Great. Thanks very much. Super happy to be moderating this chat with the COMPASS Pathways team. With me is Steve Levine, Chief Patient Officer, and Lori Englebert, Chief Commercial Officer. COMPASS just got the NDA submission in, so congratulations on that. Happy to kick it over to whoever wants to start, but I think the most interesting conversation here really just sort of centers around what you're doing right now with launch prep and stuff like that. So, feel free to take it away.
You want to start?
Yeah, I'll start and, of course, make the obligatory statement that we may make forward-looking statements, so please refer to the Investor page of our website.
Can I just, since we know each other so well. I saw a really funny thing online today that said, "Biotech companies lead off by saying, 'We're making forward-looking statements,' and AI companies lead off by saying, 'We are curing cancer, all cancer in the next 10 years.'" I was like, "That is awesome".
Nonetheless.
Do you want us to jump in?
This is for SEC filing.
Sure, that's fine. But anyways, it just reminded me of it.
We're going to cure cancer.
We're lawyered up much more than the AI companies are, right?
Yeah. Apparently, yeah.
That's all.
With that, go ahead.
Yeah. First, for those that aren't familiar with COMPASS Pathways, we are a biotechnology company that has been developing a synthetic proprietary formulation of psilocybin that we call COMP360. Earlier this week, we announced that we have completed the submission of our NDA, which we had already been submitting on a rolling basis and has been reviewed on a rolling basis, for our lead indication in treatment-resistant depression. This represents two large phase III studies and supported by a large phase II, in which we have demonstrated a generally safe and well-tolerated profile with a very highly differentiated set of efficacy outcomes with very rapid onset of effect, detected as of the first measured time point, 24 hours after the first administration.
And with data now out to up to 52 weeks, demonstrating that with just up to a few administrations in a year, there may be durable efficacy with a frequency of treatment that we've never seen before. We are very excited for the ongoing review of this application under our national priority review voucher. This potentially is a contracted review period, and with that, we've been very busy preparing for commercialization, which I will hand over to Lori.
Yeah, you want me to just keep rolling?
Please.
Before we keep going, I just want to say, if Steve and I act like we share a brain, we do.
Because we do.
He is a real psychiatrist. I play one on TV. You can debate who is the better one up here. We will definitely be handing back and forth to each other, so just FYI. As Steve's mentioned, we have this product that we are extremely excited about, one, because it is in treatment-resistant depression. Treatment-resistant depression currently has only one pharmacologic product approved to treat treatment-resistant depression. The reason that this is important is that there are 55 MDD products being used on an annualized basis every year, and there have been plenty of those that have tried to prove efficacy through clinical trials in a TRD patient population and have failed.
It is important to understand the value of what we have produced in TRD and the replicability of what we have produced. We have had a very large phase II-B and two very large phase IIIs.
We have treated over 1,000 patients with COMP360 in treatment-resistant depression, so we understand the safety and efficacy profile of this product really well. The thing that I think is most remarkable, and if you ask our Chief Medical Officer, Guy Goodwin, what he is most impressed about the data, it is that it is remarkably consistent. All three trials, the efficacy you see within 24 hours in a patient population that has otherwise not had efficacy. The average duration of depressive episode in our clinical trials is somewhere between two and four years.
Imagine being depressed for that long with no effects, and then you have one treatment, and the next day you wake up, and you are feeling remarkably better. That durability can last anywhere from six months to 12 months based on the data that we are looking at now, with just an additional treatment or two.
We have been preparing for launch. We have said very publicly for some time now that we would be launch-ready by the end of the year, knowing our timelines for when we were going to finalize the NDA submission or about the approximate time of finalizing it, and what the national priority review voucher could afford us, and that is what Steve mentioned, is that contracted timelines to approval.
Great. As it relates to the NDA review, maybe talk about how much of this has sort of already mostly been done already with the FDA. What specifically have you deeply engaged upon? With the voucher, having this expedited review time, it still kind of leaves things open-ended. Do you feel like the FDA is going to actually really act like that quickly within the next couple months?
With the voucher, there are two things, two benefits with the voucher. One is a more active engagement with the FDA. Under normal timelines without a voucher, the FDA is, you request a meeting, 30 days later they get back to you and say, "Yes, you can have a meeting at some point in the next 60 days." The time periods are extremely elongated if you request a meeting for some specific reason. Under the voucher, the communication is active. It's almost daily. We are in communication with project manager all the way up through the top of the division in a very active and engaging way. We get information requests. Part of the review, part of the voucher commitment is that you respond to information requests under the review within 24 hours, which is not heard of under normal review time periods.
