SAGE Therapeutics Inc at RBC Capital Markets Global Healthcare Conference Transcript

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

Question: Brian Abrahams - RBC Capital Markets - Analyst : So maybe starting with just what's, I think, on the top of most people's minds, zuranolone and the ongoing review process. Can you give us any sense, maybe generally speaking, on just how the FDA's review process for zuranolone's been going and your sense overall as to the FDA's

Question: Brian Abrahams - RBC Capital Markets - Analyst : Good. And then I guess your level of confidence overall that the randomized Phase 3 studies that you guys have done plus the SHORELINE studies will fulfill the totality of what the FDA might be interested in characterizing both on terms of the initial effects of the drug and its durability?

Question: Brian Abrahams - RBC Capital Markets - Analyst : Got it. Good. And then maybe speaking of SHORELINE, I know we're going to see some additional data this year. Can you talk a little bit more about what we should expect there in terms of both the CORAL rollover patients who I know will be new, as well as the additional follow-up data from other patients, and maybe how those might be incorporated and interpreted in the broader context?

Question: Brian Abrahams - RBC Capital Markets - Analyst : Great. It sounds like continues to be very consistent there. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 17, 2023 / 3:30PM, SAGE.OQ - SAGE Therapeutics Inc at RBC Capital Markets Global Healthcare Conference

Question: Brian Abrahams - RBC Capital Markets - Analyst : Good. You've started to talk more about how you guys are thinking about market positioning. The physician feedback that we've gotten has been -- in general, treatment-resistant depression patients are the highest need group. And they're really eager to try zuranolone in that population. But those patients are also tough to treat. You guys have talked about prioritizing going into, earlier, first-relapse patients. So can you talk about some of the ways that you can approach this and maybe try to bridge some of those gaps?

Question: Brian Abrahams - RBC Capital Markets - Analyst : I want to dig into the pricing and access element of that a little bit more, maybe starting with pricing. And obviously, free label, you can't necessarily say what the price could be. But I am just curious to learn more about how you're thinking about it, more like how you think about optimizing pricing as you look to position it in early lines, as you've said. What sort of health economic analyses does one need to do to help frame or benchmark what a price could be? How close are you to determining what the optimal price is?

Question: Brian Abrahams - RBC Capital Markets - Analyst : Got it. I'd love to dive a little bit deeper into this and into the value-based pricing strategy. Because I know you guys have talked about it a lot. Can you expand upon that a little bit more? Should we think about this is just like a guaranteed cap for insurers? Is this something that would be structured at the individual patient level? Or is there a way you can seamlessly apply this to the population level? And are there any precedents to think about how this could be implemented? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 17, 2023 / 3:30PM, SAGE.OQ - SAGE Therapeutics Inc at RBC Capital Markets Global Healthcare Conference

Question: Brian Abrahams - RBC Capital Markets - Analyst : Got it. How is the partnership with Biogen going? There's obviously been some leadership changes over there. I guess, how has that shaped or changed things, if at all? And what are each company's roles with regards to the regulatory and review process, commercial and pricing planning, and additional development work?

Question: Brian Abrahams - RBC Capital Markets - Analyst : Got it. Any changes at all since the change in leadership there, just in terms of the way the program is being executed on, prioritized; potential for additional expansions? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 17, 2023 / 3:30PM, SAGE.OQ - SAGE Therapeutics Inc at RBC Capital Markets Global Healthcare Conference

Question: Brian Abrahams - RBC Capital Markets - Analyst : How do you think about resourcing the launch and gating spend? And what beyond just, I guess, approval would be sort of the gating factors for expanding out? Because obviously, there's a balance between getting it right early on. Because you only get one chance to launch. But you also want to be careful about overspending at risk. I'm curious how you think about that balance and kind of how these factors shape your year-end cash goals.

Question: Brian Abrahams - RBC Capital Markets - Analyst : Got it. Assuming that this is approved and -- successfully approved and then (inaudible) schedule in '24, 2024 is going to be a big year potentially for zuranolone. What types of additional details on the launch plans and expectations should we expect as we get closer to some of those time points? And is this the type of products that we should expect to have like a front-loaded launch, where the docs and patients are just so eager to try it out right out of the gate? Or is this something we should be thinking about as having a more gradual uptake as you get it into physicians' hands through sampling, get them to have more experience using it in their earlier-line patients, and it's just going to take time for that and for formulators to carry it?

Question: Brian Abrahams - RBC Capital Markets - Analyst : I have more. Please don't worry.

Question: Brian Abrahams - RBC Capital Markets - Analyst : Got it. Maybe we can talk about some of the rest of the pipeline, 324, ongoing Phase 2b KINETIC 2 study. Can you talk about just overall enrollment, conduct, and your expectations for that trial?

Question: Brian Abrahams - RBC Capital Markets - Analyst : Great. And then on 718, I think we're going to start to see more data over the next 12 to 18 months from that program. I'm just curious, like, how you guys are thinking about balancing safety and efficacy for something with an NMDA modulation mechanism and how you're thinking about the role 718 could play in Alzheimer's, given that there has been renewed focus on that. Obviously, this is more -- it's different from a beta amyloid antibody in a lot of regards, mechanistically and approach wise. But just -- you're already partnered with a company who is going to be launching an Alzheimer's drug. So I guess, how do you think about that aspect as well? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 17, 2023 / 3:30PM, SAGE.OQ - SAGE Therapeutics Inc at RBC Capital Markets Global Healthcare Conference

Question: Brian Abrahams - RBC Capital Markets - Analyst : Great. And then maybe kind of wrapping up on the pipeline front, zuranolone is sort of a pipeline and a product and a lot of other places you can take it. What are your latest plans for next indications for zuranolone, such as in bipolar or anxiety? Have you made any decisions internally that you can share about what you want to pursue or what your most -- maybe talk about what you're most excited about. And then in addition to other indications in the US, anything you could say about the international opportunity for the drug as well. I know that's more in Biogen's domain, but any perspectives you might have on 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. MAY 17, 2023 / 3:30PM, SAGE.OQ - SAGE Therapeutics Inc at RBC Capital Markets Global Healthcare Conference

Question: Brian Abrahams - RBC Capital Markets - Analyst : Great. It looks like we're out of time. But Kimi, Chris, Al, great to catch up. And thanks again for being here.