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

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Herriot Tabuteau: Thanks for the questions. With regards to AXS-12 cataplexy is the primary endpoint of the trial. So, we are also looking at other endpoints and specifically the endpoints that we looked at in the Phase 2 CONCERT study. One of those was cognition, as you mentioned. So, we do demonstrate a reduction or an improvement in Auvelity to concentrate in that trial. So that’s exploratory, obviously, but it’s something that we’re definitely looking at. Because the cognition, cognitive difficulty, it is one of the key symptoms or one of the symptoms that that’s experienced by the majority of patients some with narcolepsy.

Nick Pizzie: Hi Yatin, it’s Nick. As it relates to the gross net for Auvelity for the quarter, it was in the low to mid-50s. This was an improvement from the high upper 50s in Q1, mostly due to higher proportion of refills of the scripts, which had a more favorable if you can [ph] versus new scripts. And I think your second question related to inventory. I want to be clear that the performance for Auvelity was not impacted by changes in the inventory level. As we stated previously, normal inventory levels will be and remain around two weeks. So, no impact specifically as it relates to inventory levels.

Yatin Suneja: Okay. Just one quick one on gross to net. Do you expect that to – I mean just curious how do, you expect it to change over time. And once you have sort of full reimbursement, I’m just trying to understand where it should sort of shake out? Thanks.

Nick Pizzie: Thank you. Thanks, Yatin. We expect the GTN for Auvelity to remain in that mid-50% range for the foreseeable future. It’s obviously volatile depending on when payer access comes in and then that offsets the co-pay reimbursement. So for the foreseeable future, we expect in that mid-50% range for GTN.

Yatin Suneja: Thanks.

Operator: Thank you. Next question is coming from Marc Goodman from Leerink Partners. Your line is now live.

Unidentified Analyst: This is [Rudy] on line for Mark. Can you provide more color on the duration of effect and persistency for Auvelity? I know you’re still in the early stage of launch, but any color will be helpful. And also painful one like the gross line for Sunosi and inventory changes in the quarter? Thanks.

Herriot Tabuteau: Yes, good. Thanks for the question. Could you repeat the second part of the question, we had problem hearing?

Unidentified Analyst: The second part, I’m just wondering the gross line our inventory changes for Sunosi in the quarter?

Herriot Tabuteau: Okay. Thanks. So with regards to the duration of effect for Auvelity, what we saw in the CONCERT trials, as you know, our clinical trials were six weeks. And the primary endpoint was at six weeks. So we showed early onset of action at one week, at two weeks and wait for every time point and including at six weeks. And then subsequently in very large as follow-on studies. We looked at the duration of effect, patients were treated out to at least one year. And what we saw was that the improvement either increased or was maintained out to at least one year. And what we’re seeing from – the actual use of the product in the field as we got now, we have what how many patients on that.

Mark Jacobson: 40,000.

Herriot Tabuteau: Yes, 40,000 patients who’ve been treated with the product. It’s still early, but the experience and the prescription trying to support this, we’re seeing that the patients are being on therapy at the rate that we would have expected.

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