The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Andrew Tsai - Jefferies - Analyst
: Great. Thanks. And on my side, industry discussions is less about the clinical data. So today, I think we'll talk more about market adoption and
uptake -- potential uptake.
So the natural question would be, if an investor were to ask you, Dave, why can the potential uptake of this drug be strong right off the bat? What
would you say? As well as, our peak, likely to be pretty robust as well.
Question: Andrew Tsai - Jefferies - Analyst
: Right. And so the -- I think the point is you can use it as an add-on. You're not necessarily taking market share from existing players that you're --
you could possibly grow the market share frankly.
Question: Andrew Tsai - Jefferies - Analyst
: Understood. Okay. Before we dig in a little bit deeper, I just wanted to kind of check the box here. You're on track to file an NDA over the coming
weeks, maybe even days because technically, I think, the guidance is June. So do you plan to file for standard or a priority review? And secondly,
should we expect an AdCom?
Question: Andrew Tsai - Jefferies - Analyst
: Right. Makes sense. And do we have to think about any potential risks to -- like a drug plus device combo type of situation? Or are we thinking --
is the filing based on a drug? Basically, how do we think about the nebulizer?
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JUNE 07, 2023 / 12:00PM, VRNA.OQ - Verona Pharma PLC at Jefferies Healthcare Conference
Question: Andrew Tsai - Jefferies - Analyst
: Got it. So you're following a tried-and-true path. Okay. And so let's just say, it got approved standard or priority, that would be first half next year
anyway. So what would be your launch strategy or go to market? Where is the low hanging fruit where you're confident you can get strong sales
right off the bat?
Question: Andrew Tsai - Jefferies - Analyst
: Makes sense. And you're pretty sure -- certain that 100 is enough. And secondly, do you think you would hire those 100 at risk before approval or
do you hire them after approval?
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JUNE 07, 2023 / 12:00PM, VRNA.OQ - Verona Pharma PLC at Jefferies Healthcare Conference
Question: Andrew Tsai - Jefferies - Analyst
: Yeah, makes sense. And based -- on my side, when I do doc checks, I feel like the initial penetration would be the post triples to start the -- so
patients who have been on Trelegy, Breztri, for instance. So the question would be, if that's truly -- you guys have clearly done way more survey
work. You've spoken maybe thousands of dollars already.
But in any case, if that premise is somewhat true, the question would be how do you penetrate more so into the single and post dual type of patients
out there? What would be the messaging? How do you convince those pulmonologists or PCPs? Hey, consider ensifentrine, don't necessarily think
about going to a triple per se. What do you say?
Question: Andrew Tsai - Jefferies - Analyst
: Right. And what kind of price are you guys thinking both [list and net]? And how would that compare to the other branded -- recently branded
drugs out there?
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JUNE 07, 2023 / 12:00PM, VRNA.OQ - Verona Pharma PLC at Jefferies Healthcare Conference
Question: Andrew Tsai - Jefferies - Analyst
: Got it. So part B as in boy. And to be clear, because sometimes I get confused, Part B, I think of it as a hospital drug that here you're using that now.
Question: Andrew Tsai - Jefferies - Analyst
: Got it. Okay. And so then the natural question investors might ask then is, are there any precedents where another COPD drug went through the
same pathway but also commanded or reached very strong sales? Are there any precedence or are you in a pretty unique situation here?
Question: Andrew Tsai - Jefferies - Analyst
: And to be clear, you're very focused on this approval and launch, you have that as -- going for you. There's no broad pipeline per se. You're focused
on ensifentrine.
Question: Andrew Tsai - Jefferies - Analyst
: Okay. And so let's just say it did launch, what would be some of the kind of leading indicators to suggest, yeah, we're on the right track. What are
you looking at specifically?
Question: Andrew Tsai - Jefferies - Analyst
: And would you do a DTC?
Question: Andrew Tsai - Jefferies - Analyst
: Got it. And maybe GOLD guidelines, do you view that as a potential driver in terms of the GOLD guidelines establishing ensifentrine as whatever
standard of care. And when is the next time that guideline could be updated?
Question: Andrew Tsai - Jefferies - Analyst
: Great. And then maybe last question, since we have a minute left. Talk about your IP, patent estate, why are you confident in your patent situation?
And secondly, are there ways for you to extend your IP?
Question: Andrew Tsai - Jefferies - Analyst
: Very good. Okay. I think that's all the time we have. Dave, Chris, thank you so much for joining our fireside.
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