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5/6/2020
morning and welcome to the Ionis Pharmaceuticals first quarter 2020 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 Walks, Vice President, Investor Relations, to lead the call off. Please begin.
Thank you, Alyssa. Before we begin, I encourage everyone to go to the investor section of the Ionis website to find the press release and related financial tables. including a reconciliation of the GAAP and non-GAAP financial measures that we will discuss today. 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 our discussion today. With me on today's call are Brett Monia, Chief Executive Officer, Beth Haugen, Chief Financial Officer, and Richard Geary, Executive Vice President of Development. Additionally, Vanessa Catteray, Chief Corporate Development and Commercial Officer, and Eric Swayze, Executive Vice President of Research will join us for Q&A. I would like to draw your attention to slide three, which contains our forward-looking language statement. We'll be making forward-looking statements which 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 discussed in our SEC filings for additional detail. And with that, I'll turn the call over to Brett.
Thanks, Wade. Good morning and thank you for joining us on today's call. Our strong performance in the first quarter reflects the sustainability of our business and unwavering commitment of our team. Ionis was established to deliver transformational medicines to patients in need, which remains the foundation for everything we do. I'm proud of our dedicated employees who are going above and beyond to serve the patients who depend on our medicines. Because of the dedication of our organization, we have continued executing on our goals and have already achieved many successes across our business while effectively managing our response to the pandemic. We are approaching the rest of 2020 from a position of strength given our operational momentum and strong balance sheet. We remain on track to achieve our goals of advancing our late stage pipeline towards potential near term approvals, advancing our Iona's own pipeline broadening the reach of our technology and building our commercial capabilities. Moreover, we are reaffirming our financial guidance for this year. Now to briefly recap our recent achievements, we are pleased with the continued growth of our commercial medicine. Spenraza's strong performance continued with growth in global markets despite some impact in new patient starts and maintenance dosing from COVID-19. And both Tecseti and Wayliver maintain consistent quarterly growth with new country launches underway. Our pipeline has also continued to deliver many important successes. Enrollment in the phase three generation HD1 study of Tominersen in patients with Huntington's disease is now complete. While there's still much to do to bring this study to its planned completion, we're now one very important step closer to providing a treatment for people living with this devastating disease. The phase three program For Axia Apo little a, LRX continues to advance. Importantly, this medicine recently received fast-track designation in the U.S., reflecting the significant unmet need that exists for the millions of patients with Lp little a-driven cardiovascular disease with no approved treatment options. Additionally, earlier this year, we in Axia reported positive top-line results from Phase II proof-of-concept studies of AXIA APOC3-LRX and AXIA angiopoietin-like 3-LRX, which we will now refer to as rupinorsin. We plan to present full data from both studies later this year. We and our partners have over 40 clinical studies underway at sites around the world. While some of our studies have experienced limited disruptions, primarily in countries most impacted by COVID-19, we remain confident that the mitigation strategies we deployed early in the pandemic should minimize the impact to our clinical studies and business operations. Looking ahead, we are continuing to invest in our strategic priorities and remain on track to achieve our 2020 objectives. We at Nexia expect to initiate the Phase III study of APOC3-LRX in patients with SDS, bringing us to a total of six Phase III studies with five medicines. We're on track to refile the MDA for roid liver in the U.S., and we plan to report additional clinical proof of concept results from several programs this year. We are well positioned to achieve our goal of delivering 10 or more NDAs through 2025. I'll now turn the call over to Beth to review our financial performance, followed by Richard, who will discuss our pipeline progress, and then I'll open up the call for questions after some brief closing remarks. And now to you, Beth.
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