Ari Maizel: Yeah. Hey, this is Ari. Thanks for the question. We have seen a really nice increase since last quarter in line of therapy. The increase is — we saw roughly 5% increase in first or second line use. So, at this point, we’re around 50% of Auvelity prescriptions are first or second line, which is a very healthy trend and we expect that to continue. Your question around the GPO contract and the impact on line of therapy, generally speaking, when we negotiate with plans and PBMs, we are negotiating for first or second line access for patients. And so, we would expect, if we’re successful in pulling through that — those contract terms that, that would further increase the earlier usage of Auvelity in patients.
Joel Beatty: Thanks. Last question is, can you provide any kind of context on how the spending trajectory is looking going forward?
Ari Maizel: I’m sorry, you were hard to hear. Do you mind repeating the question?
Joel Beatty: Sure. How does this spending trajectory look going forward, just spending overall for R&D and SG&A and so on?
Nick Pizzie: Got it. Thanks for your question. So, as for R&D, our expense for the quarter was $37 million, which ticked up slightly from the previous quarter. We expect R&D spend to continue to increase gradually as we — as the two solriamfetol Phase 3 trials commenced during the quarter with the third starting in Q2 in shift work. These will be partially offset by the completion of the SYMPHONY trial for AXS-12. And as a reminder, in Q2, we do plan to submit the NDA for fibromyalgia, so we will have a one-time charge for the NDA filing fee. As for SG&A, total expense for the quarter was $99 million, as I mentioned in my opening remarks. That was higher than the previous quarter, but anticipated, as it really related to the sales force expansion. We would anticipate SG&A expense to be in this range in future quarters.
Joel Beatty: Thank you.
Operator: Our next question comes from David Hoang with Citi. Please proceed with your question.
David Hoang: Hi, good morning, and thanks for taking my question. Congrats on the quarter. I want to ask about the impact of the GPO negotiations in terms of timing on any increases in the number of commercial covered lives? Just, I guess, what could the cadence in covered lives that you pick up look like? And can we look towards next quarter as potentially seeing a meaningful step up in the number of covered lives? Thanks.
Ari Maizel: Thanks for the question, David. So, we expect coverage to increase, but it is difficult to predict the exact timing. The way to think about GPOs are effectively gatekeepers for PBMs, which is why the first step towards securing access is agreeing on contract terms, which include the rebates and utilization management paraments. So, the agreement we announced today enables the PBMs under that umbrella to now access the contracted rates for their members. I can’t provide a specific percentage increase in cover lives from the 48% we have today, but I will say that depending on how many of the PBMs underneath that umbrella access the rate, it is a meaningful increase over and above the 48%. The timing is just it’s too difficult to provide, and your question about next quarter, obviously, our intent is to try to improve it as quickly as possible, and then we’ll provide updates at the appropriate time.
Operator: Our next question comes from Graig Suvannavejh with Mizuho. Please proceed with your question.
Unidentified Analyst: Hi. This is [Avantika] (ph) for Graig. I just had a question about AXS-05. Have you thought more about the branding for AXS-05 in AD agitation? And if you would keep it under the Auvelity brand? Thanks, and congrats on the quarter.
Herriot Tabuteau: Thanks for the question. So, whenever you have a new indication, and especially one which is different as it is in the case of AXS-05 for Alzheimer’s disease agitation versus major depressive disorder, that is always a consideration, and it’s one that requires a lot of good thought and it’s not just that something that can just be answered on the fly. So, this would require us to really think about it and do some quantitative work. So, stay tuned, and this is something that we would not obviously communicate or announce ahead of time, but it’s something that we’re working on. Ari, anything that you add to that?
Ari Maizel: No, I think you’re spot on, and I think the reality is that there is advantage and the disadvantages to either maintaining the same name or having an alternative brand name, and we are going through the work right now in anticipation of filing down the road.
Unidentified Analyst: Great. Thank you.
Operator: Our next question comes from Vikram Purohit with Morgan Stanley. Please proceed with your question.
Vikram Purohit: Hi, good morning. Thanks for taking our questions. We had two, one on Auvelity, one on the pipeline. So, for Auvelity, could you talk a bit more about how you expect the sales force expansion that you completed recently to help kind of inflect scripts and inflect sales throughout the rest of the year and whether you’d expect there to be kind of a visible kind of acute lift in either of those metrics over the next couple of quarters? And then secondly, for solriamfetol in ADHD, can you confirm is this Phase 3 readout expected in the second half of the year? Is this going to be the study based on which you can submit potentially a filing for the indication? And then, also if you could just kind of frame out for us, what you’ll be reporting and what you would think constitutes a successful readout here, that’d be helpful. Thank you.
Ari Maizel: Sure. Yes, I’ll start with the Auvelity question. So, sales force expansion, we are seeing an impact certainly on activity levels and effort with customers. We’re seeing roughly 40% increase in weekly calls to customers. We are engaging with a broader group of providers that includes a primary care audience, and we are seeing that a meaningful increase in new prescriptions and total prescriptions from primary care, which is sort of commensurate with the additional focus we’ve been able to provide with the expanded sales team. I would say that we’re in the early phases of seeing the impact from a demand perspective. Referenced on the opening comments that we’ve seen a 30% increase in weekly new patient starts, that is typically the first indicator that demand growth is reaching an inflection, but it’s still early days in many ways, and we expect that, that growth to continue over time.
