Conference Transcript - XENE 2026-05-14

Jason Gerberry, Analyst — Bank of America

All right, everybody, we're going to get going here with our next company presenter at the B of A annual health care conference. My name is Jason Gerber. I cover biotech and pharma, and I'm pleased to be introducing Xenon Pharmaceuticals and Tucker Kelly, CFO. So, Tucker, thanks for joining us.

Tucker Kelly, CFO

Great, Jason. Wonderful to be here in Vegas with you and the B of A team and appreciate the opportunity.

Jason Gerberry, Analyst — Bank of America

Great. So maybe we'll start with just a zetsu counter for FOS epilepsy. you recently had your confirmatory pivotal study and the next step is going to be regulatory, but maybe just at a high level, how would you, coming out of that data, say the elevator hook is looking for a Z2 counter in the ASM space? There's a lot of different ASM alternatives. So maybe if you could just sort of frame the why and then we can go from there.

Tucker Kelly, CFO

Yeah, absolutely. So we were really excited when we reported out in March, the second, as you say, of our pivotal studies for Zetokalner in focal onset seizures. So this is the XTOL-2 study, which had a tremendous result, largest median percent change in seizure frequency on a placebo-adjusted basis ever seen in a registration study. And helpfully as well, it was incredibly confirmatory of the initial XTOL-2 study, the XTOL study we had done in the phase 2b. So the efficacy, the safety, all the metrics that you really care about were incredibly consistent with what we'd seen before. So we think we've got a really great drug on our hands. As you said, we're going to be marching toward filing our NDA submission in Q3. And we have a really different product. So as you say, there's a lot of ASMs that are on the market today. It's a generic market for the most part. There's now just one branded ASM remaining. But we have a really different approach. We've got a potassium channel modulator. Most of the class today in ASMs is around sodium channel blockers or SV2As. So we have a different mechanism of action. We have got a compelling efficacy profile and an ease of use and tolerability that we think is going to be really important as we touch on the commercial opportunity and the physician that we intend to go after. So, yeah, we're really excited about the data from Exitol 2. We've got some initial feedback from KOLs and physicians, and it's all been incredibly positive. So the plan, as I understand it, will be to file the NDA in 3Q. what are sort of the if you can kind of just give us a sense of regulatory interactions what are the steps needed to get that NDA through so we had a really productive series of conversations with the FDA over the years and the team has been working hard even before the XTOL2 data was announced to get the NDA submission ready so all the things that we could do beforehand without that data we really worked on and got done so a lot of the CMC work the module 3 components of the NDA submission were all kind of prepped and ready to go. That still means there's a lot of work left to be done. This will be our first NDA submission as a company, so it's a big lift. Not at all worried about the packet, but it is a lot of work. So the team's working really hard right now to pull together the integrated safety summary and the other modules with the combined data sets, and we'll have our interactions with FDA leading up to the NDA submission later this year, and we're really excited about that.

Jason Gerberry, Analyst — Bank of America

Okay. So your base case is standard review. The last branded approval, Excopri, was also standard review, so that all makes sense. Are there any scenarios that could, you know, bump that up to prior review, expedite things?

Tucker Kelly, CFO

Yeah, you know, as you say, when you look back at prior approvals in ASMs, they're always standard reviews. We think that's likely to be the case here. Look, we'll always be a strong advocate for our drug. We think it's got great properties. We think it's bringing a real differentiated clinical benefit in a way that other current approved products don't. So we'll always be a strong advocate for it. But I think, as you say, the base case really should be standard review, so 12 months from NDA submission.

Jason Gerberry, Analyst — Bank of America

Got it. And you mentioned the reductions in the seizure frequency. Can you maybe talk a little bit about some of the data that you had at AAN around seizure freedom and how important that durability metric is ultimately to commercial adoption?

