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8/9/2022
Good morning and welcome to the Ionis Pharmaceuticals second 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 Julie Tepper, Investor Relations, to lead off the call. Please begin.
Thank you, Betsy. 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 Richard Geary, Executive Vice President of Development. And joining us for the Q&A portion of the call are Eric Swayze, Executive Vice President of Research, Eugene Schneider, Chief Clinical Development Officer, and Oneza Katare, Chief Global Product Strategy and Operations Officer. I would like to draw your attention to slide three, which contains our forward-looking statement. 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 SDC filings for additional detail. With that, I'll turn the call over to Brett.
Thanks, Julie. Good morning, everyone, and thanks for joining us today. In the first half of this year, we moved significantly closer to delivering an abundance of transformational medicines to the market. The first half was highlighted by the positive results from the Phase III Neurotransform Study of Eplon-Tersen in patients with TTR polyneuropathy. Eplon-Tersen met the co-primary and key secondary endpoints in neurotransform. demonstrating highly statistically significant and clinically meaningful improvements in neuropathy impairment and in quality of life. Based on these positive results, we're well on our way towards filing an NDA later this year. And at the same time, me and our partner, AstraZeneca, are advancing our global go-to-market preparations to launch Eplon-Tersen for the treatment of ATTR polyneuropathy. We're also continuing to advance our ongoing CardioTransform phase three study, which we expect will enable us to move into this much larger market for patients with APTR cardiomyopathy. We in AstraZeneca are quite confident that Amplon-Tersen is well positioned to successfully compete in this space. We're also pleased that Tofersen is now under priority review with the FDA for the treatment of Sod-1 ALS. could become the first disease-modifying therapy for a genetic cause of ALS. With the PDUFA date of January 25th, 2023, Tofersen has the potential to be our next product on the market, with epontericin following shortly behind. Additionally, we continue to advance our late-stage pipeline, including completing enrollment in two of our Phase III studies. We have now fully enrolled the balanced study of olizarcin in patients with familial cholomycronemia syndrome, or SCS, making this study our next potential phase three data readout plan for next year. And Novartis also achieved full enrollment of more than 8,000 patients in the LP little a horizon cardiovascular outcome study of Pellicarson, further solidifying our first mover advantage for this important medicine. Beyond the positive data we reported from our late stage pipeline, we also reported positive data from six of our mid-stage programs so far this year. Based on positive phase two study results, our partners are planning to advance two new medicines into phase three studies next year. As a result, we expect to expand our rich phase three pipeline to at least eight medicines across 10 different indications. In addition to advancing our pipeline, we're also making excellent progress in advancing our go-to-market activities for our near-term product opportunities, Eflon Tersen, Ola Zarsen, and Donnie Velorsen. With the potential to add two new medicines to our commercial portfolio next year, along with a steady cadence of phase three data readouts in the near and midterm, we're looking forward to bringing numerous transformational medicines to the market. All of this positions us well to maximize value for patients and value for shareholders. With that, I'll turn the call over to Beth to review our second quarter financial results. Then Richard will discuss our recent key data readouts pipeline updates, and we'll preview upcoming catalysts for the rest of the year. After Richard, I'll wrap up our prepared remarks before taking your questions. Now over to Beth.
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