So, we feel really optimistic about the impact the sales force expansion has had thus far and expect that to continue to build over the course of the year.
Herriot Tabuteau: Great. And with regards to solriamfetol and the current ADHD study, that Phase 3 trial is registration trial. So, this is the study that would enable an NDA filing along with a study in pediatric patients. So, we do need to include data and efficacy data from pediatric patients that’s required for any kind of ADHD in the filing. So, we’re looking forward to the results of the FOCUS 3 trial in the second half of this year. So, we’re on track for that. As it relates to what we’re looking for, I think the first thing that we’re looking for is to demonstrate efficacy in the first large multicenter randomized parallel group study. So that’s what we’re looking for. The result of that will inform the profile of the product. There has been one prior study with solriamfetol in ADHD, which we sponsored, that was an investigator initiated trial, that was a single center study. So, this will be — the FOCUS study will be the first of multicenter trial.
Operator: Our next question comes from Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.
Matt Kaplan: Hey, good morning, guys, and congrats on the quarterly results. Just a quick follow-up on the ADHD program for solriamfetol. Will you I guess wait for the readout of the adult study prior to starting the pediatric study in ADHD?
Herriot Tabuteau: No, we would not. Our goal is to start the pediatric study as soon as practicable.
Matt Kaplan: Great. Thanks.
Operator: We have time for questions from two more analysts. Our next question comes from Myles Minter with William Blair.
Myles Minter: Hey, guys. Thanks for taking the questions. Just on the Alzheimer’s disease agitation program, you’re enrolling from the open-label extension of ADVANCE-2 into this new ACCORD-2 study. So, does that really imply that you’ve already got all of the long-term safety data that is required for a potential AXS-05 filing for that indication? And then the second one is about the messaging that ACCORD-2 could be a pivotal study if it is required. Why is that the case when I believe ACCORD-1 went through some protocol amendments and was obviously concluded early? And I think the messaging was that, that may have been pivotal when it first started, then it turns out it wasn’t. So, I guess what has changed there to say that ACCORD-2 would be pivotal and ACCORD-1 wasn’t? Thanks.
Herriot Tabuteau: Thanks for the questions. With regards to the open-label extension study, so we continue to enroll the open-label safety extension trial. As a reminder, that requires — or what we’re trying to do is to meet ICH guidelines, which are 300 patients treated for six months and 100 patients treated for one year, and we’re well on track to accomplish those goals. So, of course, this does not affect that. And then, also the patients who are completing ACCORD-2 are also able to then go on and continue to be dosed. So, we’re very comfortable with regards to meeting the necessary number of patients. As it relates to ACCORD-2 being pivotal study and then also comparing that to ACCORD-1, so what’s nice about ACCORD-2 is we completed ACCORD-1.
And so, all of the learnings in terms of our confidence around the endpoint, which would be necessary in a study like this, we have. And so, we’re able to design ACCORD-2 very prospectively and we have also received feedback from the FDA that this could be a registration trial based on the design. So, I think that is the fact that ACCORD-2, we are designing and we have designed it with the benefit of the knowledge from ACCORD-1, which is a benefit in this case.
Myles Minter: Thanks for the questions.
Operator: Our next question comes from Troy Langford with TD Cowen. Please proceed with your question.
Troy Langford: Hi, congrats on the progress this quarter, and thanks for taking our question. On AXS-14, how confident do you feel that the FDA has all it would need from a clinical efficacy perspective to approve the application? And then, on Sunosi, can you just provide any additional color on the powering assumptions for the Phase 3 trial in MDD?
Mark Jacobson: Sure. Hey, I’ll take 14. This is Mark. So, we’re targeting this quarter here. And in terms of content, that’s substantially complete. So, those things are being finalized and really it’s just building out the submission. And we’re going through that, we’re going to take the time to get that as robust as possible, but the work is substantially complete.
Herriot Tabuteau: As it relates to the powering for solriamfetol in MDD, we powered that study similar to — similarly to the way that we powered our other studies in major depressive disorder. So — and as you know, we do have quite a bit of experience there with the Auvelity program. So, think about the powering as being similar. And I think in general for MDD studies, the effect sizes, which one would expect with these drugs, is very well laid out, and there’s a lot of precedence. So, that’s how we power the study. So, to summarize, it’s 90% powered to detect an effect size, which is similar to the effect size which we detected in the Auvelity program.
Troy Langford: Great. Thanks for the color.
Operator: Since there are no more questions, I will now turn the call back over to Axsome’s CEO for concluding remarks.
Herriot Tabuteau: Well, thank you for taking the time to join us for today’s quarterly update. The first quarter of 2024 marks strong progress for Axsome. We look to continue our focus on commercial and pipeline execution throughout the balance of the year, with a goal of delivering innovation and value to patients, healthcare professionals and investors alike. Thank you, and have a great rest of your day.
Operator: This concludes today’s conference. Thank you for your participation. You may disconnect your lines at this time.
