Ionis Pharmaceuticals, Inc.

Good morning and welcome to Iona's Pharmaceuticals fourth quarter and full year 2022 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. As a reminder, this call is being recorded. At this time, I would like to turn the call over to Wade Walk, Senior Vice President of Investor Relations, to lead off the call. Please begin, sir.

Thank you, Vaishnavi. Before we begin, I encourage everyone to go to the Investors section of the ONIS website to view the press release and related financial tables we will be discussing today, including reconciliation of GAAP to non-GAAP financials. We believe non-GAAP financial results better represent the economics of our business and how we manage our business. We've also posted slides to our website that accompany today's call. With me this morning are Brett Monia, our Chief Executive Officer, Eugene Snyder, Chief Clinical Development Officer, Oneza Katare, Chief Global Product Strategy and Operations Officer, and Beth Haugen, our Chief Financial Officer. And Eric Swayze, our Executive Vice President of Research, will join us for the Q&A portion of the call. I would like to draw your attention to slide three, which contains our forward-looking statement. During this call, we will be making forward-looking language statements that 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 contained in our SEC balance for additional detail. With that, I'll turn the call over to Brett.

Thanks, Wade. Good morning, everybody, and thanks for joining us today. As we begin this year, we are building on the significant momentum from the key successes we achieved in 2022, highlighted by our progress in advancing our three near-term commercial opportunities towards the market. With Eplon-Tersen, we delivered positive data from the 35-week interim analysis, which formed the basis for our MDA submission in December. With Olazarsen, we completed enrollment in the phase three balance study for FCS, putting us on track for data in the second half of this year. The FDA recently granted fast track designation for Olazarsen for FCS, underscoring the significant unmet medical need for these patients. We also advanced and expanded our clinical program supporting olzarsen for the broader SHTG indication. And with Donna DeLorsen, we delivered multiple positive data readouts, all further strengthening our belief in this medicine's potential best in-class profile for the prophylactic treatment of HAE. And we're pleased to report that the phase three study of Donna DeLorsen continues to progress well, keeping us on track to complete enrollment this year. We've also made excellent progress in building our commercial organization. As a result, we are well-positioned to successfully launch these medicines beginning with co-commercializing at von Thursen with AstraZeneca. We're also on track for our first independent launches of Olizarsen and Donny Dolorsen. Beyond our three near-term commercial opportunities, our partner pipeline also continues to make great progress. which is partnered with Biogen, is under review in the U.S. and EU, positioning it to be added to our commercial portfolio this year. And our rich late-stage pipeline recently grew this year when GSK initiated phase 3 development for papiroversin for HPV. Further, we expect our late-stage pipeline to grow even more later this year when Roche advances Ionis FDL-RX into phase 3 development in patients with IgA nephropathy. Indeed, our strong pipeline progress sets us up very well to deliver a steady cadence of new products to the market for many years to come. We also took important steps last year to broaden and diversify our technology, including advancing programs utilizing muscle Leica and programs utilizing novel MSPA backbone chemistry. Furthermore, Biogen recently initiated an SMA follow-on phase one study that utilizes advanced ionist chemistry, potentially enabling long interval dosing. And we entered into a collaboration with Metagenome, an industry leader in next generation gene editing. By adding gene editing capabilities to complement our existing platform, we expect to tackle more diseases, reach more patients, and further strengthen our leading position in genetic medicine. Importantly, we further strengthened our financial foundation recently to support our future cash needs. The capital we raised from the royalty monetization and sale leaseback transactions will directly support the investments we're making in advancing our late stage programs and building our commercial organization ahead of our planned upcoming launches. With that, I'll turn the call over to Eugene to discuss our recent pipeline progress and preview our upcoming key events. Next, Onesa will provide an update on our commercialization efforts, and then Beth will review our 2022 financial results, as well as review our 2023 financial guidance. And after Beth, I'll wrap up our prepared remarks before taking your questions. So now, over to Eugene. Thank you, Brad.