Xenon Pharmaceuticals Inc Q4 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Paul Matteis - Stifel Nicolaus - Analyst : Hey, thanks for taking my questions. And Sherry, sorry to see you leave Xenon; wishing you all the best. A couple of quick questions for me. One, as it relates to the first Phase 3 and epilepsy, I was wondering if you can share anything more on just how close you are to full enrollment and is it still realistic the data could come in 3Q or does it look more like 4Q now? And then on bipolar, as you guys move full steam ahead here, how are you interpreting the results from other Kv7 readouts this year? If those data were negative, would that impact your enthusiasm at all? Thank you.

Question: Caroline Pocher - J.P. Morgan - Analyst : Hi team, this is Caroline Poacher. I'm for Tessa Romero with JP Morgan. Thanks for taking our questions; just a couple from us. So just a quick housekeeping question but can you just clarify that enrollment in X-TOLE2 is not yet complete? And then on bipolar depression, can you just provide any additional insight into the design of the Phase 3s that you intend to initiate in terms of patient population and end points you might assess? Thank you.

Question: Caroline Pocher - J.P. Morgan - Analyst : Okay awesome. Thank you.

Question: Matthew Barcus - Jefferies - Analyst : Hello, this is Matthew Barcus on for Andrew. First of all, congrats, Sherry, on your time at Xenon and our team wishes you the best. For the Phase 3 focal epilepsy study can you just talk a little bit about what the minimum efficacy threshold is for Azetukalner that you want to see for best-in-class status in your view? And then also for the Phase 2 study from Mount Sinai, the data set MDD, how granular of a data set can we expect to see on the secondary measures like MADRS, [KP] SHAPS et cetera? And can we expect to see efficacy kinetics there as well? Thanks.

Question: Matthew Barcus - Jefferies - Analyst : Great, thank you.

Question: Unidentified Participant - - Analyst : Hi, everyone, this is Nevin on for Brian. Thanks for taking our questions and Sherry, just wanted to extend our best to you on your next steps as well. So just a couple of questions from me, I guess how are you guys seeing XCOPRI doing on the ground and based on its current uptake can you tell us a little bit about how a Kv7 might fit into the treatment paradigm? And relative to kind of the sales that you're seeing with the XCOPRI since launch and other competitors like lorazepam, how do you kind of see the sales for Azetukalner relative to them on its potential launch? Do you see this as a potential comp for the initial launch or what are you -- or are there reasons to think that it could be even better?

Question: Unidentified Participant - - Analyst : Great, thank you so much.

Question: Brian Skorney - Baird Equity Research - Analyst : Hey. Good afternoon, guys. Thanks for taking the question. Sherry, also let me express my gratefulness for all the work you've done at Xenon and wish you the best in the future. So there's just another sodium channel modulator approved for acute pain and I know we've talked about the merits of Nav 1.7 versus Nav 1.8 which is -- as we kind of get to the end of IND staging here and start looking forward to kind of proof of concept. I'm just wondering where you're currently thinking kind of the initial indication target would be like? What's the quickest way to kind of determine how you're now 1.7 modulator might address pain indications? Is it in sort of like a postoperative pain setting, is it in sort of a more chronic setting, and you know I know pain studies are generally done both against placebo and active control with this approval, would you look to actually use that as an active comparator in that study?

Question: Brian Skorney - Baird Equity Research - Analyst : Great, thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 27, 2025 / 9:30PM, XENE.OQ - Q4 2024 Xenon Pharmaceuticals Inc Earnings Call

Question: Jason M. Gerberry - Bank of America Merrill Lynch - Analyst : Hey, good evening, guys. Thanks for taking my questions and Sherry, sorry to see you go but best of luck in in future endeavors. So I guess, firstly, with the BPD program I know there's -- you're going to hold off on giving details. I'm just curious if you plan on looking at this drug as an adjunct to lithium or valproate. I know the most recent approval on the space looked at this both from a monotherapy in an adjunctive basis. And then secondly, with the second gen Kv7, is the focus there going to be novel indications or do you believe that the molecule may offer advantages over as at the counter and that there can be opportunities for this follow on there?

Question: Sarah Schram - William Blair - Analyst : Thanks for taking our questions and just want to add my thanks and congratulations to Sherry. I have one quick clarifying question and then one additional. So first, understanding that the focus is on bipolar depression would you expect to see or could we see benefits on mania as well or are you guys only looking at depression? And then secondly, for the pre-clinical Nav 1.1 program,do you see this as a development opportunity in Dravet only or would you look to kind of position this for other types of epilepsies and if only in Dravet, how do you see the treatment landscape evolving over the next three to four years? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 27, 2025 / 9:30PM, XENE.OQ - Q4 2024 Xenon Pharmaceuticals Inc Earnings Call

Question: Sarah Schram - William Blair - Analyst : Great, very helpful. Thank you.

Question: Unidentified Participant - - Analyst : [Brennan] for Laura Chico. So for one for Azetukalner. So at launch, what type of patients are most likely to be the early adopters? Will this be driven more by patients seeking better seizure control or could this be more from patients who are experiencing mood disorders on their current ASMs? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 27, 2025 / 9:30PM, XENE.OQ - Q4 2024 Xenon Pharmaceuticals Inc Earnings Call

Question: Joseph Thome - Cowen - Analyst : Hi there, good afternoon. Thank you for taking my question and adding my best wishes to Sherry. Maybe on the bipolar depression study, I saw that you're looking to launch two with the MDD you have three planned Phase 3 studies. I guess, is there anything behind that decision? Is it a little bit easier to manage placebo response or anything in the bipolar depression population? And then maybe jumping over to PGTCS, can you just comment a little bit on how enrollment is going there? Obviously, quite a bit of competition in FOS maybe not as much in PGTCS. I guess what are you finding maybe easy or challenging when enrolling that study? Thank you.

Question: Joseph Thome - Cowen - Analyst : Thank you very much.

Question: Douglas Tsao - H.C. Wainwright - Analyst : Hi, good afternoon. Thanks for taking the questions. And first I just want to wish Sherry all the best and they enjoyed working with us. Maybe two things first. I want to start with the point that you sort of briefly touched on, Ian, in terms of the [pope on set] epilepsy study and the benefits for mood, obviously you're not powered for endpoints for patients with mood disorders but I'm just curious if you provide some detail or perspective on how -- what endpoints there will be to help us characterize the mood benefits for patients with FOS and even though they're not necessarily powered is there any chance that perhaps some of them could end up on the label? And then the second sort of follow up question I did. I just wanted to touch on or get some perspectives on just your R&D spend just given the significant acceleration in terms of your pipeline expansion both with as to tell there in terms of new indications but as well as additional molecules entering the clinic? Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 27, 2025 / 9:30PM, XENE.OQ - Q4 2024 Xenon Pharmaceuticals Inc Earnings Call