Sage Therapeutics, Inc. (NASDAQ:SAGE) Q4 2022 Earnings Call Transcript

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Tazeen Ahmad: Hi, good morning. Thanks for taking my question. Just wanted to clarify something that was said in the prepared remarks, because I think Barry, you said that post the PDUFA in August, you expect to be able to launch Zuranolone, if approved by the end of the year. What would be rate limiting factors that would prevent you from immediately launching and can you just narrow down when you think you would be able to start recording sales? Would it be in calendar 2023? Or would be assume it should be more in 2024? Thanks.

Barry Greene: Yes, Tazeen, thank you and thanks for the question and the attention. Look, we’re really excited that the FDA has accepted the NDA filing for Zuranolone for MDD and PPD with a PDUFA action date of August 5. I’ll remind you that following approval occurs on August 5 without delay, we then move to a three-month DEA scheduling period. There are actions we could take during that period, but we can’t start selling Zuranolone recorded sales until we have that official label with the DEA schedule. So that will happen towards the end of the year and we’ll be very well prepared to launch and excited to do so.

Operator: We’ll move next to Salveen Richter from Goldman Sachs.

Salveen Richter: Good morning. Thanks for taking my question. With regards to the payer work here, could you just comment on their understanding of pricing a drug at an annual price for a every — once a year, two-week period or using it maybe twice a year? And then secondly, I think the commercial payer mix is about 51% of the payer mix. And so when you think about DBAs and the strategy here, how effective are there going to be to kind of help you position the drug with the physicians in terms of adopting a new treatment paradigm? And then what do you do with the remainder of the kind of non-commercial payer aspect?

Barry Greene: Yes, Salveen. That was a few different aspects in there, one outcomes of the proactive value-based agreement strategy that we envision on employing, that the concept for us is to help payers with some budget certainty. That’s really what they want. They know that the prices is now well managed. Chris will get into that in a bit. But they want prices certainty. In return, we want if a physician or health-care provider believes that a patient requires Zuranolone or other script, we want that script so quickly. So, that’s sort of there is more detail to that we can get into. From a pricing perspective is that they think about per patient per year. They’re not thinking about per pill, per pack. They are really focused on understanding per patient per year. Chris, you want to comment further?

Chris Benecchi: Yes. So I think the DBA key to this, Barry is just frankly one component. I think to be truly transformational; we have to be accessible and that really starts with payers in and around understanding unmet need. I think in all of the interactions that we’ve had so far, there’s a high understanding of unmet need in and amongst the payers and truly a perception that they need something that looks quite differently than what they’ve seen historically. They’ve been impressed with the data, as I think they certainly understand for those interactions the opportunity that Zuranolone presents to deliver something that works, you know, in a rapid acting fashion after just three days, 14-day course something that’s durable over time, does it come with this phenotype of side effects so often associated with other therapies and actually has the potential to return patients to a state of welding.

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