Verona Pharma plc (NASDAQ:VRNA) Q2 2023 Earnings Call Transcript

Andrew Tsai: Hi, good morning. Thanks for taking my questions. and again, congrats on the progress. So two questions on our side. Maybe one on the on-going filing as we wait for the potential acceptance from the FDA. Has the agency — what kinds of questions has the agency maybe set you since you’ve submitted the filing? What’s the correspondence been like? And if there haven’t been any correspondent, would you then say no news is good news? And then secondly, as we think about the sales trajectory of ensifentrine and think about launch precedents, are there any relevant launch comps that you think applies to ensifentrine, not necessarily within the COPD space, but maybe even in the neuro space in general. Any other kind of SMID Cap type launches with a similar situation? You’ve got it like a novel MOA for a big market, strong efficacy, clean safety and so forth. So what would be the best case studies for investors? Thank you.

David Zaccardelli: Thanks, Andrew, for the questions. I’ll take the first and then hand it over to Chris to take the second on launch comps. As you’d expect, we’re not going to comment on regulatory interactions in detail. But just to say that the submission is in, as you know, and that we are in a proper communication with the FDA. I think that is from my perspective, normal course of business, with them. And I think that we will see where they stand right now near the end of August would be our target expectation of around day-60. And as you know, they will also deliver a day-74 letter as well. That provides additional detail on the submission and it includes the PDUFA date, etcetera. So I would say, normal course of business from my perspective. And with that, I’ll turn it over to Chris.

Christopher Martin: Thanks, Andrew, on the question on sales trajectory and comp. In the COPD space, there’s really not a comp that fits the ensifentrine profile because — as we think about the launch for ensifentrine, ensifentrine is not a drug that needs to replace another drug in the treatment armamentarium. It’s a drug that can be added to what the patient is currently taking. And so it provides that extra benefit. But if I look more broadly at other categories and diseases where you have a mid-tech — mid-sized biotech competing against larger Pharma. I really go back to the most recent example of Biohaven in the migraine space where they were able to successfully launch an oral drug for migraine indication against a large competitor and do it very effectively.

And I think part of the — what we’ve learned and got an insight from around that is part of the work that we’re doing that was explained with Yas around how you set up the launch beforehand with market shaping, how you use data to be more efficient in your deployment are things that we’ve learned from that launch to make us very competitive and overly competitive against the larger Pharma players within there. So I really look at that example as a precedent for Verona and ensifentrine.

Andrew Tsai: Makes sense, thanks.

Operator: The next question comes from Edward Nash from Canaccord Genuity. Please go ahead.

Edward Nash: Hi, good morning. Thanks for taking the question. Could you just remind us, I think you’ve spoken to this before, but how quickly do patients move from first-line therapy to the point of needing ensifentrine? And then another question I have is just — I guess, just on the — as far as the future R&D development besides combo therapy, ensifentrine being applied, applied?