patent decision being upheld, and the 793 decision of the District Court being upheld, then we would have to wait for the IPR appeal to play out. And as we noted, we expect that oral argument that will likely be held some time in fourth quarter this year, or first quarter of next year, or first half of next year. And again, same thing after that oral argument is we could get a decision as quickly as a few days afterwards or as long as a few months afterwards.

Roger Jeffs : Thank you, Rusty. Very clear. Operator, next question, if there are any.

Operator: Thank you. One moment please. And I see no further questions at this time in the queue. I will turn the call back to Roger Jeffs for closing remarks.

Roger Jeffs : Great. And firstly, I think, we appreciate everybody calling in and listening. I hope you share the excitement we have around our building momentum. We’re really trying to build on the back of some very positive news as it related to the legal situation. And as we continue to go to the market, you can hear our excitement around the product capabilities of YUTREPIA and how it could be introduced uniquely into the marketplace and benefit patients in a differentiated way. We thank you again for joining us, and we look forward to reporting on our continued progress in the coming quarters. Thank you, everyone. Bye-bye.

Operator: This concludes today’s conference call. Thank you all for participating. You may now disconnect, and have a pleasant day.

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