Jeffrey Dayno: I think Jeff can speak to that. I think obviously, positive signals from the agency on the importance of that indication in pediatric narcolepsy patients. So Jeff, what’s the opportunity look like?
Jeffrey Dierks: So I mean, Danielle, we estimate there’s about 4,000 pediatric narcolepsy patients in the US. And although, it’s not a large opportunity, it’s an important one and it’s a very underserved patient population with only one FDA approved treatment option being sodium oxybate being a Schedule III REMS product right now. And I think we’re very excited about the potential if successful to bring a non-scheduled treatment option given what we’ve seen the impact of narcolepsy on these individuals’ lives.
Jeffrey Dayno: And Danielle, let me just also add. With regards to the pediatric narcolepsy, that sNDA. It’s also important that those data, we’re also pursuing pediatric exclusivity, which is obviously an important commercial opportunity with regards to an additional six months of regulatory exclusivity. So those data are one component of that along with the data that we’ll be generating in the Phase 3 Prader-Willi TEMPO study. So both of these components are important. And we are advancing both of these and making progress in terms of pediatric narcolepsy data through that submission and then the initiation of the Phase 3 trial in Prader-Willi syndrome. And both of those components are sort of what would be required as we pursue pediatric exclusivity and additional six months of protection.
Operator: We’ll take our next question from Graig Suvannavejh with Mizuho.
Unidentified Analyst: This is Avantika on for Graig. I just have a question about the — one about the Fragile X opportunity. I know you said that the time line has been pushed a little bit due to enrollment. But were there any changes in the trial design as there originally were, which also caused delays? And then also on the pediatric opportunity, I know you said it’s a pretty small opportunity. But do you anticipate growing the WAKIX sales force at all if approved?
Jeffrey Dayno: With regards to the Fragile X study, Kumar?
Kumar Budur: With Fragile X syndrome, the time lines were not pushed out with that. We had mentioned that we will evaluate the time lines once the asset is in house and we had an opportunity to evaluate the time lines. And based on the historical recruitment plan and the anticipated recruitment in this patient population, we arrived at completing the enrollment in the first quarter of 2025 with top line anticipated in wake of mid-2025. And there is no change in the study design.
Jeffrey Dayno: And I would just add. I think that the opportunity is for Harmony, for us to put our resources towards driving the Phase 3 RECONNECT trial forward. With regards to the experience of the clinical development team, more capacity from an operational perspective and really engaging with the patient community through our patient advocacy efforts as well to drive that forward towards a significant market opportunity of 80,000 diagnosed patients in the US. Turning to pediatric narcolepsy, we keep here in sort of small market opportunity but an important one. And I think Jeff sort of alluded to this, an important one in terms of potential new non-scheduled treatment option for pediatric patients with narcolepsy rather than Schedule II stimulants. So we are looking forward to working with the agency towards that. And then with regards to the impact on the market opportunity, Jeff?
Jeffrey Dierks: So in looking at the sales force coverage for pediatric narcolepsy, we believe that we’re optimized for the narcolepsy opportunity with our existing sales force footprint. There will be some new prescribers that we’ll be adding to our target list if successful. But we believe that our current team that is very excited about the potential to bring this forward is optimized to be able to take on this new opportunity with these additional patients. And with the addition of a handful of healthcare professionals, there’s a high overlap between adult narcolepsy prescribing and pediatric narcolepsy prescribing. So we believe we’ve got relationships established with a good portion of those prescribers but we are absolutely optimized with our team and if successful, very excited to bring this new indication forward.
Unidentified Analyst: And can I just squeeze in one more. For gross to net, I know you said that there will be headwinds in first quarter. But can you just quantify what you think it will be for the full year?
Jeffrey Dayno: Sandip?
Sandip Kapadia: As I mentioned, typically in the first quarter across the industry, there are general headwinds from just higher copay obligations and insurance plans resets in the first quarter. So we’ll see a couple of percentage points impact from that typically is what we’ve seen in the past in the first quarter, and that sort of improved as we go throughout the year generally.
Operator: Thank you. I am showing no further questions. I would now like to turn the call back to management for closing remarks.
Jeffrey Dayno: Thank you, Brittany. And thanks everyone for joining our call today and for your interest in Harmony. As you heard from us this morning, our strong execution in 2023 and solid momentum going into this year positions Harmony well for continued growth in 2024. We look forward to providing updates as we execute on our growth strategy. Thank you, and have a great day.
Operator: This does conclude today’s Harmony Biosciences fourth quarter and full year 2023 financial results conference call. You may now disconnect your line, and have a wonderful day.
