So I think our submission was comprehensive in nature. With regard to pricing, yes, I think that with approval, we’ll have our — we’ll be well-versed in how we’re pricing ensifentrine. But I’ll ask Chris just to comment on the range of pricing.
Chris Martin: Yes. Thanks Dave. And Yas, I appreciate the question as well. When it comes to pricing, we have provided a fairly large range there. I think when we think about the market today, we know that the current nebulized products like YUPELRI are somewhere in the $1,400 a month range. And then, we also use DUPIXENT upwards of $3,800 a month as kind of an upper bound of pricing. The other thing that we have done from a work standpoint is understand kind of the value that ensifentrine brings to the marketplace to patients, to physicians in the system. We believe that value is substantial. When we think about exacerbation data, lung function data, symptom improvement data and the benefit-risk profile that Dave described numerous times, we believe that value is very high.
And so, when we’ve had discussions with primarily on the Medicare Advantage side with those payers, what they’ve told us is they expect ensifentrine to be a premium to the current nebulized products. Remember, the current nebulized products are single LAMA or LABA. So the profile of ensifentrine with bronchodilation nonsteroidal anti-inflammatory is very different. So, we believe we do have some pricing flexibility based on the value ensifentrine brings to the marketplace. I think we are also looking at other dynamics that are in play including IRA, Inflation Reduction Act, to ensure that we’re pricing ensifentrine appropriate to the value that it provides to patients and the physicians and the system. And as Dave said, we’ll be in a very good place come PDUFA to be able to provide specifics around that.
Mark take — Mark OpEx.
Mark Hahn: Yes. I’ll take the OpEx question. So yes, the OpEx for Q4 was about $19 million, a little over $19 million. I think you can expect that over the course of 2024 to tick up sequentially, with a couple of caveats, and get to maybe a little bit more than double where it is today by the end of the year. Along the way there will be a couple of bumps. One is upon approval we have a £5 million milestone payment that’s due Ligand. So, that will be an incremental one-time expense in Q2 presumably. And then upon launch, we have a $15 million milestone payment due to Ligand as well. So, another one-time — expense in the period of launch.
Yasmeen Rahimi: Thank you so much Mark.
Mark Hahn: Thanks Yas.
Operator: The next question comes from Caroline Pocher with Wedbush Securities. Please go ahead.
Caroline Pocher: Hi, good morning. This is Caroline on for Andreas and thanks for taking our questions. So, just one for us. We noticed the Dupixent sBLA for COPD has a PDUFA date of June 27th, which happens to be the day after ensifentrine’s PDUFA date. Even though Dupixent can only be used in a subset of COPD patients and ensifentrine more broadly, does this proximity and potential approval and launch change anything about your commercial strategy?
David Zaccardelli: I think — hi, good morning Caroline. I think the short answer is no. I think also we noted that and I think it’s good for COPD in general and the attention is severe disease is getting. And I think it’s great for the patients that Dupixent applies to as well as you mentioned is a fairly small subset of the entire COPD population in the U.S. that’s under treatment. But it doesn’t change our view of ensifentrine, how ensifentrine would be utilized in patients who are symptomatic across the spectrum of the disease. And for that matter, I don’t know if there’s anything that really conflicts with ensifentrine and Dupixent from a pharmacology basis as well. So, we see ensifentrine’s application the same as we did before.
Caroline Pocher: Thanks. Awesome. Thank you so much and congrats on all the progress.
David Zaccardelli: Thanks so much.
Operator: The next question comes from [indiscernible] with Canaccord Genuity. Please go ahead.
Unidentified Analyst: Hi, good morning. This is [indiscernible] on for Edward. Sort of a follow-up question after the Dupixent one. We would like to ask about the physicians’ mind share. So, based on the feedback that you have collected from the prescribers do you maybe project it or do you foresee if they would have a preference in how they would use different therapies? Thank you.
David Zaccardelli: Yes. So, thank you so much for the question. Maybe I’ll have Chris comment on that in general.
Chris Martin: Thanks Dave. When we look at our market research, I mean the market research that we’ve done is extraordinarily expensive. I think we’re closed well over 1,000 physicians surveyed across all specialties both pulmonology primary care and we’ve also spent a lot of focus on nurse practitioners and PAs. What we see in that market research is I’m going to boil it down to really two things. One is we see consistency in the unmet need that exists and we see this both from patients and physicians. We see that patients are complaining, as Dave described in his opening comments of persistent symptoms, at least half of these patients are having persistent symptoms regardless of therapy. And then we also hear from the physicians, when a patient has persistently symptomatic, they lack options or new ways to treat these patients.
What they’re excited about in our market research is how broad of the utilization ensifentrine can have. They see the, this drug in a very wide variety of places and they see it as potentially as an add-on to all therapeutic classes that exist today when a patient remains persistently symptomatic, but they also continue to express to us why this drug couldn’t be potentially used on its own and maybe push ICS and the steroids to a later-line therapy. Across all of our research what we see is that, the adoption and the willingness to try ensifentrine is very high. I think when we did represent in October we talked about almost 90% of the physicians surveyed talking about adopting ensifentrine within the first 12 months. That doesn’t change with entry of Dupixent or even potentially either other products that are in the pipeline, because foundationally what ensifentrine provides them is the first novel mechanism that works broadly across all their patient populations.