Tucker Kelly, CFO

So the phase three studies in FOS cover usually either an eight or 12-week double-blind period. So that's the principal data from the primary endpoint for both the X-TOL study and the X-TOL-2 study. And what we touched on at AAN were two things. One is some additional data from X-TOL-2 talking about seizure freedom, or as we really just call it, 100% seizure reduction in the double-blind period. Typically, seizure freedom from a clinical standpoint is thought of as six or more likely 12 months of no seizures. And that's important because for these patients in most states that you can't drive if you've had a seizure within either 6 or 12 months. So seizure freedom is really thought of as a long-term goal that physicians are trying to achieve with their patients. What we talked about at AN was both 100% seizure reduction in the double-blind period, so over 12 weeks. And what we saw was, again, really consistent, what we've seen in XTOL, as well as consistent with the OLE data. So from the Extol study initially, we have patients that after the double-blind period ended, stayed on drug, and we've got data that we put out at AS last year and as well at AN this year, out to four years on therapy for a lot of these patients. And what we see is whether it's in the double-blind period or in the OLE period, especially in years, that the efficacy continues to improve. And we saw that as well in terms of 100% seizure reduction in the double-blind, where we're up at that level that you mentioned by the last 12 weeks. And as you look back from four or six weeks out, it continued to go up. So we think that's really important. We bridge that to the OLE data, showing that if you're staying on drug longer, you're getting much more significant periods of seizure freedom. And we had a lot of patients out to four years. And for those patients that had been made on for four years, a very high percentage of those were able to get at least 12 months of seizure reduction at some point over those four years. So almost 40%. and there was another 10% that were able to get seizure reductions, 100% seizure freedom over that four years. So really compelling long-term efficacy data that we think is going to be impactful for us clinically as well as commercially.

Jason Gerberry, Analyst — Bank of America

So we've also heard just in our physician calls that the uniqueness of the KV-7 mechanism is an important attribute. There are others pursuing the KV-7 approach. I think Jazz has an early stage one, Biohaven has a later stage one, not a lot of data that are out there. So it's kind of difficult to know what you're up against. But do you feel like the lead is so far and the bar is so high that you don't really concern yourself? The focus is just internally what you have to do. Or how do you think about the defensibility given that there are other KV7s out there?

Tucker Kelly, CFO

Yeah, that's right. So we feel really good about our positions. As you mentioned, we certainly have the pole position. We're furthest out with a really robust and deep data set for Zetucalendar. So we've got the two phase three studies that have read out. We've got the long-term extension data. We have over 800 patient years of experience now on the drug, and we think we've got a really complete package that we think is going to set up well. So we both have a temporal head start in terms of others that may be coming behind us. We think we've got the best chemistry, highly potent molecule that gets good CNS penetration that obviously drives efficacy. and we've got a lot of other strong attributes as well so we're going to try and get four doses on label with two doses that we'd studied in the initial phase 2b 10 milligrams and 20 milligrams alongside the 15 and 25 milligram doses that we studied in extol 2 and we think that's really important because not all patients are going to require or want or need the same dosage formulation so we've got a kind of a really strong data set across a variety of doses that will allow physicians to figure out kind of what they're trying to solve for in a particular patient are Are they looking to try and maximize seizure reductions? Are they trying to get a different balance between seizure reduction and adverse events that you see with a lot of ASMs? So we think we've got a really broad moat that we've built around our franchise with the Zetucallender in epilepsy. And we think the data, as we talked about before, kind of speaks for itself in terms of the strength of the efficacy data in the class overall. But certainly, we're the only ones that have read out a pivotal study or registration study with a KV-7 today in epilepsy.

Jason Gerberry, Analyst — Bank of America

Can you outline, I know price is becoming a little bit more of a discussion point, and you mentioned maybe starting some payer discussions now as you get ready for launch preparations. Some of the unique aspects of being kind of a later line, probably a 2L or a 3L, a drug in the FOS epilepsy space. It's a protected category, so maybe just think about the proportion of the business that's Medicare and how you envision policies. I know in past conversations with xenon management, I think in epilepsy, the payers will typically let one branded agent be included in a multi-drug cocktail. So as you think about sort of what the desired outcome would be from a... ease of access standpoint and how the policies will get crafted. Maybe you can talk a little bit about that.

