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: Paul Matteis - Stifel Financial Corp. - Analyst
: All right. That's awesome. Cool, okay. With that, do you want to just give us an update of the 1101 pivotal program, PGTCS and MDD, and I don't
know what else you can say, Ian. But as you're well aware, right, there has been some confusion and concern, right, on timelines and pace of
enrollment in epilepsy trials. So maybe as you set the stage for Xenon, anything else you can add there, I think, would be super helpful to investors
who are listening in.
Question: Paul Matteis - Stifel Financial Corp. - Analyst
: Okay. Great. So just to kind of put a bow on it, you're comfortable of what you're seeing so far in terms of enrollment, comfortable that things are
not all running behind, and I guess, do you feel like there's going to be a key point in time where you'll give us more specific guidance on exactly
when we will get the data?
Question: Paul Matteis - Stifel Financial Corp. - Analyst
: Yeah, yeah. Okay. Fair enough. So I don't really want to belabor discussion too much on efficacy empowering because I think from the investor
side, most folks have seen Xenon at least decently well [right around] take for granted, but the drug works and should work in Phase 3.
What I'd be curious about is, when you think about any clinical risk going forward, how well characterized is durability of benefit, long-term safety,
and also pigmentation, right, which I think only appeared after approval or was only obvious after approval with ezogabine. And so how comfortable
are you there? And what sort of data can you point us to?
Question: Paul Matteis - Stifel Financial Corp. - Analyst
: Yeah, yeah.
Question: Paul Matteis - Stifel Financial Corp. - Analyst
: Yeah, yeah. Okay. Great. So maybe let's talk a few commercial questions for epilepsy and then we can talk a little bit about MDD too. But on the
commercial side, Ian. So I think investors sometimes feel like they meet a lot of companies in epilepsy, all the epilepsy companies use Keppra and
Vimpat as analogues because they're awesome analogues, and they're big drugs.
And in the meantime, right, there has been a number of drugs sprinkled in that have done like okay. And cenobamate is off to a decent start,
nothing to [add] but maybe not on track to sell $1 billion. We'll see. In the context of all of that, right, how should we actually make sense of getting
comfortable that for a drug like 1101, I mean, my words not yours, but that we should be using [bull case comps] as realistic analogues?
Question: Paul Matteis - Stifel Financial Corp. - Analyst
: Yeah. Okay. Very good. Should we talk about MDD briefly. On that study, can you just speak to the evidence that came from ezogabine? And then
just going into these data, earlier [I was to ask it] but MDD is hard. How would you characterize your level of optimism here versus how you felt
ahead of the X-TOLE (inaudible)
Question: Paul Matteis - Stifel Financial Corp. - Analyst
: Right, yeah. Okay. If that study works, what's next for Xenon? Do you envision yourself developing that all the way to market?
Question: Paul Matteis - Stifel Financial Corp. - Analyst
: Yeah, yeah. Okay, great. To finish things up because I know we don't have plenty of time, I thought -- I'm sure you get a lot of questions on the
competitive landscape, right, with Biohaven and also Eliem who has a preclinical Kv7. The Biohaven molecule, we've seen a little bit of blinded
safety data. I guess, what's your -- how would you characterize your level of confidence in that you have a best-in-class drug in this category?
Question: Paul Matteis - Stifel Financial Corp. - Analyst
: Great. Anything else to add before we wrap up?
Question: Paul Matteis - Stifel Financial Corp. - Analyst
: Yeah, that came up with Neurocrine on the call before, and they are hopeful that it can show better efficacy and maybe better safety. So let's see.
Well, thank you both very much for taking the time, and we appreciate it. I know the investors appreciate it too.
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