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: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: So maybe to start off, you could give us some background, for the audience, with regards to the drug itself, ensifentrine, and the commercial
preparations that are currently in process.
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: And I think an important point to bring out also is that while this is a new therapeutic that we haven't seen quite some time that the mechanism
itself is not unknown, right? It's a well-known mechanism. Physician is not something that they're unfamiliar with, or there has not been a lot of
peer review on the PDE3, PDE4. Is that correct?
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: And maybe could you just talk a little bit about the normal progression of these patients when they get treated? When they present, what's the
reason why they're presenting? What's the first therapy? And then how it just follows through to the point, where I would normally say, ensifentrine
would be used, but there seems to be the ability to put that in throughout the treatment paradigm at this point? Perhaps you can just talk a bit
about that.
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AUGUST 09, 2023 / 4:00PM, VRNA.OQ - Verona Pharma PLC at Canaccord Genuity Growth Conference
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: So with FEV1 and exacerbations, how did those two endpoints interplay with each other? Is FEV1 purely a more R&D endpoint when you're
developing a drug clinical development? Or an exacerbation is really what counting at the end of the day? Or is FEV1 to the physician's looking
like and exacerbation to what the patient's looking?
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: And then maybe you could talk a little bit about -- and you guys talked about this in your quarterly call to what was really important is. We've talked
about -- from day one, we covered this name, is the low-hanging fruit of those patients that are on multiple therapy but still have breakthrough
symptoms where there're no other options. And that's really low-hanging fruit, which I think obviously still exist. Those would probably be the first
adopters and early on.
But maybe talk a little bit -- you get asked a lot about the drug. How long will it take the drug to move further up in the treatment paradigm earlier
usage? Maybe you could talk about the difference areas when the drug could be intervened for usage.
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AUGUST 09, 2023 / 4:00PM, VRNA.OQ - Verona Pharma PLC at Canaccord Genuity Growth Conference
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: Got it. And then could you maybe just talk a little bit about the 100-person sales force reps? Who's going to be their initial target? Are these going
to be major medical centers or their centers of excellence? Or are there major or tertiary hospitals you're able to target already that you know you're
going to have a large patient population because they just fit to demographics of people with COPD? Could you give a little color on that?
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: So one of the things that I was -- you guys did a great job on your quarterly call. It was really talking a bit about the reimbursement and how that
works. And for those that did not listen, and I think if they did, it would behoove repeating it is.
Maybe you could walk us through how from the Medicare standpoint, which I assume is the majority of patients are in Medicare of that disease.
Just talk about the J-Code, if you're going to have a temporary J-Code or permanent. Maybe just walk us through that along with the timelines and
expectations.
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: Got it. And then maybe talk a little bit about the Medicare Part B and advantage. And just from when you spoke, it seems to me that the only
difference was on the utilization of criteria.
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: Sorry, I might have missed this earlier. But what is the normal -- I'm assuming there's a lot of patient variability on this. But how long does it take a
normal patient to move from being a first-line therapy to the point where there are multiple therapy but [not] still seeing breakthrough? (inaudible)
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: And then what does the -- you guys, I know, are looking for a combo treatment as well. So could you maybe talk a little bit about the clinical path
forward with regards to combo treatment with ensifentrine?
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: So beyond the Phase 2b, the additional trial, you would just need to be one trial to be able to show that? Is that correct?
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: It's in -- so those trials would be of the same size that we saw with the ensifentrine?
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: And then what about other combination? So you mentioned that adding the LAMA into. Is that something that you would look at too, or is LAMA
makes sense that it's first?
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: But my own personal assumption has been when looking -- you're having run that initial combination trial that at some point down the road,
there's going to be a lot of investigator-sponsored trials looking at the addition of other drugs. And the doctors will react to that based on these
(multiple speakers)
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: And maybe just as we go beyond -- you already have an ex-US partnership in one territory. Maybe you could just talk a little bit about, are there
other territories that are more appealing than others just because maybe there's a differentiation of prevalence? Or is it pretty much equal across
the board?
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: Great. And the last question I have is that -- you submitted your NDA for filing. And we should be (inaudible) will be sometime in August. Is that
correct?
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: Later this month. Okay. And we'll hear both on that as well as priority review, which you've filed for or submitted for?
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: Okay. Which would give us that answer?
Question: Edward Nash - Canaccord Genuity Group Inc. - Analyst
: (inaudible) Perfect. Well, thank you, guys, very much. Really appreciate you attending. And we look forward to strong positive news rest of the year
on the outcome on the drug.
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AUGUST 09, 2023 / 4:00PM, VRNA.OQ - Verona Pharma PLC at Canaccord Genuity Growth Conference
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