Tucker Kelly, CFO

So there's a lot of impact there. So maybe first to set the stage, what we see in terms of clinical use today is that patients typically go on like an SV2A inhibitor as a monotherapy to start. And then oftentimes if they can't get seizure and control, luckily a lot of patients can get seizure and control with a frontline agent. They'll often go to a second monotherapy, typically a sodium channel blocker. And then after that, it gets more muddied. and there's a lot of heterogeneity in terms of the clinical practice so oftentimes it moves to a polypharmacy approach and so you're mixing in sv2a inhibitors sodium channel blockers but there aren't many mechanisms available so there's really just a handful of kind of general options available to physicians and what that means is that you've got a market that's highly genericized there's only one sodium channel blocker today that is still branded and so that leads to some interesting dynamics on the commercial side. So the payer mix is roughly 40% for commercial. And then after that, it's Medicaid because a lot of these patients and people who suffer with epilepsy are on disability and then Medicare after that. And as you mentioned, it's a protected class for Medicare purposes. And from a commercial standpoint, you know, because it's a highly genericized market, it's not heavily managed. So, you know, there's a high medical need and burden with these patients. There aren't a lot of category spend here because there aren't many branded agents and there hasn't been a lot of innovation and in addition when we look at it there are certainly still with the branded agent that's out there and the ones that just came off patent in the last year or two you know there certainly are some of the traditional step edits prior authorizations and formulary restrictions but because of the way the clinical medicine is practiced today they they don't mean quite as much in the sense that patients are already going to be on an SV2 neighbor or an initial sodium channel blocker. So we don't in practice see that branded agents have a particularly challenging time getting reimbursement. Their formulary placements are very manageable and reasonable. So we think we actually have a really nice setup from a commercial standpoint. As you mentioned, the team's been out already now talking with payers and PBMs and really introducing Xenon as a company, introducing Exetucalner as a drug, talking about its benefits its novel moa the unmet medical need and doing a lot of education so this will be the first fos launch uh since uh excopri launched in 2019 so by the time we're on the market you know seven eight nine years and uh and so there's education to be done it's not a category that the commercial payers have had to pay attention to and we think we've got a great story to tell uh with a great drug and we intend to try and get really good value for the benefit we think we bring i think what's been said um on different calls i want to make sure i summarize this right is that the company believes that there could be

Jason Gerberry, Analyst — Bank of America

a price premium relative to, say, where XCOPRI comes out. That's the current most widely used branded agent in the ASM space.

Tucker Kelly, CFO

Yeah, so obviously the team's doing a lot of work on pricing with the data from the phase three in hand, and we'll continue to talk with payers and really, again, press the benefit and the unmet need and the novel MOA and all the other features. You know, it's interesting to name it because the last branded launch of Dimensions in 2019. So it's been a number of years. I think if you look across the landscape of biotech and pharma in general, prices have gone up in that time in terms of launch prices for a lot of new drugs. And we think we've got a really strong, compelling value proposition to provide. So we'll continue those conversations. We do think there's the potential for premium pricing to where those agents are today.

Jason Gerberry, Analyst — Bank of America

And we think it's justified based on the strong efficacy, safety, and overall clinical benefit that we bring with a novel mechanism yep can you talk a little bit about i think the market for kind of these more refractory patients in the past has been estimated at around u.s half of them or 500 000 or so five six hundred thousand if i have my numbers right what i wonder is like of those you know what proportion are presenting for a new treatment cocktail in a given year because that's kind of your in play dynamic uh market in any given year And I think a lot of people who followed launches in this space, there's a bit of a slow year one too and then a build, right? And so I do wonder, is it just the dynamic where it's 10%, 20% of those patients are maybe presenting in a given year for something new and that's what you're fighting for, competing against like Xcopri and other treatment options to get that incremental patient? Yeah.

Tucker Kelly, CFO

So the FDA would tell you there's about, in focal onset seizures, there's probably about 1.9 million patients in the U.S. As I mentioned earlier, the good news is for a lot of those patients, you know, they're well controlled with an existing medication. So, you know, say roughly half of those patients don't need and aren't looking for, on a regular basis, a new therapy. But the others do. So only roughly half of those patients are not well controlled. Some of them are not well controlled at all and really are uncontrolled patients. And, you know, what we're looking at is that half of those patients is the ones that we think within FOS are going to be the addressable. Half of the 1-9. Half of the 1-9, yeah. And then amongst those, there's probably just over half of those are partially controlled. So they're getting decent seizure reductions. They're not having their seizures as frequently, but they're certainly not, you know, well controlled to the point where they're not looking for other possibilities. And then, you know, just under half of those are really uncontrolled. And so I think at the outset, when you look at our commercial launch in FOS, you know, we're likely to be making our first headway into that group of uncontrolled patients. But we do think that, again, given the novel mechanism, the strong data, you know, that our goal is to rapidly move up earlier in the treatment paradigm and be, you know, one of those early add-ons to your initial SV2A or sodium channel blockers. So, you know, we think it's a really large patient population that has a significant unmet medical need, and we're bringing something very different to the table. This is all about FOS. We can also talk a little bit about the generalized seizures or PDTCS. That's a smaller market opportunity. It's probably about 900,000 patients overall that have generalized seizures with a similar mix of patients who are controlled and uncontrolled. So we think it's a really substantial number of patients that need new therapies and new options in the U.S., and we think that translates into a really strong commercial opportunity for Zetokalmer.

