Operator: Thank you. The next question is coming from Vikram Purohit of Morgan Stanley. Please go ahead.
Vikram Purohit: Hi. Good morning. Thanks for taking our questions. Two from our side. One on narcolepsy, it seems like there was a little bit of a slip on timing for expected data readout from late this year to one cue of next year. Just wanted to get some context on what might have driven that. And then secondly, for the Auvelity launch, What is your latest sense on the breakup of patients you’re seeing across lines of therapy? Thanks.
Herriot Tabuteau: Great. Thank you. I’ll take the first question and we’ll have Lori take the second question. With regards to narcolepsy and the AXS-12 study, the change in terms of when we expect to have top-line results is driven purely by enrollment. And we’re on track to complete enrollment by the end of the year.
Lori Englebert: Hey, Vikram. So in terms of the type of patients that we’re seeing, right now, about 10% to 12% are first-line therapy, but the majority, and the overwhelming majority is about 60% of the patients that we’re seeing have failed one or two product therapies. So, sum it all up, 70% have failed one or two or brand new to therapy.
Herriot Tabuteau: Yeah. And I would just add that we’re really pleased that this early on in the launch, 40% of patients either are brand new or have failed one treatment.
Vikram Purohit: Understood. Thank you.
Operator: Thank you. The next question is coming from David Amsellem of Piper Sandler. Please go ahead.
David Amsellem: Hey, thanks. Just a couple. So first on the esreboxetine filing and opportunity, how are you thinking about the fit of that commercially within the organization? I mean, my understanding is, it’s a large sort of GP-focused indication. So where does that fit exactly in terms of just where you’re taking the organization? That’s number one. Then number two for reboxetine is your expectation that you’ll be filing on this dataset or are there any other gating items to filing in the narcolepsy setting for that drug. Thanks.
Lori Englebert: Yeah, hi. I’ll take the first one on fibromyalgia. So you’re exactly right. Fibromyalgia is an incredibly underserved market. 5 million patients in the US, only three products approved to treat right now. They’re all generic, widespread. There hasn’t been any promotional dollars in the area for a very long time. Patients, HCPs are all very, very frustrated with this patient type because they don’t have effective products to treat. So, in terms of where we’re taking the market, it’s way too premature for us to speculate on how we will structure our sales force. But what we’re focusing on right now is really making sure that we understand the marketplace, make sure that we have really strong disease state educational efforts to make sure that HCPs and patients are educated well on the disease state, and then we’ll focus our field force on the highest to prescribe, highest likelihood to prescribe HCPs.
Herriot Tabuteau: Great. And then just add to what Lori said. I think one of the things that we’ve always been mindful of in designing our commercial approach is to make sure that we built a commercial infrastructure and platform to enable us to leverage the pipeline. So we’re ready. We’re really happy with the way our DCC or digital central commercialization platform is performing with – to Auvelity as well as the Sunosi and so that experience is allowing us to hone it to make it even better and we will be leveraging that with the fibromyalgia launch. With respect to your question on the reboxetine team and the dataset for the filing, the dataset will consist of the SYMPHONY Phase III trial, which is ongoing, as well as the Concert Phase-II trial. In addition, there is an ongoing open label safety extension trial that is also required for the filing. So those 3 studies will form the basis for the NDA filing.
David Amsellem: Okay, that’s helpful. Thank you.
Operator: Thank you. The next question is coming from Jason Gerberry of Bank of America. Please go ahead.
Jason Gerberry: Oh, hey, guys. Good morning. Thanks for taking my questions. I guess, firstly, just on the patent front, a little surprising, we’re about a year post launch with only a single paragraph for. So curious, any views on your end? Like, what might be going on here perhaps most of the generics are going paragraph three since they can’t get first to file, but on the flip side, maybe this trend might be real and maybe there’s going to be limited IP challenges giving the breadth of your IP. And then my second question is just your thoughts specifically to narcolepsy, maybe how the orexin could competitively have an interplay with 05. You know, it looks like a drug that’s very potent on MWT, but may have a trade-off with insomnia rates as a sleep disorder trade-off. So just curious, your thoughts on the emerging profile of orexin and how that could competitively interplay with 05. Thanks.
Hunter Murdock: Jason, this is Hunter Murdock. Thanks for the question. As a matter of practice, we really can’t comment on ongoing legal proceedings, but, you know, I can tell you we’re very proud of our extensive portfolio on Auvelity and we don’t have any further comment on it.
Herriot Tabuteau: And maybe I’ll touch on your question around the orexin and how they might impact the market. So we like our portfolio, we do have Sunosi, which is approved to treat excessive daytime sleepiness in patients with narcolepsy. And then we have AXS-12 and as you know we’re awaiting the readout of the Phase III trial. And the primary endpoint for that study is cataplexy. So when we think about the market and the need, and I’ll let Lori talk about that, one of the aspects of the disease to be cognizant of is that there are multiple symptoms that these patients experience. So no one treatment will address each symptom. So we like our portfolio which should be able to address more than one of those symptoms, Lori.
