Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) Q3 2018 Earnings Conference Call Transcript

Nov 01, 2018 • 08:00 am ET


Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) Q3 2018 Earnings Conference Call Transcript


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Good morning, and welcome to Agios' Third Quarter 2018 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 Agios' request.

I would now like to turn the call over to Renee Leck, Associate Director, IR.

Renee Leck

Thanks, Nicole. Good morning, everyone, and welcome to Agios' third quarter 2018 conference call. You can access slides for today's call by going to the Investors section of our website,

With me on the call today are Dr. David Schenkein, our CEO, who will review key business updates and milestones for 2018; Dr. Chris Bowden, our Chief Medical Officer, who will provide an update on our clinical development activities; Steve Hoerter, our Chief Commercial Officer, who will provide an update on the launch of TIBSOVO; and Andrew Hirsch, our CFO, who will summarize our third quarter 2018 financial results. Dr. Scott Biller, our Chief Scientific Officer, will also be available for Q&A.

(Forward-Looking Cautionary Statement)

With that, I'll turn the call over to David.

David Schenkein

Thanks, Renee, and good morning, everybody, and welcome to our third quarter earnings call. The third quarter of 2018 was an exciting time for Agios as the hard work and dedication of our team culminated in the achievement of important clinical and regulatory milestones and put us on track to complete the remaining milestones that we laid out at the beginning of the year. In addition, we began to lay the groundwork to support our next phase of growth in 2019 and beyond, focused on expanding indications for our wholly-owned precision medicine, TIBSOVO, also known as ivosidenib, rapidly advancing both our cancer and rare genetic disease clinical development programs and continuing to foster our rich research pipeline.

Notably, the July approval and launch of TIBSOVO, the first and only treatment for IDH1 mutant relapsed or refractory acute myeloid leukemia was a remarkable achievement for our organization. We're pleased with the progress of the US launch, and Steve will share additional details later in the call. With both of our IDH inhibitors now available to patients, we are rewriting the textbooks on treating IDH mutant AML. Just last week, out of the field of 20 nominees, IDHIFA won the US Prix Galien award for Best Pharmaceutical Product of 2018, which recognizes outstanding achievements in improving patients' lives through the development of innovative therapies. We're incredibly honored and humbled by the recognition of the practice-changing impact in medicine like IDHIFA can have for patients and are committed to continuing the work that makes an achievement like this possible.

For TIBSOVO, we know that our work has just begun to provide access to more patients within IDH1 mutation. Today, we announced two key updates to our ambitious clinical development strategy in newly diagnosed AML. Most importantly, we plan to submit a supplemental new drug application for single agent TIBSOVO in AML patients who are not eligible for standard therapies, which Chris will