Sage Therapeutics, Inc. (SAGE) Earnings Call Transcript & Summary

All right. Good morning, everybody. Welcome back to day 4 of the SVB Leerink Healthcare Conference. I'm Marc Goodman, one of the biopharma analysts. And we are happy to start this morning off with Sage Therapeutics. Appreciate you guys joining us. We have Steve Kanes, who's the Chief Medical Officer, been at the company, I believe, about 8 years; and Mike Cloonan, who's the Chief Operating Officer, and Mike joined the company about 4 years ago. And so thank you both for joining us. And I think, Mike, you're going to make some opening comments before we jump into a Q&A session.

Yes. Thanks, Marc, and good morning, everyone. Thanks for having us today. Thanks for jumping on the call and listening in, and I'll be quick with -- I know people want to get into the questions. But just to set the stage and where Sage is at. We're really excited about where we're at. You know a lot about Sage, but our vision really is to be a leader in the brain health space. We want to be a leading biopharmaceutical company in the next 5 years. We're well positioned to do that. And I think now, more than ever, that mission and that vision to be a leader in brain health is so important when you think about what's happening with the pandemic and mental health issues on the rise. We're very focused to deliver on that vision on our 3 franchises. So our depression franchise, led by zuranolone; our neurology franchise, led by SAGE-324; and then our NMDA platform is the underscoring of our neuropsychiatry franchise. So we're in a really good position. 2020, as many of you know, was a strong year of execution that teed us up. All of our clinical trials are on track at this point. And 2021 has the potential to be a very transformational year for Sage when you think about all of the catalysts that we have, 10 clinical readouts this year alone. We're really excited about what 2021 allows us to do and continue on that vision. And then we're well positioned from a financial perspective with over $2 billion of cash coming off the backs of the Biogen collaboration that we did at the end of last year. We're well positioned now to really build on that strategy of expanding and accelerating our deep pipeline. So very excited about that. And real quick on the Biogen collaboration, very pleased with where we're at with the collaboration a couple of months in. Great collaboration on both sides, like-minded partnership, exactly what we hoped for. And so again, very exciting time for Sage, very much looking forward to the balance of 2021 and looking forward to the discussion today.

Thanks, Mike, for doing that. Okay. So let's start off with 718. Steve, maybe you can help us understand what we're going to see with the upcoming data. Maybe set the stage for the product or the opportunity with the data coming. I think that's a great start for the morning.

Great. Thanks, Marc, and thanks for the invite to the meeting. So SAGE-718 is our first-in-class NMDA receptor positive modulator. It works on the glutamate system. And it's the lead candidate in our neuropsychiatry franchise. Its development -- it's in development as an oral therapy for cognitive disorders. And the ones that we're studying initially are Huntington's disease, where we've had data, early Phase I data -- Phase II data last year, and we're also exploring in Parkinson's disease and Alzheimer's disease. The approach that we're taking with 718, it harkens back to what we've done with GABA very early on, which is we leverage biomarker data and we conduct a series of small, open-label signal-finding studies, and we use that to inform the strategies that we'll use moving forward. Primarily, the question we're looking to answer is, what effect does an NMDA-positive modulator have on cognition broadly? We've seen some very provocative data on executive performance, which we can talk about. And we're also interested in seeing what other cognitive domains it might have an impact in, whether it has effects on core memory, deficits in Alzheimer's or working memory deficits or others. So the beginning phases of all this development is exploring where the utility is best. And this is unique. The potential is to identify a class of compounds that will help in areas that there haven't been drugs that have been developed previously. We announced recently that we're enrolling and dosing in a LUMINARY study. This is a Phase IIa open-label trial in Alzheimer's disease, cognitive dysfunction. And we have a number of readouts that we'll be using for a strategic decision-making in the upcoming year. One of them is the PARADIGM study. This is, as I said, an open-label study in Parkinson's disease. We'll have those data in early 2021. And later in the year, in late 2021, we'll have the outcomes from the LUMINARY study. This is also that exploratory study in Alzheimer's. So a lot coming in this really compelling area.

And help us understand like what the confidence you have that this is going to work. What have you done that said, "Aha! We are really seeing cognition improvement here with this modulation"?

