Verona Pharma plc (NASDAQ:VRNA) Q4 2022 Earnings Call Transcript

Joon Lee: Good morning. This is Autumn on for June. Thanks for taking the questions. Our first question is about the NDA, just wondering how the NDA process is going? And then just also wondering what’s the rate limiting step to getting a European partner on board, your strategy for your European regulatory process and things of that nature? Thank you.

David Zaccardelli: Sure. Thanks so much for the question. The NDA is progressing very well and as we guided, we’re tracking to have a submission in the second quarter. All the components to it are coming together, not only of course, the clinical, which is always important, and in this case it was one of the rate limiting steps, but also, of course, the CMC, the nonclinical, and other aspects of the NDA. So we’re very pleased where we’re at with it and looking forward to that submission. And as far as partnering goes, our strategy remains the same and that we are looking to partner ensifentrine outside the United States. As you know, we have done that already in greater China with Nuance Pharma. You know, these conversations are all different as partners are different, their needs are different, their size, their scope, et cetera.

And so, some of these timings, you know, we can’t control other than sticking with our strategy, which we’re very confident in. And so I expect partnering to be a focus of 2023 as I’ve mentioned before. And we look forward to updating everyone as we have more to report on partnering, but it is definitely our articulated strategy.

Joon Lee: Thank you.

Operator: Our next question will come from Tom Shrader with BTIG. You may now go ahead.

Thomas Shrader: Good morning. Thanks for taking the questions. Some general questions, do you expect to launch on approval? Do you expect that will be your level of preparedness? And then for Chris, can you give us a sense of what a good pay or acceptance ramp would look like in this area? We’re a little less experienced. What should you have in terms of say, at a year or something like that? And then also what do you expect for the copay to be for this drug? Thank you.

David Zaccardelli: Chris, do you want to go ahead and take those?

Christopher Martin: Yes. Tom, I’ll start on launch on approval. Across the organization, we’ve been working a very comprehensive launch readiness plan that involved not only the commercial departments, but as Dave mentioned in his talk, other support commercial as we get ready for launch, including CMC finance and that plan is progressing very well. We — our plan is to launch as soon as possible after approval. It is an important point that once we get approval, we will have to get product into the channel, and that does take a couple weeks. And then we also will be hiring reps at the time of approval, so there will be training. But our plan is to launch as quickly after approval as possible and the organization is working toward those plans, and we’re in a very good shape to launch as quickly as possible after approval.

As far as your second question on payer acceptance, I think it’s really important to think about ensifentrine differently than what you typically see with launches today, because launches today typically launch within Medicare Part D as in Dog is involved or commercial and those payer channels tend to have very tight restrictions for new products at launch. Ensifentrine’s primary reimbursement channel is Medicare Part B as in boy. And we know within Medicare Part B that our access will be available at launch for physicians. And we can see that with what will happen with YUPELRI. YUPELRI had very high access and acceptance rates at launch with YUPELRI in that channel, and that caused the product to be able to be used by the physicians. There are some important steps that we have to go through within the Medicare Part B channel, but those are things that we’re working on today.