The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Andrew Tsai - Jefferies Jefferies Group LLC - Analyst
: Good afternoon. Thanks for taking my questions. Congratulations on the quarter and thanks for the updates. With this new data set, are we
interpreting this correctly in that the overall seizure reduction for patients at 3 to 4 mg doses through the maintenance period is now 56% on 10
total patients, which would compare 85% flat time? So, is the next batch of four patients performing in a way that decreased the overall seizure
reduction from 75% to 58% or 56%, sorry?
Question: Andrew Tsai - Jefferies Jefferies Group LLC - Analyst
: Yes, thank you. Thank you. And as for the apomorphine pump under review, noticed AbbVie's pump was recently approved and they spoke highly
of its own. Thinking about reading across to your own review, how might AbbVie's fast approval serve as a positive for you, if at all. Just curious?
Question: Andrew Tsai - Jefferies Jefferies Group LLC - Analyst
: Great. And the last question. Thank you. Is SPN-820 for where you saw the 22 point or so MADRS reduction by day 10 in your recent MDD study.
Do you expect that similar level of drug effect to be replicated in your TRD study with data in first half? And I'm just curious what you're assuming
for drug and placebo at week five, that TRD study? Thank you.
Question: Andrew Tsai - Jefferies Jefferies Group LLC - Analyst
: Right Okay, thank you so much.
Question: Stacy Ku - TD Cowen - Analyst
: Hey there. Congrats on a nice quarter. We have a few questions, so first, just on kind of the key Qelbree launch, how are you thinking about the
current volumes that you're seeing and whether you're on the right trajectory for 2025 Qelbree consensus? I think expectations are closer to $282
million at least on FactSet. What are your views there? And then as we think about kind of the net pricing we saw this quarter? How should we be
thinking about the remainder of the year and how that might look as we go to 2025 as we tie in that question around consensus? So just curious
your views as we look to next year as much as you can comment, just give us some understanding about kind of the growth dynamics into next
year. That's the first kind of set of two questions.
And then a quick follow-up. For 820, the dosing strategy in the MDD trial was a touch different than TRD. Are you expecting the placebo response
to be a touch more well controlled since you're not having the patients come in as frequently? There seems to be kind of a need for the patients
in the open label trial to come in very frequently. So just help us understand that dynamic as we think about placebo response and what could be
expectations for the TRD study? Thanks so much.
Question: Stacy Ku - TD Cowen - Analyst
: Okay. Understood. Thank you.
Question: David Amsellem - Piper Sandler Companies - Analyst
: Thanks. So I have a couple. First, can you give us your latest thoughts on capital deployment and how you're thinking about M&A specifically
whether you're prioritizing commercial stage assets versus pipeline focused assets and just how you're thinking about that, particularly in the
context of the advancement of your internal pipeline; so that's number one.
Then secondly, regarding Qelbree; wanted to pick your brain about how you're thinking about the competitive landscape longer-term. We're going
to get data for Axsome solriamfetol, I believe in adult patients in the near future. So, as you're thinking about other non-stimulant entrants like that
product, how are you thinking about the potential impact to Qelbree longer term, if at all? Thank you.
Question: David Amsellem - Piper Sandler Companies - Analyst
: That's helpful. If I may just sneak in a quick follow up. Just regarding M&A, is there a pro forma net leverage target beyond which you would not
be comfortable going in the context of a transaction, particularly for a commercial stage asset?
Question: David Amsellem - Piper Sandler Companies - Analyst
: Thank you.
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