Kevin Mak on X
$CMPS Update on Compass Pathways (1) We're currently waiting for the company to complete its rolling NDA (New Drug Application) submission to the FDA, expected this quarter. The FDA has already started reviewing portions of the application. Reminder that Compass has been granted both rolling review and a Commissioner’s National Priority Voucher, which targets a review period of roughly 1–2 months once the complete application is filed. That timeline isn't guaranteed, but this is one of the fastest review processes available. It doesn't guarantee approval either, but it clearly shows that the FDA is prioritizing getting this drug reviewed. (2) The company presented at the STAT Summit, and the CEO said they will “go slow before we go fast.” My guess is that's being interpreted in a slightly negative way, suggesting that the initial drug launch won't necessarily get quick traction. As an investor in the company, my first reaction is that I don't want to hear that. I want to hear that revenues are going to explode out of the gate. But just because I want to hear something doesn't make it true. Taking a step back, Compass has taken a deliberate approach to developing this drug and preparing for launch. The CEO's point was that bad early experiences for patients or providers could set back both Compass and the broader industry. Getting those first experiences right matters. I think calibrating expectations and not being overly promotional is a smart choice. That could mean a more measured initial revenue ramp, and I'm fine with that if it sets them up for sustained adoption. At the same time, the company has been preparing to scale. Its strategic collaborations span more than 1,000 sites, including Neuronetics/Greenbrook and other established treatment networks. There is already substantial infrastructure to build on. I think this is the correct approach. (3) The company has now explicitly communicated expected annualized drug pricing of $50k–$65k per patient, based on an average of roughly three doses per year. That implies approximately $17k–$22k per dose, before clinic administration and monitoring costs. The final launch price hasn't been announced, but management has given us a much clearer pricing framework. In terms of M&A, which isn't part of my base case, my guess is the best window is after the label is set. At that point, a potential buyer will know much more clearly what they're buying and how it can be commercialized. From a positioning perspective, I think completing the NDA submission could bring new investors into the stock. It removes another layer of timeline uncertainty and puts an FDA decision much more directly in view. My guess is that matters to investors who have been watching but haven't wanted to get involved yet. My long-term outlook on the stock is unchanged. I think they get a good label, and I think concerns about the length of clinic visits are overblown. The market is massively underserved, and Spravato (which I believe COMP360 will offer a more attractive alternative to) is already selling at roughly a $2.5B annualized rate. My PT remains $45, and my full write-up is below. https://t.co/rVZOU3yIz6 Disclosure: Creek Drive and its affiliated funds holds a positions in CMPS. Views expressed are current opinions for information only, subject to change and are not investment advice or a recommendation to buy or sell any security. Investing involves the risk of loss and past performance is not indicative of future performance. See the disclosures link in my bio for more important information.
