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4/30/2025
Good morning and welcome to the IONIS First Quarter 2025 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, Amy. 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 that we will be discussing today. including a reconciliation of our 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, our Chief Executive Officer, Kyle Genet, Chief Global Product Strategy Officer, and Beth Haugen, Chief Financial Officer. Richard Geary, Chief Development Officer, Eugene Schneider, Chief Clinical Development Officer, Eric Swayze, Executive Vice President of Research, and Jonathan Birchall, Chief Commercial Officer, will also join us for the Q&A portion of our 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 consider 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. Before we discuss our Q1 earnings and recent progress, I want to take a moment to acknowledge the rapidly evolving environment we're living in today. Recent changes at the FDA and the introduction of new tariff policies have introduced a degree of uncertainty with the potential for disruption in our industry. Despite these external uncertainties, IONIS remains well-positioned to execute on our strategic priorities, including all of our many value-driving catalysts coming up this year and next. We remain focused on our purpose to drive meaningful value for all Iona stakeholders by successfully bringing better futures to people with serious diseases. We are executing very well against all our strategic priorities. A clear example of our ongoing successes is the completion of two strategic licensing transactions recently, which enabled us to substantially increase our 2025 financial guidance. This includes higher expected revenue in cash, along with improved operating loss. Raising guidance this early in the year reflects our confidence in our ability to continue executing well, including our ability to deliver transformational medicines to patients even amid the current volatility, and our commitment and expectation to drive long-term value for shareholders. We achieved a major milestone for Ionis with our first independent commercial launch, now successfully underway. I'm pleased to share that in its first full quarter on the market, Tringolza, the first and only FDA-approved treatment for familial chylomicronemia syndrome, exceeded expectations. This encouraging start reflects our commercial team's thoughtful planning, outstanding execution, and highlights the commercial capabilities that we have built. Right behind Tringolza is our second independent launch, Donna DeLorsen for Hereditary Angioedema, or HAE, which is rapidly approaching. The team is laser-focused on ensuring success. Donna DeLorsen has the potential to become a preferred treatment for HAE, and we remain on track to launch in the third quarter. These launches are just the beginning. We're poised to report data from two Ionis-owned Phase III programs later this year, which, if positive, will enable us to continue delivering a steady cadence of important medicines to even more patients. These are a second indication for Olazarsen, severe hypertriglyceridemia, or SHCG, a large population with high and mid-need, and Zilganersen for Alexander disease, a severe, rare leukodystrophy with no approved therapies. Collectively, these four programs represent needed patient breakthroughs and multibillion-dollar revenue potential for Ionis. Additionally, in the next three years, we expect four launches from our late-stage partnered medicines currently in development to treat a range of serious life-threatening diseases. These medicines are poised to significantly increase our revenues by expanding the reach of Ionis-discovered medicines to more patients that are in need. With the recent launch of Tringolza and our upcoming independent and partner launches, IONOS is on a path to bring important medicines to patients for years to come, positioning us to achieve substantial and sustained revenue growth and positive cash flow. With that, I'll turn the call over to Kyle.
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