Right. So we started first with a healthy volunteer study. So there are a number of experimental medicine studies that allow us to understand whether we're hitting the target and whether we're improving cognition in meaningful ways. And those were studies in healthy volunteers where we both induced a deficit and reduce the deficit related to the biology. The first patient population we went into was Huntington's disease, and these are patients that were known to have a deficit in the underlying biology that we think that we're touching. Now it's Huntington's, and we've seen improvements in executive function as well as in working memory. What we're looking to do is to see how extensive that impact is, and that will drive the strategy of where we want to go for subsequent Phase II trials. The plan, quite frankly, is to initiate a placebo-controlled Phase II study in late 20 -- where are we, 2021, with this molecule to explore one or more of those indications. So first, we look to see how far we can go with it, where the most impact might be and then use that to decide the pathway forward.

Right. So Mike, as we fast forward with this product, and let's say that it hits on helping Huntington's or Parkinson's, Alzheimer's, I wouldn't even know how to, it's such a big opportunity. I mean how do you think about the commercial opportunity and what it would compete with? Just think about it logistically, like what's going on today and how this product can fit into the real world?

Yes, Marc, good questions. And as Steve said, a lot of this is going to be driven by the data we get from the open-label because there's still questions that we want to see, what is the true benefit, not only on cognition, but memory, executive function, all the things Steve said. If you think about hitting on all of those dimensions, I think many of us know, in those areas, Huntington's disease, Parkinson's disease, Alzheimer's, the unmet need is so high. And even if this is symptomatic treatment of that and used in disease-modifying aspects, there's real potential here given the size of these markets. Obviously, Huntington's is more of a rare disease but not many options for patients today, and we know that the burden of the disease is significant, especially when you talk about things like cognition. So this is early days still. We want to see that data before we really get at what the commercial potential is. But just given the unmet need of Huntington's, the size and the unmet need of both Parkinson's and Alzheimer's, we're really excited about the potential here to make a meaningful difference for patients across all the spectrum of those diseases.

So Steve, what if we see improvement in executive function but we don't see improvement in memory? I mean what does that tell you?

So let me just say -- and thanks for the question. Executive function is something that we have yet to have a medicine that results in improvement. And I'll explain what executive function is. This is the ability to plan and then carry out complicated tasks. It's the leading cause of disability in that early phase of Huntington's disease, for sure, in Parkinson's and early Alzheimer's. So the way I think about it, as a psychiatrist, as a physician is executive function equals independence. Meaning the longer you're able to preserve and enhance executive function, the more you're able to work and live independently. And that's what this is about. So before we think about what the opportunity is, each of those profiles, whether it's working memory or executive function, is absolutely unique and would, I believe, have real benefit to patients, mainly because of the mechanism as well as the fact that these are areas that haven't been -- we haven't seen medicines that can improve previously.

So it sounds like this would be a pill that would be added on to any patient's regimen, right? I mean if they have Parkinson's, they're obviously taking the carbidopa, they're getting treated, and if they have dyskinesias, they're taking another drug. Have you done some work with drug-drug interactions with all the typical drugs that these types of patients will be taking?

Those are studies that would come next. The first -- this is entirely new science. So the first thing I want to know is our first step in is really understanding what we have in our hands. Where is the benefit? What's the right patient population? And how best to impact those things. That will really decide and really guide which kinds of studies we need to do subsequently. So it all begins with the science and I'll be excited as we start to land with that strategy and to be able to narrow it down and what studies we need to do to facilitate that, yes.

Okay. So those are all the next steps, basically.

Exactly.

But you do think you'll end up having to do that, right? That does make sense.

Oh, for sure. I mean we're talking about -- depending upon -- so it's going to depend a lot on the patient population there and whatever co-morbidities and medications that are used in those areas. But yes, of course, we'll need to do a full package that's going to allow for the best use of this medicine in the context of the patients that are being treated.

And Steve, let's flip gears to 324 and maybe set the stage of what we're going to see there.

