Sage Therapeutics, Inc. (NASDAQ:SAGE) Q3 2018 Earnings Conference Call Transcript
Nov 06, 2018 • 08:00 am ET
Good morning, and welcome to Sage Therapeutics Third Quarter 2018 Financial Results Conference Call. (Operator Instructions) This call is being webcast live on the Investors & Media section of Sage's website at sagerx.com. This call is the property of Sage Therapeutics and recording, reproduction and transmission of the call without the express written consent of Sage Therapeutics is strictly prohibited. Please note that this call is being recorded.
I would now like to introduce Paul Cox, Investor Relations at Sage.
Good morning. Today, we issued a press release with our third quarter 2018 financial results along with recent company highlights, upcoming milestones and progress on our corporate strategy. The press release referenced on this call can be found on the Investors & Media section of our website at sagerx.com. We will begin the call with prepared remarks by Dr. Jeff Jonas, CEO; Mike Cloonan, Chief Business Officer; and Kimi Iguchi, CFO. We will be joined for the Q&A session by Dr. Steve Kanes, Chief Medical Officer, and Dr. Jim Doherty, Chief Research Officer.
(Forward-Looking Cautionary Statements)
I would now like to turn the call over to Jeff.
Thanks, Paul, and good morning, everyone. And thank you for joining us today on our call. We're excited to discuss another productive quarter. And we continue to make progress across our entire portfolio of differentiated medicines. I will walk through the major updates on the call today.
As many of you know, our lead product candidate, ZULRESSO, or brexanolone injection, is being developed for the treatment of postpartum depression or PPD. On Friday, the US FDA held a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the safety and efficacy of ZULRESSO for PPD. We're pleased with the new unanimous vote on the benefit-risk profile that supports the approval of ZULRESSO. This positive meeting outcome is an important milestone in the development of this potential new treatment for women, who are suffering from PPD. In the meeting, there was clear recognition by the advisory committees that PPD affects not only the mother, but also has significant impact on her infant and family, and that there is an urgent need to provide an innovative treatment that rapidly alleviates the symptoms of PPD. We believe that ZULRESSO, if approved as a onetime infusion, could potentially transform the treatment of PPD, the most common complication of childbirth, by potentially relieving symptoms within days instead of weeks or months. More broadly, we believe ZULRESSO may set the stage for rethinking how psychiatric disorders are treated as illnesses rather than chronic lifetime conditions. The joint committee based their recommendation on the safety and efficacy data from three placebo-controlled clinical studies, where we demonstrated that ZULRESSO rapidly resolves symptoms of this critical disorder in just 2.5 days. These detailed results, including the safety data were recently published in The Lancet.
Mike will further discuss the outcome of the Advisory Committee meeting, our commercial launch plans and expected pricing for