Ionis Pharmaceuticals, Inc.

Good morning, and welcome to IONIS Pharmaceuticals' second quarter 2021 financial results conference call. As a reminder, this call is being recorded. At this time, I would like to turn the call over to Dave Nakasona, Investor Relations, to lead off the call. Please begin.

Thank you, Debbie. Before we begin, I encourage everyone to go to the Investor section of the IONIS website to find the press release and related financial tables, including a reconciliation of the GAAP to non-GAAP financial measures that we will discuss today. We believe non-GAAP financial results better represent the economics of our business and how we manage our business. We've also posted slides on our website that accompany our discussion today. With me on today's call are Brett Monian, Chief Executive Officer, Beth Haugen, Chief Financial Officer, and Richard Geary, Executive Vice President of Development. And joining us for Q&A, Vanessa Catteray, Chief Corporate Development and Commercial Officer, and Eric Swayze, Executive Vice President of Research. I would like to draw your attention to slide three, which contains our forward-looking language statement. We will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. With that, I'll turn the call over to Bert.

Thanks, Dave. Good morning, and thank you for joining us on today's call. Last year, when I took on my new role as CEO of IONIS, I put forth a plan intended to bring substantially greater success to IONIS and substantially greater value for all stakeholders. This plan was to leverage our well-established foundation of scientific innovation by focusing on three strategic objectives. First, to evolve our business model to include commercializing products of our own. This includes building the necessary capabilities to prepare for multiple Ionis commercial launches. Second, to expand our drug discovery capabilities through new initiatives to enhance our technology. And third, to significantly advance and grow our late-stage pipeline to ensure for a substantial increase in the number of new products reaching the market in the near and longer term. So now let's see how we're progressing against these three strategic goals for this year. The Ionis-Jolion pipeline is advancing on track and growing significantly. Last week, we reached full enrollment in the Neurotransform study of F-1 With this study now fully enrolled and on track for data by mid-2022, this medicine is one important step closer to reaching the market. We're also developing epilentersin for the treatment of cardiomyopathy in the Phase III CardioTransform study, which continues to enroll well. Our Phase III study involving our A-plus C-3 Leica medicine in patients with FCS is enrolling in schedule, and our second Phase III study for A-plus C-3 Leica is on track to begin later this year in patients with severe hypertriglyceridemia, a much larger patient population. Our Phase III study for ION363 in patients with a genetic form of ALS due to mutations in the FUS gene is also progressing well. Furthermore, we look forward to initiating a Phase III study for our PKK-LICA medicine in patients with hereditary angioedema late this year or early next year. And as our wholly-owned pipeline advances, we're also making great progress in building out our commercial capabilities and our strategy. Our acquisition of XSEA was a key step in advancing our commercial strategy in building these capabilities. We've now completed the integration of XSEA within IONIS, and we're pleased with the progress being made in our SOBE partnership for the distribution of Tecseti and Waylivera in Europe and North America. As a reminder, we established this partnership to continue providing these important medicines to patients while we focus on Hep1 Pearson and ApoC3 Leica. We have also made significant additional progress this year against our strategic objective to expand the reach of our drug discovery capabilities through new investments to enhance our technology. Our efforts include broadening our internal technology initiatives as well as in-licensing new technologies. We recently announced a new partnership with Bicycle Therapeutics for exclusive access to Bicycle's proprietary platform chemistry for oligonucleotide drugs focused primarily on targeted delivery to skeletal and cardiac muscle. This collaboration complements our significant internal efforts as well as the progress we're making under our ARO Therapeutics and Genuity Sciences collaborations, all of which potentially enables us to significantly expand the reach of our technology. And lastly, we're making great progress this year in achieving our third strategic objective to have 12 or more marketed products in 2026. In addition to completing enrollment in the Yvonne Pearson Neurotransform study, we also recently achieved key phase three milestones with Topherson and Pellikarson. All three of these significant milestones move these programs closer to reaching the market and highlight the excellent progress we're making across our late stage pipeline. Biogen completed the placebo-controlled treatment portion of the Phase 3 Valor study of Tophercin, data expected by this fall, and is now offering Tophercin to SOD1 ALS patients on an individual compassionate use basis. If the Phase 3 Valor results are successful, Tophercin could become the first-ever disease-modifying therapy for a genetic cause of ALS and our next commercial product. And this week, we announced achievement of a key enrollment milestone in the LP little a horizon phase three study for Pellicarsen in patients with LP little a driven cardiovascular disease. As we announced, we have now achieved enrollment of nearly 4,000 patients in this cardiovascular outcome trial, representing 50% of our target enrollment goal for the study. This achievement, along with the substantial progress we're making across all of our mid- and late-stage LICA programs, demonstrates the consistently attractive profile for all our LICA medicines in development today. So, in wrapping up my opening comments, we are very pleased with the progress we're making to achieve all our strategic objectives. We've made great progress this year, and we are looking forward to an exciting second half of the year as we focus further on executing on our strategy and achieving the goals that lie ahead. And importantly, we are well positioned for growth with the people and the financial strength to achieve all this and more. And with that, I'll now turn the call over to Beth to review our financial results. Then Richard will discuss recent pipeline updates and preview key pipeline catalysts expected for the remainder of the year. After Richard, I'll wrap up our prepared remarks before taking your questions. Now over to Beth.