COMPASS Pathways Plc American Depository Shares CG 46th Annual Growth Conference
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Good morning, everyone. I'm Sumant Kulkarni, a senior biotechnology analyst here at Canaccord Genuity, and welcome to the second day of our 46th annual Growth Conference. We're really pleased to have COMPASS Pathways here with us today. They are a pioneering company in the mental health therapeutic space, and it's a really interesting time for the field that they play in. As I said, they are pioneers. There is a product called COMP360, which is psilocybin. It's passed two phase III trials with positive results for treatment-resistant depression, which is a high unmet need indication. We're happy to have Steve Levine, who's the Chief Patient Officer, and Lori Englebert, the Chief Commercial Officer. They're the people in the hot seat right now, given where the product is at from a regulatory standpoint and from a potential commercialization standpoint as well.
In the audience, we have Stephen Schultz, who knows everything about the company as well. Thank you everyone for attending, and we'll keep this interactive. There will be a mic going around the room, so if you have any questions, please feel free to raise your hands, and we'll get a mic across to you. With that, I'll just ask you guys to set the stage a bit with a few opening remarks, and then we'll have an interactive session.
Thanks, Sumant. Good morning, everyone. First, just a disclosure, we may be making forward-looking statements during the presentation today, so please refer to our website and SEC filings for risk factors.
Nicely done. Thank you. Hi, everyone.
Thanks, Sumant, for having us. I will just open up by saying, and echoing Sumant's comments, that this is a very exciting time for COMPASS and COMP360, as we are, as some may say, barreling towards a potential filing date, and potential approval. We had earnings last week, where we reiterated that we will complete our NDA filing in Q4 of this year. As a reminder, we have received, back in April, a national priority review voucher. We have also had agreement with the FDA that we would perform a rolling submission and review, and we also confirmed that the FDA is actively working through our early submissions. We have already started submitting modules, and the data is flowing into the FDA as we speak.
Whereas we will not have complete clarity on PDUFA dates and things like that, I can speak to you guys in generalities around what we expect in terms of launch, after the approval or after the filing is complete in Q4. The way that we are thinking about in terms of timelines, and Sumant, I will just go ahead and address that because I know it is a big question for everyone right now, is after the filing, the FDA may or may not take the typical, traditional 60-day acceptance period. That is an uncertainty with the priority review voucher, but we are hopeful that they can beat some of that timelines, given the fact that they are actively reviewing right now. Once that happens, they will likely give us a PDUFA date that is consistent with a priority review, given we have Breakthrough Therapy designation.
We are expecting a PDUFA date that seems a little bit outside of the 1-2 month review target that the FDA has set with the voucher, but that they will most likely try and attempt to beat that. Tiffany has stated publicly that the target is 1-2 months, but obviously that is a target. It is not a definite. There are examples out in the space. Foundayo with Lilly went for a 50-day approval. The FDA is actively working to try and beat the 1-2 month target they have stated. With that, we also have a Schedule I product that we are working with. We will need to go through DEA rescheduling after approval.
If everyone remembers, the executive order back in April stated that the DEA and FDA should work closer together to expedite that timeline of review for DEA rescheduling. That is also a bit uncertain in terms of timing. Traditionally, the DEA has 90 days to reschedule after an FDA approval, then the states will need to reschedule. Timelines from filing to approval feel very good for us to reconfirm that we expect a launch somewhere in the first half of 2027. As we get further along in our discussions with the FDA and closer to finalizing the filing, we hope to firm up some of those into a much tighter timeline. We are very excited. The market is excited. By market, I mean the physicians who will prescribe and the patients who will receive it.
We are having very active conversations with payers right now. We are looking forward to commercializing this, getting it to patients.
I think the room is excited. This is a nice turnout for an 8:00 A.M. fireside.
Yeah. That is great. I think you answered all my questions there.
I can keep going if you like.
We value sufficiency. The FDA, timeline-wise, we know this is just a 1-2 month target, right, quote, unquote.
Given that and given DEA rescheduling is also strongly suggested by the executive order, there is nothing really that mandates that. How conservative do you think a 1H 2027 timeline is for a launch for you?
I think 1H 2027 feels very good for us. Again, obviously we are working to make sure that we can expedite this as much as possible. We have stated frequently that we would be launch-ready by the end of this year. There is a very important nuance to launch-ready versus launching, and that is if we were to receive an approval, given the uncertainty and the fluidity with our timelines, we would be ready. That is what our intent is. We continue to be launch-ready by the end of the year, but the likelihood is that given the uncertainties around the 1-2 month review period, if there is an acceptance period, how long the DEA will actually take to reschedule. That one half feels very good and solid for us.
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