Jason Gerberry, Analyst — Bank of America

So for that uncontrolled group, do you have a sense of, you know, those people will trial a regimen three, six months, and then the determination is made that they're not achieving control or is the profile a bit variable? Some, that lack of control is discerned early, and others, it takes a while. Maybe it works early and then stops working.

Tucker Kelly, CFO

Yeah, I think it's really, you know, patient-specific. I think there's a couple of flavors of what you see. You typically see patients who, you know, either are looking for new therapies because they're not getting the efficacy that they desire. They're getting breakthrough seizures and uncontrolled seizures. and again there they would look to typically add on another asm so again these see stacking like in our clinical studies you know patients had been on uh an average of you know six prior asms they were on the study in in both arms on an average of two to three uh asm so patients kind of have this polypharmacy approach um and you know what we see then is other patients who maybe don't have uh the ability to tolerate the drug there's certainly you know a lot of adverse events that patients suffer from with a lot of sodium channel blockers and so oftentimes you'll see patients who'll be looking for new therapies and discontinue their existing asms for tolerability concerns so i think each physician is really looking at their patient individually and figuring out what they're trying to solve for in terms of adverse event profile seizure reduction and and that's again where i think you know they're cycling through different agents at different rates but they've got a limited toolbox to work with in terms of the types of agents that they can go to So, again, we think AZK provides a really nice option for them to look at, whether it's a tolerability issue because they've been on sodium channel blockers and they get a series of adverse events that are challenging there, or, again, whether they're trying to get additional efficacy, which they've been going off the same mechanistic basis, having a potassium channel modulator could provide a very different option for them to try and maximize efficacy.

Jason Gerberry, Analyst — Bank of America

Okay. Can we talk a little just about, like, the marketplace and who is the likely prescriber of a drug like Gazette to CalNERS? And so if I talk to a neurologist in a tertiary care setting, right, and they kind of get to the third, fourth line, they kind of feel like the value of an adding another different therapeutic option starts to diminish, and they may go to put a patient on a clinical trial or a non-therapeutic option. this drug's a lot easier to give than the competitive brand which is excopri so that makes me think all right this could play well uh more with the community uh who may be less inclined to do these non-therapeutic options so maybe can you just paint a picture of who the likely uh early users or or bulk of utilization is going to come from yeah so that's what we think as eka can really have a different impact because it does have the ease of use attributes in addition

