Agios Pharmaceuticals, Inc.

Good day, and thank you for standing by, and welcome to Q3 2022 Adios Pharmaceuticals, Inc. Earnings Conference Call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Holly Manning. Please go ahead.

Thank you, Operator. Good morning, everyone, and welcome to Agios' third quarter 2022 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 Brian Goff, our Chief Executive Officer, Dr. Sarah Guins, our Chief Medical Officer and Head of Research and Development, Richa Poddar, our Chief Commercial Officer, and Cecilia Jones, our Chief Financial Officer. 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 our most recent filings with the FCC and any other future filings that we may make with the FCC. With that, I will turn the call over to Brian.

Thanks, Holly, and good morning, everyone. It's a privilege to join you today on my first AGIOS financial results call as Chief Executive Officer nearly three months after assuming the role in August. AGIOS has a longstanding legacy of scientific excellence in clinical execution and is on the cusp of broadening its ability to change the treatment landscape of rare and genetically defined diseases. With the recent launch of PyroKine and its extensive clinical and preclinical pipeline, the opportunity that lies ahead for Agios and the patients it serves is exciting. Since joining in August, as I've dug into the business and met so many of our talented team, my optimism and excitement for the future of Agios has grown for several reasons. The strength of the culture and patient orientation is even better than I perceived during my diligence process. The emphasis on our shared mission of improving lives is palpable across all functions within the organization and part of the fabric of the decisions we make, the people we hire, and the reason we come to work every day. Second, for a company of our size, the depth and breadth of activity across all areas of the business is remarkable. 2022 has been a year of execution with five pivotal studies and two early-stage trials underway, an ongoing commercial launch in the U.S., an active filing in the EU and Great Britain, an advancing preclinical pipeline, and broad business development efforts to continue to build out our pipeline. And finally, while the PyroKine launch was always attractive based on my experience and passion for rare diseases, I've come to further appreciate the unique combination of a first-in-class, first-in-disease launch with a pipeline of significant near-term indication expansion opportunities. In addition to the importance of this launch as the first ever treatment available for patients with PK deficiency, it also serves as a foundation for us to build commercial capabilities as we prepare for future potential expansion into similar but meaningfully larger rare diseases like thalassemia. IGOS has all the ingredients to make a difference in the lives of patients with rare and genetically defined diseases, and I'm honored to lead this team to drive long-term growth and value together. Turning to the third quarter and recent progress as outlined on slide five, we accomplished several key priorities and advanced others as we head into the end of the year. First, I'm pleased to welcome Cecilia Jones to Agios in her first quarterly call as our Chief Financial Officer. Cecilia, who started at the end of September, has extensive experience working for rare disease-focused companies and a strong track record of financial leadership, shaping strategy, and talent development. She has already proved to be an excellent thought partner for myself and the leadership team. In addition, we strengthened our Board of Directors with the additions of Dr. Raul Bilal and Cynthia Smith. Raul and Cynthia are seasoned biopharmaceutical executives with critical expertise that will help us maximize our potential. Within R&D, the clinical and medical teams have been busy securing a positive CHMP opinion for pyrokine in the EU, initiating the AG946-MDS Phase 2A trial, publishing data from our thalassemia and PK deficiency clinical programs in top-tier medical journals, securing an expansive set of data for presentation at ASH in December, and making progress on enrollment for our thalassemia and sickle cell disease trials, which Sarah will cover in more detail. On the commercial front, with just two full quarters under our belt since the approval of PyroKind earlier this year, We continue to make important progress and are very much in the dynamic learning phase of launch. We've identified several important lessons this quarter that allow us to further tailor our tactical approach and evolve our marketing mix to more efficiently target HCPs, drive disease education and urgency to treat, and facilitate initiation of pyrokine therapy. Richa will discuss some of these learnings and tactics shortly. And finally, last week, we completed the monetization of the TIPSOVO royalty that we obtained from the survey transaction, providing us with more than $130 million in capital to invest in high-value opportunities for the business. As I look to the last few weeks of the year, our priorities, as shown on slide six, are very clear. Continue to drive enrollment across our thalassemia and sickle cell disease pivotal trials, secure approval of pyrokine for PK deficiency in the EU and Great Britain, and drive towards continued commercial success for our U.S. launch. I'd like to thank each and every Agios employee for the fantastic work accomplished this quarter and for their support in my own learning and onboarding during these first few months. With that, I'll turn it over to Sarah.