Ionis Pharmaceuticals, Inc.

Good day, and welcome to the IONIS Pharmaceuticals third quarter 2021 financial results conference call. As a reminder, this call is being recorded. And at this time, I would now like to turn the call over to Jennifer Capozzella. Please go ahead.

Thank you, Tom. 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 gap to non-gap financials. We believe non-gap 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 on this call this morning are Brett Monia, Chief Executive Officer, Beth Haugen, Chief Financial Officer, and Richard Geary, Executive Vice President of Development. And joining us for the Q&A portion of the call are Richard, sorry, Eric Swayze, Executive Vice President of Research, and Oneza Katare, Chief Corporate Development and Commercial Officer. I'd now like to draw your attention to slide three, which contains our forward-looking statement. During this call, we will be making forward-looking 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, Jen. Good morning, everybody, and thanks for joining us on today's call. In the second half of 2021, IONIS has made important progress on several fronts. We expanded our late-stage pipeline at the start of our Phase III core study of olizarcin, which we previously referred to as Ionis ApoC3 LRX. This study will evaluate olizarcin in patients with severe hypertriglyceridemia, an indication with an estimated 3 million patients or more in the United States. We completed enrollment in the Phase III neuro-transform study of eplantericin in patients with TTR polyneuropathy putting us on track for data in mid-2022. And we are on track to initiate our phase three study of donodilersin, which we previously referred to as Ionis PKK-LRX in patients with hereditary angioedema before the end of this year. We also advanced our commercial strategy and go-to-market initiatives in anticipation of phase three data readouts and potential commercial launches of these programs. Additionally, transaction with Bicycle Therapeutics. While Topherson missed the primary endpoint in the placebo-controlled phase 3 VALOR study in patients with SAD1 ALS, we are encouraged by the totality of evidence from VALOR and the open-label extension, which showed signs of slowing disease progression in these patients. Importantly, Biogen is now actively engaged with regulators and other key stakeholders to determine the next steps for this program. Biogen also plans to expand its early access program to the broader population of people living with SOD1 ALS. And given the importance of treating patients early in their disease, as reinforced by top-line data from Valor and the OLE, we are pleased that the ATLAS study in pre-symptomatic SOD1 ALS patients continues as originally planned. Coming up in the next 12 months, we're looking forward to a number of key catalysts, including our presentation summarizing the phase Doloreson in patients with hereditary angioedema at the ACAAI annual meeting on Sunday. And at our virtual Investor Day event on December 9th, we look forward to sharing our strategy, plans, and progress to bring our most advanced programs to market and achieve commercial success. Importantly, we remain financially strong, on track to achieve our financial guidance, and have the resources to meet our strategic objectives. Then Richard will discuss recent pipeline updates and upcoming pipeline catalysts. After Richard, I'll wrap up. I'll prepare remarks before taking your questions. So now over to Beth.