Sure. So 324 is a next-generation GABA PAM. This is the receptor system we've been working in with ZULRESSO and zuranolone. And it's our lead asset in our neurology franchise. It's in development as a potential oral therapy for neurological conditions, and the one we're starting with is essential tremor, but we're also interested in areas as diverse as epilepsy and Parkinson's disease, where it had some early findings with this mechanism. The approach that we're taking is that GABA deficits are associated with essential tremor. The biology is there, the pathology is there, the molecular biology is there. And when we've done some pilot work with other molecules, we've seen benefits both in people as well as in animal models. And assuming that we can identify our path forward, the next study is positive, this just gives us a pathway to a development of the first drug in this area in half a century. There's really been no medications developed in over 50 years here. So to set the stage for the study, I'll lay out the questions that we're asking ourselves with this initial study, Phase II study. Can we see an overall benefit to patients that's sustained? And we're looking for a 30% to 50% improvement in tremor symptoms over the course of that 4 weeks of therapy, so that's what we're looking for. We've seen that with single doses with 324. We've seen similar responses with 217 with repeated doses. So we know that's the range that's both clinically meaningful, represents an improvement in therapy for patients. And it's what we're expecting to see, so 30% to 50%. And what we're also looking for is that, that benefit is sustained over the treatment period, right? We want to make sure that it doesn't wear off. There isn't tachyphylaxis. We want to see sustained improvement. Now recall, this is a new mechanism to be tested in these patients. There hasn't been a study like this before. So the approach that we take is we're dosing it at essentially the highest end of the dosing range. The philosophy here is in neuroscience, in particular, studies often fail because we're not testing the highest dose. And we're looking both for effect as well as any unexpected adverse events. I mean we know that the mechanism can cause somnolence. We're expecting to see that. And we'll use that to guide what dose selection we do later on in the Phase II development and beyond. So the first study is just really looking to see that effect. It's not even about statistical significance, quite frankly, but what we're looking to do is make sure that we see both benefit, and this will also be the longest time we're dosing patients for 30 days. So large effect, sustained effect and then use that to drive what we do for subsequent dose-finding studies or other development activities. Those are data that will be available in early '21, and something we're really looking forward to. I think you know this, Marc, we've been working in essential tremor since very early days. We worked with SAGE-547, which is now ZULRESSO. 217, which is zuranolone now, and we've used that to define the measurements, the outcomes, what we think are the most meaningful primary endpoints, and now we're looking forward to subsequent development.

And the scenarios after that. So you see the data that you want, right? You get the efficacy that you just referred. You get the durability. And the side effect profile is kind of what you expect. So it's not -- there aren't -- we're not getting massive sedation at this high dose. You're like, well, we can go forward with this. What do you do now? You go forward in essential tremor, normal? Is it straight into a pivotal? Or how does this work?

So just to be clear, we expect to see sedation at these levels, sleepiness and so forth. So really what comes next is optimizing dosing, whether that's split dosing, dose at night. Do we think about formulations? All of that will be -- do we think about different doses? So there'll be additional work in Phase II is a programming that we are collaborating with Biogen on. And we'll optimize the profile. An important thing for everyone to keep in mind is the profile that we'll see in our first Phase II study is not the profile of the drug as we move into Phase III. That's what we do during the rest of Phase II to optimize that profile and make sure it fits what would be appropriate for a long-term treatment, either for essential tremor or some of the other conditions that we've identified.

You mentioned epilepsy. Obviously, that's an obvious one. You mentioned Parkinson's. So what kind of work is being done on those indications right now? Or what's the plan?

So these are notions. And what we've done previously is a lot of nonclinical data and epilepsy. The mechanism clearly has activity in all of -- in almost all of the major epilepsy models. So it's an area that we'd be looking to get started with. Parkinson's likewise. We did some very early work. This was using zuranolone actually in patients with Parkinson's disease, both on and off L dopa. We saw improvement not only in Parkinson's tremor, but overall improvement in patients' quality of life. So unwinding those, really going after them, this will happen in the context of the partnership. So the focus right now, essential tremor, that's the one that we're -- that we've been pursuing for quite some time, but a lot of interest in other neurological conditions as well.

Mike, if we fast forward, essential tremor. You've got a drug on your hands. I don't know how many years from now, but fast forward several years, explain to us that opportunity and how this product would fit in?

Yes, Marc, and maybe just to set the context because I think people may not know a lot about essential tremor, I think it's getting some airtime now. You can see there's some opportunities with essential tremor given that there hasn't been any innovation in the space for over 50 years. There's only one product ever approved. It's propranolol, it's generic today. And so when you think about the opportunity, 6 million people in the U.S. alone with the prevalence of essential tremor. You've got about 1 million diagnosed looking for treatment. So there's -- it's a big patient population for sure, high unmet need given that there hasn't been much innovation that's taken place in the last 50 years. And so as Steve talked about, Marc, what we're really trying to do is hone that product profile as we think about what the efficacy is going to be demonstrated in the Phase II and then the tolerability profile. But if it is what we think it can be, this can really deliver real value to patients because it just gives options, right? There's only one option today for patients, and propranolol is a beta blocker, you have some patients who can't take it, there are some patients who aren't controlled. And so just having multiple options for patients with this profile, we think could be very meaningful. It has strong potential.

