10/29/2025

speaker
Chuck
Conference Operator

Good morning, and welcome to the IONIS Third Quarter 2025 Financial Results Conference Call. As a reminder, this call is being recorded. At this time, I would like to turn the conference over to Mr. Wade Walk, Senior Vice President of Investor Relations, to lead off the call. Please begin, sir.

speaker
Wade Walk
Senior Vice President of Investor Relations

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 on the call this morning are Brett Monia, our Chief Executive Officer, Richard Geary, our Chief Development Officer, Kyle Jenea, our Chief Global Product Strategy Officer, and Beth Haugen, our Chief Financial Officer. Also joining us are Eugene Schneider, Chief Clinical Development Officer, and Eric Swayze, Executive Vice President of Research, who 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 language 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. With that, I'll turn the call over to Brett.

speaker
Brett Monia
Chief Executive Officer

Thanks, Wade. Good morning, everyone, and thank you for joining us on today's call. The third quarter was a watershed moment for Ionis as we made important progress advancing first and best in class medicines for several serious diseases, including in our core focus areas of neurology and cardiometabolic diseases. Our first independent launch for Trigulza the only FDA-approved treatment for familial chylomicronemius syndrome, or FCS, continues to build strong momentum. This performance reflects Tringolza's compelling clinical profile, strong launch execution, and the significant unmet need that we are addressing. Based on this performance and confidence in our continued success across the business, we are raising our 2025 financial guidance, including Tringolza revenues, which Beth will review in more detail shortly. Tringolza also recently received European approval, and we are pleased that our partner Sobe expects to begin bringing this transformative medicine to patients across Europe in the fourth quarter. In August, the FDA approved Donzara for hereditary angioedema, or HAE, marking our second independent launch. This is an important milestone for people living with HAE and for Ionis. I am especially proud of the launch execution by our commercial team, which Kyle will further highlight in a few moments. And in September, we reported positive top-line results from two pivotal programs from our wholly-owned pipeline, both of which were groundbreaking in their own right. Olazarsen in severe hypertriglyceridemia, or SHTG, showed highly significant reductions in triglycerides and became the first medicine ever to show a significant reduction in acute pancreatitis in this population. And in neurology, Zilgenersen showed the first ever disease-modifying effect and Alexander disease, a rare and often fatal neurologic disease. These results reinforce the strength of our science and position Ionis for two additional independent launches next year. Together, these two programs, along with Tringolza and Donzera, represent significant breakthroughs for patients and the potential for multibillion-dollar revenue for Ionis. And complementing our Rich-Holyone pipeline is our partner pipeline, which continues to progress very well. By the end of 2027, we anticipate four key launches from our partnered pipeline targeting both rare and highly prevalent life-threatening diseases. We expect these partnered programs will further expand the impact of Ionis discovered medicines and meaningfully increase total revenue for Ionis. With a strong momentum across our business, including our first two independent launches underway in advancing wholly owned late-stage pipeline and a robust partnered portfolio, IONIS is well-positioned to deliver transformative medicines for patients year after year, driving sustained growth. And with that, I'll turn the call over to Richard.

Disclaimer

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Investor presentation