Ionis Pharmaceuticals, Inc.

Good morning, and welcome to IONIS Pharmaceuticals' fourth quarter and full year 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 Walk, Vice President of Investor Relations, to lead off the call. Please begin.

Thank you, Tom. 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 gap to non-gap financial measures that we will discuss today. We believe non-gap financial results better represent the economics of our business and how we manage our business. We also have 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. And joining us for Q&A are Onesa Kateray, Chief Corporate Development and Commercial Officer, and Eric Swayze, Executive Vice President of Research. I would like to draw your attention to slide three, which contains our forward-looking language statement. We will 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 details. 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. Last year marked a new beginning for Ionis. With new leadership in place, we laid out a bold new vision for the business and took important steps towards realizing our goal of having 12 or more medicines on the market in 2026. Key to our new vision is our strategy to maximize the value of each medicine in our wholly owned portfolio. Today, our focus is primarily on commercializing our rare neurological and cardiometabolic disease medicines. For those opportunities outside these core areas, we will set a course forward that maximizes the value of each medicine, which may include Ionis commercialization or partnering. Last year, we accelerated our commercial strategy by acquiring Axia. This transaction also enabled us to strengthen our organization and to recognize the full value from Exia's rich product portfolio. Further, our distribution agreement with Sobe made it possible for us to restructure our European operations, which further streamlined our business. We were able to unlock substantial resources through these transactions, which we are investing in the business in the following three key areas. First, we're advancing and expanding our Holyoke pipeline. Second, we're building our commercial capabilities in support of our rich pipeline as we prepare to launch prioritized medicines from the Ionis Holyoke pipeline. And third, we're broadening the reach of our technology through investments in medicinal chemistry, human genomics, validation of new routes of delivery, and through other means. We believe investing in these three key areas provides the greatest potential to drive future growth and to achieve our goal of 12 or more medicines on the market in 2026. Last year, we made substantial progress towards achieving this goal with numerous significant advances across our rich, late, and mid-stage pipeline. We now have six phase three studies underway, including three studies with whole new medicines. We also have a prolific mid-stage pipeline of medicines advancing towards phase three development, many of which are expected to reach pivotal trials in the near term. With so many programs in mid to later stages of development, together with our historically high rate of clinical success, today we are in the enviable position of delivering a steady cadence of phase three data readouts for many years to come. And we're especially excited about the upcoming phase three readout of the VALOR study for Tofersen in patients with SOD1 ALS, with data expected in the second half of this year. Positive results from this study would put us one step closer to providing the first-ever disease-modifying therapy for ALS. And importantly, positive Topherson results would also provide, for the first time, tangible clinical evidence that treatment is possible for patients with ALS, providing hope for all patients suffering from this devastating disease. And more broadly, Topherson's success once again demonstrates the power of our antisense technology to pioneer new markets and deliver transformational medicines to patients. In addition to advancing our pipeline, we're also expanding the utility of our technology, having now demonstrated proof of concept for aerosol delivery of antisense medicines to the lung. Based on these results, we're well on our way in building a new pulmonary disease franchise with the potential to treat conditions such as cystic fibrosis, COPD, IPF, and asthma. We've only scratched the surface of the unique capabilities of our NSS platform. With the medicines advancing in our pipeline today, we have the potential to continuously pioneer new markets in areas of significant unmet medical need and change the standards of care for diseases needing better treatment options for many years to come. As we began the year in 2020, we of course could not have imagined the challenges society would face from the global COVID-19 pandemic. Because of the dedication of our employees and strength of our technology and our business, we were able to successfully manage the evolving pandemic and achieve our key goals for 2020. This includes achieving our 2020 financial guidance while advancing our pipeline and our technology. As Beth will describe in more detail, we plan to put our substantial financial resources to work even more this year by increasing our investments in our medicines and our technology. We believe this has the greatest potential to drive future revenue and earnings growth. And with that, I'd like to turn the call over to Beth to review our 2020 financial results and our 2021 financial guidance, which is focused on maximizing the value of our wholly owned pipelines. Then Richard will discuss our key recent pipeline achievements and highlight important areas of focus for this year. After Richard, I'll wrap up. I'll prepare remarks before taking your questions. Now over to Beth.