Ionis Pharmaceuticals, Inc.

Good morning and welcome to IONIS' second quarter 2023 financial results conference call. 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.

Thank you, MJ. 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 have also posted slides on our website that accompany today's call. With me on the call this morning are Brett Monia, our Chief Executive Officer, Richard Geary, Chief Development Officer, and Beth Haugen, our Chief Financial Officer. Eric Swayze, Executive Vice President of Research, Eugene Schneider, 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'd 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. With that, I'll turn the call over to Brett. Thanks, Wade.

Good morning, everybody, and thanks for joining us today. We achieved a great deal in the first half of 2023 as we continued to focus on our most important strategic priorities. We advanced our pipeline in many important ways. We made great progress in building our commercial capabilities. We are writing the next chapter for IONIS as we transform IONIS into a highly successful fully integrated biopharma focusing on delivering an abundance of new medicines to patients. Launch preparations for our three near-term commercial opportunities, Eplon-Tersen, Olazarsen, and Donna-Delorsen, are right on track. Eplon-Tersen is currently under regulatory review for ATTR polyneuropathy in the U.S., and we're on track to submit additional filings outside the U.S. before the end of the year. We in AstraZeneca share the goal of bringing Eplon-Tersen to ATTR patients globally who today have limited treatment options. We're also pleased with the longer-term week 85 data for Eplon-Tersen from the phase three neurotransform study that we reported last month. These longer-term data showed continued improvements from baseline out to 19 months, highlighting Eplon-Tersen's durable efficacy and contributing further to its overall attractive profile. And in a few minutes, Richard will dive deeper into the importance of these data. And just last week, we reported that our landmark Cardiotransform study of epilonturacin in patients with ATTR cardiomyopathy completed full enrollment with more than 1,400 patients. This is the largest study ever conducted in this patient population. Our next major late-stage milestone is the top-line readout of the olizarcin phase rebalance study in FCS in the second half of this year. We expect olazarsin in FCS to be the first independent commercial launch for Ionis, and we're well prepared. In parallel, we're advancing our olazarsin phase 3 pivotal studies in the much larger patient population, severe hypertriglyceridemia, or SHTG, which we're also well prepared for. We also completed enrollment in the phase 3 OASIS-HAE study of donodolarsin earlier this year. This important milestone keeps us on track for data in the first half of next year. We continue to be encouraged by the efficacy data Don DeLorsen has generated to date. We recently announced two-year open label extension data that showed consistent and sustained protection against HAE attacks in line with what we previously reported from our randomized phase two study and our open label extension study at one year. I also want to highlight the continued success we've achieved developing medicines Spinraza continues to be the global market leader for the treatment of all types of SMA. And just recently, Spinraza's proven strong efficacy was reinforced further with highly encouraging new data from the ongoing response study in SMA patients who had a suboptimal response to gene therapy. And with the recent approval of CALSATI in the U.S., we now have two breakthrough commercial medicines on the market to treat two severe neurodegenerative diseases. The FDA's accelerated approval of CALSATI brings hope and a breakthrough treatment to people with side 1 ALS and their families. And CALSATI's approval further validates our capabilities to treat intractable neurological diseases. Today, we have 12 medicines in clinical development for neurological diseases, including treatments for other forms of ALS, dementias, neurodevelopmental diseases, and much more. Our industry-leading neurology research team is also making remarkable achievements to further advance our leadership in neurology therapeutics. With a track record of driving innovation, we are focused in making great progress in advancing new cutting-edge medicines into development to address severe neurological diseases for patients in need. Additionally, for the second quarter in a row, our robust late-stage phase III pipeline has expanded Roche recently initiated phase three development of Ionis FDLRX and IgA nephropathy, increasing our late stage phase three pipeline to eight drugs being developed for 10 separate indications. Our robust late stage pipeline sets us up for a steady cadence of phase three data readouts over the next few years, positioning Ionis to deliver many new important transformational products to the market for years to come. And just last week, we were pleased to announce our expanded collaboration with Novartis, demonstrating their confidence in Ionis' capabilities to create a next-generation compound, targeting LP little a as a potential follow-on to Pella-Carson, utilizing our latest cutting-edge technologies. As a reminder, Pella-Carson is in an ongoing phase three cardiovascular outcome study called LP little a Horizon, which is fully enrolled with more than 8,000 patients. The Horizon study is progressing well with data and a potential filing plan for 2025. We also recently expanded our cardiovascular franchise when we advanced our first cardiac muscle like a drug into preclinical development. This muscle targeting drug is our first to enter development utilizing our in-license bicycle technology. This achievement further highlights the potential for us to expand our drug discovery capabilities for cardiovascular and neuromuscular diseases. And importantly, we remain on track to accomplish our other key strategic goals across the business, including achieving our 2023 financial guidance. With that, I'll turn the call over to Richard to discuss our recent pipeline progress and preview upcoming key events. Next, Beth will review our second quarter and first half financial results. And then I'll wrap things up before taking your questions. Richard?