Agios Pharmaceuticals, Inc.

Good morning, and welcome to Agios' second quarter 2020 conference call. At this time, all participants are in 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 Holly Manning, Director of Investor Relations.

Thank you, Operator. Good morning, everyone, and welcome to Agios' second quarter 2020 conference call. You can access slides for today's call by going to the investor section of our website, agios.com. With me on the call today with prepared remarks are Dr. Jackie Fels, 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 Andrew Hirsch, our Chief Financial Officer and Head of Corporate Development. 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 SEC 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 second quarter 2020 results call. The second quarter was an incredibly productive and important time for Agios as we made significant progress across the business and accomplished several of the key objectives that we set for 2020. The steps we took in Q2 solidified our strategic priorities for the remainder of the year and move us closer to achieving our 2025 vision. Seven years ago, we discovered the first pyruvate kinase R activator, Minipivet, and since then we've led the science behind this mechanism, advanced the Phase III program in pyruvate kinase deficiency, and became the first company to establish that activating wild-type PKR may provide therapeutic benefit in other hemolytic anemias, such as thalassemia and sickle cell disease. Over the past quarter, we further underscored our leadership in the space and shared key updates that support our next phase of development for mitopivate. To start, we established compelling proof of concept for mitopivate in sickle cell disease, demonstrating that PKR activation has the potential to treat chronic hemolytic anemia and markers of sickling in these patients. In addition, at EHA, we presented data for the first time at a medical meeting for menopivac and thalassemia, showing sustained hemoglobin responses in both beta thalassemia and alpha thalassemia patients. In May, the FDA granted us orphan drug designation for this indication. As we look ahead, we are firmly committed to the rapid advancement of menopivac across all three of these disease areas. The remainder of 2020 will be focused on preparations for top-line data from the PK Deficiency Phase III studies and the submission of an NDA for medipivats first indication and the indication of pivotal programs in both thalassemia and sickle cell disease in 2021. In June, we secured $255 million of non-equity capital through the sale of our IDFA royalty and future milestones to Royalty Pharma to help fund these efforts. In addition to our progress on the rare genetic disease side of the business, we've continued to drive commercial execution for TIPSOVO and advance our malignant hematology and solid tumor clinical programs. At ASCO and EHA, we presented data underscoring the utility of IDH inhibitors in both areas. And in May, we published a manuscript in Lancet Oncology highlighting data from the CLARITY Phase 3 study of TIPSOVO and cholangiocarcinoma. As a result of the manuscript, the NCCN guidelines were updated to recommend treatment with TIPSOVO for patients with advanced IDH1 mutant cholangiocarcinoma. We look forward to having overall survival data from the CLARITY study in the near future, which will support an expected S&DA submission in the first quarter of 2021. I'm proud of our team for accomplishing all this great work while continuing to combat the challenges and complexities caused by the ongoing COVID-19 pandemic. The disruption to global healthcare systems continues to evolve as infection rates fall in some parts of the world while rising in others. including in many states here in the U.S. Our organizational resiliency team and clinical operations response team remain active in assessing COVID-19's impact on every facet of our business on an ongoing basis. While the majority of our employees continue to work from home, all lab employees who need access to our Cambridge research labs have returned to work under a set of operating procedures designed to protect their health and well-being. In addition, as local regulations and institutions have allowed, some of our field team can interact with their customers in person again. We continue to evaluate additional operating procedures that will allow a broader return to on-site work. I would like to thank each and every Agios employee for continuing to advance our programs for patients while balancing the pandemic's significant impact on their personal and professional lives. Before I turn the call over to Chris, I think it's important to acknowledge recent events which have once again exposed the realities of racism and racial violence in our country. At Agios, we believe matters of racial injustice should be acknowledged and decried, and we are committed to act in allyship against this destructive force in our communities. All of us at Agios believe in the value of diversity, and we are committed to making Agios a welcoming and diverse workplace where individuals of all backgrounds can thrive and contribute meaningfully to our mission on behalf of patients. Chris, let me turn it over to you.