Xenon Pharmaceuticals Inc. (NASDAQ:XENE) Q4 2022 Earnings Call Transcript

Page 2 of 11

As we’re in a Phase 3 program, we do have obligations to do pediatric work, both in focal epilepsy and primary generalized tonic-clonic seizures and Chris can kind of walk you through the extrapolation rule and how we get into younger patients in both of those indications.

Chris Kenney: Sure. Sure. Thanks Ian. So, just kind of high level before I do that. I mean I think we’re already doing — we’re sort of already embarking on our fairly ambitious program, right? I mean typically, doing focal onset seizures and primary generalized tonic-clonic seizures is usually done in series, not in parallel. So, we’re doing that. And then plus we also have the proof of concept going on in MDD. So, there’s, I would say, more than an average amount of activity already. To Ian’s point, you the regulators in the US and in Europe will require specific attention to the pediatric population. And so those conversations are ongoing. It’s fairly regulated because — and we have a strong interest. There’s no reason to think that XEN1101 wouldn’t work in the pediatric population of it gets approved in the adult population. So, all those plans are well underway and sort of adhering to regulatory guidance.

Ian Mortimer: And Brian, maybe lastly, Chris Von Seggern can just give a little bit of perspective at least as it relates to focal epilepsy and primary generalized tonic-clonic seizure, the commercial opportunity. As Chris mentioned, we’ll be moving as agreed upon with the regulators, we’ll be moving into adolescents and then into younger populations as we move ahead with the development. But there are patients that are diagnosed with focal epilepsy and generalized seizures, much younger. So, Chris can comment about some of the commercial dynamics.

Chris Von Seggern: Yes, absolutely. So when you think about the total epilepsy opportunity, you always start with 3 million adults in the US. There are about 300,000 to 400,000 pediatric patients that have durable epilepsy that’s going to fall into the same categories with both focal seizures or generalized seizures. And we believe the value attributes that are associated with XEN1101 as they apply to adults being viewed very favorably. What we’ve heard from our market research in the pediatric populations is those same attributes are actually just as compelling in the pediatric population. So, we’re very excited about that opportunity in both focal onset as well as primary generalized tonic-clonic seizures with the opportunity to move the product into those patients when appropriate.

Brian Abrahams: Very helpful. Thanks again.

Operator: Our next question comes from the line of Tessa Romero from JPMorgan. Please proceed.

Tessa Romero: Yes, good afternoon and team, thanks so much for taking our questions. So, one from us on the Phase 2 X-NOVA data that we’re expecting here in the third quarter. So, how should we be thinking about how important the totality of the data is that you gather here? Or with respect to your go or no-go decision? And — or is this really just about hitting stat sig on the primary end point of the MADRS? Are there specific endpoints that you think are more important to a no-go decision here? Thanks so much.

Ian Mortimer: Thanks Tessa. I think it’s an important question because I think we’ve used language similar that we believe the totality of not just the data but the analysis of moving into major depressive disorder is multifactorial, and we’re doing a lot of that work right now. So, obviously, we’re running the X-NOVA study to generate important clinical data on MADRS as the primary endpoint as part of the input to the decision-making. But we’re also doing even more commercial work as we think about the opportunity to do registration work, both in epilepsy and depression. We think a lot about the co-morbid population. We know that 30% to 50% of epilepsy patients have the lifetime co-morbidity of depression. And so generating data through X-NOVA could be really important as we continue to think about 1101 also as an epilepsy drug.

Page 2 of 11