Ionis Pharmaceuticals, Inc.

Good morning and welcome to the IONIS third quarter 2023 financial results conference call. As a reminder, this call is being recorded. At this time, I would like to turn the call over to Mr. Wade Walk, Senior Vice President of Investor Relations, to lead off the call. Please begin, sir.

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 this morning are Brett Monia, Chief Executive Officer, Oneza Katare, Chief Global Product Strategy and Operations Officer, Richard Geary, Chief Development Officer, and Ben Haugen, Chief Financial Officer. Eric Swayze, Executive Vice President of Research, and Eugene Schneider, Chief Clinical Development Officer, will also 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 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 SEC filings for additional details. With that, I'll turn the call over to Brett.

Thanks, Wade. Good morning, everyone, and thanks for joining us on today's call. Since taking the helm at Ionis nearly four years ago, we have executed on a strategy to deliver next-level value, and we have done so with a clear vision and laser focus on our strategic objectives to bring our medicines directly to patients, build our wholly-owned pipeline, and to extend our leadership in oligonucleotide therapeutics. Our successes this year, which are a direct result of our efforts in these key areas, move us closer to achieving our ultimate goal to deliver a steady cadence of new transformational medicines to patients and to generate next-level value for all Iona stakeholders. We are on the cusp of delivering our near-term commercial medicines to patients, starting with the first potential approval of epilontersin this year. We and our co-commercialization partner, AstraZeneca, are prepared to launch Eplon-Tersen following U.S. approval. We're also executing on a global regulatory strategy with potential approvals in the EU and Canada next year. Additional filings are also planned, positioning us for a steady cadence of approvals around the world. We recently achieved another of our key objectives for Eplon-Tersen with the publication of a comprehensive review of the Phase III Neurotransform study results in JAMA. Publishing our results in a highly respected journal like JAMA reflects the importance of our Phase III neurotransform study for the treatment of ATTR polyneuropathy and showcases the strength and quality of our results. Based on its strong overall profile, including highly positive Phase III data, together with the freedom of a simple at-home monthly self-administration profile, we believe Eplon-Tersen is well-positioned to become the therapy of choice for ATTR patients who remain underserved by current therapies. Falling closely behind Eplon-Tersen are Olazarsen and Donny-Delorsen, our wholly-owned near-term commercial opportunities. We were very pleased with the positive top-line data we reported last month from our Olazarsen Phase III balance study in patients with FCS. Olazarsen showed significant triglyceride reductions, which was the study's primary efficacy endpoint, along with a favorable safety and tolerability profile. But most importantly for patients, Olazarsen demonstrated substantial reductions in acute pancreatitis events, making Olazarsen the first lipid-lowering therapy to achieve this result in a clinical setting. With these highly positive results, we are on track to file for marketing approval in the U.S. and EU early next year, positioning Olazarsen for its first potential approval as early as the end of next year, assuming priority review in the U.S. We also continue to be encouraged by the performance of donidolorsin, our medicine for the prophylactic treatment of HAE. We recently reported two-year open-label extension data, which demonstrated favorable safety and tolerability, along with durable and sustained protection against HAE attacks, consistent with the previously reported one-year OLE results and our Phase II results. We are getting closer and are looking forward to our Phase III readout with data expected in the first half of next year for donidolorsin. We also made significant progress recently in further strengthening our wholly-owned neurology pipeline by advancing Zilgenersen, our treatment for Alexander disease, into Phase III development. Advancing Zilgenersen further expanded our rich Phase III pipeline to a total of nine drugs in development for 11 separate indications. And importantly, we remain on track to accomplish our other key strategic goals across the business, including achieving our 2023 financial guidance. With that, I'll turn the call over to Ineza to discuss our expectations for the Epon-Thurston launch and to briefly review the status of our go-to-market activities for Olizarsen and Donny Dolorsen. After Ineza, Richard will discuss our recent pipeline progress. And after that, Beth will review our third quarter financial results. And then I'll wrap things up before taking your questions. And with that, over to Ineza.