Axsome Therapeutics 3rd Annual Guggenheim Healthcare Innovation Conference

Sure. Thanks for having us, Yatin. Good to be here, and good morning, everyone.

Thanks, Yatin. You're right. We, last week, reported Q3, and if you step back, Axsome as a business now, we have three commercial products, four indications, one recent approval, and we'll get into that is of course AUVELITY for Alzheimer's disease agitation.

The commercial business is growing robustly, and we're very excited about AUVELITY's performance in particular in both major depressive disorder and AD agitation, and what's to come there. I'm sure that will be a focus of the discussion, so I'll pass the details for now. That is, of course, backed by SUNOSI for excessive daytime sleepiness. That is growing very steadily. We're very pleased with the number of patients that's reaching and the state of affairs for that business. Then there's SYMBRAVO, very pleased with, that's our product for the acute treatment of migraine. Very, very strong clinician and prescriber and patient feedback.

That's growing from a volume perspective, and our work there is to navigate the commercial dynamics that are in play and in place. We can talk about those, but we're very pleased with how that part of the business is growing. Then behind that, we have a very, very deep and robust and broad pipeline of innovative products that are 10 programs, and we can talk about those, but heavily weighted towards NDA stage or phase III stage programs, many of which already have one positive phase III trial behind them. So those are all moving in the background.

Of course, much of the focus outside the company is on the performance of AUVELITY, but that part of the business is advancing very robustly and steadily, and 2027 could be a big year, or we expect it to be a big year in terms of potential milestones and catalysts for a number of programs. We'll touch on those. We have a PDUFA date for AXS-12, that's reboxetine for cataplexy and narcolepsy. That is May 1st, so we're a bit over halfway through that review cycle, and that's moving forward as expected, and we can talk about opportunity there. So it's just an amazing time for the business and our history. So frankly, things have never been better from the perspective of the business, and I don't know if, Nick, you want to share anything?

Sure. Yeah. Yeah. Love to talk a little bit about the financials.

Revenue for the quarter was $260 million, surpassing on a run rate, annualized run rate of $1 billion for the first time ever. So exciting time, exciting milestone for Axsome. AUVELITY, our leading product, had $208 million in revenue for the quarter. That was 53% year-over-year growth. That accelerated from 51% year-over-year growth in Q2, sequentially growing 15%. That's led by continued growth in our MDD indication and accelerated growth in our new indication for Alzheimer's disease agitation. So pleased with where that is, and we can talk a little bit about how we're thinking about future growth for that product. Then with our second product, SUNOSI did around $46 million for the quarter, and that was continued growth in that brand. We did have a milestone recognized in the quarter of roughly $8.5 million.

Finally, for SYMBRAVO grew again quarter-over-quarter up to $3.9 million. As Mark said, I have heard very positive things clinically and from a safety profile as it relates to SYMBRAVO. We expect future growth, continued future growth from there. Turning to the balance sheet, $314 million in cash, and this quarter we were actually cash flow positive for the first time. Our net loss was $13 million, but if you take out our employee stock-based compensation expense, which was around $28 million, and take out other one-time things, we were about $5 million-$6 million profit from a cash flow perspective. The balance sheet is looking great. The P&L continues to grow robustly, and as we shared, it is an exciting time right now at Axsome.

Sure. I think the best way to look at future growth is based on the NBRXs. That is the leading indicator by far of how we anticipate growth for any indication. We have said that historically as well when we have done field force expansions, and we have seen that robust growth. A couple things to think about, specifically the AD agitation indication, Yatin, you were asking. We did put a few slides to show, to break out the 65 and older cohort and 65 and under cohort. That is in our slide deck on our website, and you will be able to see that, specifically in NBRXs, they have grown 3.6x within a very short period of time. Maybe just putting some more numbers to that, their NBRXs per month were roughly 1,000 NBRXs from January of 2025 up until every month, up until our approval. So, 1,000 NBRXs per month.

Upon the approval, even prior to starting the detail, you started seeing an increase, and as recently as the end of September, you saw that 1,000 number is now 3,600 NBRXs per month. Taking that into consideration, they will ultimately lead into refills, and that is how you will get your TRX growth. Same goes for, I know this is not specifically your question on AD agitation, but just in totality for AUVELITY, you see the NBRX growth every quarter by month. It is basically 2,400 NBRXs per week. This is for the entire AUVELITY line, 2,400 NBRXs per week in Q1. It went to 3,000 in Q2. It went to 3,550 in Q3, and we are currently tracking at 3,800 NBRXs in October. Seeing that robust growth, that is not included yet in the TRX, right?

The TRX that you have seen, and we have talked about 14% TRX growth sequentially Q3 to Q2, the NBRX increase has not caught up yet into that TRX. That is the future growth that we would anticipate. We are really pleased with how not only the launch has gone, but the expansion has gone. Yes, are there things that we are going to continue to optimize and improve as it relates to the field team? We have more than doubled the team in a very short period of time. That is the work that is going on, that has gone on behind the scenes and continues to do so.