The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Sure. So I'll just start off with a big picture question. You've been at Sage for some time now, first as a director, now as a CEO. You just had a recent
stock purchase. Could you just give us some of your thought process behind that and how you're thinking about the stock for now?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: And then I've got some questions on zuranolone here, specific ones. First, just to clarify, is it still fair to assume that Sage and Biogen are mostly
interested in treating MDD episodically with the product, and that's changing the paradigm?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Sure. And you alluded to this a bit, the Z-Pak analogy. What would you say to people who might perhaps be paying too much deep thought on
day 42 because, as we know, 42 is not the answer to life and everything?
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AUGUST 11, 2021 / 12:00PM, SAGE.OQ - SAGE Therapeutics Inc at Canaccord Genuity Growth Conference
(Virtual)
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: On the SHORELINE data, is it fair to assume a dose dependence on the cuts of people that might need re-treatment over time as you go to a higher
dose?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: And then moving on to CORAL, which a lot of people are focused on. What would you think would be an ideal result in CORAL, given we've seen
zuranolone work relatively rapidly so far?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: So that brings me to my next question. You have WATERFALL. So you have a fileable product as you've said. Some safety data, my understanding,
may be necessary from CORAL, but maybe not all the data for a fileable package. But how important do you think the CORAL data would be in
terms of potential real-world usage and commercial implications of that?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: And we know there's been a lot of unpredictability with the FDA recently. So -- and I'm not sure this is a fair statement over time, it might always
be unpredictable. But when was your last discussion with the agency to ensure that you are completely on board with the regulatory requirements?
And I'm assuming the last discussion was the one that resulted in not requiring REDWOOD and RAINFOREST? Is that a fair assumption?
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AUGUST 11, 2021 / 12:00PM, SAGE.OQ - SAGE Therapeutics Inc at Canaccord Genuity Growth Conference
(Virtual)
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Got it. Next is, again, a real-world type question. So if zuranolone is approved, how does a physician reconcile what might be an episodic treatment
versus the potentially "safer way" of using iconic treatment to make sure patients are always on a standard of care? And does that mean that episodic
treatments will mostly see use as an adjunct therapy?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Right. And I kind of see this as the migraine market in reverse, where that went from like acute as-needed treatment to more prevention chronic
type aspects, and now you have a blurring of the lines with an older product or 2 coming. So that's why I look at the MDD market sort of in reverse.
So we'll see how that plays out, hopefully, in the real world.
So what are your latest thoughts on how an episodic treatment might or should be priced? And what do you think real-world durability could look
like? We've seen some SHORELINE data. We know that. But -- and how would all this change if the PPD market comes along?
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AUGUST 11, 2021 / 12:00PM, SAGE.OQ - SAGE Therapeutics Inc at Canaccord Genuity Growth Conference
(Virtual)
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: So Barry, from your discussion just now, it's clear that you've put a lot of thought into the commercial aspect, but your partner, Biogen, has a lot of
things going on right now. How confident are you that the asset will get the appropriate attention it deserves, especially when Biogen will also be
learning along the way when it comes to targeting primary care? Are other partners thinking of this as initially especially focused with the pricing
dynamics that come along with that?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Got it. How do you expect to position yourself versus competing approaches from maybe a practice and the potential use of psychedelics in MDD
or treatment-resistant depression?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Yes. And do you expect to target other types of depression with zuranolone, for example, depression and bipolar disorder?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Got it. Now moving to SAGE-324 now. How are you thinking about the next steps there? And any refinements that might need to be made as the
product progresses to the next stage of trials?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Got it. And we just have about a minute left so I'm going to squeeze in 2 questions. First, on SAGE-718, could you give us a sense of what you expect
to learn or see in the upcoming LUMINARY study?
And the last question, big picture. You've been CEO for some time now, hopped on ahead of a very important data set. But behind that now, there's
a lot of things ongoing. So where do you see Sage in the next 3 to 5 years? And how does your significant cash balance help you to achieve that,
specifically in terms of how many products might be in pivotals before you may need to replenish?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Okay. That about wraps it up. So thank you, Barry, and thanks, everyone, for tuning in and listening to the replay.
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