Axsome Therapeutics, Inc. (NASDAQ:AXSM) Q2 2023 Earnings Call Transcript

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Matt Kaplan: Hi. Good morning, guys. And congrats on the strong quarter. I just wanted to focus a little bit more on the Sunosi and solriamfetol expansion into additional indications. Can you give us some more detail in terms of the positive feedback that you received from the FDA with respect to binge eating disorder and shiftwork disorder. Specifically, how many studies will you need to complete to file for these indications, NDAs?

Herriot Tabuteau: Thank a lot for the questions, Matt. So with regards to the FDA feedback that we received, we received feedback on the entire clinical development plan. In other words, our plan studies to get the products approved. So for binge disorder, with only two stays and for shiftwork we’ll need one stay.

Matt Kaplan: And in terms of endpoints and for these studies, what will you be – can you give us more detail on that

Herriot Tabuteau: Yes. So typically, we provide the details on the trial design and the endpoint of the trial once we started the trial. So we intend to – so stay tuned and we’ll be providing more details on both of those studies because we do intend to launch some in very short order. So continue this order in the fourth quarter and shiftwork disorder in the first quarter.

Matt Kaplan: Great. And then with respect to the initiation that you – for the Phase 3 study in ADHD, can you give us a little bit more detail in terms of the opportunity that you see, Sunosi or solriamfetol selling in that indication?

Herriot Tabuteau: Yes. So it’s a very large patient population, as you know, close to or maybe even rivaling or [MDU]. So just extending the only patients who have ADHD. And right now, if you think about the therapies that are available, they fall into roughly two categories. You have the stimulus with work, which had very large effect sizes, but which have the issues with tolerability and then scheduling. And then you have the nonstimulants which have lower effect sizes. So it remains to be seen, obviously, what we’ll see with solriamfetol. That’s why we’re conducting the trial. But the indications from what we see with regards to the currently approved indication. So except at any times spins is that there’s a very large effect size and that the growth does – in fact translates to ADHD, and we think that it could provide to [indiscernible] patients. And then we’ll still a need right now, which is not addressed by the current treatments.

Matt Kaplan: Thanks. Thanks Herriot.

Operator: Thank you. At this time we have time for two more questions. Our next question is coming from Graig Suvannavejh from Mizuho Securities. Your line is now live.

Graig Suvannavejh: Okay. Thanks for taking my questions. Congrats on the quarter. Just my first one on the sales force expansion, I was curious, we’ve seen a flattening of NRx growth on a four-week rolling basis. So I’m just wondering if the sales force expansion was somewhat related to seeing that? And – or does that sales force expansion, is there a contemplation of perhaps down the line additional sales force adds? And then just my second question, just on the pipeline updates. There were a number of shifts in the timing, and I’m just trying to get a sense of what your current confidence in the new time lines that were laid out? Or are there potential uncertainties or swing factors that still exist that could trigger additional delays? Thanks.

Herriot Tabuteau: So I’ll take the second question and then Lori will take the first. With regards to pipeline update, what we’re trying to do is make decisions that will generate the most long-term value. So we’re fortunate to have so many different potential clinical programs, which are high value and which are late stage. So a lot of this has to do with one prioritization and two, the natural uncertainties that occur with enrolling trials, so that’s what we’re seeing. So we’re very happy with where we are, what the pipeline expansion. We think that that’s the right thing to do. And also we’re very well resourced to execute and create value. So that’s where we are. And I think in the grand scene of things there will be shift within the standard decision that you might expect with regards to running any kind of business that involves B2B? Lori?

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