That's the commitment that the company makes, and we have been adhering to that. What we can tell, they have completed a lot of the review along the way, CMC, pre-clin. They've never said, "We've completed," but we can tell based on information requests that are coming in where we believe they may be in their review. We feel we have done everything possible to give them the responses that they need to be able to approve in an expedited timeframe if they so wish.
Just one additional thing to add is that along with what Lori just described about the cadence of interaction with the review division, with the FDA, through the CNPV, is that even prior to us receiving that national priority review voucher, we had already had alignment with the Division of Psychiatry on submitting data as soon as possible. They've been very encouraging all along for us to get data in as quickly as we can, because they've been interested in being able to start their review as quickly as possible. Indeed, as Lori said, based upon their information requests, they certainly have.
Okay. That's great. I don't know how much you'll comment on it, but I got to give it a try. There was obviously this news in the past week or so around another player in the space, the Usona Institute, completing an NDA submission for their psilocybin. It's a nonprofit, so there's this whole question of, like, how might they price. From your perspective on the commercial side, like, if this does come to market at a lower price, how are you thinking about the setup for COMP360 and your confidence that you can kind of position it the way you always intended to commercially?
Yeah. The confidence is still high. First of all, they did receive a national priority review voucher as well, so this is not a surprise to anyone that they are moving forward. It is important to note that they are studying their psilocybin product in MDD, which again, very different patient population than treatment-resistant depression. It is also worth noting that they supposedly have only performed one phase III clinical trial. Part of what the FDA has stated in the past is that they are not going to lower evidentiary standards for psychedelics, nor would we want them to. We like to say we're in this for the long run. We feel an enormous responsibility, potentially being the first to market, in making sure, again, we've treated over 1,000 patients.
This is extremely important for making sure that patients feel safe as well as physicians feel supported and secure in what they're prescribing. Then if you translate over to payers, so to answer your question directly, again, MDD versus TRD is very different. With an MDD product with payers, again, 55 of them are already currently being prescribed right now. Five of them are branded, and by the time we get to market, there may be a potential other one that is branded. Those products have to negotiate to get moved up earlier in the line because the other 50 products are generics and very, very cheap for payers to cover.
With treatment-resistant depression, the important thing to note is, again, what I mentioned earlier, is that proving efficacy in this patient population, which payers know provides a disproportionate burden to the healthcare system once you hit TRD, becomes very important for proving the value that you are bringing to the healthcare system. So from a pricing standpoint, and for clarity, we have not set pricing yet. That would be irresponsible to do unless you have a label and you know what you're pricing to. But we certainly are thinking how the other product that is priced in the marketplace is priced at right now and what that might mean for us. So we will price to the value that we're going to bring to the healthcare system with this patient population.
Okay. Okay. As it relates to the distribution model for COMP360, maybe talk about how you've prepared, I don't know, for lack of a better word, the cost it takes to launch in this space, right? There's the SP, they're supporting the REMS, there's other sort of dynamics with supporting these practices. One, how well prepared are you, and two, how replicable is this model for someone else, I guess?
Unfortunately, as the Chief Commercial Officer, it does pain me a little bit to say this, it is extraordinarily expensive to commercialize a product, especially a product that has a REMS associated with it. The requirements that the FDA have alone for being compliant with a REMS is an incredible financial burden.
So what does that look like in a literal sense?
Like, as in dollars?
Well, sure, or just like, what are those, yeah, like those requirements? Like, what does that mean on a day-to-day basis?
On a day-to-day basis, first of all, you have to have a REMS provider. You have a third-party logistics provider who is setting up your REMS. It is mapped. Every site will need to be REMS- certified. Patients will need to be REMS- certified. The specialty pharmacies will need to be REMS- certified. All of that has to be tracked and is auditable by the FDA. Because of that, you have to maintain a very high level of compliance in making sure that that is not being abused or not adhered to, because that comes back on the company, not the sites. You have to put forth quite a considerable amount of effort, both from a human resource, but also financially.
On top of that, specialty pharmacy, because this is a product that is a scheduled product and we will be white bagging it, so to speak, through specialty pharmacy. We will also enable buy-and-bill, which is specialty distributors. There is a portion of your price that gets paid to the specialty pharmacies. It's a percentage of your price that gets paid to these specialty pharmacies and distributors. Of course, the higher you price, the bigger their cut, and so they like that quite a bit. It does become very, very expensive because they are taking a cut of your price and what you price. All of that goes into the calculation of how you price a drug.