Yes. Yes, for sure. Let's look here as to SAGE-217, zuranolone. Kind of a hot topic, obviously, for the past year or so. Can you help us understand how we should think about the filing, the indication, depending on which one of these studies works, and I guess the commercial opportunity. I'm trying to understand, let's say, the WATERFALL study, we get that data, comes out first. We get -- you nailed it, the endpoint, right? Day 6, 15, you stat sig, check the box. We know we got a drug, okay? But now let's figure out what kind of drug we got. What if it goes out to day 42 and works is one scenario, and then the other scenario is what if it doesn't? What happens? What do we do? Assuming that this is the only study that's positive, for a second. I'm just kind of curious, how does that play out? What do we do? What does the label look like? And commercially, Mike, what does it look like?

Yes. So what I can speak to is the overall program, right? So every bit of data that we have points to a very clear profile. We have a lot of confidence in that profile, which is rapid onset, large effect and sustained improvement. And that we've seen across all of our trials. And so our strategy right now is a suite, as you say, of pivotal trials that are all going on simultaneously. WATERFALL is one that's an MDD. There's a CORAL study, which is zuranolone when given in conjunction with another antidepressant, initiative in the antidepressant in one of postpartum depression. Each of those leads to a differentiated opportunity. And each of which would support a filing. The question is like what -- when will ultimately be the filing? So that's -- I mean the short answer and the, I would say, the high-level answer is that depends upon the data, of course. So -- but let's think -- because you're asking about scenarios, let's take a look a little bit at scenarios. First and foremost, in the case of a positive WATERFALL study, and we have a positive primary endpoint, that's the goal of the study. So that's what it's designed to demonstrate. Everything else is ancillary. We've taken opportunities to enhance our ability to look at subgroups and different time points, including earlier and later time points. The goal of the study is show that it works during the period of time in which is intended to demonstrate benefit. And of course, to demonstrate that safety as well. In terms of how it fits into a long-term treatment, those data actually come from the long-term studies that we've been doing, and this has continued. So I'll just remind folks about what we've shown already with our long-term study. So the data that I look to for really durability of effect is the SHORELINE study, and this is a first of its kind naturalistic study. These are the kind of data that payers are interested in, physicians are interested in and patients are interested in, quite frankly, what do I expect after the dosing stops? And there, what we've seen, and we're doing a lot of work, the study continues, but it's an open-label study. We've done some data cuts already. What we've seen is that with the 30 milligram dose, more than 70% of the patients don't require more than 2 courses of therapy in a year, and half of those patients only require one. So what does that mean? That means that if you get better with this medicine, you stay well and you're able to be followed appropriately and retreated as necessary, those are the data that's going to really drive how this is adopted into the overall treatment paradigm. Short-term studies are intended to show short-term benefit. In MOUNTAIN, same thing. We've even followed patients from the MOUNTAIN study, and while it didn't hit the primary endpoint, we've been able to show continued benefit for those patients that did well. And so that speaks to how this will be used. And the only other thing I would say around the filing strategy is we have other studies that have been built into our program that are on pause. And I know there's been a lot of interest in understanding what is REDWOOD, which is this fixed-dose retreatment study, how does that fit and so forth. That was a thing that was designed before we had any idea of the SHORELINE data and how often people would, in reality, need to be treated. So a study that we don't think matches at all the data that we've seen, and we don't believe that it's necessary for filing. It's a discussion that you have, though. When you have the positive data, typically, you would go to the FDA, have the discussion about what the most efficient filing pathway is, and then use that to sort of guide your hand. But as I said, it's not something that we're pursuing at the moment, mainly because it doesn't seem to match the data that we've been seeing. But Mike, maybe you want to talk a little bit about how the clinical program integrates into the way you're thinking about this, both commercially and strategically for patients?

