Ionis Pharmaceuticals, Inc.

Good morning and welcome to Iona's first quarter 2023 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 touchtone phone. To withdraw your question, please press star then two. 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. Before we begin, I encourage everyone to go to the Investor section of the IONIS 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 on our website that accompany today's call. With me this morning are Brett Monia, Chief Executive Officer, Richard Geary, Chief Development Officer, and Beth Haugen, Chief Financial Officer. Eric Swayze, Executive Vice President of Research, Eugene Snyder, Chief Clinical Development Officer, and Oneza Katare, Chief Global Product Strategy and Operations Officer, will also 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 filings for additional detail. And with that, I'll turn the call over to Brett.

Thanks, Wade. Good morning, everyone, and thanks for joining us today. This year is off to a strong start with several important achievements already, especially from our neurology franchise. Last week, the FDA granted CALSATI accelerated approval for the treatment of SAG1 ALS. This approval represents a major scientific breakthrough. CALSATI is the first and only approved treatment to target a genetic form of ALS. And with this approval, CALSATI joined Spinraza as our newest product to reach the market for patients with a devastating neurological disease. In addition, to being a tremendous advance for the ALS community, this approval further validates our RNA-targeted therapeutic platform to treat neurological diseases that today includes 12 medicines in clinical development. We also just reported positive data from the Phase III Neurotransform study of Eplon-Tersen in patients with ATTR polyneuropathy. In this study, Eplon-Tersen was shown to halt neuropathy disease progression with approximately half of patients experiencing improvement. in the co-primary efficacy endpoints MNIST plus 7 and Norfolk quality of life. Eplon-Tersen also demonstrated favorable safety and tolerability. Based on the totality of the data, we are confident in Eplon-Tersen's strong product profile and its potential to be an important treatment for the largely untapped hereditary ATTR polyneuropathy population. With these data, we and our partner, AstraZeneca, are working towards additional regulatory submissions in countries outside the U.S. This, of course, is in addition to our NDA, which is under review with a PDUFA date of December 22nd of this year. And as Oneza discussed during our webcast last week, we're working hand-in-hand with AstraZeneca to bring this important medicine to the market as quickly as possible. Our two other near-term commercial opportunities, Olazarsen and Donny Delorsen, are also progressing very well. With Olazarsen, we remain on track for data from the phase three balance study in FCS in the second half of this year. And we're preparing for our first independent commercial launch in this rare disease indication. We also continue to make really good progress in our pivotal SHTG studies of Olazarsen. With Donna Doloresen, we're on track to complete enrollment in the Phase 3 OASIS-HAE study soon, keeping us on track for data in the first half of next year. Additionally, our robust late-stage pipeline continues to expand, now with seven programs advancing in nine separate indications with the initiation of phase redevelopment of the periversin in chronic HPV. Our expanding late stage pipeline sets us up for a steady and growing cadence of data readouts over the next few years, increasing the potential for a substantial number of new Ionis medicines to reach the market. And importantly, we remain on track to accomplish our key strategic goals across the business and achieve our 2023 financial guidance. With that, I'll turn the call over to Richard to discuss our recent pipeline progress and preview our upcoming key events. Next, Beth will review our first quarter financial results, and then I'll wrap up our prepared remarks before taking your questions.