On the provider side, this needs to be easy for them, right? In order for them to actually get the drug to administer to patients, in order for them to comply with the REMS that they do not want to violate, in order for them to navigate some of the administrative requirements to actually treat patients, this needs to be easy for them. Psychiatrists, and I'm speaking as a psychiatrist, they don't like to take on complex things, complex systems, move across different systems in order to deliver care, et cetera. That means that there's a tremendous amount of work, set-up, infrastructure, cost, et cetera, associated with creating all of that structure so that the providers never knew what went into that. They just know that it's an easy button and they're able to treat their patients.
How do you make it easy? How much of that burden can you take off their hands?
A lot. It depends on how much the company is willing to take, right? It usually starts first and foremost, and Steve will certainly chime in here, but first and foremost, there are two golden rules of commercializing a product. One, if a patient can't afford it because the drug's not reimbursed, they're not going to take it. Two, especially in this situation, and it is still relatively new in psychiatry, with the time period that needs to be billed to payers to get reimbursed for their monitoring and support time, if they can't get reimbursed, they're not going to prescribe it. We knew that. We've known that for a very long time. It doesn't take a very smart individual to know that this is going to prohibit uptake.
We have been highly focused on making sure that we are prepared to make it, quote unquote, "easy" for patients. You can do that in the form of patient assistance programs, patient support programs, affordability programs. You can do that with, and we are planning to do with having a very robust field reimbursement team out, almost handholding the sites to make sure that they are coding correctly and getting reimbursed in any way possible. Obviously, you'll do that with your sales force team and that field team that you're-
Makes sense. Once COMP360 is approved, assuming it's approved and it gets rescheduled, then what in those coming months as it relates to the practice adoption? What I'm kind of referencing is, let's say a physician wants to prescribe it, wants to use it. Will all of this be in place where they can use it and bill for the monitoring time at the outset? Or are some of these things still going to be kind of working out?
I will start and then I will toss it to Steve. There is a reason why we have said we would be launch-ready by the end of the year, and that is we need to flip the switch. By flipping the switch, it will not be perfect. No launch ever is. I am just going to let you know there will be some figuring things out as you go through. This is not unique to COMPASS or this product launch, but we are going to do everything we possibly can to make sure that we maximize the time and understanding of when we get an approval to when we get DEA rescheduled, which means that is when we actually can, the product can be prescribed. It is not just federal. The states also have to reschedule as well.
Once all of that happens, we will be able to start booking sales or booking prescriptions through IQVIA that everybody loves to watch.
Will that track accurately?
It will.
Well, as accurately as IQVIA tracks.
Okay. But some drugs, it is super accurate, and others, there is all this variability in the capture rate and things like that.
Yeah, that is right. And we have done everything we possibly can, especially through the specialty pharmacies, which is where the capture rate will be at. The ones that we have chosen are ones that will report.
Okay.
On an accurate basis.
All right. That will be a fun Friday routine.
Yeah. Every morning at 6:00 A.M. Love it.
Yeah. Okay.
There is one important component that I do want to toss to Steve, and that is around the coding time. The second thing that will prohibit any uptake is that is sites getting reimbursed, and Steve's done a tremendous amount of work for many years.
Yeah. Is that ready at this point and fully ready to go?
Yeah. There's the coding and reimbursement considerations. There's also physical infrastructure, workforce, the preparation training of that workforce, and other implementation support. This all kind of goes hand in hand, both with our direct efforts as well as third parties that are very interested in supporting sites to implement this and coming psychedelic treatments, we really are kind of building a 3D surround sound of that. Starting, because your question was directly about coding there, but then filling in around it, we did do work a few years ago to secure new Category III CPT codes that are specific to the reimbursement of the monitoring period for the in-office administration of COMP360. Those codes are in place. They are a very good fit for the services that will actually be provided, so that is ready and waiting.
They are not yet progressed to their Category I form, which is where they receive evaluation from CMS and become permanent codes. Along with what Lori was saying earlier about our field reimbursement support, we will help sites, number one, understand which codes they can use today to make sure they're reimbursed for their services and potentially supplemented by patient support programs in the early days, but then also making sure that they attach these Category III codes to their claim submissions so that payers are paying, so that the AMA is aware that these codes are being used, and that helps to progress them to Category I.