Yes. Thanks, Stephen. Marc, I know that's what you were going too, is how do we think about this commercially, depending on different outcomes. And let me, rather than just say, hey, what happens at WATERFALL, let's take it, again, as the landscape program. I think that is the easiest way to think about how we think about the paths and what does it mean in different scenarios. Probably the easiest to understand is PPD, right? With SKYLARK, we already have one positive study with SKYLARK. We would have an opportunity to file for PPD 500,000 patients in the U.S. with post partum depression, high unmet need. You're familiar with this, an oral formulation like this and the product profile that we've seen with zuranolone would really be a strong potential. We've heard that over and over again from patients and physicians around the profiles around, well, in PPD specifically. So that in of itself is an attractive opportunity. It allows us to have a franchise with ZULRESSO, give patients multiple options in a disease that they haven't had any choice before ZULRESSO. So we're excited about that as a standalone, and that's the easiest one. I think on the MDD side, when you think about rapid response treatment of the RRT, which is the CORAL study, as Steve said, and then WATERFALL, which is the treat-as-needed on-demand episodic indication, the way we think about this is, as Steve said, they are independent paths, but they're actually synergistic. And the way we think about this is, if both are successful and we file for both and we have an indication that includes both RRT, which is co-initiation with an antidepressant or standalone on treat-as-needed only with zuranolone, if you have both of those options, what that really is, is we're treating the same patients. These are the same patients, the 17 million patients in the U.S. every year having an episode. They're the same patients that we would go after, whether it's RRT or treat-a- needed. But really, what we're doing is giving physicians and patients the option to decide, do they want to use zuranolone as this treat-as-needed concept every 2 weeks, or to treat for 2 weeks if they have the response, as Steve said, and we saw what we saw in SHORELINE, you might go a period of time where you don't need a retreatment, that's a paradigm shift. You've heard us talk a lot about what depression is today. It's a chronically treated disease today. Our end game is to shift that paradigm and really disrupt the way depression is thought about and treated and discussed. We believe patients should only be on medication when they need to, not when they don't. And so that's what that on-demand of that treat-as-needed concept is about. And we think that's -- we really believe that's the end game where we want to take it. But we also know, and you know this well, too, that's a level of change in a marketplace that has been stable for a long period of time that's going to take time to really shift the way people think about depression. So that's where RRT comes in. You have physicians that are very comfortable treating with multiple agents to treat depression. We give them that option now with RRT to say, "Okay, you can start a new antidepressant with zuranolone, get the benefit of the rapid uptake of zuranolone, keep them on that background ADT and get them comfortable that zuranolone has a real place." They'll get real-world experience by using zuranolone in that way, start to build up confidence in the profile that may then lead them to say, I'm comfortable switching to this treatment-as-needed concept, right, the on-demand concept. So it really is 2 different pathways that you're giving patients and physicians the opportunity to pick. Am I more comfortable with RRT and co-initiation? Or do I really believe I can treat this patient on the episodic and treat-as-needed way for zuranolone? And you're going to see a mixture of some physicians will be early adopters of the treat-as-needed concept. Some will want to fall back to, hey, I want to test out zuranolone, get comfortable with the profile before I make that leap to treat-as-needed. So we really love the way these 2 can work together synergistically, not competitively, and it just gives multiple options and will help us shift that paradigm in time.

Right. So I guess in the real world, today, doctors start out with an SSRI. They usually move to an SNRI next. And then that third line, it opens up a little bit for some, right? You could actually spend a little with the brand, some type of -- other times, you have to do a third line where you maybe use Wellbutrin. And then you get to the fourth line, and that's -- all of the patients end up in fourth line. So it doesn't really matter, there's millions of them, obviously. And then I guess my question is, if you're going to use your product, you would use the product for 14 days on top of the SSRI that they're already on or one of those drugs, right? That's what I'm trying to get at. So probably on an SNRI, even though that may not have been proven, or Wellbutrin. I mean how does that work? And then off for 14 for a while? And if the episodic ends up working, and then they can put them back on for another 14 days, maybe in 2 months, means that's how you would anticipate this?

Yes. Those are the options you're talking about, Marc. And Steve can talk to this as a psychiatrist, too, but I'll just quickly elaborate on what you said. You have it right. And that -- again, the RRT is you're starting at the same time, more or less, or basically around the same time, you're starting up a new antidepressant and zuranolone. And you work that through, then zuranolone comes off after 2 weeks and you can continue on that baseline therapy. What the treat-as-needed is, it's what you said, for 2 weeks, you take zuranolone. If you have a response or you're in remission, you can come off and you can stay off. As Steve said, we have the SHORELINE data that 70% of patients only given 1 or 2 treatments of zuranolone over the course of a year. That's, again, where we ultimately want to get the market to is that treat-as-needed concept, where we think that's what's best for patients. But we also have, and Steve can elaborate on this, in the current trials, we allow patients to come in on background ADTs, they just have to be stable. So we already have information of patients using zuranolone on top of a background medication. So again, it's really there's a lot of options here in terms of physicians and patients and how they want to use zuranolone based on their comfort level. But as I said, the end game, we believe, can really disrupt and shift that paradigm just to get it to that treat-as-needed concept.

