Blueprint Medicines Corporation

Ladies and gentlemen, thank you for standing by, and welcome to the Blueprint Medicine's fourth quarter 2020 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand this conference over to your speaker today, Kristen Hodes of Blueprint Medicine. Thank you. Please go ahead, ma'am.

Thank you, Operator. Good morning, everyone, and welcome to Blueprint Medicine's fourth quarter 2020 financial and operating results conference call. This morning, we issued a press release which outlines the topics we plan to discuss today. You can access the press release as well as the slides that we'll be reviewing today by going to the investor section of our website at www.blueprintmedicine.com. Today on our call, Jeff Albers, our Chief Executive Officer, will discuss Blueprint Medicine's recent business highlights and 2021 corporate priorities. Christy Rossi, our Chief Commercial Officer, will provide a commercial update. Fuad Nemuni, our President of Research and Development, will discuss our R&D efforts. And Mike Lansdell, our Chief Financial Officer, will review our financial results. Before we get started, I would like to remind everyone that statements we make on this conference call will include forward-looking statements. Actual events or 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 annual report on Form 10-K and any other filings that we have made or may make with the SEC. In addition, any forward-looking statement made on this call represents our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. Now, here's our CEO, Jeff Albers.

Thanks, Kristen, and good morning, everyone. We're happy to provide an update on recent progress and a look forward to our 2021 priorities and catalysts. I know our industry tends to use the word transformational quite a bit, but it really isn't hyperbole to say that 2020 was a transformational year for Blueprint Medicines. With four Avakit and Gavretto regulatory approvals in the United States and Europe, and a global collaboration signed with Roche, we're now a fully integrated global biopharmaceutical company, and we're exceptionally well positioned to drive our next wave of growth. As we progress into 2021, we're focused on three strategic pillars to build on our recent progress. One, to accelerate the global adoption of Avakit and Gavretto. Two, to advance a new wave of therapeutic candidates to clinical proof of concept. And three, to further expand our precision therapy pipeline. The first, as Christy will discuss, is centered around the anticipated approval of Avakit in advanced systemic mastocytosis and the acceleration of our Gavarito launch. With the Avakit SMDA now accepted and a PDUFA date in the second quarter, we're on the verge of expanding into what we have long discussed as our most significant growth opportunity. Additionally, the development of Avakit in non-advanced systemic mastocytosis is also progressing via the registration-enabling Pioneer trial. This offers the potential to further expand our commercial efforts in the near future. And for Devretto, the expanded U.S. approval for forms of thyroid cancer in December positions us to continue to advance the launch in the U.S. while also focusing on applications and additional geographies. The second and third priorities, as Fuad will cover, focus on advancing our new therapeutic candidates to clinical proof of concept and continuing to productively tap into our prolific research platform. We expect to make significant progress on these fronts with several upcoming presentations of new preclinical data. including the first data for our latest and newly named development candidate, BLU701, in double mutant EGFR-driven lung cancer. We also plan to initiate clinical trials for BLU945 in EGFR-driven lung cancer and BLU263 in non-advanced systemic mastocytosis. Finally, we're excited to announce a new research program focusing on CDK2, a compelling therapeutic target across multiple tumor types, as well as a mechanism of resistance in a subset of patients who progress on CDK4-6 therapies. I'm particularly excited to share more information about these research programs over the coming months given the quality of the science and the scope of their respective opportunities. All of this is further supported by our strong financial position. With more than $1.5 billion in cash at the end of 2020, which enables us to continue to invest in these programs and our research engine, while we also consider opportunities to bring in external innovation where there's a strategic fit. So with that introduction, I'll hand the call over to Christy to provide a commercial update. Christy?