Ionis Pharmaceuticals, Inc.

Good morning, and welcome to the Ionis Pharmaceuticals first quarter 2022 financial results conference call. As a reminder, this call is being recorded. At this time, I would like to turn the call over to Ms. Julie Tepper, investor relations, to lead off the call. Please begin, ma'am.

Thank you, Chuck. 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 a 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 this morning are Brett Monia, Chief Executive Officer, Beth Haugen, Chief Financial Officer, and Eugene Schneider, Chief Clinical Development Officer. And joining us for the Q&A portion of the call are Eric Swayze, Executive Vice President of Research, and Anaza Kateri, Chief Product Strategy and Operations Officer. I would like to draw your attention to slide three, which contains our forward-looking statements. 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 filing for additional detail. With that, I'll turn the call over to Brent.

Thanks, Julie. Good morning, everyone, and thanks for joining us on today's call. This year, we are already off to a very strong start. We continue making excellent progress in building our commercial organization, advancing and expanding our technology and moving towards delivering an abundance of new medicines to the market. This includes the great progress we're making with our near-term commercial opportunities, Eplon-Tersen, Olazarsen, and Donny-DeLorsen. The Phase III Neurotransform study of Eplon-Tersen in patients with PTR polyneuropathy remains on track for data mid-year. And working hand-in-hand with AstraZeneca, we're preparing for regulatory approval by the end of the year, assuming positive data. At the same time, we're also trying to be advancing our go-to-market preparations. We recently achieved our original enrollment goal in our CardioTransform study for patients with ATTR cardiomyopathy. And last week, we announced that we took a bold step by increasing the size and duration of our study. And in doing so, better positioning us to successfully compete in this dynamic market estimated to grow to well in excess of $10 billion. Based on these updates and our current brisk enrollment rate, we expect a modest shift in our timeline with data reading out shift, with data readout shifting from late 2024 to the first half of 2025. We also continue to advance our oligosarcin-based program in patients with high triglycerides. The BALAM study of patients with familial cardiomyocardemia syndrome, or FCS, remains on track for data next year. And the CORE study in patients with severe hypertriglyceridemia, SHTG, continues to progress with data expected in 2024. Severely elevated triglycerides is a key independent cardiovascular disease risk factor for which current standard of care therapies are in effect. With over 3 million patients in the U.S., severe hypertriglyceridemia, and our first mover advantage, we believe olizarcin represents a blockbuster opportunity for Ionis. Our Phase III OASIS HAE study with donavolarsin in patients with hereditary angioedema also continued to progress well, with data expected in 2024. We believe donavolarsin has been for HAE patients, and as a result, Donna Dolores represents a significant opportunity for us given the significant unmet medical need of these patients in this growing billion-dollar-plus market. We also made excellent progress across our rich mid-stage pipeline. AstraZeneca presented positive Phase IIb data in ACC in April from the antigen study of IM449, our PCSK9 medicine in patients who are at high risk for cardiovascular disease with hypercholesterolemia. The study managed primary and secondary endpoints, showed good safety and tolerability, and IM449 demonstrated a potential best-in-class profile. With more than 10 million patients in the U.S. who remain above their LDL-C goal, despite maximum statin and acetamide therapy, we believe IM449 could be a significant opportunity for us. Additionally, we reached full enrollment in the Phase IIb study of Ionis AGT-LRX in patients with treatment-resistant hypertension with data expected in the second half of this year. We're also evaluating Ionis AGT-LRX in a Phase II study in patients with chronic heart failure with reduced ejection fraction. These indications combined represent over 15 million patients in the U.S. alone. Despite advances in therapies, a significant need remains for more effective treatments to address treatment-resistant hypertension and heart failure. Looking ahead, we expect numerous additional catalysts highlighted by the phase 3 of Montursen data readout mid-year and our planned regulatory filing by year-end. We also expect three more phase 2B data readouts, several key study initiations, and updates on important technology advances. And with that, I'll turn the call over to Beth to review our first quarter financial results. Then Eugene will discuss our recent key pipeline updates and preview upcoming catalysts for the rest of the year. After Eugene, I'll wrap up our prepared remarks before taking your questions. Now over to Beth.