Tucker Kelly, CFO

to the efficacy and safety that we think are going to drive broader adoption, not only amongst the epileptologists, the specialists who treat epilepsy patients day in and day out, and the general neurologist. And as you say, you know, Xcopri is a good drug. It does really well for a lot of patients. But because it has issues in terms of its titration, the need to manage drug interactions, it really is very much relegated to the epileptologist. So most of the scripts for excopria are in that setting and very few are in the general neurology setting we think with azetra calendar we've got a very different profile it has for the ease of use of one of the prior drugs called vimpat again it's a once daily doesn't have drug drug interactions doesn't require titration we've got a rapid onset of action and again the efficacy and and safety profile that we think is really favorable so that provides us the opportunity not only to be really impactful for the epileptologists who see maybe the more refractory severe patients and on a capita basis certainly prescribe more than general neurologists do but a lot of these patients are still at the at the general neurologist and as you say they they tend to stay there even beyond the first second third therapy even though that's more difficult to manage they don't necessarily get things like excopia that could be beneficial to them because it's just not really in the wheelhouse a lot of these general neuros and they may hold on to patients until they look at things like non-surgical options non-medication options things like surgery and then refer out to an epileptologist so we think from our commercial standpoint we want to penetrate both we want to try and get this drug widely used at both call points it'll be gradual in the sense that we'll certainly make better penetration sooner with the epileptologist right they're more up to speed on the novel therapies they're going to be more intrigued by the novel mechanism of action they see more patients they've got more severe patients but we're going to try both at the outset and we're going to really work hard to penetrate into the general neurologist community and we're going to do that in a really targeted way. So if you look at the kind of prescribing base, there's probably about 2,400 epileptologists in the U.S. There's 18,000 general neurologists. We're going to really target about 7,000 to 8,000 physicians at the outset. So all those epileptologists, but then a subset of the general neurologists who either write some brandeds or have patients that are, we think, more ready for a zetocallender. And the goal really is to be a widely used ASM across both parts of the channel, and we think we've got the profile to be successful there and for apologies if i missed this but if you said how many sales reps that would generally entail and how that might compare to what sk or or lundbeck have done in the past in this space yeah so we're going to start with about 75 reps on the commercial side our field force in total um you know will cover both the commercial reps but then we'll also have medical science liaisons a number of whom are already on board today we We already have about a dozen MSLs on staff doing scientific communication, and they've been great about really getting some initial feedback from KOLs on the data. But, yeah, we think that that profile can capture, you know, that strong market share that we're looking for amongst the epileptologists for the personal promotion, and we're going to use a lot of non-personal promotion efforts as well to broaden the reach and targeting in areas like general neurology where, again, you might want a larger field force over time as well. So, yeah, we think that's a really good starting point for us. We think it's going to be an effective way to do it. It's similar to what SK has today. I think they started with a little bit higher number of reps. They were probably in the 120 range at the beginning, and they've dialed that back now to somewhere in that sort of 75-ish range, we think. So we think it's a great starting point, very manageable for us to do, and will allow us to capture the opportunity in both settings.

Jason Gerberry, Analyst — Bank of America

And when you think about the launch curve and comps that are out there, would you advise investors to say hey look at how excopria looked in the first four to eight quarters how maybe vinpat adoption looked in those quarters apply a haircut potentially given i don't know later mover i don't know how would you kind of advise investors when you think about comps or even go outside the fos space for comps yeah so the commercial teams can be doing a lot of work now to refine their go-to-market strategy and their launch forecast so i think we'll have more color as we get closer to launch itself.

Tucker Kelly, CFO

But what I'd say is that in the past, certainly if you look at prior launches in ASMs, that like Xscope, a lot of them are like the prescribing patterns that a lot of these physicians do. They're kind of low and slow. So these are not hockey stick ramps, rare disease launches where you get in a huge number of patients that are warehoused or bolus, and you've got this kind of revenue number that just is up and at the right really quickly. It tends to be a more gradual slope of the curve. Our goal is to have the best fos launch ever um you know we hope to bend the slope of that curve some of that will be i think driven by the strong data we have in our execution on the commercial side and again it's it's a relatively conservative physician base and so we're going to have to do a really strong job to try and help bend that i think excorpi was unfortunately hampered a little bit by the fact they launched during the pandemic so that certainly didn't didn't help them um but again we think we've got a really good value proposition a strong story to tell and a commercial team that's very experienced in doing new drug launches new drug launches in epilepsy and so we think we've got the opportunity to have a fantastic launch but you know exactly how long it takes us to sort of get that reach and breadth with physicians and get that uptake we'll have to see as we get closer to the line yeah maybe just a quick word on OUS and regulatory possible partnership and what you'd envision being kind of the the split US OUS for a drug like or is that the counter yeah yeah so look we think it's a great drug and we want to get it to as many patients as we can not only in the u.s but but around the world it it can help thousands and thousands of patients uh based on the data we've seen in the study and so we certainly uh want to make that widely available on the other hand we are not going to be uh the company that that puts in infrastructure in europe or in asia um you know it just doesn't make economic sense for us given that uh the economics abroad but also the fact that we don't have other drugs today that we could put in our our commercial business bag so it's not really a viable proposition for us but we think there's great value there um you know we'll continue to build value in the in the data packet um everything from running x toll 3 which is another phase 3 study um that is ongoing now and we've said we'll finish enrollment for the non-japanese portion of subjects later this year that is very much a carbon copy of x toll 2 the reason we're running that study is principally for x us purposes so in europe for instance uh the regulatory guidance is that you have two 12-week studies. Our initial X-TOLS trial was an eight-week double line period. It was 12 weeks in X-TOL-2, so this would give us two 12-week studies. And what we announced earlier this year as well is that we had gotten in alignment with the PMDA in Japan based on the results of an ethno-bridging study we had done that would allow us to take 60 patients out of the 360 from the X-TOL-3 trial and allocate those to Japanese subjects. So that would allow us to not have to run a separate you know efficacy study in japan so we think that's great value creation for the brand uh internationally i think for us the challenge is finding the right time to do that and one of the issues today for a lot of sponsors and manufacturers like us is you know the potential for uh most favored nation or mfn uh here in the u.s you know the economic value from a pricing standpoint and return um heavily favors the u.s so if you look like at excopri you know they're doing about 500 million kind of annualized here in the u.s it's about 100 million in europe so you know it's a fraction of what it is so for us the economic return is still heavily dependent on our ability to capitalize on stronger pricing here in the u.s uh and so at the moment you know i think we'll be cautious about how we think about partnering but certainly at the right time you know we think it'd be great to get it in the hands of somebody who's got a good presence and can bring the drug to a lot of patients around the world yep okay maybe just you know focus on the next thing which is, I guess, MDD data in the story next year.

