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5/5/2021
Good morning and welcome to Ionis Pharmaceutical's first quarter 2021 financial results conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on a touch-tone phone. To withdraw your question, please press star then two. As a reminder, this call is being recorded. I would like to turn the conference over to Wade Walk, Vice President, Investor Relations, to lead off the call. Please begin.
Thank you, Betsy. Before we begin, I encourage everyone to go to the Investor section of the IOMIS 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 have also posted slides on our website that accompany our discussion today. With me on today's call are Brett Monia, Chief Executive Officer, Beth Haugen, Chief Financial Officer, and Richard Geary, Executive Vice President of Development. And joining us for our Q&A will be Oneza Katarae, Chief Corporate Development and Commercial Officer, and Eric Swayze, Executive Vice President of Research. I would like to draw your attention to slide three of our presentation, which contains our forward-looking language statements. 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. And with that, I'll turn the call over to Brett.
Thanks, Wade. Good morning, and thank you for joining us on today's call. Last year, we introduced a new strategy to drive growth by developing and commercializing medicines from our the own pipeline. Since that time, we have taken a number of key steps that have advanced our strategy and moved us closer to successfully commercializing our own products. Most recently, we expanded our SOVI distribution agreement and restructured our Texetti operations. This transaction unlocked significant resources that we are redeploying to advance our wholly owned pipeline and prepare for commercialization of our highest priority medicines, which include GTR-Leica and ApoC3-Leica. We are also using savings from the SOBI transaction to invest even more in our technology to further broaden the reach of our therapeutic capabilities. Turning now to our pipeline, we were particularly with hereditary angioedema, or HAE. Based on these encouraging results, we're advancing into a phase three study where we hope to further demonstrate the potential of this medicine as a best in-class product that could change the standard of care for patients with this disease. We also recently initiated pivotal studies with two wholly-owned neurological disease medicines, ION363 and ION373, for patients with FUS ALS and Alexander disease, respectively. Given the severe unmet need of these patients and the progress we have made with regulators, both medicines are on an accelerated path to the market. And we are pleased with the progress we're making across our rich phase three pipeline with medicines for patients with ATTR amyloidosis, FCS, LP little a driven cardiovascular disease, and ALS. These phase three programs remain on track with data from the phase three Valor study of Tofersen in patients with side one ALS expected this fall. Positive Tofersen results would demonstrate for the first time that a disease-modifying treatment is possible for patients with ALS. A positive outcome in this study would also move Tofersen one step closer to becoming our next commercial product. And additionally, Tofersen's success would further solidify our leadership position in the development of first in-class medicines for the treatment of neurological diseases. In support of our strategic and pipeline objectives, earlier this year we launched a large capital project to expand our manufacturing and R&D capacity. This project is important as we move our late and mid-stage medicines toward the market. It's also important as we advance our technology with new chemistries, including novel Leica chemistry and new routes of administration. We have made significant progress in advancing our pipeline and our business strategy. Our financial results reflect our strategic investments and keep us on track to achieve our 2021 guidance. And importantly, we remain well positioned to have 12 or more marketed products in 2026. With that, I'd like to turn the call to Beth to review our first quarter financial results, and Richard will discuss recent pipeline updates and preview key upcoming catalysts through the rest of the year. After Richard, I'll wrap up our prepared remarks before taking your questions. So now, on over to Beth.
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