Barry E. Greene - Alnylam Pharmaceuticals, Inc.
Management
Thanks, Manmeet. As you heard from John and Akshay, we're looking forward to some critical data points this year, which, if positive, will push us closer to Alnylam 2020 profile, marking our transition from a late-stage R&D company to a multiproduct, commercial organization with a sustainable development pipeline, achieving a profile, as John said, rarely achieved in the biopharmaceutical industry. As part of this transition, we're very focused on expanding our medical affairs, quality, manufacturing and commercial capabilities to support the potential for multiple consecutive product launches in 2018, 2019, 2020 and beyond. These efforts include building our capabilities in the United States, Canada and Western Europe for patisiran and fitusiran and growing globally with givosiran and in future products. As John commented earlier, I encourage you to listen to the webcast of our recent patisiran RNAi Roundtable to understand the comprehensive medical affairs and commercial (28:12) efforts (28:13) this very important program. Now, let's turn to our 2017 goals and guidance on upcoming data presentations. With our patisiran program, we look forward to reporting top line data from the APOLLO Phase 3 study in the coming weeks, with full results planned for the European ATTR Meeting in November. Assuming positive results, we expect APOLLO will enable an NDA filing in the year end, followed shortly by an MAA filing putting us in a position, assuming regulatory approval, to launch our first commercial product in 2018. With fitusiran, (28:49) additional clinical results in late 2017. Following the initiation of the ATLAS Phase 3 program in July, we expect to present top line results in mid to late 2019. Now, turning to givosiran, we look forward to initiating the Phase 3 study in late 2017 as we finalize our discussions with global regulatory authorities. Regarding inclisiran, our partners at The Medicines Company are planning to initiate the Phase 3 study in patients with atherosclerotic cardiovascular disease in late 2017. We also plan to advance additional programs from our early and mid-stage pipeline and to report additional clinical data from these programs throughout the year. Finally, as Manmeet said, we expect to end 2017 with greater than $1 billion in cash. With that, I'll now turn the call back to Christine to coordinate our Q&A. Christine?