Jason Gerberry, Analyst — Bank of America

And what are the aggregate learnings here around the profile of a Z-2 calendar on mood in the epilepsy population and to the extent you see read through to the MDD studies?

Tucker Kelly, CFO

Yeah, so what we know kind of qualitatively from our discussions with physicians and what we see in the adverse event profiles, and unlike other ASMs, we don't have any worsening of mood, which is really, really great for epilepsy. and that gives us you know a little bit more confidence in mdd but i'll talk in a second about kind of what gives us confidence as much as you can in any mdd study for the x nova 2 trial we're going to read out in the first half of next year you know we did look at at some mood pro endpoints in the epilepsy study but again that was not a trial that was either enriched for patients with depression though a lot of patients with epilepsy suffer from it you can have background medications there and what we saw was that we had a positive benefit for these patients on that PRO and also the control arm right so these patients there also saw a similar benefit to what they'd seen in the treatment arm so I think it was helpful for us it gave us continued confidence that we've got mood neutrality within the epilepsy framework and on the depression side you know we're really pleased from our ex nova trial which was a phase two study that we ran a couple years ago that came out with a positive result on measures of depression so we had a clinically significant separation from placebo in those cases on two endpoints madris and hamd and we'll be studying hamd in the action of a two trial reading out in the first half of next year you know there's been a prior generation a drug with a kv second mechanism that also had positive clinical data in depression and so we've got kind of clinical evidence that we think gives us confidence to run the study. But as you well know, these are really tough trials to run. You get a lot of placebo effect. And so the team has been working really hard to try and manage that placebo effect. In the MDD studies, a lot of operational things that we've done to try and mitigate the placebo response and try and let the drug declare itself and show in a statistically significant manner that we've got an effect on mood, which certainly would open up a large opportunity for us in MDD and would also be a tailwind for the epilepsy franchise as well if we could have a mdd positive readout even though that's not in epilepsy patients that certainly would be in a strong uh additional state of data because a lot of those patients already suffer from depression today this this may be a reach but um when we look ahead you have three pivotals going on for for mdd fda is communicated you only need one pivotal study now so if x nova 2 is positive does that create a potential regulatory path in this whole discussion

Jason Gerberry, Analyst — Bank of America

I don't know if it's confounded by recent changes at FDA and sort of the catalyst behind that.

Tucker Kelly, CFO

Yeah, so, you know, we're going to read out the first of the phase threes in MDD and the first half of next year. So, you know, our hope is that we maybe know a little bit more about FDA's posture on, you know, one study approvals. And that will, you know, give us a little bit of time. I'm glad we're not having to make that decision today. And we'll have the other studies. We've got one other study that we're running there as well today and then one that's currently ongoing in bipolar depression. you know i think the caution that you know we think about with respect to the one study approach is that uh you know that may not be as um relevant or as quick to come in certain indications i think mdd is probably one of those where it would be further along the risk curve for for fda in terms of having a willingness to look at one study there's just a lot of variabilities we touched on so um yeah if we get a positive read i'm sure we'll consider it and think about it and we'll evaluate where the FDA is you know in a year's time but we're also cautious given the indication in general and the fact that you know it may be one of the more conservative areas of FDA when it comes to looking at one study but we'll see.

Jason Gerberry, Analyst — Bank of America

All right great well we're out of time so Tucker thanks so much for joining us.

Tucker Kelly, CFO

Great thanks so much for having me Jason. All right.