Around that, in terms of any other long lead time items, if you will, fortunately, the physical infrastructure is one-for-one with what these sites already have in place, those that are delivering SPRAVATO and other interventional psychiatry treatments today, those that require in-office delivery, multi-hour monitoring. A room that is being used for those treatments today will flip immediately and become a COMP360 room on approval. Similarly, the workforce that currently works as a team to monitor multiple treatments being administered and require monitoring simultaneously is one for one, and that is already in place. They will need to be trained. That training will be embedded within our REMS so they know what is the content that they need to know.
Alongside of that, we provided grants to training organizations so that there are examples of best-in-class trainings for how this workforce gets prepared to understand how to support these patients. Simultaneously, we also made materials available publicly on request so that anyone can develop their own training so that there is no access bottleneck as far as people being concerned about the time or cost of satisfying any training requirements. Additionally, I mentioned this is sort of a 3D surround sound. We are creating all kinds of optional educational resources for providers, for patients, for the field, really to understand any of the aspects necessary for them to feel comfortable delivering a new treatment.
Yep. Okay. Do you have an expectation for what the first couple quarters could look like from a demand perspective? We know the patient demand is there, but from an actual, like, how this plays out at the physician practice level.
Yeah. I will fully admit that we do talk out of both sides of our mouth when we talk about no one has ever done this before.
That is the game.
Taking a page out of the AI groups.
Yeah.
We do talk about no one's ever done this before a lot, and we will be first to market, and this important new class. All of that is 100% accurate and true. What we do talk out of both sides of our mouth on is that the infrastructure is already established. When SPRAVATO launched seven years ago, there were only a handful of sites that could actually administer these multi-hour treatments. Now there are 8,500, growing at about 500 a quarter. By the time we launch, there's likely going to be well over 9,000 of these sites that will be capable, based on the infrastructure that Steve just described in terms of workforce, room configuration, ability to monitor patients for multi-hours. That will be well established and in place. That's the easy part, right? That infrastructure there is easy for us.
What's different, and Steve hit on this a little bit, but just to reemphasize the importance, is you are actually treating a patient who will be, it's a psychedelic, so I'm not going to tell you something you don't know, in an altered state for a period of time. Making sure that patients understand what they're about to go through is incredibly important so that they don't have anxiety and they don't interrupt the experience and the treatment that they are having, and making sure that sites are prepared to the training, the grants that Steve just mentioned. Extremely important to make sure that sites understand what patients are going through and how to support those patients. Now, for the most part, patients are, and Steve does a great impression, so I'm going to ask him to do it, how a COMP360 patient looks.
Right now?
Do it.
Ready? I've been working on this impression. Here we go.
Exactly. For the most part, it's an inward experience. It's very silent. We've published papers and data on this where over 80% of the experience is completely silent. It's usually a little bit of talking in the beginning before the onset of action, then as you're coming out would be your bookends. But during the experience, it's largely silent. But sites need to be prepared to understand what to do and how to support patients through this. All that will take some time.
Can I ask a question? We talk about SPRAVATO and how concentrated it is. How many of the clinics that are heavy users of SPRAVATO have been participants in COMP360 or other psychedelic clinical trials?
Most of these sites haven't been trial sites.
Kind of what I would have thought, right?
Yeah.
It's usually the academic sites that are more experienced.
Correct.
These are different.
Yeah. It's difficult to both have efficient clinical operations delivering clinical care.
And do research.
And also do research. Most sites don't do that, at least at scale. However, through our strategic collaborations, which we've been engaged with over the past few years, which, as a reminder, are a number of differentiated sites of care where people living with TRD receive their care today, inclusive of interventional psychiatry clinic networks, which are already delivering high volumes of SPRAVATO, hospital systems, community behavioral health, integrated models, decentralized models, et cetera. Those represent more than 1,000 sites that are delivering SPRAVATO today. And that really has been an incredible opportunity to share information and to understand any potential barriers to uptake in those settings of care and how they prepare to deliver this treatment.
Yep. Okay. Let's see. One more question just on this dynamic of a competitive psilocybin. I know I'm jumping around a little bit, but just to be clear, is it extremely unlikely, no chance that there would be a shared REMS for all psilocybin products? Is that possible?
I mean, right now, anything's possible.
Yeah.
Yeah, I mean, that's a little bit hard to.
Just trying to think about the barriers to entry to the model and things like that, right?
Even if it was shared, each company would have to maintain their own infrastructure for.
Is that right?
For doing it. Therefore, shared cost or they have their individual costs.
Okay.
It's not going to be. It would be cost prohibitive.
It's not like a piggyback kind of thing.
