Agios Pharmaceuticals, Inc.

Good morning and welcome to AGO's third quarter 2020 conference call. At this time all participants are in a listen only mode. There will be a question and answer session at the end. Please be advised that this call is being recorded at AGO's request. I would now like to turn the call over to Holly Manning, Director of Investor Relations.

Thank you, Operator. Good morning everyone and welcome to AGO's third quarter 2020 conference call. You can access slides for today's call by going to the Investors section of our website, audios.com. With me on the call today with prepared remarks are Dr. Jackie Faust, our Chief Executive Officer, Dr. Chris Bowden, our Chief Medical Officer, Darren Miles, our Senior Vice President of U.S. Commercial and Global Marketing, and Jonathan Biller, our Chief Financial Officer and Head of Legal and Corporate Affairs. Dr. Bruce Carr, our Chief Scientific Officer, will join for Q&A. Before we get started, I would like to remind everyone that some of the statements we make on this call will include forward-looking statements. Actual events and results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors, including those set forth in the risk factor section of our most recent Form 10-Q filed with the FCC and any other filings that we may make with the FCC. With that, I will turn the call over to Jackie.

Thanks, Holly. Good morning, everyone, and thanks for joining our third quarter 2020 results call. Our activities this quarter were focused on execution against our key priorities for 2020, significant planning and preparation for a catalyst-rich fourth quarter in 2021, and a clear commitment to doing what's right for patients and our people as we continue to navigate the ongoing impact of the COVID-19 pandemic. We made important strides toward getting our medicines to patients who need them. This includes generating mature overall survival data from the CLARITY study, which enables our first solid tumor regulatory filing, and initiating our healthy volunteer study of AG946, our next generation PKR activator. Behind the scenes, we've been hard at work preparing for important milestones coming later this year and throughout 2021, including offline data readouts for our ACTIVATE and ACTIVATE-T studies, the supplemental NDA submission for tibsovo and cholangiocarcinoma, and the initiation of our global pivotal studies of midipivate in thalassemia and sickle cell disease. To help lead us toward these key value inflection points, We appointed Jonathan Biller to the role of Chief Financial Officer, Head of Legal and Corporate Affairs in September. Jonathan is a longtime colleague of mine whose expertise has been a welcome addition to our leadership team since he joined in November of last year. You'll hear from him later in the call as we discuss our quarterly financials. We also dealt with some challenges. including the need to withdraw our marketing authorization application for TIPSOVO in the relapsed refractory AML setting in the EU. Our ongoing phase three combination studies of TIPSOVO in the frontline AML setting remain on track for those much larger patient populations. The decision to withdraw our MAA will not result in any near-term changes to our approach in the region. Our lean EU team is largely focused on supporting AGO's clinical trial and medical affairs activities and PKD market development efforts, including patient advocacy, disease education, and patient identification. Investment in the EU will continue to be gated and aligned with the timing of future product approvals in the region. Looking ahead to the remainder of the year, we have a number of key events for our MediPIVAT program that further elucidate the potential value of the PKR activation mechanism to treat serious hemolytic anemias. First, on November 19th, we will hold an investor webinar focused on our PKR franchise, which will include a deep dive into the mechanism of action, the unmet patient needs in thalassemia, sickle cell disease, and PK deficiency, our view of these market opportunities, and the commercial preparations underway for our first potential rare disease launch. In conjunction with ASH, we will host an investor event on December 8th to share the updated data from the NIH phase one study of menopivac and sickle cell disease, as well as an overview of our phase three plans and thalassemia. And finally, we now expect top line data from the ACTIVATE study of menopivac and non-transfusion dependent PK deficiency by the end of the year, thanks to the tremendous efforts of our team. We have a busy few months ahead of us, And I want to thank each and every Agios employee for continuing to advance our programs for patients while balancing the pandemic's continued impact on their personal and professional lives. Chris, let me now turn it over to you.