Verona Pharma plc (NASDAQ:VRNA) Q3 2023 Earnings Call Transcript

Mark Hahn: Sure. So if you look at SG&A over the last couple of years, you’ll see that it has been ramping a year ago, it was $5-ish million in Q3, and this year, it’s $13-ish million. And I think what you should expect is that, that ramp will continue for the next several quarters. Through Q2, I think that our total expense through Q2 of next year, I think that our total expense should be in the $20 million to $25 million range on a quarterly basis. That includes both SG&A and R&D. And then once we get to Q3, assuming approval at the end of June, you would see that the SG&A ramps again as we bring on the sales reps that Chris will talk about.

Chris Martin: Thanks, Mark, on that. As we think about Joon, the reps and how we would potentially hire these people, we first have to think about how a structure looks like for that type of an organization. And typically, when we have a field force of about 100, you’re going to look at 2 area executive directors or executive sales directors that cover the east and the west. We’ve brought those 2 individuals on. And then we are actively looking at the next level under that, which is the RSDs, our regional sales directors, which cover are directly rep managers. And you would expect those people to be hired maybe 3 to 4 months before PDUFA. And our plan for reps is to hire them around at PDUFA contingent on PDUFA. We’ve done this in the past as a team where we create a pool of candidates that we’re able to hire and kind of hold until the drug is approved around the PDUFA date and quickly convert those offers into active employees with an organization.

So our plan would be to have those reps come on right after PDUFA and then have them trained and ready to go sell ensifentrine if it’s approved. I think the other important aspect here is we believe that a proper field force covering ensifentrine not only includes field-based reps, but also ways that we can interact with doctors virtually and also support the reimbursement pathway with field reimbursement managers. So I think as you think about the totality of the commercial organization, we want to make sure that we cover the physicians and the patients in a way that they can — they see how the utility of the product but then can also get the product to the patients that are most in need. And again, all those — that large number of representatives and people to support that would be coming around PDUFA right after PDUFA.

Operator: Next question comes from Tom Shrader with BTIG.

Tom Shrader: I’ve all combination questions. So the specific LAMA you used, how derisking is that for the class? The molecules ever not play together? Or is it really the mechanisms you’re working out? And then there’s some old data for ensifentrine. It was really quite striking that it made LAMA’s work faster. Maybe for Kathy, does that data hold up in your mind? And is that something that you would be very eager to try to see if you can repeat? And I have a follow-up on bronchiectasis.

Dr. David Zaccardelli: Great. Thanks, Tom. Yes, I’ll turn it over to Kathy to talk about her glycopyrrolate, in general and then potentially how ensifentrine and glycopyrrolate work together.

Dr. Kathy Rickard: Yes. So glycopyrrolate is like other LAMAs. Works very similar. They’ve been in use for a long time. So we know a lot about them from that perspective, and they all work fairly similar. So I don’t expect to have any surprises from their FSC or whatever that we look at in studies from that perspective. As far as acting faster, we do have some older data that shows that it’s not just LAMAs, but also for beta agonist that when you combine the 2 together, you do get a shortening of the response time to peak efficacy. Again, those were done in shorter studies, but I wouldn’t expect that that would go away. I would expect to still see that in the combination type of when we use them together from that perspective. I don’t — was there another question I’m forgetting?

Tom Shrader: I haven’t asked it yet. Just historically on bronchiectasis, have bronchodilators been tried and failed? Are you mostly betting or focused on the anti-inflammatory properties to show this as an effective drug?