No.
I get it.
No.
I get it. Okay. Anything else as it relates to the launch and how you guys are sort of going to be judging how successful it is on your end or setting expectations for us of when we should start to say, "Okay, this is going to be ready to ramp and inflect a little bit more"?
Yeah, so let me walk you through the timelines just to make sure everyone's kind of clear on expectations.
Yeah.
So, on Monday, we announced the NDA submission was in. Technically, that should start some clock with the FDA in terms of review period. We, and this is honest, we do not know if we're going to get an acceptance with a PDUFA date or if we're just going to get an approval.
Have people gotten PDUFAs with vouchers?
They have gotten PDUFAs, and they typically are based on. If we have breakthrough therapy designation, it would be a priority review, so the PDUFA would be six months out in the future.
Right.
Other companies have done the same thing. What the FDA does is they beat that timeframe to the one to two month timeframe that they have committed with a review voucher, and they say, "Great job, FDA. We've achieved our goal here." So, we may get a PDUFA date that's out six months in the future at some point, and then they will work to beat it, which makes it very hard from a commercialization standpoint, just so you guys know, to just have a random approval drop in your lap one day. But we are ready. So that could happen, or there are incidences with the CNPV that you just get an approval at some point in the next couple of months.
We expect to have some communication with the FDA to get a little more understanding there, but right now, we're sitting in a We just announced it on Monday, so.
Yeah.
We don't know what that PDUFA date or what that timeframe looks like. Once you get an approval, then that kicks off the statutory 90 days for DEA to reschedule. It's important to note that back in April, there was an executive order encouraging the DEA to reschedule in a more timely fashion, psychedelics in particular. Now, hopefully, as comfort to all of you, it is certainly comfort to me, even if I wasn't in the pharma space, the DEA does not engage with manufacturers. They don't, and you wouldn't want the perception of manufacturers influencing DEA decisions for scheduling. They do not engage with manufacturers. However, we have done everything we possibly can to make sure that they have what they need so that if they want to expedite, and they can, they can do that.
We have submitted, or we submitted our eight-factor analysis way early in the process, which usually doesn't come until the end, and that kicks off that timeframe for them. Then the states need to reschedule. Right now, we're currently sitting with about 45 states that will intend to reschedule within 30 days of the DEA, and the other handful of states, we're obviously doing a lot of work there with them to get them to expedite their timelines as well. But that represents about 93% of the population of the U.S.
Okay, great. And then after that?
After that, based on all the things I mentioned earlier about the importance of training, getting sites REMS -certified, all of that, obviously, we're going to expedite as much as possible in that timeframe between approval and DEA rescheduling, but a lot of that will not kick off until that final scheduling is done. Can't legally kick off until that final scheduling is done. We will obviously be doing everything we possibly can, but I would not expect a real start of revenue to start happening until probably the Q3, or late Q2.
Yeah.
Q3, next year. But I do also want to caution, we are not expecting, even though there is demand, I mean, I've mentioned in plenty of the earnings calls, the studies we are doing, the demand, the willingness to prescribe, demand from patients is off the charts. It's not going to be a massive bolus and everyone's just going to start prescribing. They're going to need to prescribe, they're going to need to make sure that the experience is good, that they feel well-trained and supported, they can get reimbursed for their time of that six hours that they're spending with a patient, and then they will start scheduling again. So that ramp will be pretty slow, but then we expect it to ramp up pretty quickly.
Okay, great. We have 30 seconds left. Anything else you guys would like to add?
PTSD.
Yeah, so that was.
You want to just.
Yeah.
We all know TK.
Like you said, we share a brain.
You got some data. Just maybe talk about that anyway.
Of course, we're incredibly focused at the moment on the coming approval of our product and then commercial launch. But yes, PTSD. We have a late-stage trial that is underway. This will be in up to 300 or around 300 participants. This is an area where there is tremendous unmet need and potentially even a larger opportunity than TRD itself. 13 million people who currently have only two options, which are two old generics that are modestly effective at best in PTSD. There hasn't been an approval in about 25 years in PTSD.
Based on what we saw in our phase II study, which was a very well-tolerated profile, and an efficacy signal that was incredibly exciting, we are moving forward as quickly as we can there to meet this major need for patients. Really excited for the potential. I mentioned it's a late-stage study. It is designed to potentially be registrational with a single trial. Really excited about that as well.
Great. Awesome. Well, best of luck. Thanks for taking the time.
Thanks, Paul.
Appreciate it.
Really appreciate it.