SAGE Therapeutics Inc at Stifel CNS Days (Virtual) Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Paul Matteis - Stifel Financial Corp. - Analyst : I don't think we need any background. I think folks know what you guys are about. So maybe we can kind of get started. And obviously, probably somewhat limited on what you can say, but maybe, Jim, could you just sort of speak to how the regulatory process is going for zuranolone? We're really surprised that there's not an AdCom. I mean, that's certainly a good thing. No AdCom, no priority review is usually great, but were you surprised?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Yes. Well, congrats on all the progress. PDUFA, it's not that far away now. Obviously, far away enough that there's no labeling discussions or anything like that. But I guess to me, one of the main questions for the label, and it does have some downstream commercial implications, is what the FDA determines is appropriate for the dosing interval and any restrictions on that. And then two, whether they let patients get four, five, six courses of therapy in a year if they want to, given that there's not a lot of safety data there. How do you think about these two variables, Jim? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 29, 2023 / 3:00PM, SAGE.OQ - SAGE Therapeutics Inc at Stifel CNS Days (Virtual)

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay. All right. Honestly, I don't really know what else to ask about the regulatory process. I mean, there's a million things that get asked, but not much you can say. Is there anything else you'd like to add as we gear up for an approval decision?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Yes, okay. And you expect, post approval, assuming it comes through that there would be 90 days for DEA scheduling. They would likely take all 90 and that it would likely be scheduled for by functionally default, is that right?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Great. That makes sense. All right. Let's talk about the commercial side. Chris, one of the main questions I get from investors is just like how do I model this drug? By year three in my model and [by modeling all NRX] because patients have gotten it, it's almost the drug's strength that makes it more complicated to forecast. When you walk this through with folks, how do you think about this issue?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Makes sense. Based on the SHORELINE data, Chris, do you expect -- I would imagine you've got some really long-term data now. But do you expect patients to come back from year two or even year three for another course?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay, makes sense. As it relates to the line of therapy this drug is used in -- again, the other major investor concern that is shared with me about just how to model zuranolone is that the drug has largely been studied in early depression. But looking at where Axsome's drug is being used right now, it's all in TRD and insurance companies. They don't care, right? Like they're just going to push the expensive thing to be used after a typical antipsychotic, right? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 29, 2023 / 3:00PM, SAGE.OQ - SAGE Therapeutics Inc at Stifel CNS Days (Virtual) Now I guess, with zuranolone, because of the way it dosed, it may not be the best CRD drug. So what work have you done, Chris, and what confidence can you share that this is going to be a drug that's actually going to be reimbursed earlier in the treatment paradigm than, say, the average new branded antidepressant medicine?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : What would a sample VBA look like that would enable you to kind of be used after one failure -- one-line failed SSRI? Is that realistic?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : And how long do you think that would take? Do you think you're going to need a year or two on the market to kind of show them volumes to get it there, or could that be early on?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay. Great. What can you say about pricing, and how you're thinking about that and how that fits into this?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay. Do you ever -- this might come -- feel like it's out of left field, but do you ever hear any concern from payers on price per pill?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Yes. I'm making it up like if drug cost a few thousand -- no? Some investors bring that up.

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay. All right. This is great. As it relates to what a sales force looks like and how that looks in tandem with Biogen and things like DTC, what -- can you at least paint a picture over the next year what the infrastructure might look like and what's Sage's obligation within that?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay, great. Kimi, how do you think about cash runway in your ability to -- I guess, Biogen wholly owns this drug, right? They would have -- they have some capital constraints, but they're Biogen, right? They've got lots of revenue coming in the door. They could really blow it out. How do you think about that from your seat on what you're going to spend on this launch and how that runway balances with milestones you can earn and things like that? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 29, 2023 / 3:00PM, SAGE.OQ - SAGE Therapeutics Inc at Stifel CNS Days (Virtual)

Question: Paul Matteis - Stifel Financial Corp. - Analyst : How much money could you earn on just regulatory approvals and first commercial sale and things like that?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay. And that kind of supplants any approval milestones, is that right?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay, that's the next one. Okay. Makes sense. All right. Great. Well, maybe in the last five minutes here, we can talk briefly about 718. I'll turn it back over to Jim and -- I guess, yes, where are you with the various studies, and when might we get some more data here?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay. Is there a way you could rank order the strength of the mechanistic rationale? I know some of it -- it somewhat stems right from observations in Huntington's patients. Can you speak to that?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay. NMDA is such a cool system, but it's so complicated. And I think one thing that I've had trouble with is the directionality of it, in like which way you want to modulate. And I think Namenda, right, is a weak antagonist, but it's maybe modestly procognitive. How does the PAM approach sort of fit into what else has been tried out there?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : All right, awesome. All right, any final comments before we wrap things up?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay. Great. Congrats on all the progress and good luck.