I would just say with this, the number of patients with major depression, Marc, is just going through the roof right now. I mean all you need to do is pick up the New York Times or any other paper and you see between 3 and 4x the number of people are being diagnosed with depression than have been previously. And the patient population that we're testing, and this is exactly what Mike was referring to, is pretty much everybody, whether you've been on antidepressants and haven't achieved benefit, whether you've never been treated with an antidepressant before, whether a physician is interested in co-initiating this to get that early benefit and then maintain patients. The totality of the program is intended to really be able to articulate options and how to best use the medicine in the event that it's approved in any of those scenarios that are deemed appropriate by physicians. And that's capturing the way and that's the way psychiatrists practice, that's the way primary care doctors practice. So it's why we think it's as important to medicine as it is.

So the one question I have is, the doctors will have data that if you've been on an SSRI for a while and you have some type of relapse or whatever, add your product on after they've been on it a while and your product works, like that's -- they'll have that proof because the reason I'm asking is because in the rapid response study, it's new patients going on Zoloft and your drug at the same time.

Yes. In fact, anywhere between 1/4 and 1/3 of all the patients, both in the 2 of 1 study that was published in the New England Journal of Medicine, in our current study with WATERFALL or even in MOUNTAIN, were on underlying antidepressants and remain symptomatic. So those data are already there. We are now also talking about when you co-initiate, so that's that rapid response. And we also have patients that are either new onset or at the time of initiation of the trial, certainly have just stopped their medicine and would like to try something new. So each of the scenarios you might imagine are contemplated by the data set that we'll have at the time of registration.

Well, I mean there's a pretty consistent message out there. The doctors are excited about having a new mechanism. This is a product that they're most excited about amongst ones, if you really ask, most of them. And the question that keeps coming back is, how is this company going to price this thing? So I've heard in the past from Sage, well, we're going to -- these drugs cost generally $5,000 a year, so we're going to work backwards on how many pills they need to take, and we'll price it per fill that way. Is that still your thought process? Or what is your thought process about how we go?

Yes, Marc, I think we always take -- it is a complex pricing because you have PPD and you have MDD, right? So we have to think very carefully around the level of innovation we're bringing to the market. We want to make sure we're very focused on access for patients. That's priority #1 for us, but we'll always take this thoughtful approach to pricing. And now with Biogen, we'll work through it in the combined companies. And I think you're right, we've always talked about the pricing of the system. I'm thinking about it from an annualized perspective, what's the annualized sort of benefit, right? Because the treatment is going to be different for every patient, some shape or form. So we have to think about this as an annualized pricing strategy from the beginning, and then we can back into what is more the per course. Yes, you'll get down on a pill, but what's the per course, the 2-week price that you'll get back to. Based on things like SHORELINE and the retreatment data that we have, we can start to think about, on average, how often do we think patients will get retreated. Because payers really -- they want that budget certainty. There's a big part for them is generic category, they really want to understand what's the budget certainty. And for us, what's most important is making sure patients have access to the medicines, right? So that's what we'll work through over the pricing strategy. There's more work to be done there. We'll be very thoughtful and practical. But we also -- you've heard Barry talk about this since he's come on board, we're very much -- want to focus on value-based agreements as well. We think that's an opportunity here given the paradigm shift and how this pricing model will be different, how can we create that certainty for the payers, but also make sure access is there for patients. And that's the work that we've got to do going forward.

Right. But for right now, if we're thinking that the product works for -- you need it for 42 days out of a full year, let's just say. We end up if that's your number, you just take 365, divide it by the 42 and that's the cost per pill. That's the thought process you're thinking about right now?

That's where we're at, to the -- yes, you're -- that's the general thinking that we have right now, right. So we got to do some more on that, but that's the thought process and continue to gauge the payers .

Yes. Thanks very much for joining us, guys. I really appreciate it. It's great.

Thanks, Marc. Appreciate your time.

Thank you, Marc. Take care.

All right.